Subpart M--Personnel For Nonwaived Testing §493.1351 General. - SFGH-POCT

acceptable experience. Research experience is also acceptable experience if it is obtained while performing tests on human specimens. (b)(2)(ii)(A) At least one year directing or supervising non-waived laboratory testing; or (b)(2)(ii)(B) Beginning September 1, 1993, have at least 20 continuing medical education credit hours in laboratory practice commensurate with the director responsibilities defined in §493.1407; or Interpretive Guidelines §493.1405(b)(2)(ii)(B) The 20 CMEs must be obtained prior to qualifying as a laboratory director. The CME courses must encompass preanalytic, analytic, and postanalytic phases of testing, and be of such quality as to provide the physician with education equivalent to the experience described in §493.1405(b)(2)(ii)(A). Courses related to laboratory payment and CPT coding would not fulfill this requirement. For a list of CME providers, please see the CLIA web page at www.cms.hhs.gov/clia. (b)(2)(ii)(C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section obtained during medical residency. (For example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or Interpretive Guidelines §493.1405(b)(2)(ii)(C) The residency program should provide the director the knowledge in principles and theories of laboratory practice including: quality control and quality assessment, proficiency testing, the phase of the total process (i.e., preanalytic, analytic and postanalytic), as well as, general laboratory systems, facility administration, and development and implementation of personnel policy and procedure manuals. This training should also include hands-on laboratory testing. (b)(3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution; and Interpretive Guidelines §493.1405(b)(3) See §493.2 for the definition of and guidance for accredited institution. (b)(3)(i) Be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or (b)(3)(ii) Have had at least one year experience directing or supervising non-waived laboratory testing; (b)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; (b)(4)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing; and (b)(4)(iii) In addition, have at least one year of supervisory laboratory experience in nonwaived testing; or (b)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; (b)(5)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing; and (b)(5)(iii) In addition, have at least 2 years of supervisory laboratory experience in nonwaived testing; (b)(6) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under §493.1406; or Interpretive Guidelines §493.1405(b)(6)

For tests of moderate complexity, individuals qualify as laboratory directors, if on February 28, 1992, they previously qualified, or could have qualified under the Federal regulations, published on March 14, 1990, as a laboratory director. After February 28, 1992, individuals must meet the requirements at §§493.1405(b)(1)-(5) to qualify as a laboratory director, unless the individual can demonstrate compliance with §493.1405(b)(6), (that is, on February 28, 1992, he or she could have qualified as a laboratory director under Federal regulations published on March 14, 1990). (b)(7) On or before February 28, 1992, qualified under State law to direct a laboratory in the State in which the laboratory is located. §493.1406 Standard; Laboratory director qualifications on or before February 28, 1992. The laboratory director must be qualified to manage and direct the laboratory personnel and test performance. (a) The laboratory director must possess a current license as a laboratory director issued by the State, if such licensing exists; and (b) The laboratory director must: (b)(1) Be a physician certified in anatomical or clinical pathology (or both) by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (b)(2) Be a physician who: (b)(2)(i) Is certified by the American Board of Pathology or the American Osteopathic Board of Pathology in at least one of the laboratory specialties; or (b)(2)(ii) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board in one of the laboratory specialties; or (b)(2)(iii) Is certified by the American Society of Cytology to practice cytopathology or possesses qualifications that are equivalent to those required for such certification; or (b)(2)(iv) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(3) For the subspecialty of oral pathology only, be certified by the American Board of Oral Pathology, American Board of Pathology or the American Osteopathic Board of Pathology or possesses qualifications that are equivalent to those required for certification; (b)(4) Hold an earned doctoral degree from an accredited institution with a chemical, physical, or biological science as a major subject and (b)(4)(i) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board acceptable to HHS in one of the laboratory specialties; or (b)(4)(ii) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(5) With respect to individuals first qualifying before July 1, 1971, have been responsible for the direction of a laboratory for 12 months between July 1, 1961, and January 1, 1968, and, in addition, either: (b)(5)(i) Was a physician and subsequent to graduation had at least 4 years of pertinent full-time laboratory experience; (b)(5)(ii) Held a master's degree from an accredited institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 4 years of pertinent full-time laboratory experience; (b)(5)(iii) Held a bachelor's degree from an accredited institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 6 years of pertinent full-time laboratory experience; or

