CHAPTER 11

PERSONNEL FOR MODERATE COMPLEXITY TESTING (INCLUDING THE SUBCATEGORY), HIGH COMPLEXITY TESTING, OR ANY COMBINATION OF THESE TESTS

11-1. General (§493.1351)

This Chapter consists of the personnel requirements that must be met by laboratories performing moderate complexity testing, PPM procedures, high complexity testing, or any combination of these tests. As feasible, medical laboratories located outside of the United States will meet these personnel rules to ensure quality laboratory services, but OASD(HA) or TSG may waive specific personnel requirements if necessary for national defense.

11-2. Laboratories Performing Provider-Performed Microscopy (PPM) Procedures: Scope (§493.1353)

In accordance with paragraph 2-5 above, the moderate complexity procedures specified as PPM procedures are considered such only when personally performed by a health care provider during a patient visit in the context of a physical examination. PPM procedures are subject to the personnel requirements in paragraphs 11-3 through 11-8 below.

11-3. Condition: Laboratories Performing PPM Procedures: laboratory director (§493.1355)

The laboratory must have a director who meets the qualification requirements of paragraph 11-4 below and provides overall management and direction in accordance with paragraph 11-5 below.

11-4. Standard: Laboratories Performing PPM Procedures: laboratory director qualifications (§493.1357)

The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of PPM procedures as specified in paragraph 11-5 below and must be eligible to be an operator of a laboratory within the requirements of this paragraph.

The laboratory director must meet one of the following requirements:

a. Be a physician, as defined in Appendix A, Glossary, privileged to practice medicine in a DoD medical treatment facility.

b. Be a midlevel practitioner, as defined in Appendix A, Glossary, privileged to practice independ-ently in a DoD medical treatment facility.

c. Be a dentist, as defined in Appendix A, Glossary, privileged to practice dentistry in DoD medical treatment facility.

11-5. Standard: Laboratories Performing PPM Procedures: laboratory director responsibilities (§493.1359)

The laboratory director is responsible for the overall operation and administration of the laboratory, including the prompt, accurate, and proficient reporting of test results. The laboratory director must:

a. Direct no more than five laboratories.

b. Ensure that any procedure listed under paragraph 2-5 above is personally performed by an individual who meets the qualification requirements in paragraph 11-7 below, and is performed in accordance with applicable requirements in Chapters 6, 7, 8, 9, 10, 11, and 12.

11-6. Condition: Laboratories Performing PPM procedures: testing personnel (§493.1361)

The laboratory must have a sufficient number of individuals who meet the qualification requirements of paragraph 11-7 below to perform the functions specified in paragraph 11-8 below for the volume and complexity of testing performed.

11-7. Standard: Laboratories Performing PPM Procedures: testing personnel qualifications (§493.1363)

Each individual performing PPM procedures must meet one of the following:

a. Be a physician, as defined in Appendix A, Glossary, and be privileged to practice medicine in a DoD medical treatment facility.

b. Be a midlevel practitioner, as defined in Appendix A, Glossary, under the supervision of a physician, or privileged to practice independently in a DoD medical treatment facility.

c. Be a dentist, as defined in Appendix A, Glossary, privileged to practice dentistry in a DoD medical treatment facility.

11-8. Standard: Laboratories Performing PPM Procedures: testing personnel responsibilities (§493.1365).

The testing personnel are responsible for specimen processing, test performance, and for reporting test results. Any PPM procedure must be:

a. Personally performed by one of the following practitioners:

(1) A physician during the patient's visit on a specimen obtained from his or her own patient or from a patient of a group medical practice for which the physician is a member or employee.

(2) A midlevel practitioner, under the supervision of a physician or privileged to practice independently in a DoD medical treatment facility, during the patient's visit on a specimen obtained from his or her own patient or from a patient of a clinic, group medical practice, or other health care provider, in which the midlevel practitioner is a member or employee.

(3) A dentist during the patient's visit on a specimen obtained from his or her own patient or from a patient of a group dental practice for which the dentist is a member or employee.

b. Performed using a microscope limited to a bright field or a phase/contrast microscope.

11-9. Condition: Laboratories Performing Moderate Complexity Testing: laboratory director (§493.1403)

The laboratory must have a director who meets the qualification requirements of paragraph 11-10 below and provides overall management and direction in accordance with paragraph 11-11 below.

11-10. Standard: Laboratories Performing Moderate Complexity Testing: laboratory director qualifications (§493.1405)

The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests.

a. For medical field units deployed during periods of war, mobilization, or national emergency, the qualifications for laboratory director listed in paragraph b below may be modified or waived by OASD(HA), or TSG.

b. The laboratory director must meet one of the following qualifications:

(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and privileged to practice medicine in a DoD medical treatment facility; and be certified in anatomic 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.

(2) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine, licensed to practice medicine, osteopathy, or podiatry by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and privileged to practice medicine in a DoD medical treatment facility; and have had laboratory training or experience consisting of one of the following:

(a) At least one year directing or supervising non-waived laboratory testing.

(b) Beginning 1 September 1993, have at least 20 continuing medical education credit hours in laboratory practice commensurate with the director responsibilities defined in paragraph 11-11, and approved by TSG or their designee.

(c) Laboratory training equivalent to paragraph 11-10b(2)(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).

(3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and one of the following:

(a) 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.

