Iowa Code Ann. § 730.5; Iowa Admin. Code R. 641-12.1 to 12.21

Iowa Code Ann. § 730.5; Iowa Admin. Code R. 641-12.1 to 12.21 - Laws Affecting Drug and Alcohol Testing 

730.5  Private sector drug-free workplaces.

1.  Definitions.  As used in this section, unless the context otherwise requires:

a.  "Alcohol" means ethanol, isopropanol, or methanol.

b.  "Confirmed positive test result" means, except for alcohol testing conducted pursuant to subsection 7, paragraph "f", subparagraph (2), the results of a blood, urine, or oral fluid test in which the level of controlled substances or metabolites in the specimen analyzed meets or exceeds nationally accepted standards for determining detectable levels of controlled substances as adopted by the federal substance abuse and mental health services administration.  If nationally accepted standards for oral fluid tests have not been adopted by the federal substance abuse and mental health services administration, the standards for determining detectable levels of controlled substances for purposes of determining a confirmed positive test result shall be the same standard that has been established by the federal food and drug administration for the measuring instrument used to perform the oral fluid test.

c.  "Drug" means a substance considered a controlled substance and included in schedule I, II, III, IV, or V under the federal Controlled Substances Act, 21 U.S.C. § 801 et seq.

d.  "Employee" means a person in the service of an employer in this state and includes the employer, and any chief executive officer, president, vice president, supervisor, manager, and officer of the employer who is actively involved in the day-to-day operations of the business.

e.  "Employer" means a person, firm, company, corporation, labor organization, or employment agency, which has one or more full-time employees employed in the same business, or in or about the same establishment, under any contract of hire, express or implied, oral or written, in this state. "Employer" does not include the state, a political subdivision of the state, including a city, county, or school district, the United States, the United States postal service, or a Native American tribe.

f.  "Good faith" means reasonable reliance on facts, or that which is held out to be factual, without the intent to be deceived, and without reckless, malicious, or negligent disregard for the truth.

g.  "Medical review officer" means a licensed physician, osteopathic physician, chiropractor, nurse practitioner, or physician assistant authorized to practice in any state of the United States, who is responsible for receiving laboratory results generated by an employer's drug or alcohol testing program, and who has knowledge of substance abuse disorders and has appropriate medical training to interpret and evaluate an individual's confirmed positive test result together with the individual's medical history and any other relevant biomedical information.

h.  "Prospective employee" means a person who has made application, whether written or oral, to an employer to become an employee.

i.  "Reasonable suspicion drug or alcohol testing" means drug or alcohol testing based upon evidence that an employee is using or has used alcohol or other drugs in violation of the employer's written policy drawn from specific objective and articulable facts and reasonable inferences drawn from those facts in light of experience.  For purposes of this paragraph, facts and inferences may be based upon, but not limited to, any of the following:

(1)  Observable phenomena while at work such as direct observation of alcohol or drug use or abuse or of the physical symptoms or manifestations of being impaired due to alcohol or other drug use.

(2)  Abnormal conduct or erratic behavior while at work or a significant deterioration in work performance.

(3)  A report of alcohol or other drug use provided by a reliable and credible source.

(4)  Evidence that an individual has tampered with any drug or alcohol test during the individual's employment with the current employer.

(5)  Evidence that an employee has caused an accident while at work which resulted in an injury to a person for which injury, if suffered by an employee, a record or report could be required under chapter 88, or resulted in damage to property, including to equipment, in an amount reasonably estimated at the time of the accident to exceed one thousand dollars.

(6)  Evidence that an employee has manufactured, sold, distributed, solicited, possessed, used, or transferred drugs while working or while on the employer's premises or while operating the employer's vehicle, machinery, or equipment.

j.  "Safety-sensitive position" means a job wherein an accident could cause loss of human life, serious bodily injury, or significant property or environmental damage, including a job with duties that include immediate supervision of a person in a job that meets the requirement of this paragraph.

k.  "Sample" means such sample from the human body capable of revealing the presence of alcohol or other drugs, or their metabolites, which shall include only urine, saliva, breath, and blood.  However, "sample" does not mean blood except as authorized pursuant to subsection 7, paragraph "l".

l.  "Unannounced drug or alcohol testing" means testing for the purposes of detecting drugs or alcohol which is conducted on a periodic basis, without advance notice of the test to employees, other than employees whose duties include responsibility for administration of the employer's drug or alcohol testing program, subject to testing prior to the day of testing, and without individualized suspicion.  The selection of employees to be tested from the pool of employees subject to testing shall be done based on a neutral and objective selection process by an entity independent from the employer and shall be made by a computer-based random number generator that is matched with employees' social security numbers, payroll identification numbers, or other comparable identifying numbers in which each member of the employee population subject to testing has an equal chance of selection for initial testing, regardless of whether the employee has been selected or tested previously.  The random selection process shall be conducted through a computer program that records each selection attempt by date, time, and employee number.

2.  Applicability.  This section does not apply to drug or alcohol tests conducted on employees required to be tested pursuant to federal statutes, federal regulations, or orders issued pursuant to federal law.  In addition, an employer, through its written policy, may exclude from the pools of employees subject to unannounced drug or alcohol testing pursuant to subsection 8, paragraph "a", employee populations required to be tested as described in this subsection.

