59A-7.034: Alternate-Site Testing
PURPOSE AND EFFECT: The agency is proposing to amend the rule that specifies the parameters around which tests can be performed at alternate test sites within hospitals.
SUMMARY: Revisions to clarify where alternative site testing can be performed, who can perform the tests and the qualifications of those performing alternative site testing.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
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.
SPECIFIC AUTHORITY: 483.051 FS.
LAW IMPLEMENTED: 483.051, 483.106, 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: October 29, 2009, 1:30 p.m.
PLACE: Agency for Health Care Administration, Building 3, Conference Room C, 2727 Mahan Drive, Tallahassee, Florida
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 5 days before the workshop/meeting by contacting: Karen Rivera, Laboratory Unit, 2727 Mahan Drive, Building 1, Mail Stop 32, Tallahassee, Florida 32308, (850)487-3109. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
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, (850)487-3109
THE FULL TEXT OF THE PROPOSED RULE IS:
59A-7.034 Alternative-Site Testing.
Alternate-site testing shall include laboratory tests performed in a hospital facility licensed under Chapter 395, F.S., out of the physical or administrative confines of the central laboratory which is licensed under Chapter 483, Part I, F.S. A clinical laboratory licensed under Chapter 483, Part I, F.S. may establish satellite locations under its administrative confines on the same or adjoining grounds of a hospital licensed under Chapter 395, F.S. that is not an alternate-site. Clinical laboratory testing within the satellite locations shall be performed by clinical laboratory personnel licensed under Chapter 483, Part III or exempt from licensure under that part, whereas testing at an alternate-site location shall be performed by personnel permitted under paragraph 59A-7.034(5)(a), F.A.C. Alternate-site testing allows specific personnel, who are not licensed clinical laboratory personnel, and are listed under subparagraphs 59A-7.034(5)(a)1.-7. and 9., F.A.C., to perform limited laboratory tests identified under paragraphs 59A-7.034(7)(a)-(e), F.A.C. Locations of alternate-site testing include, patients bedsides, nurses stations as well as locations determined appropriate by the laboratory director in a written plan that meets the requirements of Rule 59A-7.034, F.A.C.
(1) through (2)(a) No change.
(b) The laboratory must be licensed in all specialties or subspecialties in which testing is performed at the sites referenced in paragraph (a), above. Testing at these sites shall be limited to those tests for which the supervising director and laboratory personnel are qualified pursuant to Title 64B3 59O and authorized under Chapter 59A-7, F.A.C.
(3) Testing shall be the responsibility of the clinical laboratory director and shall be performed under the directors supervision and administrative control as specified under subsection 59A-7.035(1), F.A.C. The director shall be responsible for selecting the tests to be performed in accordance with Rule 59A-7.034, F.A.C. All such testing is subject to requirements specified in Chapter 59A-7, F.A.C. The laboratory director has the authority and responsibility to determine corrective action to be taken to maintain an equivalent standard of care for the entire hospital facility up to and including termination of alternate-site testing where there is documentation of noncompliance with Chapter 59A-7, F.A.C.
(a) A written protocol shall be established by the director and implemented by the service(s) performing alternate-site testing as required under subsection 59A-7.029(3), F.A.C., applicable to tests performed.
1. through 3. No change.
(b) through (c) No change.
(d) The director shall designate in writing, for each test site, a director, supervisor or technologist qualified under Chapter 483, Part III, IV, F.S., who in the absence of the director, monitors the performance of testing personnel, reporting of results and compliance with established policies.
(4) Records.
(a) All records of personnel authorized to perform alternate-site testing must be readily available for inspection by the agency for at least two years. These records shall include the name of each person performing such testing and documentation that each individual performing alternate-site testing is licensed by the state or certified by a national organization in a health care profession as required in subsection 59A-7.034(5), F.A.C., competency evaluations, patient results, quality control, corrective actions, proficiency surveys, and instrument maintenance.
(b) Results of all testing performed shall be made a part of the patient's permanent medical record and shall meet the requirements specified in Rule 59A-7.028, F.A.C.
(5) Alternate-site testing personnel requirements.
(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. through 4. No change.
5. Is licensed as a physician assistant pursuant to Chapters 458 and 459, F.S.
6. Is a perfusionist certified by the American Board of Cardiovascular Perfusionists.
7. Is a cardiovascular technician certified by the Cardiovascular Credentialing International (CCI) American Board of Cardiovascular Perfusion, or
8. Is licensed as a director, supervisor, technologist or technician under Chapter 483, Part III IV, F.S., or exempt from such licensure as provided in that chapter, or
9. Is a licensed Emergency Medical Technician (EMT) or Paramedic pursuant to Chapter 401, Florida Statutes.
(b) through (c) No change.
(6) Responsibilities of the laboratory director pertaining to the alternate-test site.
(a) The laboratory director shall:
1. Ensure that testing personnel are limited to those who meet the requirements of paragraph 59A-7.034(5)(a), F.A.C.; and
2. No change.
(b) through (c) No change.
(d) Documentation of licensure or certification, as applicable, pursuant to subsection 59A-7.034(5), 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.
(7) Tests performed. Only test procedures approved by the laboratory director 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) through (d) No change.
(e) Notwithstanding paragraph (b), above, Wwaived tests are permitted to be performed by hospital staff designated to provide the testing under the hospitals policies and proceedures. under a certificate of exemption as provided in Section 483.106, F.S. Such testing shall meet the requirements specified for a certificate of exemption as specified under Chapter 59A-7, F.A.C.
(8) No change.
Rulemaking Specific Authority 483.051 FS. Law Implemented 483.051, 483.106, 483.181, 483.201, 483.221, 483.23 FS. History New 12-27-95, Amended________.
