The purposes is to modify an existing rule to update an incorporated application form; update the licensure fee to reflect adjustments made in accordance with subsection 408.805(2), F.S., remove duplicative language currently found in statute; add ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NO.:RULE TITLE:

59A-24.006Drug Testing Laboratories

PURPOSE AND EFFECT: The purposes is to modify an existing rule to update an incorporated application form; update the licensure fee to reflect adjustments made in accordance with subsection 408.805(2), F.S., remove duplicative language currently found in statute; add references to align with our uniform licensure statute and rule, and remove the requirement for licensed laboratories to participate in annual agency supplied proficiency testing surveys.

SUMMARY: Rule 59A-24.006 is amended to delete provisions currently found in statute; update incorporated application forms and fee; add references to align with our uniform licensing statute and rule; delete duplicative language; and remove the requirement for licensed laboratories to participate in annual agency supplied proficiency testing surveys.

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 been prepared by the Agency.

A statement of estimated regulatory costs has been prepared for proposed rule revisions in Rule 59A-24.006 and is available from the person listed below. The following is a summary of the SERC:

For proposed rule subsection 59A-24.006(13)(b), F.A.C., licensure fees are increased by the Consumer Price Index pursuant to 408.805(2), F.S.. The biennial licensure fee will increase by $435.00. Based on the number of currently licensed facilities the total impact over five years will be $11,965.50.

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 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: 112.0455(13)(a), 408.819, 440.102(10) FS.

LAW IMPLEMENTED: 112.0455(12), (13), 408.805, 408.806, 408.813, 408.814, 408.815, 408.816, 440.102 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: Monday, March 9, 2015, 3:00 p.m. – 4:00 p.m.

PLACE: Agency for Health Care Administration, Building 3, Conference Room C, 2727 Mahan Drive, Tallahassee, Florida 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 7 days before the workshop/meeting by contacting: Dayle Mooney via e-mail: [e-mail] or by phone: [phone]. 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: Dayle Mooney via e-mail: [e-mail] or by phone: [phone]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59A-24.006 Drug Testing Laboratories – Standards and Licensure.

Laboratories shall be licensed by the agency in accordance with Section 112.0455, F.S., Section 440.102, F.S., Chapter 408, Part II, F.S., and this rule chapter in order to collect or analyze specimens for an employer’s drug testing program and shall also comply with the provisions of Chapter 483, Part I, F.S.

(1) Laboratory Personnel.

(a) Qualifications of Director. The laboratory shall have a qualified director to assume professional, technical, educational, and administrative responsibilities for the laboratory’s drug testing. The director shall meet one of the following requirements:

1. Is duly licensed as a physician in the state in which he or she practices medicine; and is licensed under Chapter 458 or 459, F.S., if the laboratory is located in the State of Florida; and has had at least four years of experience in forensic analytical toxicology; or

2. Holds a doctoral degree from an accredited institution with Chemistry, Toxicology or Pharmacology as a major subject of study; and has had at least four years of experience in forensic analytical toxicology; and shall be licensed as a director under Chapter 483, Part IV, F.S., in the specialty of clinical chemistry, if the laboratory is located in the State of Florida.

(b) Responsibilities of Director. The director shall be responsible for the following:

1. The director shall be engaged in and responsible for the day-to-day management of the drug testing laboratory.

2. The director shall be engaged in and responsible for ensuring that there are sufficient personnel with adequate training and experience to supervise and conduct the work of the drug testing laboratory. He or she shall assure the continued competency of laboratory personnel by documenting their inservice training, reviewing their work performance, and verifying their skills.

3. The director shall ensure that the laboratory has a procedure manual which is complete, up-to-date, available to the personnel performing tests. All such procedures must, at a minimum, meet the requirements stipulated in this rule chapter. The director shall ensure that the procedures are followed by personnel performing tests. The procedure manual shall be reviewed, signed, and dated by this director whenever procedures are first placed into use, or changed, or when a new director assumes responsibility of the drug testing laboratory. Copies of all procedures and the dates that they are in effect shall be maintained as required in paragraph 59A-7.029(3)(e), F.A.C.

4. The director shall be responsible for maintaining a quality assurance program to assure the proper performance and reporting of all test results; for maintaining acceptable analytical performance for all controls and standards; for maintaining quality control testing; and for assuring and documenting the validity, reliability, accuracy, precision, and performance characteristics of each test and test system.

5. The director shall be responsible for taking all remedial actions necessary to maintain satisfactory operation and performance of the laboratory. The director shall ensure that sample results are not reported until all corrective actions have been taken and that he or she can assure that the tests results provided are accurate and reliable.

