Wisconsin Legislature: DHS 75.59(17)(a)

3. The bathroom used for collection shall be clean and always supplied with soap, paper towels, and toilet articles.

4. Specimens shall be collected in a manner that minimizes the possibility of falsification.

5. When service staff must directly observe the collection of a urine sample, this task shall be done with respect for patient privacy.

(d) Response to positive test results.

1. Service staff shall discuss positive test results with the patient within one week of the sample being taken by the service and shall document them in the patient’s case record with the patient’s response noted.

2. The service shall provide counseling, casework, medical review and other interventions when continued use of substances is identified.

3. When there is a positive test result, service staff shall allow sufficient time before re-testing to prevent a second positive test result from the same substance use.

4. Service staff confronted with a patient’s denial of substance use shall consider the possibility of a false positive test. Patients shall be given the opportunity to challenge a test result by having the sample given retested.

5. Service staff shall review a patient’s dosage and shall counsel the patient regarding their use when test reports are positive for morphine-like substances and negative for the FDA-approved treatment.

(e) Frequency of drug screens.

1. The frequency that a service shall require drug screening shall be clinically appropriate for each patient, allow for a rapid response to the possibility of relapse, and occur at least on a monthly basis.

2. A service shall arrange for drug screens with sufficient frequency so that they can be used to assist in making informed decisions about take-home privileges.

(16) Treatment duration and retention.

(a) Patient retention. Patient retention shall be a major objective of treatment. The service shall do all of the following to retain patients for the planned course of treatment:

1. Render treatment in a way that is least disruptive to the patient’s travel, work, educational activities, ability to use supportive services, and family life.

2. Determine hours based on patient needs.

3. Ensure that a patient has ready access to clinical staff, particularly to the patient’s primary counselor.

4. Ensure that clinical staff are adequately trained and are sensitive to gender- and culture-specific issues.

5. Provide services that incorporate evidence based practice standards for substance use treatment.

6. Ensure that patients receive adequate doses of medication based on their individual needs.

7. Ensure that all clinical staff are accepting of medication-assisted treatment.

8. Ensure that patients understand that they are responsible for complying with all aspects of their treatment, including participating in counseling sessions.

(b) Effort to retain patients. Since treatment duration and retention are directly correlated to rehabilitation success, a service shall make a concerted effort to retain patients within the first year following admission. Evidence of this concerted effort shall include written documentation of all of the following:

1. Whether the patient continues to benefit from the treatment.

2. Whether the risk of relapse is discontinued.

3. Whether the patient exhibits no side effects from the treatment.

4. Whether continued treatment is medically necessary in the professional judgement of the service physician.

(c) Referral for further treatment. A service shall refer a patient discharged from the service to a more suitable treatment modality when further treatment is required or is requested by the patient and cannot be provided by the service.

(17) Multiple substance use and co-occurring treatment.

(a) Assessment. A service shall assess a prospective patient for admission during the admission process to distinguish substance use, abuse and dependence, and determine patterns of other substance use and self-reported etiologies, including non-prescription, non-therapeutic and prescribed therapeutic use and mental health problems.

(b) Multiple substance use patients.

1. A service shall provide a variety of services that support cessation by a patient of alcohol and prescription and non-prescription substance use as the desired goal.

2. Service objectives shall indicate that abstinence by a patient from alcohol and prescription and non-prescription substance use should extend for increasing periods, progress toward long-term abstinence and be associated with improved life functioning and well-being.

3. Service staff shall instruct multiple substance use patients about their vulnerabilities to cross-tolerance, drug-to-drug interaction and potentiation and the risk of dependency substitution associated with self-medication.

1. A service shall have the ability to provide concurrent treatment for a patient diagnosed with both a mental health disorder and a substance use disorder. The service shall arrange for coordination of treatment options and for provision of a continuum of care across the boundaries of physical sites, services and outside treatment referral sources.

2. When a co-occurring disorder exists, a service shall develop with the patient a treatment plan that integrates measures for treating all alcohol, drug and mental health problems. For the treatment of a patient with co-occurring disorders, the service shall arrange for a mental health professional to help develop the treatment plan and provide ongoing treatment services. The mental health professional shall be available either as an employee of the service or through a written agreement. The mental health professional shall complete a mental health assessment within 3 business days of admission.

