The Agency proposes to amend the rule to update quality control procedures to include an Individualized Quality Control Plan.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NO.:RULE TITLE:

59A-7.029General Quality Control Requirements

PURPOSE AND EFFECT: The Agency proposes to amend the rule to update quality control procedures to include an Individualized Quality Control Plan.

SUMMARY: Quality Control requirements related to Clinical Laboratory licensure.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

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. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: A SERC has not been prepared by the agency. For rules listed where no SERC was prepared, the Agency prepared a checklist for each rule to determine the necessity for a SERC. Based on this information at the time of the analysis and pursuant to section 120.541, Florida Statutes, the rule will not require legislative ratification.

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, F.S.

LAW IMPLEMENTED: 483.051, F.S.

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: January 10, 2017 at 2:00 PM EST

PLACE: Agency for Health Care Administration, Conference Room B, 2727 Mahan Drive, Building #3, Tallahassee, FL 32308

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 3 days before the workshop/meeting by contacting: Zachary Masters, Bureau of Health Facility Regulation, 2727 Mahan Drive, Tallahassee, Florida, [phone] or by e-mail at [e-mail].. 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: Zachary Masters at [phone] or email at: [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59A-7.029 General Quality Control Requirements for Non-waived Testing.

(1) The laboratory shall establish and follow written quality control procedures for monitoring and evaluating the quality of the testing process of each method to assure the accuracy and reliability of patient test results and reports in accordance with CLIA requirements. The laboratory shall follow the manufacturers’ instructions and recommendations for instrument or test system operation and test performance if such instructions exceed requirements specified in this rule. In the event of a conflict between these rules and CLIA requirements, the more stringent requirement(s) shall prevail.

(2) The laboratory must utilize test methods, equipment, instrumentation, reagents, materials, and supplies that provide accurate and reliable test results and test reports as required by CLIA.

(a) Methodologies and equipment must be selected and testing must be performed in a manner that provides test results within the laboratory’s stated performance specifications for each test method and reflect procedures that are generally accepted by leading authorities such as the Centers for Disease Control and Prevention (CDC), CLIA recognized accreditation organizations, the American Association of Blood Banks (AABB) or other nationally recognized organizations. Documentation that the test methodologies and equipment meet the requirements of this rule must be maintained by the laboratory and available for review by the Agency.

(b) The laboratory must have equipment, instruments, reagents, materials, and supplies for the type and volume of services provided during the preanalytic, analytic, and postanalytic phases of testing.

(c) All equipment and supplies shall be in good working order, checked and calibrated for the proper performance of tests and services offered in accordance with this rule and CLIA requirements. The laboratory must, at a minimum, follow the manufacturers’ recommendations and instructions for equipment operation and document all such activities required for maintenance and operation of such equipment.

(d) The manufacturers’ instructions and documentation of maintenance and operation of equipment must be maintained by the laboratory and available for review by the Agency.

(e) Out-of-service equipment and supplies shall be clearly labeled to indicate their status.

(f) Expired, substandard or unusable supplies shall be promptly removed from use and clearly labeled to indicate their status. Such supplies shall be isolated from usable supplies until they are removed from the premises.

(g) Procedures must be approved, signed, and dated by the current laboratory director both initially and biennially thereafter.

(3) Quality Control Procedures. In accordance with CLIA requirements and any additional provisions of this rule, the laboratory shall perform control procedures to monitor the ability of the method or test system to give accurate, precise and reliable patient test results.

(a) Quantitative controls shall be of different concentrations that approximate the analytical range of that analyte, e.g., normal and abnormal patient values.

(b) No daily quality control testing is required for those tests listed as Provider-Performed Microscopy tests in 42 CFR 493.19(c)(1-9), provided the laboratory has instituted a quality assessment program containing the elements found in Rule 59A-7.031, F.A.C., Quality Assessment, to verify the accuracy of those tests at least every 6 months.

(c) All control procedures required above shall be documented and available to the Agency upon request.

(d) Use of Individualized Quality Control Plan (IQCP). Equivalent Quality Control (EQC).

1. A laboratory is permitted to use IQCP EQC testing pursuant to 42 CFR 493.1256(d) provided that those electronic, procedural or internal controls or combinations thereof are met; and the following requirements are met:

a. The plan process describes the practices, procedures, and resources needed to ensure the quality of the testing performed evaluates each step in the testing process.

b. The plan process evaluates and identifies the potential failures and sources of error for the preanalytic, analytic and postanalytic phases of testing as it relates to specimen, the test system, reagent, environment, and testing personnel.

c. The plan’s process evaluation includes specific assessment and documentation of how each step of the testing process is potentially impacted evaluated by the IQCP EQC process; and evaluates each step of the testing process for potential sources of error.

d. The implications of reducing the frequency of the use of external controls and the possibility of providing inaccurate and unreliable test results are evaluated, and found acceptable, by the clinical consultant and approved in writing by the laboratory director.

e. The choice of IQCP EQC options described in 42 CFR 493.1256(d) is consistent with the extent to which the electronic, procedural or internal controls or combinations thereof ensure that the provisions of this rule are met.

f. All IQCP EQC studies shall be composed of no less than 20 consecutive different test samples.

g. All IQCP EQC evaluations, reevaluations, assessments, actions or other such IQCP EQC studies shall be documented and available for review by the Agency.

2. After an acceptable IQCP EQC evaluation has been completed in accordance with these rules, the laboratory is permitted to institute IQCP EQC in lieu of external quality control requirements of 42 CFR 493.1256(d). However, if any of the following conditions occur, the laboratory shall cease testing or reinstitute the external quality control provisions of 42 CFR 493.1256(d):

a. A proficiency testing score of less than 80% is obtained for any of the last three proficiency testing events;

b. Personnel competency problems are identified;

c. Major preventive maintenance or replacement of critical parts occurs;

d. Any IQCP EQC result that was outside acceptable limits as specified in 42 CFR 493.1256(d); or

e. When there is any indicator that inaccurate, imprecise or unreliable patient testing is being reported.

3. Before IQCP EQC can be resumed, the laboratory must repeat the IQCP EQC evaluation in accordance with the requirements of this rule and adjust the IQCP as the data warrants. External quality control procedures in accordance with 42 CFR 493.1256(d) shall be performed until the subsequent IQCP EQC evaluation meets the requirements of this rule.

4. When an IQCP EQC failure occurs, the laboratory’s clinical consultant must conduct an investigation to identify the cause of the failure and examine all patient test results reported during the time that the IQCP EQC evaluation was used to determine if there was any clinical impact on the patients tested during that time. Appropriate action shall be taken and documented if such patient impact is found.

Rulemaking Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Amended 6-22-06.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Zachary Masters

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Justin M. Senior

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: November 18, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 15, 2016