CHAPTER 12
APPROVAL OF LABORATORIES
FOR EMPLOYEE DRUG TESTING
641—12.1(730) Purpose. The purpose of this chapter is to describe the procedures that a laboratory must follow to receive approval by the department to analyze specimens for the detection of drugs and alcohol in job applicants and employees. The department shall approve laboratories that test specimens collected from employees for any of the following drugs:

AMPHETAMINES	ETHANOL	
BARBITURATES	OPIATES	
CANNABINOIDS	PHENCYCLIDINE	
COCAINE	 	
641—12.2(730) Definitions. For the purpose of these rules, the following definitions shall apply:
“Alcohol” means ethyl alcohol (ethanol).
“CLIA” means Clinical Laboratory Improvement amendments of 1988.
“Confirmatory test” means a test for alcohol, a drug, or a drug’s metabolites using a testing method as stipulated in rule 641—12.7(730) “Confirmation of screening test results.”
“Department” means the Iowa department of public health.
“Director” means director of the Iowa department of public health.
“Drug and alcohol testing” means analysis of a specimen for the purpose of detecting the presence or absence of alcohol, drugs, or their metabolites in the sample tested.
“Drug test” means a test conducted for the purpose of detecting the presence of a drug in the fluid or tissue of an employee or job applicant.
“Employee” means a person who performs services for compensation, in whatever form, for an employer.
“Employer” means a person or entity located or doing business in Iowa and having one or more employees, and includes the state of Iowa and all political or other governmental subdivisions of this state.
“GC/MS” means gas chromatography/mass spectrometry.
“HCFA” means Health Care Financing Administration. HCFA is the federal agency responsible for implementing and administering CLIA regulations.
“Laboratory” means a facility inside or outside the state of Iowa that analyzes specimens for the detection of chemical substances.
“Physician” means a person currently licensed pursuant to Iowa Code chapter 148, 150, 150A or the equivalent from other states.
“SAMHSA” means Substance Abuse and Mental Health Services Administration.
“Screening test” means an initial drug or alcohol test which is capable of detecting the presence of specific drugs, or their metabolites.
“Specimen” means a sample of blood, urine, saliva, or skin tissue.
“UHL” means university (state) hygienic laboratory.
641—12.3(730) Powers and duties. The department shall be responsible for the following actions:
	12.3(1) Processing applications from laboratories requesting approval to analyze specimens submitted by employers for the detection of drugs and alcohol as required by Iowa Code section 730.5.
	12.3(2) Developing an application package:
	a. 	The package shall be provided to all laboratories requesting approval to conduct drug and alcohol testing.
	b. 	The package shall contain application procedures, administrative rules, standardized application forms and a self-inspection questionnaire.
The self-inspection questionnaire shall assist the department in assessing the quality of a laboratory’s performance as a drug testing laboratory. This questionnaire will comprise the major, but not the sole, objective criteria used for on-site inspections by the UHL.
	c. 	The package shall be available upon request from the Iowa Department of Public Health, Division of Health Protection, Lucas State Office Building, Des Moines, Iowa 50319-0075.
	12.3(3) Reviewing each application submitted and determining the adequacy for approval.
	12.3(4) Designating the UHL to conduct an on-site inspection of each laboratory at least once every two years. Inspection may be waived by the director if the laboratory has been inspected and certified for drug and alcohol testing by SAMHSA or another state whose requirements are at least equal to Iowa’s.
	12.3(5) Maintaining and providing upon request an updated list of all approved laboratories.
	12.3(6) Providing written notice of approval and assigning an expiration date.
641—12.4(730) Application procedures.
	12.4(1) Laboratories desiring to conduct drug testing for Iowa’s employers shall apply to the department for approval.
	12.4(2) Laboratories requesting to be approved by the department which have been certified by SAMHSA will receive Iowa approval following the submission of evidence of their current SAMHSA certification.
	12.4(3) and 12.4(4) Rescinded IAB 6/8/94, effective 7/13/94.
641—12.5(730) Application requirements for drug and alcohol testing. Each laboratory requesting Iowa approval for drug and alcohol testing shall provide the following to the department:
	12.5(1) A completed laboratory survey checklist on a form provided by the department.