(b)(5)(iv) Achieved a satisfactory grade through an examination conducted by or under the sponsorship of the U.S. Public Health Service on or before July 1, 1970; or (b)(6) Qualify under State law to direct the laboratory in the State in which the laboratory is located. Note: The January 1, 1968 date for meeting the 12 months' laboratory direction requirement in paragraph (b)(5) of this section may be extended 1 year for each year of full-time laboratory experience obtained before January 1, 1958 required by State law for a laboratory director license. An exception to the July 1, 1971 qualifying date in paragraph (b)(5) of this section was made provided that the individual requested qualification approval by October 21, 1975 and had been employed in a laboratory for at least 3 years of the 5 years preceding the date of submission of his qualifications. D6004 §493.1407 Standard; Laboratory director responsibilities. The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. Interpretive Guidelines §493.1407 If the laboratory has more than one person qualifying as director, the laboratory is required to designate one individual who has ultimate responsibility for overall operation and administration of the laboratory. The requirement that a laboratory must be under the direction of a qualified person is not automatically met simply because the director meets the education and experience requirements. It must be demonstrated that the individual is, in fact, providing effective direction over the operation of the laboratory. In determining whether the director responsibilities are met, consider deficiencies found in other conditions, e.g., facility administration, general laboratory systems, preanalytic systems, analytic systems, postanalytic systems, and proficiency testing. a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of §§493.1409, 493.1415, and 493.1421, respectively. Interpretive Guidelines §493.1407(a) If the laboratory director is not qualified as a technical consultant or clinical consultant, he or she must employ individuals meeting the appropriate qualifications. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. D6005 §493.1407 Standard; Laboratory director responsibilities. (c) The laboratory director must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed.

Interpretive Guidelines §493.1407(c) If the director cannot practically provide personal, onsite supervision it must be demonstrated that the director: Provides direction and consultation by telephone, as necessary; or Delegates to qualified personnel specific responsibilities as provided in the regulations. The laboratory director may reapportion to a technical consultant, in writing, the responsibilities in: §§493.1407(e)(3), (4), (5), (6), (7), (11), (12), and (13). The laboratory director may reapportion to a clinical consultant, in writing, the responsibilities in: §§493.1407(e)(8) and (9). D6006 §493.1407 Standard; Laboratory director responsibilities. (d) Each individual may direct no more than five laboratories. Interpretive Guidelines §493.1407(d) An individual may serve as a director of 5 certified laboratories. An individual may serve as a technical consultant or clinical consultant for any number of laboratories. D6007 §493.1407 Standard; Laboratory director responsibilities. (e) The laboratory director must-(e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; D6010 §493.1407 Standard; Laboratory director responsibilities. (e)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and Interpretive Guidelines §493.1407(e)(2) OSHA/EPA issues cannot be cited using these requirements. If immediate jeopardy exists, the director should be informed immediately. If you observe or obtain information regarding potential safety violations not applicable under CLIA, notify the appropriate State or local authority. Consult with the Regional Office (RO) for notification to other Federal agencies such as the Occupational Safety and Health Administration (OSHA) www.osha.gov, Environmental Protection Agency (EPA) www.epa.gov, or Nuclear Regulatory Commission (NRC). The appropriate Federal, State or local authority, if warranted, will investigate and, if necessary, conduct an on-site visit. D6011

§493.1407 Standard; Laboratory director responsibilities. provide a safe environment in which employees are protected from physical, chemical, and biological hazards; D6012 §493.1407 Standard; Laboratory director responsibilities. (e)(3) Ensure that-(e)(3)(i) The test methodologies selected have the capability of providing the quality of results required for patient care; D6013 §493.1407 Standard; Laboratory director responsibilities. (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and D6014 §493.1407 Standard; Laboratory director responsibilities. (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; D6015 §493.1407 Standard; Laboratory director responsibilities. (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that-- D6016 §493.1407 Standard; Laboratory director responsibilities. (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; D6017 §493.1407 Standard; Laboratory director responsibilities. (e)(4)(ii) The results are returned within the timeframes established by the proficiency testing program; D6018 §493.1407 Standard; Laboratory director responsibilities.

