INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection and methadone monitoring inspection conducted on March 22, 2022 by staff from the Department of Drug and Alcohol Programs, Bureau of Program Licensure. Based on the findings of the on-site inspection, PA Care, LLC d/b/a State College Medical 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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704.7(b) LICENSURE Counselor Qualifications
704.7. Qualifications for the position of counselor.
(a) Drug and alcohol treatment projects shall be staffed by counselors proportionate to the staff/client and counselor/client ratios listed in 704.12 (relating to full-time equivalent (FTE) maximum client/staff and client/counselor ratios).
(b) Each counselor shall meet at least one of the following groups of qualifications:
(1) Current licensure in this Commonwealth as a physician.
(2) A Master's Degree or above from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a clinical specialty in the human services) or other related field which includes a practicum in a health or human service agency, preferably in a drug and alcohol setting. If the practicum did not take place in a drug and alcohol setting, the individual's written training plan shall specifically address a plan to achieve counseling competency in chemical dependency issues.
(3) A Bachelor's Degree from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a clinical specialty in the human services) or other related field and 1 year of clinical experience (a minimum of 1,820 hours) in a health or human service agency, preferably in a drug and alcohol setting. If a person's experience did not take place in a drug and alcohol setting, the individual's written training plan shall specifically address a plan to achieve counseling competency in chemical dependency issues.
(4) An Associate Degree from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a clinical specialty in the human services) or other related field and 2 years of clinical experience (a minimum of 3,640 hours) in a health or human service agency, preferably in a drug and alcohol setting. If a person's experience was not in a drug and alcohol setting, the individual's written training plan shall specifically address a plan to achieve counseling competency in chemical dependency issues.
(5) Current licensure in this Commonwealth as a registered nurse and a degree from an accredited school of nursing and 1 year of counseling experience (a minimum of 1,820 hours) in a health or human service agency, preferably in a drug and alcohol setting. If a person's experience was not in a drug and alcohol setting, the individual's written training plan shall specifically address a plan to achieve counseling competency in chemical dependency issues.
(6) Full certification as an addictions counselor by a statewide certification body which is a member of a National certification body or certification by another state government's substance abuse counseling certification board.
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Observations
Based on one of eight employee personnel records reviewed, the facility failed to provide documentation of the qualification of counselors for employee # 6. Employee # 6 was hired as a counselor on September 13, 2021 and was still in this position at the time of the inspection. Based on a review of employee # 6's personal record and resume, there was no documentation of at least one year of clinical experience with a bachelor's degree. These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Should a candidate for counseling position be considered where his/her clinical experience is questionable, Executive Director will require that a written job description from prior job will be provided. If necessary, DDAP will be consulted to verify that experience is considered to be clinical in nature. This will be implemented immediately.
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709.28 (a) (1) LICENSURE Confidentiality
§ 709.28. Confidentiality.
(a) A written procedure shall be developed by the project director which shall comply with 4 Pa. Code § 255.5 (relating to projects and coordinating bodies: disclosure of client-oriented information). The procedure must include, but not be limited to:
(1) Confidentiality of client identity and records. Procedures must include a description of how the project plans to address security and release of electronic and paper records and identification of the person responsible for maintenance of client records.
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Observations
Based on the observation of patient dosing, the facility failed to ensure the confidentiality of client identity and records. Client ' s take-home bottles were being thrown away by the client into trash receptacle without the client's identity being removed from the take-home bottle labels.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
A black Sharpie marker will be kept at the dosing window. Patients will be required to black their names out before disposing of empty take home bottle. Should they refuse to do so, the bottle will be passed through the window to the dispensing nurse, where she will black the name out before disposing of bottle. The nurses will be trained on this on 4/12/2022
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709.28 (c) (4) LICENSURE Confidentiality
§ 709.28. Confidentiality.
(c) The project shall obtain an informed and voluntary consent from the client for the disclosure of information contained in the client record. The consent must be in writing and include, but not be limited to:
(4) Dated signature of client or guardian as provided for under 42 CFR 2.14(a) and (b) and 2.15 (relating to minor patients; and incompetent and deceased patients).
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Observations
Based on two of seven client records reviewed, the facility failed to obtain an informed and voluntary consent from the client for the disclosure of information contained in the client record to include a dated signature of the client.Client # 1 was admitted on September 18, 2017 and was still active at the time of the inspection. An informed and voluntary consent from the client for the disclosure to a funding source and emergency contact did not include a dated signature by the client but instead had "telehealth signature".Client # 4 was admitted on June 28, 2021 and was still active at the time of the inspection. An informed and voluntary consent from the client for the disclosure of information to a funding source was not signed by the client until February 28, 2022. Authorizations to the funding source occurred on June 28, 2021.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
All Signatures for consent to release information will obtained in person, with a physical signature. The "telehealth signature" on past consents that were obtained during COVID 19 telehealth work will be updated with a physical signature.
All intake consents will be reviewed by Clinical Supervisor to ensure that all necessary consents were obtained and completed at the time of intake and prior to the release of any information.
This will be reviewed with clinical staff on 4/13/2022 |
715.12(1-5) LICENSURE Informed patient consent
A narcotic treatment program shall obtain an informed, voluntary, written consent before an agent may be administered to the patient for either maintenance or detoxification treatment. The following shall appear on the patient consent form:
(1) That methadone and LAAM are narcotic drugs which can be harmful if taken without medical supervision.
