INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection conducted on July 3, 2019 by staff from the Department of Drug and Alcohol Programs, Bureau of Quality Assurance for Prevention and Treatment. Based on the findings of the on-site inspection, Freedom Healthcare Services, LLC was found not to be in compliance with the applicable chapters of 28 PA Code which pertain to the facility. The following deficiencies were identified during this inspection:
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Plan of Correction
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709.22 (c) LICENSURE Governing Body
§ 709.22. Governing body.
(c) If a facility is publicly funded, the governing body shall make available to the public an annual report which includes, but is not limited to, a statement disclosing the names of officers, directors and principal shareholders, when applicable.
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Observations
The facility failed to document an annual report which included a statement disclosing the names of officers, directors and principal shareholders.
The 2018 Annual Report was reviewed on June 25-26, 2019 at the Bridgeville site. The report did not include the names of the officers, directors and/or principal shareholders.
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
709.22- F.H.S.'s annual report will include the names of officers, directors and/or principal shareholders. This information will be added to the report by July 30, 2019 by the Project Director. The Project Director will be responsible for including the names of the officers, directors and/or principal shareholders yearly. |
709.24 (a) (4) LICENSURE Treatment/rehabilitation management.
§ 709.24. Treatment/rehabilitation management.
(a) The governing body shall adopt a written plan for the coordination of client treatment and rehabilitation services which includes, but is not limited to:
(4) Written procedures for referral outlining cooperation with other service providers including, but not limited to, provisions for access to emergency services.
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Observations
The facility failed to document a written plan for the coordination of client treatment and rehabilitation services which included written procedures for referral outlining cooperation with other service providers and access to emergency services.
The policy and procedure manual was reviewed on June 25-26, 2019 at the Bridgeville site. The manual did not include a written plan for the coordination of services.
These findings were reviewed during the licensing process
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Plan of Correction
709.24 (a) (4) F.H.S. shall have written procedures for outlining cooperation with other service providers including but not limited to, provisions for access to emergency services. F.H.S. maintains a list of service providers through referral agreements. Provisions have been made for emergency services. The Clinical Director will be responsible for permanently adding 709.24 (a) (4) to the policies by July 22, 2019. |
715.10(f) LICENSURE Pregnant patients
(f) The narcotic treatment program shall ensure that each female patient is fully informed of the possible risk to her or her unborn child from continued use of illicit drugs and from use of, or withdrawal from a narcotic drug administered or dispensed by the program in comprehensive maintenance or detoxification treatment.
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Observations
The facility failed to ensure that each female patient was informed of the possible risks to her or her unborn child in three of three patient records.
Nine client records were reviewed on July 3, 2019. Six reviewed were receiving Suboxone. Three of the six were female patients.
There was no documentation in patient records # 1, 2 and 3 that the females were informed of the risks.
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
715.10 (f)- Consent to Treatment that is signed by all patients entering into treatment will inform female patients of the risk to her and her unborn child. The following information has been added to the consent. This information was added by the Clinical Director, who is also responsible for implementation of this updated form to occur July 22,2019.
Addendum for Women only
- To the best of my knowledge I am not pregnant at this time
- I have been informed by my physician that should I become pregnant while in treatment with buprenorphine/naloxone (Suboxone/Zubsolv), certain changes to my treatment plan will be recommended to protect my health and that of my unborn child.
- I accept my responsibility to inform my physician immediately should I become pregnant.
- Trying to quit cold turkey and go through a hard withdrawal from opiates, heroin or Buprenorphine is very risky. Opiate withdrawal is tough on the body, and the risk of miscarriage during a period of withdrawal is very high.
- Methadone Maintenance is the approved treatment recommended for opiate addicted pregnant females, and it will be offered to me but I may choose to voluntarily refuse it and elect to enter Subutex treatment instead
- Subutex is an addictive drug and may have harmful effects during and after my pregnancy
- Subutex can be harmful if taken without medical supervision
- Subutex/Suboxone treatment may need to continue throughout the duration of my pregnancy and possibly afterwards.
- Subutex crosses the placenta in a pregnant woman to the unborn child. It may cause physical dependency in the fetus and research is limited to the side effects it may cause on the fetus.
- I understand that the true effects of Subutex on pregnant women and their fetus have not been fully researched and or understood by the medical community. FHS makes no guarantee that taking Subutex will avoid serious side effects for myself or to my fetus during or after my pregnancy.
- I understand that after birth, the baby may show signs and symptoms of withdrawal, irritability, or other serious health concerns, that may be induced by or made possible due to my use of Subutex during my pregnancy.
- Taking any other drugs at the same time as Subutex may cause harm to myself and the fetus.
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715.15(b) LICENSURE Medication dosage
(b) The narcotic treatment physician shall determine the proper dosage level for a patient, except as otherwise provided in this section. If the narcotic treatment physician determining the initial dose is not the narcotic treatment physician who conducted the patient examination, the narcotic treatment physician shall consult with the narcotic treatment physician who performed the examination before determining the patient 's initial dose and schedule.
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Observations
The facility failed to ensure that the narcotic treatment physician determined the patient's subsequent dose and schedule in one of six records reviewed.
Nine client records were reviewed on July 3, 2019. Six reviewed were receiving Suboxone. In the record of patient #1, a nurse's note, dated January 28, 2019, indicated that the pharmacy called to state the patient was not authorized for 2 mg 3 SLQD and asked that it be switched to 1-4 mg 1 SLQD #7 & 1-2 mg SLQD #7. The nurse noted "I authorized ok to switch".
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
715.15 (b) The narcotic treatment physician will determine the proper dosage and authorize any changes in medication. Nurses or other staff members are not permitted to make any changes to medication. The Clinical Director will hold a meeting with all nursing staff in July 2019 reviewing this policy and the procedure for changes to medication. The Clinical Director will be responsible for assuring that any changes made to prescriptions are only done so by a physician. |