INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection and buprenorphine/methadone monitoring inspection conducted on November 13-15, 2018 by staff from the Department of Drug and Alcohol Programs, Bureau of Quality Assurance for Prevention & Treatment with the inspection also conducted for the approval to use Methadone and Buprenorphine in the treatment of narcotic addiction. Based on the findings of the on-site inspection, Habit OPCO, 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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704.6(e) LICENSURE Supervisory Meetings
704.6. Qualifications for the position of clinical supervisor.
(e) Clinical supervisors are required to participate in documented monthly meetings with their supervisors to discuss their duties and performance for the first 6 months of employment in that position. Frequency of meetings thereafter shall be based upon the clinical supervisor's skill level.
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Observations
One personnel record was reviewed for the clinical supervisor position, for the licensing renewal inspection conducted on November 13-15, 2018. For employee # 3, the facility failed to provide documentation of monthly supervisory meetings conducted for the first six months of employment in the clinical supervisor position.
Employee # 3 was hired by the facility on September 12, 2016 and was promoted to the clinical supervisor position on January 14, 2018. The employee's personnel record did not contain documentation of monthly supervision meetings with their supervisor.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
The Facility Director will ensure that all supervisory meetings and communications are documented for all new management staff during the transitional six month period.
Ongoing review and compliance to this will be adhered to and reviewed by the Project Director or designee.
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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, for the licensing renewal inspection conducted on November 13-15, 2018. The facility failed to fully document the provision of close supervision and direct observation for employee records # 10 and 11.
Employee # 10 was hired by the facility on June 18, 2018 as a bachelor's degree level counselor assistant. The employee was then promoted to the counselor position on September 21, 2018. The employee required close supervision while employed as a counselor assistant, which was to include at least 1 hour of direct observation per week. Weekly supervision notes were reviewed for the period of June 18, 2018 - September 21, 2018. The facility failed to demonstrate that weekly close supervision included at least 1 hour of direct observation per week. In addition, the facility failed to provide complete supervision notes for the following weeks:
-Week of June 24, 2018
-Week of July 1, 2018
-Week of July 8, 2018
-Week of July 15, 2018
-Week of July 22, 2018
-Week of July 29, 2018
-Week of August 12, 2018
-Week of August 26, 2018
-Week of September 2, 2018
Employee # 11 was hired by the facility on November 7, 2017 and began employment as a high-school diploma level counselor assistant position on September 27, 2018. The employee may only counsel clients under the direct observation of their supervisor for the first 3 months of employment in the counselor assistant position. The employee then requires close supervision, to include direct observation, for the next nine months of employment in this position. Weekly supervision notes were reviewed for the period September 27, 2018 - November 10, 2018. Based on a review of supervision notes and pertinent client records, the facility failed to demonstrate the provision of direct observation. In addition, the facility failed to provide complete supervision notes for the following weeks:
-Week of October 14, 2018
-Week of October 21, 2018
-Week of October 28, 2018
-Week of November 4, 2018
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
The facility management team (Facility Director, Clinical Supervisor, and Office Manager) will ensure that direct supervision of counselor assistants will occur under the regulation of 704.9 based on their educational background and necessity, upon hire of each new counseling staff member. A review of this regulation was discussed with the clinical supervisor and office manager on November 16th, 2018 and will be corrected in order to ensure that appropriate training, documentation, and direct observation is occurring with the counselor assistant starting with their first day of employment. This information was also discussed with the Office Manager to be included in counselor assistant personnel files." |
705.23 (3) LICENSURE Counseling or activity areas and office space
705.23. Counseling or activity areas and office space.
The nonresidential facility shall:
(3) Ensure privacy so that counseling sessions cannot be seen or heard outside the counseling room. Counseling room walls shall extend from the floor to the ceiling.
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Observations
During a physical plant inspection conducted on November 15, 2018. The facility failed to ensure privacy within counseling areas so that sessions could not be heard from outside.
The counseling meeting spaces did not have sound machines to alleviate sessions from being heard.
