Date: February 25, 1999
In the Case of:
A PRO Home Health Care Agency,
Petitioner,
- v. -
Health Care Financing Administration.
Docket No. C-98-095
Decision No. CR578
I decide that the Health Care Financing Administration (HCFA) correctly determined to terminate Petitioner's participation in the Medicare program. In this case, HCFA asserted that Petitioner failed to comply with four conditions of participation in the Medicare program; 42 C.F.R. �� 484.14, 484.18, 484.30, and 484.32. I find that the preponderance of the evidence is that Petitioner did, in fact, fail to comply with these four conditions of participation.
I. Background
A. Applicable Law and regulations
Petitioner is a home health agency that participates in the Medicare program. The services provided by home health agencies that are covered by the Medicare program are described in section 1861(m) of the Social Security Act (Act). The statutory requirements of participation for a home health agency are described in section 1861(o) of the Act.
The Secretary of the Department of Health and Human Services (Secretary) has published regulations which govern the participation in the Medicare program of home health agencies. These regulations are contained in 42 C.F.R. Part 484. The regulations which define the Secretary's requirements for Medicare participation for home health agencies establish conditions of participation for those agencies. 42 C.F.R. � 484.10 - 484.52. The regulations express these conditions of participation as broadly stated participation criteria. For example, 42 C.F.R. � 484.18 states as a part of the condition of participation contained in that regulation that care provided to patients by a home health agency must follow a written plan of care(1) that is established and periodically reviewed by a physician.
The regulations also state standards of participation as subsidiary components of the conditions of participation. For example, in 42 C.F.R. � 484.18, there are specific standards governing: what a plan of care must contain (42 C.F.R. � 484.18(a)); who must review a plan of care (42 C.F.R. � 484.18(b)); and how a physician's orders, prepared pursuant to a plan of care, are to be made, issued, and carried out, (42 C.F.R. � 484.18(c)).
The Secretary is required to determine whether a participating Medicare provider, including a home health agency, is complying substantially with Medicare participation requirements established by the Act and the regulations. Section 1866(b)(2) of the Act. The Secretary may terminate a provider's participation in the Medicare program if the Secretary finds the provider is not complying substantially with participation requirements. Section 1866(b)(2)(A) of the Act.
The process and criteria for determining whether a provider is complying substantially with Medicare participation requirements are established by regulations contained in 42 C.F.R. Part 488. Pursuant to the Act and regulations, the Secretary has entered into agreements with State survey agencies to conduct periodic surveys of Medicare providers, including home health agencies, in order to ascertain whether these providers are complying with Medicare participation requirements. Section 1864(a) of the Act; 42 C.F.R. �� 488.10, 488.11, 488.20.
In determining whether there has been compliance with a particular condition of participation, a State survey agency evaluates the manner and degree of the provider's compliance with the various standards within each condition. 42 C.F.R. � 488.26(b). The State survey agency documents its findings in a HCFA Form 2567, which is given to the provider after completion of the survey. The State survey agency makes a recommendation to HCFA as to whether there is a basis for termination, which HCFA may accept or reject after reviewing the findings of the survey.
HCFA may terminate a provider's participation in the Medicare program if HCFA determines, either on its own initiative or based on a survey report from a State survey agency, that the provider is not complying with one or more Medicare conditions of participation. Failure to comply with a condition of participation occurs where deficiencies, either individually or in combination, are --
. . . of such character as to substantially limit the provider's . . . capacity to furnish adequate care or which adversely affect the health and safety of patients . . .
42 C.F.R. � 488.24 (b).
Where HCFA determines that there is a deficiency, but that the deficiency is not so severe as to constitute a condition-level deficiency, then HCFA may not terminate the provider's participation in the Medicare program without first affording the provider the opportunity to correct the deficiency. 42 C.F.R. � 488.28.
Termination of participation is a remedy intended to protect the health and safety of program beneficiaries and not a punishment. Termination of participation should be invoked in the circumstances where a provider's deficiencies establish that the provider is substantially incapable of providing care consistent with Medicare participation requirements. Termination should not be invoked unless the evidence proving a provider's failure to comply with participation requirements establishes that the provider cannot provide care consistent with that which is required by the Act and regulations.
CSM Home Health Services, DAB CR440, at 3 (1996).
Finally, under section 205(b) of the Act, I hear this case de novo. Individuals and entities entitled to hearings under section 205(b) include providers who are adversely affected by certain determinations made by HCFA. Act, sections 1866(b)(1)(2), 1866(h)(1). Section 205(b) requires that a hearing conducted by the Secretary (who, in this case, has delegated the authority to hear and decide the case to me) be a full evidentiary hearing, and that the final decision is to be based exclusively on the evidence adduced at hearing. This final decision is made independent of HCFA's determination. Howard Schreibstein, D.P.M., DAB CR517, at 5 - 9 (1998).
B. Burden of Proof
The burden of proof in this case is governed by the decision of an appellate panel of the Departmental Appeals Board in Hillman Rehabilitation Center, DAB No. 1611 (1997). Under Hillman, HCFA bears the burden of coming forward with evidence sufficient to establish a prima facie case that Petitioner failed to comply with participation requirements. Petitioner has the burden of proving, by a preponderance of the evidence, that it complied with participation requirements. In determining whether HCFA has met its burden of establishing a prima facie case, I may consider rebuttal evidence offered by Petitioner that HCFA's evidence is neither credible nor relevant to the issue of Petitioner's compliance with participation requirements, or that the weight of the evidence establishes that the regulatory deficiency alleged by HCFA did not occur. Hillman Rehabilitation Center, DAB CR500, at 3 - 8 (1997). If I conclude that the preponderance of the evidence establishes that such circumstances exist, then I will find that HCFA has not met its burden of establishing a prima facie case (but rather its case is based on unsubstantiated allegations) and Petitioner will not be obligated to prove that it was complying with participation requirements.(2)
C. History of this case
Petitioner operated a home health agency in Houston, Texas, with offices in Beaumont and Texas City, Texas. On September 25, 1997, Lynnae Schatz, R.N., B.S.N. (Schatz) and Jean Ann Reynolds, R.N. (Reynolds), surveyors employed by the Texas Department of Health (State survey agency) and Thelma McGee, R.N., B.S.N. (McGee), a surveyor employed by HCFA, completed a revisit (also called a follow-up) survey of Petitioner. HCFA Exhibit (Ex.) 1, 2. These surveyors prepared a Statement of Deficiencies (HCFA Form 2567) which was forwarded to HCFA for review. Id. The HCFA Form 2567 reflected the surveyors' determination that four conditions of participation were out of compliance. By letter dated October 15, 1997, HCFA informed Petitioner it was in agreement with the surveyors' findings and that Petitioner did not meet the requirements for participation in the Medicare program, due to non-compliance with Medicare conditions of participation. Specifically, HCFA found Petitioner out of compliance with the following four conditions of participation: 42 C.F.R. � 484.14 Organization, Services and Administration; 42 C.F.R. � 484.18 Acceptance of Patients, Plan of Care, and Medical Supervision; 42 C.F.R. � 484.30 Skilled Nursing Services; and 42 C.F.R. � 484.32 Therapy Services.
HCFA informed Petitioner also that its Medicare participation agreement would be terminated on November 15, 1997. HCFA Ex. 1, at 5. However, termination of Petitioner's Medicare participation agreement was preliminarily enjoined by the United States District Court, Southern District of Texas, Galveston Division, on November 6, 1997, based on Petitioner's claim of racial discrimination.(3)
HCFA has appealed the District Court's decision to the Fifth Circuit Court of Appeals, but, as far as I know, the Court has not yet ruled on its appeal. Thus, Petitioner's Medicare participation agreement has not yet been terminated.
Petitioner timely requested a hearing, and the case was assigned to me for hearing and decision. I agreed with Petitioner's arguments that the hearing should proceed pending the appeal. The hearing was held in Houston, Texas, from August 7 - 11, 1998. At the hearing, I admitted into evidence: HCFA Ex. 1 - 9, 11, 12 (pages (pps.) 1 - 4), 13 - 16, 18 - 21, 24 - 27, 29 - 30, 32 - 34, 36 - 38, 40 - 41, 44, 45 (pps. 1, 7 - 8, 10, 15, 23, 26 - 27, 31, 35 - 36, 38, 44, 59, 63 - 67, 69 - 73, 75 - 76, 83 - 84, 87 - 88, 104 - 106), 46 - 47, and 49; and Petitioners Exhibits (P. Ex.) 1 (pps. 21 - 22, 42, 65 - 75), 2 (pps. 457 - 460), 3 (pps. 740 - 740A), 4 (pps. 1681, 1705), 5 (pps. 2335 - 2336, 2346), 6 (pps. 2844 - 2845, 2853), 7 (pps. 3317, 3450, 3455), 8 (pps. 4093 - 4096), 9 (pps. 4475 - 4476), 10 (pps. 4682 - 4683, 5061 - 5062, 5064 - 5066), 11 (pps. 5156 - 5157, 5167, 5176 - 5177, 5180 - 5181, 5185 - 5187), 12 (pps. 5353 - 5354), 13 (pps. 5987 - 5988), 14 (pps. 6823 - 6824, 6826), 17, 22, 26, 28, 29 (pps. 1 - 6), 30 - 31.(4)
Following the hearing, the parties submitted posthearing briefs and reply briefs. I base my decision in this case on the governing law, the evidence I received at hearing, and on the parties' arguments as expressed in their briefs.(6)
D. HCFA's procedural argument
In its response brief, HCFA for the first time raised a legal argument, in that it asserted that Petitioner preserved for appeal only those issues set out in its initial request for hearing and that any other issues raised by Petitioner are untimely, improperly raised, and must be disregarded. The recent decision of an appellate panel of the Departmental Appeals Board in Birchwood Manor Nursing Center, DAB No. 1669 (1998) makes clear that the hearing request submitted by a petitioner pursuant to 42 C.F.R. � 498.40(b) establishes the parameters for the administrative hearing. It is based on such notice (and any subsequent amendments allowed by the administrative law judge) that HCFA and the administrative law judge know what issues are to be addressed at the hearing.(7) I agree with the reasoning of the appellate panel that absent such notice either prehearing or during the hearing, HCFA would not have a fair opportunity to be heard on such issues nor would the administrative law judge have sufficient information to rule on the relevancy of evidence offered at the hearing. To allow Petitioner to broaden the issues beyond which it provided notice at this point, would unduly prejudice HCFA and unnecessarily delay the resolution of its appeal. Petitioner had ample opportunity to raise new issues earlier in the proceeding, but did not do so. The only affirmative defenses which I will address in my decision are the ones Petitioner raised prior to its posthearing briefing: racial bias; allegations of fabricated complaints; HCFA's alleged failure to accept a corrective action plan; and HCFA's alleged failure to resurvey Petitioner after completion of the survey in issue. However, I make one exception for the issue of random selection. This argument was aggressively made by Petitioner at the hearing and HCFA was given an opportunity to respond. Thus, as to this issue, Petitioner gave adequate notice of an amended issue and HCFA was given an opportunity at the hearing to respond. I address it below also.
E. Petitioner's affirmative defenses
The numbered paragraphs set out in italics, and any subheadings thereunder, are my findings of fact and conclusions of law (Finding(s)). The descriptive text under each heading is my rationale for such determinations.
1. There is no basis upon which to invalidate the September 1997 survey based on any violation by the surveyors of the random selection of patient records.
2. The patient records selected by the surveyors involved in the September 1997 survey provide a sufficient basis for me to determine whether Petitioner's deficiencies are of such a character as to substantially limit its capacity to furnish adequate care or which adversely affect the health and safety of patients.
Random selection: Petitioner has argued here that the surveyors did not follow the correct process for selecting patient charts. I find, however, that whether or not the process the surveyors followed was correct or consistent with the State Operations Manual (SOM)(8)
is irrelevant. As I stated in the case of CASHA Resource Home Health & Hospice, Inc., DAB CR472 (1997), the hearing in this case is, by law, de novo (see my discussion, supra, at page 3). Act, section 205(b). In deciding Petitioner's appeal, I must make an independent evaluation of whether the applicable regulatory provisions and the record before me support HCFA'S determination. Since the parties have had the opportunity to fully argue and present all relevant evidence supporting their positions, the prior processes that led to HCFA's action are not at issue before me. Thus, these processes have nothing to do with whether, for the patients under consideration here, Petitioner was complying with the Medicare conditions of participation under the criteria established in section 488.24(b) of the regulations. I must decide this case on its merits, not in terms of the procedures HCFA or the surveyors followed in making the determination. Petitioner's argument here does not provide a basis to invalidate the survey.
However, even if I were not conducting an independent evaluation of the evidence, I would still find that Petitioner's argument does not provide a basis to invalidate the survey. The SOM provides for three types of surveys: a "standard" survey (conducted to determine the quality of care and services furnished by the home health agency as measured by indicators of medical, nursing, and rehabilitative care); a "partial extended" survey (conducted when standard level deficiencies are found during a standard survey and it is suspected that a more comprehensive review would determine condition level deficiencies, or to determine if other standard or condition level deficiencies are present which were not examined in the standard survey); and an "extended" survey (conducted to review and identify policies and procedures that produced substandard care identified under the standard or partial extended survey). SOM, section 2196; HCFA Ex. 47, at 29 - 30. The SOM also provides for a "follow-up" survey to verify corrections of deficiencies previously cited on a HCFA Form 2567. SOM, section 2732; HCFA Ex. 47, at 20.
When conducting a standard survey, the surveyors are to use, to the extent practical (emphasis added), a case-mix, stratified sample of clinical records of a home health agency's patients where the patient sample is: randomly drawn; includes a range of primary admitting diagnoses (stratification); and represents patients who are receiving various kinds of services (case mix). SOM, section 2200; HCFA Ex. 47, at 26 - 28. When conducting a follow-up survey, however,
the requirements are less structured. Surveyors can use documentation or onsite verification to determine whether a deficiency cited during a previous visit has been corrected. SOM, section 2732; HCFA Ex. 47, at 20.(9)
I find in this case that this survey was a follow-up survey. Petitioner had previously been found out of compliance with participation requirements, had completed a plan of correction, and failed to achieve compliance when the surveyors completed their review of the corrective action. See HCFA Ex. 1, 2. Thus, the requirements for case mix and stratification are not as stringent (although I note again that, even for a standard survey, the requirements are only to be utilized "to the extent practical," SOM, section 2200; HCFA Ex. 47, at 28) and are not a basis to invalidate the survey.
Moreover, even under section 2200, there is no special requirement for how the sample is to be drawn. The SOM merely requires the surveyor to meet with the home health agency staff to develop, as simply as possible and in the shortest period of time, a survey sample to meet the criteria that the sample be randomly drawn, stratified and case mixed. SOM, section 2200; HCFA Ex. 47, at 27. There is no requirement that, for a home health agency with multiple locations, a certain number of samples must be drawn from each location (as Petitioner would argue here, in that the majority of the patients sampled came from only one of Petitioner's three locations).
According to Petitioner's Director of Nursing, Alice Miles, during the survey, the surveyors asked for Petitioner's active patient rosters for Petitioner's three locations, which rosters were provided; from Petitioner's Beaumont location on the day the roster was requested and from its Houston and Texas City locations the following day. Tr. at 646 - 649. Although the rosters did not contain any information regarding the patients' diagnosis or services, that is the only information Petitioner gave the surveyors from which to pick a sample. The surveyors asked for 12 files from Beaumont (Tr. at 652) and three others from Petitioner's other two locations (the surveyors need 11 to do a valid standard survey, although they do not need any specific number for a follow-up (Tr. at 742 - 743)). Three of the patients selected were identified in complaints. Tr. at 722. The other patients were selected at random from the list. Id. Petitioner implies that these patients were somehow improperly selected. However, Petitioner has presented no evidence to prove its allegation. There is nothing wrong with the surveyors reviewing patient charts where a complaint has been tendered (in fact, they must) and there does not appear to be any evidence that the choice of the other patient samples was anything other than picking names off of patient rosters. Petitioner argues that another surveyor, Angela Madole, was instrumental in impermissibly selecting patients to be sampled. However, as I discuss below (under Racial Bias) there is no credible evidence to support Petitioner's claim.
It appears here that the surveyors received patient rosters from Petitioner, then chose the names of three patients who had been the subject of complaints and 12 others off the rosters. While the surveyors may not have had information regarding the patients' conditions and services, I do not believe, on a follow-up survey, that this is necessary. Further, even on a standard survey, such selection need only be done where practicable. I note also that, in my consideration of each of the deficiencies, the patients have a wide variety of health conditions and receive numerous different services from Petitioner, including skilled nursing services, home health aide services, and occupational and physical therapy services. I find no evidence or basis upon which to invalidate the survey based on any violation of random selection. Moreover, I find that the patient records selected by the surveyors provide a sufficient basis for me to determine whether Petitioner's deficiencies, which I have found to exist (see my examination of Petitioner's deficiencies below), are of such a character as to substantially limit Petitioner's capacity to furnish adequate care or which adversely affect the health and safety of patients. 42 C.F.R. � 488.24(b).
3. There is no evidence of racial bias on the part of the surveyors engaged in the September 1997 survey and no evidence that racial bias played any role in HCFA's decision to terminate Petitioner's Medicare participation agreement.
Racial bias: Petitioner has asserted essentially that the surveyors engaged in a racially motivated conspiracy to put Petitioner out of business. However, after carefully considering all the evidence of record, I find no evidence of racial bias on the part of the individuals engaged in the September 1997 survey and no evidence that racial bias played any role in HCFA's decision to terminate Petitioner's Medicare participation agreement.
Petitioner has asserted the following to bolster its argument: 1) Petitioner is a black-owned and operated home health agency; 2) no African-Americans worked on the September 1997 survey; 3) the surveyors' supervisor is white; 4) during a survey of another home health agency Ms. Schatz, when told of potential violations by a white nurse, did not respond to the individual reporting the white nurse and did not report the white nurse to the Board of Nursing Examiners; and 5) during a telephone conversation, Ms. Angela Madole(10) asked the employee of a physician what race the physician was. Petitioner's Posthearing Brief (P. Br.) at 17 - 18. None of these assertions lead me to the conclusion that racial bias played any role in HCFA'S decisions regarding Petitioner. Instead, I agree with HCFA that absent from Petitioner's argument is evidence, such as testimony by a nurse, aide, administrator, or other employee of Petitioner, regarding statements made or actions taken by Ms. McGee, Ms. Schatz, or Ms. Reynolds, the surveyors actually conducting the survey, during this September 1997 survey, which would suggest that racial bias played a role in the findings of the September 1997 survey or the decision to terminate Petitioner's Medicare participation agreement.
Petitioner has asserted that Ms. Madole is racially biased and that her bias is shown by her having made an anonymous complaint during the September 1997 survey (which complaint was investigated by the surveyors during the survey),(11) by her comments to the physician's employee, and by Petitioner's allegation that Ms. Madole preselected the patients to be surveyed. While it is true that the State surveyors did examine the records of one patient, Patient 7, based on Ms. Madole's complaint, I have found no persuasive evidence (either in the record of this case, or in my in-camera review of documents Ms. Madole compiled during her unrelated audit of Petitioner) which would lead me to believe that Ms. Madole influenced the selection of any of the other case files examined by Ms. Schatz, Ms. Reynolds, or Ms. McGee, or exercised any control over or influenced the results of the September 1997 survey. While Ms. Madole did file the complaint regarding Patient 7, did work with Ms. Reynolds and Ms. Schatz, and may have talked with, had lunch with, or taken a break with Ms. Reynolds or Ms. Schatz during the period of and surrounding the survey (P. Br. at 14) this does not in any way prove that she preselected the patient roster, improperly influenced the survey, or is otherwise biased against Petitioner.
