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 September 28 through September 30, 2010 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Discovery House 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 October 26, 2010.
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Plan of Correction
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715.6(a)(2) LICENSURE Physician staffing
(a) A narcotic treatment program shall designate a medical director to assume responsibility for administering all medical services performed by the narcotic treatment program.
(2) When a narcotic treatment program is unable to hire a medical director who meets the qualifications in paragraph (1), the narcotic treatment program may hire an interim medical director. The narcotic treatment program shall develop and submit to the Department for approval a training plan for the interim medical director, addressing the measures to be taken for the interim medical director to achieve minimal competencies and proficiencies until the interim medical director meets qualifications identified in paragraph (1)(i), (ii) or (iii). The interim medical director shall meet the qualifications within 36 months of being hired.
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Observations
Based on a review of personnel records and an interview with the facility director, the facility failed to document the development of a training plan with the interim medical director, as required.
The findings include:
The personnel record of the interim medical director was reviewed on June 29, 2010. Per regulation, when a narcotic treatment program is unable to hire a medical director who meets the qualifications, the narcotic treatment program may hire an interim medical director. The narcotic treatment program shall then develop and submit to the Department for approval a training plan for the interim medical director. The facility failed to provide documentation of an approved training plan for the interim medical director.
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Plan of Correction
The clinic Director will draft and submit an updated training plan to the Division's reviewer by November 12, 2010.
The clinic Director will monitor the situation for ongoing compliance and remin in contact with the Reviewer until the plan has been approved.
Completion date: 11/29/2010. |
715.6(a)(3)(i) LICENSURE Physician staffing
(a) A narcotic treatment program shall designate a medical director to assume responsibility for administering all medical services performed by the narcotic treatment program.
(3) The medical director 's responsibilities include the following:
(i) Supervision of narcotic treatment physicians.
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Observations
Based on a review of administrative documentation and the medical director's job description the facility failed to include all of the required responsibilities of the medical director in the medical director's job description..
The findings include:
The policy and procedure manual and medical director's job description were reviewed on September 28, 2010. Per regulation, the medical director's job description is to include "supervision of narcotic treatment physicians." The medical directors's job description did not include this responsibility.
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Plan of Correction
The Human Resource Department for Discovery House will amend the Job Description for the Medical Director to include the 'supervision of narcotic treatment physicians'.
The clinic Director will work with the Human Resource Department to ensure that changes are made to the Medical Director's Job Description and the updated Job Description is signed by the Medical Director
Completion Date: 11/29/2010 |
715.6(b)(1-9) LICENSURE Physician Staffing
(b) A narcotic treatment program may employ narcotic treatment physicians to assist the medical director. A narcotic treatment physician 's responsibilities include:
(1) Performing a medical history and physical exam.
(2) Determining diagnosis and determining narcotic dependence.
(3) Reviewing treatment plans.
(4) Determining dosage and all changes in doses.
(5) Ordering take-home privileges.
(6) Discussing cases with the treatment team.
(7) Issuing verbal orders pertaining to patient care.
(8) Assessing coexisting medical and psychiatric disorders.
(9) Treating or making appropriate referrals for treatment of these disorders.
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Observations
Based on the review of administrative documentation and the narcotic treatment physician's job description, the facility failed to include all of the required responsibilities of the narcotic treatment physician.
The findings include:
The policy and procedure manual and physician job description were both reviewed on September 28, 2010. Per regulation ,the physicians job description needs to include "Assessing coexisting medical and psychiatric disorders," and Treating or making appropriate referrals for treatment of these disorders." The physicians job description did not contain these responsibilities.
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Plan of Correction
The Human Resource Department for Discovery House will amend the Job Description for the Physician to include 'assessment of coexisting medical and psychiatric disorders and treating or making appropriate referrals for treatment of these disorders'.
The clinic Director will work with the Human Resource Department to ensure that changes are made to the Physician's Job Description and the physician signs the new Job Description.
The clinic Director will review the required duties by Friday, November 5, 2010.
Completion date: 11/29/2010 |
715.6(e) LICENSURE Physician Staffing
(e) A physician assistant or certified registered nurse practitioner may perform functions of a narcotic treatment physician in a narcotic treatment program if authorized by Federal, State and local laws and regulations, and if these functions are delegated to the physician assistant or certified registered nurse practitioner by the medical director, and records are properly countersigned by the medical director or a narcotic treatment physician. One-third of all required narcotic treatment physician time shall be provided by a narcotic treatment physician. Time provided by a physician assistant or certified registered nurse practitioner may not exceed two-thirds of the required narcotic treatment physician time.
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Observations
Based on the review of the certified registered nurse practitioner (CRNP) job description, the facility failed to restrict the functions of the CRNP to those allowed by regulation.
The findings include:
The job description for the CRNP was reviewed for content on September 28, 2010. The job description was signed on July 7, 2009 an allowed for the CRNP to "prescribe medication and insure appropriate dose", exceeding what state regulations allow.
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Plan of Correction
The Human Resource Department for Discovery House will amend the Job Description for the CRNP. The amendment will remove the following: 'prescribe medication and insure appropriate dose'.
The clinic Director will work with the Human Resource Department to ensure that changes are made to the CRNP Job Description and the CRNP signs the new Job Description.
The interim Medical Director will review and train the CRNP on the restricted duties.
Completion date: 11/29/2010 |
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 and an interview with the facility director, the facility failed to obtain an informed, voluntary, written consent prior to the administration of a narcotic agent for maintenance treatment.