3.  Testing optional.  This section does not require or create a legal duty on an employer to conduct drug or alcohol testing and the requirements of this section shall not be construed to encourage, discourage, restrict, limit, prohibit, or require such testing.  In addition, an employer may implement and require drug or alcohol testing at some but not all of the work sites of the employer and the requirements of this section shall only apply to the employer and employees who are at the work sites where drug or alcohol testing pursuant to this section has been implemented.  A cause of action shall not arise in favor of any person against an employer or agent of an employer based on the failure of the employer to establish a program or policy on substance abuse prevention or to implement any component of testing as permitted by this section.

4.  Testing as condition of employment — requirements.  To the extent provided in subsection 8, an employer may test employees and prospective employees for the presence of drugs or alcohol as a condition of continued employment or hiring. An employer shall adhere to the requirements of this section concerning the conduct of such testing and the use and disposition of the results of such testing.

5.  Collection of samples.  In conducting drug or alcohol testing, an employer may require the collection of samples from its employees and prospective employees, and may require presentation of reliable individual identification from the person being tested to the person collecting the samples. Collection of a sample shall be in conformance with the requirements of this section.  The employer may designate the type of sample to be used for this testing.

6.  Scheduling of tests. 

a.  Drug or alcohol testing of employees conducted by an employer shall normally occur during, or immediately before or after, a regular work period.  The time required for such testing by an employer shall be deemed work time for the purposes of compensation and benefits for employees.

b.  An employer shall pay all actual costs for drug or alcohol testing of employees and prospective employees required by the employer.

c.  An employer shall provide transportation or pay reasonable transportation costs to employees if drug or alcohol sample collection is conducted at a location other than the employee's normal work site.

7.  Testing procedures.  All sample collection and testing for drugs or alcohol under this section shall be performed in accordance with the following conditions:

a.  The collection of samples shall be performed under sanitary conditions and with regard for the privacy of the individual from whom the specimen is being obtained and in a manner reasonably calculated to preclude contamination or substitution of the specimen.  If the sample collected is urine, procedures shall be established to provide for individual privacy in the collection of the sample unless there is a reasonable suspicion that a particular individual subject to testing may alter or substitute the urine specimen to be provided, or has previously altered or substituted a urine specimen provided pursuant to a drug or alcohol test. For purposes of this paragraph, "individual privacy" means a location at the collection site where urination can occur in private, which has been secured by visual inspection to ensure that other persons are not present, which provides that undetected access to the location is not possible during urination, and which provides for the ability to effectively restrict access to the location during the time the specimen is provided.  If an individual is providing a urine sample and collection of the urine sample is directly monitored or observed by another individual, the individual who is directly monitoring or observing the collection shall be of the same gender as the individual from whom the urine sample is being collected.

b.  Collection of a urine sample for testing of current employees shall be performed so that the specimen is split into two components at the time of collection in the presence of the individual from whom the sample or specimen is collected.  The second portion of the specimen or sample shall be of sufficient quantity to permit a second, independent confirmatory test as provided in paragraph "i". The sample shall be split such that the primary sample contains at least thirty milliliters and the secondary sample contains at least fifteen milliliters.  Both portions of the sample shall be forwarded to the laboratory conducting the initial confirmatory testing.  In addition to any requirements for storage of the initial sample that may be imposed upon the laboratory as a condition for certification or approval, the laboratory shall store the second portion of any sample until receipt of a confirmed negative test result or for a period of at least forty-five calendar days following the completion of the initial confirmatory testing, if the first portion yielded a confirmed positive test result.

c.  Sample collections shall be documented, and the procedure for documentation shall include the following:

(1)  Samples, except for samples collected for alcohol testing conducted pursuant to paragraph "f", subparagraph (2), shall be labeled so as to reasonably preclude the possibility of misidentification of the person tested in relation to the test result provided, and samples shall be handled and tracked in a manner such that control and accountability are maintained from initial collection to each stage in handling, testing, and storage, through final disposition.

(2)  An employee or prospective employee shall be provided an opportunity to provide any information which may be considered relevant to the test, including identification of prescription or nonprescription drugs currently or recently used, or other relevant medical information.  To assist an employee or prospective employee in providing the information described in this subparagraph, the employer shall provide an employee or prospective employee with a list of the drugs to be tested.

d.  Sample collection, storage, and transportation to the place of testing shall be performed so as to reasonably preclude the possibility of sample contamination, adulteration, or misidentification.

e.  All confirmatory drug testing shall be conducted at a laboratory certified by the United States department of health and human services' substance abuse and mental health services administration or approved under rules adopted by the Iowa department of public health.

f.  Drug or alcohol testing shall include confirmation of any initial positive test results.  An employer may take adverse employment action, including refusal to hire a prospective employee, based on a confirmed positive test result for drugs or alcohol.

(1)  For drug or alcohol testing, except for alcohol testing conducted pursuant to subparagraph (2), confirmation shall be by use of a different chemical process than was used in the initial screen for drugs or alcohol.  The confirmatory drug or alcohol test shall be a chromatographic technique such as gas chromatography/mass spectrometry, or another comparably reliable analytical method.

(2)  Notwithstanding any provision of this section to the contrary, alcohol testing, including initial and confirmatory testing, may be conducted pursuant to requirements established by the employer's written policy.  The written policy shall include requirements governing evidential breath testing devices, alcohol screening devices, and the qualifications for personnel administering initial and confirmatory testing, which shall be consistent with regulations adopted as of January 1, 1999, by the United States department of transportation governing alcohol testing required to be conducted pursuant to the federal Omnibus Transportation Employee Testing Act of 1991.

