U.S. Office of Personnel Management

Office of Merit Systems Oversight and Effectiveness

Classification Appeals and FLSA Programs

Philadelphia Oversight Division

600 Arch Street, Room 3400

Philadelphia, PA 19106-1596

Robert D. Hendler

Classification Appeals Officer

/S/ 8/26/99

Date

As provided in section 511.612 of title 5, Code of Federal Regulations (CFR), this decision constitutes a certificate that is mandatory and binding on all administrative, certifying, payroll, disbursing, and accounting officials of the government. The agency is responsible for reviewing its classification decisions for identical, similar, or related positions to ensure consistency with this decision. There is no right of further appeal. This decision is subject to discretionary review only under conditions and time limits specified in the Introduction to the Position Classification Standards (PCS's), appendix 4, section G (address provided in appendix 4, section H).

Decision sent to:

PERSONAL

[appellants' names].

[appellants' addresses]

[name], Chief

Human Resources Management Service

U.S. Department of Veterans Affairs

[name & location] VA Medical Center

Mr. Ronald E. Cowles

Deputy Assistant Secretary for

Human Resources Management

U.S. Department of Veterans Affairs

810 Vermont Avenue, NW

Washington, DC 20420

Introduction

On May 17, 1999, the Philadelphia Oversight Division of the U.S. Office of Personnel Management (OPM) received a classification appeal from [appellants' names]. They occupy identical additional positions classified as Medical Technician, GS-645-6. They are assigned to position number 1087A in the Pathology and Laboratory Medicine Activity under the Chief of Staff at the U.S. Department of Veterans Affairs (VA), [name] VA Medical Center, [location]. We have accepted and decided their appeal under section 5112 of title 5, United States Code (U.S.C.).

General issues

The appellants believe that their position description (PD) compares favorably with the GS-7 grade level, as described in the Medical Technician Series, GS-645 PCS. In their appeal rationale, the appellants stated that they are responsible for independently performing a variety of difficult and complex laboratory procedures and examinations within various disciplines of the clinical laboratory. In addition, they stated they are each responsible for a section of the clinic and its compliance with the College of American Pathologists (CAP) guidelines.

The appellants stated that the appeal decision from their agency contained many inaccurate statements. Further, they stated that the decision contained wording right out of the PCS regarding assignments expected at a particular grade level instead of what the appellants actually do. They emphasized their freedom from oversight, the quality of their experience, and the pressures of work volume in which accurate testing was vital.

In supplemental information provided to OPM, the appellants stated they are responsible for the entire laboratory when working off-tour (weekends, second, or third shift), work that is also rotated with other higher graded employees. During the 24-hour Saturday and Sunday shift, the appellants work 8 hours and are on call 16 hours. During off-tour periods the appellants stated they work alone. They are responsible for drawing blood specimens, preparing the sample for analysis, analyzing the sample, evaluating the result, and reporting out the result. This includes cross-matching units in the Bloodbank. If the results are a critical or panic value, i.e., results that reflect such a variance with a normal range as to be considered life threatening, the appellants are responsible for verifying the values by reanalysis, and then notifying the attending physician. They stated they are responsible for the daily maintenance, calibration, quality control, and temperature checks for all analyzers, incubators, and reagent storage compartments. If a problem arises during a weekend shift, the employee responsible for the section is the first contact for help. [One appellant's name] is called for Bloodbank, [one appellant's name] for Hematology and Coagulation and [one appellant's name] for Cytology and Computers.

Further, they stated that they conduct Normal Population, Linearity, Parallel and Comparison, and Instrument to Instrument studies for which no guidelines exist. Once the studies are completed and the data reviewed, the physicians are informed of any changes in the test results or a new reference range that may have been observed. The appellants are responsible for submitting monthly quality control results to the manufacturer for processing, evaluating the results, and making equipment adjustments as needed.

