c) The medical director shall also develop a format to ensure that the following information is collected from all patients as part of Dimension 1, 2, and 3 ASAM assessment inquiry:

1. 1) Primary complaint per patient;
2. 2) Date of the last physical exam and identification of the patient's primary care physician;
3. 3) History of any SUD;
4. 4) History of any withdrawal symptoms;
5. 5) Evidence and/or history of any infectious or communicable disease, including current symptoms;
6. 6) History of concurrent medical symptoms, complications, or conditions, including sexual activity and risk for pregnancy or other sexually transmitted infections (STIs);
7. 7) Determination of the need to verify pregnancy status, as applicable;
8. 8) History of concurrent psychiatric symptoms, complications, or conditions, including suicide or homicide potential;
9. 9) History of trauma, including physical, verbal, emotional, and sexual;
10. 10) Hospitalizations; and
11. 11) Medications currently prescribed and any allergies.

d) Physical Examinations: The medical director shall develop protocol and authorize procedures for any physical examination, the components of the physical examination, and the professional requirements for any individual who will conduct physical examinations and review laboratory results, in the same facility, under the supervision of the medical director.

1. 1) Physical examinations and associated laboratory tests are required during or after admission, and every 12 months thereafter, for any patient who will be prescribed Methadone or other medications for MAR. For any patient receiving MAR from another provider other than the licensed organization, another physical is not required but documentation of the previous and ongoing physicals shall be available for review in the patient record.
2. 2) Physical examinations are not required for patients in Level 1, 2, or 3.1 care unless they are receiving MAR or unless required after medical review. If required, the physical shall be completed within 7 calendar days after admission unless a different timeframe is determined by the medical director.
3. 3) Physical examinations are required for any patient in Level 3.2, 3.5, or 3.7. Such physical examinations shall be part of the initial treatment plan and shall be completed within 24 hours after admission if the patient is pregnant and/or on MAR or in Level 3.2 or 3.7 withdrawal management. All other patients shall receive a physical within 72 hours after admission, unless a different timeframe is determined by the medical director. Patients may provide documentation of a physical examination completed within 30 calendar days prior to admission for review and acceptance by the medical director in lieu of this requirement.
4. 4) Each patient shall receive a referral and contact information for any medical, surgical, obstetric, prenatal, or psychiatric treatment deemed necessary as a result of the physical examination. Documentation of this referral shall be included in the patient record.

f) Medication Dispensary Services: The organization shall follow the policy and procedures developed by the medical director, for any patient in Level 3 care, relative to the administration of all prescription and non-prescription medication and shall ensure that patients are not denied access to medications during their SUD treatment. Medication dispensary services shall be in accordance with the Medical Practice Act of 1987 [225 ILCS 60]; the Pharmacy Practice Act [225 ILCS 85]; the Illinois Controlled Substances Act [720 ILCS 570]; the Special Packaging of Household Substances for Protection of Children, commonly known as the Poison Prevention Packaging Act (15 U.S.C. 1471); Substances Requiring Special Packaging (16 CFR 1700.14); and rules and regulations of the U.S. Drug Enforcement Administration (21 CFR 1300). The administration or dispensing of patient-owned medications during any Level 3 care service shall comply with the following:

1. 1) Patients shall surrender all medications upon admission;
2. 2) Medications brought by patients shall not be administered unless they can be identified;
3. 3) Self-administration of medication shall be permitted and observed;
4. 4) Self-administration of medication shall be documented and include the date, time, dosage of all medications, and signature of the staff person who observed the self-administration;
5. 5) In those cases where patients are unable to self-medicate, medication shall be dispensed or administered as specified by the medical director;
6. 6) All medications surrendered by the patient at admission that are not used shall be packaged, sealed, stored, or disposed of in accordance with established procedure, or if approved by the medical director, returned to the patient at the time of discharge; and
7. 7) Medications for minors who are in residence with patients shall be reviewed by the medical director or physician, nurse practitioner, advanced practice registered nurse or physician assistant working under their supervision. Permission to keep medication at bedside in their possession and to self-administer to a dependent child shall be given by the medical director or physician, nurse practitioner, advanced practice registered nurse or physician assistant working under their supervision.

g) Opioid Treatment Program (OTP): DHS/SUPR authorizes, regulates, and inspects organizations that also provide Methadone for patients diagnosed with an opioid use disorder (OUD). These organizations shall meet the following requirements:

1. 1) Satisfy all applicable requirements under 42 CFR 8 (www.samhsa.gov/medication-assisted-treatment) and all Federal Drug Enforcement Administration (DEA) requirements (https://www.deadiversion.usdoj.gov/) specific to the treatment of an OUD and the delivery, storage, security, and accountability of Methadone. Documentation of SAMHSA approval, DEA registration, and accreditation must be maintained on-site and available for DHS/SUPR review on demand. The organization shall notify DHS/SUPR in writing immediately upon any change or delay in accreditation approval status. DHS/SUPR authorization for Methadone use in any level of care is considered conditional for a maximum of one year or until confirmation of the applicable accreditation approval and authorization from the DEA is received by DHS/SUPR. If the organization is not able to achieve full compliance within the maximum one-year period, authorization to continue admissions will be suspended and the licensed organization may be subject to additional sanctions as specified in Section 2060.396;
2. 2) Forward to DHS/SUPR as the State Methadone Authority, copies of all Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Treatment (CSAT)-approved accrediting body survey reports, organization responses to these surveys, accrediting body responses and subsequent documentation of accrediting body awards or denials. DHS/SUPR shall review these documents and require corrective action as specified in Section 2060.396;