(3)  Notwithstanding any provision of this section to the contrary, collection of an oral fluid sample for testing shall be performed in the presence of the individual from whom the sample or specimen is collected.  The specimen or sample shall be of sufficient quantity to permit a second, independent, confirmatory test as provided in paragraph "i".  In addition to any requirement for storage of the initial sample that may be imposed upon the laboratory as a condition for certification or approval, the laboratory shall store the unused portion of any sample until receipt of a confirmed negative test result or for a period of at least forty-five calendar days following the completion of the initial confirmatory testing, if the portion yielded a confirmed positive test result.

g.  A medical review officer shall, prior to the results being reported to an employer, review and interpret any confirmed positive test results, including both quantitative and qualitative test results, to ensure that the chain of custody is complete and sufficient on its face and that any information provided by the individual pursuant to paragraph "c", subparagraph (2), is considered.  However, this paragraph shall not apply to alcohol testing conducted pursuant to paragraph "f", subparagraph (2).

h.  In conducting drug or alcohol testing pursuant to this section, the laboratory, the medical review officer, and the employer shall ensure, to the extent feasible, that the testing only measure, and the records concerning the testing only show or make use of information regarding, alcohol or drugs in the body.

i.  (1)  If a confirmed positive test result for drugs or alcohol for a current employee is reported to the employer by the medical review officer, the employer shall notify the employee in writing by certified mail, return receipt requested, of the results of the test, the employee's right to request and obtain a confirmatory test of the second sample collected pursuant to paragraph "b" at an approved laboratory of the employee's choice, and the fee payable by the employee to the employer for reimbursement of expenses concerning the test.  The fee charged an employee shall be an amount that represents the costs associated with conducting the second confirmatory test, which shall be consistent with the employer's cost for conducting the initial confirmatory test on an employee's sample.  If the employee, in person or by certified mail, return receipt requested, requests a second confirmatory test, identifies an approved laboratory to conduct the test, and pays the employer the fee for the test within seven days from the date the employer mails by certified mail, return receipt requested, the written notice to the employee of the employee's right to request a test, a second confirmatory test shall be conducted at the laboratory chosen by the employee.  The results of the second confirmatory test shall be reported to the medical review officer who reviewed the initial confirmatory test results and the medical review officer shall review the results and issue a report to the employer on whether the results of the second confirmatory test confirmed the initial confirmatory test as to the presence of a specific drug or alcohol.  If the results of the second test do not confirm the results of the initial confirmatory test, the employer shall reimburse the employee for the fee paid by the employee for the second test and the initial confirmatory test shall not be considered a confirmed positive test result for drugs or alcohol for purposes of taking disciplinary action pursuant to subsection 10.

(2)  If a confirmed positive test result for drugs or alcohol for a prospective employee is reported to the employer by the medical review officer, the employer shall notify the prospective employee in writing of the results of the test, of the name and address of the medical review officer who made the report, and of the prospective employee's right to request records under subsection 13.

j.  A laboratory conducting testing under this section shall dispose of all samples for which a negative test result was reported to an employer within five working days after issuance of the negative test result report.

k.  Except as necessary to conduct drug or alcohol testing pursuant to this section and to submit the report required by subsection 16, a laboratory or other medical facility shall only report to an employer or outside entity information relating to the results of a drug or alcohol test conducted pursuant to this section concerning the determination of whether the tested individual has engaged in conduct prohibited by the employer's written policy with regard to alcohol or drug use.

l.  Notwithstanding the provisions of this subsection, an employer may rely and take action upon the results of any blood test for drugs or alcohol made on any employee involved in an accident at work if the test is administered by or at the direction of the person providing treatment or care to the employee without request or suggestion by the employer that a test be conducted, and the employer has lawfully obtained the results of the test.  For purposes of this paragraph, an employer shall not be deemed to have requested or required a test in conjunction with the provision of medical treatment following a workplace accident by providing information concerning the circumstance of the accident.

8.  Drug or alcohol testing.  Employers may conduct drug or alcohol testing as provided in this subsection:

a.  Employers may conduct unannounced drug or alcohol testing of employees who are selected from any of the following pools of employees:

(1)  The entire employee population at a particular work site of the employer except for employees not subject to testing pursuant to a collective bargaining agreement, or employees who are not scheduled to be at work at the time the testing is conducted because of the status of the employees or who have been excused from work pursuant to the employer's work policy prior to the time the testing is announced to employees.

(2)  The entire full-time active employee population at a particular work site except for employees not subject to testing pursuant to a collective bargaining agreement, or employees who are not scheduled to be at work at the time the testing is to be conducted because of the status of the employee or who have been excused from work pursuant to the employer's working policy.

(3)  All employees at a particular work site who are in a pool of employees in a safety-sensitive position and who are scheduled to be at work at the time testing is conducted, other than employees not subject to testing pursuant to a collective bargaining agreement, or employees who are not scheduled to be at work at the time the testing is to be conducted or who have been excused from work pursuant to the employer's work policy prior to the time the testing is announced to employees.

b.  Employers may conduct drug or alcohol testing of employees during, and after completion of, drug or alcohol rehabilitation.

c.  Employers may conduct reasonable suspicion drug or alcohol testing.

d.  Employers may conduct drug or alcohol testing of prospective employees.

e.  Employers may conduct drug or alcohol testing as required by federal law or regulation or by law enforcement.

f.  Employers may conduct drug or alcohol testing in investigating accidents in the workplace in which the accident resulted in an injury to a person for which injury, if suffered by an employee, a record or report could be required under chapter 88, or resulted in damage to property, including to equipment, in an amount reasonably estimated at the time of the accident to exceed one thousand dollars.