The appellants stated that they are required to have an in-depth knowledge of all laboratory instruments to troubleshoot problems. In the Chemistry section there are two analyzers, the Beckman CX-9 and the Abbott Axsym. Hematology uses the Coulter STKS for CBC's and the Dade Sysmex for Coagulation studies. In Urinanalysis, the Ames Clinitek 200+ is used to perform urinalysis. They also perform STAT (immediate) EKG's when necessary. In Microbiology, they stated they set up cultures, perform STAT gram stains and process positive blood cultures.

These statements raise procedural issues warranting clarification. The classification appeal process is a de novo review that includes a determination as to the duties and responsibilities assigned to the appellants' positions and performed by the appellants, and constitutes the proper application of PCS's to those duties and responsibilities. Therefore, any actions taken or not taken previously by the appellants' agency are moot. It is an established classification principle that only the effect of properly performed work is to be considered in the classification appeal process. The size of the appellants' workload and the quality of their work, are not germane to the classification appeal process. They are matters covered by the performance management and awards programs.

Many positions in the Government perform a variety of functions. Not all functions, however, will be classifiable at the same grade level. For example, many technicians perform clerical functions classifiable at grade levels below the technician work that controls the grade level worth of the position. Thus, if other positions perform duties that are similar to some major functions of the appellants' positions, those duties may not be the grade controlling duties of those other positions.

The appellants and their supervisor agree the appellants' identical additional positions (hereinafter referred to as position) are accurate. Our telephone audits with the appellant on July 2 and 23, 1999, and an interview with their immediate supervisor, [name], on July 13, 1999, confirmed that the PD contains the major duties and responsibilities assigned by management and performed by the appellants and is hereby incorporated by reference into this decision.

Position information

The PD states the position is that of "Medical Laboratory Technician in a Clinical Laboratory of a general medical and surgical hospital. The incumbents rotate through the major sections of Chemistry/Urinalysis and Hematology/Blood Bank with limited duties in Microbiology."

The medical center serves as VA clinic of jurisdiction for 17 counties in Pennsylvania, with 24 acute patient care beds and approximately 65 long term care and nursing home beds. The medical center performs ambulatory surgery. It does not have a trauma center.

Series and title determination

The agency has placed the position in the Medical Technician Series, GS-645 and titled it Medical Technician (with no parenthetical specialization) in conformance with titling practices of the GS- 645 PCS. The appellants agree with the series and title determination made by the agency, and we concur. The position is allocated properly as Medical Technician, GS-645, for which there is a directly applicable published PCS that must be applied for grade level determination.

Grade determination

The GS-645 PCS uses two classification factors for grade determination, Nature of the Assignment and Control over the Work. These factors are definitive for the grade evaluation of medical technician work. They serve to provide both the framework within which the occupation is structured and specifically applicable criteria for the appraisal of level of work.

OPM PCS's must be applied in conjunction with position classification theories, principles, and practices established by OPM. The Introduction to the PCS's states that:

Some positions involve performing different kinds and levels of work which, when separately evaluated in terms of duties, responsibilities, and qualifications required, are at different grade levels. . . .

In most instances, the highest level of work assigned to and performed by the employee for the majority of time [emphasis added] is grade-determining. When the highest level of work is a smaller portion of the job, it may be grade controlling only if:

-	The work is officially assigned to the position on a regular and recurring basis;

-	It is a significant and substantial part of the overall position (i.e., occupying at least 25 percent of the employee's time); and

-	The higher level of knowledge and skills needed to perform the work would be required in recruiting for the position if it became vacant.

In 1988, Congress passed the Clinical Laboratory Improvement Amendment of 1988 (CLIA-88) as part of the Public Health Service Act (Title 42 U.S.C. 263a). This amendment codified into law requirements for the staffing, management, procedures and oversight of U.S. laboratories that perform testing used in the diagnosis and/or treatment of patients. The U.S. Department of Health and Human Services (DHHS) then published implementing regulations for CLIA, Title 42 CFR Part 493.

