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How to meet the new personnel requirements while continuing to operate your laboratory.

No, the Government isn't telling you to hire the worst and the cheapest. In fact, if you do, you'll probably regret it.

In one move the Health Care Financing Administration (HCFA) "solved" the personnel shortage for clinical laboratories across the United States by giving high school graduates permission to perform tests of moderate complexity and, for the next five years, tests of high complexity. A person who holds a bachelor's degree in biologic, chemical, physical, or medical laboratory science may serve as director of a lab that does only tests of moderate complexity. A person with an associate's (two-year college) degree can be the general supervisor of a laboratory doing high-complexity testing.

In short, except for director and cytotechnologist, titles historically held in the clinical laboratory are not honored by the rules for the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). Medical technologists and medical technicians are now grouped together as "testing personnel." Supervisors and section directors are now called general supervisors, technical consultants, or technical supervisors. New to the laboratory is a clinical consultant required for every laboratory holding a certificate for either moderately or highly complex testing. The regulations make no mention of the manager, coordinator, clinical microbiologist, clinical chemist, or laboratory assistant. Pathologists are listed by name only in conjunction with anatomic pathology or immunohematology. The box above summarizes the requirements for education and experience of laboratorians who perform or supervise patient tests in laboratories that hold certificates for moderate- and high-complexity testing.

CLIA '88 makes the laboratory director responsible for all aspects of laboratory operation. Particularly explicit are the requirements for establishing and monitoring the experience and training of testing personnel. While requirements for personnel are to be found in virtually all sections of the rules, they reside primarily in section M, "Personnel for Moderate and High Complexity Testing" ([section]493.1405 through [section]493.1495), and section P, "Quality Assurance for Moderate or High Complexity Testing, or Both" ([section]493.1713).

CLIA's complexity model, explained in Part 1 of this series (MLO, August 1992), forms the basis for the personnel stipulations. The requirements for education and experience of directors or consultants (supervisors) in laboratories holding certificates authorized to perform tests of moderate complexity are less rigorous than those for the same job titles in laboratories with certificates for high-complexity testing. * Director's responsibility. The director is held responsible for 18 specifically named duties. The laboratory director must "employ a sufficient number of laboratory personnel with appropriate education and either experience or training to provide appropriate" laboratory functions. The director is also responsible for ongoing assessment of employee competence to assure proper education and experience or training for the level of testing provided. This assessment must include all preanalytic, analytic, and postanalytic phases of testing. The stated goal is to improve and maintain employee competence to insure the accuracy and timeliness of test results. Further, the director is to put in writing specifically which tests each employee may do:

The laboratory director must - Specify,

in writing, the responsibilities and duties

of each consultant and [each supervisor,

as well as] each person, engaged in the performance

of the preanalytic, analytic, and postanalytic

phases of testing, that identifies which

examinations and procedures each individual

is authorized to perform, whether supervision

is required for specimen processing, test performance

or results reporting, and whether

consultant or director review is required prior

to reporting patient test results.

* Technical supervisor's duties. Among the nine duties assigned to technical supervisors or consultants is to set standards for the quality of personnel, establish needs for training, and develop evaluation procedures to be used for employment, ongoing and remedial training, and the documentation of competence of testing personnel. Direct observation and documentation of employee competence are mandated in the following section of the document:

The technical consultant is responsible for -

(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to -

(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;

(ii) Monitoring the recording and reporting of test results;

(iii) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records;

(iv) Direct observation of performance of instrument maintenance and function checks;

(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and

(vi) Assessment of problem solving skills; and (9) Evaluating and documenting the performance of individuals responsible for moderate [or: high] complexity testing at least semi-annually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation.

For the next five years, before stricter CLIA requirements kick in, employees whose highest level of education is a high school diploma (or equivalent) and who do high-complexity testing must be trained to be competent in the following: patient preparation, specimen handling and storage, standard laboratory and specific testing procedures, results reporting, instrument maintenance, reagent stability and storage, and quality control and quality assurance policies. The technical supervisor is responsible for establishing and maintaining the requisite training programs for these employees. * Tips on compliance. The trick to keeping your laboratory operating under this new personnel configuration and distribution of duties is to pay strict attention to the following observations:

The new personnel model is very different from what most laboratories are accustomed to. You must, of course, consider all the duties and qualifications required by CLIA '88 in your laboratory's operation. Nevertheless, proceed slowly and deliberately in modifying the job titles now in use in your laboratory. Proceeding too quickly may damage morale and undermine employees' sense of security far more than necessary.

Carefully document the level of education and experience of all employees named in the regulations. Specifically, document both their testing and their supervisory experience to give your staff the greatest opportunity to grow in their careers. The more broadly you can specify experience and training, the better you can staff your laboratory.

For every testing method and instrument introduced or modified in your laboratory on or after Sept. 1, 1992, initiate a training system that covers all preanalytic, analytic, and postanalytic phases of testing for each procedure. Training must be completed before any patient test results are reported and should cover all steps of testing, from patient preparation to delivery of the final report.

