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, in the treatment of narcotic addiction. This inspection was conducted on February 4, 2014 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Polaris Renewal Services, Inc 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)(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
Based on the review of patient records, the facility failed to document that the narcotic treatment physician documented in the patient's record the basis for the determination of current physiological dependency and evidence of a 1 year history of addiction in three of eight patient records. The findings include:Eleven patient records were reviewed on February 4, 2014. Eight patient records required documentation of the narcotic treatment physician's basis for the determination of current physiological dependency and evidence of a 1 year history of addiction. The facility failed to include documentation of the narcotic treatment physician's basis for the determination of current dependency and evidence of a 1 year history of addiction in patient records # 4, 5 and 7. Patient # 4 was admitted on October 30, 2013. The narcotic treatment physician conducted a physical examination on October 30, 2013 and noted the patient was "opiate dependent". There was no documentation of the physician's basis for the determination of current dependency or evidence of a 1 year history of addiction. Patient # 5 was admitted on November 12, 2013. The narcotic treatment physician conducted a physical examination on November 13, 2013 and noted the patient was "opiate dependent". There was no documentation of the physician's basis for the determination of current dependency or evidence of a 1 year history of addiction.Patient # 7 was admitted on November 4, 2013. The narcotic treatment physician conducted a physical examination on November 4, 2013 and noted the patient was "opiate dependent". There was no documentation of the physician's basis for the determination of current dependency or evidence of a 1 year history of addiction.The Project/Facility Director was interviewed on February 4, 2014 and confirmed the findings.
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Plan of Correction
The physician failed to document evident of current physiological dependency of three patients or that the treatment was medically justified in three patient records. It is the responsibility of the physician to document medical justification and document basis for determining physiological dependency for a patient in determining eligibility for MMT. The physician will review results of UA drug screen, meet face to face with patient to determine dependency and complete physician determination for opiate dependency prior to admission to program. The facility director has consulted with the physician related to the criteria located in 715.9[a] on 10/30/2013, 11/13/2013 and 11/04/2013. Oversight related to ongoing compliance will be the responsibility of the facility director. |
715.10(a)(1) LICENSURE Pregnant patients
(a) A narcotic treatment program may place a pregnant patient, regardless of age, who has had a documented narcotic dependency in the past and who may return to narcotic dependency, on a comprehensive maintenance regime.
(1) For these patients, evidence of current physiological dependence on narcotic drugs is not needed if a narcotic treatment physician certifies the pregnancy and, exercising reasonable clinical judgment, finds treatment to be medically justified.
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Observations
Based on the review of patient records, the facility failed to document evidence of current physiological dependency of a pregnant patient and/or that the treatment was medically justified in one of one patient record. The findings include:Eleven patient records were reviewed on February 4, 2014. One record was reviewed as a pregnant patient. The facility failed to include documentation of current physiological dependency or that the treatment was medically justified in patient record # 7. Patient # 7 was admitted on November 4, 2013. The narcotic treatment physician conducted a physical examination on October 30, 2013 and noted the patient was "opiate dependent". There was neither documentation of the physician's basis for the determination of current physiological dependency, nor was there documentation that the narcotic treatment physician found treatment to be medically justified.The Project/Facility Director was interviewed on February 4, 2014 and confirmed the findings.
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Plan of Correction
The physician failed to document evident of current physiological dependency of a pregnant patient or that the treatment was medically justified in one patient record. It is the responsibility of the physician to document medical justification and document basis for determining physiological dependency for a pregnant patient in determining eligibility for MMT. The physician will review results of UA drug screen, meet face to face with patient to determine dependency and complete physician determination for opiate dependency prior to admission to program. The facility director has consulted with the physician related to the criteria located in 715.10[a] on 02/14/14. Oversight related to ongoing compliance will be the responsibility of the facility director. |
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
Based on the review of patient records, the facility failed to 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 in one of one patient record. The findings include:Eleven patient records were reviewed on February 4, 2014. One record was reviewed as a pregnant patient. The facility failed to include documentation that the patient was fully informed of the possible risk to her or her unborn child in patient record # 7. Patient # 7 was admitted on November 4, 2013. The patient is pregnant. There was no documentation in the record to confirm that the patient was fully informed of the possible risks to her or her unborn child. The Project/Facility Director was interviewed on February 4, 2014 and confirmed the findings.