I note here that Ms. Madole's testimony during the survey was not consistent. However, I do not believe that her credibility affects my decision here. Ms. Madole was involved in this case only tangentially and to the extent that she made an anonymous patient complaint concerning Patient 7. The evidence presented that she may have sought to review the charts of two other patients on the roster I do not find credible because I do not believe the testimony of the witness, Beverly Adjei, to be enough to support Petitioner's allegation. See P. Br. at 16. However, I do not have to resolve the question of Ms. Madole's credibility in order to reach my decision here. Her involvement in this case was limited to making an anonymous complaint regarding Patient 7. HCFA did not rely on any evidence concerning Patient 7 at hearing, and I have not considered Patient 7 in making my decision here.
I find also the credibility of the surveyors to be intact. From their testimony, I am satisfied that Ms. Madole's limited participation in the survey did not affect the outcome of the survey or HCFA's conclusion that Petitioner's provider agreement should be terminated.
Fabricated complaints: In its request for hearing, Petitioner claimed, in item 7 of its list of contentions, that "A PRO believes most, if not all, alleged patient complaints used by surveyors to further their findings were fabricated (i.e. one such complaint was from a deceased person)." As pointed out by HCFA (HCFA Reply Brief (R. Br.) at 4), Petitioner offered no evidence or testimony at the hearing to support this contention, nor did Petitioner argue this point in its posthearing brief. As Petitioner apparently has abandoned this contention, I am not addressing it in this decision.
HCFA's failure to accept a corrective action plan: Again, Petitioner offered no evidence or argument to support this position at the hearing or in its briefs. Thus, as Petitioner apparently has abandoned this contention, I am not addressing it in this decision.
HCFA's failure to resurvey Petitioner subsequent to the survey in issue here: Petitioner did not argue this position at the hearing or in its briefs. Thus, as Petitioner apparently has abandoned this contention, I am not addressing it in this decision.
II. The alleged deficiencies
Below, I evaluate each of the deficiencies identified by the surveyors and adopted by HCFA. In my analysis of each deficiency, I must determine whether, for each deficiency, HCFA has established a prima facie case that a deficiency existed. If HCFA has put together this prima facie case, I must then determine whether Petitioner has successfully rebutted HCFA'S prima facie case and proved, by a preponderance of the evidence, that no deficiencies existed which caused it to be out of compliance with the conditions of participation. Finally, if, after evaluating all the evidence, I find that one or more deficiencies existed, I must determine whether such deficiency or deficiencies rise to a level of a condition of participation (and not just a standard within the condition of participation) which would support termination of Petitioner's participation in the Medicare program.
I use the following format for my Decision. The conditions and standards at issue, as set forth in the HCFA Form 2567, are set forth in boldface. As I stated above, the numbered paragraphs set out in italics, and any subheadings thereunder, are my findings of fact and conclusions of law (Finding(s)). The descriptive text under each heading is my rationale for such determinations.
I will address each alleged deficiency in the order that the deficiencies appeared on the HCFA Form 2567.(12) Each of the statements describing the alleged deficiencies are taken verbatim from the HCFA Form 2567 completed by the surveyors. I am taking this approach as the HCFA Form 2567, along with HCFA's October 15, 1997 termination notice, provide the only formal notice, as set forth in Hillman, of the deficiencies Petitioner needed to contest at the hearing. If the deficiency was not raised by HCFA in such documents, and if the deficiency cannot be reasonably extrapolated from such documents, then Petitioner has not received adequate notice and cannot be held accountable for failing to demonstrate compliance with any unnoticed deficiency.
Part One of my discussion concerns Petitioner's alleged failure to comply with the condition of participation set forth in 42 C.F.R. � 484.14; Part Two concerns Petitioner's alleged failure to comply with the condition of participation set forth in 42 C.F.R. � 484.18; Part Three concerns Petitioner's alleged failure to comply with the condition of participation set forth in 42 C.F.R. � 484.30; and Part Four concerns Petitioner's alleged failure to comply with the condition of participation set forth in 42 C.F.R. � 484.32.(13)
Part One
The surveyors summarized Petitioner's failure to comply with the condition set forth at 42 C.F.R. � 484.14 as follows:
G 123 484.14 CONDITION: ORGANIZATION, SERVICES & ADMINISTRATION
CONTINUING DEFICIENCY CONDITION NOT MET
The administrator failed to organize and direct the agency's ongoing functions. The administrator failed to employ qualified staff. Patient care was not
coordinated.
HCFA Ex. 2, at 3.
Under this condition of participation, the surveyors alleged four standard-level deficiencies at G Tags 134, 143, 144, and 145 of the HCFA Form 2567.
G 134 484.14(c) STANDARD: ADMINISTRATOR: The administrator, who may also be the supervising physician or registered nurse required under paragraph (d) of this section, employs qualified personnel and ensures adequate staff education and evaluations.
Based on a review of the clinical records and personnel records, the surveyors determined that Petitioner's administrator failed to employ qualified staff. The surveyors alleged that the staff were not able to identify and demonstrate accurate classification of medications for patients. The surveyors alleged also that Petitioner utilized a medication profile which included the action, side effects, and interactions of medication based upon the medication classification and at times such profile was inaccurate.
4. For Patients 5, 10, 14, and 2, HCFA has not presented a prima facie case that Petitioner's administrator failed to employ qualified personnel.
Patient 5
The surveyors made the following assertion regarding Patient 5:
This patient was on enteric coated aspirin. On 090997, the registered nurse classified this medication as an anti-convulsant. Aspirin is used [as] an anticoagulant, antipyretic, analgesic and/or anti-inflammatory.
HCFA Ex. 2, at 7.
A medication profile is a teaching tool for patients, providing them with information about their medications. Tr. at 61. Petitioner utilized a medication profile form for this task containing classifications (represented by letters of the alphabet) which provided information about various types of medications, such as side effects and contraindications. HCFA Ex. 4 - 7. The record reflects that on a September 9, 1997 medication profile form for Patient 5, Petitioner's nurse incorrectly classified enteric coated aspirin as an anti-convulsant. HCFA Ex. 4, at 1 - 2; Tr. at 61. An anti-convulsant on the form in question is classified as an "O" and an anticoagulant is classified as an "N." After the September 25, 1997 survey, the "O" classification was crossed out and the classification was changed to an "N." HCFA Ex. 4, at 1 - 2. However, I find that it is immaterial that a nurse may have corrected the classification subsequent to the hearing. HCFA's decision to terminate must be evaluated on the basis of the conditions prevailing at the time of the survey. Carmel Convalescent Hospital, DAB CR389 (1995), aff'd in part and rev'd in part, DAB No. 1584 (1996), as cited in Prescribed Care, Inc., DAB CR492, at 6 (1997). Here, the nurse incorrectly classified the drug.
Patient 10
The surveyors made the following assertion regarding Patient 10:
Mexilitene was classified as an antineoplastic. It is an antiarrhythmic. Norvasc was classified as an antineoplastic. It is an antihypertensive.
HCFA Ex. 3, at 7.
The record reflects that on Patient 10's medication profile form of September 4, 1997, Petitioner's nurse incorrectly classified these two medications. HCFA Ex. 5, at 3 - 4; Tr. at 81 - 83. Specifically, Petitioner's nurse classified the Mexilitene and Norvasc as "S" (which stood for antineoplastic) instead of the appropriate alphabetical classification. Id. Petitioner argues that a change in medication profile forms caused the error. P. Br. at 26. However, there is nothing of
record to support Petitioner's contentions, in that there is no evidence as to when Petitioner changed its medication profile forms or to confirm that two different medication profile forms were used interchangeably for weeks.
Patient 14
The surveyors made the following assertion regarding Patient 14:
The medications Hydrocodone 5/500 and APAP with codeine were both classified as being a sedative/hypnotic. APAP with codeine is actually Tylenol or acetaminophen with codeine. Both of these medications would be considered to be a narcotic analgesic.
HCFA Ex. 2, at 8.
Petitioner admits that the nurse made a clerical error in the classification of these drugs, labeling them as "FF" (sedative/hypnotics). P. Br. at 27; HCFA Ex. 6, at 1 - 2. Petitioner argues, however, that the nurse understood the use of the drugs and knew the proper instructions to give the patient. Id. Moreover, Petitioner argues that, although the drugs are technically analgesics, they both have sedative effects. P. Br. at 26. I note that, although the medication profile form used by Petitioner did not include a classification for a narcotic analgesic, it did leave blank spaces for the nurse to write in medications not already listed and assign them an alphabetic classification. The nurse should have done so rather than misclassify the drug.
Patient 2
The surveyors made the following assertion regarding Patient 2:
This patient was on 2 medications. Verapamil was classified as an antacid. Mulitvitamin was classified as an cholinergic. Verapamil is an antianginal and Multivitamin is a vitamin.
HCFA Ex. 2, at 8.
Petitioner does not dispute that these medications were improperly classified. Petitioner asserts instead that it had changed its medication profile forms and argues that if the appropriate classification form had been used the medications would have been properly identified. Again, however, there is no evidence of record that at the time of the survey two different medication classification forms were being used. HCFA Ex. 7, at 1 - 2.(14)
I have found for each of the four patients above that Petitioner's nurses incorrectly classified certain medications on medication profile forms. However, I do not believe these miss-classifications violate the standard, as alleged by HCFA, based on the HCFA Form 2567. The question here is whether the administrator failed to employ qualified personnel, not whether classification mistakes were made. The best evidence of nurses' qualifications is their education and experience. HCFA presented no evidence regarding Petitioner's nurses' education and experience. Instead, HCFA relies on secondary evidence of the deficient classification of drugs to establish the existence of this deficiency. Such a showing is too remote and tangential to the specific regulatory deficiency cited in the HCFA Form 2567. While the deficiencies may raise an inference that the employees lacked qualifications, I note that the same argument could be made about every deficient practice cited in the HCFA Form 2567, and HCFA did not make such argument. Moreover, to meet its prima facie case, HCFA had the obligation to establish by credible evidence what the proper qualifications are for Petitioner's personnel. Only after that showing has been made can a conclusion be drawn as to whether a particular employee lacked the proper qualifications. Here, HCFA failed to offer any proof on the requisite qualifications for the employees in question. Consequently, any inference that may be drawn from this deficiency is meaningless, since it cannot be compared to a particular required qualification.
G 143 484.14(g) STANDARD: COORDINATION OF PATIENT SERVICES: All personnel furnishing services maintain liaison to ensure that their efforts are coordinated effectively and support the objectives outlined in the plan of care.
Based on clinical record reviews and telephone interviews with patients, the surveyors determined that all personnel furnishing services failed to maintain liaison to ensure that efforts were coordinated.
5. For Patients 5, 8, 6, 3, 10, 13, 14, 2, and 11, Petitioner failed to assure that all personnel furnishing services to these patients maintained liaison to ensure that their efforts were coordinated, a violation of 42 C.F.R.. � 484.14(g).
Patient 5
The surveyors made the following assertions concerning Patient 5:
The medical social worker visited the patient on 073197 and discharged the patient as medical social worker goals had been met. The plans of treatment of 081497 - 101497 and 101597 - 121597 indicated that medical social worker visits were ordered and contained the same goals for the medical social worker visits as the plan of treatment from
the period 061397 - 081397. The goal for the medical social worker for every certification period was understand and utilize community resources.
The agency policy was that case conferences were to be conducted every two weeks. The last case conference on the clinical record was December 1996.
HCFA Ex. 2, at 10.
Two separate deficiencies have been identified here. One involves whether the medical social worker discharge was adequately coordinated with Petitioner's other personnel, and the other involves an alleged lack of case conferences regarding Patient 5.
Deficiency 1: HCFA presents persuasive evidence that the medical social worker discharge was not adequately coordinated with other personnel caring for Patient 5. On July 31, 1997, the medical social worker discharged Patient 5. HCFA Ex. 8, at 8. Despite the discharge, two subsequent plans of care contained the same medical social worker goals. HCFA Ex. 45, at 7. These subsequent plans of care, continuing a service which was deemed no longer necessary, reflect a lack of coordination between Petitioner's personnel who were caring for Patient 5. Petitioner's argument that the continuation of the medical social worker services was on an as needed basis does not address the basic underpinning of this deficiency, which is that the services were deemed no longer necessary as the patient goals had been met and there was a discharge. I sustain the deficiency.
Deficiency 2: The second deficiency involves case conferences. Agencies utilize case conferences as one of the tools by which they can coordinate services. Petitioner's policy and procedures manual mandated that case conferences were to be conducted every two weeks, and Petitioner had a form to memorialize such conferences. Tr. at 125 - 127. The surveyors documented that the last case conference for Patient 5 was held in December 1996, nine months prior to the survey in question. HCFA Ex. 45, at 7; Tr. at 124 - 125. Petitioner argues that it changed its policy from regularly scheduled case conferences to conferences on an as needed basis. It further argues (and I agree) that clinical progress notes can be used to coordinate care. Tr. at 125 - 127. Here, however, HCFA has established a prima facie case that Petitioner has failed to adhere to its own procedures. Petitioner has failed to offer any proof substantiating its argument that the policy of regularly scheduled case conferences had been changed to case conferences on an as needed basis. Petitioner also failed to present evidence that clinical progress notes were used to coordinate services for this patient. The record reflects no clinical progress notes which were used to coordinate services. The absence of such records, particularly with Petitioner being in a position to produce them if they exist, strongly suggests that such coordination did not occur through the use of clinical progress notes.(15) I sustain the deficiency.
Patient 8
The surveyors made the following assertions regarding Patient 8:
The Medical social worker note from the visit on 080797 indicated that the patient could be discharged from medical social worker services. The plan of treatment for the period 081597 - 101597 indicated that medical social worker visits were to continue.
A licensed vocational nurse saw the patient on 080697 and then no nurse visited the patient again until 082197.
HCFA Ex. 2, at 10 - 11.
Two separate deficiencies have been identified here. One involves whether the medical social worker's recommendations were coordinated with Petitioner's other personnel and Patient 8's physician. The other involves whether Petitioner failed to coordinate the provision of physician ordered skilled nursing visits to Patient 8.
Deficiency 1: For the first deficiency, the medical social worker's note of August 7, 1997, reflected that Patient 8's basic needs were met and that Patient 8 could possibly be discharged from medical social worker services. HCFA Ex. 9, at 2. The medical social worker then indicated that Patient 8's plan for follow-up visits was indicated to be one to two visits a month with one to three as needed visits (1 - 2 Month 3 PRN(16)). Id. However, despite the social worker's recommendation, Patient 8's subsequent plan of care showed a continuation of medical social worker visits at one to two visits per week for nine weeks and as needed visits (1 - 2XWX9 (PRN)). HCFA Ex. 19, at 1. This reflects that the plan of care following the medical social worker's August 7, 1997 visit (the plan of care from August 15, 1997 to October 15, 1997) was not changed from the previous plan of care upon which the medical social worker had made her August 7, 1997 visit (the plan of care from June 14, 1997 through August 14, 1997), after which visit the medical social worker determined that the frequency of the visits could be changed. See HCFA Ex. 19, at 3. The orders were the same for these two certification periods even after the medical social worker indicated a need to reduce the level of visits to Patient 8. The subsequent certification period for the plan of care was signed by the patient's physician and Petitioner's nurse. However, there is nothing in the record to demonstrate that the medical social worker's August 7, 1997 assessment and recommendation was considered by the physician or by Petitioner's other personnel in determining the level of social work services that Patient 8 would need for the subsequent certification period. This demonstrates that Petitioner manifested a lack of coordinated services, as required by this part of the regulations. I sustain the deficiency.
Deficiency 2: The second deficiency relates to an alleged lack of coordinated services on Petitioner's part after a July 28, 1997 change of orders by Patient 8's physician. Specifically, on July 28, 1997, Patient 8's physician changed the frequency of skilled nursing services from five times a week (5XWX( 3 - 4 PRNS)) to once a week (SNV to 1XW). HCFA Ex. 19, at 3, 6. The plan of care for the 60-day certification period starting on August 15, 1997, reflected this change (SN 1XWX9(3 - 4 PRNs)). HCFA Ex. 19, at 1. However, despite this, Petitioner did not provide any skilled nursing visits to Patient 8 for the period from August 6, 1997 to August 21, 1997, a period of more than one week. Tr. at 117 - 118. HCFA argues that a lack of coordination on Petitioner's part caused the missed visits. P. Br. at 16. While I cannot be certain what caused the missed visits, I agree with HCFA that better coordination among Petitioner's staff could have avoided the missed visits. It is incumbent upon Petitioner to ensure that changes in the plan of care are transmitted to the skilled nursing staff so that the physician's orders can be carried out. Petitioner provided no explanation for the missed visits, merely arguing that they were isolated circumstances. P. Br. at 33. Therefore, I find that a lack of coordination is established. I sustain the deficiency.(17)
Patient 6
The surveyors made the following assertions regarding Patient 6:
For reviewed time frame 08/15/97 to current the R.N. failed to inform the physician of the patient's frequent complaints of headache which the nurse documentation stated was associated with eyes. The nurse also failed to inform the physician that the patient was to go to an eye doctor but could not go until a medical bill was paid. The clinical record did not show that medical intervention was obtained to address the patient's headaches or eye problem.
The also nurse [sic] failed to inform the physician of red eyes, runny nose and sore throat, vomiting, nausea, pain in the back, and dizziness.
Seven extra skilled nursing visits were provided for the time period reviewed (072397 - 092397). There was no order for these extra visits. The physician was not notified of the need for the extra visits.
HCFA Ex. 2, at 11.
Three deficiencies are alleged here. The first two relate to Petitioner's failure to inform Patient 6's physician with regard to changes in Patient 6's condition and to Petitioner's failure to get Patient 6's physician to address those symptoms. The third relates to the provision of skilled nursing visits without a physician order and without notification to the physician of the need for a change in the number of visits. The record supports that a lack of coordination results here, both from the failure to notify Patient 6's physician of a change in the patient's symptoms and to obtain physician intervention, as well as from the provision of seven extra skilled nursing visits without notifying the physician of a need for a change in the plan of care with regard to the extra skilled nursing visits. The basis for this determination is set forth below.
Based upon a skilled nurse's evaluation of a patient, it is incumbent upon a skilled nurse to provide information regarding a significant change in a patient's condition to a physician in order that the physician can decide whether to alter a plan of care. See Pacific Coast Home Health, DAB CR534, at 64 (1998); Access Home Care, DAB CR528, at 11 (1998).(18) Without such coordination between skilled nurse and physician, especially without notifying a physician of a patient's changing condition, there is a clear potential for harm, as it is the physician who should be diagnosing and directing treatment for a patient, not a skilled nurse. It is up to the patient's physician to determine whether the new symptoms or findings justify a change in the care provided. If there is a reasonable medical probability that the change in condition could adversely affect the patient, then it is incumbent upon the skilled nurse, who is acting as the eyes and ears of the physician, to transmit such information to the physician. Furthermore, as I found in Pacific Coast also, the issue of treatment authorization (here the provision of seven extra skilled nursing visits not authorized by the physician in the plan of care) should be construed strictly. The regulatory intent is that care be given only under a physician's orders. There is no provision for non-physician caregivers to provide unauthorized care. Before extra visits are provided, a physician must be apprised of the need for the extra visits and must order them. Pacific Coast, DAB CR534, at 25.
Deficiency 1: With regard to the failure to notify the physician of a change in Patient 6's symptoms regarding the complaint of headache, I note that Patient 6 was scheduled to see an eye doctor, but was waiting to make an appointment until after his bill for prior ophthalmological services was paid. HCFA Ex. 20, at 15, 17. During this period, Patient 6 complained of eye pain and headaches. On three successive R.N. (skilled nursing) visits (those of August 19, 22, and 28) where such complaints were mentioned by Patient 6, the skilled nurse did not notify Patient 6's physician regarding the complaints, nor did the skilled nurse inform the physician of the fact that Patient 6 was not going to visit the eye doctor until Patient 6's bill was paid. HCFA Ex. 20, at
15 - 17.