In 1992, Congress passed Public Law 102-139 Sec. 101 that exempted VHA from CLIA-88 and stated that the Secretary of VA would, in consultation with Secretary of DHHS, publish regulations that would establish standards equal to those applicable to other medical facility laboratories in accordance with the requirements of section 353(f) of the Public Health Services Act. This, in essence, requires VA laboratories to meet the requirement of CLIA-88 but left the enforcement and oversight of the regulations to VA.

The VA published VHA Handbook 1106.1 dated February 12, 1988, entitled Pathology and Laboratory Medicine Service Procedures. The handbook contains procedures for the administration, accreditation, staffing, and functioning of clinical and pathology laboratories in VA facilities or managed by VA facilities. It requires all laboratory testing within VA, utilized for the diagnosis and/or treatment of patients, to meet the requirements of Title 42 CFR Part 493, (CLIA-88), as well as other accreditation bodies, where applicable.

VA laboratories are accredited under the Laboratory Accreditation Program of the College of American Pathologists (CAP). One requirement under this program is that a complete standard operating procedure manual be written in substantial compliance with and meet the intent of the National Committee for Clinical Laboratory Standards. The manual should be used by personnel at the workbench, and must include principle, clinical significance, specimen type, required reagents, calibration, quality control, procedural steps, calculations, reference ranges and interpretation for each test.

CLIA and its implementing regulations categorize specific laboratory test systems, assays, and examinations by three levels of complexity, i.e., high, moderate and waived from CLIA requirements, i.e., tests that are so simple and accurate as to render the likelihood of erroneous results negligible, pose no reasonable risk of harm to the patient if the test is performed incorrectly, and have been cleared by the Food and Drug Administration (FDA) for home use. The regulatory requirements between moderate and high complexity testing differ mainly in the standards for quality control and personnel, since the testing itself is more complicated. To determine the complexity of the tests conducted in the laboratory, we referred to the CLIA standards, statements made by the appellants and their supervisor during the telephone audits, documentation submitted by the appellants in support of their appeal, and publicly available program information.

Nature of the Assignment

This factor measures the difficulty and complexity of the test and examination procedures performed. It also covers the skills, knowledges, and judgment required to perform them. The nature of assignment includes such elements as the technical complexity of the procedures, the level of knowledges and skill required, and the significance and influence of the test results. For example, test and examination procedures range from relatively simple qualitative urinalysis to fluorescent antibody treponemal antibody absorption tests.

An individual job is evaluated in terms of the actual difficulties and responsibilities involved in that assignment rather than in terms of the function of the particular laboratory or laboratory section in which it is located. For example, a position located in a reference laboratory or in a laboratory having the full range of laboratory services may, in fact, involve performing relatively routine tests and examinations.

The appellants perform a variety of difficult and highly complex laboratory tests and examinations. Their duties include specimen collection, processing, accessioning and testing; reagent preparation, equipment calibration and standardization; preventive maintenance; troubleshooting; and reporting results. They collect quality assurance data, and record quality control values. They are also responsible for identifying unusual or discrepant results, and take appropriate action to resolve such problems.

Each appellant is responsible for a particular section of the laboratory; i.e., Hematology and Coagulation, Cytology and Computers, and Bloodbanking. These responsibilities include insuring that their respective sections conform with the CAP requirements in terms of laboratory procedures, quality control and documentation. The appellants and their supervisor characterized the tests conducted in the Bloodbank section and any tests conducted manually as the most complex of their assignments.

In support of their appeal the appellants provided copies of their work schedules from June 20, 1999 through July 16, 1999, weekly work assignments from May 23, 1999, through July 17, 1999, and a computer printout of the actual numbers and types of tests performed in the month of June. The appellants stipulated that the rotational assignments and tests conducted during these timeframes are representative of their work. In addition, they supplied a list of each of the tests conducted in each of the sections, and a copy of a local Manual on Ward and Laboratory Procedures used by the medical staff on the floor. Their supervisor provided a copy of the Quality Control Program for the medical center laboratory.

