Subpart H--Participation in Proficiency Testing for Laboratories
Performing Tests of Moderate Complexity (Including the Subcategory),
High Complexity, or Any Combination of These Tests
Source: 57 FR 7146, Feb. 28, 1992, unless otherwise noted.
Sec. 493.801 Condition: Enrollment and testing of samples.
Each laboratory must enroll in a proficiency testing (PT) program
that meets the criteria in subpart I of this part and is approved by
HHS. The laboratory must enroll in an approved program or programs for
each of the specialties and subspecialties for which it seeks
certification. The laboratory must test the samples in the same manner
as patients' specimens. For laboratories subject to 42 CFR part 493
published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the
rules of this subpart are effective on September 1, 1992. For all other
laboratories, the rules of this subpart are effective January 1, 1994.
(a) Standard; Enrollment. The laboratory must--
(1) Notify HHS of the approved program or programs in which it
chooses to participate to meet proficiency testing requirements of this
subpart.
(2)(i) Designate the program(s) to be used for each specialty,
subspecialty, and analyte or test to determine compliance with this
subpart if the laboratory participates in more than one proficiency
testing program approved by CMS; and
(ii) For those tests performed by the laboratory that are not
included in subpart I of this part, a laboratory must establish and
maintain the accuracy of its testing procedures, in accordance with
Sec. 493.1236(c)(1).
(3) For each specialty, subspecialty and analyte or test,
participate in one approved proficiency testing program or programs, for
one year before designating a different program and must notify CMS
before any change in designation; and
(4) Authorize the proficiency testing program to release to HHS all
data required to--
(i) Determine the laboratory's compliance with this subpart; and
(ii) Make PT results available to the public as required in section
353(f)(3)(F) of the Public Health Service Act.
(b) Standard; Testing of proficiency testing samples. The laboratory
must examine or test, as applicable, the proficiency testing samples it
receives from the proficiency testing program in the same manner as it
tests patient specimens.
(1) The samples must be examined or tested with the laboratory's
regular patient workload by personnel who routinely perform the testing
in the laboratory, using the laboratory's routine methods. The
individual testing or examining the samples and the laboratory director
must attest to the routine integration of the samples into the patient
workload using the laboratory's routine methods.
(2) The laboratory must test samples the same number of times that
it routinely tests patient samples.
(3) Laboratories that perform tests on proficiency testing samples
must not engage in any inter-laboratory communications pertaining to the
results of proficiency testing sample(s) until after the date by which
the laboratory must report proficiency testing results to the program
for the testing event in which the samples were sent. Laboratories with
multiple testing sites or separate locations must not participate in any
communications or discussions across sites/locations concerning
proficiency testing sample results until after the date by which the
laboratory must report proficiency testing results to the program.
(4) The laboratory must not send PT samples or portions of samples
to another laboratory for any analysis which it is certified to perform
in its own laboratory. Any laboratory that CMS determines intentionally
referred its proficiency testing samples to another laboratory for
analysis will have its certification revoked for at least one year. Any
laboratory that receives proficiency testing samples from another
laboratory for testing must
[[Page 913]]
notify CMS of the receipt of those samples.
(5) The laboratory must document the handling, preparation,
processing, examination, and each step in the testing and reporting of
results for all proficiency testing samples. The laboratory must
maintain a copy of all records, including a copy of the proficiency
testing program report forms used by the laboratory to record
proficiency testing results including the attestation statement provided
by the PT program, signed by the analyst and the laboratory director,
documenting that proficiency testing samples were tested in the same
manner as patient specimens, for a minimum of two years from the date of
the proficiency testing event.
(6) PT is required for only the test system, assay, or examination
used as the primary method for patient testing during the PT event.
[57 FR 7146, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993]
Sec. 493.803 Condition: Successful participation.
(a) Each laboratory performing nonwaived testing must successfully
participate in a proficiency testing program approved by CMS, if
applicable, as described in subpart I of this part for each specialty,
subspecialty, and analyte or test in which the laboratory is certified
under CLIA.
(b) Except as specified in paragraph (c) of this section, if a
laboratory fails to participate successfully in proficiency testing for
a given specialty, subspecialty, analyte or test, as defined in this
section, or fails to take remedial action when an individual fails
gynecologic cytology, CMS imposes sanctions, as specified in subpart R
of this part.
(c) If a laboratory fails to perform successfully in a CMS-approved
proficiency testing program, for the initial unsuccessful performance,
CMS may direct the laboratory to undertake training of its personnel or
to obtain technical assistance, or both, rather than imposing
alternative or principle sanctions except when one or more of the
following conditions exists:
(1) There is immediate jeopardy to patient health and safety.
(2) The laboratory fails to provide CMS or a CMS agent with
satisfactory evidence that it has taken steps to correct the problem
identified by the unsuccessful proficiency testing performance.
(3) The laboratory has a poor compliance history.
