DHS 75.59(9)(b)(b) Proposed research. All proposed research involving patients shall meet the requirements of s. 51.61 (1) (j), Stats., 45 CFR part 46 and this subsection.
DHS 75.59(9)(c)(c) Written consent. No patient may be subjected to any experimental diagnostic or treatment technique or to any other experimental intervention unless the patient gives written informed consent and the research and human rights committee established under s. 51.61 (4), Stats., has determined that adequate provisions are made to do all of the following:
DHS 75.59(9)(c)1.1. Protect the privacy of the patient.
DHS 75.59(9)(c)2.2. Protect the confidentiality of treatment records in accordance with s. 51.30, Stats., and ch. DHS 92.
DHS 75.59(9)(c)3.3. Ensure that no patient may be approached to participate in the research unless the patient’s participation is approved by the person responsible for the patient’s treatment plan.
DHS 75.59(10)(10)Medical services.
DHS 75.59(10)(a)(a) Primary medical services. An OTP may provide primary medical services for patients. The OTPs may use all FDA-approved medications and formulations for use in treating the patient with a substance use disorder.
DHS 75.59(10)(b)(b) Coordination with medical providers. For medical needs of a patient that exceed the scope of the service under this chapter, the service shall coordinate with appropriate medical providers.
DHS 75.59(10)(c)(c) Medical director responsibilities. The medical director of a service is responsible for all of the following:
DHS 75.59(10)(c)1.1. Overseeing all medical services provided by the service.
DHS 75.59(10)(c)2.2. Ensuring that the service complies with all federal, state, and local statutes, ordinances and regulations regarding medical treatment of an opioid use disorder.
DHS 75.59(10)(c)3.3. Ensuring that evidence of current physiological or psychological dependence, length of history of addiction and exceptions as granted by the SOTA to criteria for admission are documented in the patient’s case record before the initial dose is administered.
DHS 75.59(10)(c)4.4. Ensuring that a medical evaluation including a medical history and a physical examination have been completed for a patient before the initial dose is administered.
DHS 75.59(10)(c)5.5. Making a clinical judgment that treatment is medically justified for a person who has resided in a penal or chronic care institution for one month or longer, under the following conditions:
DHS 75.59(10)(c)5.a.a. The patient is admitted to treatment within 14 days before release or discharge or within 6 months after release without documented evidence to support findings of physiological dependence.
DHS 75.59(10)(c)5.b.b. The patient would be eligible for admission if he or she were not incarcerated or institutionalized before eligibility was established.
DHS 75.59(10)(c)5.c.c. The admitting service physician or service personnel supervised by the service physician records in the patient’s case record evidence of the person’s prior residence in a penal or chronic care institution and evidence of all other findings of addiction.
DHS 75.59(10)(c)5.d.d. The medical director signs and dates the recordings under subd. 5. c. before the initial dose is administered to the patient or within 48 hours after administration of the initial dose to the patient.
DHS 75.59(10)(c)6.6. Ensuring that appropriate laboratory studies have been performed and reviewed.
DHS 75.59(10)(c)7.7. Signing or countersigning all medical orders as required by federal or state law, including all of the following:
DHS 75.59(10)(c)7.a.a. Initial medical orders and all subsequent medical order changes.
DHS 75.59(10)(c)7.b.b. Approval of all take-home medications.
DHS 75.59(10)(c)7.c.c. Approval of all changes in frequency of take-home medication.
DHS 75.59(10)(c)7.d.d. Orders for additional take-home medication for an emergency situation.
DHS 75.59(10)(c)8.8. Reviewing and countersigning each treatment plan 4 times annually.
DHS 75.59(10)(c)9.9. Ensuring that justification is recorded in the patient’s case record for reducing the frequency of service visits for observed drug ingesting and providing additional take-home medication under exceptional circumstances or when there is physical disability, as well as when any medication is prescribed for physical health or psychiatric problems.
DHS 75.59(10)(c)10.10. Ensuring the correct amount of medication is administered or dispensed, and for recording, signing and dating each change in the dosage schedule in a patient’s case record.
DHS 75.59(10)(c)11.11. Ensuring that all physician orders are executed by the date given in the order or, if no date is specified, within 24 hours of the order being written.
DHS 75.59(10)(c)12.12. Having a valid DEA registration for prescribing, administering, or dispensing controlled substances, and having a DEA waiver if they or any other healthcare professional they supervise prescribes, administers, or dispenses partial opioid agonists.