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 January 22, 2014, through January 23, 2014, by staff from the Department of Drug and Alcohol Programs, Program Licensure Division. 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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715.5(1-5) STANDARD Patient capacity
The Department may increase or decrease the number of patients a narcotic treatment program may treat. The Department may raise the patient capacity, upon the written request of the narcotic treatment program, based upon the Department 's review of the narcotic treatment program. The factors the Department will consider include:
(1) Safety. Considerations include dispensing time, internal patient flow and external traffic patterns.
(2) Physical facility. Considerations include the number and size of counseling offices, waiting areas, restrooms, and dispensing and nursing windows.
(3) Staff size and composition. Considerations include the number of narcotic treatment physicians, dispensing and counseling staff.
(4) Ability to provide required services. Considerations include compliance with licensing and narcotic treatment program regulations as determined during licensing, monitoring and special visits to the narcotic treatment program.
(5) Availability and accessibility of service. Considerations include the location of the narcotic treatment program and the hours of operation.
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Observations
Based on administrative documentation, the facility failed to maintain a census at or below the licensed capacity.
The findings included:
The administrative documentation that included the daily census and counselor caseloads was reviewed during the on-site monitoring visit. A review of presented documentation at the time of the inspection indicated the facility was currently providing outpatient maintenance treatment to 203 patients. The facility is licensed for 175 outpatient maintenance patients.
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Plan of Correction
The facility will remain in compliance as it relates to patient capacity by ensuring all clients receiving Suboxone treatment receive these services strictly under drug free outpatient setting throughout the client's length of stay. This practice will ensure that each LOC is captured under the correct licensed capacity.
This will continue to be monitored by the Program Director weekly to ensure each admission is correctly identified by LOC.
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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 and the physician patient schedule, the facility failed to provide at least one hour of physician time a week, on site, for every ten patients.
The findings included:
Physician time sheets and and census reports for the months of September, October, November and December, 2013, were reviewed on January 22, 2014. There were insufficient onsite physician hours during October. Additionally, during the observation of the dispensing area on January 23, 2014, the physician schedule included primarily patients not receiving outpatient maintenance services.
During the week of October 6-12, 2013, the patient census was 165 and 11 physician hours were documented of the required 16.5 physician hours.
During the week of October 20-26, 2013, the census was 170 patients and 15.25 physician hours were documented of the required 17 physician hours.
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Plan of Correction
The NT physician and extender will continue to provide services to clients according to regulation 1 physician hour for each ten patients during posted business hours weekly.
Monthly invoice documentation submitted to and reviewed by the Program Director will serve as evidence of compliance.
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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 one of one record reviewed.
The findings included:
Nine patient records were reviewed during the on-site monitoring review. One patient record required contacting the prior narcotic treatment facility for the previous treatment history that was reported by the patient, # 2.
Patient record # 2 contained documentation the patient had received narcotic treatment services at another narcotic treatment program. The facility failed to document contact with the previously attended narcotic treatment facility to obtain the patient's prior treatment history.
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Plan of Correction
The one deficient record will receive documentation of contact made via DAP note by February 25, 2015
Program Director will review program policies with all counselors concerning obtaining consents for previous treatment information. Information will be faxed following assessment and confirmation receipt will be included in client's chart. Review of policies will occur February 20, 2014.
Program Director, Clinical Supervisor and counselors will conduct random monthly chart reviews to ensure compliance.
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715.10(d) LICENSURE Pregnant patients
(d) Within 3 months after termination of pregnancy, the narcotic treatment physician shall enter an evaluation of the patient 's treatment status into her record and state whether she should remain in comprehensive maintenance treatment or receive detoxification treatment.
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Observations
Based on the review of patient records, the facility failed to ensure the narcotic treatment physician documented an evaluation of the patient's treatment status in one of one record.
The findings included:
Nine patient records were reviewed during the on-site monitoring review. One patient record required an evaluation within 3 months of the termination of pregnancy, # 6.