(c) Certifying Scientists. The laboratory shall have a qualified individual who serves as certifying scientist. This individual reviews all pertinent data and quality control results in order to attest to the validity of the laboratory’s test reports. A laboratory may designate more than one person to perform this function.

1. The certifying scientist(s) shall have a minimum of 2 years experience in forensic analytical toxicology and be qualified as a director or licensed as a supervisor under the provisions of Chapter 483, Part IV, F.S., in the specialty of clinical chemistry if the laboratory is located in the State of Florida.

2. The laboratory director is permitted to designate technical personnel to certify results that are negative on the initial screening test. These individuals shall be technologists licensed in the specialty of clinical chemistry in accordance with the provisions of Chapter 483, Part IV, F.S., if the laboratory is located in the State of Florida.

(d) Laboratory Operation and Supervision.

1. The laboratory’s drug testing facility shall have an individual(s) responsible for day-to-day operation of the laboratory and the supervision of the technical analysts. This individual(s) shall be licensed as a laboratory supervisor in the specialty of clinical chemistry or qualified as a director in accordance with Chapter 483, Part IV, F.S., in the specialty of clinical chemistry if the laboratory is located in the State of Florida; and

2. Have a minimum of 2 years experience in forensic analytical toxicology.

(e) Technical and Non-Technical Personnel.

1. Technical personnel shall have the training and skills to conduct forensic toxicology testing and shall be licensed in accordance with Chapter 483, Part IV, F.S., if the laboratory is located in the State of Florida. Documentation of such training and skills shall be maintained by the laboratory and available upon request by the agency.

2. Non-technical personnel, including all persons collecting specimens under these rules shall have the necessary training and skills for the tasks assigned but shall not perform drug testing.

(f) Collection Site Person or Persons Collecting Specimens. A specimen for a drug test shall be taken or collected by:

1. A physician, a physician’s assistant, a registered professional nurse, a licensed practical nurse, a nurse practitioner, or a certified paramedic who is present at the scene of an accident for the purpose of rendering emergency medical service or treatment.

2. A qualified person employed by a licensed laboratory who has the necessary training and skills for the assigned tasks.

(2) Training. The laboratory’s drug testing program shall make available continuing education programs to meet the needs of laboratory personnel.

(3) Files. Laboratory personnel files shall include: resume of training and experience; certification or license, if any; references; job descriptions; records of performance evaluations and advancement; incident reports; and results of tests which establish employee competency for the position he or she holds, such as a test for color blindness, if appropriate.

(4) Specimen Security and Analysis Procedures.

(a) Specimen Security and Internal Chain of Custody.

1. Drug testing laboratories shall be secure at all times. They shall have in place sufficient security measures to control access to the premises and to ensure that no unauthorized personnel handle specimens or gain access to the laboratory processes or to areas where records or specimens are stored. Access to these secured areas shall be limited to specifically authorized individuals whose authorization is documented. For the purposes of subparagraph 59A-24.006(4)(a)1., F.A.C., authorized individuals means those persons designated by the laboratory to have access to the drug testing laboratory. All authorized visitors, including maintenance and service personnel, shall be escorted by laboratory personnel at all times. Documentation of individuals accessing these areas, dates, time of entry and egress, and purpose of entry must be maintained for no less than 2 years.

2. Laboratories shall use internal chain of custody procedures to maintain control and accountability of specimens from receipt through completion of testing, reporting of results, during storage, and continuing until final disposition of specimens. The date and purpose shall be documented on the internal chain of custody form each time a specimen is handled or transferred, and every individual in the chain shall be identified. Accordingly, authorized personnel shall be responsible for each specimen or aliquot in their possession and shall sign and complete internal chain of custody forms for those specimens or aliquots as they are received. Aliquots and internal chain of custody forms shall be used by laboratory personnel for conducting both initial and confirmation tests.

(b) Receiving Specimens. When a shipment of specimens is received, laboratory personnel shall inspect each package for evidence of possible damage or tampering and compare information listed on specimen containers within each package to the information on the accompanying chain of custody forms. The laboratory shall establish written standards for the rejection or acceptance of specimens. In addition, any evidence of tampering, mismatched or omitted specimen identification numbers, spillage, damage or other discrepancies in the information on specimen containers and the chain of custody form shall render a specimen invalid and shall be rejected by the laboratory for testing. The laboratory shall immediately report any rejection to the employer and shall note such rejection on the chain of custody form.