During the hearing, Ms. McGee testified that the physician is the head of the health team and should be informed as to all symptoms a patient is having. Tr. at 427. She testified that Patient 6's primary diagnosis was hypertension and that a diagnosis of hypertension could relate to the headaches the patient experienced. Tr. at 426 - 427. Further, Patient 6's blood pressure had increased on each successive skilled nursing visit. Tr. at 427. I find that there is a sufficient medical probability that these symptoms could lead to adverse health consequences. As such, the headaches and eye pain were significant changes in this patient's condition which should have been reported to the patient's physician so that the physician could determine if the complaints were significant and related to the patient's diagnosis. Tr. at 427. It is up to the physician to decide whether or not to change a patient's plan of care. Here, not notifying the physician could potentially have harmed Patient 6. I sustain the deficiency.
Deficiency 2: Other symptoms noted in the HCFA Form 2567 were also significant and justified reporting to Patient 6's physician. On September 2, 1997, Patient 6 complained of a runny nose, a sore throat, coughing, and a non productive cough. Such symptoms, as the nurse instructs Patient 6, might reflect sinus problems or the beginning of a respiratory infection. HCFA Ex. 20, at 13. Instead of immediately notifying the treating physician so that the physician could decide the correct course of treatment, the nurse undertook her own treatment, instructing Patient 6 to force fluids and drink extra water (despite the fact that this compromised patient, as well as a principal diagnosis of hypertension, has secondary diagnoses, among which are anemia, osteoarthritis and malnutrition (HCFA Ex. 20, at 1)). The next day, Patient 6 still had symptoms, accompanied by an increase in temperature and vomiting. The skilled nurse directed the patient to contact the physician if the cold symptoms worsened, but did not contact the physician herself. HCFA Ex. 20, at 12. I find that, in this instance, for a patient with anemia and malnutrition, the skilled nurse should not have monitored these significant symptoms, instituted treatment on her own, and placed the burden on the patient to notify the physician if the cold symptoms worsened instead of contacting the physician herself to describe the symptoms. The fact that the cold symptoms were resolving on September 5, 1997 (see HCFA Ex. 20, at 11) does not relieve the skilled nurse from her obligation to inform the physician of this significant change in condition so the physician could consider whether to modify the plan of care.
Other symptoms reported to the skilled nurse by the patient, but not reported to the physician which should have been reported to the physician, include the patient's complaint of back pain (HCFA Ex. 20, at 7 - 8) which continued over two skilled nursing visits and the patient's complaint of dizziness (HCFA Ex. 20, at 6). Although Petitioner was being treated for conditions which might include symptoms of back pain and dizziness (HCFA Ex. 20, at 1), it is up to the physician to determine whether an exacerbation in symptoms (as in the case of the back pain) or the dizziness reported (HCFA Ex. 20, at 6) justified a change in the patient's plan of care. Petitioner's argument that at one time the nurse instructed the patient to call the physician if the patient experienced dizziness (HCFA Ex. 20, at 19) does not absolve the nurse from contacting the physician when the patient reported that symptom to her.
Petitioner argues that Patient 6 had reported these symptoms over many months and that the physician had been notified several times, signing the last summary on September 16, 1997, indicating his awareness. Petitioner does not, however, cite any evidence of record for its statement. Moreover, even if, on occasion, the physician was notified of similar symptoms, that does not relieve the skilled nurse from the duty of reporting the patient's current symptoms to the treating physician for the physician's analysis of a need to change the plan of care. The skilled nurse is in an unique position between the treating physician and the patient. It is the home health agency's responsibility under this regulation to coordinate the services rendered by a skilled nurse and a treating physician. A necessary and important aspect of such coordination is the reporting of changes in the patient's condition which may adversely affect the health and safety of the patient. I sustain the deficiency.
Deficiency 3: Petitioner admits that it apparently provided this patient with seven unauthorized skilled nursing visits. P. Br. at 30. Petitioner argued, however, that this was simply an oversight, as the skilled nurse failed to document a change in physician orders. P. Br. at 30. There is no support in the record for Petitioner's contention. This is more than an oversight. The provision of services not authorized by a physician reflects a lack of coordination of services and a failure to adhere to services authorized by a physician. Pacific Coast, DAB CR534, at 25. I sustain the deficiency.
Patient 3
The surveyors made the following assertions concerning Patient 3:
The agency indicated that home health aides were needed daily Monday through Friday and twice a day on the weekends for the period 081997 - 101997 for personal cares [sic].
The agency provided twice a day home health aide visits for the period reviewed
(081997 - 092197). The twice a day home health aide visits resulted in 22 extra documented home health aide visits for that period of time.
HCFA Ex. 2, at 11 - 12.
Petitioner admits that extra visits occurred based on the plan of care from August 19, 1997 through October 19, 1997. P. Br. at 30. Ms. McGee documented that 22 extra visits occurred. HCFA Ex. 45, at 31; Tr. at 441 - 445. Petitioner argues, however, that the plan of care for this certification period carried forward an earlier order from the certification period of June 18, 1997 through August 18, 1997, without noting a change in physician orders on June 23, 1997, which change would have authorized the extra visits. However, there is nothing of record to support Petitioner's contention. Petitioner should not make visits to a patient without physician authorization. Thus, Petitioner did not coordinate these visits with the patient's physician. Even if I accept Petitioner's explanation, Petitioner would have violated this regulation by not coordinating the June 23, 1997 order with the physician and making sure it was incorporated in Patient 3's plan of care. Finally, Petitioner argues that the facts of the deficiency do not establish an agency pattern of violating the standard and therefore should be discounted. I do not look at each deficiency in a vacuum to determine whether it establishes a violation of the regulation. A single episode could be sufficient to establish a violation of the standard. The issue of pattern relates more appropriately to whether a single deficiency or a series of deficiencies establishes the requisite legal requirement that Petitioner lacks the capacity to furnish adequate patient care or that Petitioner's care adversely affects the health and safety of patients. See 42 C.F.R. � 488.24(b). Such a finding would support a conclusion that a condition of participation is out of compliance. I do not need to reach that determination for purposes of determining whether the deficiency has been proven. I sustain the deficiency.
Patient 10
The surveyors made the following assertion concerning Patient 10:
The agency policy was for case conferences to be conducted every 2 weeks. The last documented case conference was for 032097.
The medical social worker visited the patient on 081397. During that visit, it was indicated that medical social worker visits for 1 - 2 a month with 1 - 3 PRN was indicated. No additional medical social worker visits had been done.
HCFA Ex. 2, at 12.
The surveyors identified two deficiencies under this standard: that Petitioner did not conduct case conferences every two weeks to coordinate services and that Petitioner failed to coordinate medical social worker services.
Deficiency 1: With regard to the case conferences, the record reflects that, based on Ms. Schatz's review of the clinical records, the last case conference for this patient occurred on March 20, 1997. HCFA Ex. 45, at 66. As I held in the case of Patient 5 (supra, at page 16), HCFA has established a prima facie case that Petitioner failed to adhere to its own procedures (which were to hold a case conference every two weeks to coordinate services) and, thus, failed to coordinate services. Petitioner has failed to present evidence rebutting HCFA's prima facie case. I sustain the deficiency.
Deficiency 2: With regard to Petitioner's failure to coordinate medical social worker services, in a follow-up visit by the medical social worker on August 13, 1997, the medical social worker noted that the patient appeared to be confused. HCFA Ex. 12, at 3 - 4. The social worker then recommended, in a plan for follow up visits, that visits of 1 - 2 Month 1 - 3 PRN were indicated. Id. at 4. When reviewing the clinical records, Ms. Schatz concluded that no additional medical social worker visits occurred after August 13, 1997. HCFA Ex. 45, at 66. Thus, HCFA argues that the standard was violated because the medical social worker identified a need for social work visits, but the patient did not receive them. Further, HCFA alleges that the coordination error stemmed either from the failure of the social worker to schedule the visits or to let the employee of Petitioner responsible for scheduling visits know that visits were to be scheduled. Tr. at 132 - 133.
Petitioner does not deny that there were no visits by a medical social worker after August 13, 1997. Instead, Petitioner argues, without citing to record support, that the recommendation was for a possible need for follow-up visits within the next three months as needed. P. Br. at 31. I do not agree with Petitioner. Petitioner's argument would be more credible if Petitioner had offered testimonial evidence from Petitioner's personnel as to what was meant. After the fact rationale by counsel cannot substitute for evidence that was not produced. Moreover, Petitioner's argument conflicts with Ms. Schatz's credible testimony that the medical social worker's notation meant that there were to be social work visits a bare minimum of one time a month, but that one to three visits could be provided PRN. Tr. at 134. Absent other evidence to the contrary, such testimony remains uncontroverted. I agree with HCFA that a coordination error occurred here with regard to the coordination of the medical social worker visits. I sustain the deficiency.
Patient 13
The surveyors made the following assertions concerning Patient 13:
A note on the record indicated that a physician identified as personnel #54 was the patient's physician as of May 1997. For the period 052397 - 072397 the physician identified as personnel #54 signed the plan of treatment even though the plan of treatment contained another physician's name who will be identified as personnel #55. For the period 072397 - 092397, the agency received a plan of treatment signed from the physician identified as personnel #55.
The clinical record did not contain a discharge summary. The agency stopped providing services to this patient on 082097. Review of the record did not reveal this patient's status with the agency. Interview with personnel #51 on 092497 confirmed that the patient had been discharged from services. There was no discharge summary on the record as required.
The agency policy was that case conferences were to be conducted every 2 weeks. The last case conference on this patient was 060597.
HCFA Ex. 2, at 12 - 13.
Three deficiencies are alleged here: that Petitioner did not coordinate care with Patient 13's primary attending physician; that the clinical record did not contain a discharge summary; and that Petitioner did not conduct case conferences every two weeks. HCFA's Posthearing Brief (HCFA Br.) at 21.
Deficiency 1: With regard to the coordination of care with the patient's primary attending physician, as of May 1997, Dr. Willis (personnel #54) was Patient 13's physician. HCFA Ex. 45, at 75. Thus, in May 1997, Petitioner was on notice as to who Patient 13's primary attending physician was. In coordinating the care of a patient, a home health agency has an obligation to ensure that care is coordinated and authorized by the physician who is treating the patient at the time of the certification period (here the period from July 23, 1997 through September 23, 1997). The regulation requires that all personnel furnishing services maintain liaison. 42 C.F.R.
� 484.14(g). The summary report of care is to be sent to the attending physician. A home health agency is to prepare a HCFA Form 485 (the Home Health Certification and Plan of Treatment) and send it to the physician caring for the patient. Here Petitioner sent Patient 13's 485 for the certification period July 23, 1997 through September 23, 1997, to a physician who was not the patient's primary attending physician (Dr. Louis, personnel #55). While that physician may have signed the 485, he was not authorized to do so. There is nothing in the record to suggest that Dr. Louis succeeded Dr. Willis as the primary attending physician and no evidence that Dr. Louis was otherwise covering for Dr. Willis.(19)
In fact, to the contrary, Dr. Willis was noted by Petitioner as the primary attending physician at the time of Patient 13's discharge in August 1997. HCFA Ex. 13, at 5 - 6. Moreover, the surveyor contacted Dr. Willis' office and Patient 13 to confirm that Dr. Willis was Patient 13's attending physician at all relevant times. Tr. at 141 - 144, 148 - 149, 160; HCFA Ex. 45, at 75. Petitioner should have coordinated Patient 13's care with Dr. Willis. I sustain the deficiency.
Deficiency 2: The second allegation concerns Patient 13's discharge summary. Patient 13 was discharged on August 20, 1997, but the record of the discharge was not available to the surveyor at the time of the September 25, 1997 survey (although Petitioner's personnel #51 informed Petitioner that Patient 13 had been discharged), and the copy of the discharge summary produced at the hearing in this case is dated October 15, 1997, after the survey. HCFA Ex. 13, at 5 - 6; Tr. at 153 - 154. A fair reading of the regulations is that effective coordination requires preparation of a discharge summary, placement of the discharge summary in a patient's record, and notification of the discharge to the patient's physician within a reasonable period of time.(20) Here, the discharge summary reflects that the patient's daughter withdrew the request for Petitioner's services, and there is an indication of a referral to the physician for continuity of care. HCFA Ex. 13, at 5 - 6. Without preparation of the discharge summary within a reasonable period of time, however, there would be no way to inform the patient's physician of the withdrawal of Petitioner's care. The physician might have wanted to transfer the patient to another home health agency (especially here where the patient is severely compromised) to prevent possible harm to the patient. Id. at 6. Moreover, without accurate patient records, and without the status of the patient accurately reflected in the records, there was no way for Petitioner's personnel to know of the patient's discharge and, thus, no effective and timely communication between Petitioner's personnel. I sustain the deficiency.
Deficiency 3: As I discuss above (supra, at pages 16, 22), Petitioner's policy is to do case conferences every two weeks. The last case conference regarding Patient 13 was held on June 5, 1997. Tr. at 156 - 157; HCFA Ex. 45, at 76. Petitioner failed to address this deficiency in its brief. See P. Br. at 31 - 32. Indeed, I note that a case conference for Patient 13 may have cleared up the record as to which physician was Patient 13's primary attending physician. See Tr. at 157 - 158. Failure to hold such case conferences can lead to a failure by Petitioner's personnel to coordinate a patient's care which has the potential to harm patients. I sustain the deficiency.
Patient 14
The surveyors made the following assertion concerning Patient 14:
This patient received physical therapy treatment visits without a physician's order.
HCFA Ex. 2, at 13.
Petitioner cannot provide any treatment without a physician's order. 42 C. F. R. � 484.18(c). On August 6, 1997, Petitioner's treating physician, at the request of the patient's family, apparently authorized Petitioner to refer the patient for a physical therapy evaluation. HCFA Ex. 31; 14, at 12 - 13; 45, at 87. This prompted a physical therapy evaluation of the patient on August 6, 1997. HCFA Ex. 14, at 12 - 13. The therapist recommended a therapy schedule of TIWX8 wks. HCFA Ex. 14, at 13; 45, at 87. Petitioner provided physical therapy treatment from August 6, 1997 through September 22, 1997 (which stretched over two certification periods; August 30, 1997 through October 30, 1997, and the certification period preceding that). HCFA Ex. 45, at 84; 44; 14, at 5 - 11; Tr. at 162 - 164, 168, 172 - 173.
Under the regulations, Patient 14's physician had to approve the physical therapy before it was given, either by written order(21) or by an oral order put in writing and signed and dated with the date of receipt by the registered nurse or qualified therapist responsible for furnishing or supervising the ordered services. 42 C.F.R. � 484.18. The physical therapy evaluation form contains a place for the physician's signature. HCFA Ex. 14, at 12; 45, at 87. However, Petitioner did not have the signed evaluation and order approving the provision of physical therapy services in its records at the time of the survey, and the signed evaluation was apparently not faxed to Petitioner until October 8, 1997. HCFA Ex. 14, at 12. Moreover, the plan of care for this patient for the certification period of August 30, 1997 to October 30, 1997, does not provide for physical therapy services. HCFA Ex. 14. If Petitioner did not have a signed authorization for treatment, it should have at least had a phone authorization in its records before the therapy was provided.
The absence of the authorization in Petitioner's records as of the date of the survey reflects a lack of the coordination required under this part of the regulation. Petitioner's brief fails to address the fact that the physical therapy visits occurred prior to receipt of the treating physician's authorization. See P. Br. at 32 - 33. Petitioner acknowledges that the unsigned authorization was in the file, according to Petitioner it was waiting for the receipt of a signed copy from the physician's office. Id. However, a record of a verbal authorization should have been in the record. None was present. At best, the record suggests that Patient 14's physician retroactively approved these visits. However, the regulation requires authorization of physical therapy services prior to their initiation. Petitioner's personnel did not properly coordinate the provision of physical therapy services with Patient 14's physician. I sustain the deficiency.
HCFA argues also that Patient 14 suffered actual harm because the physical therapist wrapped Patient 14's hand too tightly, causing bruising. HCFA Br. at 26. According to the patient's daughter, the physical therapist had an ace bandage on too tightly and the damage lasted a month. HCFA Ex. 37 at 1; Tr. at 172 - 176. Petitioner argues that the daughter was the only one to report this, and the report was not verified by another source. P. Br. at 32 - 33. Petitioner also asserts that when the nurse reported the bruising to the patient's physician on August 22, 1997, the physician issued no new orders for the patient's care, which, Petitioner argues, meant that the physician was aware of the situation and did not view it as serious enough to warrant a change in orders. P. Br. at 33. I find that the record supports a conclusion that the patient's hand was most likely injured by the physical therapist. There is nothing in the record to suggest another source of injury. Petitioner argues that the daughter's report was not independently verified, but there is no need to do so. If Petitioner had knowledge regarding a different cause for this injury, it was incumbent on Petitioner to offer such evidence in the record. None was presented. Therefore, the daughter's statement remains uncontroverted. As to injury, there was clear injury as reflected by the skilled nurse in her note. HCFA Ex. 37, at 1. The fact that the physician did not suggest additional treatment other than the treatment provided by the skilled nurse does not lessen the harm caused by the unauthorized treatment. The nurse's communication with the treating physician raises the issue only as to whether such communication and lack of orders suggests that the physician, at least as of August 22, 1997, was aware of the physical therapy. This is a reasonable inference, but, to be in compliance with this standard, the regulations require more. There must be either written or oral authorization by the treating physician. Such authorization was not timely done in this case. Therefore, I sustain the deficiency.
Patient 2
The surveyors made the following assertions concerning Patient 2:
This patient for the period 063097 - 083097 was to receive skilled nursing visits 3 times a week. There was no skilled nursing visit from 080797 until 090497. The physician was not notified. The record did not reflect any reason as to why the visits were not provided at the frequency ordered.
The agency policy was that case conferences would be conducted every two weeks. The last case conference was done 060597.
HCFA Ex. 2, at 13.
Two deficiencies are cited here. One involves Petitioner's failure to make missed skilled nursing visits according to the plan of care and without physician notification, the other that Petitioner did not conduct case conferences every two weeks.
Deficiency 1: This deficiency covers two certification periods. From June 30, 1997 through August 30, 1997, Patient 2 was to receive three skilled nursing visits per week. HCFA Ex. 15, at 3. The next plan of care, covering the period August 31, 1997 through October 31, 1997, reflects that Patient 2 was to receive skilled nursing visits twice a week. However, no skilled nursing visits were reflected in the record for a 28 day period from August 7, 1997 through September 4, 1997. Tr. at 199 - 200; HCFA Ex. 45, at 23.
Petitioner admits that Patient 2 received fewer skilled nursing visits than ordered for these periods. P. Br. at 33. However, Petitioner asserts that the evidence submitted does not establish this isolated incident as either an agency pattern of substandard practice or a threat of serious and immediate harm. Id. I disagree.