(2) That methadone and LAAM are addictive medications and may, like other drugs used in medical practices, produce adverse results.
(3) That alternative methods of treatment exist.
(4) That the possible risks and complications of treatment have been explained to the patient.
(5) That methadone is transmitted to the unborn child and will cause physical dependence.
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Observations
Based on one of eight patient records reviewed, the facility failed to obtain an informed, voluntary, written consent before an agent being administered to the patient for either maintenance or detoxification treatment in patient record # 8.Patient # 8 was admitted on July 26, 2021 and was discharged on October 27, 2021. The patient was provided administration of an agent on July 26, 2021 however, the informed, voluntary, written consent was not signed or acknowledged by the patient until July 30, 2021.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Should a time sensitive document need to be corrected after completion, and in doing so, the document will need to be resigned (which will change the signature date), a note will be added to the record indicating that there was an error and the document was being corrected/res-signed. A print out of the original signed document will be printed and uploaded to the patient record before being corrected. This will be reviewed with clinical staff on 4/13/2022
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715.13(a) LICENSURE Patient identification
(a) A narcotic treatment program shall use a system for patient identification for the purpose of verifying the correct identity of a patient prior to administration of an agent.
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Observations
Based on the observation of patient dosing, the facility failed to verify the identity of a patient prior to the administration of an agent. Patients were approaching the dosing window and were not providing name, identification number, or dose information prior to agent being provided to the patient.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Nursing staff will be retrained on proper dosing procedures, which includes verbal confirmation of the patient's name, ID number, and dose information prior to passing the medication.
This will be reviewed with nursing staff on 4/12/2022
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715.17(c)(1)(i-vi)) LICENSURE Medication control
(c) A narcotic treatment program shall develop and implement written policies and procedures regarding the medications used by patients which shall include, at a minimum:
(1) Administration of medication.
(i) A narcotic treatment physician shall determine the patient 's initial and subsequent dose and schedule. The physician shall communicate the initial and subsequent dose and schedule to the person responsible for the administration of medication. Each medication order and dosage change shall be written and signed by the narcotic treatment physician.
(ii) An agent shall be administered or dispensed only by a practitioner licensed under the appropriate Federal and State laws to dispense agents to patients.
(iii) Only authorized staff and patients who are receiving medication shall be permitted in the dispensing area.
(iv) There shall be only one patient permitted at a dispensing station at any given time.
(v) Each patient shall be observed when ingesting the agent.
(vi) Administering and dispensing shall be conducted in a manner that protects the patient from disruption or annoyance from other individuals.
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Observations
Based on the observation of patient dosing, the facility failed to observe each patient while ingesting the agent. Patients were observed walking away from the window and turning away from staff while ingesting the agent and then throwing the cup it is provided in.These findings were reviewed with facility staff during the licensing process.This is a repeat citation from the May 19, 2021 annual licensing inspection.
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Plan of Correction
Nursing staff will be retrained on proper dosing procedures, which includes having the patient face the nurse at all times while ingesting the dose. Only when the dose is fully swallowed will the patient be permitted to turn to water cooler to obtain a sip of water.
This will be reviewed with nurses on 4/12/2022
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715.23(b)(4) LICENSURE Patient records
(b) Each patient file shall include the following information:
(4) The results of an initial intake physical examination.
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Observations
Based on four of four applicable patient records reviewed, the facility failed to include vital statistics as part of the initial intake physical examination in patient records # 3, 4, 5, and 8.Patient # 3 was admitted on November 8, 2021 and was still active at the time of the inspection. A physical was conducted on November 8, 2021 however, the patients vital statistics was not included in the physical.Patient # 4 was admitted on June 28, 2021 and was still active at the time of the inspection. A physical was conducted on June 28, 2021 however, the patients vital statistics was not included in the physical.Patient # 5 was admitted on July 16, 2021 and was discharged on September 30, 2021. A physical was conducted on July 12, 2021 however, the patients vital statistics was not included in the physical.Patient # 8 was admitted on July 26, 2021 and was discharged on October 27, 2021. A physical was conducted on July 26, 2021 however, the patients vital statistics was not included in the physical.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Medical Director and Physician Assistant will resume all aspects of the physical exam, including obtaining vitals. They will no longer defer "close contact" items due to concerns for exposure to COVID. Executive Director will monitor to ensure that physicals are complete.
This will be reviewed with staff on 4/13/2022
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709.93(a)(11) LICENSURE Client records
709.93. Client records.
(a) There shall be a complete client record on an individual which includes information relative to the client's involvement with the project. This shall include, but not be limited to, the following:
(11) Follow-up information.
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Observations
Based on two of four applicable client records reviewed, the facility failed to provide documentation of follow-up information in accordance with the facility policy and procedure manual. The facility policy and procedure manual indicate the first follow-up to the client will occur within seven days of discharge and the second within 30 days.Client # 5 was admitted on July 16, 2018 and discharged on September 30, 2021. There was no documentation of a follow-up in the client record.Client # 7 was admitted on July 10, 2019 and discharged on August 23, 2021. The first follow-up did not occur until October 15, 2021.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Pinnacle's Policy and Procedure manual regarding the timing of follow ups is being ammeneded to reflect the frequency of which Methsoft generates follow ups.
This is expected to be completed by 5/1/2022
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