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 October 16, 17, and 18, 2007 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 28 PA Code which pertain to the facility. The following deficiencies were identified during this inspection and a plan of correction is due on November 8, 2007.
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Plan of Correction
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715.9(a)(1) 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:
(1) Verify that the individual has reached 18 years of age.
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Observations
Based on the review of 27 patient records, the facility failed to provide verification that patients # 1, 2, 4, 7, and 8 were 18 years of age or older at the time of their admission.
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Plan of Correction
M053 ? The "Assessment Quality Assurance Chart Review" form has been revised to add a section specific to clients being referred to the NTP, which includes a compliance check for verifying proof of age. Clients who do not provide adequate proof at the time of the assessment are given a "Client Letter of Understanding" indicating that they must provide this proof. The outpatient coordinator is responsible for reviewing every assessment chart and the verifying the compliance status for all of the required items on Assessment QA form prior to sending it to the pharmacotherapy (NTP) coordinator. The pharmacotherapy coordinator will be responsible for insuring that clients will not be scheduled for an intake/orientation or admissions physical until adequate proof is provided. |
715.9(a)(2) 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:
(2) Verify the individual 's identity, including name, address, date of birth, emergency contact and other identifying data.
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Observations
Based on the review of 27 patient records, the facility failed to provide proof of identity for patients # 1, 2, 4, 7, and 8.
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Plan of Correction
M053 ? The "Assessment Quality Assurance Chart Review" form has been revised to add a section specific to clients being referred to the NTP, which includes a compliance check for verifying the client's identity. Clients who do not provide adequate proof at the time of the assessment are given a "Client Letter of Understanding" indicating that they must provide this proof. The outpatient coordinator is responsible for reviewing every assessment chart and the verifying the compliance status for all of the required items on Assessment QA form prior to sending it to the pharmacotherapy (NTP) coordinator. The pharmacotherapy coordinator will be responsible for insuring that clients will not be scheduled for an intake/orientation or admissions physical until adequate proof is provided to verify the client's name, address, date of birth, emergency contact and other identifying data. |
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
Based on the review of 27 patient records, the facility failed to maintain compliance with the regulations regarding confidentiality. Specifically, patients # 2 and 17 had signed consents that exceeded the information that may be released per 4 Pa. Code Chapter 255.5 ( received approval to provide pregnancy and drug result information to probation and children and youth ), patient # 13 signed a blank consent form, patient # 16 had two separate consents to release the same information to the same entity indicating different reasons to release information, and patient # 17 signed a consent that did not include the relationship of the receiving party, hence legality of the information released could not be determined.
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Plan of Correction
M093 ? The staff person completing the consent form with the patient is responsible for ensuring compliance with applicable regulations. At a recent staff meeting, the pharmacotherapy and outpatient coordinators, and Aldie's QA & compliance officer, conducted a training on the required elements for a valid consent form and 4 Pa. Code Chapter 255.5 restrictions on the release of client identifying information. The pharmacotherapy coordinator has implemented a peer chart review process with the NTP's counseling staff that will include reviewing clients' consent forms for appropriateness. The pharmacotherapy coordinator will also monitor the appropriate completion and use of consent forms via quarterly quality assurance chart reviews. |
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
Based on the review of 27 patient records, the facility physician did not sign order to initiate methadone dosing for patient # 17; order was prepared but failed to have the physician's signature. Additionally, a review of patient # 5's chart identified that facility had failed to secure physician review and approval for patient's methadone taper; specifically, an order reads, "taper per X employee."
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Plan of Correction
M115 ? The program physician is responsible for properly completing and signing all medication orders and related documentation. The pharmacotherapy coordinator has begun reviewing physician orders and documentation on a monthly basis to ensure they are properly completed, signed and filed in the patient's chart, as well as properly entered in the computer system. |
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 the review of 27 patient records, the facility failed to follow to review take-home eligibility for patient # 9. Specifically, patient had recently tested positive for illicit drug use but the facility determined 2 take-homes could be provided to patient.