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Plan of Correction
The facility failed to document that a female patient was fully informed of the possible risk to her or her unborn child from continued use of illicit drugs and from use of, or withdrawal from a narcotic drug administered or dispensed by the program in comprehensive maintenance or detoxification treatment. It is the responsibility of the facility to ensure that each existing female is provided with the consent as part of the new intake process. On 02/14/14, the facility staff were thoroughly trained on the policies included in the consent form and all existing female patients were provided a copy of the consent form. Oversight related to ongoing compliance will be the responsibility of the facility director. |
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
Based on a review of patient records, the facility failed to obtain an informed, voluntary, written consent prior to the administration of a narcotic agent for maintenance treatment in five of eight patient records. The findings include:Eleven patient records were reviewed on February 4, 2014. Eight patient records were reviewed for the completion of an informed, voluntary written consent prior to the administration of a narcotic agent. The facility failed to document the completion of an informed, voluntary, written consent prior to the administration of a narcotic agent in patient records # 2, 3, 4, 5 and 8.Patient # 2 was admitted into treatment on June 29, 2013. The patient received their initial dose of methadone on June 29, 2013. The written consent to treatment was signed by the patient on July 9, 2013. Patient # 3 was admitted into treatment on August 1, 2013. The patient received their initial dose of methadone on August 1, 2013. The written consent to treatment was signed by the patient on August 7, 2013. Patient # 4 was admitted into treatment on October 30, 2013. The patient received their initial dose of methadone on October 30, 2013. The written consent to treatment was signed by the patient on August 31, 2013. Patient # 5 was admitted into treatment on November 12, 2013. The patient received their initial dose of methadone on November 13, 2013. The written consent to treatment was signed by the patient on December 24, 2013. Patient # 8 was admitted into treatment on July 8, 2013. The patient received their initial dose of methadone on July 8, 2013. The written consent to treatment was signed by the patient on July 31, 2013. The Project/Facility Director was interviewed on February 4, 2014 and confirmed the findings.
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Plan of Correction
The facility failed to obtain an informed, voluntary, written consent prior to the administration of a narcotic agent for maintenance treatment in five of eight patient records. The facility counselors are responsible for reviewing the Consent to Treatment Paperwork with new patients on the patient's day of admission, prior to the patient receiving their first dosage of medication. On 02/14/14, the facility director thoroughly trained facility staff on the policies included in the consent form, as well as those procedures related to the intake process, and all existing patients were provided a copy of the consent form. Oversight related to ongoing compliance will be the responsibility of the facility director. |
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 document that the narcotic treatment physician determined the patient's subsequent doses in one of nine patient records. The findings include:Eleven patient records were reviewed on February 4, 2014. Nine patient records were reviewed for the administration of medication. There was no documentation that the narcotic treatment physician determined the patient's subsequent doses in patient record # 2.Patient record # 2 was admitted on June 29, 2013. An order dated July 24, 2013 was for the patient to dose at 70 mgs. The patient was dosed at 80 mgs on August 25, 2013, at 70 mgs on October 21, 2013 and at 80 mgs on October 23, 2013. There were no documented orders for the changes in the patient's doses. An order dated October 30, 2013 was for the patient to be dosed at 80 mgs. The patient was dosed at 70 mgs on January 6, 2014 and 80 mgs on January 7, 2014. There were no documented orders for the changes in the patient's doses. The Project/Facility Director was interviewed on February 4, 2014 and confirmed the findings.
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Plan of Correction
The facility failed to document that the narcotic treatment physician determined the patient's subsequent doses in one of nine patient records. It is the responsibility of the physician to determine appropriate dose and schedule for those patients. After the physician has determined and documented the dose change order including his signature it is the responsibility of the nursing staff to implement his order. The facility director has provided training to both nursing staff and physician in this area. Ongoing compliance will be the responsibility of the facility director through regular review of medical records and ongoing consultation with medical director. |
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
Based on the review of patient records, the facility failed to provide each patient with an average of 2.5 hours of psychotherapy per month during the patient 's first 2 years in eight of ten patient records. The findings include: Eleven patient records were reviewed on February 4, 2014. Ten patient records reviewed required an average of 2.5 hours of psychotherapy per month. The facility failed to document an average of 2.5 hours of psychotherapy per month in patient records # 1, 2, 3, 4, 5, 6, 7 and 8. Patient # 1 was admitted on June 7, 2013 and required an average of 2.5 hours of psychotherapy per month. The patient received 1 hour of psychotherapy in November 2013, .5 hours in December 2013 and 1.5 hours in January 2014, for an average of 1 hour of psychotherapy per month. Patient # 2 was admitted on June 29, 2013 and required an average of 2.5 hours of psychotherapy per month. The patient received 1.5 hour of psychotherapy in November 2013, .5 hours in December 2013 and 2.5 hours in January 2014, for an average of 1.5 hours of psychotherapy per month. Patient # 3 was admitted on August 1, 2013 and required an average of 2.5 hours of psychotherapy per month. The patient received 1 hour of psychotherapy in November 2013, .5 hours in December 2013 and 1.5 hours in January 2014, for an average of 1 hour of psychotherapy per month. Patient # 4 was admitted on October 30, 2013 and required an average of 2.5 hours of psychotherapy per month. The patient received 1.5 hour of psychotherapy in November 2013, .5 hours in December 2013 and 1.5 hours in January 2014, for an average of 1.16 hours of psychotherapy per month. Patient # 5 was admitted on November 12, 2013 and required an average of 2.5 hours of psychotherapy per month. The patient received .5 hours in December 2013 and 1 hour in January 2014, for an average of .75 hours of psychotherapy per month. Patient # 6 was admitted on October 11, 2012 and required an average of 2.5 hours of psychotherapy per month. The patient received 0 hours of psychotherapy in November 2013, .5 hours in December 2013 and 2 hours in January 2014, for an average of .833 hours of psychotherapy per month. Patient # 7 was admitted on November 4, 2013 and required an average of 2.5 hours of psychotherapy per month. The patient received 2 hours of psychotherapy in November 2013, 1 hour in December 2013 and 1 hour in January 2014, for an average of 1.33 hours of psychotherapy per month. Patient # 8 was admitted on July 8, 2013 and required an average of 2.5 hours of psychotherapy per month. The patient received 1 hour of psychotherapy in November 2013, .5 hours in December 2013 and 1.5 hours in January 2014, for an average of 1 hour of psychotherapy per month. The Project/Facility Director was interviewed on February 4, 2104 and confirmed the findings.