Prepare a checklist, to be signed by both the personnel being trained and the technical supervisor. The training and periodic evaluation must show specifically what training was done. This must then be confirmed by the technical supervisor and approved by the laboratory director.

All staff members who perform testing must demonstrate to the technical consultant or supervisor that they can do every step in the procedure competently. This must be documented twice a year for the first year and once a year thereafter. If you change or modify a method, the cycle starts again. A checkoff sheet will be very helpful in tracking this information. All required training and authorization must be completed for each employee before he or she reports any patient test results.

After reviewing the training documents, the director should determine which tests each supervisor is to supervise and which tests each employee may perform. These specifics should be authorized in writing. This documentation can be used in assigning backup personnel for supervision and testing. To keep scheduling manageable, authorize each staff member to do as many tests as possible. You can get into a real trap if personnel who are qualified by education and training to do only tests of moderate complexity must work on a shift during which tests of high complexity are done. The problem can be particularly serious when staffing is tight, such as on weekends and holidays and on the night shift.

CLIA '88 stipulates minimal education and experience requirements for directors, supervisors, consultants, and testing personnel. You are not, however, confined to hiring minimally qualified personnel. One requirement of CLIA '88 is that every problem, error, and complaint must be documented and that policies must then be generated or modified to solve them. You will save yourself a lot of headaches and paperwork to prepare extra documentation by hiring highly qualified personnel and training them well.

The experience required for the director and technical consultant or supervisor is especially critical because of the technical responsibilities those positions entail. in laboratories doing tests of high complexity, technical supervisors must have a specified amount of experience in the specialties or subspecialties in which they work. Some details about the experience required appear on pages 7176 through 7181 of the Federal Register for Feb. 28, 1992. Although the extent of training and experience is not explained fully, it's clear that more than incidental contact is required, according to the instructions to the inspectors (or, as HCFA calls them, surveyors) found in the State Operations Manual. (The next installment of this series will provide helpful tips for reading the regulatory documents associated with CLIA.)

While the director and technical consultants/supervisors need not be on site at all times, they must be available as needed to provide supervision. The director and technical supervisor can accomplish their duties on site, by telephone, or via electronic communication. Directors and technical supervisors should make sure they document all their duties and appear on site as often as required.

A director may direct no more than five laboratories - that is, be listed as director on no more than five certificates. The director may delegate many duties but no responsibilities. All delegated duties must be listed in writing. The director must insure that delegated duties are carried out.

Inspectors (surveyors) will be looking for any tests performed by nonqualified or unauthorized personnel. You should therefore document all personnel authorization. You must be able to trace specific test results through the testing system and to show that all tests are being done by authorized personnel. * Hire the best anyway. CLIA '88 permits clinical laboratories to employ a wide variety of personnel. Each person who performs and/or oversees patient testing must have a specific kind and amount of experience and must have been trained to do every task that he or she is doing. The director and technical supervisor are responsible for employees' performance, training, and evaluation. Using unqualified personnel may put the entire laboratory in jeopardy because such workers are unlikely to pass proficiency testing. All problems and corrective actions must be documented. Unless you are willing to document problems continually and to answer unsatisfactory proficiency testing challenges frequently, you will want to hire the best employees available - just as you always have.

Personnel qualifications under CLIA '88

FOR MODERATE-COMPLEXITY TESTING

Director(1)

M.D./D.O.(2): If not board certified in anatomic or clinical pathology: one year directing or supervising nonwaived testing, or by Aug. 2, 1993, have 20 hours of continuing education (for laboratory directors, consistent with [section]493.1407); or residency training equivalent to the 20 hours specified above, or Ph. D.(3): HHS-recognized boards; or one year of training or experience or both directing or supervising nonwaived testing, or Master's degree(4) with one year of training or experience or both plus one year's experience as a supervisor, or Bachelor's degree(4) with two years of training or experience or both plus two years as a supervisor; or previously qualified under [section]493.1415 (March 14, 1990) before Feb. 28, 1992; or, before Feb. 28, 1992, qualified under state law to direct a laboratory in the state

Technical consultant(1)

M.D./D.O.(2): If not board certified in anatomic or clinical pathology, having one year of training or experience or both in the designated specialty or subspecialty of service, or Ph. D.(3) or master's degree(3) with one year of training or experience or both in the designated specialty or subspecialty of service, or Bachelor's degree(4) with two years of training or experience or both in the designated specialty or subspecialty of service

Clinical consultant(1)

Qualified as a director (M.D./D.O.(2) or board-certified Ph.D(3)), or M.D./D.O.(2)

Testing personnel(1)

M.D./D.O.(2), Ph.D.(4), master's degree(4), bachelor's degree(4), associate's degree(5), or high school diploma or equivalent(6) Must have successfully completed a military lab procedures course of at least 50 weeks and held an enlisted occupational specialty of medical lab specialist or high school diploma (or equivalent) with documented training in eight specified areas