(b) Have had at least one year experience directing or supervising non-waived laboratory testing.

(4) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution with at least one year of laboratory training or experience, or both in non-waived testing plus have at least one year of supervisory laboratory experience in non-waived testing.

(5) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution, with at least 2 years of laboratory training or experience, or both in non-waived testing plus have at least 2 years of supervisory laboratory experience in non-waived testing.

11-11. Standard: Laboratories Performing Moderate Complexity Testing: laboratory director responsibilities (§493.1407)

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, accurately, and proficiently and for assuring compliance with the applicable regulations.

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 paragraphs 11-13, 11-16 and 11-19 respectively.

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.

c. The laboratory director must be accessible (generally within a one-hour time frame) to the laboratory to provide on-site, telephone or electronic consultation as needed.

d. Each individual may direct no more than five laboratories limited to performing moderate complexity testing.

e. The laboratory director must:

(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 pre-analytic, analytic, and post-analytic phases of testing;

(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards;

(3) Ensure that:

(a) The test methodologies selected have the capability of providing the quality of results required for patient care.

(b) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method.

(c) Laboratory personnel are performing the test methods as required for accurate and reliable results.

(4) Ensure that the laboratory is enrolled in an OASD(HA) approved proficiency testing program for the testing performed, and that:

(a) The proficiency testing samples are tested as required under Chapter 6.

(b) The results are returned within the time frames established by the proficiency testing program.

(c) 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.

(d) An approved corrective action plan is followed when any proficiency testing results are found to be unacceptable or unsatisfactory.

(5) Ensure that the quality control and quality assurance programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur.

(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.

(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified, and that patient test results are reported only when the system is functioning properly.

(8) Ensure that reports of test results include pertinent information required for interpretation.

(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.

(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 chapter.

(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.

(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.

(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process.

(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.

11-12. Condition: Laboratories Performing Moderate Complexity Testing: technical consultant (§493.1409)

The laboratory must have a technical consultant who meets the qualification requirements of paragraph 11-13 below and provides technical oversight in accordance with paragraph 11-14 below.

11-13. Standard: Laboratories Performing Moderate Complexity Testing: technical consultant qualifications (§493.1411)

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 chapter.

a. For medical field units deployed outside the United States during periods of war, mobilization, or national emergency, the qualifications for technical consultant listed in paragraph b below may be modified or waived by OASD(HA) or TSG.

b. The technical consultant must meet one of the following qualifications:

(1) Be a doctor of medicine or doctor of osteopathy medicine licensed to practice medicine or osteopathy by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and privileged to practice medicine in a DoD medical treatment facility; and be certified in anatomic 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.

(2) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and privileged to practice medicine in a DoD medical treatment facility, and have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology).

(3) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution, and have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible.

(4) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution, and have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible.

Note: The technical consultant requirements for "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. For example, an individual, who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service.

11-14. Standard: Laboratories Performing Moderate Complexity Testing: technical consultant responsibilities (§493.1413)

The technical consultant is responsible for the technical and scientific oversight of the laboratory. The technical consultant is not required to be on-site at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide consultation, as specified in paragraph a below.

a. The technical consultant must be accessible to the laboratory to provide on-site, telephone, or electronic consultation.

b. The technical consultant is responsible for:

(1) Selection of test methodology appropriate for the clinical use of the test results.

(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system.

(3) Enrollment and participation in an OASD(HA) approved proficiency testing program commensurate with the services offered.

(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results.

(5) Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.

(6) Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly.

(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed.

(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:

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

(b) Monitoring the recording and reporting of test results.

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

(d) Direct observation of performance of instrument maintenance and function checks.

(e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.

(f) Assessment of problem solving skills.

(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually 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.

11-15. Condition: Laboratories performing moderate complexity testing: clinical consultant (§493.1415)

The laboratory must have a clinical consultant who meets the qualification requirements of paragraph 11-16 below and provides clinical consultation in accordance with paragraph 11-17 below.

11-16. Standard: Laboratories Performing Moderate Complexity Testing: clinical consultant qualifications (§493.1417)

The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must be qualified as a laboratory director under paragraph 11-10b(1), (2), or (3)(a) above.

11-17. Standard: Laboratories Performing Moderate Complexity Testing: clinical consultant responsibilities (§493.1419)

The clinical consultant provides consultation regarding the appropriateness of the testing ordered and interpretation of test results. The clinical consultant must:

a. Be available to provide clinical consultation to the laboratory's clients.

b. Be available to assist the laboratory's clients in ensuring that appropriate tests are ordered to meet the clinical expectations.

c. Ensure that reports of test results include pertinent information required for specific patient interpretation.

d. Ensure that consultation is available and communicated to the laboratory's clients on matters related to the quality of the test results reported and their interpretation concerning specific patient conditions.

11-18. Condition: Laboratories Performing Moderate Complexity Testing: testing personnel (§493.1421)

The laboratory must have a sufficient number of individuals who meet the qualification requirements of paragraph 11-19 below, to perform the functions specified in paragraph 11-20 below for the volume and complexity of tests
performed.

11-19. Standard: Laboratories Performing Moderate Complexity Testing: testing personnel qualifications (§493.1423)

Each individual performing moderate complexity testing must meet one of the following requirements:

a. Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and be privileged to practice medicine in a DoD medical treatment facility, or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution.

b. Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution

c. Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician).

d. Have earned a high school diploma or equivalent, and have documentation of the completion of a formal training program, not solely limited to on-the-job training, appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has:

(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens.