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Plan of Correction
CORRECTIVE ACTION:
1.The facility will provide an average of 2.5 hours of psychotherapy per month during the patient's first 2 years of participation in the MMT program.
SYSTEMIC/PREVENTATIVE CHANGES:
1.On 02/05/2014, auditing was implemented of all clinical charts. Director and Counselors audited charts, flagging those patients who were not in compliance with treatment program standards. Those patients not fulfilling 2.5 hours of psychotherapy per month were placed on compliance contracts. Furthermore, an additional Full-time Counselor was hired on 01/20/2014, increasing the availability of treatment, contact hours.
MONITORING/QUALITY ASSURANCE:
1.The Director and Counselors will continue to complete bi-annual chart audits, quarterly case consults, weekly clinical supervision meetings, reviewing the frequency of treatment, ensuring that patients are complying to program standards and are fulfilling the required 2.5 hours of psychotherapy per month during the patient's first 2 years of participation in the MMT program.
DATE OF COMPLETION: Ongoing
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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 the review of patient records, the facility failed to 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 in two of two patient records. The findings include:Eleven patient records were reviewed on February 4, 2014. Two patient records were reviewed for documentation of notification to the transferring facility of the admission and initial dose of the transferred patient. There was no documentation of the transferring narcotic treatment program being notified of the admission and initial dose given to the patient in patient records # 1 and 8. Patient #1 was a transfer from another treatment facility and was admitted on June 7, 2013. The documentation for the notification of the transfer indicated that the patient would be admitted and would be dosed. The facility failed to document both the date the patient was admitted and the date of the patient's initial dose. Patient # 8 was a transfer from another treatment facility and was admitted on July 8, 2013. The facility failed to document in the record that it had notified the transferring narcotic treatment program of the admission of the patient and the date of the initial dose given to the patient. The Project/Facility Director was interviewed on February 4, 2014 and confirmed the findings.
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Plan of Correction
CORRECTIVE ACTION:
1.Upon receiving the transfer of a patient from another narcotic treatment program, upon admission of a patient, the 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.
SYSTEMIC/PREVENTATIVE CHANGES:
1.Medical Director and Nurses audited medical charts, flagging any inconsistencies in transfer records. Paperwork utilized to notify transferring narcotic treatment programs was revised on 02/05/2014 to notify transferring narcotic treatment program of the admission of the patient and date of the initial dose.
MONITORING/QUALITY ASSURANCE:
1.The Medical Director and Nursing Staff will continue to complete semi-annual chart audits, reviewing that transfer paperwork is properly documented, notating the patient's medication dose, while also ensuring that all other paperwork is up to date.
DATE OF COMPLETION: Ongoing |
715.23(b)(5) LICENSURE Patient records
(b) Each patient file shall include the following information:
(5) The results of all annual physical examinations given by the narcotic treatment program which includes an annual reevaluation by the narcotic treatment physician.
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Observations
Based on the review of patient records, the facility failed to document an annual physical evaluation by the narcotic treatment physician in three of three patient records. The findings include:Eleven patient records were reviewed on February 4, 2014. Three patient records required an annual physical evaluation. The facility failed to document an annual physical evaluation in patient records # 6, 9 and 11. Patient # 6 was admitted on October 11, 2012. An annual physical evaluation by the narcotic treatment physician was due to be completed by October 11, 2013. There was no documentation of an annual physical evaluation as of February 4, 2014. Patient # 9 was admitted on October 11, 2012. An annual physical evaluation by the narcotic treatment physician was due to be completed by October 11, 2013. There was no documentation of an annual physical evaluation as of February 4, 2014. Patient # 11 was admitted on December 13, 2012. An annual physical evaluation by the narcotic treatment physician was due to be completed by December 13, 2013. There was no documentation of an annual physical evaluation as of February 4, 2014. The Project/Facility Director was interviewed on February 4, 2014 and confirmed the findings.