The [installation] VAMC Quality Control Program is based upon a "daily, weekly, and monthly review process of quality control records, proficiency surveys, preventive maintenance records and short accession lists." The objective of the plan is to eliminate systematic and random variances and improvement in the precision and utilization of laboratory tests; define quality control policies and procedures; establish tolerance limits; and document all corrective measures whose values are out of tolerance limits.

Under their plan, daily quality control is performed by each section. The appellants are responsible for performing actual analysis (standard controls, patient samples) and recording the daily quality assurance records for each section. They are also responsible for detecting control problems as they occur and for taking immediate corrective action and/or consulting with the supervisor. They review all quality control records for their particular section near the end of each shift. The supervisor reviews these records on a weekly basis.

The appellants have a working knowledge of most sections within the Clinical Laboratory. These include: Urinalysis, Bloodbanking, Hematology, Chemistry and Coagulation, Histology and Microbiology. They perform routine and complex analyses on blood and body fluids, taking into consideration specimen collection and handling and other factors. They initiate troubleshooting or back up procedures when problems occur. They recognize grossly abnormal laboratory specimens or results, correlating them with improperly drawn and/or submitted specimens or test interferences, and provide this information on the report and/or to the supervisor. They recognize and report every critical (panic) value as established on critical value sheets.

According to their work assignment sheet, each of the appellants rotated through the Bloodbank section of the laboratory. [appellant's name] worked two weeks in that section, and [appellant's name] and [appellant's name] each spent one week in that section from May 23 through July 16.

The computer printout of the tests conducted in June 1999 indicates that out of approximately 30,000 tests performed in the laboratory in the month of June, 61 were conducted in the Bloodbank section. And approximately 10 percent of the overall total number of tests performed at the VA laboratory were identified as manual.

CLIA identifies all procedures in certain laboratory subspecialties and more than 50 general tests or procedures as high complexity. The subspecialities are Histocompatibility, Histopathology, Cytology and Clinical Cytogenetics. High complexity tests are generally characterized as involving manual procedures with multiple steps in sample or reagent preparation or the analytic process or automated or semi-automated procedures requiring operator intervention during the analytic process.

Moderate complexity tests are generally characterized by manual procedures with limited steps and with limited sample or reagent preparation or automated procedures that do not require operator intervention during the analytic process. For example, microscopic analysis of urinary sediment, manual hematology or coagulation procedures with limited steps and with limited sample or reagent preparation, manual white blood cell differentials without identification of atypical cells, primary culture inoculation, and microscopic evaluation of direct wet-mount preparations.

Many of the tests identified on the June 1999 printout are relatively standardized tests and examinations. That is, the procedures and techniques are well established and may be waived under CLIA standards, e.g., fecal occult blood. Other tests performed in large volume were CBCs, albumin, chloride, cholesterol HDL, and potassium. These tests are categorized as moderately complex under CLIA standards.

At the GS-5 grade level, the PCS describes rotating to most areas of the laboratory and describes assignments which individually and collectively are difficult and complex although typically covered by laboratory manuals and written instructions. During the course of the tests and examinations, there is often a need for a number of additional tests because of the results of early phases or stages of the test. There are also determinations and examinations that involve the use of complex equipment. The tests require fine and precise measurements or delicate equipment control adjustments, or both.

GS-5 grade level work includes cross-matching or compatibility testing of blood or issuance to a specific patient. Although these tests have to be verified and signed by the supervisor or a physician, the technician has initial responsibility for selecting the type of blood requested, performing the necessary minor and major cross-matching tests, rejecting specific blood which is not compatible with that of the patient's, and making necessary setups for verification or confirmation of the supervisor or the physician. Medical technicians having this type of assignment often also participate in processing prospective donors. They interview donors to secure information in accordance with established donor criteria (when atypical information is secured consults with supervisor as to acceptability of the donor), take blood pressure, pulse, and temperature; make hemoglobin determination, take blood in accordance with established procedures, notifying supervisor if the donor has reactions; determine the specific blood group, and RH-type as well as other blood factors when necessary, and determine issoglutinin titer in group O blood, record results and label specimens. Another GS-5 work illustration involves performing more advanced analyses, such a protein electrophoresis, etc. That work assignment includes checking quality control standards and charting results, and daily calibrating laboratory equipment against standards.