[57 FR 7146, Feb. 28, 1992, as amended at 60 FR 20048, Apr. 24, 1995; 63
FR 26737, May 14, 1998]
Sec. 493.807 Condition: Reinstatement of laboratories performing
nonwaived testing
(a) If a laboratory's certificate is suspended or limited or its
Medicare or Medicaid approval is cancelled or its Medicare or Medicaid
payments are suspended because it fails to participate successfully in
proficiency testing for one or more specialties, subspecialties, analyte
or test, or voluntarily withdraws its certification under CLIA for the
failed specialty, subspecialty, or analyte, the laboratory must then
demonstrate sustained satisfactory performance on two consecutive
proficiency testing events, one of which may be on site, before CMS
will consider it for reinstatement for certification and Medicare or
Medicaid approval in that specialty, subspecialty, analyte or test.
(b) The cancellation period for Medicare and Medicaid approval or
period for suspension of Medicare or Medicaid payments or suspension or
limitation of certification under CLIA for the failed specialty,
subspecialty, or analyte or test is for a period of not less than six
months from the date of cancellation, limitation or suspension of the
CLIA certificate.
[58 FR 5228, Jan. 19, 1993, as amended at 60 FR 20048, Apr. 24, 1995]
[[Page 914]]
Proficiency Testing by Specialty and Subspecialty for Laboratories
Performing Tests of Moderate Complexity (Including the Subcategory),
High Complexity, or Any Combination of These Tests
Sec. 493.821 Condition: Microbiology.
The specialty of microbiology includes, for purposes of proficiency
testing, the subspecialties of bacteriology, mycobacteriology, mycology,
parasitology and virology.
Sec. 493.823 Standard; Bacteriology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) Remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two years from
the date of participation in the proficiency testing event.
(e) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.825 Standard; Mycobacteriology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) Remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two years from
the date of participation in the proficiency testing event.
(e) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
[[Page 915]]
Sec. 493.827 Standard; Mycology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) Remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two years from
the date of participation in the proficiency testing event.
(e) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.829 Standard; Parasitology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) Remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two years from
the date of participation in the proficiency testing event.
(e) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.831 Standard; Virology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame
[[Page 916]]
for submitting proficiency testing results of the suspension of patient
testing and the circumstances associated with failure to perform tests
on proficiency testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unsatisfactory testing events, remedial action must be
taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the
proficiency testing event.
(e) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.833 Condition: Diagnostic immunology.
The specialty of diagnostic immunology includes for purposes of
proficiency testing the subspecialties of syphilis serology and general
immunology.
Sec. 493.835 Standard; Syphilis serology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unacceptable testing event score, remedial action must
be taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the
proficiency testing event.
(e) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.837 Standard; General immunology.
(a) Failure to attain a score of at least 80 percent of acceptable
responses for each analyte in each testing event is unsatisfactory
analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame
[[Page 917]]
for submitting proficiency testing results of the suspension of patient
testing and the circumstances associated with failure to perform tests
on proficiency testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory analyte or test performance or testing
event for reasons other than a failure to participate, the laboratory
must undertake appropriate training and employ the technical assistance
necessary to correct problems associated with a proficiency testing
failure.
(2) For any unacceptable analyte or testing event score, remedial
action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of
participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
or test in two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
(g) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.839 Condition: Chemistry.
The specialty of chemistry includes for the purposes of proficiency
testing the subspecialties of routine chemistry, endocrinology, and
toxicology.
Sec. 493.841 Standard; Routine chemistry.
(a) Failure to attain a score of at least 80 percent of acceptable
responses for each analyte in each testing event is unsatisfactory
analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory analyte or test performance or testing
event for reasons other than a failure to participate, the laboratory
must undertake appropriate training and employ the technical assistance
necessary to correct problems associated with a proficiency testing
failure.
(2) For any unacceptable analyte or testing event score, remedial
action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of
participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
or test in two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
(g) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.843 Standard; Endocrinology.
(a) Failure to attain a score of at least 80 percent of acceptable
responses for each analyte in each testing event is unsatisfactory
analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
[[Page 918]]
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory analyte or test performance or testing
event for reasons other than a failure to participate, the laboratory
must undertake appropriate training and employ the technical assistance
necessary to correct problems associated with a proficiency testing
failure.
(2) For any unacceptable analyte or testing event score, remedial
action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of
participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
or test in two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
(g) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.845 Standard; Toxicology.
(a) Failure to attain a score of at least 80 percent of acceptable
responses for each analyte in each testing event is unsatisfactory
analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory analyte or test performance or testing
event for reasons other than a failure to participate, the laboratory
must undertake appropriate training and employ the technical assistance
necessary to correct problems associated with a proficiency testing
failure.
(2) For any unacceptable analyte or testing event score, remedial
action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of
participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
or test in two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
(g) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.849 Condition: Hematology.
The specialty of hematology, for the purpose of proficiency testing,
is not
[[Page 919]]
subdivided into subspecialties of testing.
Sec. 493.851 Standard; Hematology.
(a) Failure to attain a score of at least 80 percent of acceptable
responses for each analyte in each testing event is unsatisfactory
analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory analyte or test performance or testing
event for reasons other than a failure to participate, the laboratory
must undertake appropriate training and employ the technical assistance
necessary to correct problems associated with a proficiency testing
failure.
(2) For any unacceptable analyte or testing event score, remedial
action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of
participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
in two consecutive events or two out of three consecutive testing events
is unsuccessful performance.