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Plan of Correction
CORRECTIVE ACTION:
1.Physicals will be completed on an annual basis by a narcotic treatment physician for all patients enrolled in the MMT program.
SYSTEMIC/PREVENTATIVE CHANGES:
1.Nursing staff audited medical charts on 02/05/2014, flagging any patients who needed to have their annual physicals updated and appointments were scheduled for those patients. As of 02/14/2014, Medical Director is providing an additional day of physician services at the facility. Quarterly audits will continually be completed by the M.D. and nursing to ensure that physicals are current.
MONITORING/QUALITY ASSURANCE:
1.The Medical Director and Nursing Staff will continue to complete quarterly chart audits, reviewing the services that have been rendered to patients, including annual physical dates, ensuring that all labs and/or other paperwork is up to date.
DATE OF COMPLETION: Ongoing
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715.23(b)(14) LICENSURE Patient records
(b) Each patient file shall include the following information:
(14) Case consultation notes regarding the patient.
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Observations
Based on the review of patient records, the facility failed to document quarterly case consultations in eight of eight patient records. The findings include:Eleven patient records were reviewed on February 4, 2014. Eight patient records required quarterly case consultations. The facility did not document quarterly case consults in patient records # 1, 2, 3, 6, 8, 9, 10 and 11. Patient # 1 was admitted on June 7, 2013. Quarterly case consultations were to be completed by September 30 and December 31, 2013. There were no case consultations documented. Patient # 2 was admitted on June 29, 2013. Quarterly case consultations were to be completed by September 30 and December 31, 2013. There were no case consultations documented. Patient # 3 was admitted on August 1, 2013. A quarterly case consultation was to be completed by December 31, 2013. There was no case consultation documented. Patient # 6 was admitted on October 11, 2012. An annual case consultation was to be completed by October 11, 2013. There was no documented annual case consultation.Patient # 8 was admitted on July 8, 2013. A quarterly case consultation was to be completed by December 31, 2013. There was no case consultation documented. Patient # 9 was admitted on September 7, 2012. An annual case consultation was to be completed by September 7, 2013. There was no documented annual case consultation.Patient # 10 was admitted on January 3, 2013. Quarterly case consultations were to be completed by June 30, September 30 and December 31, 2013. There were no case consultations documented.Patient #11 was admitted on December 13, 2012. An annual case consultation was to be completed by December 13, 2013. There was no documented annual case consultation. The Project/Facility Director was interviewed on February 4, 2014 and confirmed the findings.
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Plan of Correction
The facility failed to document case consultation notes in eight of eight patient records. The facility director conducted in service training focusing on the ensuring complete client records that include case consultation on 02/21/14. Ongoing compliance will be the responsibility of the facility director and will be monitored through daily individual record review and weekly clinical supervision. Ongoing in service trainings will occur as needed to ensure ongoing compliance. |
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
Based on the review of patient records, the facility failed to document an annual evaluation of each patient's status, completed by the patient 's counselor, and reviewed, dated and signed by the medical director in two of four patient records. The findings include:Eleven patient records were reviewed on February 4, 2014. Four patient records required documentation of an annual evaluation by the patient's counselor. The facility failed to document an annual evaluation in patient records # 9 and 11. Patient # 9 was admitted on September 7, 2012 and an annual evaluation was to be completed by September 7, 2013. The facility failed to document an annual evaluation as of February 4, 2014. Patient # 11 was admitted on December 13, 2012 and an annual evaluation was to be completed by December 13, 2013. The facility failed to document an annual evaluation as of February 4, 2014.The Project/Facility Director was interviewed on February 4, 2014 and confirmed the findings.
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Plan of Correction
CORRECTIVE ACTION:
1.Annual Evaluations will be completed on an annual basis by the patient's counselor for all patients enrolled in the MMT program. The completed evaluation will be signed/dated by the counselor and medical director.
SYSTEMIC/PREVENTATIVE CHANGES:
1.Director and Counselors audited clinical charts, flagging any patients who needed to have their annual evaluations updated. Audits will continually be completed by the Director and Counselors to ensure that Annual Evaluations are current.
MONITORING/QUALITY ASSURANCE:
1.The Director and Counseling Staff will continue to complete semi-annual chart audits, reviewing the services that have been rendered to patients, including annual evaluation dates, ensuring that all paperwork is up to date.
DATE OF COMPLETION: Ongoing
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