Patient # 6 was admitted on March 7, 2013. The narcotic treatment physician documented that the patient was pregnant on the assessment for admission. There was no other qualifying documentation of admission identified in the patient record. The record contained documentation of progression of the pregnancy and contact with the prenatal provider that identified a due date of June 2013. The patient record did not contain documentation of the termination of the pregnancy or an evaluation of the patient's treatment status at the time of the review.
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Plan of Correction
Required documentation was reviewed with the NTP on January 30, 2014.
The one deficient record will receive documentation of evaluation by February 27, 2014.
Nursing will conduct random monthly chart reviews of pregnant clients to ensure ongoing compliance.
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715.12(1-5) LICENSURE Informed patient consent
A narcotic treatment program shall obtain an informed, voluntary, written consent before an agent may be administered to the patient for either maintenance or detoxification treatment. The following shall appear on the patient consent form:
(1) That methadone and LAAM are narcotic drugs which can be harmful if taken without medical supervision.
(2) That methadone and LAAM are addictive medications and may, like other drugs used in medical practices, produce adverse results.
(3) That alternative methods of treatment exist.
(4) That the possible risks and complications of treatment have been explained to the patient.
(5) That methadone is transmitted to the unborn child and will cause physical dependence.
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Observations
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 in one of five records.
The findings included:
Nine patient records were reviewed during the on-site monitoring review. Five 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 record # 8.
Patient # 8 was admitted into treatment on August 22, 2013. The patient signed the informed, voluntary, written consent on September 5, 2013, after the initial administration of a narcotic agent.
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Plan of Correction
Program Director reviewed program policy regarding informed consent for the administration of an agent prior to it being administered with Nursing on February 20, 2014.
Program Director or Clinical Supervisor will conduct random monthly chart reviews to ensure ongoing compliance.
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715.16(b)(1-8) LICENSURE Take-home privileges
(b) The narcotic treatment physician shall consider the following in determining whether, in exercising reasonable clinical judgment, a patient is responsible in handling narcotic drugs:
(1) Absence of recent abuse of drugs (narcotic or non-narcotic), including alcohol.
(2) Regular narcotic treatment program attendance.
(3) Absence of serious behavioral problems at the narcotic treatment program.
(4) Absence of known recent criminal activity.
(5) Stability of the patient 's home environment and social relationships.
(6) Length of time in comprehensive maintenance treatment.
(7) Assurance that take-home medication can be safely stored within the patient 's home.
(8) Whether the rehabilitative benefit to the patient derived from decreasing the frequency of attendance outweighs the potential risks of drug diversion.
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Observations
Based on a review of patient records, the facility failed to ensure the narcotic treatment physician documented the determination of patient responsibility in handling narcotic drugs in one of three records.
The findings included:
Nine patient records were reviewed during the on-site monitoring review. Three patient records were reviewed for the narcotic treatment physician's determination of the patient responsibility of handling narcotic drugs.
Patient record # 8 documented a call back on November 1, 2013, that the patient failed due to not having all prescribed narcotic medication presented. The documentation noted the patient was not taking the narcotic medication as prescribed per the patient's report. Additionally, the patient tested positive for alcohol in the January 23, 2014, monthly urine drug screen. The documentation in the patient record indicated that the patient continued to receive take-home privileges.
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Plan of Correction
Program Director will review program policies concerning take-home privileges with all clinicians on February 20, 2014.
All clinicians will review the callback procedures relating to take-home privileges. Program Director will be required to sign off on all rescinds.
Program Director, Clinical Supervisor and Clinicians will conduct random chart reviews on a monthly basis to ensure documentation is completed and take-home policies are followed.
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715.17(a) LICENSURE Medication control
(a) A narcotic treatment program shall comply with applicable Federal and State statutes and regulations regarding the storing, compounding, administering and dispensing of medication.
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Observations
Based on a review of patient records, the facility failed to ensure the narcotic treatment physician complied with applicable Federal and State statutes and regulations regarding the storing, compounding, administering and dispensing of medication.