(c) Short-Term Refrigerated Storage. Urine or blood specimens that do not receive an initial test within 72 hours of arrival at the laboratory shall be placed in locked, secure refrigerated units. Temperatures of these units shall not exceed 6 degrees Celsius. Emergency power equipment shall be available and used in case of power failure.

(d) Specimen Testing Requirements. A laboratory must be capable of testing for all drugs listed in Section 112.0455(5)(a), F.S., and be capable of conducting testing to ensure that a specimen has not been diluted or adulterated. The laboratory shall test and report drug test results no more than 3 working days after the receipt of the specimen in the laboratory.

(e) Initial Test. The initial screen for all drugs shall be an immunoassay except that the initial test for alcohol shall be an enzyme oxidation methodology.

1. Levels on initially screened urine specimens which are equal to or exceed the following shall be considered to be presumptively positive and submitted for confirmation testing:

Amphetamines	1,000 ng/mL
Cannabinoids (11-nor-Delta-9- tetrahydrocannabinol-9-carboxylic acid)	50 ng/mL
Cocaine (benzoylecgonine)	300 ng/mL
Phencyclidine	25 ng/mL
Methaqualone	300 ng/mL
Opiates	2,000 ng/mL
Barbiturates	300 ng/mL
Benzodiazepines	300 ng/mL
Methadone	300 ng/mL
Propoxyphene	300 ng/mL

The only specimen for alcohol testing shall be blood and the intially screened specimen shall be considered presumptively positive and submitted for confirmation testing if the level is equal to or exceeds 0.04 g/dL.

2. Levels which exceed the following for hair specimens shall be considered presumptively positive on initial screening and submitted for confirmation testing:

Marijuana	10 pg/10 mg of hair
Cocaine	5 ng/10 mg of hair
Opiate/synthetic narcotics and metabolites	5 ng/10 mg of hair
Phencyclidine	3 ng/10 mg of hair
Amphetamines	5 ng/10 mg of hair

3. Laboratories are permitted to use multiple screening tests for the same drug or drug class to eliminate any possible presumptive positives due to structural analogs, provided that such tests meet the requirements of this rule chapter.

(f) Confirmation Test. All specimens identified as presumptively positive on the initial test shall be confirmed using mass spectrometry/mass spectrometry (MS/MS) or gas chromatography/mass spectrometry (GC/MS), except that alcohol will be confirmed using gas chromatography. All confirmations shall be done by quantitative analysis.

1. Levels on confirmation testing for urine specimens which are equal to or exceed the following shall be reported as positive:

Amphetamines (amphetamine, methamphetamine)1	500 ng/mL
Cannabinoids (11-nor-Delta-9-tetrahydrocannabinol- 9-carboxylic acid)	15 ng/mL
Cocaine (benzoylecgonine)	150 ng/mL
Phencyclidine	25 ng/mL
Methaqualone Opiates	150 ng/mL
Codeine	2000 ng/mL
Morphine	2000 ng/mL
6-Acetylmorphine2	10 ng/mL
Barbiturates	150 ng/mL
Benzodiazepines	150 ng/mL
Methadone	150 ng/mL
Propoxyphene	150 ng/mL

1A laboratory shall not report a specimen positive for methamphetamine only. The specimen must contain amphetamine at a concentration equal to or greater than 200 ng/mL, by the confirmation test. If this criterion is not met, the specimen shall be reported as negative for methamphetamine.

2Tests for 6-Acetylmorphine when the morphine concentration exceeds 2000 ng/mL.

The alcohol level on confirmation testing for blood which is equal to or exceeds 0.04 g/dL shall be reported as positive.

2. Levels for hair specimens on confirmation testing which are equal to or exceed the following shall be reported as positive:

Marijuana Metabolites	1 pg/10 mg of hair
Cocaine	5 ng/10 mg of hair
Opiate/synthetic narcotics and metabolites	5 ng/10 mg of hair
Phencyclidine	3 ng/10 mg of hair
Amphetamines	5 ng/10 mg of hair

(g) Reporting Results.

1. The laboratory shall report all test results to the MRO indicated on the chain of custody form. Before any test result is reported by the laboratory, the results of initial tests, confirmation tests, and quality control data of such tests shall be reviewed by the certifying scientist and the test certified as an accurate report. The report, at a minimum, shall identify the drugs or metabolites tested for, the results of the drug test either positive or negative, the specimen number assigned on the chain of custody form, the name and address of the laboratory performing the testing, and the drug testing laboratory’s specimen accession number.