Patient 2's care plan for the certification period of August 31, 1997 to October 31, 1997, indicates that Patient 2 suffered from hypertension (exac)(22); S/P CVA (R)side; tremors; gait abnormality; and urinary incontinence. HCFA Ex. 15, at 1 - 2. Given these serious health conditions, Patient 14's physician wanted him monitored several times a week over the two certification periods. HCFA Ex. 15, at 1 - 4. The coordination problem here stems from the fact that Petitioner was not ensuring that the skilled nurse visits occurred in accordance with the physician's orders. No monitoring of Patient 2's condition took place during this time, which could have led to potential harm to this compromised, elderly patient. There is no indication that any of Petitioner's personnel assumed responsibility to see that the physician's orders were carried out. Tr. at 200 - 201. I find this to be a significant contravention of the regulations. The patient had multiple, serious, debilitating conditions which required continued regular attention. The treating physician was relying on Petitioner to carry out his instructions so the safety and health of the patient could be maintained. Allowing the patient to go approximately one month without ongoing visits, Petitioner placed this patient in grave jeopardy. Rather than an isolated instance, it appears to represent a continuing failure on Petitioner's part to coordinate services and to carry out the services ordered by the treating physician. Such action on Petitioner's part, even without more evidence of a pattern of conduct, could be the basis for determining that this condition of participation was not met by Petitioner. I sustain the deficiency.
Deficiency 2: Petitioner's policy, as I have previously stated (supra, at pages 16, 22, and 25), was to have case conferences every two weeks. The last case conference was held on June 5, 1997. HCFA Ex. 45, at 23; Tr. at 201 - 202. Petitioner does not address this deficiency. See P. Br. at 33. As I held above, HCFA has established a prima facie case that Petitioner failed to adhere to its own procedures and, thus, failed to coordinate services. Petitioner has failed to rebut HCFA's case. I sustain the deficiency.
Patient 11
The surveyors made the following assertion concerning Patient 11:
On 082697 the registered nurse documented to discontinue the home health aide as the patient performed self care. Home health aide services continued after that for three times a week.
HCFA Ex. 2, at 14.
Patient 11's plan of care authorized home health aide visits 3XWX9 for the certification period August 11, 1997 through October 11, 1997. HCFA Ex. 27, at 1. On August 26, 1997, a registered nurse made a home health aide supervisory visit. HCFA Ex. 16, at 1. During the visit, the registered nurse wrote, "Recommend DC HHA. Pt is presently performing self care." Id.
The sheet on which the registered nurse wrote this recommendation was signed by both the home health aide and the registered nurse. Id. However, home health aide visits continued by a different aide until September 5, 1997. HCFA Ex. 16, at 3.(23)
This deficiency is based on the lack of coordination of services. Here, Patient 11's physician, who authorized the services, appears not to have been notified that the services were no longer needed. While HCFA appropriately refers to Petitioner's failure to notify the second home health aide of the recommendation of the discontinuation of services (in that the aide signing the supervisory visit form and the aide signing the patient care record were different) the greater failure here may be the failure to notify the physician and get the physician's authorization to discontinue services. The recommendation of the skilled nurse should have been communicated to the treating physician for his or her approval. At the same time, failure to promptly notify the physician could lead to provision of unnecessary care.
The visits (for one week only) provided after the recommendation to stop have been characterized by Petitioner as an appropriate winding down of the home health aide in preparation for Patient 11's taking on self care. P. Br. at 33. Petitioner also makes the point that the patient, the aide, and the skilled nurse signed the supervisory form. Id. This was not the case, as the aide who provided the additional services did not sign the form. Even if I accept the argument that such additional home health aide care may have been appropriate, Petitioner cannot make this decision. The decision is the prerogative of the treating physician. Here the standard is violated in two ways. Petitioner did not coordinate the recommendation of the skilled nurse with the second home health aide or with agency personnel who schedule home health aide visits and Petitioner failed to coordinate the need for a change in the plan of care with Patient 11's physician. I sustain the deficiency.
G 144 484.14(g) STANDARD: COORDINATION OF PATIENT SERVICES: The clinical record or minutes of case conferences establish that effective interchange, reporting and coordination of patient care does occurs.
Based on clinical record review and telephone interviews with patients, the surveyors determined that the clinical records failed to establish that effective interchange, reporting and coordination of patient care occurred. The surveyors stated that they were making a cross-reference to G Tag 148.
6. For Patients 5, 8, 6, 3, 10, 13, 14, 2, and 11, Petitioner failed to assure that the clinical record or minutes of case conferences established that effective interchange, reporting, and coordination of patient care occurred, a violation of 42 C.F.R. � 484.14(g).
The fact situations for the deficiencies cited under this part of the standard (G 144) for Patients 5, 8, 6, 3, 10, 13, 14, 2, and 11, is the same as the fact situations under G Tag 143 above. However, the part of the standard set forth at G Tag 143 concerns whether all personnel furnishing services coordinate effectively. Here, at G Tag 144, the issue is slightly different; whether the patients' clinical records establish that effective interchange, reporting, and coordination of patient care occurred. In short, if there is effective coordination, the coordination should be documented in the clinical record, which record should reflect communication between the various services and physicians to show that a patient's care was effectively coordinated. Tr. at 534 - 535. Below, in my evaluation of each patient, I will not set out the facts of each patient's situation if such facts have already been discussed above at G Tag 143. Instead, I will discuss only how the facts, as set forth above at G Tag 143, relate to the standard at G Tag 144.
Patient 5
Patient 5's clinical record established that: 1) despite the medical social worker's recommendation that goals had been met, the social work visits were continued; and 2) case conferences were not regularly conducted to assist in the coordination of services. HCFA Ex. 8; 45, at 7. There is an absence of documentation in the clinical record to establish that the required effective interchange, reporting, and coordination of services occurred. I sustain the deficiency.
Patient 8
Patient 8's clinical record established that even though the medical social worker recommended that Patient 8 could be discharged from medical social worker services, social work services continued (HCFA Ex. 9, at 2; 19, at 1 - 3). Similarly, the patient's clinical records for deficiencies one through three evidence a lack of coordinated services. Such records fail to establish that the required effective interchange, reporting, and coordination of services occurred. I sustain the deficiency.
Patient 6's clinical record established that: 1) the skilled nurse did not inform the physician of the patient's symptoms (HCFA Ex. 20); and 2) unauthorized skilled nursing visits were made. There is an absence of documentation to support that the required effective interchange, reporting, and coordination occurred. I sustain the deficiency.
Patient 3
Patient 3's clinical record establishes that 22 extra home health aide visits were provided without a physician's order. HCFA Ex. 45, at 31. There is an absence of the required documentation to support that the required effective interchange, reporting, and coordination of services occurred. I sustain the deficiency.
Patient 10
Patient 10's clinical record established that: 1) Petitioner failed to conduct case conferences every two weeks to coordinate services (HCFA Ex. 45, at 66); and 2) Petitioner failed to coordinate medical social worker services. HCFA Ex. 12, at 3 - 4; 45, at 66. There is an absence of the required documentation to support that the required effective interchange, reporting, and coordination of services occurred. I sustain the deficiency.
Patient 13
Patient 13's clinical record established that: 1) Patient 13's primary attending physician did not sign the plan of treatment (HCFA Ex. 45, at 75; 13, at 5 - 6); 2) there was no discharge summary in Patient 13's clinical record; and 3) case conferences were not conducted every two weeks. HCFA Ex. 45, at 76. There is an absence of the required documentation to support that the required effective interchange, reporting, and coordination occurred. I sustain the deficiency.
Patient 14
Patient 14's clinical record established that Patient 14 had received physical therapy services without a physician's order authorizing such services. HCFA Ex. 14; 45, at 84. There is an absence of the required documentation to support that the required effective interchange, reporting, and coordination occurred. I sustain the deficiency.
Patient 2
Patient 2's clinical record established that: 1) the skilled nurse did not inform Patient 2's physician that Patient 2 went without ordered skilled nursing services for 28 days (HCFA Ex. 15, at 1 - 4; 45, at 23); and 2) Petitioner failed to conduct case conferences every two weeks. HCFA Ex. 45,
at 23. There is an absence of the required documentation to support that the required effective interchange, reporting, and coordination occurred. I sustain the deficiency.
Patient 11
Patient 11's clinical record established that, although the skilled nurse documented in the clinical record to discontinue home health aide services, home health aide services continued to be provided. HCFA Ex. 27, at 1; 16, at 3. There is an absence of the required documentation to support that the required effective interchange, reporting, and coordination occurred. I sustain the deficiency.
The examples above establish that all of the clinical records of these patients do not show that the effective interchange, reporting, and coordination of patient care contemplated by this part of the standard has occurred.
G 145 484.14(g) STANDARD: COORDINATION OF PATIENT SERVICES: A written summary report for each patient is sent to the attending physician at least every 62 days.
Based on a review of 14 applicable clinical records (records of patients on service longer than 62 days), the surveyors determined that a written summary report was not sent to the attending physician at least every 62 days for two patients.
7. For Patients 4 and 10, a written summary report was not sent to the attending physician at least every 62 days, a violation of 42 C.F.R. � 484.14(g).
Patient 4
Ms. Reynolds review of Patient 4's clinical record established that the last summary report sent to and signed by Patient 4's physician was dated June 30, 1997. Tr. at 536; HCFA Ex. 45, at 36. The clinical record did contain a summary report dated August 28, 1997, but it was not signed by the physician, indicating it had not been sent. Tr. at 537; HCFA Ex. 45, at 36. There were no other summary reports in Patient 4's clinical record. I sustain the deficiency.
Patient 10
Ms. Schatz's review of Patient 10's clinical record established that the record contained a summary report dated April 28, 1997, and one other undated summary report. However, between April 28, 1997, and the date of the survey there should have been at least two other 62- day summaries sent; one in June and one in August. Thus, Petitioner missed at least one 62-day summary. HCFA Ex. 45, at 66; Tr. at 207, 209.
Petitioner does not dispute the surveyors' factual findings in either example above. Petitioner does argue, however, that the HCFA Form 487 (the patient summary report form) was done for every HCFA 485 generated. Petitioner further asserts that the deficiencies in both instances result from Petitioner's failure to have in the patient record a copy of the summary signed by the attending physician.
However, HCFA proved, and Petitioner did not address, that, for Patient 10, even if the undated summary was for one of the missed 62-day periods, there was still one instance in which no summary had been prepared within a 62-day period.
Moreover, Petitioner seems to believe that the regulation requiring the physician be notified does not require that a signed copy of the summary report be in a patient's record file. Such belief might be correct if there was other evidence in the record file that the appropriate notification had occurred. However, what Petitioner does not address is that there must be some evidence in the file reflecting that the required physician notification has been met. Here, Petitioner did not provide evidence of such notification for either Patient 4 or Patient 10. The lack of timely physician notification is a deficiency, in that a physician must be kept up to date on a patient's condition, because changes in a patient's condition might prompt a change in a patient's plan of care.
Summary of deficiencies under the condition at 42 C.F.R. � 484.14
Generally, a determination as to whether a provider is not complying with a condition of participation depends on the extent to which the provider is found not to be complying with the standards that are components of the condition. 42 C.F.R. � 488.26(b). A provider may be found not to have complied with a condition of participation where it is shown that a provider has committed a pattern of failures to comply with the standards that comprise the condition. But, proof of a pattern of failures to comply with a standard or standards may not be the only basis to find that a provider has failed to comply with a condition of participation. The determinative issue in any case where noncompliance is demonstrated is whether the failure to comply is so egregious as to limit the provider's capacity to furnish adequate care or adversely affect the health and safety of patients.
8. The deficiencies found in the standards under the condition set forth at 42 C.F.R. � 484.14 are of such character as to substantially limit Petitioner's capacity to furnish adequate care or which adversely affect the health and safety of its patients.
Here, I found, in examining the allegedly deficient standards HCFA cited with regard to the condition of participation at 42 C.F.R. � 484.14 for Organization, Services & Administration, that Petitioner was: 1) deficient regarding nine patients cited under G Tag 143, the standard requiring that all personnel furnishing services maintain liaison to ensure that their efforts are coordinated effectively and support the objectives outlined in the plan of care; 2) deficient regarding nine patients cited under G Tag 144, the standard requiring that the clinical record or minutes of case conferences establish that effective interchange, reporting, and coordination of patient care occurs; and 3) deficient regarding two patients cited under G Tag 145, the standard requiring that a written summary report for each patient be sent to the patient's attending physician at least every 62 days. In these standards, I have found a pattern of failure leading me to believe that Petitioner's deficiencies are of such a nature as to substantially limit its capacity to furnish adequate care and which has, in at least one case (see supra, at 26 - 27), adversely affected the health and safety of a patient.
Under G Tag 143 (referring to the standard at 42 C.F.R. � 484.14(g)), which requires that Petitioner's personnel furnishing services maintain liaison to ensure that their efforts are coordinated effectively and support the objectives outlined in the plan of care, I found above that the examples cited by the surveyors show a pattern of failures by Petitioner to effectively coordinate services both among its own personnel and with the patients' physicians, a failure which included a lack of coordination largely in the areas of medical social worker visits (for Patients 5, 8, and 10); skilled nursing visits (for Patients 6 and 2); home health aide services (for Patients 3 and 11); physical therapy services (for Patient 14); physician notification (for Patients 8, 6, 13, 14); and case conferences (for Patients 5, 10, 13, and 2). I note here that, had Petitioner timely conducted case conferences, it may have been able to obviate some of its problems with coordination of patient care. Further, I note that Petitioner's failures were found in nine of the 15 cases surveyed, a large and disturbing proportion of the patients surveyed, and that these failures were spread across many of the areas in which Petitioner provided home health services. This lack of coordination, which I believe substantially limits Petitioner's ability to furnish adequate care, might have a serious impact on patients' health and safety. Here, at least one patient, Patient 14, was injured due to Petitioner's failure to comply with this standard. As a result of this standard alone, I would find the condition of participation at 42 C.F.R. � 484.14 out of compliance with Medicare participation requirements, due to this lack of coordination regarding patient care. However, I have sustained two other allegations made by the surveyors, that Petitioner was out of compliance with the standards identified at G Tags 144 and 145.
Under G Tag 144 (referring to 42 C.F.R. � 484.14(g)), the fact situations are the same as under G Tag 143. The issue, however, is whether the patients' clinical records established that the effective interchange, reporting, and coordination of patient care occurred. I found in all nine cases that coordination was not documented in the clinical record, a critical lapse where the clinical record is the best communication between Petitioner's various services and patients's physicians. I find Petitioner's failure to properly manage its clinical records in this respect to be further evidence of Petitioner's inability to furnish adequate care to its patients.
Under G Tag 145 (referring to 42 C.F.R. � 484.14(g)), I found that for Patients 4 and 10, written summary reports were not sent to their physicians in conformance with regulatory requirements. Such failure might lead to patient harm, in that a physician must be kept up to date on his or her patient's condition in order that changes to the patient's plan of care be made. Without such
reports, the patients' health and safety might be adversely affected. Thus, this G Tag further supports my belief that, under this condition, Petitioner is not capable of providing care consistent with the regulations.
Part Two
The surveyors summarized Petitioner's failure to comply with the condition set forth at 42 C.F.R. � 484.18 as follows:
G 156 484.18 CONDITION: ACCEPTANCE OF PATIENTS, POC, MED SUPER
CONTINUING DEFICIENCY CONDITION NOT MET
Services were not administered in accordance with the plan of care. The physician was not notified of the need to alter the patient's plan of care. Plans of care failed to match the patient's condition.
The surveyors determined that two examples of a deficiency existed under this general condition. The surveyors determined also that there were seven standard-level deficiencies under this condition at G Tags 158, 159, 162, 163, 164, 165, and 167. HCFA Ex. 2.
9. For Patients 10 and 6, services were not administered in accordance with their plans of care; the patients' physicians were not notified of the need to alter the patients' plans of care; and the plans of care failed to match the patients' conditions; all violations of 42 C.F.R. � 484.18.
.
Patient 10
The surveyors made the following assertions concerning Patient 10:
The last skilled nursing visit provided to patient #10 was on 091097. During that visit the patient's blood pressure was elevated (160/100 and 164/102) and wheezing was noted with lung auscultation. The skilled nurse was to visit the patient two additional times that week. No additional skilled nursing visits were made to this patient. The patient was hospitalized on 091697 with respiratory distress. Not following the physician's plan for visit frequency and assessment of the patient was a serious and immediate threat to the patient. This patient had just been hospitalized from 083197 - 090397 with hypertension. The patient also had a secondary diagnosis of chronic obstructive pulmonary disease.
HCFA Ex. 2, at 15 - 16.
Patient 10 had diagnoses of an infected stasis ulcer in his right leg, chronic obstructive pulmonary disease (COPD), congestive heart failure, emphysema, and hypertension. HCFA Ex. 18, at 1. Patient 10 was hospitalized from August 31, 1997 through September 3, 1997, for hypertension. Tr. at 223. Upon Patient 10's release from the hospital, his attending physician ordered five skilled nursing visits for the first week and three visits per week for the remainder of the certification period. HCFA Ex. 45, at 65. The parties agree that the five required visits occurred in the first week of the certification period. However, HCFA argues that in the second week, which was also the last week of the certification period, Petitioner missed two visits. HCFA Br. at 39. Specifically, that week there were to be three skilled nursing visits, but only one occurred. I agree with Petitioner that there is no requirement that it must complete the requisite skilled nursing visits in the last week of a certification period when the visit can properly take place in the first week of the next certification period and where the patient's health will not be adversely affected. However, that is not the case here.
Patient 10 was released from the hospital on September 4, 1997. The first skilled nursing visit occurred on that date and the five initial skilled nursing visits were completed by September 8, 1997. The second week started on September 10, 1997, and a skilled nursing visit occurred on that date. However, the next skilled nursing visit did not take place until September 15, 1997, which was two days after the certification period ended on September 13, 1997. I note also that on September 10, 1997, Patient 10 had elevated blood pressures of 160/100 and 164/102.
While I agree that there is no requirement that the three skilled nursing visits ordered by Petitioner's physician must be crammed into the shortened certification week which ended on September 13, 1997, the circumstances of this case suggest that here there may have been other reasons Petitioner should have visited Patient 10 at earlier dates. Patient 10 had been recently released from the hospital, his health was compromised, as indicated by the elevated blood pressure which necessitated notifying the physician on September 10, 1997 (HCFA Ex. 18, at 11) and Patient 10 had other existing medical conditions placing him in jeopardy. Under such circumstances, it is not reasonable for Petitioner to have waited five days (from September 10 through September 15, 1997) to visit this patient.
The record does not contain any indication as to what action, if any, Patient 10's attending physician took when notified on September 10, 1997, of Patient 10's elevated blood pressure. However, given Patient 10's condition, Petitioner should have visited him the next day to see if his blood pressure remained elevated. If it was elevated, Petitioner should have notified the physician again. To leave Patient 10 without any skilled nursing visits for five days (from September 10 to September 15, 1997) was irresponsible and placed Patient 10 at unnecessary risk.
I concur with the surveyors that, in this instance, Petitioner's failure to provide proper care to this patient was a serious and immediate threat to the patient's health. Ms. Hamilton Bryant's testimony that Petitioner's care of Patient 10 was proper (Tr. at 1176 - 1178) is not supported by the record. I concur with HCFA that the record indicates a lack of stability in Patient 10's condition on September 10, 1997, with the skilled nurse suggesting that the patient accompany his wife to the hospital. Even though Patient 10 was not hospitalized that day, this does not reduce the danger he was in from his existing conditions and ongoing hypertension. Sending Patient 10 to the hospital to have his blood pressure checked does not absolve Petitioner from carrying out this patient's physician's orders of three skilled nursing visits per week. I sustain the deficiency.
Patient 6
The surveyors made the following assertions concerning Patient 6:
The physician was not informed of a patient's frequent complaints of headaches which the skilled nurse documentation showed was associated with an eye problem and the nurse failed to inform the physician that the patient frequently complained of eye pain.
HCFA Ex. 2, at 16.
Patient 6's case was fully discussed at G Tag 143, example 3. Here, Patient 6's physician should have been notified of the patient's complaints because, without such physician notification, the physician lacked necessary information which should have been considered in deciding whether to alter the patient's plan of care. I sustain the deficiency.
