SECTION 5. RL 7.06 (2) (d) is repealed.
SECTION 6. RL 7.06 (2) (e) is renumbered RL 7.06 (2) (d) and amended to read:
RL 7.06 (2) (d) Agrees to file reports as required to the coordinator, including quarterly progress reports and immediate reports if a credential holder withdraws from therapy, submits a positive blood or urine screen, relapses, or is believed to be in an unsafe condition to practice.
SECTION 7. RL 7.11 is created to read:
RL 7.11 Approval of drug testing programs. The department shall approve drug testing programs for use by credential holders who participate in drug and alcohol monitoring programs pursuant to agreements between the department or boards and credential holders, or pursuant to disciplinary orders. The standards for approval of drug testing programs are at Appendix II.
SECTION 8. Appendix II of Chapter RL 7 is created to read:
Chapter RL 7
APPENDIX 2
DRUG TESTING PROGRAM
STANDARDS FOR APPROVAL OF PROGRAMS
To be approved as a drug testing program for the Department of Regulation and Licensing, programs must satisfactorily meet all of the following standards:
A. Program Administration Requirements
1. The drug-testing program (program) shall enroll participants (donors) by assigning the donor an account number, a Private Identification Number (PIN) and establish a method of payment with the donor. No costs are to be incurred by the department.
2. The program shall provide the donor with an adequate supply of preprinted chain of custody forms and notify the donor when additional forms must be purchased.
3. The program shall provide the donor with the address and phone number of the nearest collection site. The program shall assist the donor in locating a qualified collection site when traveling outside their home area.
4. Once enrollment is complete, random selection shall begin immediately and the program shall notify the designated department staff person that selection has begun.
5. The program shall maintain a nationwide 800 number capable of processing 300-500 department calls per day that is operational 24 hours per day, 7 days per week, including holidays. In the alternative, this requirement may be met by providing random notification to donors through a secure Internet website.
6. The 800 number or secure website shall be accessible for donors to contact daily and provides for computer randomization of each participant that automatically designates whether the donor must provide a specimen, based on a frequency determined by the department.
7. The program shall maintain data that is updated on a daily basis verifying the date and time each donor was notified, date, time and location each specimen was collected, results of drug screen and whether or not the donor complied as directed.
8. The program shall make available through secure Internet access data that is updated on a daily basis such as notification times, noncompliance to notification procedures, day, time and site of each collection performed along with the drug test results.
9. The program must utilize appropriate internal (e.g., test call-ins, record audits, off-site computer backups, etc.) and external (e.g., random checks of collection sites, control specimens routed through courier service to laboratory, etc.) quality controls.
10. The program shall maintain the confidentiality of donors in accordance with federal confidentiality regulations.
11. The program shall not sell or otherwise transfer or transmit names and other personal identification information of the credential holders to other persons or entities without permission from the department. The program will not solicit from credential holders presently in the monitoring program or formerly in the monitoring program or otherwise contact credential holders except for purposes consistent with administering the program and only with permission from the department.
12. The program shall provide a detailed inventory of all services and supplies that are included in the standard fee paid by the donor. The program will clearly inform donors of the bundled cost for each drug screen that includes the cost for program administration, collection, transportation, analysis, reporting and confirmation. Cost should not include Medical Review Officer (MRO) review.
13. The program shall provide the department with at least three (3) references of current businesses that use its services with the names and phone numbers of contact people.
14. The program shall immediately report to the department if the program, laboratory or any collection site fails to meet these standards. The department reserves the right to remove a program from the approved list if the program fails to comply with the standards.
15. The program shall make available expert testimony, at a reasonable cost, regarding the drug-testing program. The cost for this service shall be part of the costs of investigation incurred by the department. The program shall make litigation services available for five (5) years after the termination of the agreement.
16. The program must agree to protect the contents of all drug panels and not disclose the contents to donors. The program must also obtain agreement from the laboratory to protect the contents of all drug panels and not disclose the contents to donors.
