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 July 5 through July 7, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Pyramid Healthcare York Pharmacotherapy Services 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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715.6(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
Based on the review of administrative documentation, the facility failed to provide at least one hour of physician time a week, on site for, every ten patients for seven of the seventeen weeks reviewed.
The findings include:
Physician time sheets for the months of March, April, May and June were reviewed on July 5, 2011. Seventeen weeks were reviewed along with the average census for those weeks. Seven weeks provided insufficient onsite physician hours during March, April, May and June.
During the week of March 27 through April, 2, 2011, the patient census was 148. The facility was required to provide at least 14.8 physician hours. There were 12.25 physician hours documented. The amount of physician hours documented did not meet the required hours.
During the week of April 17 through April 23, 2011, the patient census was 153. The facility was required to provide at least 15.3 physician hours. There were 13 physician hours documented. The amount of physician hours documented did not meet the required hours.
During the week of May 1 through May 7, 2011, the patient census was 157. The facility was required to provide at least 15.7 physician hours. There were 12 physician hours documented. The amount of physician hours documented did not meet the required hours.
During the week of May 22 through May 28, 2011, the patient census was 164. The facility was required to provide at least 16.4 physician hours. There were 14 physician hours documented. The amount of physician hours documented did not meet the required hours.
During the week of May 29 through June 4, 2011, the patient census was 167. The facility was required to provide at least 16.7 physician hours. There were 10.75 physician hours documented. The amount of physician hours documented did not meet the required hours.
During the week of June 5 through June 11, 2011, the patient census was 166. The facility was required to provide at least 16.6 physician hours. There were 11.5 physician hours documented. The amount of physician hours documented did not meet the required hours.
During the week of June 19 through June 25, 2011, the patient census was 166. The facility was required to provide at least 16.6 physician hours. There were 14 physician hours documented. The amount of physician hours documented did not meet the required hours.
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Plan of Correction
Physicians have been instructed to document exact hours of service on their timesheet to ensure compliance with 715 regulations as it relates to physician to client ratio and have been retrained on the weekly requirement.
Compliance will be monitored by the program director weekly when reviewing and receiving physician schedules and timesheets. |
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.
The findings include:
Twenty-four patient records were reviewed on July 5-7, 2011. Six patient records required 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 record # 6. Additionally, patient # 15 signed their form after the administration of a narcotic agent.
Patient # 6 was admitted into treatment on April 29, 2011. The patient received their initial dose of methadone on April 29, 2011. There was no documentation of an informed, voluntary written consent prior to the administration of a narcotic agent in patient record # 6.
Patient # 15 was admitted into treatment on May 16, 2011. The patient received their initial dose of methadone on May 16, 2011. The documentation of an informed voluntary written consent to treatment with a narcotic agent was not signed until May 19, 2011. This was three days after the initial dose.
The counselor for patient # 6 was interviewed on July 5, 2011 and confirmed that the written consent for treatment had not been obtained since the client's readmission into treatment on April 29, 2011.
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Plan of Correction
All staff will be retrained on the intake process which includes having clients sign written consent for treatment and the use of a narcotic agent. Nursing staff will review and present consent during the nursing assessment which will be verified by the physician prior to the initial dose being aministered. Compliance will be monitored by the program director and DON (or designee) through random monthly audits of medical files and evidenced by written consents that have client signatures and dates prior to or same day of initial dose being administered. |
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 a review of patient records and an interview with the narcotic treatment physician, the facility failed to ensure that the patient was initially dosed following the completion of a drug-screen urinalysis in three of eight patient records.
The findings included:
Twenty-four patient records were reviewed on July 5-7, 2011. Eight patient records were reviewed for drug screen urinalysis results prior to a patient's initial dose. Per regulation, a narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter. The facility failed to document the completion of a drug screen urinalysis prior to dosing in patient records # 2, 5, and 11.
Patient # 2 was admitted into treatment on January 26, 2011. Patient # 2 received a dose of 30 mg on January 26, 2011 at 11:50 a.m. The urinalysis results were not received by the the facility until 8:20 p.m. on January 26, 2011. The patient was dosed prior to the completion of drug urinalysis results.
