INITIAL COMMENTS
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This report is a result of an on-site inspection conducted for the approval to use a narcotic agent, specifically Methadone, and the use of buprenorphine by a waiver, in the treatment of narcotic addiction . This inspection was conducted on May 13 to 15, 2013, by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Kirkbride Center, was found not to be in compliance with the applicable chapters of 4 PA Code and 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)(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
Based on the review of patient records, the facility failed to verify the identity of the patient prior to the administration of a narcotic agent in five of fifteen patient records.
The findings include:
Fifteen patient records were reviewed on May 13 through 15, 2013. All patient records were specifically reviewed for patient identity information. Patient records # 2, 3, 5, 7 and 8 did not contain documentation of the verification of the patient's identity.
The findings were reviewed and confirmed with the project director and clinical director.
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Plan of Correction
Admissions Representative will generate a list of new admits who do not have a source of identification document.
The NTP will be provided with the patient listing to be apprised of patient status so that a Methadone dosing decision can be made.
The NTP clerical staff will also be provided a copy so that efforts will be initiated to obtain the client's identification verification.
Clinical Compliance Coordinator will audit this process for the period of four months through September 2013 and report results monthly to QA known as the Chemical Dependency Dashboard.
The facility will apply for an exception in cases where there is no opportunity to access identification verification documents as such that occurs with the homeless population. The Admissions Department will monitor the number of these occurrences and report the results to the Chemical Dependency Dashboard monthly for a period of four months. This will allow for data gathering and a review of the turn around time for exception grants to identify areas where improvement can be afforded. Overall results will be reported to the Executive Management Committee on a monthly basis for oversight and monitoring and organizational identification of opportunities for improvement.
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715.9(c) LICENSURE Intake
(c) If a patient was previously discharged from treatment at another narcotic treatment program, the admitting narcotic treatment program, with patient consent, shall contact the previous facility for the treatment history.
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Observations
Based on the review of patient records, the facility failed to contact the previous narcotic treatment facility for the patient's treatment history in six out of six patient records reviewed.
The findings include:
Fifteen patient records were reviewed on May 13 through 15, 2013. Six patient records contained information that indicated prior narcotic treatment experience and this required the facility to contact the prior narcotic treatment facility for the previous treatment history that was reported by the patient, specifically # 6, 7, 8, 11, 13 and 15.
The findings were reviewed with the project director, facility director, clinical director, clinical supervisor, medical director and management. The findings were not disputed.
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Plan of Correction
Effective immediately the Methadone Coordinator will meet with each client admitted to the NTP within 72 hours of admission to determine prior NTP history. The Methadone Coordinator will fax a release of information requesting previous treatment history from that provider. The Methadone Coordinator will file the fax confirmation on the client's chart. The Clinical Supervisor will audit this process for compliance and report monthly to the Chemical Dependency Dashboard.
This process will be audited by The Clinical Leadership Team via chart reviews for a period of 3 months. Results will be reported at the Chemical Dependency Dashboard for oversight and monitoring.
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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
Based on the review of patient records, the facility failed to obtain a complete initial drug-screen urinalysis from a CLIA and Department of Health approved laboratory in four of four patient records.
The findings include:
Fifteen patient records were reviewed on May 13 through 15, 2013. Four patient records reviewed required the completion of an initial drug-screening urinalysis prior to the administration of a narcotic agent, # 2, 7, 9 and 11.
Patient # 2 was admitted on March 25, 2013. The complete CLIA and Department of Health laboratory urinalysis results were received on March 27, 2013 at 8:00 a.m. The first dose of Methadone, a narcotic agent, was given to the patient on March 25, 2013, at 10:00 p.m. The facility failed to document a complete drug screen urinalysis prior to the administration a narcotic agent.
Patient # 7 was admitted on May 3, 2013. The complete CLIA and Department of Health laboratory urinalysis results were received on May 4, 2013 at 12:07 p.m.. The first dose of Suboxone, a narcotic agent, was given to the patient on May 4, 2013, at 9:00 a.m. The facility failed to document a complete drug screen urinalysis prior to the administration a narcotic agent.
Patient # 9 was admitted on January 4, 2013. The complete CLIA and Department of Health laboratory urinalysis results were received on January 5, 2013 at 12:05 p.m.. The first dose of Methadone, a narcotic agent, was given to the patient on January 5, 2013, at 9:00 a.m. The facility failed to document a complete drug screen urinalysis prior to the administration a narcotic agent.