In contrast, GS-6 work involves performing a wide variety of laboratory tests, examinations, and determinations of a complex and responsible nature every aspect of which is not covered in detail in the instructions or guidelines. Typically, each of the tests and examinations involves many steps with the approaches and procedures in the alter stages dependent upon the findings of the early steps. Most GS-6 positions, are, in a sense, "specialist" in nature. They involve either a high degree of specialization, the ability to perform difficult tests in a narrow area, (e.g., Bloodbanking) or an unusual breadth of assignments, and the versatility and skill to perform tests in a full range of areas (Microbiology, Hematology, Chemistry, Blood banking).

Many of the appellants' work assignments are described at the GS-5 grade level in the PCS in that the appellants are assigned on a rotational basis to most areas of the laboratory and perform a variety of tests and examinations which, individually and collectively, are difficult and complex although typically covered by laboratory manuals and written instructions.

However, the nature of assignments exceeds the GS-5 grade level, in that, the appellants have an unusual breadth of assignments. They are required to have a broad working knowledge of most areas of the laboratory, and perform a wide variety of complex and difficult tests. For example, they maintain responsibility for the conformance of each of their respective sections with CLIA requirements and any other accreditation body, e.g., FDA for the bloodbanking section. That is, they develop the local standard operating procedures, based on CAP guidelines, to be used at the workbench by all laboratory personnel, review the quality control for their section and bring anything unusual to the attention of their supervisor. In addition, they install and perform studies on new lots of reagent and/or new pieces of equipment that are received in the laboratory. These studies include, normal population studies, Linearity studies, Parallel and Comparison studies, Lot-to-Lot comparison studies and Instrument-to-Instrument studies. Although guidelines to conduct them are more limited in nature, they must be performed according to accepted testing and quality control practices. They are also responsible for troubleshooting equipment on an as needed basis.

In contrast, at the GS-7 grade level, medical technicians perform difficult and complex laboratory tests and examinations for which procedures and instruction have not been standardized locally. In contrast to the volume of standardized and well established testing performed by the appellants, GS-7 grade level tests are relatively new and involve very fine distinctions. There are typically very many extremely delicate and exacting steps, the instrumentation is elaborate and complex, and the settings and measurements are very fine.

The assignments performed by the appellants, as described previously, including the more complex assignments, do not meet the level of complexity described at the GS-7 grade level, or require the individual to be a "specialist" in one of the laboratory sections as depicted in the PCS at the GS-7 grade level. The supervisor and the appellants stated that they are all generalists in the laboratory. They are required to be such, so that they can work off-tours and weekends alone and perform the full range of assignments as dictated by the immediate needs of the hospital. The appellants have the versatility and skill to perform tests in a full range of areas (Microbiology, Hematology, Chemistry, Bloodbanking) and maintain their section in full conformance with established protocols, typical of work assignments at or below the GS-6 grade level. Based on the amount of time the appellants spend on their most complex manual and other tests and section program assignments, we find they perform sufficient GS-6 grade level work to permit evaluation of this factor at the GS-6 grade level.

Control over the Work

This factor covers the availability of guidelines and instructions, and the direction, control, and guidance exercised by pathologists, medical technologists, and/or supervisory medical technicians. It includes the kind and degree of supervision over work during its performance and the nature and extent of the review of reports of tests, examinations, and determinations performed.

The appellants' PD states that they work under the general supervision of the Laboratory Supervisor. They receive designated work block assignments by the Laboratory Supervisor that are to be completed within a specific timeframe, based on laboratory priorities. They plan, organize, and implement testing procedures in accordance with established protocols, previous training or accepted laboratory practices. Deviations from established procedures and problems are brought to the attention of the Laboratory Supervisor. Work is reviewed by the Laboratory Supervisor for accuracy and completeness on the next working day.

