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 buprenorphine, in the treatment of narcotic addiction. This inspection was conducted on June 7 through 9, 2010 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, ARS of Lancaster, LP 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 and a plan of correction is due on July 5, 2010.
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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 time sheets, census reports and interviews with the medical director and the facility director, the facility failed to provide at least one hour of physician time per week on site for every ten patients.
The findings include:
On June 7-9, 2010, census reports and physician time sheets were reviewed for the months of March, April, May, and June There were insufficient onsite physician hours in April.
During the week of March 29-April 4, 2010 the census was 337 patients and the facility was required to provide at least 33.7 physician hours on site. The facility documented a total of 13.5 physician hours during this time period.
During the week of April 5-11 , 2010 the census was 340 patients and the facility was required to provide at least 34 physician hours on site. The facility documented a total of 9 physician hours during this time period.
During the week of April 12-18, 2010 the census was 314 patients and the facility was required to provide at least 31.4 physician hours on site . The facility documented a total of 13.5 physician hours during this time period.
During the week of April 19-25, 2010 the census was 341 patients and and the facility was required to provide at least 3.41 physician hours on site. The facility documented a total of 13.5 physician hours during this time period.
In interviews with the medical director and the facility director, the medical coverage shortage during April was acknowledged.
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Plan of Correction
Medical Director and Executive Director will obtain a contract with another physician or group to provide backup coverage in the event of an emergency. This will completed by 7/30/2010. Medical Director will review schedules each month and ensure that there is adequate coverage. In the event that there is an emergency, and no other coverage is available, the Medical Director will provide the coverage. |
715.16(c)(1)(i-iv) LICENSURE Take-home privileges
(c) A narcotic treatment program shall require a patient to come to the narcotic treatment program for observation daily or at least 6 days a week for comprehensive maintenance treatment, unless a patient is permitted to receive take-home medication as follows:
(1) A narcotic treatment program may permit a patient to reduce attendance at the narcotic treatment program for observation to three times weekly and receive no more than a 2-day take-home supply of medication when, in the reasonable clinical judgment of the narcotic treatment physician, which is documented in the patient record:
(i) A patient demonstrates satisfactory adherence to narcotic treatment program rules for at least 3 months.
(ii) A patient demonstrates substantial progress in rehabilitation.
(iii) A patient demonstrates responsibility in handling narcotic drugs.
(iv) A patient demonstrates that rehabilitation progress would improve by decreasing the frequency of attendance for observation.
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Observations
Based on the review of administrative policies and procedures, patient records, and interviews with the medical director and facility director, the facility failed to follow the facility's policy regarding reduced attendance.
The findings include:
Sixteen patient records were reviewed on Jun 7-9, 2010. Eleven patient records were reviewed for reduced attendance at the facility. The policy and procedures states, "Approved Take Home Levels (Maximum); 90 days: Two take-home doses, attend clinic at least 3 days a week. Patient must have satisfactory adherence to 8 point criteria and program rules for at least 3 months, without interruption." Patient #5 was permitted one take home within two months, which does not follow the facility policy nor regulatory requirements for reduced attendance at the facility.
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Plan of Correction
Policy and Procedures for take home medication will be reviewed with all staff during medical/team meetings by 7/30/2010. The medical staff will audit 25 percent of the patients that have take home medication privileges for a three month period to ensure compliance. Continued compliance will be monitored through regular random chart audits by Clinical Supervisor, Lead Counselor and Peer Reviews. |
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 restrict the determination of a patient's dose to the physician.
The findings include:
Sixteen patient records were reviewed on Jun 7-9, 2010. Eleven patient records were reviewed for dose change orders. Patient records # 8 and 13 contained documentation and notes by the counselor to "suggest a blind taper of 2 mg" and "to increase dose by no more than 2 mg."
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Plan of Correction
Medical Director and Staff Physician are the only staff authorized to make recommendations regarding prescription medication. Non Medical staff will be re-trained to not recommend specific dose information during clinical team meeting. The form that patients complete regarding their medication changes will be changed to have a check box where the clinical team agrees or disagrees with the change request. This change and training will be in effect by 7/30/2010. Medical Director and Executive Director will monitor compliance through participation in meetings and ongoing chart audits. |
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 the annual physical to include a re-evaluation by the physician.
The findings include:
Sixteen patient records were reviewed on June 7-9, 2010. Five patient records were reviewed for documentation of an annual physical examination.
Patient #6 was admitted on 7/31/08. The most recent annual physical examination was completed on 10/27/09 and did not include a re-evaluation by the physician.
Patient # 8 was admitted on 2/22/07. There was no documentation of a current annual physical examination or a re-evaluation by the physician.
Patient #9 was admitted on 1/11/07. The most recent annual physical examination was completed on 3/3/10 and did not include a re-evaluation by the physician.
Patient # 12 was admitted on 5/5/09. There was no documentation of a current annual physical examination.
Patient #16 was admitted on 3/10/08. There was no documentation of a current annual physical examination.
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Plan of Correction
A complete audit of records will be completed by Medical staff by 8/1/10 to ensure that all annual History and Physicals are complete and up to date. The Physician Assistant and/or Director of Nursing will utilize Methasoft Scheduler to track physicals monthly from this point forward. Continued compliance will be monitored through regular random chart audits by Clinical Supervisor, Director of Nursing or his designee, Lead Counselor and Peer Reviews. |
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 complete annual evaluations in accordance the regulations.
The findings included:
Sixteen patient records were reviewed on June 7-9, 2010. Four patient records were reviewed for documentation of annual evaluations.
Patient #9 was admitted on 1/11/07. An annual evaluation was due on 1/11/10 but was not documented in the patient record until 2/1/10.
Patient # 16 was admitted on 3/10/08. An annual evaluation was due on 3/10/10 but was not documented in the patient record until 4/9/10.
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Plan of Correction
The policy regarding Annual Evaluations will be reviewed by Clinical Supervisor in Clinical Team Meeting by 7/15/2010. Clinical Supervisor will complete a random audit of 10% of clinical records for patients in treatment for more then one year for a period of 3 months to ensure compliance. Continued compliance will be monitored through regular random chart audits by Clinical Supervisor, Lead Counselor and Peer Reviews. |
715.29(5) LICENSURE Exceptions
A narcotic treatment program is permitted, at the time of application or any time thereafter, to request an exception from a specific regulation.
(5) If the exception relates to a specific patient, the narcotic treatment program shall maintain documentation of the exception in the patient 's record.
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Observations
Based on a review of patient records and interviews with the medical and facility directors, the facility failed to request an exception to provide take home bottles beyond the 6 take home bottles allowed by regulation.
The findings include:
Sixteen patient records were reviewed on June 7-9, 2010. Patient #9 was granted privileges to dose once weekly, providing the patient with 6 days of take home bottles. However, patient was on "split-dosing" giving the patient 13 take home bottles at one time. Patient #11 was granted privileges to dose twice weekly, providing the patient with 5 days of take home bottles. However, the patient was on "split-dosing", giving the patient 10 take home bottles at one time.
An exception request was not documented in either patient record.
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Plan of Correction
Policy and Procedures for Exceptions will be reviewed in Medical/Team meeting by 7/20/2010. All current exceptions will be reviewed to ensure facility is in compliance, this will be completed by 7/30/2010. All exceptions will be processed by Medical Director, per policy. All potential exceptions will be reviewed in medical/team meeting. Compliance will be monitored through regular chart audits. |