9.  Written policy and other testing requirements. 

a.  (1)  Drug or alcohol testing or retesting by an employer shall be carried out within the terms of a written policy which has been provided to every employee subject to testing, and is available for review by employees and prospective employees.  If an employee or prospective employee is a minor, the employer shall provide a copy of the written policy to a parent of the employee or prospective employee and shall obtain a receipt or acknowledgment from the parent that a copy of the policy has been received.  Providing a copy of the written policy to a parent of a minor by certified mail, return receipt requested, shall satisfy the requirements of this subparagraph.

(2)  In addition, the written policy shall provide that any notice required by subsection 7, paragraph "i", to be provided to an individual pursuant to a drug or alcohol test conducted pursuant to this section, shall also be provided to the parent of the individual by certified mail, return receipt requested, if the individual tested is a minor.

(3)  In providing information or notice to a parent as required by this paragraph, an employer shall rely on the information regarding the identity of a parent as provided by the minor.

(4)  For purposes of this paragraph, "minor" means an individual who is under eighteen years of age and is not considered by law to be an adult, and "parent" means one biological or adoptive parent, a stepparent, or a legal guardian or custodian of the minor.

b.  The employer's written policy shall provide uniform requirements for what disciplinary or rehabilitative actions an employer shall take against an employee or prospective employee upon receipt of a confirmed positive test result for drugs or alcohol or upon the refusal of the employee or prospective employee to provide a testing sample. The policy shall provide that any action taken against an employee or prospective employee shall be based only on the results of the drug or alcohol test.  The written policy shall also provide that if rehabilitation is required pursuant to paragraph "g", the employer shall not take adverse employment action against the employee so long as the employee complies with the requirements of rehabilitation and successfully completes rehabilitation.

c.  Employers shall establish an awareness program to inform employees of the dangers of drug and alcohol use in the workplace and comply with the following requirements in order to conduct drug or alcohol testing under this section:

(1)  If an employer has an employee assistance program, the employer must inform the employee of the benefits and services of the employee assistance program.  An employer shall post notice of the employee assistance program in conspicuous places and explore alternative routine and reinforcing means of publicizing such services.  In addition, the employer must provide the employee with notice of the policies and procedures regarding access to and utilization of the program.

(2)  If an employer does not have an employee assistance program, the employer must maintain a resource file of alcohol and other drug abuse programs certified by the Iowa department of public health, mental health providers, and other persons, entities, or organizations available to assist employees with personal or behavioral problems.  The employer shall provide all employees information about the existence of the resource file and a summary of the information contained within the resource file.  The summary should contain, but need not be limited to, all information necessary to access the services listed in the resource file.

d.  An employee or prospective employee whose drug or alcohol test results are confirmed as positive in accordance with this section shall not, by virtue of those results alone, be considered as a person with a disability for purposes of any state or local law or regulation.

e.  If the written policy provides for alcohol testing, the employer shall establish in the written policy a standard for alcohol concentration which shall be deemed to violate the policy.  The standard for alcohol concentration shall not be less than .04, expressed in terms of grams of alcohol per two hundred ten liters of breath, or its equivalent.

f.  An employee of an employer who is designated by the employer as being in a safety-sensitive position shall be placed in only one pool of safety-sensitive employees subject to drug or alcohol testing pursuant to subsection 8, paragraph "a", subparagraph (3).  An employer may have more than one pool of safety-sensitive employees subject to drug or alcohol testing pursuant to subsection 8, paragraph "a", subparagraph (3), but shall not include an employee in more than one safety-sensitive pool.

g.  Upon receipt of a confirmed positive alcohol test which indicates an alcohol concentration greater than the concentration level established by the employer pursuant to this section, and if the employer has at least fifty employees, and if the employee has been employed by the employer for at least twelve of the preceding eighteen months, and if rehabilitation is agreed upon by the employee, and if the employee has not previously violated the employer's substance abuse prevention policy pursuant to this section, the written policy shall provide for the rehabilitation of the employee pursuant to subsection 10, paragraph "a", subparagraph (1), and the apportionment of the costs of rehabilitation as provided by this paragraph.

(1)  If the employer has an employee benefit plan, the costs of rehabilitation shall be apportioned as provided under the employee benefit plan.

(2)  If no employee benefit plan exists and the employee has coverage for any portion of the costs of rehabilitation under any health care plan of the employee, the costs of rehabilitation shall be apportioned as provided by the health care plan with any costs not covered by the plan apportioned equally between the employee and the employer.  However, the employer shall not be required to pay more than two thousand dollars toward the costs not covered by the employee's health care plan.

(3)  If no employee benefit plan exists and the employee does not have coverage for any portion of the costs of rehabilitation under any health care plan of the employee, the costs of rehabilitation shall be apportioned equally between the employee and the employer.  However, the employer shall not be required to pay more than two thousand dollars towards the cost of rehabilitation under this subparagraph.

