Alternate-Site Testing

AGENCY FOR HEALTH CARE ADMINISTRATION
Health Facility and Agency Licensing

Rule No.: RULE TITLE
59A-7.034: Alternate-Site Testing

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 36 No. 38, September 24, 2010 issue of the Florida Administrative Weekly.

Changes include revisions to subsection 59A-7.034(10), where subparagraph 6. was inadvertently placed in subparagraph 7.

59A-7.034 Alternate-Site Testing.

(1) through (4) No change.

(5) Approval of Alternate-Site Testing:

(a) A request for approval of any new instrument or testing methodology not currently listed by the Agency’s Internet site Clinical Laboratory Hospital Alternate-Site Testing, November 2010: http://ahca.myflorida.com/mchq/health_facility_regulation/laboratory_licensure/altsiterule.shtml and incorporated herein by reference, as approved for alternate-site testing, must be submitted to the Agency for review and approval prior to implementation. If the instrument is listed as an unapproved test, then it cannot be performed at an alternative-site. If a test is listed as approved under specific circumstances, those circumstances must be met in order for the test to be performed.

(b) A request for approval of any new instrument or testing methodology must include the location of the alternate-site, category of personnel who will perform the tests, name of the instrument or method to be used, instrument manufacturer and model number if applicable, and any other information necessary for the Agency to determine whether tests to be performed meet the criteria established in subparagraph subsubparagraph 10.

(c) No change.

(d) Instruments or testing methodologies previously approved and listed on the Agency’s alternate-site testing website Clinical Laboratory Hospital Alternate-Site Testing, November 2010 at: http://ahca.myflorida.com/mchq/health_facilityregulation/laboratory_licensure/altsiterule.shtml do not require prior approval.

(f) No change.

(6) through (7) No change.

(8)(a)1.-9. No change.

10. Meets the staff training and education educational requirements set out in the alternate-site policy and procedure manual developed by the laboratory director for individuals performing tests categorized as waived.

(b) No change.

(c) The laboratory director shall, in consultation with medical staff designated by the hospital, establish the training needs for the test methods used at each site. This training at a minimum must ensure that alternate-site testing personnel have had instruction in the following areas:

1. Specimen collection, handling and storage including infection control procedures.

2. Instrument procedures including skills required to perform preventive maintenance, calibration and troubleshooting.

3. Skills required to implement quality control procedures and evaluate quality control results.

4. Skills required to perform specific test procedures.

5. Result reporting and documentation techniques including knowledge of reporting procedures for life threatening results.

6. Awareness of the factors that influence test results including the skills required to assess and verify the validity of patient test results through the assessment and correlation of pre-analytical and post-analytical phases of testing with laboratory data generated during the analytical phase of testing as they relate to common physiological conditions and quality control, and Awareness of the factors that influence test results including the skills required to assess and verify the validity of patient test results through the assessment and correlation of pre-analytical and post-analytical phases of testing with laboratory data generated during the analytical phase of testing as they relate to common physiological conditions and quality control, and

7. Monitoring of systems and results for errors including instruction on corrective action including whether or not results can be reported. Monitoring of systems and results for errors including instruction on corrective action including whether or not results can be reported.

(d) No change.

(9) through (10) No change.

(11) The Agency shall take administrative action pursuant to Sections 483.201, 483.221, 408.806, 408.813, 408.814, 408.816 and 483.23, F.S., up to and including revocation of the approval for operation of any or all alternate-testing sites where the agency determines that said sites have operated in violation of Chapter 483, Part I, F.S., and the provisions of Chapter 59A-7, F.A.C. In addition, pursuant to Sections 483.201, 483.221, and 483.23, F.S., in the event of such a violation, the Agency shall take administrative action up to and including revocation of the laboratory license of the laboratory maintaining the alternate-testing site.

Rulemaking Authority 483.051, 408.819 FS. Law Implemented 408.806, 408.813, 408.814, 408.816, 483.051, 483.181, 483.201, 483.221, 483.23, 483.813 FS. History–New 12-27-95, Amended 12-8-09,________.