(e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require corrective action; and D6019 §493.1407 Standard; Laboratory director responsibilities. (e)(4)(iv) An approved corrective action plan is followed when any proficiency testing results are found to be unacceptable or unsatisfactory; D6020 §493.1407 Standard; Laboratory director responsibilities. (e)(5) Ensure that the quality control D6021 §493.1407 Standard; Laboratory director responsibilities. and quality assessment programs are established and maintained to assure the quality of laboratory services provided and D6022 §493.1407 Standard; Laboratory director responsibilities. to identify failures in quality as they occur; D6023 §493.1407 Standard; Laboratory director responsibilities. (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; D6024 §493.1407 Standard; Laboratory director responsibilities. (e)(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified, and D6025 §493.1407 Standard; Laboratory director responsibilities. that patient test results are reported only when the system is functioning properly;

D6026 §493.1407 Standard; Laboratory director responsibilities. (e)(8) Ensure that reports of test results include pertinent information required for interpretation; D6027 §493.1407 Standard; Laboratory director responsibilities. (e)(9) Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions; D6028 §493.1407 Standard; Laboratory director responsibilities. (e)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; D6029 §493.1407 Standard; Laboratory director responsibilities. (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; D6030 §493.1407 Standard; Laboratory director responsibilities. (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; D6031 §493.1407 Standard; Laboratory director responsibilities. (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and D6032

§493.1407 Standard; Laboratory director responsibilities. (e)(14) Specify, in writing, the responsibilities and duties of each consultant and 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. Interpretive Guidelines §493.1407(e)(14) The director must assign, in writing, the duties/responsibilities to each person involved in all phases of the testing process. The list of assigned duties must be current. D6033 §493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant. The laboratory must have a technical consultant who meets the qualification requirements of §493.1411 of this subpart and provides technical oversight in accordance with §493.1413 of this subpart. Interpretive Guidelines §493.1409 The Condition of technical consultant is not met when the technical consultant: Position is not filled; Is not qualified; or Does not fulfill the technical consultant's responsibilities. D6034 §493.1411 Standard; Technical consultant qualifications. The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. Interpretive Guidelines §493.1411 The type of experience required under this regulation is clinical in nature. This means, examination and test performance on human specimens for purposes of obtaining information for the diagnosis, treatment, and monitoring of patients, or for providing information to others who will do the diagnosing and treating of the patient's condition. Patient or medically-oriented experience, which is defined as the ordering of tests and interpreting and applying the results of these tests in diagnosing and treating a patient's illness is unacceptable to meet the requirement for laboratory training or experience. The term "laboratory training or experience" means that the individual qualifying has the training and experience in the specialties and subspecialties in which the individual is providing technical consultation.

Technical consultants should have documentation of hands-on testing experience. This documentation may consist of, but is not limited to, the individual's initials on worksheets or work cards, attestation of the laboratory director to the experience the individual has, or formal laboratory rotation through a medical residency program or laboratory internship program. Teaching experience directly related to a medical technology program, clinical laboratory sciences program, or a clinical laboratory section of a residency program is considered acceptable experience. Research experience is also acceptable experience if it is obtained while performing tests on human specimens. D6035 §493.1411 Standard; Technical consultant qualifications. (a) The technical consultant must possess a current license i

§493.1405 of this subpart and provides overall management and direction in accordance with §493.1407 of this subpart. Interpretive Guidelines §493.1403: The Condition: laboratory director is not met when the laboratory director: Position is not filled; Is not qualified; or Does not fulfill the laboratory director's responsibilities.