Patient # 11 was admitted on April 13, 2013. The complete CLIA and Department of Health laboratory urinalysis results were received on April 15, 2013 at 3:41 p.m. The first dose of Methadone, a narcotic agent, was given to the patient on April 14, 2013. The facility failed to document a complete drug screen urinalysis prior to the administration a narcotic agent.
The findings were reviewed and confirmed with the Project Director.
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Plan of Correction
The NTP physician will be notified by the Methadone clerical staff when urine drug analysis lab confirmation results have been placed on the client chart and/or are available.
The Clinical Compliance Team will audit the NTP client charts for 4 months to monitor compliance with initial drug-screen urinalysis result availability (as documented as obtained by the nurse and/or hard laboratory copy) prior to ordering and administration of Methadone and or Suboxone.
Results of audits will be reported to the Executive Management Committee for oversight and monitoring. The standard will be reviewed at the next Medical Staff Organization meeting on June 20, 2013 for in-servicing and compliance purposes across Licensed Independent Practitioner staff. |
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
Based on the review of patient records, the facility failed to ensure that the narcotic treatment physician determined the proper dosage level in six of six patient records. Additionally, the narcotic treatment physician must document orders in accordance with applicable Federal and State Statues and regulations.
The findings include:
Fifteen patient records were reviewed on May 13 through 15, 2013. Six patient records were reviewed for the physician's documentation in determining the proper dose, specifically, # 2, 5, 9, 11, 13 and 15 had orders documented for determining the patient's dose for multiple days without physician assessment.
Patient # 2 was admitted on March 25, 2013, and received an initial dose of 10 mg of methadone on March 25, 2013, at 10:00 p.m. Documented in the patient record was an order dated March 25, 2013 for Methadone 10 mg PO tonight on arrival to unit, Methadone 5 mg in am 3/26. Methadone induction protocol for MMT. On March 26, 2013, an order was documented for Methadone 30 PO, 3/26/2013, Methadone PO 35 mg, 40 mg PO daily. On March 28, 2013, another order stated Methadone 45 mg PO 3/29, Methadone 50 mg PO 3/30, Methadone 55 mg PO daily. On April 3, 2013, an order was documented for Methadone 60 mg 4/4, 65 mg 4/5 and 4/6, 70 mg daily. On April 15, 2013, an order was documented for 75 mg 4/15, 80 mg 4/16, 85 mg daily. On May 10, 2013, an order was documented for 90 mg PO 5/11, 95 mg po 5/12 and 5/13, 100 mg PO daily. There was no documentation that the narcotic treatment physician continued to assess the patient to determine if an increase in the patient's dose was needed.
Patient # 5 was admitted on May 10, 2012, and received an initial dose of 20 mg of Methadone on May 10, 2012, at 5:00 p.m. Documented in the patient record was an order dated 5/10/2012, Methadone 20 mg now, Methadone 25 mg 5/11, Methadone 30 mg 5/12 and 35 mg 5/13 and keep at this dose. There was no documentation that the narcotic treatment physician continued to assess the patient to determine if an increase in the patient's dose was needed.
Patient # 9 was admitted on January 4, 2013, and received an initial dose of 30 mg of Methadone on 1/5/13 at 9:00 a.m. Documented in the record was an order written on 1/5/2013, Methadone induction protocol, Methadone 30 mg PO today 1/5, Methadone 35 mg PO once daily beginning 1/6. On 1/7/2013 an order was written to stop Methadone. Methadone 40 mg po 1/7 and 1/8, then 45 mg daily. There was no documentation that the narcotic treatment physician continued to assess the patient to determine if an increase in the patient's dose was needed.
Patient # 11 was admitted on April 13, 2013, for detoxification and received an initial dose of 30 mg of Methadone on 4/14/2013. There was a detox taper order written to received 30 mg on 4/14/2013, 25 mg 4/15, 20 mg 4/16, 15 mg 4/17, 10 mg 4/18, 5 mg 4/19. On 4/19/2013 an order was written for the patient to receive an additional 15 mg of Methadone today, 25 mg PO on 4/20, then 30 mg PO daily, Methadone induction protocol. On 4/22/2013 an order was written, stop Methadone, 35 mg po 4/23, then 40 mg PO daily. On 4/26/2013 an order was written, stop Methadone, Methadone 45 mg PO 4/27, then 50 mg PO daily. On 4/30/2013 an order was written, stop Methadone, Methadone 55 mg PO daily. There was no documentation that the narcotic treatment physician continued to assess the patient to determine if an increase in the patient's dose was needed.