(2) The skills required for implementing all standard laboratory procedures that are offered in the laboratory where the individual works.

(3) The skills required for performing each test method and for proper instrument use.

(4) The skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed.

(5) A working knowledge of reagent stability and storage.

(6) The skills required to implement the quality control policies and procedures of the laboratory.

(7) An awareness of the factors that influence test results.

(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control samples values prior to reporting patient results.

11-20. Standard: Laboratories Performing Moderate Complexity Testing: testing personnel responsibilities (§493.1425)

The testing personnel are responsible for specimen processing, test performance, and for reporting test results.

a. Each individual performs only those moderate complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities.

b. Each individual performing moderate complexity testing must:

(1) Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results.

(2) Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient samples.

(3) Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed.

(4) Follow the laboratory's established corrective action policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance.

(5) Be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the technical consultant, clinical consultant or director.

(6) Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications.

11-21. Condition: Laboratories Performing High Complexity Testing; laboratory director (§493.1441)

The laboratory must have a director who meets the qualification requirements of paragraph 11-22 below and provides overall management and direction in accordance with paragraph 11-23 below.

11-22. Standard: Laboratories Performing High Complexity Testing: laboratory director qualifications (§493.1443)

The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of high complexity tests.

a. For medical field units deployed outside the United States during periods of war, mobilization, or national emergency, the qualifications for laboratory director listed in paragraph b below may be modified or waived by OASD(HA) or TSG.

b. The laboratory director must meet one of the following qualifications:

(1) Be a doctor of medicine or doctor of osteopathy, licensed to practice medicine or osteopathy by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and be privileged to practice medicine in a DoD medical treatment facility; and be certified in anatomic 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.

(2) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and be privileged to practice medicine in a DoD medical treatment facility plus have one of the following:

(a) At least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine).

(b) At least 2 years of experience directing or supervising high complexity testing.

(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and one of the following:

(a) Be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, the American Board of Medical Laboratory Immunology or other board deemed comparable by OASD(HA).

(b) Until 1 July 1998, must have at least 2 years of laboratory training or experience, or both; or 2 years of experience directing or supervising high complexity testing; and on 1 July 1998, individuals must meet the qualifications specified in paragraph b(3)(a) above.

(4) For the subspecialty of oral pathology, 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 for certification.

(5) Be a commissioned officer of the Armed Forces, and have earned a master's degree in a chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution, and:

(a) Be certified by the American Board of Medical Microbiology, the National Registry for Clinical Chemistry, the American Board of Bioanalysis, the American Society of Clinical Pathology, the National Certifying Agency for Medical Laboratory Personnel, or other board deemed comparable by OASD(HA).

(b) Have at least 4 years of laboratory training or experience, or both, directing or supervising high complexity testing.

(c) Have an appointed pathology consultant who meets the qualifications listed in paragraph 11-22b(1) above and performs the duties as described in paragraph 11-23e(9) below for the directed laboratory.

(6) Be a commissioned officer of the Armed Forces, and have earned a bachelor's degree in a chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution, and

(a) Be certified by the American Board of Medical Microbiology, the National Registry for Clinical Chemistry, the American Board of Bioanalysis, the American Society of Clinical Pathology, the National Certifying Agency for Medical Laboratory Personnel, or other board deemed comparable by OASD(HA).

(b) Have at least 6 years of laboratory training or experience, or both, directing or supervising high complexity testing.

(c) Have an appointed pathology consultant who meets the qualifications listed in paragraph 11-22b(1) above and performs the duties as described in paragraph 11-23e(9) below for the directed laboratory.

11-23. Standard: Laboratories Performing High Complexity Testing: laboratory director responsibilities (§493.1445)

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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations.

a. The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under paragraphs 11-25, 11-28, 11-31, and 11-41 below, respectively.

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.

c. The laboratory director must be accessible (generally within a one-hour time frame) to the laboratory to provide on-site, telephone or electronic consultation as needed.

d. Each individual may direct no more than five laboratories that perform moderate and high complexity testing, or high complexity testing alone.

e. The laboratory director must:

(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.

(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards.

(3) Ensure that:

(a) The test methodologies selected have the capability of providing the quality of results required for patient care.

(b) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method.

(c) Laboratory personnel are performing the test methods as required for accurate and reliable results.

(4) Ensure that the laboratory is enrolled in an OASD(HA) approved proficiency testing program for the testing performed and that:

(a) The proficiency testing samples are tested as required under Chapter 6.

(b) The results are returned within the time frames established by the proficiency testing program.

(c) 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.

(d) An approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory.

(5) Ensure that the quality control and quality assurance programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur.

(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.

(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance characteristics are identified, and that patient test results are reported only when the system is functioning properly.

(8) Ensure that reports of test results include pertinent information required for interpretation.

(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.

(10) Ensure that a general supervisor provides on-site supervision of high complexity test performance by testing personnel qualified under paragraph 11-41e below.

(11) 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 chapter.

(12) 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.

(13) 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.

(14) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process.

(15) 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 result reporting and whether supervisory or director review is required prior to reporting patient test results.

