INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection conducted on July 25-27, 2018 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Malvern Institute for Psychiatric and Alcoholic Studies, 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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704.9(c) LICENSURE Supervised Period
704.9. Supervision of counselor assistant.
(c) Supervised period.
(1) A counselor assistant with a Master's Degree as set forth in 704.8 (a)(1) (relating to qualifications for the position of counselor assistant) may counsel clients only under the close supervision of a trained counselor or clinical supervisor for at least the first 3 months of employment.
(2) A counselor assistant with a Bachelor's Degree as set forth in 704.8 (a)(2) may counsel clients only under the close supervision of a trained counselor or clinical supervisor for at least the first 6 months of employment.
(3) A registered nurse as set forth in 704.8 (a)(3) may counsel clients only under the close supervision of a trained counselor or clinical supervisor for at least the first 6 months of employment.
(4) A counselor assistant with an Associate Degree as set forth in 704.8 (a)(4) may counsel clients only under the close supervision of a trained counselor or clinical supervisor for at least the first 9 months of employment.
(5) A counselor assistant with a high school diploma or GED equivalent as set forth in 704.8 (a)(5) may counsel clients only under the direct observation of a trained counselor or clinical supervisor for the first 3 months of employment. For the next 9 months, the counselor assistant may counsel clients only under the close supervision of a lead counselor or a clinical supervisor.
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Observations
Two personnel records were reviewed for the counselor assistant position on July 25, 2018. The facility failed to fully document the provision of close supervision and direct observation for employee records #13 and 14.
Employee # 13 was hired by the project on August 5, 2014 and began employment as a high-school diploma level counselor assistant on August 22, 2016. The employee was then promoted to the counselor position on August 23, 2017, upon meeting all required qualifications for that position. The employee required direct observation and close supervision for the first 12 months of employment in the counselor assistant position. Weekly supervision notes were reviewed for the period of July 13, 2017 - August 22, 2017. Supervision notes were not documented for following weeks:
-August 6, 2017
-August 13, 2017
The facility also failed to fully demonstrate that weekly close supervision included at least 1 hour of direct observation per week.
Employee # 14 was hired by the project on May 31, 2016 and began employment as a bachelor's degree level counselor assistant on March 19, 2018. The employee requires close supervision, to include direct observation, for the first 6 months of employment in the counselor assistant position. Weekly supervision notes were reviewed for the period of March 19, 2018 - July 23, 2018. The facility failed to demonstrate that weekly close supervision included 1 hour of direct observation at least once per week.
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
For employee #13, since he has been promoted to a counselor as of August 23, 2017, we are unable to correct the documentation of close supervision to include direct observation.
For employee #14, although we do believe that direct observation occurred during the close supervision, it was not documented appropriately. Therefore we will begin the documentation of close supervision with one hour of direct observation at least once per week immediately.
Documentation will be reviewed monthly by the Compliance Manager to ensure they meet regulatory standards. |
709.34 (c) (4) LICENSURE Reporting of unusual incidents
§ 709.34. Reporting of unusual incidents.
(c) To the extent permitted by State and Federal confidentiality laws, the project shall file a written unusual incident report with the Department within 3 business days following an unusual incident involving:
(4) Event at the facility requiring the presence of police, fire or ambulance personnel.
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Observations
The facility's documentation of unusual incidents was reviewed on July 27, 2018. The facility failed to report to the Department documented events at the facility that required the presence of ambulance personnel, with the events occurring on April 29, 2018, May 23, 2018, and June 16, 1018.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
All incidents are currently reported to the safety committee and the compliance manager. Effective immediately the compliance manager will review these incident reports each business day for unusual incidents. Any unusual incident including incidents that involve ambulance, police or fire personnel will be promptly reported within 3 days to DDAP. The records of any reported incidents will be kept in a file for review.The Chief Clinical officer will have a weekly review of unusual incidents with the compliance manager to ensure that no unusual incidents were missed. |
715.6(e) LICENSURE Physician Staffing
(e) A physician assistant or certified registered nurse practitioner may perform functions of a narcotic treatment physician in a narcotic treatment program if authorized by Federal, State and local laws and regulations, and if these functions are delegated to the physician assistant or certified registered nurse practitioner by the medical director, and records are properly countersigned by the medical director or a narcotic treatment physician. One-third of all required narcotic treatment physician time shall be provided by a narcotic treatment physician. Time provided by a physician assistant or certified registered nurse practitioner may not exceed two-thirds of the required narcotic treatment physician time.
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Observations
Eight client records were reviewed for the use of Buprenorphine in the inpatient detoxification and inpatient rehabilitation activities on July 26-27, 2018. The facility failed to document the countersignature of either the medical director or a narcotic treatment physician on records pertaining to functions performed by the physician assistant for client record # 7.
Client # 7 was admitted into inpatient rehabilitation treatment on May 7, 2018 and was discharged on May 14, 2018. The client's record contained documentation of a physical examination conducted by the physician assistant on May 8, 2018. The physical examination record was not countersigned by a physician.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
Effective immediately, all records completed by the physician's assistant will be countersigned by the physician on staff. This will be tracked by the Director of Nursing through monthly chart checks. |
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
Eight client records were reviewed for the use of Buprenorphine in the inpatient detoxification and inpatient rehabilitation activities on July 26-27, 2018. For client records # 1 and 9, the facility failed to document verification of the client's identity prior to the administration of an agent.