Rehabilitation required pursuant to this paragraph shall not preclude an employer from taking any adverse employment action against the employee during the rehabilitation based on the employee's failure to comply with any requirements of the rehabilitation, including any action by the employee to invalidate a test sample provided by the employee pursuant to the rehabilitation.

h.  In order to conduct drug or alcohol testing under this section, an employer shall require supervisory personnel of the employer involved with drug or alcohol testing under this section to attend a minimum of two hours of initial training and to attend, on an annual basis thereafter, a minimum of one hour of subsequent training.  The training shall include, but is not limited to, information concerning the recognition of evidence of employee alcohol and other drug abuse, the documentation and corroboration of employee alcohol and other drug abuse, and the referral of employees who abuse alcohol or other drugs to the employee assistance program or to the resource file maintained by the employer pursuant to paragraph "c", subparagraph (2).

10.  Disciplinary procedures. 

a.  Upon receipt of a confirmed positive test result for drugs or alcohol which indicates a violation of the employer's written policy, or upon the refusal of an employee or prospective employee to provide a testing sample, an employer may use that test result or test refusal as a valid basis for disciplinary or rehabilitative actions pursuant to the requirements of the employer's written policy and the requirements of this section, which may include, among other actions, the following:

(1)  A requirement that the employee enroll in an employer-provided or approved rehabilitation, treatment, or counseling program, which may include additional drug or alcohol testing, participation in and successful completion of which may be a condition of continued employment, and the costs of which may or may not be covered by the employer's health plan or policies.

(2)  Suspension of the employee, with or without pay, for a designated period of time.

(3)  Termination of employment.

(4)  Refusal to hire a prospective employee.

(5)  Other adverse employment action in conformance with the employer's written policy and procedures, including any relevant collective bargaining agreement provisions.

b.  Following a drug or alcohol test, but prior to receipt of the final results of the drug or alcohol test, an employer may suspend a current employee, with or without pay, pending the outcome of the test.  An employee who has been suspended shall be reinstated by the employer, with back pay, and interest on such amount at eighteen percent per annum compounded annually, if applicable, if the result of the test is not a confirmed positive test result for drugs or alcohol which indicates a violation of the employer's written policy.

11.  Employer immunity.  A cause of action shall not arise against an employer who has established a policy and initiated a testing program in accordance with the testing and policy safeguards provided for under this section, for any of the following:

a.  Testing or taking action based on the results of a positive drug or alcohol test result, indicating the presence of drugs or alcohol, in good faith, or on the refusal of an employee or prospective employee to submit to a drug or alcohol test.

b.  Failure to test for drugs or alcohol, or failure to test for a specific drug or controlled substance.

c.  Failure to test for, or if tested for, failure to detect, any specific drug or other controlled substance.

d.  Termination or suspension of any substance abuse prevention or testing program or policy.

e.  Any action taken related to a false negative drug or alcohol test result.

12.  Employer liability — false positive test results. 

a.  Except as otherwise provided in paragraph "b", a cause of action shall not arise against an employer who has established a program of drug or alcohol testing in accordance with this section, unless all of the following conditions exist:

(1)  The employer's action was based on a false positive test result.

(2)  The employer knew or clearly should have known that the test result was in error and ignored the correct test result because of reckless, malicious, or negligent disregard for the truth, or the willful intent to deceive or to be deceived.

b.  A cause of action for defamation, libel, slander, or damage to reputation shall not arise against an employer establishing a program of drug or alcohol testing in accordance with this section unless all of the following apply:

(1)  The employer discloses the test results to a person other than the employer, an authorized employee, agent, or representative of the employer, the tested employee or the tested applicant for employment, an authorized substance abuse treatment program or employee assistance program, or an authorized agent or representative of the tested employee or applicant.

(2)  The test results disclosed incorrectly indicate the presence of alcohol or drugs.

(3)  The employer negligently discloses the results.

c.  In any cause of action based upon a false positive test result, all of the following conditions apply:

(1)  The results of a drug or alcohol test conducted in compliance with this section are presumed to be valid.

(2)  An employer shall not be liable for monetary damages if the employer's reliance on the false positive test result was reasonable and in good faith.

13.  Confidentiality of results — exception. 

a.  All communications received by an employer relevant to employee or prospective employee drug or alcohol test results, or otherwise received through the employer's drug or alcohol testing program, are confidential communications and shall not be used or received in evidence, obtained in discovery, or disclosed in any public or private proceeding, except as otherwise provided or authorized by this section.

b.  An employee, or a prospective employee, who is the subject of a drug or alcohol test conducted under this section pursuant to an employer's written policy and for whom a confirmed positive test result is reported shall, upon written request, have access to any records relating to the employee's drug or alcohol test, including records of the laboratory where the testing was conducted and any records relating to the results of any relevant certification or review by a medical review officer.  However, a prospective employee shall be entitled to records under this paragraph only if the prospective employee requests the records within fifteen calendar days from the date the employer provided the prospective employee written notice of the results of a drug or alcohol test as provided in subsection 7, paragraph "i", subparagraph (2).

c.  Except as provided by this section and as necessary to conduct drug or alcohol testing under this section and to file a report pursuant to subsection 16, a laboratory and a medical review officer conducting drug or alcohol testing under this section shall not use or disclose to any person any personally identifiable information regarding such testing, including the names of individuals tested, even if unaccompanied by the results of the test.

d.  An employer may use and disclose information concerning the results of a drug or alcohol test conducted pursuant to this section under any of the following circumstances:

(1)  In an arbitration proceeding pursuant to a collective bargaining agreement, or an administrative agency proceeding or judicial proceeding under workers' compensation laws or unemployment compensation laws or under common or statutory laws where action taken by the employer based on the test is relevant or is challenged.

