INITIAL COMMENTS
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Based on the concerns arising from COVID-19, The Department of Drug and Alcohol Programs, Bureau of Program Licensure, has implemented temporary procedures for conducting an annual renewal inspection.
The inspection will be divided into two parts.
1, an abbreviated off-site inspection, will be conducted off site, and will require the submission of administrative information via email to a Licensing Specialist.
2, an abbreviated on-site inspection, will be conducted on-site at a later date and will include a review of client/patient records, and a physical plant inspection.
This report is a result of Part 2, an abbreviated on-site inspection, conducted on January 27, 2021 by staff from the Department of Drug and Alcohol Programs, Bureau of Program Licensure. Not all regulations were reviewed, the remainder of the regulations were reviewed during Part 1.
Based on the findings of Part 2, an abbreviated on-site inspection, Catholic Charities Diocese of Harrisburg, PA, Inc.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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709.28 (c) (2) 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:
(2) Specific information disclosed.
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Observations
Based on seven of eight client records reviewed, the facility failed to obtain an informed and voluntary consent from the client for the disclosure of information to include specific information disclosed in client records # 1, 2, 3, 4, 5 ,6, and 8.
Client # 1 was admitted on November 6, 2020 and was still active at the time of the inspection. An informed and voluntary consent from the client for the disclosure of information dated November 6, 2020 to a funding source allowed for the release of the ASAM Criteria and PCPC.
Client # 2 was admitted on September 18, 2020 and was still active at the time of the inspection. An informed and voluntary consent from the client for the disclosure of information dated September 30, 2020 to a funding source allowed for the release of the ASAM Criteria and PCPC. Also, an informed and voluntary consent from the client for the disclosure of information dated January 15, 2021 to an employer allowed for the release of "nature of the facility".
Client # 3 was admitted on September 21, 2020 and was still active at the time of the inspection. An informed and voluntary consent from the client for the disclosure of information dated September 21, 2020 to a funding source allowed for the release of the ASAM Criteria and PCPC.
Client # 4 was admitted on September 9, 2020 and was still active at the time of the inspection. An informed and voluntary consent from the client for the disclosure of information dated September 9, 2020 to a funding source allowed for the release of the ASAM Criteria and PCPC.
Client # 5 was admitted on August 17, 2020 and was discharged on January 8, 2021. An informed and voluntary consent from the client for the disclosure of information dated August 18, 2020 to a funding source allowed for the release of the ASAM Criteria and PCPC.
Client # 6 was admitted on May 4, 2020 and was discharged on September 19, 2021. An informed and voluntary consent from the client for the disclosure of information dated August 18, 2020 to a funding source allowed for the release of the ASAM Criteria and PCPC.
Client # 8 was admitted on February 28, 2020 and was discharged on March 11, 2021. An informed and voluntary consent from the client for the disclosure of information dated February 28, 2020 to a funding source allowed for the release of the ASAM Criteria and PCPC.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Program Director will train all staff on March 3,2021 on requiring two releases to be signed for a funding source going forward: one for the funding source in general which will stay within the 5 permitted areas of release and only release the minimum such as dates attended and the nature of the program. The second release will be for the funding source, but for Care Management who will review the clinical needs, ASAM, and referral coordination needs for case development and continuum of care. Additional releases will be placed in current client charts by March 5 which will identify Care Management and for the purpose of care coordination. |
709.32 (c) (3) (i) - (v) LICENSURE Medication control
§ 709.32. Medication control.
(3) Inspection of storage areas that ensures compliance with State and Federal laws and program policy. The policy must include, but not be limited to:
(i) What is to be verified through the inspection, who inspects, how often, but not less than quarterly, and in what manner it is to be recorded.
(ii) Disinfectants and drugs for external use are stored separately from oral and injectable drugs.
(iii) Drugs requiring special conditions for storage to insure stability are properly stored.
(iv) Outdated drugs are removed.
(v) Copies of drug-related regulations are available in appropriate areas.
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Observations
Based on a review of the facility inventory log, the facility failed to document an inspection of the medication storage areas for the months of June 2020 and October 2020. The last inventory documented occurred in February 2020.
Documentation must include what is to be verified through the inspection, who inspects, how often, but not less than quarterly, and in what manner it is to be recorded. Disinfectants and drugs for external use are stored separately from oral and injectable drugs. Drugs requiring special conditions for storage to ensure stability are properly stored. Outdated drugs are removed. Copies of drug-related regulations are available in appropriate areas for the months of June and October.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Program Director will re-write the agency policy so that not only a pharmacist will inspect medication storage, but also trained staff. This will allow the option to use a pharmacist or not. Current policy dictates only a pharmacist can complete the inspection. Due to the pandemic and the government shut down, no outsiders wanted or were permitted to visit the building to conduct the inspection. Staff will inspect and document these inspections going forward, except for when a pharmacist can do it. |