Patient # 13 was admitted on April 26, 2013, for detoxification and completed a detox taper with Methadone on May 2, 2013. On May 6, 2013, an order was written to start a Methadone induction protocol, Methadone 30 mg po on 5/6, 35 mg 5/7, 40 mg 5/8 then 45 mg PO daily. On 5/9/2013 an order was written Methadone 50 mg PO 5/10, 55 mg 5/11, 60 mg 5/12, then 65 mg daily. There was no documentation that the narcotic treatment physician continued to assess the patient to determine if an increase in the patient's dose was needed.
Patient # 15 was admitted on November 14, 2012, and received an initial dose of 30 mg on November 14, 2012, at 11:00 a.m. An order was written on November 14, 2012, 30 mg PO on 11/14, 35 mg PO 11/15, 40 mg daily, Methadone induction protocol. An order was written on 11/16/2012 Methadone 45 mg 11/17, 50 mg 11/18, 55 mg daily. On November 21, 2012, 0900, an order was written for Methadone 60 mg 11/22, 65 mg 11/23, 70 mg daily. There was no documentation that the narcotic treatment physician continued to assess the patient to determine if an increase in the patient's dose was needed.
An interview was conducted with the medical director and confirmed that the physician did not assess the patient prior to the requested dose increases.
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Plan of Correction
The Narcotic Treatment Physician will assess the patient prior to Methadone Induction, Methadone Taper and Methadone Detox and where a narcotic will be utilized to assist in the treatment program.
The Narcotic Treatment Physician will assess/evaluate the patient prior to any Methadone dose increase. The Narcotic Treatment Physician will record the results of the assessment in the patient's clinical record.
The Licensed Independent Practitioner which includes Physicians, Nurse Practitioners, and Physician Assistants will also continue to monitor the patient's response to Methadone assisted treatment throughout the patient's course of stay to support and supplement the Narcotic Treatment Physician's monitoring of the patient.
The Licensed Independent Practitioner will report findings directly to the Narcotic Treatment Physician and document findings/actions in the patient's clinical record.
The Clinical Compliance Team will monitor the compliance of assessment and documentation of the patient's status that is required prior to any Methadone dosage increase for a period of 4 months. Results will be reported to the Medical Director and the Physician's Medical Committee Meeting weekly. Results will be reviewed at the Chemical Dependency Dashboard for assessment of quality improvement opportunities of the process and for adherence sustainability.
Results will be reported and reviewed at the Executive Management Committee level for overall oversight and monitoring. Challenges and variances detected if any will be addressed with the Narcotic Treatment Physician as it becomes detected for immediate correction and process improvement on an ongoing basis. |
715.20(3) LICENSURE Patient transfers
A narcotic treatment program shall develop written transfer policies and procedures which shall require that the narcotic treatment program transfer a patient to another narcotic treatment program for continued maintenance, detoxification or another treatment activity within 7 days of the request of the patient.
(3) The transferring narcotic treatment program shall document what materials were sent to the receiving narcotic treatment program.
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Observations
Based on a review of patient records, the narcotic treatment program failed to document what materials were sent to the receiving narcotic treatment program in one of two patient records.
The findings include:
Fifteen patient records were reviewed on May 13 through 15, 2013. Two records required documentation of the materials sent to the receiving provider of the transfer. Materials sent to the receiving narcotic treatment program were not documented in patient record #15.
The findings were reviewed and confirmed with the clinical director and Methadone coordinator.
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Plan of Correction
The Methadone Coordinator began on May 16, 2013 ensuring that documentation of materials sent to the receiving narcotic treatment program were evidenced on the client's clinical record in the form of a first person documentation or via fax confirmation of the materials sent.
The clinical leadership team will conduct audits on 15% of all transfer charts to determine compliance with this regulation. Audits will be conducted for the period of 3 months with results reported monthly to the Chemical Dependency Dashboard for monitoring and oversight.
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715.20(4) LICENSURE Patient transfers
A narcotic treatment program shall develop written transfer policies and procedures which shall require that the narcotic treatment program transfer a patient to another narcotic treatment program for continued maintenance, detoxification or another treatment activity within 7 days of the request of the patient.
(4) The receiving narcotic treatment program shall document in writing that it notified the transferring narcotic treatment program of the admission of the patient and the date of the initial dose given to the patient by the receiving narcotic treatment program.