2. The following criteria shall be used when reporting drug testing results.

a. Specimens that test negative as specified in subparagraphs 59A-24.006(4)(e)1. and 2., F.A.C., on the initial test shall be reported as negative. If an employer wishes to retest a negative specimen under the provisions of Section 112.0455(9)(a), F.S., such testing is authorized to be conducted only once and must be requested no more than 7 working days from the time the original negative test result was reported to the employer by the MRO. Hair specimens may be re-collected only once to perform repeat confirmation testing under the provisions of Section 112.0455(9)(a), F.S.

b. Specimens that test positive as specified in subparagraph 59A-24.006(4)(e)1., F.A.C., on initial immunoassay tests, but test negative as specified in pargraph 59A-24.006(4)(f), F.A.C., on confirmation shall be reported as negative.

c. The laboratory is permitted to report drug test results for specimens that do not meet the adulteration/dilution criteria of the laboratory. Reports on specimens that do not meet the laboratory’s adulteration/dilution requirements shall not indicate the actual results of the adulteration/dilution tests, but the report shall indicate the adulteration/dilution test results in non-quantitative terms.

d. The laboratory report shall indicate solely that the test(s) resulted in a positive drug test result or resulted in a negative drug test result.

3. The MRO may request from the laboratory, and the laboratory shall provide, detailed quantification of initial and confirmation test results.

4. The laboratory may transmit results to the MRO by various electronic means (for example, teleprinter, facsimile, or computer) in a manner designed to ensure confidentiality of the information. The laboratory and MRO must ensure the security of the data transmission and restrict access to any data transmission, storage, and retrieval system to only those individuals authorized under these rules to obtain such information.

5. The laboratory shall send the MRO a copy of the original chain of custody form (copy 2) signed by the certifying scientist responsible for attesting to the validity of the test report.

6. The laboratory shall make available copies of all analytical results of donor testing upon request by the MRO or the agency.

7. Unless otherwise specified in this rule chapter, all records pertaining to a given specimen shall be retained by the drug testing laboratory for a minimum of 2 years.

(h) Storage of Specimens. Drug testing laboratories shall retain and place all confirmed positive urine specimens in locked, secured long-term frozen storage (-15 degrees Celsius or less) and confirmed positive blood specimens in locked, secured long-term refrigerated storage (2-8 degrees Celsius) for a minimum of 210 days. Within this 210 day period an employer, employee, job applicant, or MRO is permitted to request in writing that the laboratory retain the specimen for an additional period of time. If no such request is received, the laboratory is permitted to discard the specimen after 210 days of storage. When notified in writing, the laboratory shall be required to maintain any specimens under legal challenge until such challenge is resolved. To maintain applicable storage temperatures for stored specimens, emergency power equipment shall be available and used in the case of power failure. After the required retention time has passed, laboratories are permitted to either discard the specimens or pool all or part of these specimens for use in the laboratory’s internal quality control program.

1. When an employee or job applicant undertakes an administrative or legal challenge to the test result, it shall be the employee’s or job applicant’s responsibility to notify the employer and laboratory in writing of such challenge and such notice shall include reference to the chain of custody specimen identification number. After such notification, the sample shall be retained by the laboratory until the case or administrative appeal is settled.

2. During a 180 day period after written notification of a positive test result, the employee or job applicant who has provided the specimen shall be permitted by the employer to have a portion of the specimen retested, at the employee or job applicant’s expense. The laboratory which performed the original test for the employer shall be responsible for transferring a portion of the specimen to be retested at a second laboratory licensed under these rules, selected by the employee or job applicant, and shall be responsible for the integrity of the specimen and for the chain of custody during such transfer.

3. Urine specimens that test negative shall be stored in locked, secured refrigerated (2-8 degrees Celsius) or frozen storage (-15 degrees Celsius or less). Blood specimens that test negative shall be stored in locked, secured, refrigerated storage (2-8 degrees Celsius). These specimens shall be retained for no less than 7 working days after the test result has been reported to the employer by the MRO. After the required retention time has passed, laboratories are permitted to either discard the specimens or pool all or part of these specimens for use in the laboratory’s internal quality control program.

4. The laboratory is permitted to discard or pool specimens that test negative immediately after the negative test result is transmitted to the MRO, provided that the laboratory has written authorization from the employer that specimens which test negative are not to be retained for retesting under Section 112.0455(9)(a), F.S.

5. Under no circumstances shall a laboratory be required to retain a specimen, which has been reported as negative, for a period longer than 14 working days after receipt of that specimen in the laboratory unless a confirmation test has been requested by the employer under the provisions of Section 112.0455(9)(a), F.S.

