59A-7.034: Alternate-Site Testing
PURPOSE AND EFFECT: The Agency is proposing to amend the rule that establishes criteria for alternate-site testing within hospitals to consider advancements in clinical laboratory testing equipment and clarify the requirements regarding internal needs assessments and the responsibilities of the laboratory director.
SUMMARY: Revisions are needed to address advancements in clinical laboratory testing equipment, who may perform clinical laboratory testing at alternate-sites within hospitals, what is required to be submitted to the Agency for review and approval and timeframes for reviews.
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, 483.181, 483.201, 483.221, 483.23 408.806, 408.813, 408.814, 408.816, 483.813 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 21, 2010, 2:30 p.m. – 5:00 p.m.
PLACE: Agency for Health Care Administration, Building 3, Conference Room D, 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)412-4500. 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)412-4500
THE FULL TEXT OF THE PROPOSED RULE IS:
59A-7.034 Alternate-Site Testing.
(1) Agency Intent: This rule implements Section
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 483.051(9) , Part I, F.S., regarding criteria for alternate-site testing to be performed under the supervision of a clinical laboratory director. 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 l icensed 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 Ill, F.S., 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) Location and Required Licensure of Alternate-Site Testing: All alternate-site testing must be performed on the same or adjoining grounds, and on the physical premises of, the hospital facility licensed under Chapter 395, F.S referenced in Rule 59A-7.034, F.A.C. Alternate-sites are sites that are located outside of the physical or administrative confines of the central laboratory, but still under the administrative control of the hospital.
(a) Hospitals may hold more than one clinical laboratory license. For each clinical laboratory license held by the hospital, a licensed clinical laboratory director must supervise the laboratory and any alternate-sites of that licensed laboratory.
(2) A hospital laboratory licensed under Chapter 483, Part I, F.S., located in a hospital licensed under Chapter 395, F.S., shall be permitted to maintain under its supervision, one or more testing sites as authorized under this section provided the laboratory submits written notification of such testing to the agency. Such notification shall specify the categories of personnel as provided in subsection 59A-7.034(5), F.A.C., that perform alternate-site testing in that hospital facility. The laboratory director must maintain a current listing of all personnel authorized to perform alternate-site testing as required under subsection 59A-7.034(4), F.A.C. (a) Alternate-sites for testing authorized under Rule 59A-7.034, F.A.C., shall be noted on all laboratory licensure applications submitted to the agency.
(b) The laboratory must be licensed in all specialties or subspecialties in which testing is performed at the alternate-sites
referenced in paragraph (a), above. Testing at these sites shall be limited to those tests for which the laboratory supervising director or designated supervisory and laboratory personnel are licensed qualified pursuant to Chapter 64B3, F.A.C., and authorized under Chapter 59A-7, F.A.C.
(3) Supervision of Alternate-Site Tests: All alternate-site tests must be performed under the supervision of the clinical laboratory director who is responsible for all laboratory testing conducted under the hospital’s clinical laboratory license(s).
(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 (8) through (12) are met.
(b) The selection of alternate-site test methods shall assure that performance and operational characteristics meet the clinical requirements for the intended alternate-site testing location. The internal needs assessment shall include an evaluation of proposed methodologies for tests to be performed at the alternate-sites composed, at a minimum, of evaluation of accuracy, precision, comparison of test results with the hospital laboratory, instrument performance, maintenance requirements, reagent preparation, if applicable, storage and availability of supplies such as reagents, controls and proficiency samples for the testing site and a written validation procedure.
(c) Alternate-site testing shall only be conducted at sites where the director has established and documented in the internal needs assessment that such testing is necessary for the proper care and treatment of patients.
(d) The internal needs assessment must be reviewed and approved by the laboratory director prior to initiation of testing at any alternate-test site and biennially thereafter.
(e) All records related to the internal needs assessment for the purpose of alternate-site testing must be readily available for inspection by the Agency and any other surveying agency including accrediting organizations, if the laboratory is accredited, for a minimum of two years after testing is discontinued.
(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: 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 subsubparagraph 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 at: http://ahca.myflorida.com/mchq/health_facility_regulation/laboratory_licensure/altsiterule.shtml do not require prior approval.
(f) A listing of all alternate-site testing locations and laboratory tests performed at each site must be included with each laboratory license renewal application.
(3) Testing shall be the responsibility of the clinical laboratory director and shall be performed under the director’s 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.
(6) Written Protocols and Quality Assurance Programs:
(a) A written protocol shall be established by the laboratory director and implemented according to
by the service(s) being performed at the performing alternate-site testing as required under subsection 59A-7.029(3), F.A.C., applicable to tests performed.
1. There shall be a procedure manual at each site where alternate-site testing is performed.
2. The alternate-site procedure manual
located at the alternate-test site shall specifically address the alternate-site testing done at that location.
3. The procedure manual shall be reviewed and signed, documenting that it has been reviewed biennially by the laboratory director.
(b) The laboratory director is responsible for developing a quality assurance program that is appropriate for the test methods used at the alternate-testing site as required under Rule 59A-7.031, F.A.C. Criteria for repeating a result or obtaining a sample for assay in the hospital laboratory must be outlined by the director and included in the quality assurance program.