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Plan of Correction
The facility does have sound machines for all counseling spaces throughout the facility. On November 28, 2018 this Facility Director completed a review of 705.23(3) with all staff team members where they were instructed to ensure compliance moving forward with the use of sound machines for patient privacy in all settings. Compliance to this regulation will be frequently monitored by the Facility Director, Clinical Supervisor, and Clinical Team lead. |
705.28 (c) (4) LICENSURE Fire safety.
705.28. Fire safety.
(c) Fire extinguishers. The nonresidential facility shall:
(4) Instruct staff in the use of the fire extinguisher upon staff employment. This instruction shall be documented by the facility.
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Observations
Eleven personnel records were reviewed for the licensing renewal inspection conducted on November 13-15, 2018. The facility failed to ensure that the instruction in the use of the fire extinguisher was completed in a timely manner for personnel records # 6 and 10.
Employee # 6 was hired by the facility on May 29, 2018. Fire extinguisher training was completed by the employee on July 9, 2018.
Employee # 10 was hired by the facility on June 18, 2018. Fire extinguisher training was completed by the employee on July 9, 2018.
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
The facility will ensure that all staff members have fire extinguisher training as required by 705.28.
The Facility Director will ensure that all staff members who have not obtained training in the use of extinguishers will be trained within their first seven (7) days of employment.
The office manager will verify that each staff member has been instructed regarding the location and operation of extinguishers upon hire and that training materials are completed within the first seven (7) days of employment.
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709.28 (c) 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.
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Observations
The facility failed to keep disclosures of client identifying information within the limits established by 4 Pa. Code 255.5 (b) for releases of information in client record # 6. Consent to releases may be revoked verbally and the consent was expired.
Patient # 6 was admitted on July 20, 2017 and was still an active patient at the time of the inspection. There was a consent to release information to "mother" dated July 14, 2017 in the record with verbiage verbatim "I may revoke this consent in writing at any time except to the extent that action has been taken in reliance on it and that in any event this consent expires automatically as indicated below or within one year of the date of any signatures, whichever occurs sooner."
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Plan of Correction
The Facility Director has ensured that all paper releases are in newer formatting indicating that "I may verbally and/or in writing, revoke this consent..." Releases of information that are in the EHR do accurately represent the verbage necessary to meet the requirements of regulation 709.28 (c). |
715.6(d) LICENSURE Physician Staffing
(d) A narcotic treatment program shall provide narcotic treatment physician services at least 1 hour per week onsite for every ten patients
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Observations
The facility failed to document an equivalent of physician services at least 1 hour per week onsite for every ten patients and that one-third of all required narcotic treatment physician time shall be provided by a narcotic treatment physician in physician schedules reviewed dated weeks of May 6, 2018 through week of September 16, 2018.
May 6-12, 2018 with a census of 396 required 39.6 physician hours and provided only 34.3 hours.
June 24-30, 2018 with a census of 408 required 40.8 physician hours and provided only 40 hours.
July 1-7, 2018 with a census of 410 required 41.0 physician hours and provided only 35 hours. One third of the 41.0 hours required is 13.53 and only 11 hours were provided.
July 8-14, 2018 with a census of 415 required 41.5 physician hours and provided only 35 hours. One third of the 41.5 hours required is 13.69 and only 11 hours were provided.
July 15-21, 2018 with a census of 415 required 41.5 physician hours and provided only 35 hours. One third of the 41.5 hours required is 13.69 and only 11 hours were provided.
July 22-28, 2018 with a census of 419 required 41.9 physician hours and provided only 35 hours. One third of the 41.9 hours required is 13.82 and only 11 hours were provided.
July 29- August 4, 2018 with a census of 421 required 42.1 physician hours and provided only 35 hours. One third of the 42.1 hours required is 13.89 and only 11 hours were provided.
August 5-11, 2018 with a census of 421 required 42.1 physician hours and provided only 35 hours. One third of the 41.9 hours required is 13.89 and only 11 hours were provided.
August 12-18, 2018 with a census of 422 required 42.2 physician hours and provided only 23 hours.
August 19-25, 2018 with a census of 421 required 42.1 physician hours and provided only 15 hours.