The PD states the appellants use technical manuals, product guidelines, standard textbooks and journals and accreditation guidelines when applicable. They follow standard operating procedures in all departments. They must exercise professional judgment in evaluating the need for exceptions to the guidelines. They plan appropriate responses to situations not ordinarily encountered in routine laboratory analysis.

The appellants stated that they work independently on the second, third and weekend shifts, are responsible for drawing blood specimens, preparing the sample for analysis, analyzing the sample, evaluating the result, and reporting out the result. If the results are a critical value, they are responsible for verifying the values by reanalysis, and then notifying the attending physician. If a problem arises while working alone, the appellants stated they first contact the medical technician responsible for that section for assistance and/or advice. The supervisor stated she is not available (on-call) every weekend, all weekend, to respond to questions from the laboratory. The appellants are responsible for daily maintenance, calibration, quality control, and temperature checks for all analyzers, incubators, and reagent storage compartments.

At the GS-6 grade level, the PCS describes a work environment in which local laboratory manuals and instructions do not cover every aspect of the work assigned. Technical supervisory advice and guidance are always available. Because of the complexity and newness of many of the procedures, the supervisor spot checks the work and occasionally observes the progress. In contrast, at the GS-7 grade level, medical technicians receive guidance, review and direction that is described as general in nature rather than close and technical. The pathologist having the ultimate responsibility for the review of all tests and examinations, for the accuracy and reliability of the results, and for all decisions made in the laboratory. The pathologist typically approves reports of tests and examinations with only cursory review and very infrequent spot check of individual tests and examinations. The medical technician is expected to recognize and solve most problems, only very occasionally requesting supervisory assistance.

In addition, the GS-7 grade level criteria describe a "floater" assignment, that compares to that of the appellants' rotational and off-tour assignments, filling in wherever needed, and regularly having responsibility for the full range of laboratory work on evening, night, and weekend duty, that typically function without immediate on-site supervisory control. In such situations a pathologist or supervisory technologist is accessible only by telephone.

Although, the appellants work with relative independence in carrying out their assignments which compares to the work situation at the GS-7 grade level, in the current laboratory environment, there is little need for close supervision of testing work, and little demand or opportunity for deviation from established practice and protocol. Therefore, the appellants' work environment more closely matches that described at the GS-6 grade level, where standard operating procedures are established and available to all workbench personnel. As at the GS-6 grade level, the appellants must use judgment in terms of which guidelines to apply and where they cannot be applied, or where there is significant deviation from those guidelines. The planning of the work is largely reactive to the daily demands of the medical center.

The appellants do work alone on off-tour shifts, which they share with other laboratory personnel, when no supervisor or medical technologist is available in the laboratory. The supervisor stated that although physicians can request any test, if needed STAT, on an off-tour, there is generally a limited menu of tests requested during those periods. For example, the Manual on Ward and Laboratory Procedures requests physicians to order transfusions during regular working hours, Monday through Friday. This testing would occur in the Bloodbank section, characterized as the most complex work in the laboratory by the appellants and their supervisor. Therefore, the work that is being performed independent of any supervision is generally not the most complex work of the laboratory. Evaluation of this factor must be made in conjunction with the level of assignments being performed. The nature of the appellants' assignment, regardless of their freedom from supervision, is credited at the GS-6 grade level. Combined with the availability of standard operating procedures, the control over the work, notwithstanding any unique circumstances, does not fully meet the GS-7 grade level described in the PCS. Therefore, the control over the work is credited at the GS-6 grade level.

Summary

Since the appealed position is evaluated properly at the GS-6 grade level with respect to both classification factors, it must be graded at the GS-6 grade level overall.

Decision

The appealed position is correctly classified as Medical Technician, GS-645-6.