The findings include:
Eighteen patient records were reviewed on September 28 through 30, 2010. Eight 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 #2.
Patient # 2 was admitted into treatment on February 24, 2010. The patient received the initial dose of methadone on February 24, 2010. The informed, voluntary, written consent was not signed until May 10, 2010.
The facility director confirmed that a written consent for treatment had not been obtained prior to the administration of methadone.
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Plan of Correction
The Clinical Supervisor will ensure that every patient record contains an informed, voluntary, written consent prior to the adminstration of a narcotic agent for maintenance treatment on the day of admission.
The clinic Director will supervise the Clincial Supervisors compliance. This will ensure a chart audit is completed on the day of admission and includes the consent for treatment.
This action begins on: October 27, 2010. |
715.13(b) LICENSURE Patient identification
(b) A narcotic treatment program shall maintain onsite a photograph of each patient which includes the patient 's name and birth date. The narcotic treatment program shall update the photograph every 3 years.
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Observations
Based on a review of administrative documentation and an interview with the nursing staff and a tour of the dispensing area, the facility failed to ensure the photo identification maintained onsite was updated every three years as required by regulation
The findings include:
A tour of the dispensing area was conducted on September 29, 2010 between 9:30 and 10:15 AM. A discussion with nursing staff occurred concerning how often the patient identification photographs were updated. Nursing staff stated they do not recall photographs ever being updated. This was discussed with the facility director and the facility director agreed that identification photographs will need to be updated every three years per regulation.
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Plan of Correction
The clinic Director will provide a list of patients to the Administrative Assistant that were admitted to the clinic on November 1, 2008 or earlier. The Administrative Assistant will take a new patient photograph and download the photograph into the electronic file.
The clinic Director is responsible to run an admission list every month and direct the Administrative Assistant to update the photographs and downloaded the new photographs into the electronic file.
Completion date: 11/15/2010 |
715.15(f) LICENSURE Medication dosage
(f) The narcotic treatment program shall develop written policies and procedures relating to narcotic treatment medication dosage which includes the requirements of subsections (a)--(e).
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Observations
Based on the review of policy and procedure manuals and a discussion with nursing and administrative staff the facility failed to have a policy and procedure that was consistent with actual practice.
The findings include:
The policy and procedure manual identified solid form take home medication while the actual procedure is for liquid medication.
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Plan of Correction
The Operations and Compliance Director will develop policy and procedures for liquid take home medication.
Completion Date: 11/29/2010 |
715.17(b) LICENSURE Medication control
(b) A narcotic treatment program shall develop policies and procedures regarding verbal medication orders, including the issuing and receiving of orders, identifying circumstances when orders are appropriate and documenting orders, in accordance with applicable Federal and State statutes and regulations.
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Observations
Based on the review of patient records and discussion with the facility director, the facility failed to ensure the physician submitting a verbal order was the same physician who signed the verbal order and entered it into the patient record in one of three patient records.
The findings include:
Eighteen patient records were reviewed September 28 through 30, 2010. Three records contained documentation of a physician's verbal orders. In patient record #2 a verbal order was given on February 26, 2010 by the narcotic treatment physician but was signed and posted by the medical director on February 26, 2010.
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Plan of Correction
The clinic Medical Director will train the physicians on how to sign orders. The training will include: the phsician ordering the change must also be the physician signing the order.
The clinic Director and Medical Director will audit a random sampling of orders per week to ensure compliance.
Completion Date: 11/08/2010 |
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 and administrative documentation the facility failed to restrict the determination of a patient's dose to the physician in three of fourteen patient records. Per regulation "A narcotic treatment physician shall determine the patient's initial and subsequent dose schedule. The physician shall communicate the initial and subsequent dose and schedule to the person responsible for the administration of medication . Each medication order shall be written and signed by the narcotic treatment physician."
The findings include:
Eighteen patient records were reviewed on September 28 through September 30, 2010. Fourteen patient records were reviewed for dose change orders. Patient records #3 and 15 contained documentation by the CRNP to increase the patient's dosage. Patient record # 2 contained information in the physician electronic verbal order section of the patient record stating, "please titrate per details and pt. will see couns(elor)/Dr. on 3/1/10". This was signed by a counselor. The medical director then signed this order on February 26, 2010.
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Plan of Correction
The clinic Medical Director will ensure the following: 'a narcotic treatment physician shall determine that the patient's initial and subsequent dose schedule. The physician shall communicate the initial and subsequent dose and schedule to the person responsible for the administration of medication. Each medication order shall be written and signed by the narcotic treatment team physician.
The Medical Director will provide on-site training to the CRNP to ensure compliance with PA regulations.
The Clinical Supervisor provided an inservice on October 20, 2010 on the dose adjustment protocol.
The clinic Director will review a random sampling of orders weekly to ensure compliance with M159. |
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 complete case consultations as required in five of nine patient records.
The findings include:
Eighteen records were reviewed on September 28 through 30, 2010. Nine patient records were reviewed for case consultations.
Patient record # 3, 4, 7, 8 and 15 did not have any staff listed as participating in the consultation and was written as a progress note of a session with the patient.
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Plan of Correction
The Clinical Supervisor will ensure that all staff are listed on the Case Consultation form in the electronic Medical Record instead of documenting on a 'Progress Note' and placing the note in the 'hard chart'.
The Clinical Supervisor will audit each Case Consultation and ensure the staff present are listed in the note before signing-off and adding the note to the electronic record.
Effective Date: 11/8/2010 |