The findings included:
Nine patient records were reviewed during the on-site monitoring review. Two records reviewed were receiving Suboxone services at the facility. Documentation in patient record #9 revealed the narcotic treatment physician wrote a prescription that allowed for the patient to cut a suboxone strip in half. The prescription read: Suboxone 8/2 film, 2 1/2 strips, # 75. The suboxone packaging states that each strip is a dose. The The medication as prescribed by the facility physician is not consistent with the packaging directions.
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Plan of Correction
NTP reviewed regulations, policy and procedures and best practice principles regarding Suboxone maintenance prescriptions immediately following the audit.
Nursing and Medical Director will conduct random chart reviews on a monthly basis to ensure compliance is maintained.
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715.17(c)(1)(i-vi)) LICENSURE Medication control
(c) A narcotic treatment program shall develop and implement written policies and procedures regarding the medications used by patients which shall include, at a minimum:
(1) Administration of medication.
(i) A narcotic treatment physician shall determine the patient 's initial and subsequent dose and schedule. The physician shall communicate the initial and subsequent dose and schedule to the person responsible for the administration of medication. Each medication order and dosage change shall be written and signed by the narcotic treatment physician.
(ii) An agent shall be administered or dispensed only by a practitioner licensed under the appropriate Federal and State laws to dispense agents to patients.
(iii) Only authorized staff and patients who are receiving medication shall be permitted in the dispensing area.
(iv) There shall be only one patient permitted at a dispensing station at any given time.
(v) Each patient shall be observed when ingesting the agent.
(vi) Administering and dispensing shall be conducted in a manner that protects the patient from disruption or annoyance from other individuals.
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Observations
Based on observation of the dispensing area, the facility failed to ensure take home bottles are labeled accurately and that administering and dispensing are performed in a manner that protects the patient from disruption or annoyance from other individuals.
The findings included:
The dispensing area observation occurred on January 23, 2014, at approximately 9:30 a.m.
The computerized dispensing process included the printing of the medication label when a take home bottle is poured. The dispensing nurse poured six medication bottles and filled them with water. After dispensing the six bottles, the dispensing nurse removed the label from the backing and placed a label on each bottle. The process used by the dispensing nurse did not match the label to the bottle as it was poured.
Additionally, during the observation of the dispensing area, a patient received medication at one of the dispensing windows. The patient proceeded to remain in the medication area. This same patient stepped up to a second window in front of other patients waiting to receive their medication. The dispensing nurse did not redirect the patient away from the window so as to continue dispensing without disruption. Another patient was observed waiting in the medication area and was provided a prescription through the dispensing window between medicating other patients. These observations identified incidents of disruption during the administration of patient medication dosing.
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Plan of Correction
Director of Nursing and Program Director will review policy and regulations regarding appropriate labeling and dosing procedures and administering take home medication with nursing staff by March 3, 2014.
Director of Nursing and Program Director will ensure compliance by random observations of medication dispensing area during dosing hours.
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715.19(1) LICENSURE Psychotherapy services
A narcotic treatment program shall provide individualized psychotherapy services and shall meet the following requirements:
(1) A narcotic treatment program shall provide each patient an average of 2.5 hours of psychotherapy per month during the patient 's first 2 years, 1 hour of which shall be individual psychotherapy. Additional psychotherapy shall be provided as dictated by ongoing assessment of the patient.
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Observations
Based on a review of patient records, the facility failed to ensure each patient received an average of 2.5 hours of psychotherapy per month during the patient's first two years, one hour of which shall be individual psychotherapy in three of six records.
The findings included:
Nine patient records were reviewed during the on-site monitoring review. Six patient records were reviewed for the 2.5 hours of monthly psychotherapy during the first two years of treatment. Patient records # 1, 4 and 8 failed to meet the required hours.
Patient # 1 was admitted on August 28, 2013. The average therapy hours were reviewed for the months of October, November and December of 2013. The patient averaged 2.3 hours of psychotherapy per month for the three months reviewed.