1. The laboratory must maintain the capability of verifying the validity of test results obtained at the alternate-test site as specified in Rule 59A-7.029, F.A.C. 2. Subparagraph 59A-7.034(3)(b)1., F.A.C., shall not be construed to prohibit the performance of Activated Clotting Time tests or referral of infrequently performed tests to another laboratory licensed under Chapter 483, Part I, F.S., for analysis. (c) The director in consultation with the appropriate medical staff shall prepare an internal needs assessment for alternate-site testing for each testing site which shall include evaluation of patient benefits and criteria for such testing. The internal needs assessment shall also include an evaluation of proposed methodologies for tests to be performed at the alternate-sites composed, at a minimum, of evaluation of accuracy, precision, comparison of test results with the hospital laboratory, instrument performance, maintenance requirements, reagent preparation, if applicable, and storage and availability of supplies such as reagents, controls and proficiency samples for the testing site. 1. The selection of alternate-site test methods shall assure that their performance and operational characteristics meet the clinical requirements for the intended alternate-site testing location. 2. A written procedure for validating alternate-site test methods shall be developed which outlines the process and criteria used to conduct the required validation to maintain an equivalent standard of care for the entire facility. 3. The validation process shall ensure that all alternate-site test methods chosen demonstrate accuracy, precision, reliability, correlation, ease of operation, and maintenance capabilities given the environment in which each will be used. 4. In addition to requirements set forth in Rule 59A-7.029, F.A.C., each alternate-site test method shall be evaluated relative to reporting time and error. 5. Alternate-site testing shall only be conducted at sites where the director has established and documented in the internal needs assessment that such testing is necessary for the proper care and treatment of patients. 6. The internal needs assessment must be reviewed and approved by the laboratory director prior to initiation of testing at any alternate-test site and biennially thereafter. 7. Documentation of the initial and each biennial review and approval of the internal needs assessment must be maintained in the laboratory and available for review by the agency for each site for a minimum of two years after testing is discontinued. (d) The director shall designate in writing, for each test site, a director, supervisor or technologist qualified under Chapter 483, Part III, F.S., who in the absence of the director, monitors the performance of testing personnel, reporting of results and compliance with established policies.
(4) Recordkeeping Requirements: Records.
(a) All records of personnel authorized to perform alternate-site testing must be readily available for inspection by the Agency and any other surveying agency including accrediting organizations if the laboratory is accredited,
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(8) (5), F.A.C., initial and ongoing competency evaluations, in-service training, and any corrective actions 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.
(c) Records of alternate-site tests, testing locations, quality control, evaluation of accuracy, precision, correlation studies, instrument performance, instrument maintenance, and the internal needs assessment for the tests, must be maintained for a minimum of two years after testing is discontinued and available to any surveying agency including an accrediting organization if the laboratory is accredited.
(5) Alternate-Site Testing Personnel Requirements: 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),
5. Is licensed as a physician assistant pursuant to Chapter 458 and 459, F.S.,
6. Is a perfusionist certified by the American Board of Cardiovascular Perfusion
7. Is a cardiovascular technician certified by the Cardiovascular Credentialing International (CCI),
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, F.S., or
10. Meets the staff training and 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) The laboratory director will determine if the above listed personnel are suitable to perform testing at the alternate-site.
(b) 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.
7. Monitoring of systems and results for errors including instruction on corrective action including whether or not results can be reported.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
(c) 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) (b), above.
(6) Responsibilities of the Laboratory Director Pertaining laboratory director pertaining to the Alternate-Test Site: 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(8)
(5)(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
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 of personnel competency 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.
(c) Evaluation of competency for alternate-site testing personnel must be performed prior to initiation of patient testing and at least annually thereafter.
(d) Documentation of licensure or certification, as applicable, pursuant to subsection 59A-7.034(8)
(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: performed. Only test procedures approved by the Agency 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) Tests performed at these sites shall not exceed moderately complex test procedures and must:
1. Employ whole blood specimens that require no specimen or reagent manipulation, treatment, extraction, separation or any other processing of any kind by the operator; and
2. Utilize automated test systems in which a specimen is directly introduced into the system. Such instrumentation shall automatically provide for instrument calibration without access by the operator to modify or adjust calibration limits. If the instrument has a requirement to establish quality control ranges, the ranges must be established by appropriately licensed clinical laboratory personnel.
(b) Alternate-test sites are also permitted to perform 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) Data output must be directly reportable in the final units of measurement needed for patient care without need for data conversion or other manipulation, with the exception of heparin concentration, heparin assay, heparin dose response and thrombelastograph tests, which shall be interpreted by the attending physician.
(d) Electronic instrumentation must have a mechanism whereby the operator is alerted when patient results exceed the reportable operating range of the test method and when calibration is not acceptable; such results shall not be used for the diagnosis, treatment, management or monitoring of patients as required under Rule 59A-7.029, F.A.C., and shall be validated through the central laboratory.
(e) Waived tests are permitted to be performed by hospital staff designated to provide the testing under the hospital’s policies and procedures.
(8) The Agency shall take administrative action pursuant to Sections 483.201, 483.221, 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 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,________.