G 158 484.18 STANDARD: ACCEPTANCE OF PATIENTS, POC, MED SUPER: Care follows a written plan of care established and periodically reviewed by a doctor of medicine, osteopathy, or podiatric medicine.
Based on a review of clinical records, the surveyors determined that care failed to follow a written plan of care established by a physician as required for patients.
10. For Patients 10, 6, 15, 2, and 14, Petitioner failed to assure that care followed a written plan of care established and periodically reviewed by a doctor of medicine, osteopathy, or podiatric medicine, a violation of 42 C.F.R. � 484.18.(24)
Patient 10
The surveyors made the following three assertions concerning Patient 10:
The last skilled nursing visit provided to patient #10 was on 091097. During that visit the patient's blood pressure was elevated (160/100 and 164/102) and wheezing was noted with lung auscultation. The skilled nurse was to visit the patient two additional times that week. No additional skilled nursing visits were made to this patient. The patient was hospitalized on 091697 with respiratory distress. Not following the physician's plan for visit frequency and assessment of the patient was a serious and immediate threat to the patient. This patient had just been hospitalized from 083197-090397 with hypertension. The patient also had a secondary diagnosis of chronic obstructive pulmonary disease.
This patient had no plan of care after 091497. The agency provided a home health aide visit on 091597.
Also, skilled nursing and home health aide visits were provided less than ordered. The physician was not notified.
HCFA Ex. 2, at 18.
Under this standard, HCFA is alleging three separate deficiencies concerning Patient 10, the patient discussed above at G Tag 156.
Deficiency 1: Petitioner did not follow Patient 10's plan of care for visit frequency, posing a serious and immediate threat to this patient. I previously sustained this deficiency (supra, at pages 35 - 36), and I sustain it now.
Deficiency 2: This deficiency involves the absence of a plan of care for the skilled nursing visit which occurred on September 15, 1997. The prior certification period had ended on September 13, 1997, and Petitioner did not have a plan of care in place for the new certification period. The record does not indicate whether Petitioner contacted Patient 10's physician in the last week of the prior certification period to ask the physician to extend the plan of care into another certification period. All the record indicates is that Petitioner visited Patient 10 on September 15, 1997, and he was hospitalized later that day. Patient 10 was released on September 25, 1997, a period which was covered by a subsequent plan of care.
Petitioner did not challenge the absence of a plan of care for the September 15, 1997 visit. Petitioner argues instead that a single incident does not establish the pattern needed to sustain a standard-level deficiency. I agree with Petitioner that, in this instance, the particular facts of the absence of the plan of care for one visit does not in itself support a standard-level violation. Arguably, Petitioner should have had a plan of care in place on September 14, 1997. However, considering the patient's hospital visits and contact with the physician, the absence of a plan of care for one visit is not meaningful. Patient 10's next visit was covered by a plan of care. HCFA Ex. 18, at 4. I do not find a deficiency here.
Deficiency 3: This deficiency alleges that skilled nursing and home health aide visits were provided less frequently than ordered without notifying the patient's physician. With regard to skilled nursing visits, I sustained this deficiency (supra, at pages 35 - 36). Further, as I pointed out at Deficiency 2, the record does not indicate whether Petitioner notified the patient's physician that the visits were provided less frequently than ordered. In the absence of proof to the contrary in the record, I must find that the physician was not notified. With regard to the home health aide visits, during the June 14, 1997 through September 14, 1997 certification period, the plan of care called for home health aide visits seven times a week (7XWX9). HCFA Ex. 18, at 1. Ms. Schatz testified that seven home health aide visits were missed. Tr. at 236 - 240; HCFA Ex. 45, at 67. Petitioner has offered no evidence to show that the visits were made, nor provided a reason as to why the visits were missed, nor offered proof that the patient's physician was notified that the patient was not receiving the care ordered. I sustain the deficiency.
Patient 8
The surveyors made the following assertion concerning Patient 8:
Skilled nursing visits were provided less than ordered. The physician was not notified. This patient was to receive weekly skilled nursing visits. There were no visits from 080697 until 082197.
HCFA Ex. 2, at 18.
I discussed Patient 8 at G Tag 143 (supra, at pages 17 - 18). There, I found that Petitioner did provide skilled nursing visits less frequently than ordered. I note here that Patient 8 had a principal diagnosis of hypertension (exac), had a lumbar laminectomy, and had secondary diagnoses of back pain, pleural effusion, and chronic hepatitis. HCFA Ex. 19, at 1, 3. Given these diagnoses, missed home health visits could potentially harm Patient 8. Petitioner should, at least, have been monitoring Patient 8's hypertension. Tr. at 250 - 251. I sustain the deficiency.
Patient 6
The surveyors made the following assertions regarding Patient 6:
Seven extra skilled nursing visits were provided for the time period reviewed (072397-092397). There was no order for these extra visits. The physician was not notified of the need for the extra visits.
HCFA Ex. 2, at 18 - 19.
I discussed Patient 6 above at G Tag 143 (supra, at pages 18 - 21). Petitioner did not dispute that the seven unauthorized visits were made. Petitioner argued only that this was simply an oversight, as the skilled nurse failed to document a change in physician orders. I held above that there is no support in the record for Petitioner's contention. Further, as I held in Pacific Coast, DAB CR534, at 25, the intent of the regulations is that care be given only under the orders of a physician. There is no provision in the regulations for non-physician caregivers to provide
unauthorized care or services. Here, as in Pacific Coast, it does not matter whether or not the care may have been given with good intentions. The potential is there for an adverse effect on the patient. I sustain the deficiency.
Patient 15
The surveyors made the following assertion concerning Patient 15:
Patient #15 Skilled nursing visits were provided less than ordered for the time period reviewed (072397 - 092397). The physician was not notified.
HCFA Ex. 2, at 19.
On July 23, 1997, for the certification period July 23, 1997 through September 23, 1997, Patient 15's physician ordered that a skilled nurse visit seven times a week for two weeks, then five times a week for the next two weeks, and finally three times a week for five weeks (SN 7W2, 5W2, 3W5). HCFA Ex. 21, at 5. On July 29, 1997, Patient 15's physician ordered that Patient 15's dressing be changed and cleaned daily. Id. at 4. According to Ms. McGee, only a skilled nurse would change a dressing. If the skilled nurse did not visit, the old dressing would be left in place and not changed as the patient's physician had ordered. Tr. at 457.
Patient 15's clinical record shows that during the second week of the first two weeks of skilled nursing visits ordered by the physician, two skilled nursing visits were missed by Petitioner (on August 2 and 3, 1997). HCFA Ex. 21. Ms. McGee testified that there is a potential for harm here, in that Patient 15 could have developed an infection from leaving the old dressing on for three days. Tr. at 457 - 458.
Petitioner's duty as a home health agency was to ensure that the patient's care follow the written plan of care established by the patient's physician. It did not do so here. Homebound patients depend on the services they get from agencies like Petitioner, and not following a plan of care established by a physician has the potential to harm a patient. Petitioner offered no argument in its briefs to rebut the evidence presented by HCFA. I sustain the deficiency.
The surveyors made the following assertions regarding Patient 2:
This patient for the period 063097 - 083097 was to receive skilled nursing visits 3 times a week. There was no skilled nursing visit from 080797 until 090497. The physician was not notified
It should be noted that the last skilled nursing visit was done on 090597 and visits were ordered to be done for the period 083197-103197 for two times a week. (The agency confirmed that there were no clinical notes to be filed for this patient on 092397. The agency policy was that notes were to be on the record within 7 days of providing the visit.)
HCFA Ex. 2, at 19.
I discussed Patient 2 above at G Tag 143 (supra, at pages 27 - 28). Petitioner admits that Patient 2 received fewer skilled nursing visits than ordered. I found that given Patient 2's serious health condition, Patient 2's physician wanted him monitored several times a week over two certification periods. Instead, no monitoring by Petitioner of Patient 2's condition took place for Patient 2 within the confines of Patient 2's plan of care. This could have, potentially, harmed Patient 2. Moreover, Petitioner has introduced no evidence to show that the patient's physician was notified. I sustain the deficiency.
The surveyors made the following assertions concerning Patient 14:
Patient # 14 medical social worker visits were provided less than ordered. The physician was not notified.
HCFA Ex. 2, at 19.
For the certification periods June 30, 1997 through August 30, 1997, and August 30, 1997 through October 30, 1997, Patient 14's physician ordered medical social worker (MSW) services 1-2XWX9 PRN (with the latter certification period appending the word ON-GOING). HCFA Ex. 24, at 1, 3. Ms. Schatz testified that this notation means one to two visits per week, plus PRN (more visits as needed). Tr. at 265 - 268.
Petitioner does not assert that the visits were made weekly. Instead, Petitioner argues that the notation "MSW 1-2XWX9 PRN" means only that the social worker can make 1 - 2 visits a week, but does not have to do so. Thus, Petitioner asserts that the visits were not made because they were not required.
From my review of medical social worker follow-up visits, it is evident that the patient was stable and in need of minimal follow-up visits by the social worker. HCFA Ex. 24, at 5 - 12. The social worker repeatedly recommended only 1 - 2 visits per month and 1-3 as needed. HCFA 24, at 6, 8, 10, 12. There is no suggestion in any of the reports of visits that a greater visitation rate was necessary in the care of this patient. Obviously, this level of visits is not in accord with the plan of care. The surveyor was correct in that the plan of care was not followed by Petitioner and that the physician should have been notified so that the plan could be amended. While in this case no harm seems to have come to the patient, the violation results from the social worker, and not the physician, deciding what frequency of visits were necessary in the treatment of the patient. That is the physician's call under the regulations, not the social worker's. Only the treating physician can decide to alter the plan of care for the patient.
As to Petitioner's argument that the physician's order allowed Petitioner's staff to decide the number of social worker visits which were necessary, other than Petitioner's counsel's assertions there is no record support for the argument. Obviously, the best evidence of what the physician intended would have been for the physician to explain the order. This was not done. The surveyors' interpretation is reasonable, in that the physician's order called for a minimum number of visits, with additional visits to be made if necessary. Absent record evidence of a different interpretation, I accept the surveyors' interpretation. At the very least, Petitioner should have contacted the physician and clarified the meaning of the order. I sustain this deficiency.
G 159 484.18(a) STANDARD: PLAN OF CARE: The plan of care developed in consultation with the agency staff covers all pertinent diagnoses, including mental status, types of services and equipment required, frequency of visits, prognosis, rehabilitation potential, functional limitations, activities permitted, nutritional requirements, medications and treatments, any safety measures to protect against injury, instructions for timely discharge or referral, and any other appropriate items.
Based on the review of clinical records and telephone interviews with patients, the surveyors determined that the plans of care failed to accurately match the conditions of patients.
11. For Patients 2, 1, and 11, their plans of care failed to accurately match their conditions, in violation of 42 C.F.R. � 484.18(a).
Patient 2
The surveyors made the following assertions concerning Patient 2:
The plan of care for the period 083197 - 103197 included a diagnosis of hypertension which was dated 090597. The plan of care indicated that a verbal order was received for that period on 082897 by personnel #52.
HCFA Ex. 2, at 20.
The plan of care for this patient for the certification period of August 31, 1997 to October 31, 1997, contains a diagnoses of "HYPERTENSION (EXAC)" dated September 5, 1997. HCFA Ex. 25, at 1. Review of the skilled nursing visit for September 5, 1997, fails to document the existence of hypertension, and the clinical note reflects a blood pressure reading of 140/70.
HCFA Ex. 25, at 3. While the skilled nurse noted that the patient was taught the signs and symptoms of hypertension and the need to notify medical personnel of their occurrence, there is no indication from the note that hypertension was present. Id.
Ms. Schatz testified that the plan of care for the August to October certification period was based on a verbal order for the start of care dated August 28, 1997. Tr. 276 - 277; HCFA Ex. 25, at 1. She surmised that there was no way that the skilled nurse on August 28, 1997, could predict an exacerbation of hypertension one week later on September 5, 1997. Moreover, she noted from her review of the record that there was no basis for a diagnosis of hypertension from the prior certification period or on September 5, 1997. Tr. at 276 - 277.
In response, Petitioner argues that hypertension was noted on HCFA Ex. 23, at 5, for the former certification period. P. Br. at 40. However, HCFA Ex. 23 was withdrawn and, thus, is not an exhibit in this case subject to my consideration. Petitioner contends also that there are a number of references to hypertension throughout the patient's clinical record, with citations to P. Ex. 2, at 458, and HCFA Ex. 45, at 73. Id. Neither of the cited exhibits, however, refers to Patient 2.
Petitioner concludes its arguments with the assertion that the entry date of September 5, 1997, was simply a transcription error. Id. I disagree. Based on the credible testimony of the surveyor concerning the lack of evidence establishing a diagnosis of hypertension in the record as of the August 1997 certification period, and the lack of supporting documentation for such a diagnosis from the September 5, 1997 skilled nursing visit, there is nothing to support the diagnosis at all. Furthermore, even if I had determined that there was a history of hypertension, such a history would not necessarily support a current diagnosis of hypertension. I sustain the deficiency.
Patient 1
The surveyors made the following assertion concerning Patient 1:
The patient did not require skilled nursing visits in reviewed time frame 08/15/97 to current. The condition was stable and without change since 4/4/97 medication change. The patient attended dialysis clinic 3 times per week.
HCFA Ex. 2, at 20 - 21
Ms. Reynolds reviewed Patient 1's plan of care and skilled nursing visits for the period August 15, 1997, to the date of the follow-up survey on September 25, 1997. Tr. at 539 - 540. HCFA Ex. 26 reflects the three plans of care for certification periods starting March 12, 1997, and ending on September 14, 1997, with skilled nursing visits initially ordered to take place four times per week with decreases to three and two times per week in the last certification period. In an addendum to the plan of care dated August 31, 1997, Patient 1's physician described the patient as a thin, debilitated person who ambulates with a weak, slow, unsteady gait, who has poor vision and is forgetful. HCFA Ex. 26, at 8. In monthly progress notes, Patient 1 was noted to be hypotensive following her hemodialysis treatments with no changes in medication or diet. HCFA Ex. 26, at 12 - 15. The physician directed the skilled nurse to monitor the patient and to teach the patient disease entities, medication, and diet regimen. HCFA 26, at 7.
Ms. Reynolds concluded from her review of the clinical record that the patient's condition had remained stable from April 1997, when there was a medication change, to the time of her survey, and that Patient 1 was not in need of continued skilled nursing visits for this period of time. Tr. at 540. In further support of her opinion that continued skilled nursing visits were unnecessary, Ms. Reynolds pointed to the dialysis visits, where she opined the patient would have been observed, and would have received regular nursing checks and medical care. Tr. at 541 - 542. At the hearing, I quizzed the surveyor as to the basis for her opinion in light of the patient's diagnoses and the skilled nursing care ordered by the treating physician for the patient. Tr. at 542 - 547. Her response was simply that Petitioner's staff had prepared the plan of care for the physician who signed off on it in reliance on the assessments of the skilled nurses, which she contended were inaccurate as to patient needs. Tr. at 544. Ms. Reynolds elaborated further, indicating that the patient's condition was stable, and that the patient had chronic conditions but did not need repeated weekly skilled nursing visits, particularly in light of the patient's regular dialysis visits. Ms. Reynold's stated that if there had been changes in the patient's condition ( i.e., fluctuations in blood pressure) which needed monitoring by a skilled nurse or a chronic condition such as wound care that required skilled services, then continued skilled nursing care would be justified. But, Ms. Reynolds contended that such circumstances did not exist in this case. Tr. at 547. Therefore, it was incumbent on Petitioner's staff to notify the treating physician of the current status of the patient -- stable without complications -- and to recommend a change in the plan of care to reflect this status.
Petitioner responds by drawing attention to the June 30, 1997 summary, which was signed by the physician. P. Br. at 40; HCFA Ex. 26, at 9. The diagnoses are stated and reference is made to a weak, unsteady gait, poor vision, faint peripheral pulses, stable weight and complaints of fatigue after hemodialysis. Id. Based on these and other findings noted in the summary, the physician directs skilled nursing visits three times per week for nine weeks to "assess and evaluate for exacerbations of disease processes, teach disease entities, diet/medication regimen and medication expected action and side effects." Id. However, even if I were to conclude that skilled nursing was needed to carry out these activities for this certification period July 14, 1997 to September 14, 1997, the August 31, 1997 summary demonstrates that the patient was stable and that further skilled nursing services to repeat services already provided would be redundant and unnecessary. The skilled nursing visit for August 20, 1997, noted no significant findings or symptoms and indicated only a knowledge deficit regarding the need of salt in the patient's diet. HCFA Ex. 26, at 19. Considering the apparent limited mental capacity of the patient to retain information, there is little likelihood that mandated instructions, even if repeated at each visit, would be retained by the patient. Continued and repeated skilled nursing visits by August 1997, for such purposes, would be of little assistance to the patient and, thus, unnecessary.
Petitioner argues also that Ms. Reynolds does not have first hand knowledge of what occurs at a dialysis clinic. P. Br. at 40. To support its position, Petitioner relies on my questioning of Ms. Reynolds at the hearing. See, Tr. at 577 - 579. I am satisfied that Ms. Reynolds is adequately familiar with the care rendered to patients at such clinics. Whether they provide the extent of instruction that the skilled nurse was directed to do in the plan of care is not important. I have already concluded that such repetitive teaching would have limited benefit for this patient. For the reasons stated above, I sustain the deficiency.
Patient 11
The surveyors made the following assertion concerning Patient 11:
The patient did not require skilled nursing visits in reviewed time frame 08/15/97 to current. There was no change in condition related to diagnoses and a necessary skill was not provided on the skilled nurs[sic] visits. The patient had teeth extractions which required no intervention by the nurse and the physician was not informed.
HCFA Ex. 2, at 21.
Ms. Reynolds testified that based upon her review of the clinical records for this patient for the time period of July 21, 1997 to September 8, 1997, the patient was not suffering from any condition which required skilled nursing services. Tr. at 547 - 548; HCFA Ex. 27, at 17 - 25. According to Ms. Reynolds, the patient's condition was stable and without change, and the extraction of teeth would not require skilled nursing care.
Patient 11's plan of care for the certification period August 11, 1997 to October 11, 1997, indicated diagnoses of postural hypotension, tracheostomy, malnutrition and hypothyroidism. HCFA Ex. 27, at 1. The skilled nursing visits for this period show that the nurse provided repeated teaching to and assessment of the patient. Id. at 9 - 20, 23 - 28. The patient was alert and oriented times three, and was considered a good listener but a slow learner. Id. There is no indication that the tracheostomy needed special care, as it was being handled by the patient. Id. at 7. The plan of care for this certification period was essentially identical to the plans of care for the two earlier certification periods. Id. at 4 - 6. The frequency of skilled nursing visits remained the same at three times per week, and the skilled nursing services did not vary from one certification period to another.
An obligation indicated in the care plans was for the skilled nurse to "manage/evaluate patient care plan." Id. at 1, 3, 5. This comports with the regulatory obligation that the skilled nurse observe and assess the patient and report to the physician any circumstances that might warrant a change in the care plan. I agree with the assessment of the surveyor that the patient was stable and that repeated teaching areas stated in the care plan would become redundant and unnecessary to a patient who clearly had difficulty comprehending the information. Such circumstances were not reported to the physician and he apparently signed off on the same care plan over three certification periods. A goal of the care plans was to discharge the patient to the care of her family with medical follow-up. Id. at 2, 4, 6. Clearly, Petitioner failed to undertake actions with the physician which would allow this goal to be achieved.