August 26- September 1, 2018 with a census of 426 required 42.6 physician hours and provided only 35 hours. One third of the 42.6 hours required is 14.05 and only 11 hours were provided.
September 2-8, 2018 with a census of 421 required 42.1 physician hours and provided only 35 hours. One third of the 42.1 hours required is 13.89 and only 11 hours were provided.
September 9-15, 2018 with a census of 420 required 42.0 physician hours and provided only 35 hours. One third of the 42.6 hours required is 13.86 and only 11 hours were provided.
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Plan of Correction
It is noted and understood that the periods of time indicated in this citation do show a lapse in physician coverage to best meet the needs of our patient population.
The on-boarding of additional physicians and physician assistants after September 15th, 2018 now do meet the expectations of regulation 715.6(d).
Discussed and noted during the audit, and at the time of the exit interview, was that this matter has been corrected and the facility is currently in compliance to the regulations.
It will be the responsibility of the Facility Director to ensure that additional hours are added to either the existing Physicians and/or Physician Extenders where appropriate in the future, to maintain compliance.
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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
The facility failed to provide documentation that the narcotic treatment physician countersigned for the 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 in client # 3's record.
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Plan of Correction
Facility Director and Medical Director will ensure that all Physician Documentation of Addiction notes are entered into the EHR and are countersigned appropriately and in a timely manner. The Charge Nurse will oversee this process to ensure timely completion by the physician.
Additions of the countersigning feature in the EHR for the Medical Director/ Narcotic Treatment Physicians have been completed and will serve as an additional means of patient chart auditing/monitoring.
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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 patient consent to treatment in patient record # 2.
Patient # 2 was readmitted on October 11, 2018 and was still an active patient at the time of the inspection. The patient was previously discharged on July 6, 2018 and the consent for treatment form was not updated in the patient record.
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Plan of Correction
The facility will ensure that prior to initial medication administration, for a new patient or re-admit, a patient-signed copy of informed consent for medication maintenance treatment will be obtained.
A review of this regulation was discussed with the Charge Nurse and made part of the internal chart audit process to ensure compliance to regulation 715.12(1-5).
Ongoing.
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715.16(a)(3) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(3) The narcotic treatment physician shall document in the patient record the rationale for permitting take-home medication.
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Observations
The facility failed to provide documentation of an exception for take-home bottles exceeding the number of days approved by the physician.
Patient # 6 was admitted on July 20, 2017 and was still an active patient at the time of the inspection. The patient was approved for 4 take home bottles the week of September 30-October 6 and November 4-10, 2018. Documentation shows the patient received 5 take home bottles those weeks without an exception noted in the patient record.
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Plan of Correction
The facility will ensure that all communication regarding a patients take home status be thoroughly documented by the Narcotic Treatment Physician prior to a patient receiving said take home bottles. A thorough review of the patient's medical status will be reviewed in order to determine the suitability of receiving a take home exception.
A review of this regulation was discussed with the Charge Nurse and Medical Director to ensure that all documentation is in place to meet regulation 715.16(a)(3).
Ongoing.
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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
A buprenorphine patient was observed by Department of Drug and Alcohol Programming staff receive 3 tablets without the full observation of facility staff. The patient was observed being given medication and subsequently walk away without confirmation of ingestion.
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Plan of Correction
A thorough review of this regulation 715.17(c)(1)(i-iv) was completed with the Charge Nurse. Education has been provided to all dispensary nursing staff members on November 16th, 2018 regarding current facility policy that dosage shall be verified by the patient to the nurse and confirmed with the current dose order before preparing. The patient will ingest the medication in front of the dispensing nurse and will speak with the dispensing nurse prior to leaving the dispensing areas to minimize the possibility of medication diversion.
The Charge Nurse and Facility Director will monitor patient dosing to ensure compliance with this regulation.
Ongoing.
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715.19(1) LICENSURE Psychotherapy services
A narcotic treatment program shall provide individualized psychotherapy services and shall meet the following requirements:
(1) A narcotic treatment program shall provide each patient an average of 2.5 hours of psychotherapy per month during the patient 's first 2 years, 1 hour of which shall be individual psychotherapy. Additional psychotherapy shall be provided as dictated by ongoing assessment of the patient.