	12.5(2) A completed self-inspection questionnaire provided by the department that includes:
	a. 	A list of the drugs being tested.
	b. 	Copies of the two most recent and relevant graded proficiency test reports from a recognized proficiency testing program.
	c. 	Personnel qualifications for all staff involved in the technical and administrative management of the drug testing laboratory.
	d. 	Sample copies of reports.
	e. 	Chain of custody protocols and sample forms.
	f. 	Specimen collection procedures.
	g. 	Confirmation procedures, including name and address of any external reference laboratories used for confirmation.
	12.5(3) Proof of enrollment in a recognized proficiency testing program. Recognized programs include those approved by HCFA.
	12.5(4) Acceptable performance over a 12-month period in all appropriate areas of proficiency testing for any of the drugs tested shall be documented and sent to the UHL on an ongoing basis. Acceptable performance is as follows:
	a. 	Initial approval shall require at least 80 percent accuracy in the last two graded proficiency test cycles.
	b. 	Renewal shall require at least 90 percent accuracy each year with a minimum of five survey specimens per test cycle.
	c. 	Laboratories performing confirmatory testing shall test a minimum of five survey specimens for each drug per test cycle. No false positive results on survey specimens are permitted for laboratories performing confirmatory tests.
	12.5(5) Rescinded IAB 6/8/94, effective 7/13/94.
641—12.6(730) Methodology.
	12.6(1)  Screening test. The screening test may utilize immunoassay, thin layer, high performance liquid or gas chromatography, or an equivalent technology. If the screening test utilizes immunoassay, the test kit must posses a 510(k) notification by the U.S. Food and Drug Administration.
	12.6(2)  Confirmation test. Samples which have tested reactive (above threshold or cutoff level) by the screening test, with the exception of alcohol, shall be confirmed by GC/MS or by a scientifically equivalent technique approved by the department.
641—12.7(730) Confirmation of screening test results. All reactive drug screening test results, with the exception of alcohol, shall be confirmed by GC/MS or an equivalent test approved by the department before being reported as positive (or negative).
	1.	All reactive screening test results for alcohol shall be confirmed by gas chromatography, or a test that is recognized by the department as an equivalent test before being reported as positive (or negative).
	2.	Reports for drugs other than alcohol shall not be issued in the absence of confirmation by GC/MS or a scientifically equivalent test approved by the department.
	3.	Analysis of specimens for confirmation must be performed by laboratories which have been approved by the department.
	4.	Complete chain of custody procedures shall be used for referred specimens.
641—12.8(730) Specimen security and confidentiality of results. Specimens and reports must never be left unattended or unsecured.
	12.8(1) Complete chain of custody documentation shall be maintained for each specimen from the time of collection from the employee to the time the specimen is discarded. Each time the specimen is handled or transferred, the individual receiving the specimen, the time and date of transfer, and the recipient or destination of the specimen shall be documented.
	12.8(2) Confirmed positive specimens shall be retained in secure storage at freezing temperatures for at least six months.
641—12.9(730) Quality assurance procedure and procedure manual requirements. All laboratories shall have a written quality assurance program and a procedure manual which encompasses all aspects of the drug testing process.
	12.9(1) All laboratories shall have written procedures for performing drug testing which shall include the following:
	a. 	Specimen acquisition.
	b. 	Chain of custody.
	c. 	Specimen and report security.
	d. 	Test performance.
	e. 	Reporting of results.
	f. 	Confidentiality.
	g. 	Confirmation of results.
	12.9(2) The quality assurance and procedure manuals shall be available for review during the on-site inspection.
	12.9(3) All laboratories shall review their performance in each of the above areas every 12 months.
	12.9(4) Each laboratory is responsible for developing criteria for establishing and maintaining an effective quality assurance program for drug testing.
641—12.10(730) Analytical quality control. The number and position of control specimens tested within a batch, and the number of calibrators used for each batch of specimens shall be consistent with generally accepted laboratory practice for the methodology employed.
	12.10(1) Positive and negative controls shall be used in testing each batch of specimens.
	12.10(2) Procedures shall be implemented and documented to ensure that carryover from a positive specimen does not contaminate other subsequent specimens in that batch.
	12.10(3) Each laboratory shall develop criteria for the detection and rejection of adulterated specimens.
641—12.11(730) Documentation of testing process. The following documents for drug testing shall be retained and be made available for inspection for at least two years:
	12.11(1) Chain of custody documentation for each specimen tested, showing positive identification of specimen, person(s) handling and testing the specimen, storage of specimen, and disposal of specimen.
