INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection conducted on November 14, 2017 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Pyramid Healthcare 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
One personnel record was reviewed for the counselor assistant position on November 8, 2017. The facility failed to document the provision of direct observation for employee record # 4.
Employee # 4 was hired on 1/29/16 and began employment as a high school diploma level counselor assistant on 4/7/16. The employee required direct observation for the first 3 months of employment in the counselor assistant position, and then close supervision for the next 9 months. Weekly supervision notes were reviewed for the period of 12/30/16 - 4/20/17. The facility failed to demonstrate that weekly close supervision included an additional hour of direct observation at least once a week.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
A Clinical Site Supervisor was hired effective 12/17/17 and was trained on 12/28/17 on the clinical supervision requirements in 704.9 (c) as well proper documentation of clinical supervision. Effective 01/01/2018, the Eastern Clinical Coordinator will conduct monthly supervision audits to ensure regular and appropriate supervision of counselors and counselors assistants as required in 704.9 (c). Any concerns in compliance with supervision standards will be reported to the Facility Director for a corrective action plan |
704.10 LICENSURE Counselor Asst Promotion
704.10. Promotion of counselor assistant.
(a) A counselor assistant who satisfactorily completes one of the sets of qualifications in 704.7 (relating to qualifications for the position of counselor) may be promoted to the position of counselor.
(b) A counselor assistant shall document to the facility director that he is working toward counselor status. This information shall be documented upon completion of each calendar year.
(c) A counselor assistant shall meet the requirements for counselor within 5 years of employment. A counselor assistant who has accumulated less than 7,500 hours of employment during the first 5 years of employment will have 2 additional years to meet the requirements for counselor.
(d) A counselor assistant who cannot meet the time requirements in subsection (c) may submit to the Department a written petition requesting an exception. The petition shall describe the circumstances that make compliance with subsection (c) impracticable and shall be approved by both the clinical supervisor or lead counselor and the project director. Granting of the petition will be within the discretion of the Department.
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Observations
One personnel record was reviewed for the promotion of a counselor assistant on November 8, 2017. The facility promoted employee # 4, a counselor assistant, to the counselor position prior to the employee completing any of the required qualifications.
Employee # 4 was hired on 1/29/16 and began employment as a high school diploma level counselor assistant on 4/7/16. The employee was then promoted to the counselor position on 4/24/17, without having completed the required qualifications for the position.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
Employee #4 has been reclassified as a Counselor Assistant as of 12/04/2017. She is currently pursuing an approved degree, and her progress in obtaining this degree will be monitored each semester, with a review of her grades. On 12/14/17, both the Program Director and Eastern Regional Director of Inpatient Services met with Chief Compliance Officer and were trained on the DDAP requirements in 704.10. Effective 12/14/17, all Counselor Assistant Promotions must be reviewed and approved by both the Facility Director and Regional Director of Inpatient Services. |
704.11(b)(1) LICENSURE Individual training plan.
704.11. Staff development program.
(b) Individual training plan.
(1) A written individual training plan for each employee, appropriate to that employee's skill level, shall be developed annually with input from both the employee and the supervisor.
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Observations
Eleven personnel records requiring documentation of individual training plans were reviewed for the licensing renewal inspection conducted on November 14, 2017. The facility failed to provided documentation of individual training plans, for the current training year, for employee records # 2, 9, 10, and 11.
Employee # 2 was hired by the project on 12/03/05 and began employment in the facility director position on 11/10/14.
Employee # 9, a dietary coordinator, was hired by the facility on 6/6/16.
Employee # 10, a dietary kitchen supervisor, was hired by the facility on 4/22/13.
Employee # 11, a dietary worker, was hired by the facility on 11/24/14.
These findings were reviewd with facility staff during the licensing process.
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Plan of Correction
Employee #9 is no longer employed with our facility effective 10/31/2017. Employee #10, a dietary kitchen supervisor, will meet with the Facility Director on 1/18/18 to complete a 2018 training plan. Employee # 11, a dietary worker, will meet with the Facility Director on 1/18/18 to complete a 2018 training plan.