(i) Retesting Specimens. As some analytes deteriorate or are lost during freezing, refrigeration, or storage, quantification for a retest is not subject to a specific cutoff requirement but must provide data sufficient to detect the presence of the drug or metabolite.

(5) Subcontracting. Drug testing laboratories shall not subcontract, except for collection sites, and shall perform all analysis with their own personnel and equipment. The laboratory must be capable of performing testing for the classes of drugs defined in Section 112.0455(5)(a), F.S., using the specimens indicated in Section 112.0455(5)(k), F.S., and initial and confirmation methods specified in paragraphs 59A-24.006(4)(e) and (f), F.A.C.

(6) Contracted Collection Sites. Collection sites or collectors shall contract with laboratories licensed under this rule chapter to collect specimens for analysis. Such contracts shall be in writing and include the utilization of all the necessary facilities, personnel, materials, equipment, or other supplies, as needed, to collect specimens as required in Rule 59A-24.005, F.A.C. For the purposes of Section 112.0455(8)(e), F.S., persons collecting specimens under contract with a forensic drug testing laboratory shall be deemed to be employees of the licensed laboratory. In addition, the collectors shall be trained by, and shall be accountable to, the licensed laboratory. However, after an accident, if an employee is taken to a facility for medical treatment and the facility does not have a contract with the laboratory, an individual authorized in paragraph 59A-24.006(1)(f), F.A.C., is permitted to collect a specimen provided that this collector utilize, and complete to the fullest extent possible, a chain of custody form. In addition, the collector shall follow the collection procedures found in Rule 59A-24.005, F.A.C., to the fullest extent possible and shall maintain full control of the specimen until the specimen is sealed and packaged for shipment to the employer’s selected laboratory.

(7) Inspections. The agency or the representatives of the federal Department of Health and Human Services Federal Workplace Drug Testing Program shall conduct announced or unannounced inspections of the laboratory at any reasonable time for the purpose of determining compliance with this rule chapter. The right of entry and inspection shall also be extended to any collection sites under contract with the laboratory. Inspections shall document the overall quality of the laboratory setting for the purpose of licensure to conduct drug free workplace testing. Inspection reports shall also contain any requirements of the laboratory to correct deficiencies noted during the inspections.

(a) Prior to laboratory licensure and biennially thereafter at least once a year after licensure, an on-site inspection of the laboratory shall be conducted.

(b) In order to be considered for licensure renewal, Llaboratories certified by the federal Department of Health and Human Services Federal Workplace Drug Testing Programs shall submit an inspection report of the federal Department of Health and Human Services Federal Workplace Drug Testing Programs performed within the previous 24 months in lieu of the required on-site annual inspection. This provision does not apply to laboratories applying for initial licensure. In addition, such laboratories certified by the federal Department of Health and Human Services Federal Workplace Drug Testing Programs shall:

1. Maintain a policy to conduct the testing of all specimens authorized under Section 112.0455, F.S., in the same manner as required for those drugs included under the Mandatory Guidelines for Federal Workplace Drug Testing Programs. This policy must be in writing and contained in the laboratory’s policy and procedure manual.

2. Submit to the agency all reports of such inspections, post inspection activities and reports including any corrective action taken by the laboratory within 45 days of the receipt of the initial evaluation report in the laboratory.

3. Request in writing that the inspection report be accepted in lieu of an on-site inspection by the agency.

(c) Laboratories that are accredited by a nationally recognized accreditation organization may submit an accreditation survey report performed within the previous 24 months and proof of non-provisional accreditation or reaccreditation for the current year in lieu of the annual on-site inspection.

(8) Documentation. Laboratories shall maintain and make available for at least 2 years all documentation of the testing process. Except that the laboratory shall be required to maintain documents and records for any specimen(s) under legal challenge until such challenge is resolved. The required documentation shall include:

(a) Personnel files on all individuals authorized to have access to specimens;

(b) Chain of custody documents;

(c) Quality assurance records;

(d) Quality control records;

(e) Procedure manuals;

(f) All test data, calibration curves and any calculations used in determining test results;

(g) Donor test reports;

(h) Proficiency testing records;

(i) Computer generated data used for testing and reporting specimen results.

(9) Additional Requirements for Laboratory Licensure.

(a) Procedure Manual. Each laboratory shall have a procedure manual which meets the applicable requirements of paragraphs 59A-7.029(3)(b), (d) and (e), F.A.C.