(2)  To any federal agency or other unit of the federal government as required under federal law, regulation or order, or in accordance with compliance requirements of a federal government contract.

(3)  To any agency of this state authorized to license individuals if the employee tested is licensed by that agency and the rules of that agency require such disclosure.

(4)  To a union representing the employee if such disclosure would be required by federal labor laws.

(5)  To a substance abuse evaluation or treatment facility or professional for the purpose of evaluation or treatment of the employee.

However, positive test results from an employer drug or alcohol testing program shall not be used as evidence in any criminal action against the employee or prospective employee tested.

14.  Civil penalties — jurisdiction. 

a.  Any laboratory or medical review officer which discloses information in violation of the provisions of subsection 7, paragraph "h" or "k", or any employer who, through the selection process described in subsection 1, paragraph "l", improperly targets or exempts employees subject to unannounced drug or alcohol testing, shall be subject to a civil penalty of one thousand dollars for each violation.  The attorney general or the attorney general's designee may maintain a civil action to enforce this subsection.  Any civil penalty recovered shall be deposited in the general fund of the state.

b.  A laboratory or medical review officer involved in the conducting of a drug or alcohol test pursuant to this section shall be deemed to have the necessary contact with this state for the purpose of subjecting the laboratory or medical review officer to the jurisdiction of the courts of this state.

15.  Civil remedies.  This section may be enforced through a civil action.

a.  A person who violates this section or who aids in the violation of this section, is liable to an aggrieved employee or prospective employee for affirmative relief including reinstatement or hiring, with or without back pay, or any other equitable relief as the court deems appropriate including attorney fees and court costs.

b.  When a person commits, is committing, or proposes to commit, an act in violation of this section, an injunction may be granted through an action in district court to prohibit the person from continuing such acts.  The action for injunctive relief may be brought by an aggrieved employee or prospective employee, the county attorney, or the attorney general.

In an action brought under this subsection alleging that an employer has required or requested a drug or alcohol test in violation of this section, the employer has the burden of proving that the requirements of this section were met.

16.  Reports.  A laboratory doing business for an employer who conducts drug or alcohol tests pursuant to this section shall file an annual report with the Iowa department of public health by March 1 of each year concerning the number of drug or alcohol tests conducted on employees who work in this state pursuant to this section, the number of positive and negative results of the tests, during the previous calendar year.  In addition, the laboratory shall include in its annual report the specific basis for each test as authorized in subsection 8, the type of drug or drugs which were found in the positive drug tests, and all significant available demographic factors relating to the positive test pool.

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 conduct confirmatory testing of samples for the detection of alcohol or other drugs, or their metabolites, in employees or prospective employees.

641—12.2

(730)

Definitions.

For the purpose of these rules, the following definitions shall apply:

"Alcohol"

means ethanol, isopropanol, or methanol.

"Alcohol or drug testing"

means analysis of a sample for the purpose of detecting the presence or absence of alcohol or other drugs, or their metabolites, in the sample tested.

"CLIA"

means Clinical Laboratory Improvement Amendments of 1988.

"CMS"

means Centers for Medicare and Medicaid Services. CMS is the federal agency responsible for implementing and administering CLIA regulations.

"Confirmatory test"

means a test for alcohol or other drugs, or their metabolites, using a testing method as stipulated in rule 641—12.9(730), “Confirmatory testing.”

"Department"

means the Iowa department of public health.

"Director"

means the director of the Iowa department of public health.

"Drug"

means a substance considered a controlled substance and included in Schedule I, II, III, IV, or V under the federal Controlled Substances Act, 21 U.S.C. Subsections 801 et seq.

"Employee"

means a person in the service of an employer in this state and includes the employer and any chief executive officer, president, vice president, supervisor, manager, and officer of the employer who is actively involved in the day-to-day operations of the business.

"Employer"

means a person, firm, company, corporation, labor organization, or employment agency, which has one or more full-time employees employed in the same business, or in or about the same establishment, under any contract of hire, express or implied, oral or written, in this state. “Employer” does not include the state, a political subdivision of the state, including a city, county, or school district, the United States, the United States Postal Service, or a Native American tribe.

"GC/MS"

means gas chromatography/mass spectrometry.

"Laboratory"

means a facility inside or outside the state of Iowa approved to conduct confirmatory testing of samples for the detection of alcohol or other drugs, or their metabolites.

"Medical review officer"

means a licensed physician, osteopathic physician, chiropractor, nurse practitioner, or physician assistant authorized to practice in any state of the United States, who is responsible for receiving laboratory results generated by an employer’s drug or alcohol testing program, and who has knowledge of substance abuse disorders and has appropriate medical training to interpret and evaluate an individual’s confirmed positive test result together with the individual’s medical history and any other relevant biomedical information.

"Prospective employee"

means a person who has made application, whether oral or written, to an employer to become an employee.

"Sample"

means such sample from the human body capable of revealing the presence of alcohol or other drugs, or their metabolites. However, “sample” does not mean blood except as authorized pursuant to Iowa Code subsection 730.5(7), paragraph “l.” For the purpose of these rules, the substances determined by the department to be samples from the human body capable of accurately and reliably revealing the presence of alcohol or other drugs, or their metabolites, are urine, breath, blood, and saliva.

"Specimen"

means a part taken from a sample to determine the character of the whole sample.

"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 conduct confirmatory testing pursuant to Iowa Code subsection 730.5(7), paragraph “e.”

12.3(2)

Developing an application package.

a.