Patient # 5 was admitted into treatment on April 27, 2011. Patient #5 received a dose of 30 mg on April 27, 2011. The urinalysis results were provided on March 31, 2011. The urinalysis results were obtained prior to dosing on March 31, 2011; however, there were 26 days between the urine results and the date of dosing. The facility failed to have a current urine test result prior to dosing in patient record # 5.
Patient # 11 was admitted on 4/15/2011. Patient # 11 received a dose of 30 mg on April 15, 2011 at 10:58 a.m. The urinalysis results were not received by the the facility until 12:52 p.m. on April 15, 2011. The patient was dosed prior to the completion of drug urinalysis results.
An interview with the narcotic treatment physician took place on July 6, 2011 and confirmed that the urinalysis results may not be back prior to dosing.
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Plan of Correction
As a best practice standard, the facility will ensure that all clients have a urine screen completed and results will not be greater than 72 hours prior to the initial dose being given. Nursing and physician staff will be trained to this and compliance will be evidenced by dated lab results and monitored through random monthly medical chart audits conducted by the program director or desginee. |
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 a review of patient records, the facility failed to provide each patient an average of 2.5 hours of psychotherapy per month during the patient's first 2 years of treatment in 4 of 14 records.
The findings include:
Twenty-four patient records were reviewed July 5-7, 2001. Fourteen patient records were reviewed for psychotherapy hours during the first year of treatment. Patient records # 3, 8, 12 and 18 failed to have the average of 2.5 hours of psychotherapy per month during their first 2 years of treatment.
Patient # 3 was admitted June 18, 2010 and discharged April 8, 2011. The average psychotherapy hours were reviewed for the months of January, February and March of 2011. The patient averaged .83 hours of psychotherapy for the three months reviewed.
Patient # 8 was admitted June 9, 2011. The average therapy hours were reviewed for the months of April, May and June of 2011. The patient averaged 2.25 hours of psychotherapy for the three months reviewed.
Patient # 12 was admitted December 12, 2010 and discharged on March 30, 2011. The average therapy hours were reviewed for the months of January, February and March 2011. The patient averaged 2.33 hours of psychotherapy for the three months reviewed.
Patient # 18 was admitted August 10, 2010. The average therapy hours were reviewed for the months of April, May and June of 2011. The patient averaged 2.16 hours of psychotherapy for the three months reviewed.
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Plan of Correction
All counselors will be retrained on counseling guidelines and requirements for clients in methadone treatment and on the importance of thorough documentation to support all efforts and attempts made to engage each client in treatment. Each counselor is required to maintain a client tracking tool whereas the frequency of service is identified and tracked. This tracking tool will be reviewed at least twice a month by the program director to ensure compliance with counseling regulations. The program director will also conduct random monthly chart audits to ensure documentation supports efforts made by counselor. Results of both reviews will be discussed with the counselor during regular supervision. |
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 a review of the patient records, the facility failed to document the signature of the medical director on the annual evaluation in one of the seven records reviewed. Also, two of the seven required annual evaluations were not completed by the facility.
The findings include:
Twenty-four patient records were reviewed on July 5-7, 2011. Seven of the twenty-four patient records were required to include an annual evaluation. One of the seven records failed to include the medical director's signature on the annual evaluation and two of the seven records failed to have an annual evaluation documented in the record.
Patient record # 8 was admitted to treatment on June 18, 2009. The annual evaluation was completed on June 8, 2011. The evaluation was not signed by the medical director as required.
Patient record # 23 was admitted to treatment on December 16, 2008. The annual evaluation was due by December 16, 2010. The last annual evaluation in the patient record was documented on December 6, 2009. The facility failed to document a current annual evaluation in the patient record at the time of the inspection.
Patient record # 24 was admitted to treatment on November 30, 2008. The annual evaluation was due by November 30, 201. The last annual evaluation in the patient record was documented on November 30, 2009. The facility failed to document a current annual evaluation in the patient record at the time of the inspection.
An interview with the staff confirmed these findings. Also, an interview with the intake counselor confirmed that the annual evaluation was not in the client record as required.
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Plan of Correction
All staff will be retrained on the process of annual evaluations. Compliance will be monitored and evidenced by dated annual evaluation forms. The program director (designee) will conduct random monthly chart audits and discuss results with the counselor during regular scheduled supervision. |