Petitioner criticizes the surveyor for making "sweeping assumptions" and ignoring examples of teaching, occasional elevations of temperature, and memory problems. P. Br. at 41. In essence, Petitioner argues that this 85-year-old, chronically ill, fragile, and malnourished patient required skilled nursing services. Id. Petitioner fails to point to anything in the record which would warrant continued skilled nursing services for the period referenced by the surveyor. While it is true the patient had a number of chronic conditions, she was able to manage these without intervention of skilled services. Her memory problems, which Petitioner acknowledges, cannot be used to justify repetition of the same material over multiple certification periods. Instead, training of the patient and her caregivers would suffice. I sustain this deficiency.
Patient 8
The surveyors made the following assertions concerning Patient 8:
The plan of care for the period 081597 - 101597 indicated that the patient had a primary diagnosis of hypertension exacerbation dated 071697. The patient did not see the physician on that date. The skilled nurse visited the patient on 071697 and the patient's blood pressure was recorded as being 156/90.
Ms. Schatz indicated that she based this deficiency on a clinical visit of July 16, 1997, during which visit the patient's blood pressure was noted to be 156/90 (with no notification of the patient's physician) and where the care plan for the certification period of August 15, 1997 to October 15, 1997, reflected a principal diagnosis of hypertension (exac) dated July 16, 1997. Tr. at 284 - 285; HCFA Ex. 29, at 1, 4. Ms. Schatz contended at the hearing that the deficiency was based on the lack of notification to the patient's physician regarding the hypertension on July 16, 1997, and the fact that the care plan contained a diagnosis which was not based on the physician's observation of the patient. Tr. at 284.
Petitioner argues in its brief that no deficiency has been shown. P. Br. at 41. I concur. While it is arguable that the physician should have been notified on July 16, 1997, of the potential hypertensive finding, he was apparently notified subsequently due to the fact that he signed the care plan containing the hypertension diagnosis. There may have been a delay in delivering the information to the physician, the extent of which I cannot determine from this record, but such delay did not adversely impact on the patient. The regulation requires the physician be notified of a change in condition so that the plan of care can be amended to reflect treatment for such change. Here the plan of care reflected the diagnosis obtained from a skilled nursing visit. There is nothing in the record to suggest that a more emergent change was required. I find in favor of the Petitioner.
G 162 484.18(a) STANDARD: PLAN OF CARE: The therapist and other agency personnel participate in developing the plan of care.
Based on the review of records for Patients 14 and 15, who received therapy services, the surveyors determined that therapists did not participate in developing the care plans for these patients. The surveyors cross-referenced to G Tag 185.
12. For Patients 14 and 15, Petitioner failed to have the patients' physical (and for Patient 15, occupational) therapists participate in developing their plans of care, in violation of 42 C.F.R. � 484.18(a).
Patient 14
The facts for this deficiency were previously set forth in my discussion of G Tag 143, and there is a cross-reference to G Tag 185 (infra, at page 65). My prior discussion concentrated on the issue of a lack of liaison and coordination, in that physical therapy services were performed without a written and signed physician order or an oral order. See, supra, at pages 25 - 27. Additionally, the plan of care for the certification period when the physical therapy was provided did not contain an order for such therapy. Id. at 26. To the extent that such an order was provided retroactively, such order does not cure the basis for this deficiency citation, which is that the services were provided without authorization and not included in the applicable plan of care. Patient 14's plan of care should have included orders for the physical therapy provided to the patient. The deficiency under this standard is that Petitioner did not ensure that the physical therapist was involved in the development of the plan of care, which should have included physical therapy orders. This lack of communication and involvement by the physical therapist may have led to the failure to include such services in Patient 14's plan of care. Petitioner does not specifically address this deficiency in its brief. I sustain the deficiency.
Patient 15
The plan of care for this patient for the certification period of July 23, 1997 to September 23, 1997, did not contain orders for physical or occupational therapy. Nor were any separate physician orders found authorizing such therapy. Despite this, five physical therapy and 10 occupational therapy visits were provided to the patient. Tr. 460 - 462, 466; HCFA Ex. 45, at 104. There is a referral sheet in the record indicating that when the patient was discharged from the hospital such services should be provided, but it is not signed by the physician and the surveyor correctly stated that it did not constitute an order. Tr. at 460 - 461. Monthly patient status reports dated August 15, 1997 and September 15, 1997, also fail to reflect the provision of such services. HCFA Ex. 30, at 5 - 6.
The facts here are similar to the facts in Patient 14's case. The required involvement of the therapists in the development of the plan of care, which should have contained orders for such therapy, did not take place. Petitioner acknowledges the failure to obtain the physician's signature on the referral, but does not address the specifics of this deficiency. P. Br. at 42. I sustain the deficiency.
G 163 484.18(b) STANDARD: PERIODIC REVIEW OF PLAN OF CARE: The total plan of care is reviewed by the attending physician and HHA personnel as often as the severity of the patient's condition requires, but at least once every 62 days.
Based on a review of 14 applicable clinical records, the surveyors determined that the total plan of care was not reviewed by the attending physician and Petitioner's personnel at least once every 62 days, as required for Patient 10. The surveyors cross-referenced to G Tag 158.
13. Petitioner failed to have Patient 10's plan of care reviewed by the treating physician and agency personnel at least once every 62 days, a violation of 42 C.F.R. � 484.18(b).
The facts relating to Patient 10 are set forth previously in my decision (supra, at 37 - 38). I found there that Petitioner provided care to Patient 10 after the certification period of July 14, 1997 to September 14, 1997, ended, and there was no new plan of care in place. Id. The plan of care for the July to September period was established on June 30, 1997. HCFA Ex. 18, at 1. Since care was being provided after September 14, 1997, in the absence of a care plan, the record fails to demonstrate that the Petitioner met the regulatory requirement that the physician review the care plan within the 62-day limit. Petitioner does not address or provide any explanation for Petitioner's failure to meet the 62-day requirement. Consequently, I sustain this deficiency.
G 164 484.18(b) STANDARD: PERIODIC REVIEW OF PLAN OF CARE: Agency professional staff promptly alert the physician to any changes that suggest a need to alter the plan of care.
Based on a review of 15 clinical records, the surveyors determined that Petitioner's professional staff failed to promptly alert physicians to changes that suggested a need to alter the plan of care for patients. The surveyors cross-referenced to G Tags 143 and 158. HCFA's argument is limited to Patients 6, 8, 2, and 14, and the citations under G Tags 143 and 158, above. HCFA Br. at 58 - 60; HCFA Reply Br. at 27. Thus, I discuss only these patients.
14. For Patients 6, 8, 2, and 14, agency professional staff failed to promptly alert the treating physicians to changes in the patients' conditions that might warrant an alteration of the plan of care, in violation of 42 C.F.R. � 484.18(b).
Patients 6 and 14
I addressed the specifics of the deficiencies regarding these patients in my discussion of G Tag 143 (supra, at pages 18 - 21, 25 - 27). The deficiencies cited previously, in part, involved the failure of Petitioner to notify the physician of symptoms reported to the skilled nurse during visits with the patient or of treatment provided to patients without physician authorization. For the reasons cited earlier in my decision regarding G Tag 143, I sustain the deficiency here. Under G Tag 143, the lack of physician notification demonstrated a lack of coordinated services which could adversely affect the objectives of the plan of care. Here, the standard covers required physician notification when there are changes that might require an amendment to the plan of care. Both standards impose a responsibility on home health agencies to notify physicians when changes occur, either in the condition of the patient or in the provision of services, that might warrant an amendment to the plan of care. This is necessary to ensure the plan of care is current and accurately reflects the needs of the patient. For the reasons previously stated, I sustain the deficiencies under this standard as well.
Patients 6, 8, 2, 14
I have reviewed the deficiencies cited as a cross reference in G Tag 158. I have discussed those deficiencies in my decision (supra, at pages 39 - 42). In part, they deal with Petitioner's failure to provide skilled services at the frequency ordered in the plan of care. Such failure obviously impacts on the care provided to the patients, as reflected in my discussion of those deficiencies. Additionally, there is a need to inform the treating physician of the fact that the care ordered was not provided. This is to allow the physician to consider whether additional care might be needed. Any subsequent modification of the care provided would need to be documented in an amended plan of care. While the change that dictates the physician notification is not in the patient's condition per se, the failure to provide the services ordered by the physician might adversely affect the patient's health or safety and, therefore, might necessitate a change in the plan of care. The deficiency is sustained.
G 165 484.18(c) STANDARD: CONFORMANCE WITH PHYSICIAN ORDERS: Drugs and treatments are administered by agency staff only as ordered by the physician.
Based on a review of the clinical records, the surveyors determined that drugs and treatments were not administered by agency staff only as ordered by a physician.
15. For Patients 1, 4, 6, and 15, drugs and treatments were not administered by agency staff only as ordered by the patients' physicians, violations of 42 C.F.R. � 484.18(c).
Patient 1
The surveyors made the following assertions regarding Patient 1:
The skilled nurse failed to provide teaching as ordered for certification 07/14/97 to 09/14/97. There was no instruction on renal diet, hypertension, dysrythmias, cardiac insufficiency, asthma, pulse monitoring, safety, transfer, ambulation technique, and pacemaker precautions.
HCFA Ex. 2, at 24.
Petitioner's specific response to this deficiency is a comment in its brief (P. Br. at 47) that Ms. Reynolds acknowledged inaccuracies in the findings under this G Tag. Tr. at 560. Ms. Reynolds admitted that, upon review of agency documents submitted as exhibits in this hearing, she discovered that "one or two" items of teaching she previously had cited as not being provided were, in fact, taught by the skilled nurse. Id. Petitioner's counsel showed Ms Reynolds HCFA Ex. 32, at 6, which reflects instruction on "milk products containing calcium, i.e. yogurt, ice cream and milk," and asked her if that was, in fact, instruction on a renal diet. Tr. at 563. Ms. Reynolds admitted that such instruction pertained to diet, but then asserted that under a renal diet the patient should avoid milk products. Id. at 564. Here, I agree with Petitioner that renal diet instruction was provided. I do not, however, agree with Petitioner regarding the other areas of instruction. At hearing, Petitioner's counsel gave examples of instruction in the clinical notes regarding medication use, fluid overload and high and low blood pressure, regulation of body fluid, heart action and congestive heart failure (CHF). Id. at 565, 569-570; HCFA Ex. 32, at
3 - 5, 7 - 9; P. Ex. 1, at 4. While I would agree that such instruction generally applies to hypertension, dysrythmias, and cardiac insufficiency, my review of the nursing visits for this patient indicates that no instruction was provided for asthma, pulse monitoring, safety, transfer, ambulation technique, and pacemaker precautions. HCFA Ex. 32; P. Ex. 1. Petitioner offered no evidence that these areas were covered in the instruction. I sustain the deficiency as to these areas.
Patient 4
The surveyors made the following assertions regarding Patient 4:
The skilled nurse failed to provide services in accordance with the plan of care for certification 7/14/97 to 9/14/97. There was no instruction on medication administration, diet, diseases, decubitus care, muscle/bladder spasm, and infection control as ordered by the physician.
HCFA Ex. 2, at 24 - 25.
Petitioner argues in its brief that despite this patient's knowledge deficit, instruction was provided on "diet, diseases, infection control with an emphasis on the chief medical problem, 'decubitus care.'" P. Br. at 47. Petitioner referred to HCFA Ex. 33, which is the clinical record for this patient. Id. My review of this record reveals instruction on infection control, care and prevention of pressure sores (which could lead to decubitus ulcers),(25) and paraplegia as factors in causing pressure sores. Id. at 3-8, 10, 14, 17. There was no instruction on medication administration, diet, muscle spasms, and bladder spasms. Petitioner did not provide any evidence that these areas were covered in the instructions provided to the patient. I sustain the deficiency as it relates to these items.
The surveyors made the following assertions regarding Patient 6:
The skilled nurse failed to check the patient's weight weekly as per Plan of Care. Weights were documented 7/29/97, 8/12/97, 9/8/97, 9/16/97 and 9/18/97. Weights were not done for 4 of 9 weeks.
HCFA Ex. 2, at 25.
Petitioner admits the required weight checks were not done weekly as required in the plan of care. P. Br. at 47 - 48. Petitioner argues, however, that such failure is better characterized as merely an oversight in not getting an order from the physician reducing the frequency of weight checks. This argument misses the point. Petitioner's responsibility is to follow the plan of care as written by the physician. If there is to be a change in the care provided, the physician must authorize it before Petitioner can implement the change. Petitioner's post-survey rationalization is untimely and speculative. Consequently, I sustain the deficiency.
The surveyors made the following assertions regarding Patient 15:
The skilled nurse was ordered to notify the physician of blood pressure readings greater than 150/90 or less than 100/64. For thirty applicable visits from 080197-091997 the patient had blood pressure readings from 90-100/58-60. For those 30 visits the physician was not notified of the readings in accordance with the plan of care.
The skilled nurse was ordered to report blood sugar readings above 160 or below 70. For six visits the blood sugar readings were greater than 160. The physician was not notified.
HCFA Ex. 2, at 25.
Petitioner admits the existence of the deficiency, but attempts to explain it away by referring to a mistaken use of blood pressure guidelines -- arguing that Petitioner utilized average guidelines rather than patient specific guidelines. P. Br. at 48. There is nothing in the record to support the assertion. Petitioner offered no testimony or record evidence relating to such guidelines, nor does Petitioner discuss the blood sugar readings. I sustain the deficiency.
In addition to the specific arguments cited above, Petitioner makes the following general argument applicable to all patients cited under this standard. Petitioner states that the ordered services cited above, which are either instructions to be provided to patients or assessments of patients' conditions, are not treatments. Petitioner, for purposes of this argument, defines treatment as "any specific procedure used for the cure or the amelioration of a disease or pathological condition." P. Br. at 44.(26) I do not agree with Petitioner's definition. I note a few examples of some of the types of instruction that Petitioner would consider to be unrelated to treatment of the patients -- teaching patients to be aware of the signs and symptoms associated with their disease entities, proper diet to control their conditions, ambulation techniques to avoid falls caused by physical deterioration associated with their conditions, proper administration of medicine to ensure their conditions are properly treated, and care of decubitus ulcers. These instructions were mandated by treating physicians in orders contained in care plans for some of the patients cited above. The physicians obviously believed that such instruction was necessary in the care and treatment of their patients, otherwise they would not have ordered it. Such instruction is a necessary element of the treatment, in order that the patients and their caregivers have the information to act if there is an exacerbation of the symptoms of a condition or otherwise avoid complications of an existing condition.(27) Petitioner's argument, that such action is not a part of the treatment of patients, is absurd. Similarly, Petitioner's argument that periodic assessment of a patient's blood pressure, weight and blood sugar is not a necessary part of the treatment of the patient is equally meritless.
The standard cited by the surveyors simply requires that Petitioner's personnel carry out the treatment orders for patients contained in their plans of care. Petitioner, as cited in the examples above, did not do so. I sustain the deficiencies.
G 167 484.18(c) STANDARD: CONFORMANCE WITH PHYSICIAN ORDER: Agency staff check all medicines a patient may be taking to identify possible ineffective drug therapy or adverse reactions, significant side effects, drug allergies, and contraindicated medication, and promptly report any problems to the physician.
Based on a clinical record review, the surveyors determined that Petitioner's staff failed to check the patients' medications and to classify the medications as required by Petitioner's policy.
16. For Patients 5, 10, 14, and 2, Petitioner's personnel failed to check the patients' medications and classify the medications as required by Petitioner's policy, in violation of 42 C.F.R. � 484.18(c).
I have addressed the factual circumstances of the cited deficiencies for each of these patients in my discussion of G Tag 134 (supra, at 12 - 15). I found that Petitioner's skilled nurses had incorrectly classified drugs in medication profile forms that Petitioner used in connection with patient care. Among the information contained in the form were the side effects and contraindications of the listed drugs. Petitioner's failure to correctly classify at the outset such drugs as Mexilitene, Hydrocodone 5/500, APAP with codeine, and Verapamil, resulted in a contravention of the cited regulatory requirement. If the drugs are misclassified by the skilled nurses, then potential errors as to use could occur. If a possible ineffective drug was prescribed, a misclassification of the drug would not allow the skilled nurse to be in a position to know of the potential ineffectiveness. Similarly, misclassification of drugs would prevent accurate determination of potential adverse actions, side effects, drug allergies and contraindications. Likewise, the skilled nurse would not be in a position to notify the treating physician of such potential problems.
Petitioner's response to the cited deficiencies is misguided. It seems to argue that its staff, in checking the cited medications, made "some clerical errors," but that compliance with the regulatory standard is shown by the agency's completing and updating of the medication profile forms. P. Br. at 45. Petitioner's attempt to minimize the significance of the misclassifications of the drugs as clerical errors misses the point of this regulation. Drug therapy is an integral part of the treatment of a patient's condition. Errors in classification can be quite serious and potentially lead to significant complications in a patient's care. Such errors must be avoided. I sustain the deficiencies.
Summary of deficiencies under the condition at 42 C.F.R. � 484.18
17. The deficiencies found in the standards under the condition set forth at 42 C.F.R. � 484.18 are of such character as to substantially limit Petitioner's capacity to furnish adequate care or which adversely affect the health and safety of its patients.
Here, I found, in examining the alleged deficient standards HCFA cited with regard to the condition of participation at 42 C.F.R. � 484.18 for Acceptance of Patients, Plan of Care, and Medical Supervision, that Petitioner was: 1) deficient regarding two patients under G Tag 156, the actual condition of participation regarding acceptance of patients, plan of care, and medical supervision; 2) deficient regarding five patients under G Tag 158, the standard requiring that care follow a written plan of care established and periodically reviewed by a doctor of medicine, osteopathy, or podiatric medicine; 3) deficient regarding three patients under G Tag 159, the standard requiring that the plan of care developed in consultation with agency staff covers all pertinent diagnoses, including mental status, types of services and equipment required, frequency of visits, prognosis, rehabilitation potential, functional limitations, activities permitted, nutritional requirements, medications and treatments, any safety measures to protect against injury, instructions for timely discharge or referral, and any other appropriate items; 4) deficient regarding two patients under G Tag 162, the standard requiring that the therapist and other agency personnel participate in developing the plan of care; 5) deficient regarding one patient under G Tag 163, the standard requiring that the total plan of care is reviewed by the attending physician and Petitioner's personnel as often as the severity of the patient's condition requires, but at least once every 62 days; 6) deficient regarding four patients under G Tag 164, the standard requiring that Petitioner's professional staff promptly alert physicians to changes in a patient that suggest a need to alter that patient's plan of care; 7) deficient regarding four patients under G Tag 165, the standard requiring that drugs and treatments are administered by Petitioner's staff only as ordered by a physician; and 8) deficient regarding four patients under G Tag 167, the standard requiring that Petitioner's staff check all medicines a patient may be taking to identify possible ineffective drug therapy or adverse reactions, significant side effects, drug allergies, and contraindicated medication, and promptly report any problems to the physician.
Under G Tag 156 (referring to the condition of participation at 42 C.F.R. � 484.18), which requires here that services be administered in accordance with the plan of care, that patients' physicians be notified of the need to alter a patient's plan of care, and that the plans of care failed to match the patients' conditions, I sustained the deficiencies as to both patients cited, for Patient 10 that Petitioner did not follow the physician's orders, and for Patient 6 that Petitioner did not notify the patient's physician of the need to alter the patient's plan of care. Either situation could have seriously affected the health and safety of Petitioner's patients, and either situation alone might have led me to a conclusion that Petitioner is not capable of providing care consistent with the Act and regulations under this condition of participation. However, given Petitioner's failures in both situations, I find such failures clearly amount to this Medicare condition of participation being out of compliance.