(a)(b) Standards and Controls. Laboratory standards shall be prepared with pure drug standards which are properly labeled as to content and concentration. The standards shall be labeled with dates indicating when received, when prepared or opened, when placed in service, and the expiration date.

(b)(c) Instruments and Equipment.

1. Volumetric pipettes and measuring devices shall be certified for accuracy or be checked by gravimetric, colorimetric, or other verification procedures on a quarterly basis. Automatic pipettes and dilutors shall be checked for accuracy and reproducibility before being placed in service and checked quarterly thereafter.

2. There shall be written procedures for instrument setup and normal operation, a schedule for checking critical operating characteristics for all instruments, tolerance limits for acceptable function checks and instructions for major trouble shooting, repair, and maintenance in accordance with manufacturer’s specifications. Manufacturer’s specifications for, and records of preventive and regular maintenance shall be maintained for as long as the instrument is in use and for at least 2 years after the instrument is discontinued from use and shall be available upon request by the agency.

(c)(d) Remedial Actions. There shall be written procedures for the actions to be taken when test systems are not operating correctly or errors are detected. There shall be documentation that these procedures are followed and that all necessary corrective actions are taken. There shall also be in place systems to verify all stages of testing and reporting and documentation that these procedures are followed.

(d)(e) Personnel Available to Testify at Proceedings. A laboratory director shall assure that technical personnel, including the director, be available to testify in an administrative or disciplinary proceeding regarding any employee or a job applicant when that proceeding is based on a test result which was analyzed and reported by the laboratory.

(10) Quality Assurance and Quality Control. Quality assurance and quality control for hair analyses shall be conducted in accordance with Section 112.0455(13)(b)4., F.S.

(a) General. Drug testing laboratories shall have a quality assurance program which encompasses all aspects of the testing process including but not limited to specimen acquisition, chain of custody, security and reporting of results, initial and confirmation testing and validation of analytical procedures. Quality assurance procedures shall be designed, implemented, and reviewed to monitor the conduct of each step of the process of testing for drugs.

(b) Laboratory Quality Control Requirements for Initial and Confirmation Tests. At a minimum, each analytical run of specimens for an initial or confirmation test shall include the following quality control samples:

1. Negative specimens certified to contain no drug;

2. Urine specimens fortified with known standards; and

3. Positive controls with the drug or metabolite at or near the threshold (cutoff).

4. At least 1 percent of each initial screening run, with a minimum of one sample per run, shall consist of a blind sample(s) of known concentration. Such samples shall appear as ordinary test specimens to the laboratory analysts.

(11) Proficiency Testing. Proficiency testing is a part of the initial evaluation of a laboratory seeking licensure and is required as a continuing assessment of laboratory performance necessary to maintain continued licensure.

(a) General Considerations.

1. The laboratory must successfully participate in proficiency testing surveys, as described in subsection 59A-24.006(11), F.A.C.

2. Proficiency testing specimens are permitted to consist of negative specimens as specified in subparagraph 59A-24.006(4)(e)1., F.A.C., and positive specimens, as specified in paragraph 59A-24.006(4)(f), F.A.C.

3. Proficiency testing specimens are permitted to contain interfering substances.

4. Proficiency testing specimens are permitted to be identified for screening or confirmation testing only.

5. All procedures associated with the laboratory’s handling and testing of any proficiency testing specimens shall be carried out in the same manner as the laboratory tests donor samples.

6. The laboratory shall report results of proficiency testing samples using the same criteria applied to routine drug testing specimens.

7. Failure to submit the results of each proficiency testing survey within the time frames indicated in sub-subparagraphs 59A-24.006(11)(c)1.c. and 59A-24.006(11)(c)3.h., F.A.C., is considered unsuccessful participation and will result in a failing score for that proficiency testing survey and administrative action up to and including revocation of licensure, as provided in subsection 59A-24.006(12), F.A.C.

8. Failure to participate in any proficiency testing survey is considered unsuccessful participation and will result in a failing score for that proficiency testing survey and administrative action up to and including revocation of licensure as provided in subsection 59A-24.006(12), F.A.C.

9. The laboratory shall be permitted to request that the agency supply additional proficiency testing samples to be tested to document whether the source of unsuccessful proficiency testing performance has been corrected. The agency shall permit no more than two such additional shipments of proficiency testing samples. The laboratory will be required to pay the cost of such samples.

7. 10. In addition to the proficiency testing requirements, any licensed laboratory may shall be subject to blind performance testing by the agency. Blind performance testing means proficiency test samples which are shipped to a laboratory in a manner such that the samples appear to be actual drug testing samples.

