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 February 17-19, 2010 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Aldie Foundation, Inc. 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 March 13, 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 administrative documentation, the facility failed to provide at least one hour of physician time per week, on site for, every ten patients for four of ten weeks reviewed.
The findings include:
Physician time sheets for the months beginning December 9, 2009 to February 8, 2010 were reviewed on February 22, 2010. The facility is licensed to medicate 200 patients and the census during the time period reviewed was reported to have averaged 150 or more per week.
During the week ending December 26, 2009, the total physician time was documented as 2.75 hours .
During the week ending January 2, 2010, the total physician time was documented as 4.5 hours.
During the week ending January 9, 2010, the total physician time was documented as 7.5 hours.
During the week ending January 16, 2010, the total physician time was documented as 5 hours.
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Plan of Correction
The Facility's current Medical Director is contracted to provide 20 hours/week onsite, which meets present census needs. Facility has recruited another physician (psychiatrist) who will support weekly onsite NTP physician staffing requirements. The facility has now contracted with Locum Tenens services to provide coverage for medical director or other NTP Physician as needed in the interim. The Program Coordinator will maintain oversight and insure compliance with the ratio of NTP Physician hours to current census on a weekly basis; will document Physician hours based on time directly dedicated to the NTP; and will insure that a clear report of physician hours is provided during monitoring visits. |
715.9(a)(4) LICENSURE Intake
(a) Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall:
(4) Have a narcotic treatment physician make a face-to-face determination of whether an individual is currently physiologically dependent upon a narcotic drug and has been physiologically dependent for at least 1 year prior to admission for maintenance treatment. The narcotic treatment physician shall document in the patient 's record the basis for the determination of current dependency and evidence of a 1 year history of addiction.
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Observations
Based on a review of patient records, the facility failed to ensure the physician documented in the patient's record the basis for determination of current and at least one year dependency in two of six patient records.
The findings include:
Seventeen patient records were reviewed February 17-19, 2010. Six patient records were reviewed for documentation by the physician determining current and at least one year of opiate dependence. Patient records # 1 and 16 did not have this documentation.
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Plan of Correction
A form and format for clearly documenting Physicians' clinical assessment is in place at the facility. The NTP Medical Director has reviewed the facility's procedures and protocols for admission with NTP Physicians and/or Locum Tenens Physicians. All physicians will be oriented to the regulation that a physician make a face-to-face determination that an individual is currently physiologically dependent upon a narcotic drug and has been physiologically dependent for at least 1 year prior to admission for maintenance treatment. The Program Coordinator and the Medical Director will maintain oversight and insure compliance with this regulation through Quality Assurance review of newly admitted patients' charts. The Program Coordinator will review filing protocols with the Office Manager to assure that all documentation is present in each patient's chart |
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 narcotic treatment program failed to document, within three months after the termination of pregnancy, whether or not the patient should continue maintenance or receive detoxification treatment in one of one patient record.
The findings include:
Seventeen patient records were reviewed February 17-19, 2010. An evaluation of the patient's treatment status within three months after termination of pregnancy was required in one patient record. The narcotic treatment program, specifically the physician, did not document this evaluation that was due by December 15, 2009 based on the patient's termination of pregnancy on September 15, 2009 in patient record # 17.
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Plan of Correction
A protocol and checklist is in place at the facility for documentation of coordination of care for pregnant women. The Medical Director and the Program Coordinator have reviewed the Pregnant Client Checklist and revised it to include monitoring the evaluation of patient's treament status within 3 months of terminaton of pregnancy, to determine whether or not patient should continue maintenance or receive detoxification. Pregnant patients' files will be flagged to assure that patients meet with NTP Physician within 3 months of termination of pregnancy. Physicians will be provided with a form and format for clearly documenting their clinical assessment and advised that this documentation must be provided in the clinical record of each patient. The Program Coordinator and the Medical Director will maintain oversight and insure compliance with this regulation through Quality Assurance review of charts. |
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 the review of patient records, the facility failed to ensure the patient signed the informed consent prior to the administration of a narcotic agent in two of six patient records.
The findings include:
Seventeen patient records were reviewed on February 17-19, 2010. Informed consent documentation was reviewed in six patient records. The facility did not document informed patient consent prior to the administration of a narcotic agent in patient records # 10 and 11. Patient # 10 was admitted January 11, 2010 and a signed consent to administer an agent was not documented in the patient record. Patient # 11 was admitted December 22, 2009 and dosed on December 23, 2009. The patient signed the consent to administer an agent on February 19, 2010.
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Plan of Correction
A protocol and form are in place to provide informed voluntary patient consent on admission, as stated in regulation 715.12(1-5). The Program Director and the NTP Medical Director have reviewed the protocols for admission. All NTP Physicians and Locum Tenens Physicians supporting the NTP will be oriented to the regulation that a patient must sign an informed voluntary consent before an agent may be administered to a patient for either maintenance or detoxification treatment. The Program Coordinator and the Medical Director will maintain oversight and insure compliance with this regulation through quarterly Quality Assurance review of charts. The Program Coordinator will review filing protocols with the Office Manager to assure that all documentation is present in each patient's chart. |
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 medical staff, the facility failed to ensure the physician dated the signature after submitting a verbal order in three of three patient records reviewed.
