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 March 18, 2014 to March 19, 2014 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Habit OPCO, 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.
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Plan of Correction
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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 a review of patient records, the facility failed to maintain the patient's confidentiality in accordance 42 CFR 2.22 and 4 PA Code 255.5 in five of six patient records reviewed.
The findings include:
Twelve patient records were reviewed March 18-19, 2014. Six patient records were reviewed for compliance with confidentiality regulations.
Patient record # 4 contained a consent to release information to the patient's funding source that allowed for the release of the psychosocial evaluation and utilization review, exceeding 4 PA Code 255.5.
Patient record # 5 contained a consent to the Department of Public Welfare with the specific information listed as " information exchange"; a consent to the patient's lawyer with the specific information to be released identified as "any information needed for court", which is not specific; a consent for the patient's mother that listed the "specific" information as "anything regarding treatment", which is not specific.
Patient record # 6 contained a consent to release information to the patient's funding source that allowed for the release of the psychosocial evaluation and utilization review, exceeding 4 PA Code 255.5.
Patient record # 8 contained a consent to release information to the patient's funding source that allowed for the release of the psychosocial evaluation and utilization review, exceeding 4 PA Code 255.5.
Patient record # 12 contained a consent to release information to the patient's funding source that allowed for the release of the psychosocial evaluation and utilization review, exceeding 4 PA Code 255.5.
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Plan of Correction
A review of this identified deficiency was conducted by this author. It was identified that most of the identified releases were completed by a new hire. A full staff training will be conducted surrounding the development and contents that are allowable under 4 PA code § 255.5 per varying agencies. This training will be conducted by April 30, 2014 during Watsontown's Monthly Staff meeting and facilitated by the Program Director and/or their designee. |
715.16(a)(3) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(3) The narcotic treatment physician shall document in the patient record the rationale for permitting take-home medication.
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Observations
Based on the review of patient record documentation, the facility failed to ensure the physician document in the patient record the rationale for granting take home medication in two of three patient records.
The findings include:
Twelve patient records were reviewed March 18-19, 2014. Three records were reviewed for take home medication documentation. Patient records # 9 and 10 did not have the physician's rationale for granting the take home medication.
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Plan of Correction
During MDT/TH committee on April 8, the interim Clinical Director reiterated the need to ensure Physician documentation is completed with regard to supportive rationale for permitting take home medications, in excess of what is already listed on the attached application, page 3. This rationale will be reviewed during each take home committee meeting to ensure continued compliance as well as reviewed during the April 22, 2014 staff meeting. As a members of the MDT, the Clinic Director will ensure that the rationale is documented by the physician. This will be done on all applications before the orders are sent to the nursing staff to be posted. Ongoing. |
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, the facility failed to ensure the physician dated the signature after submitting a verbal order in five of five patient records reviewed.
The findings include:
Twelve patient records were reviewed March 18-19, 2014. Five patient records contained documentation of a physician's verbal orders. While the physician did sign these verbal orders, the verbal orders were not signed within 24 hours as required.
Patient record # 1 contained three separate verbal orders that were not signed by the physician within 24 hours. A verbal order was documented on 7-30-13, but not signed by the physician until 8-4-13. Another verbal order documented on 8-2-13 was not signed until 8-4-13. A verbal order documented on 11-23-13 was not signed by the physician until 11-30-13.
Patient record # 2 contained three separate verbal orders that were not signed by the physician within 24 hours. A verbal order was documented on 7-8-13, but not signed by the physician until 7-15-13. Another verbal order documented on 8-24-13 was not signed until 8-26-13. A verbal order documented on 12-28-13 was not signed by the physician until 1-1-14.
Patient record # 3 contained five separate verbal orders that were not signed by the physician within 24 hours. A verbal order was documented on 10-16-13, but not signed by the physician until 10-19-13. Another verbal order documented on 10-22-13 was not signed until 10-26-13. A verbal order documented on 11-11-13 was not signed by the physician until 11-18-13, a verbal order documented on 11-25-13 and signed on 11-30-13. A verbal order issued on 1-13-14 was not signed by the physician until 1-19-14.
Patient record # 6 contained a verbal order documented on 7-18-13 that was not signed by the physician until 7-25-13.
Patient record # 11 contained a verbal order documented on 9-7-13 that was not signed by the physician until 9-9-13.
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Plan of Correction
Acknowledging this as a repeat deficiency, continued IT steps are being taken to ensure Physician access to the EHR when Physician is not on site. IT staff were on site in Watsontown on Monday, April 14, to correct the ability for Physician to access the EHR and complete the appropriate signing within the 24 hour requirement.
Additionally, a review during the monthly staff meeting will be conducted to ensure that end of day notification is provided to the Physician electronically as to verbal orders requiring signature within the next 24 hour period. This process will be reviewed with the Nurse Manager to ensure the development of a fluid system being in place. Per dated information contained in this noted deficiency, the Physician has been made aware of the need for completion of this signing regulation and the need to comply. A review of this repeat deficiency has been shared with the appropriate supervisory staff to the Physician for ongoing review and training to the same.
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715.20(1) 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.
(1) The transferring narcotic treatment program shall transfer patient files which include admission date, medical and psychosocial summaries, dosage level, urinalysis reports or summary, exception requests, and current status of the patient, and shall contain the written consent of the patient.
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Observations
Based on the review of patient records, the facilty failed to transfer the required patient files in three of three patient records reviewed.
The findings include:
Twelve patient records were reviewed March 18-19, 2014. Three patient records required the facility transfer specific patient files to the receiving narcotic treatment program as part of the transfer process. Three patient records did not transfer the specified files.