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Plan of Correction
M137 - The primary therapist is responsible for completing the Take-home Medication Privilege Change Request form, which includes an indication for each of the eligibility criteria listed in 715.16(b), whenever a regular or temporary change in take-homes appears warranted. When the program physician in consultation with the treatment team has determined that extenuating circumstances exist for granting an exception and approving a temporary take-home, such as due to a child's emergency medical treatment, then the physician shall document the rationale for the approval when signing this form. The pharmacotherapy coordinator will monitor the appropriate documentation for all approved take-home requests by also signing this form. The coordinator shall be responsible for consulting with and obtaining approval for exceptions from DOH licensing staff in those circumstances which require DOH's prior approval. Proper documentation of this approval shall be monitored through QA chart reviews. |
715.20(3) LICENSURE Patient transfers
A narcotic treatment program shall develop written transfer policies and procedures which shall require that the narcotic treatment program transfer a patient to another narcotic treatment program for continued maintenance, detoxification or another treatment activity within 7 days of the request of the patient.
(3) The transferring narcotic treatment program shall document what materials were sent to the receiving narcotic treatment program.
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Observations
Based on the review of 27 patient records, the facility failed to document the specific materials were sent to the receiving narcotic treatment program during the transfer of patient # 23.
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Plan of Correction
M197 ? The primary therapist is responsible for documenting in the transferred patient's chart which items from the patient's record were sent to the receiving NTP. The pharmacotherapy coordinator will review the documentation of all patient transfers to ensure that policies and procedures are followed, including the appropriate documentation in patient records of the materials sent to the receiving NTP. |
715.20(4) LICENSURE Patient transfers
A narcotic treatment program shall develop written transfer policies and procedures which shall require that the narcotic treatment program transfer a patient to another narcotic treatment program for continued maintenance, detoxification or another treatment activity within 7 days of the request of the patient.
(4) The receiving narcotic treatment program shall document in writing that it notified the transferring narcotic treatment program of the admission of the patient and the date of the initial dose given to the patient by the receiving narcotic treatment program.
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Observations
Based on the review of 27 patient records, the facility failed to provide documentation that it notified the transferring narcotic treatment program of the admission of the patient and the date of the initial dose for patients # 2 and 14.
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Plan of Correction
M199 ?The process for admitting transfers has been reviewed, and it was clarified that the pharmacotherapy coordinator will have the responsibility for notifying the sending NTP when the transferred patient begins dosing at Aldie's NTP. The coordinator will monitor the documentation of this notification via the peer chart review and coordinator's quarterly QA chart review processes. |
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 document that all efforts to retain patients in treatment had been pursued for patients #10 and 12.
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Plan of Correction
M201 - The pharmacotherapy coordinator has instructed the treatment team members on the importance of correct and detailed documentation of all efforts made to keep patients in the NTP prior to initiating an involuntary termination. The primary therapist is responsible for documenting the efforts that were made to retain a patient in the NTP. The coordinator is responsible for ensuring that all appropriate efforts were made prior to approving an involuntary termination, through team meetings and individual staff supervision; and will monitor the staff's documentation of these efforts via peer and quarterly QA chart reviews. |
715.22(c) LICENSURE Patient grievance procedures
(c) Penalties may not be initiated prior to final resolution with the exception that penalties may be initiated against patients who have committed acts of physical violence or who have threatened to commit acts of physical violence in or around the narcotic treatment program premises.
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Observations
The facility failed to offer patient # 10 with an appeal process that was in keeping with regulations and facility policy; patient # 10's discharge commenced without affording the patient the right to appeal/grieve the involuntary discharge decision.
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Plan of Correction
M211 - The primary therapist is responsible for appropriately documenting the type of discharge in the patient's record (i.e., when it is a voluntary transfer to another NTP verses when it is an involuntary termination), as well as for documenting the notice given to the patient regarding the right to appeal involuntary termination decisions when applicable. The pharmacotherapy coordinator will ensure that the clinical record contains the appropriate documentation of the patient being notified of the right to appeal before approving a discharge that is an involuntary termination. The coordinator has started conducting weekly reviews of clinical record for any patients who are appealing or grieving a decision regarding their treatment in order to monitor the inclusion in the patient records of appropriate and accurate documentation of the circumstances and response(s) to the appeal or grievance. |
715.23(b)(11) LICENSURE Patient records
(b) Each patient file shall include the following information:
(11) Counselor notes regarding patient progress and status.