The package shall be provided to all laboratories requesting approval to conduct confirmatory testing for alcohol or other drugs, or their metabolites.

b.

The package shall contain application procedures, a copy of Iowa Code section 730.5, a copy of these administrative rules, a standardized application form and a self-inspection questionnaire.

c.

The self-inspection questionnaire shall assist the department in assessing the quality of a laboratory’s performance as a confirmatory testing laboratory. This questionnaire will comprise the major but not the sole objective criteria used during the initial on-site inspection when conducted by the UHL.

d.

The package shall be available upon request from the Iowa Department of Public Health, Division of Health Protection, Private Sector Drug Testing Program, 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 approved confirmatory laboratory at least once every two years. Inspection may be waived by the director if the laboratory has been inspected and accredited for forensic urine drug testing by the College of American Pathologists, or if the laboratory has been inspected and certified, licensed, or approved to conduct confirmatory testing by 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 confirmatory laboratories.

12.3(6)

Providing written notice of approval and assigning an expiration date.

641—12.4

(730)

Application procedures and requirements.

Laboratories desiring to conduct confirmatory testing for Iowa’s employers shall apply to the department for approval. Each laboratory requesting Iowa approval to conduct confirmatory testing shall provide the following to the department:

12.4(1)

A completed laboratory survey checklist on a form provided by the department.

12.4(2)

A completed self-inspection questionnaire provided by the department that includes:

a.

A list of alcohol or other drugs, or their metabolites, 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 alcohol or drug testing laboratory.

d.

Copies of the forms used to report test results.

e.

Chain of custody protocols and copies of the chain of custody forms used.

f.

Sample collection procedures.

g.

Confirmation procedures.

12.4(3)

Proof of enrollment in a recognized proficiency testing program. Recognized programs include those approved by CMS.

12.4(4)

Acceptable performance over a 12-month period in all appropriate areas of proficiency testing for alcohol or other drugs, or their metabolites, shall be documented and maintained 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 with no false positive results.

b.

Renewal shall require at least 80 percent accuracy each year on graded proficiency surveys with no false positive results.

641—12.5

(730)

Requirements of laboratory personnel involved in confirmatory testing for alcohol or other drugs, or their metabolites.

12.5(1)

The laboratory director shall be a pathologist or doctoral level individual who qualifies as a clinical laboratory director under CLIA regulations.

12.5(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 alcohol or drug testing experience. Supervisors must also have training in the theory and practice of laboratory procedures and an understanding of quality control concepts. Annual verification of the supervisor’s skills must be documented by the laboratory director.

12.5(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.

12.5(4)

Laboratory directors, supervisors and analysts involved in alcohol or drug testing shall annually complete at least one in-service continuing education program related to alcohol or drug testing. Continuing education programs include formal training programs where continuing education units are awarded, informal in-house training programs, and relevant correspondence courses. Dates, titles and subject matter for each completed course shall be documented and the information shall be available for review.

12.5(5)

The following information about each of the laboratory staff involved in alcohol or 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—12.6

(730)

Quality assurance program and procedure manual requirements.

All approved confirmatory laboratories shall have a written quality assurance program and a procedure manual which encompasses all aspects of the alcohol or drug testing process.

12.6(1)

Approved laboratories shall have written procedures for performing alcohol or drug testing which shall include the following:

a.

Sample acquisition.

b.

Chain of custody.

c.

Sample and report security.

d.

Test performance.

e.

Reporting of results.

f.

Confidentiality.

12.6(2)

The quality assurance program and procedure manuals shall be available for review during any on-site inspection.

12.6(3)

Approved laboratories shall review their performance in each of the above areas every 12 months.

12.6(4)

Approved laboratories are responsible for developing the criteria necessary to establish and maintain an effective quality assurance program for confirmatory testing of alcohol or other drugs, or their metabolites.

641—12.7

(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 used to conduct confirmatory testing.

12.7(1)

Positive and negative controls shall be used in testing each batch of specimens.

12.7(2)

Procedures shall be implemented and documented to ensure that carryover from a positive specimen does not contaminate other subsequent specimens in that batch.

12.7(3)

Approved laboratories shall develop criteria for the detection and rejection of adulterated samples.

641—12.8

(730)

Sample security and confidentiality of test results.

Samples and reports must never be left unattended or unsecured.

12.8(1)

Complete chain of custody documentation shall be maintained for each sample from the time of collection from the employee or prospective employee to the time the sample is discarded. Each time the sample is handled or transferred, the individual receiving the sample, the time and date of transfer, and the recipient or destination of the sample shall be documented.

12.8(2)

If the first portion of the sample yielded a confirmed positive test result, the laboratory shall store the second portion of that sample until receipt of a confirmed negative test result or for a period of at least 45 calendar days following the completion of the initial confirmatory testing. Urine and blood samples shall be retained in secure storage at freezing temperatures.

12.8(3)

All samples for which a negative test result was reported shall be disposed of within 5 working days after issuance of the negative test result report.

641—12.9

(730)

Confirmatory testing.

12.9(1)

Reports 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).

12.9(2)

Reports for drugs or their metabolites, other than alcohol, shall not be issued in the absence of confirmation by GC/MS or a scientifically equivalent test approved by the department.

12.9(3)

Complete chain of custody procedures shall be used for referred samples.

641—12.10

(730)

Documentation of the confirmatory testing process.

The following documents shall be retained for at least two years and, if requested, made available for inspection.

