The agency is proposing to amend the rule that specifies the elements required to operate an alternate-site within a hospital to broaden the laboratory director’s discretion for site development and remove any requirement for Agency prior approval ...

AGENCY FOR HEALTH CARE ADMINISTRATION
Health Facility and Agency Licensing

RULE NO.: RULE TITLE:
59A-7.034: Alternate-Site Testing
PURPOSE AND EFFECT: The agency is proposing to amend the rule that specifies the elements required to operate an alternate-site within a hospital to broaden the laboratory director’s discretion for site development and remove any requirement for Agency prior approval of alternate testing sites within hospitals licensed under Chapter 395, F.S.
SUMMARY: Revisions broaden parameters for alternate-site development giving laboratory directors more discretion in testing to be performed within certain parameters and allow site implementation without Agency pre-review and approval.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. An SERC has not been prepared by the agency.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
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 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE,TIME AND PLACE SHOWN BELOW(IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):
DATE AND TIME: July 21, 2011, 2:00 p.m.
PLACE: Agency for Health Care Administration, Building 3, Conference Room D, 2727 Mahan Drive, Tallahassee, Florida
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Karen Rivera, Laboratory Unit, 2727 Mahan Drive, Building 1, Mail Stop 32, Tallahassee, Florida 32308, [phone]

THE FULL TEXT OF THE PROPOSED RULE IS:

59A-7.034 Alternate-Site Testing.

(1) through (2)(b) No change.

(c) Alternate-site locations must be listed on any hospital clinical laboratory licensure application submitted to the Agency.

(3) No change.

(4) Hospital Internal Needs Assessment:

(a) The laboratory director in consultation with the appropriate medical staff shall prepare an internal needs assessment for alternate-site testing. Each testing site assessment shall include an evaluation of patient benefits and criteria for such testing, location of alternate-site, population to be served, and an evaluation of proposed instruments or testing methodologies to determine if the requirements listed in subsections (7)(8) through (9)(12) are met.

(b) through (e) 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 subsection (10).

(c) Requests must be sent to: Agency for Health Care Administration, Clinical Laboratory Unit, M.S. 32, 2727 Mahan Drive, Tallahassee, Florida 32308. The Agency will respond with either a request for additional information or approval within 30 days of receipt of the request.

(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: http://ahca.myflorida.com/mchq/health_facility_regulation/laboratory_licensure/altsiterule.shtml do not require prior approval.

(e) A listing of all alternate-site testing locations and laboratory tests performed at each site must be included with each laboratory license renewal application.

(5)(6) Written Protocols and Quality Assurance Programs:

(a) through (c) No change.

(6)(7) Recordkeeping Requirements:

(a) through (c) No change.

(7)(8) Alternate-Site Testing Personnel Requirements: Staff performing the testing at these alternate-sites, as authorized under this subsection, are not required to be licensed under Chapter 483, Part III, F.S., as clinical laboratory personnel.

(a) Testing personnel shall have a high school diploma, or its equivalent, and have met the HIV/AIDS educational requirements pursuant to Section 381.0035, F.S. In addition, all testing personnel in the alternate-test site locations shall meet one of the following requirements:

1. Is licensed as an advanced registered nurse practitioner, a registered nurse or licensed practical nurse pursuant to Chapter 464, F.S.,

2. Is licensed as a radiologic technologist pursuant to Chapter 468, Part IV, F.S.,

3. Is licensed as a respiratory care practitioner certified in critical care services or a respiratory therapist pursuant to Chapter 468, Part V, F.S.,

4. Is a phlebotomist certified by the American Society of Clinical Pathologists (ASCP), National Certification Agency for Medical Laboratory Personnel (NCA), American Society of Phlebotomy Technicians (ASPT) or American Medical Technologists (AMT),

4.5. Is licensed as a physician assistant pursuant to Chapter 458 and 459, F.S.,

5.6. Is a perfusionist certified by the American Board of Cardiovascular Perfusion, determined eligible for certification by the American Board of Cardiovascular Perfusion, or has two years of clinical experience in cardiovascular perfusion with 100 clinical perfusions conducted as of January 1, 1981.

6.7. Is a cardiovascular technician certified by the Cardiovascular Credentialing International (CCI),

7.8. Is licensed as a director, supervisor, technologist or technician under Chapter 483, Part III, F.S., or exempt from such licensure as provided in that chapter,

8.9. Is a licensed Emergency Medical Technician (EMT) or Paramedic pursuant to Chapter 401, F.S., or

9.10. Meets the staff training and education requirements set out in the alternate-site policy and procedure manual developed by the laboratory director for individuals performing tests categorized as waived. Individuals, such as phlebotomists, who meet such staff training and education requirements for performing tests categorized as waived, but who do not meet the requirements for performing moderate complexity tests as provided under this rule, are restricted to performing tests categorized as waived.