	12.11(2) Analytical information for each batch assayed; instrument identification; calibrator; reagent and identification; quality control results; and any other pertinent information.
	12.11(3) The UHL shall be designated to receive copies of proficiency testing results for ongoing monitoring and evaluation of each laboratory’s performance. Laboratories shall submit copies of proficiency testing results to the UHL or shall ensure that proficiency testing programs submit copies of proficiency testing results directly to the UHL on their behalf.
	12.11(4) Current procedure manuals must be maintained for all procedures.
	12.11(5) An annual review of manuals shall be performed and documented. Alterations and additions to procedures shall be incorporated into manuals and approved by the laboratory director before implementation.
641—12.12(730) Reporting of results to requesting medical physician.
	12.12(1) Each report shall identify the drugs being tested with the results of positive/negative or detected/nondetected clearly recorded.
	12.12(2) Each laboratory shall have available a written summary of the established cutoff point for each screening test and the sensitivity levels used for confirmatory drug tests. This information need not be issued with each report.
	12.12(3) Each laboratory shall have written procedures for making both written and telephone reports.
	12.12(4) All test results must be reviewed and signed by the laboratory director, or a qualified designee.
641—12.13(730) Requirements of laboratory personnel involved in screening and confirmatory testing for drugs and alcohol.
	12.13(1) The laboratory director shall be a pathologist or doctoral level individual who qualifies as a clinical laboratory director under CLIA regulations.
	12.13(2) Supervisors of analysts shall possess at least a bachelor of science degree in chemistry, medical technology; or comparable education and two years of analytical drug screening experience. Supervisors must also have training in the theory and practice of the laboratory procedures and an understanding of quality control concepts. Annual verification of the supervisor’s skills must be documented by the laboratory director.
	12.13(3) Analysts shall possess the necessary training and skills for assigned tasks. These individuals shall possess at least two years of college education in the physical or biological sciences. At a minimum, analysts shall be graduates of a medical laboratory technician program which is recognized by the department or have at least two years of college with a minimum of nine semester hours in chemistry.
	12.13(4) Laboratory directors, supervisors and analysts involved in drug testing shall annually complete at least one in-service continuing education program related to drug testing. Continuing education programs include formal training programs where continuing education units (CEUs) are awarded, informal in-house training programs, and relevant correspondence courses. Dates of the completed course shall be documented and the information available for review.
	12.13(5) The following information about each of the laboratory staff involved in employee drug testing shall be retained for two years from date of termination and shall be available for review.
	a. 	Résumé of training and experience.
	b. 	Certificate or license.
	c. 	Job description.
641—12.14(730) Changes from application during approval period. The following changes that occur during an approval period shall be submitted to the department within ten working days from the date the change took place:
	1.	Change in laboratory director.
	2.	Change of address.
	3.	Change in supervisor.
	4.	Change in confirmation procedures.
	5.	Change in proficiency program.
	6.	Addition or subtraction of drugs being tested.
	7.	Change of ownership.
641—12.15(730) Renewal. Approval to continue drug testing for Iowa employers must be renewed annually. Laboratories with Iowa approval shall submit their renewal request prior to their expiration date. The request for renewal shall include the following:
	12.15(1) Name and address of laboratory.
	12.15(2) Copy of supporting documents if licensed, certified, or approved through reciprocity.
	12.15(3) Appropriate information that reflects any change from the most recent approval period.
641—12.16(730) Collection of specimens. All specimens collected shall be part of a drug testing program under the direction of a physician. Physicians collecting specimens outside the state of Iowa for Iowa employers shall be licensed as a medical doctor or a doctor of osteopathy under the laws of the state in which the specimen was collected.
641—12.17(730) Enforcement. Upon a determination of noncompliance by the director that these rules have been violated, the director may immediately move to suspend, modify, or revoke any approval issued under these rules.
641—12.18(730) Denial, suspension, modification or revocation of approval.
	12.18(1) Any one of the following can result in denial, suspension, modification or revocation of approval. Failure of the laboratory to:
	a. 	Maintain the requirements of these rules.
	b. 	Provide documentation, including documentation of laboratory personnel and proficiency test results.
	c. 	Maintain confidentiality.
	d. 	Meet proficiency testing criteria.
	e. 	Provide correct information.
	f. 	Satisfactorily complete the two most recent recognized proficiency tests (for initial approval).
	g. 	Correctly represent facts on a self-inspection questionnaire or other application documents.
	h. 	Pass an on-site inspection by SAMHSA, another state whose requirements are at least equal to Iowa’s, or the UHL.