11-24. Condition: Laboratories Performing High Complexity Testing: technical supervisor (§493.1447)

The laboratory must have a technical supervisor who meets the qualification requirements of paragraph 11-25 below and provides technical supervision in accordance with paragraph 11-26 below.

11-25. Standard: Laboratories Performing High Complexity Testing: technical supervisor qualifications (§493.1449)

The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical supervision for each of the specialties and subspecialties of service in which the laboratory performs high complexity tests or procedures. The director of a laboratory performing high complexity testing may function as the technical supervisor provided he or she meets the qualifications specified in this paragraph.

a. For deployable medical units deployed outside the United States during periods of war, mobil-ization, or national emergency, the qualifications for technical supervisor listed in paragraph b through paragraph i below may be modified or waived by OASD(HA) or TSG.

b. The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor meets the following qualifications:

(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and is privileged to practice medicine in a DoD medical treatment facility.

(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possesses qualifications that are equivalent to those required for such certification.

c. If the requirements of paragraph b above are not met and the laboratory performs tests in any of the specialties of Microbiology, Diagnostic Immunology, Chemistry, Hematology, or Radiobioassay, the individual functioning as the technical supervisor must meet one of the following qualifications:

(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and be privileged to practice medicine in a DoD medical treatment facility; and be certified in clinical pathology 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.

(2) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and be privileged to practice medicine in a DoD medical treatment facility; and have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty supervised (for example, in the specialty of hematology, physicians certified in either hematology or hematology and medical oncology by the American Board of Internal Medicine). Additionally, supervisors of the subspecialties of Bacteriology, Mycobacteriology, Mycology, Parasitology, or Virology; must have a minimum of 6 months experience in high complexity testing within the subspecialty.

(3) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty supervised. Additionally, supervisors of the subspecialties of Bacteriology, Mycobacteriology, Mycology, Parasitology, or Virology; must have a minimum of 6 months experience in high complexity testing within the subspecialty.

(4) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty supervised. Additionally, supervisors of the subspecialties of Bacteriology, Mycobacteriology, Mycology, Parasitology, or Virology; must have a minimum of 6 months experience in high complexity testing within the subspecialty.

(5) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty supervised. Additionally, supervisors of the subspecialties of Bacteriology, Mycobacteriology, Mycology, Parasitology, or Virology; must have a minimum of 6 months experience in high complexity testing within the subspecialty.

(6) Be a commissioned officer in the Armed Forces, and have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution and meet the following qualifications:

(a) Have at least 3 years of laboratory training or experience, or both, in high complexity testing within the specialty supervised. Additionally, supervisors of the subspecialties of Bacteriology, Mycobacteriology, Mycology, Parasitology, or Virology; must have a minimum of 6 months experience in high complexity testing within the subspecialty.

(b) Be certified by an agency appropriate to the specialty such as the American Board of Medical Microbiology, the American Society of Clinical Pathology, the National Certifying Agency for Medical Laboratory Personnel, or other board deemed comparable by OASD(HA).

Note: The technical supervisor requirements for "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. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology.

d. If the requirements of paragraph b above are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must:

(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and privileged to practice medicine in a DoD medical treatment facility; and meet one of the following requirements:

(a) Be certified in anatomic pathology 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) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification.

(2) An individual qualified under paragraph 11-25b or paragraph 11-25d(1) above may delegate some of the cytology technical supervisor responsibilities to an individual who is in the final year of full-time training leading to certification specified in paragraphs 11-25b or 11-25d(1)(a) above provided the technical supervisor qualified under paragraph 11-25b or paragraph 11-25d(1) above remains ultimately responsible for ensuring that all of the responsibilities of the cytology technical supervisor are met.

e. If the requirements of paragraph b above are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must:

(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and be privileged to practice medicine in a DoD medical treatment facility; and be certified in anatomic pathology 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.

(2) An individual qualified under paragraph 11-25b or paragraph 11-25e(1) above may delegate to an individual who is a resident in a training program leading to certification specified in paragraph 11-25b or 11-25e(1) above, the responsibility for examination and interpretation of histopathology specimens.

f. If the requirements of paragraph b above are not met and the laboratory performs tests in the subspecialty of dermatopathology, the individual functioning as the technical supervisor must:

(1) Be a doctor of medicine or doctor of osteopathy, licensed to practice medicine or osteopathy by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and be privileged to practice medicine in a DoD medical treatment facility; and meet one of the following requirements:

(a) Be certified in anatomic pathology 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) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification.

(c) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification.

(2) An individual qualified under paragraph 11-25b or paragraph 11-25f(1) above may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs 11-25b or 11-25f(1) above, the responsibility for examination and interpretation of dermatopathology specimens.

g. If the requirements of paragraph b above are not met and the laboratory performs tests in the subspecialty of ophthalmic pathology, the individual functioning as the technical supervisor must:

(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the and be privileged to practice medicine in a DoD medical treatment facility, and must meet one of the following requirements:

(a) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology possesses qualifications equivalent to those required for such certification.

(b) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology.

(2) An individual qualified under paragraph 11-25b or paragraph 11-25g(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs 11-25b or 11-25g(1) of this section, the responsibility for examination and interpretation of ophthalmic specimens.

h. If the requirements of paragraph b above are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements:

(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and privileged to practice medicine in a DoD medical treatment facility; and be certified in anatomic pathology 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, or be certified in oral pathology by the American Board of Oral Pathology or possess qualifications that are equivalent to those required for such certification.