(b) The laboratory director will determine if the above listed personnel are suitable to perform testing at the alternate-site. The laboratory director shall:

1. Ensure that testing personnel are limited to those who meet the requirements of paragraph 59A-7.034(7)(a), F.A.C. and

2. Establish methods for the evaluation of competency to verify that alternate-site testing personnel perform procedures and report tests results promptly and accurately, Evaluation of competency shall include:

a. Specimen collection, handling and storage including infection control procedures;

b. Skills required to perform the test method;

c. Skills required to perform preventive maintenance, troubleshooting, and calibration procedures, applicable to the testing methodologies;

d. Demonstration of knowledge of reagent stability and storage applicable to the test system in use;

e. Skills required to implement quality control policies and procedures and evaluate quality control results;

f. An awareness of factors that influence test results;

g. Skills required to assess and verify the validity of patient test results through the assessment of quality control testing outcomes;

h. Demonstration of knowledge of patient preparation for each test performed;

i. Demonstration of knowledge of infection control procedures; and

j. Demonstration of knowledge of reporting procedures for life threatening results.

(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

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

(c)(d) Successful completion of a training program approved by the Board of Clinical Laboratory Personnel provided under Section 483.811, F.S., shall meet the minimum training requirements specified in paragraph (c), above.

(8)(9) Responsibilities of the Laboratory Director Pertaining to the Alternate-Test Site:

(a) The laboratory director shall:

1. ensure the Ensure that testing personnel are limited to those who meet the requirements of paragraph 59A-7.034(8)(a), F.A.C.; and

2. Establish methods for the evaluation of competency to verify that alternate-site testing personnel perform procedures and report test results promptly and accurately. Evaluation of competency shall include:

a. Sample handling skills;

b. Skills required to perform the test method;

c. Skills required to perform preventive maintenance, troubleshooting, and calibration procedures, applicable to the testing methodologies;

d. Demonstration of knowledge of reagent stability and storage applicable to the test system in use;

e. Skills required to implement quality control policies and procedures and evaluate quality control results;

f. An awareness of the factors that influence test results;

g. Skills required to assess and verify the validity of patient test results through the assessment of quality control testing outcomes;

h. Demonstration of knowledge of patient preparation for each test performed;

i. Demonstration of knowledge of infection control procedures; and

j. Demonstration of knowledge of reporting procedures for life threatening results.

(b) validation Validation of personnel competency, which shall include review of test results, quality control records, proficiency testing results and preventive maintenance records; direct observation of test performance and instrument maintenance; and assessment of performance through testing previously analyzed specimens, internal blind samples, or proficiency testing samples.

(b)(c) Evaluation of competency for alternate-site testing personnel must be performed prior to initiation of patient testing and at least annually thereafter.

(c)(d) Documentation of licensure or certification, as applicable, pursuant to subsection 59A-7.034(8), F.A.C., and competency evaluations must be maintained during the tenure of all testing personnel and for a minimum of two years thereafter and made available to the agency at the time of inspection.

(9)(10) Tests Performed: Only test procedures approved by the clinical laboratory director Agency and documented in the internal needs assessment in accordance with Rule 59A-7.034, F.A.C., shall be performed at the alternate-test site.

(a) Tests performed at these sites shall not exceed moderately complex test procedures and must:

1. Employ whole blood specimens that require no manual specimen or reagent manipulation, treatment, extraction, centrifugation, separation or any other processing of any kind by the operator, as determined by the clinical laboratory director; and

2. No change.

(b) Alternate-test sites are also permitted to perform moderately complex testing on bodily fluids such as amniotic fluid, which require minimal preparation as determined by the laboratory director waived tests, activated clotting times, gastric occult blood, gastric pH and urine specific gravity by refractometer. Heparin concentration, heparin assay, heparin dose response and thrombelastograph tests are permitted to be performed only by perfusionists certified by the American Board of Cardiovascular Perfusion or laboratory personnel licensed as director, supervisor, or technologist under Chapter 483, Part III, F.S.

(c) through (d) No change.

(10)(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., Chapter 408, Part II, and the provisions of Chapter 59A-7, and Chapter 59A-35, F.A.C. In addition, pursuant to Sections 408.813, 408.814, 408.816, 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 FS. History–New 12-27-95, Amended 12-8-09, 12-29-10,_________

NAME OF PERSON ORIGINATING PROPOSED RULE: Karen Rivera
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Secretary Dudek
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 2, 2011
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: March 25, 2011