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Observations
Based on the review of 27 patient records the facility failed to document the therapeutic interventions that occurred as a result of patient # 21's involvement in criminal activity while on facility property.
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Plan of Correction
M237 ? The primary therapist is responsible for documenting any significant events or critical incidents involving an assigned patient via an individual progress note, which is also to include a description of relevant actions taken and counseling provided or offered as warranted. If the primary therapist is not available (e.g., out sick) to provide an immediate therapeutic intervention, the pharmacotherapy coordinator will ensure that another clinical staff member provides such counseling if needed. The pharmacotherapy coordinator, through program staff supervision and as part of the quarterly QA chart reviews, will monitor the proper documentation of significant events and critical incidents, and that appropriate therapeutic interventions occurred as a result of the event/incident. |
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
Based on the review of 27 patient records, the facility failed to maintain a record of services that was consistent with documentation of the progress notes; charts for patients # 13, 14, 16, and 19 contained inconsistencies between the record of services and counselor notes.
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Plan of Correction
M241 ? The pharmacotherapy coordinator has reminded program staff of each primary therapist's responsibility for ensuring that the dates on the electronically generated record-of-service in the patient's chart are the same as the dates on the corresponding progress notes. The pharmacotherapy coordinator will monitor the consistency of these dates via quarterly QA chart reviews. Additionally, the pharmacotherapy coordinator will be conducting an in-service for the treatment team on Nov. 29, 2007 regarding clinical documentation, and will include instruction on the importance of accuracy and consistency of such items in patient records. |
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 27 patient records, the facility failed to complete psychosocial evaluations for patients # 2, 7, and 18. Further, the content of the completed evaluations for patients # 6 and 8 were not evaluative.
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Plan of Correction
M245 ? The assessment staff are responsible for including a printed copy of the bio-psychosocial evaluation, which is completed on a computer, in the assessment chart. The assessor's supervisor (i.e., outpatient coordinator) ensures that this evaluation was completed and printed-out via the Assessment QA Chart Review form. The bio-psychosocial evaluation is then presented to the program physician for review and signature. The pharmacotherapy coordinator receives the completed assessment charts of all patients referred to the NTP, and will monitor the return of the completed and signed evaluation to the patient's record. Any charts with missing or incomplete bio-psychosocial evaluations will be sent back to the outpatient coordinator for completion, printout of the evaluation, and the required signatures. |
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
Based on the review of 27 patient records, the facility failed to provide specific aftercare information for patients # 10, specifically the aftercare plan contained general information with no patient specific goals nor time frames.
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Plan of Correction
M259 - The patient was transferred to another NTP; but, the aftercare plan did not specify goals related to the transfer. The pharmacotherapy coordinator will review the aftercare plans submitted by the primary therapist, as part of the discharge paperwork, to insure that all the required information is appropriately completed and included in the documentation before it is submitted to the office manager for processing. |
715.23(b)(23) LICENSURE Patient records
(b) Each patient file shall include the following information:
(23) Discharge summary.
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Observations
Based on the review of 27 patient records, the facility failed to provide discharge summaries for patients # 10, 11, and 12 that included information on the patient's treatment objectives and specific documentation of patient's progress in treatment.
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Plan of Correction
M261 ? The pharmacotherapy coordinator will review all discharge summaries, which are to be included with the discharge paperwork, to insure that all the required information is appropriately completed before it is submitted to the office manager for processing. In addition, Aldie is currently reviewing electronic document format solutions that will substantially improve discharge summary content via automatically prompting the staff member to input information on items such as the patient's treatment objectives and progress in treatment. |
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 27 patient records, the facility failed to provide an annual evaluation for patients # 3 and 4; specifically, documentation was brief as the format was a checklist that did not offer counselor assessment. The content was non-evaluative.
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Plan of Correction
M267 - The format for the counselor's annual evaluation has been recently revised and put into an electronic format which requires entering narrative content. The pharmacotherapy coordinator will inspect the completeness of the annual evaluations, as part of the quarterly QA records review, to insure that it includes the counselor's evaluative comments; and will include this critique in the supervision of staff as indicated. |