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Observations
The facility failed to provide patient #s 1, 3, 4, 5, 6, 7 and 8 with 2.5 hours of psychotherapy per month during the patient's first 2 years of treatment.
Patient # 1 was admitted on July 3, 2018 and was still an active patient at the time of the inspection. Patient record reflects the following:
July 2018- 60 minutes individual - no groups
September 2018- 60 minutes individual - no groups
October 2018 - 2 hours individual - no groups
Patient # 3 was admitted September 14, 2018 and was still an active patient at the time of the inspection. Patient record reflects the following:
October 2018 - 60 minutes individual - no groups
Patient # 4 was admitted June 4, 2018 and was still an active patient at the time of the inspection. Patient record reflects the following:
June 2018 - 60 minutes group - No individuals
September 2018 - 30 minutes individual - no groups
Patient # 5 was admitted May 21, 2018 and was still an active patient at the time of the inspection. Patient record reflects the following:
June 2018 - 30 minutes individual and a documented No show- no groups
July 2018 - 2 documented no shows - No groups
September 2018 - 60 minutes individual - no groups
October 2018 - 60 minutes individual - no groups
Patient # 6 was admitted July 20, 2017 and was still an active patient at the time of the inspection. Patient record reflects the following:
August 2018 - A combined 2 hours
September 2018 - 90 minutes group - no individuals
October A combined 2 hours
Patient # 7 was admitted on January 12, 2017 and discharged on September 4, 2018. Patient record reflects the following:
February 2018- 30 minutes individual and a documented no show - no groups
March 2018 - 60 minutes individual - no groups
April 2018 - 30 minutes individual - no groups
May 2018 - 60 minutes individual - no groups
June 2018 - One documented no show- no groups
July 2018 - 30 minutes individual - no groups
August 2018 - One documented no show - no groups
Patient # 8 was admitted on May 17, 2018 and discharged on July 6, 2018. Patient record reflects the following:
There was no documentation of any psychotherapy hours in the patient record.
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Plan of Correction
The Facility Management Team has thoroughly reviewed the failure to meet the expectations of psychotherapy services in regulation 715.19(1) on November 16th, 2018. In order to address this deficiency, weekly clinical team meetings are more directly focusing on tracking psychotherapy hours for those patients newly admitted up to 2 years in treatment, as well as those patients active over 2 years. The focus to increase counseling engagement will be in the form of groups tailored to the specific needs of the patients and an increase in the hours that counselors are staffed on-site.
Due to significant staff turnover within this audit year, and adjustments needing to have been made to counseling schedules, it must be noted that full counselor staffing has been achieved to date and counselor utilization and productivity has been increasing month over month. A weekly review of counseling hours will be done by the Facility Director, Clinical Supervisor, and Clinical Team lead to ensure that there are no barriers for a patient to engage in psychotherapy services.
Ongoing.
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715..23(b)(1) LICENSURE Patient records
(b) Each patient file shall include the following information:
(1) A complete personal history.
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Observations
The facility failed to document a complete personal history in patient records # 1 and 2.
Patient # 1 was admitted on July 3, 2018 and was still an active patient at the time of the inspection. A note in the electronic chart stated Biopsychosocial, containing histories, could be located in paper chart and no Biopsychosocial could be located.
Patient # 2 was readmitted on October 11, 2018 and was still an active patient at the time of the inspection. Patient was previously discharged on July 6, 2018. The Biopsychosocial that would have included the personal history and drug use history and status was amended, however there was no date to confirm the update.
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Plan of Correction
Facility director and Clinical Supervisor reviewed 715.23(b)(1) and failure to be in compliance with this regulation on November 16th, 2018.
The facility will ensure that all documentation required for patients files will be completed in a timely manner and will be reviewed by the Clinical Supervisor. 5% of patient charts will be internally audited for completion on a monthly basis.
With the move to a fully electronic EHR, the counseling staff will upload all biopsychosocials and addendums, containing patient histories, into the patient's record, therefore eliminating the possibility of the paper chart being incomplete.
Ongoing.