12.10(1)

Chain of custody documentation shall be maintained for each sample tested with the identification of the sample, the person(s) handling and testing the sample, the storage of the sample, and the eventual disposal of the sample.

12.10(2)

Documents regarding the following: analytical information for each batch assayed; instrument identification; calibration records; identification of reagent lot numbers and expiration dates; quality control results; and any other pertinent information.

12.10(3)

Copies of proficiency testing results for ongoing monitoring and evaluation of laboratory performance. Approved confirmatory laboratories inspected by the UHL 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.

12.10(4)

Current procedure manuals must be maintained for all procedures.

12.10(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—12.11

(730)

Reporting of confirmed positive test results to the medical review officer.

12.11(1)

Each report shall identify the alcohol or other drugs, or their metabolites, being tested with the results of positive/negative or detected/nondetected clearly recorded.

12.11(2)

Approved confirmatory laboratories shall have available a written summary of the established sensitivity levels used for the confirmatory tests conducted for alcohol or other drugs, or their metabolites. However, this information need not be issued with each report.

12.11(3)

Approved confirmatory laboratories shall have written procedures for making both written and telephone reports to the medical review officer.

12.11(4)

All test results must be reviewed and signed by the laboratory director, or a qualified designee, before being reported to the medical review officer.

641—12.12

(730)

Reporting requirements to department.

Pursuant to Iowa Code subsection 730.5(16), approved confirmatory laboratories shall file a report with the department by March 1 of each year. The address is Iowa Department of Public Health, Division of Health Protection, Private Sector Drug Testing Program, Lucas State Office Building, Des Moines, Iowa 50319-0075. The report for the state of Iowa shall include the number of positive and negative drug or alcohol test results for the previous calendar year for the following if available to the laboratory:

1. Employees who work in non-safety-sensitive positions,
2. Employees who work in safety-sensitive positions,
3. Employees during and after completion of drug or alcohol rehabilitation,
4. Employees as a consequence of reasonable suspicion drug or alcohol testing,
5. Prospective employees,
6. As a consequence of federal law or regulation, or by law enforcement,
7. As a consequence of accident investigation in the workplace,
8. The types of drugs which were found in the positive drug tests,
9. All significant available demographic factors relating to the positive test pool, and
10. Total number of positive and negative drug or alcohol test results for the previous calendar year for all employees and prospective employees who were tested.

641—12.13

(730)

Approval, renewal, and inspection fees.

At the time of initial application and each year thereafter, laboratories shall remit to the department a fee in an amount sufficient to reimburse the department for expenses incurred in administering the confirmatory laboratory approval program. All fees shall be made payable to the Iowa Department of Public Health and are as follows:

12.13(1)

Approval.

An administration fee of $600 is required for new applications, including applicants seeking approval through reciprocity.

12.13(2)

Renewal.

An administration fee of $300 is required to renew laboratory approval.

12.13(3)

Inspections by the UHL.

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 shall 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 proficiency test results on an ongoing basis.

641—12.14

(730)

Renewal.

Laboratory approval to continue confirmatory testing for alcohol or other drugs, or their metabolites, must be renewed annually. The request for renewal shall include the following:

1. Name and address of laboratory.
2. Renewal fee.
3. Information that reflects any changes that occurred during the current approval period.
4. Copy of supporting documents if accredited for forensic urine drug testing by the College of American Pathologists, or if certified, licensed, or approved through reciprocity.

641—12.15

(730)

Reciprocity.

12.15(1)

Confirmatory laboratories certified, licensed, or approved by another state to conduct testing for alcohol or other drugs, or their metabolites, may request Iowa approval through reciprocity by:

a.

Completing and submitting the department’s application package, and

b.

Including a copy of their current certificate, license, or approval document from the state whose requirements are at least equal to Iowa’s.

12.15(2)

Laboratories approved through reciprocity that lose their certification, license or approval from another state shall notify the department within five working days.

641—12.16

(730)

Changes during approval periods.

The following changes that occur during an approval period shall be submitted to the department within five 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 testing program.
6. Addition or subtraction of alcohol or other drugs, or their metabolites, being tested.
7. Change of ownership.
8. Loss of accreditation for forensic urine drug testing by the College of American Pathologists.

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.

Any one of the following can result in denial, suspension, modification or revocation of approval. Failure of the confirmatory laboratory to:

1. Remain in compliance with the requirements of these rules.
2. Provide required documentation, including documentation of laboratory personnel and proficiency test results.
3. Maintain confidentiality.
4. Meet proficiency testing criteria.
5. Provide correct information.
6. Satisfactorily complete the two most recent and relevant graded proficiency test reports from a recognized proficiency testing program (for initial approval).
7. Correctly represent facts on a self-inspection questionnaire or other application documents.
8. Pass an on-site inspection conducted by the College of American Pathologists for forensic urine drug testing, or by another state whose requirements are at least equal to Iowa’s, or by the UHL.

641—12.19

(730)

Restoration of approval.

A confirmatory 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 the College of American Pathologists for forensic urine drug testing, or by another state whose requirements are at least equal to Iowa’s, or by the UHL.

641—12.20

(730)

Appeals process.

12.20(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.

12.20(2)

Suspension, modification, or revocation.

Confirmatory 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.

12.20(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.

641—12.21

(730)

Complaints.

The department shall accept complaints of alleged problems relating to confirmatory 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, Private Sector Drug Testing Program, 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 complainant shall be informed of the results of the action taken by the department