(2) An individual qualified under paragraph 11-25b or paragraph 11-25h(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs 11-25b or 11-25h(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens.

i. If the requirements of paragraph b above are not met and the laboratory performs tests in the subspecialty of histocompatibility, the individual functioning as the technical supervisor must either:

(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the and be privileged to practice medicine in a DoD medical treatment facility; and have training or experience that meets one of the following requirements:

(a) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility.

(b) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility.

(2) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and have training or experience that meets one of the following requirements:

(a) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility.

(b) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility.

j. If the requirements of paragraph b above are not met and the laboratory performs tests in the subspecialty of clinical cytogenetics, the individual functioning as the technical supervisor must either:

(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and be privileged to practice medicine in a DoD medical treatment facility; and have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics.

(2) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics.

k. If the requirements of paragraph b of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must:

(1) Be a doctor of medicine, or doctor of osteopathy medicine licensed to practice medicine, or osteopathy, by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands and be privileged to practice medicine in a DoD medical treatment facility; and be certified in clinical pathology 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

(2) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the and privileged to practice medicine in a DoD medical treatment facility; and have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology.

(3) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and have either:

(a) At least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of immunohematology.

(b) Successfully completed a CAHEA accredited school as a Specialist in Blood Banking.

(4) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and have either:

(a) At least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of immunohematology.

(b) Successfully completed a CAHEA accredited school as a Specialist in Blood Banking.

(5) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and have either:

(a) At least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of immunohematology.

(b) Successfully completed a CAHEA accredited school as a Specialist in Blood Banking.

(6) Be a commissioned officer in the Armed Forces, and have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and have at least 3 years of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology; and be certified by the American Society of Clinical Pathology, the National Certification Agency for Medical Laboratory Personnel, or other board deemed comparable by OASD(HA).

11-26. Standard: Laboratories Performing High Complexity Testing: technical supervisor responsibilities (§493.1451)

The technical supervisor is responsible for the technical and scientific oversight of the laboratory. The technical supervisor is not required to be on site at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide supervision as specified below.

a. The technical supervisor must be accessible to the laboratory to provide on-site, telephone, or electronic consultation.

b. The technical supervisor is responsible for:

(1) Selection of the test methodology that is appropriate for the clinical use of the test results.

(2) Verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system.

(3) Enrollment and participation in an OASD(HA)-approved proficiency testing program commensurate with the services offered.

(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results.

(5) Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.

(6) Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly.

(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed.

(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:

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

(b) Monitoring the recording and reporting of test results.

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

(d) Direct observation of performance of instrument maintenance and function checks.

(e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.

(f) Assessment of problem solving skills.

(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually 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.

c. In cytology, the technical supervisor or the individual qualified under paragraph 11-25d(2) above:

(1) May perform the duties of the cytology general supervisor and the cytotechnologist, as specified in paragraph 11-36 and paragraph 11-39 below, respectively.

(2) Must establish the workload limit for each individual examining slides.

(3) Must reassess the workload limit for each individual examining slides at least every 6 months and adjust as necessary.

(4) Must perform the functions specified in paragraph 10-30c above.

(5) Must ensure that each individual examining gynecologic preparations participates in an OASD(HA) approved cytology proficiency testing program, as specified in paragraph 8-11 above and achieves a passing score, as specified in paragraph 6-8 above.

(6) If responsible for screening cytology slide preparations, must document the number of cytology slides screened in 24 hours and the number of hours devoted during each 24 hour period to screening cytology slides.

11-27. Condition: Laboratories Performing High Complexity Testing: clinical consultant (§493.1453)

The laboratory must have a clinical consultant who meets the requirements of paragraph 11-28 below and provides clinical consultation in accordance with paragraph 11-29 below.

11-28. Standard: Laboratories Performing High Complexity Testing: clinical consultant qualifications (§493.1455)

The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must meet one of the following
qualifications:

a. Be qualified as a laboratory director under paragraph 11-22b(1),(2), or (3) or, for the subspecialty of oral pathology, paragraph 11-22b(4) above.

b. Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy be a recognized licensing agency of a state, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and privileged to practice medicine in a DoD medical facility.

11-29. Standard: Laboratories Performing High Complexity Testing: clinical consultant responsibilities (§493.1457)

The clinical consultant provides consultation regarding the appropriateness of the testing ordered and interpretation of test results. The clinical consultant must:

a. Be available to provide consultation to the laboratory's clients.

b. Be available to assist the laboratory's clients in ensuring that appropriate tests are ordered to meet the clinical expectations.

c. Ensure that reports of test results include pertinent information required for specific patient interpretation.

d. Ensure that consultation is available and communicated to the laboratory's clients on matters related to the quality of the test results reported and their interpretation concerning specific patient conditions.

11-30. Condition: Laboratories Performing High Complexity Testing: general supervisor (§493.1459)

The laboratory must have one or more general supervisors who are qualified under paragraph 11-31 to provide general supervision in accordance with paragraph 11-33 below.