Patient # 4 was admitted on March 28, 2013, and discharged on December 16, 2013. The average therapy hours were reviewed for the months of September, October and November of 2013. The patient averaged 2 hours of psychotherapy per month for the three months reviewed.
Patient # 8 was admitted on August 22, 2013. The average therapy hours were reviewed for the months of October, November and December of 2013. The patient averaged 1.83 hours of psychotherapy per month for the three months reviewed. Additionally, no individual psychotherapy occurred during October and December.
This is a repeat deficiency from the February 14, 2013, on-site monitoring visit.
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Plan of Correction
All counselors will continue to complete individual client tracking grids to record services provided. All clinicians will be required to provide documentation of any client not complying with treatment requirements and efforts made to engage client in clinical services.
Clinicians will continue to initiate behavior contracts and discuss problematic clients during weekly clinical team meetings.
Program Director will ensure compliance through bi-weekly monitoring of tracking grids and documentation submitted by clinicians.
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715.21(1)(i-iv) LICENSURE Patient termination
A narcotic treatment program shall develop and implement policies and procedures regarding involuntary terminations. Involuntary terminations shall be initiated only when all other efforts to retain the patient in the program have failed.
(1) A narcotic treatment program may involuntarily terminate a patient from the narcotic treatment program if it deems that the termination would be in the best interests of the health or safety of the patient and others, or the program finds any of the following conditions to exist:
(i) The patient has committed or threatened to commit acts of physical violence in or around the narcotic treatment program premises.
(ii) The patient possessed a controlled substance without a prescription or sold or distributed a controlled substance, in or around the narcotic treatment program premises.
(iii) The patient has been absent from the narcotic treatment program for 3 consecutive days or longer without cause.
(iv) The patient has failed to follow treatment plan objectives.
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Observations
Based on the review of patient records and administrative documentation, the facility failed to restrict the reasons for involuntary termination to those reasons allowed by regulation.
The findings include:
Nine patient records were reviewed during the on-site monitoring review as well as the grievance binder including involuntary terminations with appeals.
The grievance binder documented a patient was admitted on December 16, 2010. The documentation noted the patient was placed on a behavior contract/payment contract due to failure to follow financial agreement and had no payment since August 16, 2013. The narcotic treatment physician signed the involuntary discharge on August 27, 2013. The grievance binder contained documentation of the patient being discharged for reasons other than those listed by regulation.
The grievance binder documented a patient was admitted on October 11, 2012. The documentation noted the patient had illicit use, was placed on a behavior contract, was not attending clinical hours, and was offered inpatient. The narcotic treatment physician signed the involuntary discharge on December 26, 2013. The grievance binder contained documentation of the patient being discharged for reasons other than those listed by regulation.
The grievance binder documented a patient was admitted on June 20, 2013. The documentation noted the patient continued illicit use, was not completing counseling per month, and was disrespectful to staff members. The narcotic treatment physician signed the involuntary discharge on August 13, 2013. The grievance binder contained documentation of the patient being discharged for reasons other than those listed by regulation.
The grievance binder documented a patient was admitted on December 1, 2009. The documentation noted the patient was missing sessions for 4 consecutive months and missing dosing. The narcotic treatment physician signed the involuntary discharge on September 13, 2013. The grievance binder contained documentation of the patient being discharged for reasons other than those listed by regulation.
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Plan of Correction
If the need to discharge a client is evident, then the counselor will ensure documentation of efforts made to retain the client in treatment is identified in the client chart and the reason for discharge is clearly stated through the use of approved facility forms.
This information will be communicated to counselors by April 10, 2014 and performance will be monitored during review of discharge summaries and paperwork by the clinical supervisor and/or program director.
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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 a review of patient records, the facility failed to complete the annual physical with re-evaluation by the physician in two of two patient records reviewed.
The findings included:
Nine patient records were reviewed during the on-site monitoring review. Two patient records were reviewed for the results of an annual physical examination that included an annual re-evaluation by the narcotic treatment physician. The facility failed to document the annual physical exam in patient records # 3 and 5.
