59A-6.022. Standards of Performance

The licensee shall be responsible for the operation of the multiphasic health testing center. The licensee shall provide verification of the following upon request by the agency:

(1) Personnel Standards.

(a) The owner, administrator, or manager of the center shall retain such personnel qualified pursuant to subsection 59A-6.022(1), F.A.C., as are necessary to assure the safety and accuracy of tests given to consumers.

(b) Employees are qualified by education, training and experience, certification, licensure or registration in their specialty to perform the testing procedures for which they are employed. Personnel must be licensed as required under Florida Statutes including chapters 464, 483, part IV, 468, part IV or 468, part V, F.S., for their respective disciplines. Such training, licensure and experience shall be documented and maintained on the center premises during the tenure of such personnel and for two years thereafter.

(c) Medical assistants qualified for employment in accordance with section 483.291(7)(b), Florida Statutes, shall be certified or registered by one of the following programs accredited by the National Commission for Certifying Agencies:

1. The American Association of Medical Assistants’ Certified Medical Assistant (CMA);

2. The American Medical Certification Association’s Clinical Medical Assistant Certification (CMAC);

3. The American Medical Technologist’s Registered Medical Assistant (RMA);

4. The National Center for Competency Testing’s National Certified Medical Assistant (NCMA); or

5. The National Healthcareer Association’s Certified Clinical Medical Assistant (CCMA).

(d) There shall be a written job description for each category of personnel which outlines specific responsibilities and duties.

(2) Consumers shall not be denied multiphasic health testing services by reason of race, creed, age, or national origin.

(3) Policies and Procedures. A center shall have a current policies and procedures manual for its operation that will assure the integrity of specimens taken, the accuracy of all tests given and the safety of consumers. As a minimum, written policies and procedures shall cover the following:

(a) A written procedure shall be prepared for each test, outlining the objective of the test, the correct use of equipment, and the methodology for taking the test. The procedure manual must include the applicable test procedure including:

1. Requirements for specimen collection and processing.

2. Step by step performance of the procedure.

3. Remedial actions to be taken when instrument operation fails to meet the center’s requirement for acceptability.

4. Criteria for specimen storage and preservation to ensure specimen integrity until testing is completed or such specimen is forwarded to the laboratory that will perform the analysis.

5. Pertinent literature references.

6. Description of the course of action to be taken in the event a test system becomes inoperable.

7. Maintenance, calibration, quality control procedures and procedures for performing routine checks, daily function checks or other checks that assure proper operation of equipment and test methodologies.

8. Quality assurance program which is designed to monitor and evaluate the ongoing and overall quality of the total testing process.

(b) Identification of persons responsible for the operation of the center.

(c) Responsibilities of the medical director.

(d) Protocol for center operations which shall include:

1. Requests for clinical laboratory analysis of specimens collected at the center shall bear the name of the medical director.

2. Outside resources used by the center shall be pursuant to written agreement which must specify that the center assumes full responsibility for the services provided.

3. Neither the medical director nor any other employee of the center shall provide any diagnosis, consultation or treatment.

4. Consumers seeking clarification of their test results must be referred to their personal physician. If they do not have a personal physician, the consumer shall be given the name, address and telephone number of the local county medical or osteopathic association or society.

5. Written emergency procedures shall be established and every employee shall be familiar with these procedures.

6. Reports which provide the results of tests shall not be revealed to individuals unauthorized by law to review them.

7. A center shall not perform clinical laboratory testing, except that licensed centers are authorized to conduct dipstick urinalysis and fecal occult blood tests if such tests are conducted by licensed registered nurses, practical nurses, medical technicians, medical assistants or clinical laboratory technicians trained to perform and interpret these tests.

(e) The procedures manual must be approved, signed and dated by the medical director annually.

(f) Each change in procedures must be approved, signed and dated by the current medical director.

(g) The center must maintain a copy of each procedure with the dates of initial use and discontinuance. These records must be maintained for two years after a procedure has been discontinued.

(h) Written procedures shall be in effect to assure the prevention of infection. These procedures shall address and implement, as a minimum, the following:

1. Disposable syringes, needles and lancets must be used.

2. Procedures shall be established for the sterilizing of equipment that may transmit disease. Such equipment shall be sterilized after each test.

(4) Sanitation. The center is operated and maintained in a facility where the safety and health of consumers and employees are not endangered in accordance with this rule chapter.

(a) The center or mobile facility shall be maintained in a clean and sanitary condition in accordance with the following rules and statutes administered by the Department of Environmental Protection and the Department of Health: section 381.0098, F.S. and chapter 64E-16, F.A.C.

(b) Testing areas shall be well lighted and ventilated.

(c) Reusable items capable of transmitting infection from consumer to consumer shall be sterilized after each use consistent with rule 59A-6.022, F.A.C. A schedule for resterilization of items of equipment shall be established for those items that may transmit infection from consumer to consumer.

(5) Equipment. The center uses equipment and procedures that meet the objective of the test to which the consumer is subjected and equipment is maintained in a satisfactory operating condition required by this rule chapter.

(a) All equipment shall be operated and maintained according to manufacturers’ instructions.

(b) Documentation of maintenance, daily function checks and instrument calibration performed in accordance with manufacturers’ instructions, shall be maintained for a minimum of two years. Documentation of the maintenance, daily function checks and instrument calibration procedures and the manufacturers’ instructions must be maintained by the center and available for review by the agency as required under rule 59A-6.022, F.A.C.

(c) Equipment shall be protected from fluctuations and interruptions in electrical current that adversely affect patient test results.

(6) Physical Environment.

(a) Testing areas shall be configured so as to ensure the privacy of the consumer being tested.

(b) The center shall provide a functional, sanitary, and comfortable environment for consumers and staff.

(c) The center must be configured and maintained to ensure the space, ventilation and utilities necessary for conducting all phases of testing, as appropriate.

(7) Mobile units shall be so designed as to accommodate all necessary equipment, provide privacy for the consumer, toilet facilities and lavatory with single service towels.

(8) Clinical operation of the center shall be the responsibility of a physician licensed under chapter 458 or 459, F.S. This physician shall serve as the medical director of the center.

(9) Requests for clinical laboratory analysis of specimens collected at the center shall bear the name of the medical director.

(10) Medical services provided outside the center, including clinical laboratory, pulmonary function, electrocardiograph and radiology, services shall be pursuant to written agreement between the center and the service provider which must specify that the center assumes full responsibility for the services provided.

(11) Neither the medical director nor any other employee of the center shall provide any diagnosis, consultation or treatment.

(12) Consumers seeking clarification of their test results must be referred to their personal physician. If they do not have a personal physician, the consumer shall be given the name, address and telephone number of the local county medical or osteopathic association or society.

(13) Written emergency procedures shall be established and every employee shall be familiar with these procedures.

(14) Reports which provide the results of tests shall not be revealed to individuals unauthorized by law to review them.

(15) A center shall not perform clinical laboratory testing, except that licensed centers are authorized to conduct dipstick urinalysis and fecal occult blood tests if such tests are conducted by licensed registered nurses, practical nurses, medical technicians, medical assistants or clinical laboratory technicians trained to perform and interpret these tests.

Rulemaking Authority 483.291 FS. Law Implemented 483.291, 483.308, 483.314 FS. History–New 3-20-94, Amended 5-1-96, 5-27-18.