(18) Pregnancy. Each OTP shall have written procedures for pregnant patients including the following minimum standards:

(a) Risks. A requirement that each patient admitted to the OTP be informed of the possible risks to herself or to her unborn child from the use of medication-assisted treatment, and be informed that abrupt withdrawal from these medications may adversely affect the unborn child.

(b) Medication-assisted treatment. A requirement that a pregnant patient who has a documented past opioid dependency and who may be in direct jeopardy of returning to opioid dependency with all of its attendant dangers during pregnancy, be informed that they may be placed on a medication-assisted treatment regimen. The service shall also provide a statement that for such pregnant women, evidence of current physiological dependence on opioid drugs is not needed if the medical director or other authorized program physician certifies the pregnancy, determines and documents that the woman may resort to the use of opioid drugs, and determines that medication-assisted treatment is justified in their clinical opinion.

(c) Approval of admission. A requirement that the admission of each pregnant patient to an OTP be approved by the medical director or other authorized program physician prior to admitting the patient to the program.

(d) Coordination of care. A requirement that OTPs develop a form for release of information between themselves and the healthcare provider in care of obstetrical care. This voluntary form should be offered to all pregnant patients for coordination of medical care.

(e) Education. A requirement that each pregnant patient be given education on recognizing the symptoms of neonatal abstinence syndrome near the time of delivery.

(f) Prenatal care. Procedures for prenatal care that include:

1. Providing prenatal care by the service or by referral to an appropriate health care provider. If appropriate prenatal care is neither available on-site or by referral, or if the pregnant patient cannot afford care or refuses prenatal care services on-site or by referral, an OTP, at a minimum, should offer basic prenatal instruction on maternal, physical, and dietary care as part of its counseling services. If a pregnant patient refuses the offered on-site or referred prenatal services, the medical director or treating physician must use informed consent procedures to have the patient formally acknowledge, in writing, refusal of these services.

2. A requirement that if a patient is referred to prenatal care outside the agency, the name, address and telephone number of the health care provider shall be recorded in the patient’s clinical record.

3. A requirement that if prenatal care is provided by the OTP, the clinical record shall include documentation to reflect services provided.

4. A requirement that if a patient is referred outside of the agency for prenatal services, the provider to whom she has been referred shall be notified that she is on medication-assisted treatment; however, such notice shall only be given after the patient has signed a release of information.

5. A requirement that any changes in medication-assisted treatment be communicated to the appropriate healthcare provider if the woman has prenatal care outside the agency if the patient allows communication among providers.

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.

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.

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,

(g) Pregnant patients that refuse prenatal services. Procedures for a patient who refuses prenatal service by the OTP or an outside provider, including that

1. The medical director or other authorized program physician shall note this in the clinical record.

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.

(19) Communicable disease.

(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.

(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.

(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.

(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.

(20) Facility. A service shall provide a setting that is conducive to rehabilitation of the patients and that meets all of the following requirements:

(a) Cleanliness. The waiting area, restrooms, dosing areas, and counseling offices shall be clean.

(b) Ventilation and lighting. Waiting areas, dosing stations and all other areas for patients shall be provided with adequate ventilation and lighting.

(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.

(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.

(f) Restrooms. Separate toilet facilities shall be provided for patient and staff use.

(g) Accessibility. The facility and areas within the facility shall be accessible to persons with physical disabilities.

(h) Physical environment. The physical environment within the facility shall be conducive to promoting improved functioning and a drug-free lifestyle.

(i) Facility regulations. Meet all local, state, and federal requirements.

(j) Annual inspection. Post an annual inspection report from appropriate officials.

(k) First aid kit. The facility shall maintain stocked first aid kits for emergency use including naloxone.

(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.

(m) Accreditation body. The facility shall meet physical facility standards established by the services accreditation body.

(21) Diversion control.

(a) Staff member responsibility. Each staff member of the OTP is responsible for being alert to potential diversion of medication by patients and staff.

(b) Minimize diversion. Service staff shall take all of the following measures to minimize diversion:

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.

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:

a. The OTPs name, address and telephone number.

b. The name of the patient.

c. The name of service physician prescribing the medication.

d. The name of the medication.

e. The dosing instructions and schedule.

f. The date that the take-home dose was prepared.

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.”

h. Any other requirements pursuant to rules adopted by the department.

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.

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.