B. Collection Site Administration
1. The program will locate, train and monitor all collection sites per industry standards for drug test collections. The program will locate new collections sites as needed as well as locate sites for donors who travel out of state. The program shall make special effort to locate collection sites open 24 hours per day that utilize the U.S. Department of Transportation collection protocol.
2. The program shall provide donors and employers of donors with assistance on a 24-hour/day basis if collection is needed for cause.
3. The program shall provide the department with a list of collection sites within Wisconsin that utilize the U.S. Department of Transportation collection protocol.
4. The program shall provide the name, address and phone number of a contact person for the courier service used.
5. The program shall ensure delivery of specimens within twenty-four hours of sampling.
C. Laboratory Requirements
1. The program shall identify the laboratory by name, address and phone number of the laboratory's representative and provide a copy of their current contract.
2. The program must utilize a laboratory that holds DHHS/SAMHSA certification that has had no adverse/corrective action within the last 3 years. The laboratory must maintain DHHS/SAMHSA certification during the entire time the program is providing drug-testing services to the department.
3. The program shall utilize a laboratory that complies with all DHHS/SAMHSA standards, including those related to the handling, processing and storage of specimens.
4. The program shall utilize a laboratory that is capable of processing all specimens for the drugs listed in the department's standard panel and additional individual drugs as listed in the attached drug list.
5. Testing of participant specimens shall be initiated within 48 hours of pickup by courier.
6. Gas Chromatography/Mass Spectrometry (GC/MS), Mass Spectrometry (MS), or another acceptable method shall confirm all positives.
7. The laboratory shall allow department personnel to tour its facilities where donor specimens are tested.
D. Reporting of Results
1. The program shall provide results of each specimen to the designated department personnel within 24 hours of processing.
2. The program shall be capable of distributing results of drug screens to two or more department personnel.
3. The program shall immediately inform the designated department personnel regarding all confirmed positive test results the same day the test results are confirmed or by the next business day if the results are confirmed after hours, on the weekend or on a state or federal holiday.
4. Upon request, the program shall fax, email or electronically transmit laboratory copies of drug test results.
5. The program shall provide a medical review officer (MRO) upon request and at the donor's expense for MRO review of disputed positive test results.
6. Upon request of the donor or the department, the program shall provide chain-of-custody transfer of disputed specimens to an independent laboratory for re-testing.
Fiscal Estimate
1. The anticipated fiscal effect on the fiscal liability and revenues of any local unit of government of the proposed rule is: $0.00.
2. The projected anticipated state fiscal effect during the current biennium of the proposed rule is: $0.00.
3. The projected net annualized fiscal impact on state funds of the proposed rule is: $0.00.
Initial Regulatory Flexibility Analysis
These proposed rules will be reviewed by the Department through its Small Business Review Advisory Committee to determine whether there will be an economic impact on a substantial number of small businesses, as defined in s. 227.114 (1) (a), Stats.
Copies of Rule and Contact Information
Copies of this proposed rule are available without cost upon request to:
Pamela Haack
Dept. of Regulation and Licensing
Office of Administrative Rules
1400 East Washington Ave., Room 171
P.O. Box 8935
Madison, WI 53708
Telephone: (608) 266-0495
Notice of Submission of Proposed Rules to the Presiding Officer of each House of the Legislature, Under S. 227.19, Stats.
Please check the Bulletin of Proceedings for further information on a particular rule.
Ch. DOC 303 - Relating to inmate conduct, inmate discipline and procedures for the imposition of discipline.
S. ETF 10.10 - Relating to election procedures for the Employee Trust Funds Board.
Financial Institutions-Securities
(CR 00-117):
SS. DFI-Sec 2.02, 3.03, 4.03, 4.06, 5.03, 5.05 and 7.02 - Relating to securities registration exemptions and to securities broker-dealer, agent, investment adviser and investment adviser representative licensing procedures, record-keeping requirements, and rule of conduct provisions.
Ch. HFS 120 - Relating to the collection, analysis and dissemination of health care information.
SS. Ins 23.30, 23.35 and 23.40 - Relating to standards for insurance marketed to fund prearranged funeral plans.
Chs. RL 30 to 35 - Relating to the regulation of private detectives, private detective agencies and private security personnel.