FOR HIGH-COMPLEXITY TESTING

Director(1)

M.D./D.O.(2): If not board certified in anatomic or clinical pathology: one year of laboratory training during residency; or two years of experience directing or supervising high-complexity testing, or Ph.D.(3)) with HHS-recognized boards, or Ph.d.(3) until Sept. 1, 1994, with two years of training or experience or both; and two years of experience directing or supervising high-complexity testing; by Sept. 1, 1994, be certified by national boards or be serving as laboratory director and previously qualified or could have qualified [that is, was eligible to qualify] as director under 42 CFR [section]493.1415 (published March 14, 1990) on or before Feb. 28, 1992; or on or before Feb. 28, 1992, be qualified under state law as a laboratory director for the state

Technical supervisor(1)

The director may function as technical supervisor, or the laboratory may perform anatomic and clinical laboratory procedures if the director qualifies as an M.D./D.O.(2) The laboratory may perform tests in the specialties/subspecialties in which the technical supervisor is specifically qualified as follows: M.D./D.O.(2) Ph.D.(3), master's degree(3), or bachelor's degree(4) with one to four years of training and/or experience and at least six months of experience in many subspecialties

Special qualifications are required in [section]493.1449 for cytology, histopathology, dermatopathology, ophthalmic pathology, oral pathology, histocompatibility, cytogenetics, and immunohematology

Clinical consultant(1)

M.D./D.O.(2) (board certified), or Ph.D.(3) qualified as a director and having HHS-approved national boards, or M.D./D.O.(2)

General supervisor(1)

Qualified as a laboratory director or technical supervisor for high-complexity testing, or M.D./D.O.(2), or Ph.D.(3), or

Master's degree(3), or Bachelor's degree(4) with one year of training, experience, or both in high-complexity testing, or

Associate's degree(5) with two years of training, experience, or both in high-complexity testing; or previously qualified under 42 CFR [section]493.1427 (March 14, 1990)

For blood gas analysis:

Qualified as a laboratory director or technical supervisor, or Bachelor's degreeo with degree in respiratory therapy, plus one year of laboratory training, experience, or both in blood gas analysis, or

Associate's degree(5) with a degree related to pulmonary function, plus two years of training, experience, or both in blood gas analysis

The requirements for a general supervisor in histopathology, oral pathology, dermatopathology, or ophthalmic pathology are met because the test is done by a director or technical supervisor

Testing personnel(1)

M.D./D.O.(2), Ph.D.(3), master's degree(3), or bachelor's degree(4), or associate's degree@, or have previously qualified or could have qualified [that is, was eligible to qualify] as a technologist under 42 CFR [section]493.1433 (March 14, 1990) High school diploma(6): Until Sept. 1, 1997, have a high school diploma and documented training prior to performing testing on any patient's specimens that includes eight specific items [See [sections]493.1423(b)(4)(ii), [section]493.1489(b)(4)(ii)]

For blood gas analysis:

Bachelor's degree(4) in respiratory therapy, or Associate's degree(5) in respiratory therapy Special qualifications for cytotechnologists and anyone examining histopathology specimens have been established in [section]493.1489(b)(6)

For the next five years, a high school graduate may continue to perform tests of high complexity. As of Sept. 1, 1997, all personnel performing high-complexity testing must hold at least an associate's degree.

HHS: Department of Health and Human Services.

Key to circled numbers

(1) Currently licensed to perform the duties of the position by the state in which the laboratory is located (2) Licensed to practice medicine or osteopathy in the state in which the laboratory is located (3) Holding a degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution(*) (4) Holding a degree in a chemical, physical, biological, or clinical laboratory science or in medical technology from an accredited institution.(*) ". . . |laboratory training or experience, or both' in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests." -Note to Standard; Technical consultant qualifications [section]493.141 1, p. 7174, and repeated except for the last three words in Note to Standard; Technical supervisor qualifications [section]493.1449, p. 7180, Federal Register, Feb. 28, 1992) (5) Holding an associate's degree in a chemical, physical, or biological science or in medical laboratory technology from an accredited institution(*) (6) Holding a high school diploma or equivalent, such as a G.E.D. (general equivalency diploma). A technical school diploma is not considered an equivalent

(*) An accredited institution, defined in [section]493.2, is one that is acceptable to the Health Care Financing Administration as specified in HCFA's State Operations Manual.

The author is director of clinical chemistry at Oklahoma Medical Center, Oklahoma City. Under the aegis of the National Committee for Clinical Laboratory Standards (NCCLS) and American Association for Clinical Chemistry (AACC), he has presented workshops around the country on the final CLIA regulations since early 1992 and on CLIA '88 in general since 1990.
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Title Annotation:Coping with CLIA: Part 2; includes related article
Author:Passey, Richard B.
Publication:Medical Laboratory Observer
Date:Sep 1, 1992
Words:3004
Previous Article:Creative strategies to survive the shortage.
Next Article:Parasitic infection from blood transfusions.
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