11-31. Standard: Laboratories performing high complexity testing: general supervisor qualifications (§493.1461)

The laboratory must have one or more general supervisors who, under the direction of the laboratory director and supervision of the technical supervisor, provides day-to-day supervision of testing personnel and reporting of test results. In the absence of the director and technical supervisor, the general supervisor must be responsible for the proper performance of all laboratory procedures and reporting of test results.

a. For deployable medical units deployed outside the United States during periods of war, mobilization, or national emergency, the qualifications for general supervisor listed in paragraph b may be modified or waived by OASD(HA) or TSG.

b. The general supervisor must be qualified as either:

(1) Laboratory director under paragraph 11-22 above.

(2) Technical supervisor under paragraph 11-25 above.

c. If the requirements of paragraphs b(1) or b(2) above are not met, the individual functioning as the general supervisor must meet one of the following qualifications:

(1) Be a doctor of medicine, doctor of osteopathy or doctor of podiatry licensed to practice medicine, osteopathy, or podiatry by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and be privileged to practice medicine in a DoD medical treatment facility, or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; and have at least one year of laboratory training or experience, or both, in high complexity testing.

(2) Qualify as testing personnel under paragraph 11-41a, b, c or d below; and have at least 2 years of laboratory training or experience, or both, in high complexity testing.

(3) Have previously qualified as a general supervisor under paragraph 11-32 on or before 28 February 1992. (Exception: An individual who achieved a satisfactory grade in a proficiency examination for technologist given by HHS between 1 March 1986 and 31 December 1987 qualifies as a general supervisor if he or she meets the requirements of paragraph 11-32 on or before 1 January 1994.)

(4) On or before 1 September 1992, have served as a general supervisor of high complexity testing and as of 24 April 1995 meet one of the following requirements and have at least 2 years of clinical laboratory training, or experience, or both, in high complexity testing:

(a) Have graduated from a medical laboratory or clinical laboratory training program approved or accredited by the Accrediting Bureau of Health Education Schools (ABHES), the Commission on Allied Health Education Accreditation (CAHEA), or other organization approved by OASD(HA).

(b) Be a high school graduate or equivalent and have successfully completed an official U.S. military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician).

(5) On or before 1 September 1992 have served as a general supervisor of high complexity testing; and be a high school graduate or equivalent; and have at least 10 years of laboratory training or experience, or both, in high complexity testing, including at least 6 years of supervisory experience between 1 Septem-ber 1982 and 1 September 1992.

d. For blood gas analysis, the individual providing general supervision must meet one of the following qualifications:

(1) Be qualified under paragraph 11-31b(1) or (2), or paragraph 11-31c.

(2) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and have at least 1 year of laboratory training or experience, or both, in blood gas analysis.

(3) Have earned an associate degree related to pulmonary function from an accredited institution; and have at least 2 years of training or experience, or both, in blood gas analysis.

e. The general supervisor requirement is met in histopathology, oral pathology, dermatopathology, and ophthalmic pathology because all tests and examinations must be performed:

(1) In histopathology, by an individual who is qualified as a technical supervisor under paragraph 11-25b or paragraph 11-25e(1);

(2) In dermatopathology, by an individual who is qualified as a technical supervisor under paragraph 11-25b or paragraph 11-25f(1);

(3) In ophthalmic pathology, by an individual who is qualified as a technical supervisor under paragraph 11-25b or paragraph 11-25g(1); and

(4) In oral pathology, by an individual who is qualified as a technical supervisor under paragraph 11-25b or paragraph 11-25h(1) or (2).

11-32. Standard: Laboratories performing high complexity testing; General supervisor qualifications on or before 28 February 1992 (§493.1462)

To qualify as a general supervisor under paragraph 11-31c(3) above, an individual must possess a current license as a laboratory supervisor issued by the State, if such licensing exists; and have met or could have met one of the following qualifications as they were in effect on or before 28 February 1992.

a. The laboratory supervisor:

(1) Who qualifies as a laboratory director under paragraph 11-10b(2), (4), or (5) also qualifies as a general supervisor; therefore, depending upon the size and functions of the laboratory, the laboratory director may also serve as the laboratory supervisor.

(2) Is a physician or has earned a Ph.D. degree from an institution in one of the chemical, physical or biological sciences; and subsequent to graduation, has had at least 2 years experience in one of the lab specialties in a laboratory.

(3) Holds a master's degree from an accredited institution with a major in one of the chemical, physical or biological sciences, and subsequent to graduation has had at least 4 years of pertinent full-time lab experience of which not less than 2 years have been spent working in the designated specialty in a laboratory.

(4) Who qualifies as a laboratory technologist under paragraph 11-41 below; and after qualifying as a laboratory technologist, has had at least 6 years of pertinent full time laboratory experience of which not less than 2 years have been spent working in the designated specialty in a laboratory; or

(5) First qualifying before 1 July 1971, has had at least 15 years of pertinent full time laboratory experience before 1 January 1968; this required experience may be met by the substitution of education for experience.

11-33. Standard: Laboratories performing high complexity testing; General supervisor responsibilities (§493.1463)

The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results.

a. The general supervisor:

(1) Must be accessible to testing personnel at all times testing is performed to provide on-site, telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established either by the laboratory director or technical supervisor.

(2) Is responsible for providing day-to-day supervision of high complexity test performance by testing personnel qualified under paragraph 11-41 below.

(3) Except as specified in paragraph c below, must be on-site to provide direct supervision when high complex testing is performed by any individuals qualified under paragraph 11-41e.