(b) Initial Licensure. Laboratories applying for initial licensure shall be required to successfully complete three proficiency testing surveys supplied by the agency before the laboratory is eligible to be considered for licensure.

1. Two of these proficiency testing surveys shall be completed prior to the initial inspection of the laboratory.

2. The third proficiency testing survey shall be provided so that it arrives prior to the initial inspection. These samples will be analyzed in conjunction with the on-site inspection as directed by the agency.

3. Evaluation of initial proficiency testing surveys shall be in accordance with the requirements set forth in subparagraph 59A-24.006(11)(c)3., F.A.C.

4. Any initial applicant whose proficiency testing evaluation does not meet the requirements of subparagraph 59A-24.006(11)(c)3., F.A.C., on any of the three initial proficiency testing surveys shall automatically be disqualified for licensure. To be considered for future licensure, the laboratory must reapply for licensure and must submit the required licensure fee as a new applicant.

(b)(c) Continued Licensure. In order to remain licensed, the laboratory shall participate in three four proficiency testing surveys per year. The laboratory must participate in 3 non-agency proficiency testing surveys supplied by an approved proficiency testing organization as defined in subsection 59A-24.003(3), F.A.C. per year., and 1 annual proficiency testing survey supplied by the agency as described below. Failure to meet the applicable grading criteria established by an approved proficiency testing organization found in subparagrph 59A-24.006(11)(c)3., F.A.C., shall be considered unsuccessful proficiency testing participation. The agency shall revoke or suspend the laboratory’s license or take no further action, taking into consideration the potential for such errors to affect the reporting of reliable drug test results.

1. Non-Agency Supplied Proficiency Testing.

a. Three of the four required proficiency testing surveys shall be obtained at the laboratory’s expense from an approved proficiency testing provider, as defined in subsection 59A-24.003(3), F.A.C.

b. Proficiency testing results from the approved non-agency providers shall be graded using the grading criteria required in subparagraph 59A-24.006(11)(c)3., F.A.C.

c. The laboratory shall submit the reports of non-agency supplied proficiency testing results and any corrective action taken with regards to unsuccessful results within 14 working days of their receipt in the laboratory.

2. Agency Supplied Proficiency Testing. The remaining proficiency testing survey shall be supplied by the agency and shall be shipped to the laboratory at any time during the licensure year.

3. In order to obtain initial licensure or to remain licensed, the laboratory must meet the following criteria for successful participation on any proficiency testing shipment:

a. Report no false positive drug identifications.

b. Correctly screen 90 percent of the samples in each proficiency testing survey.

c. Achieve a combined score of 90 percent for screening and confirmation testing.

d. Correctly confirm 90 percent of the drug challenges for proficiency samples that screen as positive.

e. For all proficiency samples screened as positive, quantitate 80 percent of all drug challenges at ± 20 percent of the group mean.

f. Detect and quantitate 50 percent of the total drug challenges for any individual drug or drug classes.

g. Submit the results of agency supplied proficiency testing surveys no more than 10 working days from receipt of the samples by the laboratory.

h. Submit any remedial action taken in regard to proficiency testing errors found in agency supplied proficiency testing samples within five days of such notification by the agency.

4. Consequences of Unsuccessful Proficiency Testing Performance.

a. Failure to achieve successful proficiency testing performance as described in subsection 59A-24.006(11), F.A.C., shall result in administrative action up to and including revocation of licensure as provided in subsection 59A-24.006(12), F.A.C.

b. In the event that a laboratory’s license is suspended due to unsatisfactory proficiency testing performance, re-instatement of licensure shall not be considered until the laboratory can demonstrate:

i. Satisfactory performance on no more than 2 agency supplied proficiency surveys;

ii. That the source of unsuccessful proficiency testing performance has been corrected; and

iii. That payment for any additional proficiency testing samples supplied by the agency has been received.

(12) Administrative Enforcement and Hearings.

(a) The agency shall enforce the provisions of Sections 112.0455(12) and (13) and Chapter 408, Part II, F.S. and Chapter 59A-24, F.A.C., by administering remedies for statutory and rule violations as provided in Sections 408.813, 408.814, 408.815 and 408.816, F.S.