Client # 1 was admitted into inpatient detoxification treatment on July 19, 2018 and was transferred into inpatient rehabilitation treatment on July 24, 2018. An initial dose of Subutex was administered to the client on July 19, 2018. Documentation verifying the client's identity was not found in the client's record.
Client # 9 was admitted into inpatient rehabilitation treatment on February 1, 2018 and was discharged on March 1, 2018. An initial dose of Suboxone was administered to the client on February 7, 2018. Documentation verifying the client's identity was not found in the client's record.
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
Effective immediately, in the event that a patient enters treatment without identification, a missing identification form will be filled out with an alternative method of ID verification noted (ie family member, friend, referral source). This form will be scanned into the patients chart and will be verified by the medical records department through weekly chart checks.
All intake and medical records staff will be trained on this process in order to meet this standard. |
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
Eight client records were reviewed for the use of Buprenorphine in the inpatient detoxification and inpatient rehabilitation activities on July 26-27, 2018. The facility failed to ensure that a narcotic treatment physician clearly documented evidence of a one year history of dependence for client record # 9.
Client # 9 was admitted into inpatient rehabilitation treatment on February 1, 2018 and was discharged on March 1, 2018. Documentation in the client's record indicated that the client was administered an initial dose of Suboxone on February 7, 2018.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
Effective immediately, prior to administration of buprenorphine, the narcotic treatment physician will be required to demonstrate evidence of a one year history of dependence.
This documentation will be reviewed by the medical staff assigned to the patient and will be verified through monthly chart checks by the Director of Nursing. |
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
Eight client records were reviewed for the use of Buprenorphine in the inpatient detoxification and inpatient rehabilitation activities on July 26-27, 2018. For client records # 7 and 9, the facility failed to document that the female patient had been fully informed of the possible risk to an unborn child from continued use of illicit drugs and from use of, or withdrawal from, a narcotic drug administered in treatment.
Client # 7 was admitted into inpatient rehabilitation treatment on May 7, 2018 and was discharged on May 14, 2018. The client presented to the facility with their own prescription for Buprenorphine-Naloxone, with the medication to be stored and administered by the facility. The facility began administering this medication to the client on May 8, 2018.
Client # 9 was admitted into inpatient rehabilitation treatment on February 1, 2018 and was discharged on March 1, 2018. Documentation in the client's record indicated that the client was administered an initial dose of Suboxone on February 7, 2018.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Effective immediately, all clients who enter treatment and are administered buprenorphine will sign an informed consent, whether the patient presented with their own prescription or not. This consent includes the risks and possible adverse effects from continued use of illicit drugs and from use of, or withdrawal from, a narcotic drug administered in treatment, to both client and, in the case of female clients, to an unborn child. The Director of Nursing will train all medical staff to effectively communicate the above to clients and have a voluntary consent signed as they get admitted. This documentation of consent will be verified by monthly chart checks conducted by Director of Nursing. |
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
Eight client records were reviewed for the use of Buprenorphine in the inpatient detoxification and inpatient rehabilitation activities on July 26-27, 2018. For client records # 7, 8, and 9, the facility failed to obtain an informed, voluntary, written consent prior to the administration of a narcotic agent.
Client # 7 was admitted into inpatient rehabilitation treatment on May 7, 2018 and was discharged on May 14, 2018. The client presented to the facility with their own prescription for Buprenorphine-Naloxone, with the medication to be stored and administered by the facility. The facility began administering this medication to the client on May 8, 2018. Documentation of informed consent was not found in the client's record.
Client # 8 was admitted into inpatient rehabilitation treatment on June 5, 2018 and was discharged on July 2, 2018. Documentation in the client's record indicated that the client was administered an initial dose of Suboxone on June 7, 2018. Documentation of informed consent was not found in the client's record.
Client # 9 was admitted into inpatient rehabilitation treatment on February 1, 2018 and was discharged on March 1, 2018. Documentation in the client's record indicated that the client was administered an initial dose of Suboxone on February 7, 2018. Documentation of informed consent was not found in the client's record.
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
Effective immediately, all clients who enter treatment and are administered buprenorphine will sign an informed consent, whether the patient presented with their own prescription or not. This consent includes the risks and possible adverse effects from continued use of illicit drugs and from use of, or withdrawal from, a narcotic drug administered in treatment. The Director of Nursing will train medical staff on this standard and will verify adherence to the standard via by monthly chart checks. |
715.23(d) LICENSURE Patient records
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
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Observations
Eight client records were reviewed for the use of Buprenorphine in the inpatient detoxification and inpatient rehabilitation activities on July 26-27, 2018. The facility failed to document a comprehensive treatment plan for client record # 7.
Client # 7 was admitted into inpatient rehabilitation treatment on May 7, 2018 and was discharged on May 14, 2018. A comprehensive treatment plan was not found in the client's record.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
Client #7 was discharged on a Sunday, the day that the treatment plan was due to be completed. The comprehensive treatment plan for patients stepping down from detox to rehab will be completed within 72 hours of the advance to rehab date. For patients admitted into rehab, the comprehensive treatment plan will be completed within 7 days of admission. It has been reiterated by the Clinical Director to the counseling staff that in the event that a treatment plan or other documentation is due on a weekend, that the documentation should be completed prior to the weekend. This will be verified by the medical records department during weekly chart checks. |