(4) Is responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.

b. The director or technical supervisor may delegate to the general supervisor the responsibility for:

(1) Assuring that all remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.

(2) Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning.

(3) Providing orientation to all testing personnel.

(4) Annually evaluating and documenting the performance of all testing personnel.

c. Exception: For individuals qualified under paragraph 11-41e, who were performing high complexity testing on or before 19 January 1993, the requirements of paragraph a(3) above are not effective, provided that all high complexity testing performed by the individual in the absence of a general supervisor is reviewed within 24 hours by a general supervisor qualified under paragraph 11-31 above.

11-34. Condition: Laboratories Performing High Complexity Testing: cytology general supervisor (§493.1467)

For the subspecialty of cytology, the laboratory must have a general supervisor who meets the qualification requirements of paragraph 11-35 below, and provides supervision in accordance with paragraph 11-36 below.

11-35. Standard: Laboratories Performing High Complexity Testing: cytology general supervisor qualifications (§493.1469)

The cytology general supervisor must be qualified to supervise cytology services. The general supervisor in
cytology must either:

a. Be qualified as a technical supervisor under paragraph 11-25b or d above.

b. Be qualified as a cytotechnologist under paragraph 11-38 below; and have at least 3 years of full-time (2,080 hours per year) experience as a cytotechnologist within the preceding 10 years.

11-36. Standard: Laboratories Performing High Complexity Testing: cytology general supervisor responsibilities (§493.1471)

The technical supervisor of cytology may perform the duties of the cytology general supervisor or delegate the responsibilities to an individual qualified under paragraph 11-35 above.

a. The cytology general supervisor is responsible for the day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results.

b. The cytology general supervisor must:

(1) Be accessible to provide on-site, telephone, or electronic consultation to resolve technical problems in accordance with policies and procedures established by the technical supervisor of cytology.

(2) Document the slide interpretation results of each gynecologic and nongynecologic cytology case he or she examined or reviewed (as specified under paragraph 10-30d).

(3) For each 24 hour period, document the total number of slides he or she examined or reviewed in the laboratory as well as the total number of slides examined or reviewed in any other laboratory or for any other employer.

(4) Document the number of hours spent examining slides in each 24 hour period.

11-37. Condition: Laboratories Performing High Complexity Testing: cytotechnologist (§493.1481)

For the subspecialty of cytology, the laboratory must have a sufficient number of cytotechnologists who meet the qualifications specified in paragraph 11-38 below to perform the functions specified in paragraph 11-39 below.

11-38. Standard: Laboratories Performing High Complexity Testing: cytotechnologist qualifications (§493.1483)

Each person examining cytology slide preparations must meet the qualifications of paragraph 11-25b or d or meet one of the following requirements:

a. Have graduated from a CAHEA accredited school of cytotechnology.

b. Be certified in cytotechnology by a certifying agency approved by OASD(HA).

c. Before 1 September 1992:

(1) Have successfully completed 2 years in an accredited institution with at least 12 semester hours in science, 8 hours of which are in biology; and have completed 1 of the following:

(a) 12 months of training in a school of cytotechnology accredited by an accrediting agency approved by OASD(HA).

(b) received 6 months of formal training in a school of cytotechnology accredited by an accrediting agency approved by OASD(HA) and 6 months of full-time experience in cytotechnology in a laboratory acceptable to the pathologist who directed the formal 6 months of training.

(2) Have achieved a satisfactory grade to qualify as a cytotechnologist in a proficiency examination approved by HHS and designed to qualify persons as cytotechnologists.

d. Before 1 September 1994, have full-time experience of at least 2 years or equivalent within the preceding 5 years examining slide preparations under the supervision of a physician qualified under paragraph 11-25b or d(1) must have completed all of the following:

(1) Graduated from high school.

(2) Completed 6 months of training in cytotechnology in a laboratory directed by a pathologist or other physician providing cytology services.

(3) Completed 2 years of full-time supervised experience in cytotechnology.

e. On or before 1 September 1994, have full-time experience of at least 2 years or equivalent examining cytology slide preparations within the preceding 5 years under the supervision of a physician qualified under paragraph 11-25b or d(1); and on or before 1 September 1995, have met the requirements in either paragraph (a) or (b) above.

11-39. Standard: Cytotechnologist responsibilities (§493.1485)

The cytotechnologist is responsible for documenting:

a. The slide interpretation results of each gynecologic and nongynecologic cytology case he or she examined or reviewed (as specified in paragraph 10-30d).

b. For each 24-hour period, the total number of slides examined or reviewed in the laboratory as well as the total number of slides examined or reviewed in any other laboratory or for any other employer.

c. The number of hours spent examining slides in each 24 hour period.

11-40. Condition: Laboratories Performing High Complexity Testing: testing personnel (§493.1487)

The laboratory has a sufficient number of individuals who meet the qualification requirements of paragraph 11-41 and perform the functions specified in paragraph 11-43 for the volume and complexity of testing performed.

11-41. Standard: Laboratories Performing High Complexity Testing: testing personnel qualifications (§493.1489)

Each individual performing high complexity testing must meet one of the following requirements:

a. Be a doctor of medicine, doctor of osteopathy or, doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry by the recognized licensing agency of a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, or the U.S. Virgin Islands, and privileged to practice medicine in a DoD medical treatment facility, or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution;

b. Have met 1 of the following associate degree or equivalency requirements:

(1) Earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution.