On 1/9/2018, the Program Director met with Human Resources Coordinator and was trained on the DDAP requirements in 704.11, and reviewed current system of communication between department supervisors and the Human Resources Coordinator. Effective 1/9/2018, all communications regarding regulation 704.11 to individual department supervisors from the Human Resources Coordinator will be carbon copied for the Program Director to ensure compliance with 704.11 regulations and tasks and deadlines assigned by the HR Coordinator.
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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
Four client records were reviewed on November 14, 2017. The facility failed to obtain a valid informed and voluntary consent to release information for client records # 3 and 4. In addition, the facility failed to obtain an informed and voluntary consent that did not exceed the limitations imposed in 4 Pa. Code 255.5 (b) for client record # 4.
Client # 3 was admitted into treatment on 7/22/17 and was discharged on 9/20/17. A consent to release information to a medical assistance provider, signed and dated by the client on 7/25/17, did not document the dated signature of a witness.
Client # 4 was admitted into treatment on 8/10/17 and was discharged on 10/4/17. A consent to release information to a medical assistance provider, signed and dated by the client on 8/10/17, did not document the dated signature of a witness. In addition, the same consent form authorized the release of the following information: medication administration record, history and physical, and psychiatric evaluation.
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
A Clinical Site Supervisor was hired effective 12/17/17 and on 1/10/18, will be meeting with the Eastern Clinical Coordinator on the citation received for 709.28 (c ) The clinical site supervisor and Eastern Clinical Coordinator will then schedule a mandatory in house training for all intake and clinical staff to review 709.28 (c ) regulations, including requirement pertaining to obtainment of informed and voluntary consent from each client; documentation of the date in which the staff and client signature was obtained; expiration date of the consent; the obtainment of specific information regarding the particular name, agency, or organization to which the disclosure would be made to be conducted no later than January 30, 2018. The Clinical Supervisor and Eastern Clinical Coordinator will also re-train staff on the limitations of disclosure as defined in 4Pa. Code 255.5 no later than January 30, 2018. Effective 1/10/18 the Clinical Supervisor will conduct monthly chart audits to ensure compliance with regulation 709.28 (c ). |
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
Two client records were reviewed for the use of Buprenorphine in the inpatient rehabilitation activity on November 14, 2017. 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 certified registered nurse practitioner for client records # 1 and 2.
Client # 1 was admitted into treatment on 10/12/17 and was still active in treatment. The client's record contained documentation of a physical examination conducted by the certified registered nurse practitioner on 10/16/17. The physical examination record was not countersigned by the physician.
Client # 2 was admitted into treatment on 8/9/17 and was discharged on 11/14/17. The client's record contained documentation of a physical examination conducted by the certified registered nurse practitioner on 8/13/17. The physical examination record was not countersigned by the physician.
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
On 12/8/17, Eastern Region Director of Nursing, Quakertown Program Director and site Medical Director met to review DDAP regulation 715.6 (e), and introduced a MAT chart audit checklist to be used. This MAT chart audit checklist form was put into effect on 12/16/17 to ensure compliance with this regulation. In lieu of a full time nurse manager at this time, the Eastern Region Director of Nursing, in conjunction with the site clinical supervisor, will conduct monthly MAT chart audits for compliance. After hiring a full time nurse manager, date to be determined, it will be the responsibility of the site nurse manager to monitor all MAT charts for compliance with regulation 715.6 (e ) and report any compliance concerns to the Program Director and the Eastern Regional Director of Nursing. |
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
Two client records were reviewed for the use of Buprenorphine in the inpatient rehabilitation activity on November 14, 2017. The facility failed to document the physician's determination of addiction prior to the administration of Buprenorphine for client records # 1 and 2.
Client # 1 was admitted into treatment on 10/12/17 and was still active in treatment. The client was administered an initial dose of Suboxone on 10/30/17. Documentation of the physician's determination of addiction was dated 11/13/17.
Client # 2 was admitted into treatment on 8/9/17 and was discharged on 11/14/17. The client was administered an initial dose of Suboxone on 10/10/17. Documentation of the physician's determination of addiction was dated 11/13/17.
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
On 12/4/201, the Eastern Region Director of Nursing retrained all physicians on the required testing and documentation to be completed during the screening process when determining eligibility at a clients' initial assessment. The site nurse manager is responsible for reviewing all necessary documentation after the complete assessment, within 24 hours, to ensure compliance. To adhere to regulation 715.9(a) (4), before any buprenorphine is administered to the client, the prescribing physician will be meeting individually with the client and completing the determination of addiction in the chart to note client is appropriate for the MAT services |
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
Two client records were reviewed for the use of Buprenorphine in the inpatient rehabilitation activity on November 14, 2017. The facility failed to document an informed, voluntary, written consent prior to the administration of Buprenorphine for client record # 2.
