INITIAL COMMENTS
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This report is a result of an on-site licensure renewal and buprenorphine monitoring inspection conducted on July 16, 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, Warren General Hospital 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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715.9(a)(1) LICENSURE Intake
(a) Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall:
(1) Verify that the individual has reached 18 years of age.
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Observations
The facility failed to document the individual had reached 18 years of age prior to administration of a narcotic agent in one of four patient records reviewed on July 16, 2019.
Patient # 2 was admitted May 7, 2019 and discharged May 14, 2019. Buprenorphine was administered to patient # 2 on May 7, 2019.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The facility director will update the facility's policy and train staff on the need to obtain appropriate documentation such as a drivers license to verify the patient is at lease 18 years of age prior to the administration of Buprenorphine.
The lead Drug and Alcohol counselor will ensure the deficiency does not reoccur by reviewing patient's records to ensure the patient's age was verified and documented in the record. |
715.9(a)(2) LICENSURE Intake
(a) Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall:
(2) Verify the individual 's identity, including name, address, date of birth, emergency contact and other identifying data.
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Observations
The facility failed to document verification of the individual's identity including name, address and date of birth prior to administration of a narcotic agent in one of four patient records reviewed on July 16, 2019.
Patient # 2 was admitted May 7, 2019 and discharged May 14, 2019. Buprenorphine was administered to patient # 2 on May 7, 2019.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Facility director and lead D&A counselor will update admission policy that details the need to verify individuals identity including drivers license, name, address, and date of birth.
Staff will be trained on the updated policy and the lead D&A counselor will ensure the patients identity is reflected in the patients record prior to the administration of Buprenorphine. |
715.9(a)(4) LICENSURE Intake
(a) Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall:
(4) Have a narcotic treatment physician make a face-to-face determination of whether an individual is currently physiologically dependent upon a narcotic drug and has been physiologically dependent for at least 1 year prior to admission for maintenance treatment. The narcotic treatment physician shall document in the patient 's record the basis for the determination of current dependency and evidence of a 1 year history of addiction.
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Observations
The facility's physician failed to document a face-to-face determination of whether an individual was currently physiologically dependent upon a narcotic drug and the basis for that determination prior to administration of an agent in one of four patient records reviewed on July 16, 2019.
Patient # 2 was admitted May 7, 2019 and discharged May 14, 2019. Buprenorphine was administered to patient # 2 on May 7, 2019.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Facility director and Lead Drug and Alcohol Counselor will schedule a meeting with the physician team prior to 8/31/2019 and review the need for a physician to perform a face to face to determine on whether an individual was currently physiologically dependent upon a narcotic drug and the basis for that determination prior to administration of Buprenorphine.
The lead D&A counselor will preform an audit on all patients who were administered Buprenorphine for 6 months with 100% compliance. |
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 document that each female patient was 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 by the the program in detoxification treatment in one of four patient records reviewed on July 16, 2019.
Patient # 4 was admitted September 29, 2018 and discharged October 3, 2018.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Facility director and lead D&A Counselor will develop a fact sheet explaining the risk of using drugs while pregnant and the dangers of continued use of illicit drugs, as well as, Buprenorphine for all female patients who are administered Buprenorphine by the facility. This fact sheet will be given prior to administration of medication.
Facility director and D&A Counselor will audit all female charts who receive Buprenorphine for 6 months at 100% compliance. |
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
The facility failed to document an informed, voluntary, written consent was obtained from the patient that included all of the required components prior to administration of an agent for detoxification treatment in four of four patient records reviewed on July 16, 2019.
Patient # 1 was admitted October 29, 2018 and discharged November 2, 2018. Buprenorphine was administered to patient # 1 on October 29, 2018.
Patient # 2 was admitted May 7, 2019 and discharged May 14, 2019. Buprenorphine was administered to patient # 2 on May 7, 2019.
Patient # 3 was admitted November 4, 2018 and discharged November 8, 2018. Buprenorphine was administered to patient # 3 on November 4, 2018.
Patient # 4 was admitted September 29, 2018 and discharged October 3, 2018. Buprenorphine was administered to patient # 4 on September 29, 2018.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Facility director and lead D&A Counselor will develop a consent form containing the required regulatory components for receiving Buprenorphine.
The lead counselor will train staff on the use of the consent form. The lead counselor will review patient records to ensure consent form is being signed by the patient prior to the administration of Buprenorphine. |
715.13(b) LICENSURE Patient identification
(b) A narcotic treatment program shall maintain onsite a photograph of each patient which includes the patient 's name and birth date. The narcotic treatment program shall update the photograph every 3 years.
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Observations
The facility failed to document an onsite photograph of each patient which includes the patient's name and birth date in one of four patient records reviewed on July 16, 2019.
Patient # 2 was admitted May 7, 2019 and discharged May 14, 2019. No photograph was documented for patient # 2.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Facility director and lead D&A Counselor will train staff regarding the necessity to obtain a photo with the patient's name/date of birth during the intake process. The lead counselor will audit charts of patients receiving Buprenorphine for photograph being scanned into medical record, for 6 months with 100% compliance. |
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's physician failed to document a consult with the physician assistant who performed the examination before determining the patient's initial dose and schedule in one of four patient records reviewed on July 16, 2019.