The findings include:
Seventeen patient records were reviewed February 17-19, 2010. Three records contained documentation of a physician's verbal orders. While the physician did sign these verbal orders, the signature was not dated. Therefore, there was no way to determine whether the verbal order was signed within 24 ours as required by regulation. This matter was discussed with the physician on February 19, 2010.
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Plan of Correction
Written Policy and Procedure is in place to meet the Federal and State statutes and regulations. The Program Coordinator has reviewed these policies and procedures with the Medical Director. To insure future compliance, all NTP Physicians and Locum Tenens Physicians supporting the NTP will be oriented to the regulation that verbal orders be signed and dated within the time specified by the facility's written policy. The Program Coordinator and the Medical Director will maintain oversight and insure compliance with this regulation through Quality Assurance review of charts. |
715.23(b)(4) LICENSURE Patient records
(b) Each patient file shall include the following information:
(4) The results of an initial intake physical examination.
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Observations
Based on a review of patient records, the narcotic treatment program failed to complete an initial intake physical examination in three of seven patient records.
The findings include:
In patient record # 1, the patient was admitted to the narcotic treatment program on June 27, 2009, but the initial intake physical examination was not documented in the patient record.
In patient record # 10, the patient was admitted to the narcotic treatment program on January 11, 2010 as a direct transfer from another narcotic treatment program. The transferring facility sent transfer medical paperwork, but there was no indication the physician reviewed this paperwork, nor was a new physical examination documented.
In patient record # 16, the patient was admitted to the narcotic treatment program on June 12, 2009, but the initial intake physical examination was not documented in the patient record until February 19, 2010.
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Plan of Correction
Written Policy and Procedure is in place at the facility reflecting the Federal and State regulations that an initial intake physical examination take place at admission. A form and format for clearly documenting Physicians' physical examinations is in place at the facility. The Program Coordinator has reviewed these policies and procedures with the Medical Director. To insure future compliance, all NTP Physicians and Locum Tenens Physicians supporting the NTP will be oriented to document their initial intake physical exam utilizing this form. Physicians reviewing paperwork received for transferring patients will initial this paperwork and reference this information in the physician's intake physical exam report, as appropriate. The Program Coordinator and the Medical Director will maintain oversight and insure compliance with this regulation through Quality Assurance review of charts. The Program Coordinator will review filing protocols with the Office Manager to assure that all documentation is present in each patient's chart. |
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 the review of patient records and administrative documentation, the facility failed to ensure the psychosocial evaluations were a clinical assessment of the historical data collected or completed within the policy-stated 30 days of admission in five of six patient records.
The findings include:
Seventeen patient records were reviewed on February 17-19, 2010. Five patient records were reviewed for psychosocial evaluations.
Patient record # 1 was admitted June 27, 2009. The psychosocial evaluation was dated July 27, 2009 and contained repeated information of the data of the patient reported commentary and no clinical assessment.
Patient # 5 was admitted September 23, 2009. The psychosocial evaluation was dated September 23, 2009 and contained a repeat of the data of the patient reported commentary and no clinical assessment.
Patient # 6 was admitted August 18, 2009. The psychosocial evaluation was dated December 2, 2009.
Patient # 10 was admitted January 11, 2010. An evaluation had not been completed at the time of the site visit.
Patient # 12 was admitted January 18, 2010. The psychosocial evaluation was dated February 16, 2010 and contained a repeat of the data, patient reported commentary and no clinical assessment.
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Plan of Correction
The facility has integrated a newly revised psychosocial form for patients' records, to better comply with regulation 715.23 (b)(15). The Pharmacotherapy Coordinator will provide a training for the Pharmacotherapy counseling staff addressing clinical documentation utilizing this new format on or by 3/17/10, with attention to reviewing clinical assessment and timely execution of documentation as outlined by the facility's policy. The Pharmacotherapy Coordinator will maintain oversight of timeliness through quarterly Quality Assurance review of charts and during individual supervision with clinicians. |
715.23(d)(2) 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.
(2) The narcotic treatment physician or the patient 's counselor shall review, reevaluate, modify and update each patient 's treatment plan as required by Chapters 157, 709 and 711 (relating to drug and alcohol services general provisions; standards for licensure of freestanding treatment activities; and standards for certification of treatment activities which are a part of a health care facility).
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Observations
Based on a review of patient records, the facility failed to document the progress or lack of progress in achieving the goal statements from the prior treatment plan in three of six patient records.
The findings include:
Seventeen patient records were reviewed February 17-19, 2010. Six patient records were reviewed for treatment plan update documentation.
Patient records # 13, 14 and 16 did not include any information on the status of the prior stated goals.
Patient records # # 14 and 16 have not had an updated treatment plan since November 2009 and are still active patients.
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Plan of Correction
Written Policy and Procedure is in place at the facility to meet the Federal and State statutes and regulations for Treatment Plans. The Pharmacotherapy Coordinator will provide training for Pharmacotherapy counseling staff on or before 3/17/10 addressing the proper execution of treatment plans with regard to timeliness and to providing clinical updates meeting the standards required by Chapters 157,709, and 711. The Pharmacotherapy Coordinator will maintain oversight for completeness through quarterly Quality Assurance review of charts and during case consults in individual supervision with clinicians. The Program Coordinator will review filing protocols with the Office Manager to assure that all documentation is present in each patient's chart. |