Client # 2 was admitted into treatment on 8/9/17 and was discharged on 11/14/17. The client was administered an initial dose of Suboxone on 10/10/17. An informed patient consent for Suboxone treatment was not documented in the client's record.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
On 12/4/2017, the Eastern Region Director of Nursing retrained all physicians on the required testing and documentation to be completed during the screening process when determining eligibility at a clients' initial assessment. The site nurse manager is responsible for reviewing all necessary documentation after the complete assessment, within 24 hours, to ensure compliance.
Client #2 was provided with a paper consent form to sign as they were a current client at the time of inspection.
The facility does have an informed, voluntary, written consent in place that is given to every rehabilitation client assigned to the 3b and 3c level of care. In addition, as of 1/8/2018, the prescribing physician now has electronic signature pads available which will allow for every client to physically sign off on the document and have this reflected in the client's chart. If ever an electronic signature pad is not available, a paper consent form will be provided to the client by the medical department and subsequently scanned into the client's electronic record. The Intake Coordinator at the facility will oversee the procedure of having all clients sign a consent form upon their arrival. The facility Nurse Manager will also look into the client's electronic record to ensure that a consent was properly signed and placed into their chart.
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715.14(a) LICENSURE Urine testing
(a) A narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter.
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Observations
Two client records were reviewed for the use of Buprenorphine in the inpatient rehabilitation activity on November 14, 2017. The facility failed to document an initial drug-screen urinalysis prior to the administration of Buprenorphine for client record # 2.
Client # 2 was admitted into treatment on 8/9/17 and was discharged on 11/14/17. The client was administered an initial dose of Suboxone on 10/10/17. Documentation in the client's record indicated that the first drug-screen urinalysis was completed on 11/10/17.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
On 12/4/2017, the Eastern Region Director of Nursing retrained all physicians on the required testing and documentation to be completed during the screening process when determining eligibility at a clients' initial assessment. The site nurse manager is responsible for reviewing all necessary documentation after the complete assessment, within 24 hours, to ensure compliance. |
715.14(d) LICENSURE Urine testing
(d) A narcotic treatment program shall ensure that a laboratory that performs the testing required under this section shall be in compliance with applicable Federal requirements, specifically the Clinical Laboratory Improvement Amendments of 1998 (42 U.S.C.A. §§ 201 note, 263 and 263a notes), and State requirements, specifically the Pennsylvania Clinical Laboratory Act (35 P.S. §§ 2151-2165) and Chapter 5 (relating to clinical laboratories).
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Observations
A licensing renewal inspection was conducted on November 14, 2017. A review of client records and administrative documentation indicated that the facility was performing its' own on-site drug-screening urinalyses. The facility failed to obtain a CLIA Certification prior to implementing on-site urinalysis protocols.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
To ensure compliance with regulation 715.14 (d), effective 11/15/17, all urine specimens were sent to Quest Laboratories for testing. In November 2017, Eastern Region Director of Nursing applied for a CLIA Waiver, and it was approved and paid for on 1/2/2018 by the site Program Director. As a result, effective 1/2/2018, the facility is now in compliance with regulation 715.14 (d) Once the CLIA Waiver is obtained via mail, which is anticipated to be the week of 1/15/2018, the DON will post the CLIA waiver in the medical room to verify compliance. |
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
Two client records were reviewed for the use of Buprenorphine in the inpatient rehabilitation activity on November 14, 2017. The facility failed to document the physician's signed and written order for Buprenorphine, for client record # 1.
Client # 1 was admitted into treatment on 10/12/17 and was still active in treatment. The client was administered an initial dose of Suboxone on 10/30/17. A written physician order for the initial dose was not documented in the client's record.
In addition, the facility failed to implement written policies and procedures ensuring that Buprenorphine is administered or dispensed only by a practitioner licensed under the appropriate Federal and State laws to dispense agents to patients. Based on a review of Medication Administration Records, staff persons in the Behavioral Health Technician positions had been permitted to administer Buprenorphine.