3. 3) Be responsible for the following if automated dispensing machines are used:

   1. A) Calibrating the machine on a weekly basis according to manufacturer procedures/specifications;
   2. B) Limiting access to medical order entries (changes in dosage, pickup orders) to licensed physicians only;
   3. C) Printing daily activity reports for patient dispensing, bottle control, and no shows;
   4. D) Taking physical drug inventories and updating the machines daily; and
   5. E) Printing all reports when requested by DHS/SUPR;
4. 4) Organizations who treat patients receiving Methadone in any level of care shall be subject to all applicable clinical treatment requirements specified in this Subpart and in 42 CFR 8.12(f)(5)(i) (Counseling Services); however, patients who are reluctant or who refuse to participate in clinical services shall not be denied Methadone while the organization simultaneously attempts to provide motivational or engagement treatment strategies;
5. 5) Each organization shall maintain a current Diversion Control Plan (DCP) as part of its quality improvement plan referenced in Section 2060.340(6)(c). At a minimum, the DCP shall include specific measures to reduce the possibility of diversion of controlled substances from legitimate treatment use and assign specific responsibility to the medical director and staff for implementation. Organizations are responsible for testing each component of the DCP and documenting the results at least quarterly. The DCP shall incorporate a "Daily/Weekly Medication Accounting Sheet" and an "Exception Medication Record" which may be maintained electronically. Any other reports required by the DEA (21 CFR 1300 et seq.), whether manual or automated, must be printed and signed daily by dispensing staff;
6. 6) Each organization shall require OTP patients to undergo a complete, fully-documented physical examination by a physician, nurse practitioner, or physician assistant before admission to the OTP and ingestion of the initial dose of Methadone; however, a physician must review and sign off on all physicals and see the patient prior to admission and administration of the first dose. The physician is the only staff member who can order Methadone treatment and assign the medication dose. The physical examination shall cover major organ systems and the patient's overall health status and shall document indications of infectious disease, pulmonary, liver, and cardiac abnormalities, vital signs, general appearance of head, eyes, ear, nose, throat, chest, abdomen, extremities, and skin and physical evidence of drug use, and a medical judgment of the extent of the opioid use disorder. Women shall receive a pregnancy test at the organization site or by referral to a health center. The results of all tests, laboratory work, and other processes related to the initial medical examination shall be reviewed with the patient and documented in the patient record within fourteen days of admission. Physical exams and associated laboratory tests are required every 12 months for all OTP patients;
7. 7) The organization shall ensure that the initial dose of Methadone does not exceed 30 milligrams and the total dose for the first day does not exceed 40 milligrams unless the medical director documents in the patient's record that a 40 milligrams dose was not enough to suppress opiate abstinence symptoms;
8. 8) A recipient identification number (RIN) must be obtained from DHS/SUPR for each OTP patient which shall be used in all circumstances requiring patient identification (e.g., medication logs, take-home bottles, exception requests, and general correspondence);
9. 9) A minimum of eight random toxicology tests per year, including the initial toxicology test shall be administered to each patient (42 CFR 8). Organizations shall ensure that a result from an initial toxicology test that is negative for opioids is not exclusionary criteria for admission to OTP and also not the sole determinant of an OUD diagnosis. Organizations shall also ensure that toxicology tests that are positive for opioids or other substances are addressed promptly with patients by clinicians and as a part of continued risk assessment and treatment planning;
10. 10) Each organization shall submit opiate dispensing information on a weekly basis;

11. 11) Each organization shall have a policy regarding take-home medication in accordance with SAMHSA regulations and exceptions under 42 CFR 8. The organization shall request and have appropriate CSAT approvals for any policy exceptions to regulations as well as policies regarding supplies of take-home medication. An exception may be made to the policy regarding take-home medication which would permit a temporary or permanently reduced attendance schedule, if in the reasonable clinical judgement of the physician:

    1. A) The patient has been found to be responsible in handling narcotic drugs and has a physical disability which interferes with the patient's ability to conform to the applicable mandatory attendance schedule; or
    2. B) The patient has been found to be responsible in handling narcotic drugs and there are exceptional circumstances such as illness or infectious disease, family crises, travel, or other hardship;
12. 12) The rationale for each exception pursuant to subsection (g)(11) and the physician's approval must be documented by signature and date in the patient record.
13. 13) Each organization shall have policies and procedures regarding staff and patient safety during all hours of operation. Organizations utilizing security guards or metal detectors shall have specific policies and procedures relative to their operation or scope of responsibilities.