DHS 75.59(22)(a)6.e.e. A description of the service’s use of testing or analysis to detect substances and the purposes for which the results of testing or analysis are used as well as the frequency of use. DHS 75.59(22)(a)7.7. Documentation that there are adequate physical facilities to provide all necessary services. DHS 75.59(22)(a)8.8. Documentation that the service will have ready access to a comprehensive range of medical and rehabilitative services that will be available if needed, including the name, address, and a description of each hospital, institution, clinical laboratory or other facility available to provide the necessary services. DHS 75.59(22)(a)9.9. A list of persons working in the service who are licensed to administer or dispense narcotic drugs even if they are not responsible for administering or dispensing narcotic drugs. DHS 75.59(22)(b)(b) Approval of service sites. Only service sites approved by SAMHSA, the DEA and the SOTA may be used for treating persons with an opioid use disorder with a narcotic drug. DHS 75.59(22)(c)1.1. To operate a medication unit, a service shall apply to the department for approval to operate the medication unit. A separate approval is required for each medication unit to be operated by the service. A medication unit is established to facilitate the needs of patients who are stabilized on an optimal dosage level. The department shall approve a medication unit before it may begin operation. DHS 75.59(22)(c)2.2. Approval of a medication unit shall take into consideration the distribution of patients and other medication units in a geographic area. DHS 75.59(22)(c)3.3. If a service has its approval revoked, the approval of each medication unit operated by the service is automatically revoked. Revocation of the approval of a medication unit does not automatically affect the approval of the primary service. DHS 75.59(23)(a)(a) Service sponsor. A person who sponsors an OTP and any personnel responsible for a particular service shall agree in writing to adhere to all applicable requirements of this chapter and 21 CFR part 291 and 42 CFR part 2. DHS 75.59(23)(b)(b) Responsibilities. The service sponsor is responsible for all service staff and for all other service providers who work in the service at the primary facility or at other facilities or medication units. DHS 75.59(23)(c)(c) Written agreement. The service sponsor shall agree in writing to inform all service staff and all contracted service providers of the provisions of all pertinent state rules and federal regulations and shall monitor their activities to ensure that they comply with those rules and regulations. DHS 75.59(23)(d)(d) Replacement. The service shall notify the designated federal agency and SOTA within 5 business days after replacement of the service sponsor or medical director. DHS 75.59(23)(e)(e) Required services. OTPs shall provide adequate medical, counseling, vocational, educational, and other assessment and treatment services. These services must be available at the primary facility, except where the program sponsor has entered into a formal, documented agreement with a private or public agency, organization, practitioner, or institution to provide these services to patients enrolled in the OTP. The program sponsor, in any event, must be able to document that these services are fully and reasonably available to patients. This documentation must be provided to the department upon request. DHS 75.59(24)(24) Death reporting. An OTP shall report the death of a patient and deaths related to a patient’s medication to the SOTA within 5 business days after learning of the death. DHS 75.59(25)(a)(a) Policy and procedure. The service must develop and maintain a policy and procedure that requires the ongoing monitoring of the data from the prescription drug monitoring program (PDMP) for each patient. The policy and procedure must include how the service meets the requirements in par. (b). DHS 75.59(25)(b)(b) Requirements. If a medication used for the treatment of substance use disorder is administered or dispensed to a patient, the OTP shall be subject to the following requirements: DHS 75.59(25)(b)1.1. Upon admission a patient must be notified in writing that the medical director must monitor the PDMP to review the prescribed controlled drugs a client received. DHS 75.59(25)(b)2.2. The medical director or the medical director’s delegate must review the data from the PDMP before the patient is ordered any controlled substance including medications for maintenance therapy, and subsequent reviews of the PDMP data must occur at least every 90 days. DHS 75.59(25)(b)3.3. A copy of the PDMP data reviewed must be maintained in the client’s file. DHS 75.59(25)(b)4.4. When the PDMP data contains a recent history of multiple prescribers or multiple prescriptions for controlled substances, the physician’s review of the data and subsequent actions must be documented in the patient’s file within 72 hours and must contain the medical director’s determination of whether the prescriptions place the patient at risk of harm and the actions to be taken in response to the PDMP findings. The provider must conduct subsequent reviews of the PDMP in these circumstances on a monthly basis. DHS 75.59(25)(b)5.5. If at any time the medical director believes the use of the controlled substances places the patient at risk of harm, the service must seek the patient’s consent to discuss the patient’s opioid treatment with other prescribers and for other prescribers to disclose to the OTP’s medical director of the client’s condition that formed the basis of the other prescriptions. If the information is not obtained within 7 days, the medical director must document whether or not changes to the client’s medication dose or number of unsupervised use doses are necessary until the information is obtained. DHS 75.59(25m)(a)(a) Approval. To receive a guest dose, the patient must be enrolled in an OTP elsewhere in the state or country and be receiving the medication on a temporary basis because the client is not able to receive the medication at the program in which the client is enrolled. A patient may guest dose at a different OTP if prior approval is obtained from the patient’s medical director or program physician to receive services on a temporary basis from another OTP certified under this rule or by SAMHSA. The approval shall be noted in the patient’s record and shall include the following documentation: