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 November 13, 14, and 15, 2007 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, RHD Montgomery County Methadone Center was found not to be in compliance with the applicable chapters of 28 PA Code which pertain to the facility. Deficiencies were identified during this inspection and plan of corrections are due on December 18, 2007.
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Plan of Correction
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715.10(c) LICENSURE Pregnant patients
(c) Counseling records and other appropriate patients records shall reflect the nature of prenatal support provided by the narcotic treatment program.
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Observations
The facility failed to provide documentation of prenatal support provided by the facility. Patient # 2 became pregnant while in treatment but there is no documentation of prenatal support offered to patient by physician or clinician.
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Plan of Correction
An inservice will be held by the Program Director with MCMC staff to instruct the staff regarding proper document of prenatal support offered patient by MCMC staff.
Time for Completion: January 16, 2008 |
715.11 LICENSURE Confidentiality of patient records
A narcotic treatment program shall physically secure and maintain the confidentiality of all patient records in accordance with 42 CFR 2.22 (relating to notice to patients of Federal confidentiality requirements) and § 709.28 (relating to confidentiality).
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Observations
The facility failed to maintain the confidentiality of patient # 4 when it was stated on a release of information that drug testing results could be shared with the patient's probation officer.
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Plan of Correction
An Inservice will be held with MCMC Staff by Program Director to review the 255.5 confidentiality regulations and adherence to these regualtions.
Time for Completion: January 16, 2008 |
715.15(a) LICENSURE Medication Dosage
(a) The narcotic treatment physician shall review the dosage levels at least twice a year, with each review occurring at least 2 months apart, to determine a patient 's therapeutic dosage.
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Observations
The facility failed to document that the physician reviewed the dose levels for patients #1, 2, 5, 6, and 11; specifically, the physician's assistant, not the physician, made entries into patient charts regarding medication reviews. Only the physician can do this.
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Plan of Correction
A meeting will be held between the Program Director and the Physician and Physician Assistant to address the delineation of duties between the latter to insure that the Physician alone is responsible for reveiw of dose level changes.
Time for Completion: January 16, 2008 |
715.15(b) LICENSURE Medication dosage
(b) The narcotic treatment physician shall determine the proper dosage level for a patient, except as otherwise provided in this section. If the narcotic treatment physician determining the initial dose is not the narcotic treatment physician who conducted the patient examination, the narcotic treatment physician shall consult with the narcotic treatment physician who performed the examination before determining the patient 's initial dose and schedule.
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Observations
The facility failed to document the physician's determination of the initial dose for patients # 2, 6, and 7; specifically, there were no initial orders in the patients' charts. Additionally, a review of patient dosing levels revealed that for patients # 1, 2, 3, 5, 6, 7, 11, and 25 the physician's assistant, not the physician, determined dosing levels. Only the physician can do this.
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Plan of Correction
A meeting will be held between the Program Director and the Physician and Physician Assistant to address the delineation of duties between the latter to insure that the Physician alone is responsible for reveiw of dose level changes. Further, Initial Orders for the aforementioned clients were actually done at the proper time and it was discovered that they had not been filed in the charts by nursing at the time of monitoring. In the future, these Initial orders will be properly completed and filed in a timely fashion.
Time for Completion: January 16, 2008 |
715.16(c) 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:
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Observations
The facility failed to secure written prior approval from the Division of Drug & Alcohol Program Licensure before granting patients 13 day take home exceptions, specifically patients # 11, 12, 19, and 27 all received 13 day take homes without exception from the Division. The facility exceeded the number of days permitted for take-home doses for patient # 27. Specifically, this patient was to come to the clinic on a holiday. Instead of adjusting the dosing day, the facility gave 13 take-home doses. The dosing day may not be extended beyond the number of approved take-home doses. If a patient's dosing day is a holiday or a vacation day, the patient will need to come to the facility before the holiday or vacation day.
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Plan of Correction
An inservice will be held to review the proper procedures and criteria for written approval from the Division of Drug and Alcohol prior to granting 13 day Take Home Bottle Priveleges.
Time for Completion: January 16, 2008 |
715.16(f) LICENSURE Take-home priveleges
(f) An exception granted under subsection (d) shall continue only for as long as the temporary disability or exceptional circumstance exists. When a patient is permanently disabled, that case shall be reviewed at least annually to determine whether the need for the exception still exists.
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Observations
The facility failed to provide annual documentation for patient # 12 that an exceptional circumstance still existed to qualify patient for thirteen day take home status. The physician needs to make this determination and document the same.
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Plan of Correction
An inservice will be held by the Program Director with the staff and Physician to insure that the physician is determining and documenting the need for 13 day medical exceptions as well as the need for state approval of these exceptions.
Time for Completion: 1/16/08 |
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
The facility failed to document the physician's order for the initial dose for patients #2, 6, and 7. The facility also failed to maintain dose reviews determined by the physician. Specifically, patients # 1, 2, 3, 5, 6, 7, 11 and 25 had their dosing levels monitored by the physician's assistant. The physician's assistant also made specific dose recommendations to the physician and the physician routinely followed the recommendations. The physician must make the determination of dose and schedule.
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Plan of Correction
A meeting will be held between the program director, the physician and the physicians assistant to delineate the duties and responsibilities of each and the need for the physician soley to make determinations regarding patients doses as well as the need for the appropriate documention of all dosing levels.
Time for Completion: 1/16/08 |
715.17(c)(6)(i-iv) 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:
(6) Inventories. A narcotic treatment program shall conduct monthly inventories of agents and other controlled substances stored. Each inventory record shall include:
(i) The date the inventory was conducted.
(ii) The time of day it was conducted.
(iii) The name and amount of each product on hand at the time of the inventory.
(iv) The name of the individual conducting the inventory.
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Observations
The facility failed to provide a policy regarding inventories that was consistent with their practice; specifically, the policy stated the inventories would be conducted quarterly while the nurses provided daily inventories. The facility must conduct inventories at least monthly.
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Plan of Correction
The policy regarding inventories will be changed by the program director to reflect monthly inventories by nursing.
Time for Completion: 1/16/2007 |
715.18(b) LICENSURE Rehabilitative services
(b) A patient shall also have the opportunity to access legal services.
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Observations
The facility was unable to demonstrate that legal services could be made available to patients as needed.
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Plan of Correction
A referral agreement between MCMC and Legal Aid Society has been drawn up and mailed to Legal Aid Society for signature and will be palced on file.
Time for Completion: Completed |
715.21 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.
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Observations
The facility failed to have a policy and procedure that addressed involuntary termination that included only those reasons provided in the standards. The facility's patient handbook identified reasons for involuntary termination that exceeded the standards and included issues such as discharge for positive urine drug screen, falsification of urine sample and tampering with the security system.
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Plan of Correction
The policy and procedure regarding involuntary discharge will be amended by the program director to reflect only the reasons set forth by the standards.
Time for Completion: 1/16/2007 |
715.23(b)(13) LICENSURE Patient records
(b) Each patient file shall include the following information:
(13) Patient record of services.
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Observations
The facility failed to provide patient record of services that were consistent with progress notes for patients #2, 5, 6, 9, and 11.
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Plan of Correction
An Inservice will be held by the program director and the MCMC staff to address the need for the proper completion of the client service log to reflect the actual services done.
Time for Completion: 1/16/2007 |
715.23(b)(22) LICENSURE Patient records
(b) Each patient file shall include the following information:
(22) Aftercare plan, if applicable.
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Observations
The facility failed to provide aftercare plans for patients # 13, 14, 15, 21 and 24; aftercare plans contained in the patients' charts were done at admission and did not address the specifics of patient needs to be pursued following the conclusion of treatment.
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Plan of Correction
MCMC Aftercare policy will be revised by the program director to more accurately reflect specific needs for patients. These will be done at the beginning of treatment and at discharge. An inservice will be held to address the proper time frames and completion of these plans.
Time for Completion: 1/16/08 |
715.23(b)(24) LICENSURE Patient records
(b) Each patient file shall include the following information:
(24) Follow-up information regarding the patient.
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Observations
The facility failed to provide discharge summaries for patients # 14, 15, 16 and 21, that included the specific reasons of seeking treatment at this time and a review of the patient's progress in treatment including the treatment objectives that were met/unmet while in treatment.
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Plan of Correction
An inservice will be held by the program director to address discharge summaries and the proper documentation of patient's progress in treatment including treatment objectives.
Time for Completion: 1/16/2008 |
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
The facility failed to comply with the conditions of the exception granted by the Division regarding six and thirteen day take-home privileges. Patients on six and thirteen day status based on the exception must have quarterly call backs (an unscheduled return to the facility within 24 hours) that includes an inventory of patient's remaining take home supply, drug testing or methadone plasma levels, and an assessment as to the continued need for the exception. During review with Facility Director, it was identified that six day take exception patients are not receiving call backs.
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Plan of Correction
An inservice will be held by the program director to address the need to have state approval for 6 and 13 day Take Home Bottle exceptions as well as the need to have at least quarterly call back protocol.
Time for Completion:
1/16/2008 |