DHS 75.59(18)(f)6.6. A requirement that the service monitor the medication dose carefully throughout the pregnancy, moving rapidly to supply increased or split dose if it becomes necessary. DHS 75.59(18)(f)7.7. A recommendation that blood serum levels for methadone agonist be monitored once a trimester, and every three days for two weeks after delivery to ensure appropriate level of medication before and after delivery by the appropriate healthcare professional. The medical director shall request and review serum levels to determine whether any changes to treatment need to be made. DHS 75.59(18)(f)8.8. A requirement that the service shall offer on-site parenting education and training to all patients who are parents or shall refer interested patients to appropriate alternative services for the training; and, DHS 75.59(18)(g)(g) Pregnant patients that refuse prenatal services. Procedures for a patient who refuses prenatal service by the OTP or an outside provider, including that DHS 75.59(18)(g)1.1. The medical director or other authorized program physician shall note this in the clinical record. DHS 75.59(18)(g)2.2. Requiring that the patient be asked to sign a statement that says “I have been offered the opportunity for prenatal care by the opioid treatment program or by a referral to a prenatal clinic or by a referral to the physician of my choice. I refuse prenatal counseling by the opioid treatment program. I refuse to permit the opioid treatment program to refer me to a physician or prenatal clinic for prenatal services.” If the patient refuses to sign the statement, the medical director or other authorized program physician shall indicate in the signature block that “patient refused to sign” and affix their signature and the date on the statement. DHS 75.59(19)(a)(a) Tuberculosis - patients. An OTP shall screen patients for tuberculosis in a manner and frequency consistent with current CDC standard of practice. Tuberculosis treatment may be provided by referral to an appropriate public health agency or community medical service. DHS 75.59(19)(b)(b) Tuberculosis - staff. A service shall screen prospective new staff and ongoing staff for tuberculosis in a manner and frequency consistent with current CDC standard of practice. DHS 75.59(19)(c)(c) Screening. A service shall screen all patients via a risk factor assessment at admission and annually thereafter for viral hepatitis and sexually transmitted diseases and shall ensure that any necessary medical follow-up occurs, either on site or through referral to community medical services. Positive screening results or disease risks must have a management plan that is seen through to completion regardless of whether this is accomplished via services provided directly on-site or by referral and care coordination. DHS 75.59(19)(d)(d) Hepatitis B. A service shall ensure that all clinical staff have been immunized against hepatitis B. Documentation of refusal to be immunized shall be entered in the staff member’s personnel record. DHS 75.59(20)(20) Facility. A service shall provide a setting that is conducive to rehabilitation of the patients and that meets all of the following requirements: DHS 75.59(20)(a)(a) Cleanliness. The waiting area, restrooms, dosing areas, and counseling offices shall be clean. DHS 75.59(20)(b)(b) Ventilation and lighting. Waiting areas, dosing stations and all other areas for patients shall be provided with adequate ventilation and lighting. DHS 75.59(20)(c)(c) Confidentiality. Dosing stations and adjacent areas shall be kept sanitary and ensure privacy and confidentiality. DHS 75.59(20)(d)(d) Sound proofing. Patient counseling rooms, physical examination rooms and other rooms or areas in the facility that are used to meet with patients shall have adequate sound proofing so that normal conversations will be confidential. DHS 75.59(20)(e)(e) Security. Adequate security shall be provided inside and outside the facility for the safety of the patients and to prevent loitering and illegal activities. DHS 75.59(20)(f)(f) Restrooms. Separate toilet facilities shall be provided for patient and staff use. DHS 75.59(20)(g)(g) Accessibility. The facility and areas within the facility shall be accessible to persons with physical disabilities. DHS 75.59(20)(h)(h) Physical environment. The physical environment within the facility shall be conducive to promoting improved functioning and a drug-free lifestyle. DHS 75.59(20)(i)(i) Facility regulations. Meet all local, state, and federal requirements. DHS 75.59(20)(j)(j) Annual inspection. Post an annual inspection report from appropriate officials. DHS 75.59(20)(k)(k) First aid kit. The facility shall maintain stocked first aid kits for emergency use including naloxone. DHS 75.59(20)(L)(L) Disaster plan. Have a disaster plan and facility evacuation plan that is updated annually and posted in an area accessible to staff and patients. DHS 75.59(20)(m)(m) Accreditation body. The facility shall meet physical facility standards established by the services