(b) Grounds for Disciplinary Action. The following actions shall result in the agency taking administrative action:

1. Failure to accurately analyze and report donor drug tests;

2. Failure to participate in or uUnsuccessful participation in proficiency testing surveys;

3. A violation of a licensure standard;

4. Participation in a pretrial intervention or other first-offender agreement respecting a charge of, the entering of a plea of nolo contendere or guilty to a charge of, a finding of guilt regardless of adjudication of, or a conviction or any criminal offense under federal law or the law of any state relating to the operation of any laboratory;

5. Making a fraudulent statement on an application for a forensic toxicology license or any other document required by the agency;

3.6. Permitting unauthorized persons to perform technical procedures or issue reports;

4.7. Demonstrating incompetence or making consistent errors in the performance and reporting of drug free workplace testing or proficiency testing samples;

5.8. Performing a test and rendering a report thereon to a person not authorized by law to receive such services;

6.9. Knowingly having professional connection with or knowingly lending the use of the name of the licensed forensic toxicology laboratory or the license of the director to an unlicensed forensic toxicology laboratory;

7.10. Violating or aiding and abetting in the violation of any provision of this part or the rules promulgated hereunder;

8.11. Failing to file any report required by the provisions of this part or the rules promulgated hereunder;

9.12. Reporting a drug test result when no such test was performed;

10.13. Knowingly advertising false services or credentials;

11.14. Failure to correct deficiencies within the time required by the agency;

12.15. Failing to maintain a secured area for toxicology tests; or

13.16. Any other cause which affects the ability of the laboratory to ensure the full reliability and accuracy of drug tests and the accurate reporting of results.

14.17. Failure to submit statistical reports as required in subsection 59A-24.009(3), F.A.C.

(13) Re-instatement of Licensure. Upon the submission of evidence to the agency that the laboratory is in compliance with this rule chapter and Section 112.0455, F.S., and any other conditions imposed as part of a suspension, the agency shall reinstate the laboratory’s license. A laboratory having its license revoked shall be required to reapply for licensure in accordance with the provisions for initial applicants and pay the applicable licensure fee.

(13)(14) Licensure Fee.

(a) Laboratories seeking licensure must complete licensure application form, Health Care Licensing Application, Drug-Free Workplace Laboratory, AHCA Form 3170-5001 July 2014 95, which is hereby incorporated by reference. This form is available at http://flrules.org/Gateway/reference.asp?No=Ref-XXXXX or http://ahca.myflorida.com/HQAlicensureforms and from the Agency for Health Care Administration, 2727 Mahan Drive, MS 32, Tallahassee, Florida 32308. from the agency.

(b)1. Initial and biennial licensure renewal fees shall be $16,435 $16,000 and shall be made payable to the Agency for Health Care Administration agency.

2. For late filing of an application for renewal, the provisions of Section 408.806(2)(a), F.S., shall apply.

(b) Refunds are authorized pursuant to provisions of Section 215.26, F.S., and shall be approved only in the following instances:

1. An overpayment of a fee;

2. A payment where no fee is due; and

3. Any payment made into the State Treasury in error.

(c) Applications for refunds shall be filed with the Chief Financial Officer within 3 years from the date of the payment into the State Treasury, or else such right shall be barred. Refund claims shall not otherwise be barred under the laws of this state.

(14)(15) Statistical Information Reporting.

(a) The laboratory shall submit statistical information on drug testing to the agency. No statistical information reported to the agency shall reveal the names of the persons tested, nor shall it reveal the employer’s identity. This data shall contain the following information on specimens received for all drug testing conducted under Section 112.0455, F.S. or Section 440.102, F.S.:

1. The total number of specimens received for testing.

2. The total number of specimens that tested positive on the initial screening.

3. The total number of specimens that were confirmed and reported as positive for each drug class tested.

4. The total number of samples that were received but not tested.

(b) Statistical summaries shall be submitted to the agency on a monthly basis no later than 14 working days after the end of a reporting month. Reporting is required even if no Florida Drug Free Workplace testing has been done for that reporting month.

(c) Failure of a laboratory to submit the statistical reports as required in Section 112.0455(12)(d), F.S. or Section 440.102(9)(d), F.S., shall result in administrative action pursuant to paragraph 59A-24.006(12)(a), F.A.C.

Rulemaking Authority 112.0455(13)(a), 408.819, 440.102(10) FS. Law Implemented 112.0455(12), (13), 408.805, 408.806, 408.813, 408.814, 408.815, 408.816, 440.102 FS. History–New 3-15-90, Amended 6-28-91, Formerly 10E-18.006, Amended 5-1-96, 12-5-96, 3-11-98, 3-29-00, 5-25-10, ______________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Dayle Mooney, Program Administrator

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Elizabeth Dudek, Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: January 23, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 30, 2014