Patient # 2 was admitted May 7, 2019 and discharged May 14, 2019. Buprenorphine was ordered by the physician for patient # 2 on May 7, 2019.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Facility director and lead D&A Counselor will have a meeting with all providers regarding regulation 715.15. Facility director and lead counselor will train physicians regarding the necessity of a documented consult between the physician that completed the physical and the physician that will order the first dose of Buprenorphine.
The lead counselor will audit charts for 100% compliance for 6 months. |
715.26(b) LICENSURE Security
(b) Each narcotic treatment program shall provide the Department with a specific plan describing the efforts it will make to avoid disruption of the community by its patients and the actions it will take to assure responsiveness to the community. This plan shall designate a staff member to act as community liaison.
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Observations
The facility failed to document a specific plan describing the efforts it will make to avoid disruption of the community by the patients and the actions it will take to assure responsiveness to the community and the designation of a staff member to act as community liaison based on a review of the facility's policy and procedure manual on July 16, 2019.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Facility director and D&A counselor will develop a policy to specify the plan describing efforts to keep the community safe from disruption and specify a staff member to be the community liaison. |
715.28(a)(1-10) LICENSURE Unusual incidents
(a) A narcotic treatment program shall develop and implement policies and procedures to respond to the following unusual incidents:
(1) Physical assault by a patient.
(2) Inappropriate behavior by a patient causing disruption to the narcotic treatment program.
(3) Selling of drugs on the premises.
(4) Complaints of patient abuse (physical, verbal, sexual and emotional).
(5) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.
(6) Significant disruption of services due to disaster such as fire, storm, flood or other occurrence.
(7) Incident with potential for negative community reaction or which the facility director believes may lead to community concern.
(8) Theft, burglary, break-in or similar incident at the facility.
(9) Drug related hospitalization of a patient.
(10) Other unusual incidents the narcotic treatment program believes should be documented.
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Observations
The facility failed to develop policies and procedures to respond to all of the required unusual incidents based on a review of the facility's policy and procedure manual on July 16, 2019.
The following unusual incidents were not included in the facility's policy: inappropriate behavior by a patient causing disruption to the narcotic treatment program, selling of drugs on the premises, complaints of patient verbal/emotional abuse, serious injury due to trauma, suicide, medication error or unusual circumstances, significant disruption of services due to disaster such as fire, storm, flood or other occurrence, theft, burglary, break-in or similar incident at the facility, drug related hospitalization of a patient and other unusual incidents the narcotic treatment program believes should be documented.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Facility director and lead D&A counselor will develop a policy that specifies how to handle unusual incidents, investigate and report to the department of drug and alcohol, within the organization per regulation 715.28. |
710.23(b) LICENSURE Patient Records
§ 710.23. Patient records.
(b) Patient records shall be kept confidential in accordance with applicable Federal drug and alcohol regulations and the confidentiality requirements in 4 Pa. Code § § 255.4 and 255.5 (relating to UDCS: confidentiality and access to information and projects; and coordinating bodies: disclosure of client-oriented information).
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Observations
The facility failed to document a written, informed and voluntary consent to release information that included the specific information to be disclosed in five of five patient records reviewed on July 16, 2019.
The consents in the following records indicated the following unspecific information would be released: "face sheet with limited PHI" (protected health information) and "info consistent with 4 Pa. Code 255.5".
Patient # 1 was admitted October 29, 2018 and discharged November 2, 2018. A consent to a funding entity was dated October 30, 2018.
Patient # 2 was admitted May 7, 2019 and discharged May 14, 2019. Consents to funding entities were dated May 7, 2019. A consent to a parole agency was dated May 9, 2019.
Patient # 3 was admitted November 4, 2018 and discharged November 8, 2018. A consent to a funding entity was dated November 4, 2018.
Patient # 4 was admitted September 29, 2018 and discharged October 3, 2018. A consent to a funding entity was dated September 29, 2018.
Patient # 5 was admitted July 12, 2019 and discharged July 16, 2019. The consent to a funding entity was dated July 12, 2019.
In addition, the facility's consent to release information exceeded the limitations imposed at 4 Pa. Code 255.5 in patient records # 1, 3 and 5.
A consent in patient record # 1 dated October 31, 2018 indicated the following information would be released to a funding entity: discharge instruction sheet, medication list, treatment notes, history and physical.
A consent in patient record # 3 dated November 4, 2018 indicated the following information would be released to a funding entity: psychiatric face sheet, medications, behavioral health progress notes, history and physical.
A consent in patient record # 5 dated July 12, 2019 indicated the following information would be released to a funding entity: medication list, treatment notes, history and physical.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Facility director and lead D&A counselor will train staff on documenting the correct specific information to be released on the consents to release information. Facility director and lead counselor will adjust current release of information forms to specify what can be released per Code 255.5.
Lead counselor will conduct patient record reviews to ensure compliance. |