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
On 1/11/2018, all medical staff will be retrained on the Electronic Record System and the system's scanning procedures, as well as the 3800 regulations for a self-administered medication facility. Regular monthly chart audits will be completed by the Site Nurse Manager to ensure compliance.
In response to this citation, Eastern Region Director of Nursing spoke with DDAP inspector Tina Groff in November 2017 and clarified that at this facility, medication is self-administered by the clients. To ensure compliance with regulation 715.17 (c) (1)(i-vi), regarding buprenorphrine inductions, a meeting between the medical director, the Eastern Region Director of Nursing and site Program Director occurred on 12/18/17 and it was established effective 12/18/17 that all buprenorphrine inductions will be given by a licensed medical personnel only, and any doses after that induction will be self-administered by the client and monitored by medication certified staff.
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715.17(c)(4)(i-viii) 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:
(4) Method for control and accountability of drugs. A narcotic treatment program shall develop and implement written policies and procedures regarding who is authorized to remove drugs from the storage area and the method for accounting for all stored drugs. An agent or other drug prescribed or administered shall be documented on an individual medication record or sheet in a manner sufficient to maintain an accurate accounting of medication at all times and shall include:
(i) The name of the medication.
(ii) The date prescribed.
(iii) The dosage.
(iv) The frequency.
(v) The route of administration.
(vi) The date and time administered.
(vii) The name of the person administering the medication.
(viii) The take-home schedule, if applicable.
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Observations
Two client records were reviewed for the use of Buprenorphine in the inpatient rehabilitation activity on November 14, 2017. The facility failed to maintain a complete medication administration record for client records # 1 and 2.
Client # 1 was admitted into treatment on 10/12/17 and was still active in treatment. A medication administration record sheet documented in the client's record indicated that it was for the administration of Suboxone, for the charting month of October 2017. However, the same record sheet noted Suboxone administered to the client during the month of November, specifically on November 1-14, 2017. The facility failed to document Suboxone administered during those November dates on a separate medication administration record for the charting month of November 2017.
Client # 2 was admitted into treatment on 8/9/17 and was discharged on 11/14/17. A medication administration record documented in the client's record indicated that it was for the administration of Suboxone. The charting month or period was not documented on this record sheet.
These findings was reviewed with facility staff during the licensing inspection.
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Plan of Correction
For compliance with regulation 715.17 (c ) (4) (i-iii) The Medication Administration Record will be complete to include date and month of administration. This will be completed by the medical staff.
On 1/11/2018 and 1/12/2018, The Directors of Nursing will re-train medical staff with regard to completing the Medication Administration Record to reflect the above.
Attendance at training will be verified by attendance signature. Verification of this record will be maintained by the HR Coordinator.
The Nurse Manager will monitor on-going compliance by completing monthly chart monitors
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715.23(b)(6) LICENSURE Patient records
(b) Each patient file shall include the following information:
(6) Results of laboratory tests or other special examinations given by the narcotic treatment program.
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Observations
Two client records were reviewed for the use of Buprenorphine in the inpatient rehabilitation activity on November 14, 2017. The facility failed to document the results of laboratory tests for client records # 1 and 2.
Client # 1 was admitted into treatment on 10/12/17 and was still active in treatment. Documentation in the client's record indicated the client received a drug-screening urinalysis on 10/24/17. However, complete results for the urinalysis were not documented in the client's record.
Client # 2 was admitted into treatment on 8/9/17 and was discharged on 11/14/17. Documentation in the client's record indicated the client received a drug-screening urinalysis on 11/10/17. However, complete results for the urinalysis were not documented in the client's record.
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
Effective 1/11/2018 forward, all urine specimen cups will be labeled with the client name, client ID and date test obtained to ensure identification and to ensure the tested specimens can be traced to the donor. This task will be the responsibility of medical and BHT staff who are performing the urine. In addition, a new form will be implemented and used for all urine testing that reflects all substances tested for in the urinalysis and the results for each substance.
The medical staff will be re-trained by the Directors of Nursing with regard to the above tracking system. Verification of training attendance will be verified by staff signature attending training. HR Coordinator will verify training attendance and retain records of the same.
Nurse Manager will track on-going compliance by completing monthly chart monitors
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