Under G Tag 158 (referring to the standard at 42 C.F.R. � 484.18), which requires that care follow a written plan of care established and periodically reviewed by a doctor of medicine, osteopathy, or podiatric medicine, I sustained deficiencies in the care of the following patients: 10 (for failure to follow the physician's plan for visit frequency and for failure to follow the physician's plan for skilled nursing and home health visits, although I did not sustain a deficiency in this instance for Petitioner's failure to provide a home health aide visit in the absence of a plan of care); 8 (skilled nursing visits were provided less frequently than ordered by the patient's physician); 6 (seven skilled nursing visits were made without the authorization of the physician); 15 (skilled nursing visits were provided less frequently than ordered by the patient's physician); 2 (skilled nursing visits were provided less frequently than ordered by the patient's physician); and 14 (medical social worker visits were provided less frequently than ordered by the patient's physician and the physician was not notified). Here, I believe that HCFA has proved a pattern of practice whereby Petitioner provided care not authorized or failed to provide care as ordered. As I discussed above (supra, at 19), in these situations, a strict interpretation of the regulations must be required. It is Petitioner's responsibility to provide only those services ordered by the patients' physicians. Further, as I stated in Pacific Coast, DAB CR534, at 45, in a home health agency setting, it is contemplated that the home health care givers will follow a physician's orders. Unlike in an in-patient setting, a physician cannot come to a patient's home to determine if an agency is providing appropriate care. A physician must rely on the home health agency to implement the physician's medical judgment, not to exercise its own judgment by providing either more or less care than the physician ordered. In no instance should a home health agency be unilaterally substituting its judgment for that of the physician as to what the appropriate care of a patient should be. Thus, I find that the deficiencies under this G Tag are of such character as to substantially limit Petitioner's capacity to furnish adequate care and which deficiencies adversely affect the health and safety of patients.
Under G Tag 159 (referring to the standard at 42 C.F.R. � 484.18(a)), which provides that the plan of care include all pertinent diagnoses, I sustained deficiencies in the care of the following patients: 2 (the plan of care included a diagnosis of hypertension which the clinical record did not support); 1 (the diagnoses in the patient's clinical record did not support the provision of skilled nursing services to the patient); and 11 (the diagnoses in the patient's clinical record did not support the provision of skilled nursing services to the patient). Here, I have found that HCFA has established the existence of deficiencies that justify a certification of noncompliance with the standard, in that these deficiencies are of such character as to substantially limit Petitioner's capacity to furnish adequate care and adversely affect the health and safety of patients.
Under G Tag 162 (referring to the standard at 42 C.F.R. � 484.18(a)), which provides that a therapist and other agency personnel participate in developing a patient's plan of care, I found that for two patients (Patients 14 and 15) that physical (and for Patient 15, occupational) therapists did not so participate. Such failure, I believe, substantially limits Petitioner's capacity to furnish adequate care and adversely affects the health and safety of patients.
Under G Tag 163 (referring to the standard at 42 C.F.R. � 484.18(b)), which provides for the periodic review of the plan of care, I found that, for Patient 10, Petitioner did not assure that the patient's physician review the plan of care consistent with the 62-day regulatory requirement. I found that this could affect a patient's health and safety, in that the physician might not be in a position to alter the patient's plan of care in a timely fashion. Such failure also limits Petitioner's capacity to furnish adequate care.
Under G Tag 164 (referring to the standard at 42 C.F.R. � 484.18(b)), which requires that Petitioner is to promptly alert a physician to changes that might suggest a need to alter a plan of care, I found that Petitioner was deficient in doing so in the care of Patients 6, 8, 2, and 14. Such deficiencies also substantially limit Petitioner's capacity to furnish adequate care and adversely affect the health and safety of patients.
Under G Tag 165 (referring to the standard at 42 C.F.R. � 484.18(c)), which requires that drugs and treatments are administered only as ordered by a physician, I found that for patients 1, 4, 6, and 15, this was not done. Not following such orders clearly limits Petitioner's capacity to furnish adequate care and affects the health and safety of the patients.
Under G Tag 167 (referring to the standard at 42 C.F.R. � 484.18(c)), which requires that Petitioner check all medications, I found that the misclassification of drugs could have serious adverse affects on the health and safety of patients and limits Petitioner's capacity to furnish adequate care and affects the health and safety of patients.
The surveyors summarized Petitioner's failure to comply with the condition set forth at 42 C.F.R. � 484.30 as follows:
G 168 CONDITION: SKILLED NURSING SERVICES
The skilled nursing services were not furnished in accordance with the plan of care. The registered nurse failed to regularly re-evaluate the patient's nursing needs. The registered nurse failed to initiate the necessary changes in the plan of care. The registered nurse failed to inform the physician of changes in the condition of the patient. The registered nurse failed to coordinate services. The registered nurse failed to supervise home health aides as required.
HCFA Ex. 2, at 27.
Under this Condition of Participation, the surveyors determined that Petitioner was in violation of three standards, finding deficiencies at G Tags 170, 176, and 178. HCFA Ex. 2, at 27 - 28, 31 - 33.
G 170 484.30 STANDARD: SKILLED NURSING SERVICES: The home health agency furnishes skilled nursing services in accordance with the plan of care.
18. For Patients 10, 8, 6, 2, 1, 4, and 15, Petitioner did not provide skilled nursing services in accordance with the plan of care, in violation of 42 C.F.R. � 484.30.
The surveyors cross-referenced to deficiencies cited under G Tags 158 and 165 as the basis for their assertion that Petitioner failed to furnish skilled nursing services in accordance with the plan of care. I previously addressed the deficiencies under G Tags 158 and 165 in my decision (supra, at 37 - 42, 49 - 52). G Tag 158 pertains to Petitioner's failure to provide care pursuant to the plan of care and G Tag 165 pertains to Petitioner's failure to adhere to physician orders for certain patient assessments and instruction.
This G Tag, as with G Tags 158 and 165, requires Petitioner to provide services in accordance with the plan of care authorized by the treating physician. Here, the standard is particularized to skilled nursing services and requires that such services follow the plan of care. I have previously
found in G Tags 158 and 165 that Petitioner did not follow the plans of care for the identified patients. Those findings are applicable here, and provide a basis for my sustaining the deficiencies cited under this standard.
G 176 484.30(a) STANDARD: DUTIES OF THE REGISTERED NURSE: The registered nurse prepares clinical and progress notes, coordinates services, informs the physician and other personnel of changes in the patient's condition and needs.
Based on review of 15 clinical records, the surveyors determined that the registered nurse failed to coordinate services and failed to inform the physician of changes in the patient's condition and needs.
19. For Patient 6, Petitioner's registered nurse failed to coordinate services and failed to inform the physician of changes in the patient's condition and needs, in violation of 42 C.F.R. � 484.30(a).
Based on a review of clinical records, the surveyors determined that the registered nurse failed to coordinate services and failed to inform the physician of changes in the patient's condition and needs.
For reviewed time frame 08/15/97 to current the R.N. failed to inform the physician of the patient's frequent complaints of headache which the nurse documentation stated was associated with eyes. The nurse also failed to inform the physician that the patient was to go to an eye doctor but could not go until a medical bill was paid. The clinical record did not show that medical intervention was obtained to address the patient's headaches or eye problem.
The also [sic] nurse failed to inform the physician of "red eyes", "runny nose and sore throat", "vomiting", "nausea", "pain in the back", and "dizzyness".
HCFA Ex. 2, at 32.
The surveyors cited the factual deficiency for Patient 6 as support for their position that Petitioner did not adhere to this standard. See HCFA Ex. 2, at 32. The same facts were cited in support of G Tag 143, HCFA Ex. 2, at 11 (maintaining liaison and coordinating services among Petitioner's personnel performing services for the patient). It was also cited under G Tag 156, HCFA Ex. 2, at 16 (plan of care did not match patient's condition, the physician was not notified, and the plan of care was not amended). Further, it was cited under G Tag 164, HCFA Ex. 2, at 23 (physician not notified of any changes that suggest a need to alter the plan of care). I addressed this factual deficiency under each of the above described G Tags and I sustained the deficiency in each instance (supra, at 18 - 21, 37, 48 - 49). The surveyors cited the care of Patient 6 as the only evidence supporting a violation of this standard. A careful reading of the HCFA 2567, HCFA Ex. 2, which Petitioner has had the opportunity to respond to at this hearing, demonstrates other cited examples of patients whose care provided by Petitioner would violate this standard. There were changes in the patients' conditions or changes in the treatment frequency mandated in the plans of care which would affect patient needs and necessitate informing the treating physician. For example, see supra, at 28 - 29, 35 - 40, 43 - 45; Oak Lawn Pavilion, Inc., DAB No. 1638, at 12 (1997). I sustain the deficiency.
G 178 484.30(a) STANDARD: DUTIES OF THE REGISTERED NURSE: The registered nurse participates in in-service programs, and supervises and teaches other nursing personnel.
Based on review of applicable clinical records, the surveyors determined that the registered nurse failed to supervise the home health aides as required.
20. For Patients 5, 3, 10, and 2, Petitioner's registered nurses failed to supervise the home health aides to ensure that the care they provided these patients was in a manner consistent with instructions given to the aides by the registered nurses, in violation of 42 C.F.R. � 484.30(a).
Patient 5
The surveyors made the following assertions concerning Patient 5:
The home health aide failed to assist the patient with safe ambulation as assigned for 27 of 27 applicable visits from 082697. This patient required a walker to ambulate due to a right above the knee ambulation (sic) (amputation). Also the home health aide failed to shave the patient for 16 of 27 visits as assigned and failed to provide for food preparation for 10 of 27 visits as assigned.
HCFA Ex. 2, at 38.
To determine whether the home health aide provided the required services to the patient at each visit, an examination of the plan of care must be made. The applicable plan of care for the certification period of August 14, 1997 to October 14, 1997, for this patient contained the following order for home health aide care:
HHA to assist with bath, personal care, record vital signs, make/bed linen change, maintain safe clean patient environment. HHA to maintain optimum level of personal hygiene and comfort level, to prevent skin breakdown and maintain safe environment.
HCFA Ex. 38, at 2.
From this plan of care, the registered nurse prepares a home health aide plan of care which is done during a joint visit with the home health aide at the home of the patient. Id. at 3. Here, the home health aide was directed by the registered nurse to provide the following services to the patient: tub bath, shave, food preparation--warm/serve food, assist patient to ensure safe ambulation and light housekeeping (tidy work area) as necessary. Id. The patient was noted to have functional limitations caused by dyspnea (shortness of breath) with minimal exertion and poor endurance. Id. The patient was noted to have an amputation, a visual impairment and need for a walker. Id. The patient was in need of assistance in bathing, dressing, ambulation and light housekeeping. Id. Ms. Schatz reviewed the home health aide patient care record for this patient and determined that the care set forth in the home health aide plan of care was not provided on each visit. She testified that she examined each visit after August 26, 1997, the date of the home health plan of care, through to September 21, 1997, the date of the survey. Tr. at 379. Based on this review, she determined that the home health aide failed: 1) to assist with safe ambulation for 27 of 27 visits; 2) to shave the patient on each visit; and 3) to provide food preparation for a number of visits. Tr. at 378 - 380, 382. In reviewing Ms. Schatz's testimony, I find that she was vague as to the number of missed visits for shaves and food preparation. I have independently reviewed the daily home health aide reports for the period of August 27 through September 20, 1997. I found that shaves were not provided on 8/26 - 8/31/97, 9/2/97, 9/4/97, 9/7-13/97, 9/20/97. HCFA Ex. 38, at 5 - 13. Food preparation was not done on 8/27 - 28/97, 8/30 - 31/97, 9/3/97, 9/5/97, 9/13 - 14/97. Id.
I note that unless a physician has ordered the specific home health service in issue, then it does not matter whether the home health aide delivered the service. If a registered nurse directs a home health aide to deliver a service that is not authorized in a plan of care, and that service is not carried out in the frequency set by the registered nurse, there is no violation of any regulatory standard. There may be the need for in-house training of the home health aides, but delivery of a service not authorized by the treating physician would not contravene the regulations. See 42 C.F.R. � 484.18(c). Here, the treating physician's orders for the home health aide to assist with personal care and to maintain an optimum level of personal hygiene arguably encompassed shaving the patient on each visit. It is not unreasonable then for the registered nurse to interpret the order in that fashion. However, there is no order for food preparation and it does not reasonably fit within any of the areas covered in the home health aide orders.(28)
There is also no specific order for assistance with ambulation.(29)
When I asked Ms. Schatz at the hearing where the authority for such care came from she pointed to personal care. Tr. at 376. I cannot agree. If the physician wanted the patient to have assistance with ambulation, the physician would have specifically authorized it. Consequently, it is irrelevant to this standard whether the home health aide provided assistance with ambulation or with food preparation. Thus, I find that only the missed shaves are not in compliance with the physician's orders in this patient's plan of care.
Having decided that the patient should have received shaves on each visit from the home health aide raises the question as to whether Petitioner's registered nurse properly supervised the home health aide. Under 42 C.F.R. � 484.36 of the regulations pertaining to home health aide services, the registered nurse is to provide supervisory visits. The supervisory visits by registered nurses are required when skilled services are rendered to patients at a frequency of at least every two weeks, and, if no skilled services are provided but home health aide visits are authorized, then the supervisory visits must occur no less than every 62 days. See 42 C.F.R. � 484.36(d)(1) - (3). The record for this patient reflects only one visit to the patient by the registered nurse, which visit occurred on August 26, 1997, the day the home health aide plan of care was created. The plan of care authorized skilled services by a registered nurse. HCFA Ex. 38, at 1. The skilled nursing visits are not included in this record, so I am unable to determine whether they included efforts by the registered nurse to determine the level of care provided by the home health aide. (30) Therefore, the supervisory visits should have occurred at least every two weeks. During those visits, the registered nurse would have had the opportunity to check with the patient as to whether the services included in the home health aide plan of care were provided. Apparently, this was either not done or not adequately done. If it had been, then the failure to shave the patient would have been discovered and corrected. Since it was not discovered or corrected, it is fair to conclude that the supervision of the home health aide as required by this standard was not done. I sustain the deficiency as it relates to shaving the patient.
Patient 3
The surveyors made the following assertions regarding Patient 3:
The clinical record indicated that the patient had a provider for personal cares [sic] Monday through Friday every morning. The agency indicated that home health aides were needed daily Monday through Friday and twice a day on the weekends for the period 081997 -101997 for personal care. The agency provided twice a day home health aide visits for the period reviewed (081997-092197). The twice a day home health aide visits resulted in 22 extra home health aide visits documented for that period of time.
HCFA Ex. 2, at 38 - 39.
The factual situation described in this deficiency was previously discussed under G Tag 143 (supra, at 21 - 22). As I indicated, Petitioner admits that the extra visits occurred from August 19, 1997 to October 19, 1997, based on the plan of care for that certification period. P. Br. at 30. I rejected Petitioner's argument that an earlier physician order, which was not reflected in the applicable plan of care, would have authorized such visits. Such orders have no meaning unless they are incorporated in the plan of care or it is clear that they are intended to apply until the plan of care is amended to reflect the new orders. Petitioner offered no such evidence here. The registered nurse's failure to supervise the home health aide and to follow the plan of care caused Petitioner to make the 22 extra visits. I sustain the deficiency.
Patient 10
The surveyors made the following assertions regarding Patient 10:
For 4 of 4 applicable home health aide visits the home health aide showered the patient without being assigned to perform that task by the registered nurse. The aide also failed to assist with food preparation as assigned for those 4 of 4 visits.
HCFA Ex. 2, at 39.
The plan of care for this patient contains the following physician orders for home health aide care:
HHA to assist with bath, personal care, record vital signs, make bed/linen change, maintain safe clean patient environment and assist. with meals/preparation. HHA to maintain optimum level of personal hygiene and comfort level, to prevent skin breakdown and maintain safe environment.
HCFA Ex. 12, at 2.
The home health aide plan of care covers tub, partial bed bath and sponge bath but does not include showering the patient. HCFA Ex. 40, at 1. It also contains an instruction for food preparation. Id. Ms. Schatz testified upon her review of the clinical records that despite there being no instruction to shower the patient, the patient was showered by the aide on four occasions. Tr. at 389; HCFA Ex. 40, at 2 - 3. The surveyor testified that giving this patient a shower was contraindicated, because he had respiratory problems which could be aggravated by the humidity of the shower. Tr. at 389. Petitioner's only response is that the home health aide plan of care inadvertently left out instructions for a shower. P. Br. at 50. Petitioner misses the point. The physician ordered the provision of baths, not showers. The home health aide plan of care was consistent with the plan of care authorized by the physician. If the physician wanted the patient to be showered the physician could have ordered it, but the physician did not do so. Provision of showers not authorized for this patient, considering the patient's underlying condition, could place the patient in jeopardy. Moreover, it reflected the provision of services not authorized by the physician, which contravenes the regulations. Failure to ascertain this clear violation of the plan of care reflects that the registered nurse did not adequately supervise the home health aide as required under this standard. I sustain this deficiency.
The surveyors made the following assertions regarding Patient 2.
For the applicable period 090997 - 092197 the home health aide gave the patient a tub bath for 6 of 13 visits without being assigned, failed to dress the patient for 6 of 13 visits as assigned and failed to assist with food preparation for 9 of 13 visits as assigned.
HCFA Ex. 2, at 39.
The plan of care for this patient for the certification period of August 31, 1997 to October 31, 1997, contains the following orders for home health aide care:
HHA to assist with bath, pericare, personal care, record vital signs, make/bed linen change, maintain safe clean patient environment, assist with meals/preparation and ambulation. HHA goals are to maintain optimum level of personal hygiene and comfort level, to prevent skin breakdown, maintain safe environment.
HCFA Ex. 15, at 1 - 2.
The home health aide plan of care dated September 9, 1997, which should be derived from the physician's order, contains instructions that are material to this deficiency for sponge bath and food preparation. HCFA Ex. 41, at 1. There is no reference in this plan of care for ambulation, nor any indication that the patient requires assistance in this area.(31)
Id. Ms. Schatz reviewed the clinical records for this patient during the survey, and she testified that despite the order for sponge baths the home health aide gave the patient tub baths on six occasions. Tr. at 399 - 400. She also testified that the aide erroneously provided tub baths on 9/8/97, 9/12 - 15/97, 9/17/97, and 9/19/97, for a total of seven tub baths.(32) Tr. at 400; HCFA Ex. 41, at 3 - 6. HCFA counsel specifically asked her why a sponge bath would be required instead of a tub bath. Id. at 399. She responded that the patient's problems with endurance, ambulation, incontinence and poor vision would suggest the need for sponge baths. Id.
Petitioner does not dispute that providing tub baths by the home health aide contravened the plans of care. P. Br. at 50. Petitioner suggests simply that the home health aide should have obtained permission to give the patient tub baths and should have documented it. Again, this misses the point. If agency personnel believe that a service should be provided to a patient which is not authorized by a physician, then the physician must be notified and the plan of care amended. Here, this circumstance has been repeatedly cited in the HCFA Form 2567, and it is unfortunate that at this late date Petitioner has yet to understand its obligations under the conditions of participation for home heath agencies.
Ms. Schatz also cited Petitioner for failing to assist the patient with dress on a number of occasions. While that may be the case, there is no physician order for assistance with dress in the plan of care and it is not noted in the instructions for the home health aide. HCFA Ex. 15, at 1; 41, at 1. Consequently, there is no basis to fault Petitioner for failing to deliver this service.(33) The fact that Petitioner's home health aide may have assisted the patient with dress on a number of occasions does not alter the outcome. Gratuitous provision of a service of this type, which is not likely to adversely affect the patient, is of limited regulatory consequence.
The last portion of the deficiency deals with the failure by the home health aide to assist the patient with food preparation. The surveyor found from her review of the clinical record that Petitioner's home health aide failed to provide the required food preparation on September 9 -12, 1997 and September 14 - 19, 1997. Tr. at 401; HCFA Ex. 41, at 3 - 8. The record does not allow me to make an accurate accounting of the number of missed visits regarding food preparation. The surveyor cited nine missed visits regarding food preparation, and I found 10 in my review. Id.