(g) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.853 Condition: Pathology.
The specialty of pathology includes, for purposes of proficiency
testing, the subspecialty of cytology limited to gynecologic
examinations.
Sec. 493.855 Standard; Cytology: gynecologic examinations.
To participate successfully in a cytology proficiency testing
program for gynecologic examinations (Pap smears), the laboratory must
meet the requirements of paragraphs (a) through (c) of this section.
(a) The laboratory must ensure that each individual engaged in the
examination of gynecologic preparations is enrolled in a proficiency
testing program approved by CMS by January 1, 1995, if available in the
State in which he or she is employed. The laboratory must ensure that
each individual is tested at least once per year and obtains a passing
score. To ensure this annual testing of individuals, an announced or
unannounced testing event will be conducted on-site in each laboratory
at least once each year. Laboratories will be notified of the time of
each announced on-site testing event at least 30 days prior to each
event. Additional testing events will be conducted as necessary in each
State or region for the purpose of testing individuals who miss the on-
site testing event and for retesting individuals as described in
paragraph (b) of this section.
(b) The laboratory must ensure that each individual participates in
an annual testing event that involves the examination of a 10-slide test
set as described in Sec. 493.945. Individuals who fail this testing
event are retested with another 10-slide test set as described in
paragraphs (b)(1) and (b)(2) of this section. Individuals who fail this
second test are subsequently retested with a 20-slide test set as
described in paragraphs (b)(2) and (b)(3) of this section. Individuals
are given not more than 2 hours to complete a 10-slide test and not more
than 4 hours to complete a 20-
[[Page 920]]
slide test. Unexcused failure to appear by an individual for a retest
will result in test failure with resulting remediation and limitations
on slide examinations as specified in (b)(1), (b)(2), and (b)(3) of this
section.
(1) An individual is determined to have failed the annual testing
event if he or she scores less than 90 percent on a 10-slide test set.
For an individual who fails an annual proficiency testing event, the
laboratory must schedule a retesting event which must take place not
more than 45 days after receipt of the notification of failure.
(2) An individual is determined to have failed the second testing
event if he or she scores less than 90 percent on a 10-slide test set.
For an individual who fails a second testing event, the laboratory must
provide him or her with documented, remedial training and education in
the area of failure, and must assure that all gynecologic slides
evaluated subsequent to the notice of failure are reexamined until the
individual is again retested with a 20-slide test set and scores at
least 90 percent. Reexamination of slides must be documented.
(3) An individual is determined to have failed the third testing
event if he or she scores less than 90 percent on a 20-slide test set.
An individual who fails the third testing event must cease examining
gynecologic slide preparations immediately upon notification of test
failure and may not resume examining gynecologic slides until the
laboratory assures that the individual obtains at least 35 hours of
documented, formally structured, continuing education in diagnostic
cytopathology that focuses on the examination of gynecologic
preparations, and until he or she is retested with a 20-slide test set
and scores at least 90 percent.
(c) If a laboratory fails to ensure that individuals are tested or
those who fail a testing event are retested, or fails to take required
remedial actions as described in paragraphs (b)(1), (b)(2) or (b)(3) of
this section, CMS will initiate intermediate sanctions or limit the
laboratory's certificate to exclude gynecologic cytology testing under
CLIA, and, if applicable, suspend the laboratory's Medicare and Medicaid
payments for gynecologic cytology testing in accordance with subpart R
of this part.
[57 FR 7146, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993; 59
FR 62609, Dec. 6, 1994]
Sec. 493.857 Condition: Immunohematology.
The specialty of immunohematology includes four subspecialties for
the purposes of proficiency testing: ABO group and D (Rho) typing;
unexpected antibody detection; compatibility testing; and antibody
identification.
Sec. 493.859 Standard; ABO group and D (Rho) typing.
(a) Failure to attain a score of at least 100 percent of acceptable
responses for each analyte or test in each testing event is
unsatisfactory analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 100
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
[[Page 921]]
(2) For any unacceptable analyte or unsatisfactory testing event
score, remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two years from
the date of participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
in two consecutive testing events or two out of three consecutive
testing events is unsuccessful performance.
(g) Failure to achieve an overall testing event score of
satisfactory for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
Sec. 493.861 Standard; Unexpected antibody detection.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unsatisfactory testing event score, remedial action must
be taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the
proficiency testing event.
(e) Failure to achieve an overall testing event score of
satisfactory for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
Sec. 493.863 Standard; Compatibility testing.
(a) Failure to attain an overall testing event score of at least 100
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unsatisfactory testing event score, remedial action must
be taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the
proficiency testing event.
(e) Failure to achieve an overall testing event score of
satisfactory for two
[[Page 922]]
consecutive testing events or two out of three consecutive testing
events is unsuccessful performance.
Sec. 493.865 Standard; Antibody identification.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unsatisfactory testing event score, remedial action must
be taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the
proficiency testing event.
(e) Failure to identify the same antibody in two consecutive or two
out of three consecutive testing events is unsuccessful performance.
(f) Failure to achieve an overall testing event score of
satisfactory for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
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