Patient # 13 was discharged as a transfer to another narcotic treatment facility November 11, 2010. There was no documentation of the required patient files being transferred to the receiving facility.
Patient # 1 was discharged as a transfer to another narcotic treatment facility January 23, 2014. There was no documentation the required patient files were transferred to the receiving facility and the consent signed by the patient was restricted to 4 PA code 255.5.
Patient # 2 was discharged as a transfer to another narcotic treatment facility February 7, 2014. There was no documentation the required patient files were transferred to the receiving facility.
Patient # 4 was discharged as a transfer January 10, 2014. The only records transferred were recent laboratory results and dosing records. The consent signed by the patient did not allow for the transfer of these limited records as it was restricted to 4 PA Code 255.5.
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Plan of Correction
Clinical staff will complete appropriate notations under appropriate headings and ensure copies of fax transmission reports are filed accordingly. The Clinic Director will see if adding a new document into SMART (EHR) entitled "Transfer Notation" is feasible via IT.
A further review of the transfer procedures will be conducted as part of the April 21, 2014 monthly staff meeting to ensure continued compliance and that entries are made into SMART (EHR) along with fax sent reports being filed accordingly into each patient's patient chart under external communications. Compliance with this will be monitored via random chart audits by the clinic director, ongoing.
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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 a review of patient records, the narcotic treatment program failed to document what materials were sent to the receiving narcotic treatment program in two of three patient records.
The findings include:
Twelve patient records were reviewed March 18-19, 2014. Three patient records required documentation of the materials sent to the receiving provider of the transfer. In patient records # 1 and 2 there was no documentation of what if any, materials were sent to the receiving narcotic treatment program.
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Plan of Correction
Procedures related to the complete and appropriate notations under appropriate headings and filing of fax transmission reports will be conducted as part of the April 21, 2014 monthly staff meeting, facilitated by the Program Director and/or their designee, to ensure continued compliance. Additionally, the clinic director will ensure ongoing compliance via random monthly chart audits. |
715.21(1)(i-iv) 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.
(1) A narcotic treatment program may involuntarily terminate a patient from the narcotic treatment program if it deems that the termination would be in the best interests of the health or safety of the patient and others, or the program finds any of the following conditions to exist:
(i) The patient has committed or threatened to commit acts of physical violence in or around the narcotic treatment program premises.
(ii) The patient possessed a controlled substance without a prescription or sold or distributed a controlled substance, in or around the narcotic treatment program premises.
(iii) The patient has been absent from the narcotic treatment program for 3 consecutive days or longer without cause.
(iv) The patient has failed to follow treatment plan objectives.
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Observations
Based on a review of administrative documentation, the facility failed to restrict the reasons for involuntary termination to those areas allowed by regulation.
The findings include:
Administrative documentation that included specific policies related to the 715 regulations was reviewed March 18, 2014. The policy addressing the the required minimum of one urine drug screen per month put into place a sanction if the patient fails to provide a urine drug screen upon request. The medication will be withheld until the sample is collected. If this does not occur by the end of the medication hours, the patient will be rescheduled for the next day and will be given a "Drug Screening Agreement" that states if at any time during the next 60 days they again fail to submit a sample, they will be given a discharge notice. It goes on further to say that any patient who attempts to alter their samples will be subject to administrative review AND possible discharge.
These exceed the areas allowed as they do not meet the criteria listed within the regulations.
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Plan of Correction
A review of this internal policy will be conducted with suggested edits to succinctly meet the specific regulations of 715.21(l)(i-iv). This review will be conducted by the Program Director and submitted to the Regional Director for their approval and authorization. Upon the completion of this, the edited version will replace the existing and training will be held with all clinical and nursing staff to enforce the understanding and language associated with the approved edits. |
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 with the regulations in six of six patient records reviewed.
The findings included:
Twelve patient records were reviewed March 18-19, 2014. Six patient records required documentation of an annual clinical review. The annual clinical evaluation requires a review and signature by the medical director.
Patient # 2 was admitted was admitted October 10, 2012. The annual clinical evaluation was completed by the clinician and dated October 23, 2013. It was not reviewed or signed by the medical director at the time of the survey.
Patient # 7 was admitted was admitted October 17, 2012. The annual clinical evaluation was completed by the clinician and dated October 23, 2013. It was not reviewed or signed by the medical director at the time of the survey.
Patient # 8 was admitted was admitted November 15, 2012. The annual clinical evaluation was completed by the clinician and dated December 5, 2013. It was completed late and was not reviewed or signed by the medical director at the time of the survey.
Patient # 9 was admitted was admitted October 24, 2012. The annual clinical evaluation was completed by the clinician and dated November 11, 2013. It was completed late and was not reviewed or signed by the medical director at the time of the survey.
Patient # 10 was admitted was admitted January 26, 2013. The annual clinical evaluation was completed by the clinician and dated February 5, 2014. It was not reviewed or signed by the medical director at the time of the survey.
Patient # 11 was admitted was admitted March 1, 2013. The annual clinical evaluation was completed by the clinician and dated March 10, 2014. It was not reviewed or signed by the medical director at the time of the survey.
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Plan of Correction
A review of the timeliness in completion of all annual reviews by clinical staff and the required content will be conducted during the April 21, 2014 Monthly Staff meeting.
Additionally, a review with the Medical Director and their supervisory staff will be conducted at their discretion, to ensure understanding to this regulation and completion to the same. Nursing staff will be part of the April 21, 2014 staff meeting to ensure their understanding and support to the Physicians attention to this detail and notations to the supervisory training will be obtained and filed in the Physicians personnel record to support the completion of the same. The clinic director will ensure compliance via random monthly chart audits.
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