accreditation body. DHS 75.59(21)(a)(a) Staff member responsibility. Each staff member of the OTP is responsible for being alert to potential diversion of medication by patients and staff. DHS 75.59(21)(b)(b) Minimize diversion. Service staff shall take all of the following measures to minimize diversion: DHS 75.59(21)(b)1.1. Require that doses of Methadone shall be dispensed only in liquid form. Other FDA approved medications are allowable in their FDA-approved formats as determined by the medical staff. DHS 75.59(21)(b)2.2. Require that each take-home bottle or other form of medication packaging used for medication-assisted treatment dispensed have a label that contains the following information: DHS 75.59(21)(b)2.g.g. A warning that reads “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” DHS 75.59(21)(b)3.3. Require a patient to return all empty take-home bottles on the patient’s next day of service attendance following take-home dosing. Clinical staff shall examine the bottles to ensure that the bottles are received from the appropriate patient and in an intact state. DHS 75.59(21)(b)4.4. The service may discontinue take-home medications for patients who fail to return empty take-home bottles in the prescribed manner. If upon review of take home medication it is determined that medication is missing and cannot reasonably be accounted for the service shall discontinue take home medication. DHS 75.59(21)(c)(c) Counselor responsibility. If a service receives reliable information that a patient is diverting medication, the patient’s primary counselor shall immediately discuss the problem with the patient. DHS 75.59(21)(d)(d) Revocation of take homes. Based on information provided by the patient or continuing reports of diversion, a service may revoke take-home privileges of the patient. DHS 75.59(21)(e)(e) State revocation of take-homes. The SOTA may, based on reports of diversion, revoke take-home privileges, exceptions or exemptions granted to or by the service for all patients. If a service agency disagrees with the SOTA’s decision, it may provide additional relevant information to the SOTA, request that SOTA review the revocation decision, or file a request for review and reconsideration of the revocation decision with the Department’s Division of Care and Treatment Services. DHS 75.59(21)(f)(f) State revocation of a services ability to grant take-homes. The SOTA may revoke the authority of an OTP to grant take-home privileges when the service cannot demonstrate that all requirements have been met in granting take-home privileges to patients. If a service agency disagrees with the SOTA’s decision, it may provide additional relevant information to the SOTA, request that SOTA review the revocation decision, or file a request for review and reconsideration of the revocation decision with the Department’s Division of Care and Treatment Services. DHS 75.59(21)(g)(g) Loitering. An OTP shall have a written policy to discourage the congregation of patients at a location inside or outside the service facility for non-programmatic reasons, and shall post that policy in the facility. DHS 75.59(21)(h)(h) Callbacks. The diversion control plan shall contain, at a minimum, a random call-back program with mandatory compliance that includes: DHS 75.59(21)(h)1.1. Call-backs shall be in addition to the regular schedule of clinic visits. DHS 75.59(21)(h)2.2. Each patient receiving two or more take-home medications shall be called back randomly but no less frequently than on a quarterly basis. DHS 75.59(21)(h)3.3. Upon call back a service recipient shall report to the clinic the next day within dosing hours, with all take-home medications. The quantity and integrity of packaging shall be verified for all doses. If a take-home dose shows evidence of tampering, the clinic shall impose uniform sanctions for violating take-home policies, including sanctions for a patient’s tampering with a take-home dose. DHS 75.59(21)(h)4.4. Patients shall be informed of consequences for violating the take-home policy. DHS 75.59(21)(h)5.5. The service shall maintain individual call-back results in the patient record. DHS 75.59(22)(a)(a) Approval of primary service. An applicant for approval to operate an OTP in Wisconsin with the intent of administering or dispensing medication for the treatment of an opioid use disorder shall submit all of the following to the SOTA: DHS 75.59(22)(a)2.2. A copy of the request for registration with the DEA for the use of narcotic medications in the treatment of opiate addiction. DHS 75.59(22)(a)3.3. A narrative description of the treatment services that will be provided in addition to medication. DHS 75.59(22)(a)6.6. A copy of the policy and procedures manual for the service, detailing the operation of the service as follows: 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:
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Department of Health Services (DHS)
Chs. DHS 30-100; Community Services
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