(2) Have education and training equivalent to that specified in paragraph 11-41b(1) above that includes both:

(a) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either:

(1) 24 semester hours of medical laboratory technology courses, or

(2) 24 semester hours of science courses that include 6 semester hours of chemistry, 6 semester hours of biology, and 12 semester hours of chemistry, biology, or medical laboratory technology in any combination.

(b) Have laboratory training that includes either:

(1) Completion of a clinical laboratory training program approved by the ABHES, CAHEA, NAACLS or other organization approved by OASD(HA). (This training may be included in the 60 semester hours listed in paragraph 11-41b(2)(a) above.), or

(2) Minimum 3 three months documented laboratory training in each specialty in which the individual performs high complexity testing.

c. Have previously qualified or could have qualified as a technologist under paragraph 11-42 below on or before 28 February 1992.

d. On or before 24 April 1995 be a high school graduate or equivalent and have either:

(1) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, NAACLS or other organization approved by OASD(HA).

(2) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician).

e. Until 1 September 1997, have earned a high school diploma or equivalent; and have documentation of training appropriate to the testing performed before analyzing patient specimens. Such training must ensure that the individual has:

(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens.

(2) The skills required for implementing all standard laboratory procedures that are offered in the laboratory where the individual works.

(3) The skills required for performing each test method and proper instrument use.

(4) The skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed.

(5) A working knowledge of reagent stability and storage.

(6) The skills required to implement the quality control policies and procedures of the laboratory.

(7) An awareness of the factors that influence test results.

(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality sample values prior to reporting patient test results.

f. On 1 September 1997, testing personnel must meet the qualifications of paragraph 11-41a, b, c or d above, except for those individuals qualified under paragraph 11-41e above who were performing high complexity testing on or before 24 April 1995.

g. For blood gas analysis, the individual must:

(1) Be qualified under paragraph 11-41a, b, c, d, or e.

(2) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution, or have earned an associate degree related to pulmonary function from an accredited institution;

h. For histopathology, tissue examinations must be performed by an individual who meets the qualifications of paragraphs 11-25b or 11-25e(1).

11-42. Laboratories Performing High Complexity Testing: technologist qualifications on or before 28 February 1992 (§493.1491)

In order to qualify as high complexity testing personnel under paragraph 11-41c above, the individual must have met or could have met, the following qualifications for technologist as they were in effect before 28 February 1992.
Each technologist must:

a. Possess a current license as a laboratory technologist issued by the State, if such a licensing exists.

b. Meet one of the following requirements:

(1) Have earned a BS in medical technology from an accredited university.

(2) Have successfully completed 3 years of academic study (minimum 90 semester hours or equivalent) from an accredited college or university, which met the specific requirements for entrance into a school of medical technology accredited by an accrediting agency approved by the Secretary HHS, and has successfully completed a course of training of at least 12 months in such a school.

(3) Have earned a BS in one of the chemical, physical or biologic sciences and, in addition, has at least 1 year of pertinent full time lab experience or training, or both, in the specialty or subspecialty in which the individual performs tests.

(4) Have successfully completed 3 years (90 semester hours or equivalent) in an accredited college or university with the following distribution of courses;

(a) For those whose training was completed before 15 September 1963, at least 24 semester hours in chemistry and biology courses of which at least 6 semester hours were in inorganic chemistry, 3 hours in other chemistry courses and at least 12 semester hours in biology courses pertinent to the medical sciences.

(b) For those whose training was completed after 14 September 1963, at least 16 semester hours in chemistry of which at least 6 semester hours were in inorganic chemistry and that are acceptable toward a major in chemistry, 16 semester hours in biology courses pertinent to the medical sciences and are acceptable toward a major in the biological sciences, and 3 semester hours of mathematics; and has experience, training, or both, covering several fields of medical laboratory work of at least 1 year and of such quality as to provide him or her with education and training in medical technology equivalent to that described in paragraphs b(1) and (2) above.

(5) With respect to individuals first qualifying before 1 July 1971, the technologist was performing the duties of a lab technologist at any time between 1 July 1961 and 1 January 1968, and has at least 10 years of pertinent lab experience prior to 1 January 1968 (required experience may be met by the substitution of education for experience).

(6) Achieves a satisfactory grade in a proficiency examination approved by HHS.

11-43. Standard: Laboratories Performing High Complexity Testing: testing personnel responsibilities (§493.1495)

The testing personnel are responsible for specimen processing, test performance and for reporting test results.

a. Each individual performs only those high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities.

b. Each individual performing high complexity testing must:

(1) Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results.

(2) Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.

(3) Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed.

(4) Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance.

(5) Be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the general supervisor, technical supervisor, clinical consultant, or director.

(6) Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications.

(7) Except as specified in paragraph c below, if qualified under paragraph 11-41e, perform high complexity testing only under the on-site, direct supervision of a general supervisor qualified under paragraph 11-31.

c. Exception: For individuals qualified under paragraph 11-41e, who were performing high complexity testing on or before 19 January 1993, the requirement of paragraph b(7) of this section are not effective, provided that all high complexity testing performed by the individual in the absence of a general supervisor is reviewed within 24 hours by a general supervisor qualified under paragraph 11-31.

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