As with the other deficiencies cited above, evidence that the home health aide frequently did not follow the home health aide plan of care is strongly suggestive that the registered nurse did not adequately supervise the home health aides as required under this standard. If there were records that the registered nurse had made the required supervisory visits, Petitioner had the opportunity to place such records into evidence. It did not do so. Nor has Petitioner's counsel argued that such visits occurred. The plan of care indicates that the patient was to receive two skilled nursing visits per week. HCFA Ex. 15, at 1. During such visits, the registered nurse should have inquired as to whether the patient was receiving the care ordered in the home health aide plan of care. Such an inquiry would have ensured that the required care was provided. I sustain this deficiency for all areas other than assistance with dress.
Generally, under this standard, Petitioner does not deny that the home health aides did not adhere to the instructions given to them by the registered nurses. P. Br. at 49. Rather, Petitioner attempts to mitigate such failure by referring to the informal nature of the home setting where a patient can reject the instructed service. Id. Moreover, Petitioner contends that the supervisory home visit by the registered nurse will lead to a discovery of whether the nurses are doing as instructed. Id. I agree, but as I noted in my discussion of the specific deficiencies, the registered nurses' visits with the patients apparently failed to reveal that services either were not delivered or were not delivered as planned in the patients' plans of care. Moreover, Petitioner apparently does not understand the regulatory requirements regarding rejected services. If a patient rejects a physician-ordered service, then the home health aide is obligated to note such refusal in the patient's chart. Such action protects both the home health aide and the home health agency. The registered nurse should also be notified so that the registered nurse can promptly notify the physician and ask for instructions. This may lead to an amendment of the plan of care or a reaffirmation of the order by the physician. Petitioner offered no evidence that this was done in these cases.
Summary of deficiencies under the condition at 42 C.F.R. � 484.30
21. The deficiencies found in the standards under the condition set forth at 42 C.F.R. � 484.30 are of such character as to substantially limit Petitioner's capacity to furnish adequate care or which adversely affect the health and safety of patients.
Here, I found, in examining the allegedly deficient standards HCFA cited with regard to the condition of participation at 42 C.F.R. � 484.30 for Skilled Nursing Services, that Petitioner was: 1) deficient regarding seven patients under G Tag 170, the standard requiring that a home health agency furnish skilled nursing services in accordance with the plan of care; 2) deficient regarding one patient under G Tag 176, the standard requiring that a registered nurse prepare clinical and progress notes, coordinate services, and inform the patients' physicians of changes in their conditions and needs; and 3) deficient regarding four patients under G Tag 178, the standard requiring that the registered nurse participate in in-service programs and supervise and teach other nursing personnel. In sustaining the deficiencies cited under these standards, I have found a pattern of failure, leading me to believe that Petitioner's deficiencies are of such a nature as to substantially limit its capacity to furnish adequate care and which adversely affect the health and safety of patients.
Under G Tag 170 (referring to 42 C.F.R. � 484.30), I found that with reference to the patients cited also in G Tags 158 and 165 (Patients 10, 8, 6, 2, 1, 4, and 15), Petitioner did not provide the skilled nursing services in accordance with the plan of care. Such failure, in such a large number of cases, shows a pattern of Petitioner's inability to furnish adequate care under this standard. Such inability could also adversely affect the health and safety of a patient.
Under G Tag 176 (referring to 42 C.F.R. � 484.30(a)), I found that with reference to the patient cited, Patient 6 (the facts of whose case were referred to under G Tags 143, 156, and 164 also), Petitioner's failure to have the registered nurse inform the physician of changes in the patient's condition put the patient in a situation where the patient's health could have been adversely affected.
Under G Tag 178 (referring to 42 C.F.R. � 484.30(a)), I found that the examples cited by the surveyors show a pattern of failures by Petitioner's registered nurses to supervise home health aides so as to ensure that the care they provided was in a manner consistent with the instructions given to them by the registered nurses. These failures included failures by the registered nurses in the following instances: Patient 5 (regarding a home health aide's failure to shave a patient); Patient 3 (regarding unauthorized home health aide visits); Patient 10 (regarding giving a patient showers in contravention of physician orders); and Patient 2 (regarding giving a patient a tub bath in contravention of the patient's plan of care and failure to assist with food preparation). The registered nurses' failures show a pattern of Petitioner's inability to render adequate care under this standard and adversely affects the health and safety of patients.
The surveyors summarized Petitioner's failure to comply with the condition set forth at 42 C.F.R. � 484.32 as follows:
G 184 484.32 CONDITION: THERAPY SERVICES
Under this condition of participation, the surveyors alleged two standards out of compliance at G Tags 185 and 186 of the HCFA Form 2567.
G 185 484.32 STANDARD: THERAPY SERVICES: Any therapy services offered by the HHA directly or under arrangement are given by a qualified therapist or by a qualified therapy assistant under the supervision of a qualified therapist and in accordance with the plan of care.
Based on a review of two applicable clinical records, the surveyors determined that Petitioner failed to provide therapy services in accordance with the plans of care for two patients.
22. For Patients 14 and 15, Petitioner provided therapy services without the authorization of the treating physicians and without an order in the patients' plans of care, in violation of 42 C.F.R. � 484.32.
The factual deficiencies cited by the surveyors under G Tag 185 were previously addressed in a related G Tag, G Tag 162, which dealt with whether the therapists who treated Patients 14 and 15 participated in their plans of care. The provision of physical therapy services to Patient 14 without a physician's order was also addressed in G Tag 143. I need not repeat my analysis of the deficiencies here. In essence, I found that the treating physicians for Patients 14 and 15 did not authorize the therapy services at the time they were rendered and the applicable plans of care contained no orders for such services (supra, at 25 - 27, 47 - 48). I sustain this deficiency.
G 186 484.32 STANDARD: THERAPY SERVICES: The qualified therapist assists the physician in evaluating the patient's level of function, and helps develop the plan of care (revising it as necessary.)
Based on review of two applicable clinical records, the surveyors determined that the qualified therapists who provided services to these patients failed to help develop and revise their plans of care, as required. The surveyors cross-referenced this G Tag to G Tag 185.
23. For Patients 14 and 15, Petitioner did not ensure that its therapists assisted in the development and revision of the patients' plans of care, in violation of 42 C.F.R. � 484.32.
Again, the factual predicate for the deficiencies cited under this standard has been previously discussed in my analysis of related standards -- particularly G Tags 185, 162, and 143. Those tags relate to a home health agency's obligation to ensure that therapy services are provided in accordance with the applicable plans of care and that the treating physicians have participated with the therapists in developing such plans of care and, finally, that the treating physicians have authorized the provision of such therapy to the patients at the time the therapy is rendered. Since the plans of care for these patients did not contain orders for therapy services at the time the services were provided to the patients, it follows that therapists were not involved in the development of the plans of care, since they did not reflect the need for such therapy. I sustain the deficiency under this standard.
Summary of deficiencies under the condition at 42 C.F.R. � 484.32
For both G Tags 184 (referencing 42 C.F.R. � 484.32 and regarding whether therapy services are given by a qualified physical therapist under the supervision of a qualified therapist and in accordance with a plan of care) and 185 (referencing also 42 C.F.R. � 484.32 and regarding whether the qualified therapist assisted a patient's physician in evaluating the patient and developing the plan of care) I found for two patients, Patients 14 and 15, that Petitioner failed to comply with either of these standards (the factual situation for the patients was discussed at G Tags 185 and 162, and, for Patient 14, at G Tag 143). I believe these cases represent a pattern of failure on Petitioner's part, leading me to believe that Petitioner's deficiencies are of such a nature as to substantially limit its capacity to furnish adequate care and which adversely affect a patient's health and safety.
III. Conclusion
24. Petitioner's failure to meet the conditions of participation set forth at 42 C.F.R. �� 484.14, 484.18, 484.30, and 484.32, demonstrate that Petitioner is substantially incapable of providing care consistent with Medicare participation requirements, justifying its termination from participation in the Medicare program.
A provider of home health services, such as Petitioner, will be deemed as out of compliance with a condition of participation where the deficiencies found to exist, either individually or in combination, are of such character as to substantially limit the provider's capacity to furnish adequate care or adversely affect the health and safety of patients. 42 C.F.R. � 488.24(b). The mere fact that the deficiencies exist, however, does not necessarily support a conclusion that a provider is failing to meet a condition of participation. In such circumstances, the remedy is submission of a plan of correction and not termination. 42 C.F.R. � 488.28.
My analysis of the deficiencies here is based upon the regulatory framework set forth above. As I noted in Pacific Coast, DAB CR534, at 77, I agree with Judge Kessel's finding in CSM Home Health Services, DAB CR400. That finding states, in relevant part, that termination should not be invoked unless evidence proving a provider's failure to comply with Medicare participation requirements establishes that the provider cannot provide care consistent with what is required by the Act and regulations. Here, I conclude that the record supports a finding that Petitioner was out of compliance with Medicare conditions of participation at 42 C.F.R. �� 484.14, 484.18, 484.30, and 484.32. I further find that Petitioner has demonstrated that it lacks the capacity to provide adequate care to its patients and that such inadequate care has placed its patients in jeopardy of their health and safety. Accordingly, I conclude that HCFA had a basis for terminating Petitioner's participation in Medicare.
Edward D. Steinman
Administrative Law Judge
1. The HCFA Form 485 (completed examples of which are exhibits in this case), which is
entitled "Home Health Certification and Plan of Treatment," is a plan of care as contemplated by
the regulations. I refer to the information contained in this form as a patient's plan of care
throughout this decision, as "plan of care," not "plan of treatment," is the regulatory language.
2. When Petitioner establishes by the preponderance of the evidence that the factual basis for
the deficiency set forth by HCFA in the HCFA Form 2567 either did not occur as alleged or did
not violate any of the participation requirements, it is also tantamount to demonstrating that it is
in compliance with participation requirements. It demonstrates such compliance by challenging
the validity of the evidence offered by HCFA rather than by affirmative evidence that, despite
HCFA'S prima facie case, it was in compliance with program requirements.
3. At the hearing, the parties provided me with a copy of the District Court's decision. It was
not marked as an exhibit at the hearing. However, to complete the record in the event my
decision here is appealed, I have marked the District Court decision and taken it into evidence as
administrative law judge's exhibit (ALJ Ex.) 1.
4. I note that in minor respects the list of exhibits above differs from the lists of admitted
exhibits prepared by the parties following the hearing. However, the list above reflects the
exhibits I admitted into the record between August 7 - 11, 1997.
5. With its response brief, Petitioner attempted to submit three new exhibits for my
consideration, entitled Attachments A - C. I have considered Attachment A, Petitioner's updated
exhibit list, but am not taking it into evidence as an exhibit in this case. As for Attachments B
and C, I will not admit them here, nor will I consider them for any purposes in this case.
Petitioner was apprised of the schedule for submitting exhibits. When given the opportunity at
the hearing to submit rebuttal evidence, Petitioner chose not to submit it. Having failed to offer
this evidence at the proper time, it is patently unfair to allow Petitioner to offer new exhibits at
this late date, when there is no opportunity to have witnesses discuss their testimony in light of
these exhibits. Due to the obvious breach of due process, these untimely exhibits are rejected
and will not be considered.
6. I have evaluated carefully all arguments made by the parties in their briefs. If I do not
specifically refer to such argument in my decision, I have rejected it.
7. See also Administrative Law Judge Mimi Hwang Leahy's decision in Orchard Grove
Extended Care Center, DAB CR541 (1998).
8. At the hearing, the parties agreed that a copy of the SOM dated 3/98 was sufficiently
unchanged since the date of the survey in question that it represented the SOM regarding the
survey process used as of the survey date. See Transcript (Tr.) at 915 - 918, 942 - 943.
9. At the time of the follow-up visit, the surveyors were to complete a HCFA Form 2567B,
which is used where corrections have been completed. Petitioner argued that this was not done.
However, if, at the time of the revisit, deficiencies remained uncorrected, the surveyor was to
complete another HCFA Form 2567, which was completed in this case and is in the record as
HCFA Ex. 2. SOM, section 2732; HCFA Ex. 47, at 20.
10. At the time of the September 1997 survey, Ms. Madole, who was employed by the
State survey agency as a surveyor, was engaged in a financial audit of Petitioner that was
unrelated to the survey under consideration here. Ms. Madole did not participate in the
September 1997 survey. She did refer a complaint of a possible regulatory violation regarding
one of Petitioner's patients to the surveyors and that patient was included in the sample of
patients surveyed. However, HCFA did not rely on this patient in establishing its prima facie
case against Petitioner.
11. There is nothing inappropriate in a surveyor making a complaint when the surveyor, in
an unrelated proceeding, discovers information that might lead to a finding that a provider is out
of compliance with Medicare conditions of participation. It is a surveyor's duty to bring such
information to the proper authority. This does not mean that the process of the survey is
automatically tainted.
12. 12 I do not address each of the surveyors' findings on the HCFA Form 2567. In an effort
to narrow the issues, HCFA chose not to present evidence on each finding. Thus, I will not
address any issue for which HCFA did not present evidence.
13. HCFA did not put any evidence into the record for the standard cited at G Tag 224,
referencing 42 C.F.R. � 484.36(c)(1). HCFA R. Br. at 32. I construe HCFA's action as a
withdrawal of this standard from the proceedings. Consequently, I make no findings whether the
cited deficiencies sustain a violation of this standard. I discuss the facts underlying the alleged
deficiency under G Tag 178, and there I sustain that HCFA established a violation of 42 C.F.R. �
484.30(a) relating to the duties of the registered nurse to supervise home health aides. See, infra,
at pages 57 - 64.
14. I note here Petitioner's assertion that the surveyor did not give the most accurate
classification of Verapamil, referring to an attachment to Petitioner's posthearing brief which is
not in evidence. P. Br. at 25, n. 1; P. Br. at 27. As I indicated earlier, I give no weight to such
evidence. Even assuming that the surveyors' classification is not the most accurate, this would
not change the fact that Petitioner's nurse improperly classified the medication.
15. Had Petitioner been doing timely case conferences, perhaps it would have been able to
more adequately deal with Patient 5's discharge from social work services.
16. See, infra, at page 42, for a discussion of "PRN" orders.
17. This failure to provide the skilled nursing visits as ordered in the plan of care also violates
42 C.F.R. � 484.18, pertaining to plans of care.
18. Of course, the question that arises is whether the change in condition is of such
significance that it should be brought to a physician's attention or whether the change might be a
normal consequence of an underlying diagnosis. See Access, DAB CR528, at 11. In each
example under consideration, I must evaluate the evidence presented and make that
determination.
19. Petitioner, without the benefit of any record support, argues that Dr. Louis had no problem
signing for Dr. Willis and such was a common practice among physicians. P. Br. at 31.
Petitioner's citation to the transcript reflects a discussion I had with the surveyor and does not
support the factual proposition argued by Petitioner. In short, while Dr. Louis may have
authorized the patient's care, he had no right to do so since he was not the treating physician.
Petitioner's argument that any physician can authorize care irrespective of whether the physician
is actually treating the patient is patently absurd and contrary to the regulations. The plan of care
must be signed by the physician treating the patient or by some other physician authorized to
sign for that physician. No such circumstance exists here.
20. Petitioner's argument, that no time frame can be imposed since none is specifically stated
in the regulations (P. Br. at 32), is meritless. Obviously, such notice must be timely so that an
orderly transfer of services from one agency to another can occur to enable coordination of
continued home health services, if such services are needed in the treatment of the patient.
21. Petitioner put into evidence P. Ex. 10, at 5061 - 5062, which is a physical therapy
evaluation and plan of care for Patient 14. It is dated September 11, 1997. It is signed by the
patient's physician, but the physician did not affix to the document the date on which he signed
the form. Thus, I have no way to know whether this document had been signed by the date of the
survey in this case. However, even if this document is a valid authorization for physical therapy
treatments after September 11, 1997, this document would not authorize treatments prior to
September 11, 1997, or change my analysis of this deficiency in any material way. Moreover,
this document is signed by a different therapist than the therapist who signed the August 6, 1997
evaluation, and Petitioner's physician signed this document with the notation "Previous therapy:
not known" on it. P. Ex. 10, at 5061 - 5062; HCFA Ex. 45, at 87. This could lead to a
conclusion that Patient 14's physician did not know about the physical therapy services
previously provided to Patient 14 and that, therefore, the provision of such services was
unauthorized. Thus, this would strengthen my conclusion, above, that Petitioner's personnel
were not coordinating physical therapy services with Patient 14's physician.
22. "Exac" means an exacerbation of the hypertension. Tr. at 276. Infra, at page 42, I find that
the diagnosis of hypertension listed in the plan of care was not supported by the patient's medical
record. However, the patient's other serious medical conditions fully support my finding that the
patient had serious, debilitating medical conditions.
23. I note that the home health aide who signed the sheet recommending discontinuation of
home health aide services and the home health aide who signed the patient care record with
regard to this patient on September 1, 3, and 5, 1997 (the dates of Patient 11's final home health
aide visits) are not the same. HCFA Ex. 16, at 1 and 3.
24. In response to G Tag 158, Petitioner makes the general argument that the deficiencies cited
do not establish a pattern of practice or a threat of harm to patients. P. Br. at 38. I have
previously addressed the issue of pattern of practice. The existence of threat of harm to patients
will be addressed in the deficiency, if such is present. Petitioner argues also in its brief that its
plans of care were established and reviewed by the treating physicians. Id. This contention
misses the point of the deficiencies cited -- which is that the specific treatment requirements of
plans of care established by treating physicians were not followed by Petitioner in providing care
to its patients.
25. This is a disease entity on which the treating physician directed Petitioner to provide
instruction. HCFA Ex. 33, at 1.
26. Petitioner relies on Attachment C to its brief, which is Taber's Cyclopedia Medical
Dictionary 2031 (17th ed. 1993). For the reasons cited earlier in my decision, this attachment is
rejected as a belated exhibit. However, for the purposes of analyzing Petitioner's argument, I
will discuss this definition.
27. Petitioner fails to recognize that, in numerous instances cited in this record, patients were
visited by skilled nurses primarily to assess and teach them. Moreover, in countering HCFA's
arguments that such visits were unnecessary and redundant, Petitioner itself contended that they
were necessary in the treatment of a patient. P. Br. at 41, G Tag 159, Patient 11.
28. The physician could have easily ordered the home health aide to assist with food
preparation, as the physician did with regard to Patient 10. See HCFA Ex. 12, at 2.
29. If the physician wants a specific service to be done by the home health aide, it can be
described in the plan of care. For example Patient 2's plan of care contains specific orders for the
aide to assist the patient with "meals/preparation and ambulation." HCFA Ex. 15, at 2.
30. The surveyor testified that the registered nurses visited the patient throughout the
certification period. Tr. at 383, 385. The surveyor, upon examination of the clinical record at
the time of the survey, found only the August 26, 1997 supervisory visit. Id.
31. Although not cited by the surveyor, this home health aide plan of care does not comport
with the physician orders in the plan of care nor with the functional limitations cited there -- gait
abnormality and ambulation with the need for a walker. HCFA Ex. 15, at 1. This represents a
lack of coordination by Petitioner in: delivering ordered services, as discussed in G Tag 143;
failure to deliver services in accordance with the plan of care, as discussed in G Tag 156; and
failure to provide treatment as ordered by the physician, as discussed in G Tag 165.
32. The cited deficiency refers to six tub baths. The home health care patient record
documents seven.
33. HCFA counsel seem to recognize this, as they do not even address this portion of the
deficiency in their briefs. HCFA Br. at 71 - 72.