Patient # 3 was admitted on April 4, 2012, and discharged on October 29, 2013. An annual physical exam was to be completed by April 4, 2013. The record failed to include an annual physical exam at the time of the review.
Patient # 5 was admitted on March 9, 2011, and discharged on September 19, 2013. An annual physical exam was to be completed by March 9, 2013. The record failed to include an annual physical exam at the time of the review.
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Plan of Correction
Medical Director will review regulations regarding annual evaluations with NTP, nursing and CRNP by February 27, 2014.
Director of Nursing will conduct random chart reviews to ensure ongoing compliance.
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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 a review of patient records, the facility failed to document psychosocial evaluations in four of five records.
The findings included:
Nine patient records were reviewed during the on-site monitoring review. Psychosocial evaluations were reviewed in five patient records. The facility did not include evaluations in all the required areas in the psychosocial evaluation in patient records # 1, 2, 4 and 8.
Patient record # 1 included a psychosocial evaluation that was completed on August 28, 2013. The psychosocial evaluation was a repeat of patient history and did not include the clinical assessment of the patient.
Patient record # 2 included a psychosocial evaluation that was completed on September 2, 2013. The psychosocial evaluation was a repeat of patient history and did not include the clinical assessment of the patient. The psychosocial evaluation was due within 30 days of the July 30, 2013, admission date.
Patient record # 4 included a psychosocial evaluation that was completed on May 12, 2013. The psychosocial evaluation was due within 30 days of the March 28, 2013, admission date.
Patient record # 8 included a psychosocial evaluation that was completed on August 20, 2013. The psychosocial evaluation was a repeat of patient history which was identified as "patient reports" and did not include the clinical assessment of the patient.
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Plan of Correction
Program Director and Clinical Supervisor reviewed with Clinicians the regulations, policy and procedures regarding psychosocial evaluations on February 12, 2014.
Clinicians will be provided Informative Packets regarding Clinical Impressions on February 20, 2014.
Program Director will conduct monthly random chart reviews to ensure compliance.
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715.23(c)(1-7) LICENSURE Patient records
(c) An annual evaluation of each patient 's status shall be completed by the patient 's counselor and shall be reviewed, dated and signed by the medical director. The annual evaluation period shall start on the date of the patient 's admission to a narcotic treatment program and shall address the following areas:
(1) Employment, education and training.
(2) Legal standing.
(3) Substance abuse.
(4) Financial management abilities.
(5) Physical and emotional health.
(6) Fulfillment of treatment objectives.
(7) Family and community supports.
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Observations
Based on a review of patient records, the facility failed to complete annual evaluations in one of three records.
The findings included:
Nine patient records were reviewed during the on-site monitoring review. Three patient records required documentation of an annual clinical review.
Patient # 3 was admitted on April 4, 2012, and discharged on October 29, 2013. An annual clinical review was to be completed by April 4, 2013. The record failed to include an annual clinical review at the time of the review.
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Plan of Correction
Counselors will ensure they are completing clinical annual evaluations as required by regulation.
Expectation will be reviewed with clinicians by April 10, 2014.
Compliance will be monitored through random monthly open chart reviews conducted by the Program Director and/or clinical supervisor.
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715.23(d) LICENSURE Patient records
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
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Observations
Based on a review of patient records, the facility failed to complete a treatment plan that was individualized in five of five records.
The findings included:
Nine patient records were reviewed during the on-site monitoring review. Five patient records were reviewed for individualized treatment plans, # 1, 2, 4, 6 and 8. All patient records identified the type and frequency of services as 2.5 hours of individual therapy/group therapy. Patients # 2, 4 and 8 had urine drug screens positive for illicit substances with no change in type and frequency of services or implementation of goals to specifically address the issue of illicit use.
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Plan of Correction
All clinicians attended a training held by Corporate trainer regarding effective treatment plan writing on February 4, 2014.
All clinicians reviewed effective goal writing to individualize each plan to the specific client.
Program Director and Clinical Supervisor will conduct random monthly chart audits to ensure compliance.
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