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Observations
Based on a review of patient records, the narcotic treatment program failed to document that it notified the referring facility of admission and initial dose of the patient in three of six patient records.
The findings include:
Fifteen patient records were reviewed on May 13 through 15, 2013. Six records were reviewed for documentation of notification to the referring facility of the admission and dosing of the referred patient. Patient records # 4, 10 and 14 were referred by another narcotic treatment program and there was no documentation that the referring facility was notified of the admission and initial dosing of the patients.
The findings were reviewed and confirmed with the clinical director and Methadone coordinator.
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Plan of Correction
The Methadone Coordinator will fax within 72 hours a confirmation of admission and initial dosage. The Methadone Coordinator will file verification of its transmission and receipt on the patient clinical record notify the transferring narcotic treatment program of each client to the admitted NTP and the date of the initial dose given to the patient. The Methadone Coordinator will document this entry to the patient's clinical record by fax confirmation of notification or by notation if face confirmation is unavailable beginning on May 16, 2013.
The Clinical Leadership Team and Clinical Compliance Coordinator via chart audit will monitor compliance with this documentation for a period of 3 months. Results will be reported on a monthly basis for quality assurance purposes to the Chemical Dependency Dashboard.
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715.23(b)(15) LICENSURE Patient records
(b) Each patient file shall include the following information:
(15) Psychosocial evaluations of the patient.
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Observations
Based on the review of patient records, the facility failed to document psychosocial evaluations that provided a composite picture of the individual in relationship to the collected historical information in order to identify possible relationships, conditions and causes leading to the patient's current situation in ten of fifteen records.
The findings included:
On May 13-15, 2013, fifteen patient records were reviewed. All of the records were reviewed for the content of the psychosocial evaluation. Patient records # 1, 2, 7, 8, 9,10, 11, 12, 13 and 14 failed to include a psychological evaluation that included a composite picture of the client's problems and needs to be addressed in treatment, the client's assets and strengths, support systems, coping mechanisms, the negative factors that might inhibit treatment, and the counselor's impressions regarding the client.
Patient # 1 was admitted on 2/26/2013. The psychosocial evaluation was documented on 2/28/2013. The facility failed to document a psychosocial evaluation which included an assessment of the patient's problems/needs, assets/strengths, support systems and negative factors that might inhibit treatment.
Patient # 2 was admitted on 3/25/2013. The psychosocial evaluation was documented on 3/26/2013. The facility failed to document a psychosocial evaluation which included an assessment of the patient's problems/needs and support systems.
Patient # 7 was admitted on 5/3/2013. The psychosocial evaluation was documented on 5/6/2013. The facility failed to document a psychosocial evaluation which included an assessment that included a composite picture of the patient, an assessment of the patient's problems/needs, assets/strengths, support systems, and negative factors that might inhibit treatment.
Patient # 8 was admitted on 5/1/2013. The psychosocial evaluation was documented on 5/2/2013. The facility failed to document a psychosocial evaluation which included an assessment of the patient's problems/needs, assets/strengths, support systems, coping mechanisms and negative factors that might inhibit treatment.
Patient # 9 was admitted on 1/4/2013. The psychosocial evaluation was documented on 1/7/2013. The facility failed to document a psychosocial evaluation which included an assessment of the patient's support systems and coping mechanisms.
Patient # 10 was admitted on 3/19/2013. The psychosocial evaluation was documented on 3/20/2013. The facility failed to document a psychosocial evaluation which included an assessment of the patient's support systems and coping mechanisms.
Patient # 11 was admitted on 4/13/2013. The psychosocial evaluation was documented on 4/14/2013. The facility failed to document a psychosocial evaluation which included an assessment of the patient's assets/strengths, support systems, coping mechanisms, negative factors and attitude towards treatment. The psychosocial evaluation was identical to the evaluation documented in patient record # 13.
Patient # 12 was admitted on 5/7/2013. The psychosocial evaluation was documented on 5/9/2013. The facility failed to document a psychosocial evaluation which included an assessment of the patient's problems/needs, assets/strengths, support systems, coping mechanisms, negative factors that might inhibit treatment, attitude towards treatment, and counselor conclusions and impressions.
Patient # 13 was admitted on 4/26/2013. The psychosocial evaluation was documented on 4/27/2013. The facility failed to document a psychosocial evaluation which included an assessment of the patient's problems/needs, assets/strengths, support systems, coping mechanisms, negative factors and attitude towards treatment. The psychosocial evaluation was identical to the evaluation documented in patient record # 11.