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715.23(c)(1-7) LICENSURE Patient records
(c) An annual evaluation of each patient 's status shall be completed by the patient 's counselor and shall be reviewed, dated and signed by the medical director. The annual evaluation period shall start on the date of the patient 's admission to a narcotic treatment program and shall address the following areas:
(1) Employment, education and training.
(2) Legal standing.
(3) Substance abuse.
(4) Financial management abilities.
(5) Physical and emotional health.
(6) Fulfillment of treatment objectives.
(7) Family and community supports.
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Observations
The facility failed to provide documentation of an annual evaluation in patient record # 6.
Patient # 6 was admitted on July 20, 2017 and was still an active patient at the time of the inspection. An annual review would have been due July 20, 2018 but did not occur until November 1, 2018.
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Plan of Correction
Facility director and Clinical Supervisor reviewed 715.23(c)(1-7) and failure to be in compliance with this regulation.
The facility will ensure that all documentation required for patients files will be completed in a timely manner and will be reviewed by the Clinical Supervisor. 5% of patient charts will be internally audited for completion on a monthly basis.
The facility director will meet with the Medical Director in order to review the citation to this regulation and to ensure that all areas of this regulation are met.
Ongoing.
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709.91(b)(6) LICENSURE Intake and admission
709.91. Intake and admission.
(b) Intake procedures shall include documentation of:
(6) Psychosocial evaluation.
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Observations
The facility failed to provide documentation of a psychosocial being performed on 2 of 8 clients reviewed.
Client # 1 was admitted on July 3, 2018 and was still an active client at the time of the inspection. On July 18, 2018 a note in the electronic record indicated a psychosocial was in the paper chart, however one was not located.
Client # 2 was readmitted on October 11, 2018 and was still an active client at the time of the inspection. A Biopsychosocial was amended in the chart but there was no date to confirm it was completed after prior discharge on July 6, 2018.
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Plan of Correction
Facility director and Clinical Supervisor reviewed 709.91(b)(6) and failure to be in compliance with this regulation on November 16th, 2018.
The facility will ensure that all documentation required for patients files will be completed in a timely manner and will be reviewed by the Clinical Supervisor. 5% of active patient charts will be internally audited for completion on a monthly basis.
With the move to a fully electronic EHR, the counseling staff will upload all biopsychosocials and addendums into the patient's record, therefore eliminating the possibility of the paper chart being incomplete.
Ongoing.
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709.92(b) LICENSURE Treatment and rehabilitation services
709.92. Treatment and rehabilitation services.
(b) Treatment and rehabilitation plans shall be reviewed and updated at least every 60 days.
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Observations
The facility failed to document a treatment plan update at least every 60 days in 3 of 8 client records reviewed.
Client # 5 was admitted on May 21, 2018 and was still an active client at the time of the inspection. An initial treatment plan was developed with the client on May 6, 2018 and the next update was due no later than July 6, 2018 and again September 6, 2018. The only update in the record occurred on September 14, 2018.
Client # 6 was admitted on July 20, 2018 and was still an active client at the time of the inspection. An initial treatment plan was developed with the client on October 23, 2017 and an update completed on November 2, 2017. The next treatment plan update was due no later than January 2, 2018. Updates in the record occurred on February 8, 2018, August 21, 2018, September 27, 2018, and October 23, 2018. Other missing updates include; April 8, 2018 and June 8, 2018.
Client # 7 was admitted on January 12, 2017 and discharged on September 4, 2018. A treatment plan update was developed on November 13, 2017 and the next update was due no later than January 13, 2018, however was not completed. The following update would have been due on March 13, 2018 and was not present. The next update's developed were on April 2, 2018 and June 1, 2018 and were both present. Another update was due no later than August 1, 2018 and was not present.
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Plan of Correction
The facility director met with the Clinical Supervisor and Lead Clinician to review regulation 709.92(b) on November 29th, 2018.
A more thorough review of patient files will be conducted to ensure that counseling staff are completing necessary paperwork and documentation in a timely manner.
The utilization of the EHR will ensure that all documentation is met within allotted time frames necessary to meet this regulation.
All counseling staff will be required to complete internal audits of patient electronic and paper records on a weekly basis.
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