	12.18(2) Rescinded IAB 6/8/94, effective 7/13/94.
641—12.19(730) Restoration of approval. A laboratory whose approval has been suspended, modified, or revoked may be reinstated within 90 days following the receipt of the following:
	1.	Documentation of actions that correct the reasons for suspension, modification, or revocation.
	2.	Documentation of a successful on-site inspection, if necessary, conducted by SAMHSA, another state whose requirements are at least equal to Iowa’s, or the UHL.
641—12.20(730) Complaints. The department shall accept complaints of alleged problems relating to laboratory procedures. The information shall state in as specific a manner as possible the basis for the complaint. The complaint shall be presented in writing, in person or by telephone to the Iowa Department of Public Health, Division of Health Protection, Lucas State Office Building, Des Moines, Iowa 50319-0075.
Within 20 working days of the receipt of the complaint, the department shall communicate with the laboratory director for initial evaluation of the specific matters alleged in the complaint. The laboratory shall receive a written report of the results of department activities relating to the complaint investigation. The complainant shall be informed of the results of the action taken by the department.
641—12.21(730) Reciprocity.
	12.21(1) Laboratories certified, licensed, or approved by another state or the federal government for drug testing shall receive Iowa approval through reciprocity if the following requirements are met:
	a. 	The laboratory is approved, certified, or licensed by another state or the federal government for drug testing. In addition, the requirements of another state or the federal government shall be at least equivalent to the Iowa rules for drug and alcohol testing.
	b. 	The application must include the following:
	(1)	Name and address of laboratory.
	(2)	Name and qualifications of laboratory director.
	(3)	A copy of the current certification, license, or approval.
	12.21(2) Laboratories approved through reciprocity that lose their certification, license or approval shall notify the department within five working days.
641—12.22(730) Approval and renewal fees. Each laboratory at the time of application and each year thereafter shall remit to the department a fee in an amount sufficient to reimburse the department for expenses incurred to administer the laboratory approval program. All fees shall be made payable to the Iowa department of public health and are as follows:
	12.22(1) Approval. An administration fee of $600 is required for new applications and for laboratories approved through reciprocity.
	12.22(2) Renewal. An administration fee of $300 is required to renew laboratory approval.
	12.22(3) Approval and renewal fees for SAMHSA-certified laboratories. An administration fee of $100 is required in both instances.
	12.22(4) Inspections. Reimbursement for actual on-site inspection and related expenses shall be assessed to each laboratory after the completion of each inspection. Expenses related to the on-site inspection will be reimbursed to the UHL. These expenses shall reflect the actual cost incurred for personnel time and travel expenses consistent with state of Iowa travel reimbursement policies and procedures. These expenses shall also include the time necessary for UHL inspection staff to:
	a. 	Review the application and related laboratory materials in preparation for the on-site inspection,
	b. 	Generate the written laboratory report regarding inspection findings,
	c. 	Conduct postinspection follow-up activities, if any, and
	d. 	Review on an ongoing basis proficiency test results.
641—12.23(730) Appeals process.
	12.23(1) Denial. Laboratories shall receive written notice by certified mail, return receipt requested, setting forth the reason(s) for denial. The adverse action shall become effective 30 days after receipt of the notice unless the applicant, within 30 days, gives written notice to the department requesting a hearing. In that event, the notice shall be deemed to be suspended.
	12.23(2)  Suspension, modification, or revocation. Laboratories shall receive written notice by certified mail, return receipt requested, setting forth the reason(s) for suspension, modification, or revocation. The adverse action shall become effective 30 days after receipt of the notice unless the aggrieved party, within 30 days, gives written notice to the department requesting a hearing. In that event, the notice shall be deemed to be suspended.
	12.23(3) Contested cases. The procedures for contested cases as set out in Iowa Code chapter 17A and the rules adopted by the department in 641—Chapter 173 shall be followed in all cases where proper notice has been made to the department of the intent to formally contest any denial, suspension, modification, or revocation of approval.
[Filed emergency 2/5/88 after Notice 12/16/87—published 2/24/88, effective 2/5/88]
[Filed 5/16/94, Notice 3/30/94—published 6/8/94, effective 7/13/94]