Patient # 14 was admitted on 4/23/2013. The psychosocial evaluation was documented on 4/25/2013. The facility failed to document a psychosocial evaluation which included an assessment of the patient's problems/needs, assets/strengths, support systems, coping mechanisms, negative factors that might inhibit treatment, attitude towards treatment, and counselor conclusions and impressions.
This is a repeat citation from the November 26-29, 2012 licensing inspection.
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Plan of Correction
The facility will mandate Comprehensive Behavioral Evaluation training for all primary Therapists. Temporary (fill-in) Therapists from the agency will be required to demonstrate proficiency in Psychosocial evaluations prior to assignments of a caseload. Kirkbride Center's Primary Therapists will receive internal trainings provided by clinical leadership and external trainings provided by CBH and other training resources; seminars and workshops. Whenever possible, temporary staff will participate in internal trainings and in-services on psychosocial evaluation development. Kirkbride Center has hired two new full time Therapists to reduce the need of temporary staff. The Program Director has initiated one on one trainings with staff identified with weaknesses in this area as of May 16, 2013.
The Clinical Leadership Team partnering with Clinical Compliance will conduct chart audits weekly of 15% active MMT clinical records to monitor compliance. Results will be reported monthly to the Chemical Dependency Dashboard for a period of 3 months.
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715.28(c)(1-5) LICENSURE Unusual incidents
(c) A narcotic treatment program shall file a written Unusual Incident Report with the Department within 48 hours following an unusual incident including the following:
(1) Complaints of patient abuse (physical, verbal, sexual and emotional).
(2) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.
(3) Significant disruption of services due to a disaster such as a fire, storm, flood or other occurrence.
(4) Incidents with potential for negative community reaction or which the facility director believes may lead to community concern.
(5) Drug related hospitalization of a patient.
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Observations
Based on the review of administrative documentation, the facility failed to provide documentation of incident reports involving patient death and incidents with potential for negative community reaction to the Department.
The findings include:
Administrative documentation that included the unusual incident reports was reviewed May 13, 2013. Patient # 5 was admitted on May 10, 2012. The patient was pronounced dead on May 15, 2012. The facility did notify the Department by telephone on May 15, 2012 of the patient death, however, they failed to file a written incident report with the Department as required by the regulation.
An incident report dated April 11, 2013, for patient # 10 documented the patient had been disoriented and not alert during shift. The patient was found positive with contraband in a urine screen. The documentation noted the staff observed and monitored the patient throughout shift. The staff would continue to monitor and provide care. The patient was placed on lounge restriction for observation. Patient admitted to taking two Xanax. The unusual incidents were not reported to the Department as required.
This was discussed with the acting executive director at 1:00 p.m. on May 13, 2013, and confirmed the facility was not sending incident reports to the Department.
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Plan of Correction
The facility came under immediate compliance with regulation. Unusual incidents meeting the specified requirement will be called into The Department of Drug and Alcohol Programs Incident hot-line and followed by written report.
The Clinical Compliance Coordinator and Clinical Leadership Team will review all incident reports for their reportability to the Department of Drug and Alcohol Programs and other agencies. All incidents will be reviewed at Chemical Dependency Dashboard monthly for opportunities for improvement in processes and systems. This will be an ongoing Quality Improvement measure.
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705.8 (2) LICENSURE Heating and cooling.
705.8. Heating and cooling.
The residential facility:
(2) May not permit in the facility heaters that are not permanently mounted or installed.
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Observations
Based on observation while monitoring the medication administration process, the facility failed to have a heater that was permanently mounted or installed.
The findings include:
On May 14, 2013 during the medication administration process, a space heater was observed in the nursing station on Unit N-1. The heater was not permanently mounted or installed.
This finding was confirmed by the nursing shift supervisor at 9:25 a.m. on May 14, 2013 and was not disputed.
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Plan of Correction
The facility immediately removed the space heater and counseled the employee involved on safety hazards and maintaining a safe work environment on May 14, 2013. Kirkbride Center mandates fire safety training on hire and annual in-service.
The Facility Director will conduct weekly environment of care rounds to monitor fire safety compliance. Results will be reported monthly to the Safety Committee for quality assurance purposes. Results of Environment of Care rounds will be reviewed for a period of 4 months for oversight and compliance at the Safety Committe Meeting. Should a non compliance or safety hazard event is determined during the course of a round, the matter will be addressed immediately to re-store safety in real time.
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