INITIAL COMMENTS
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This report is a result of an on-site complaint investigation conducted on April 1, 2015, by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site complaint investigation, New Directions Healthcare, LLC 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 investigation:
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Plan of Correction
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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 narcotic treatment program failed to document that a narcotic treatment physician made a face-to face determination, prior to the administration of an agent, as to whether an individual was currently physiologically dependent upon a narcotic drug and had been physiologically dependent for at least 1 year prior to admission for maintenance treatment in one of two patient records.
The findings include:
Three patient records were reviewed on April 1, 2015. Two patient records were reviewed for the face-to face determination. There was no documentation that the narcotic treatment physician made a face-to face determination of dependency prior to administration of an agent in patient record # 1.
Patient # 1 was admitted on December 12, 2014. The Certified Registered Nurse Practitioner completed the face to face determination of dependency on December 12, 2014. The patient's initial dose was given on December 12, 2014. The narcotic treatment physician signed the face to face determination on December 20, 2014.
These findings were reviewed with facility staff during the complaint investigation.
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Plan of Correction
Regarding Patient 1 we believe the examiner missed the face to face document in our patient records. A copy of the document on patient #1 will be forwarded under separate cover to the DDAP. Patient #1 was the only patient admitted 12/12/2014 and the physician signed the document 12/12/2014. Going forward all face to face determination of dependency will be signed by the narcotic treatment physician prior to administration of an agent.
5/4/2015-The face to face will be conducted by the Narcotic Treatment Physician, not merely signed by the Physician. The Narcotic Treatment Physician, who is also the Project Director will be responsible for implementing the corrective action. submitted by Kara Bennett CRNP |
715.14(a) LICENSURE Urine testing
(a) A narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter.
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Observations
Based on a review of the patient records, the facility failed to obtain a complete drug screen urinalysis prior to the administration of methadone, a narcotic agent, in two of two patient records. A complete drug screen includes receiving the results from a CLIA and Department of Health approved laboratory.
The findings include:
Three patient records were reviewed on April 1, 2015. Two patient records were reviewed for documentation of a completed initial drug-screening urinalysis. There was no documentation of a completed initial drug-screening urinalysis in patient records # 1 and 2. The facility holds a Pennsylvania Department of Health Clinical Laboratory Permit. The facility is CLIA approved for limited service urine drugs and is CLIA waived for pregnancy. According to two separate representatives of the Department of Health, Bureau of Laboratory, the narcotic physician can read the results of the dip stick urinalysis. However, dip sticks results are to be sent to a lab for confirmation. There was no documentation that the results were forwarded to a CLIA and Department of Health approved laboratory for confirmation of the results.
Patient # 1 was admitted as a transfer on 12/12/14. The initial urinalysis was completed on 12/12/14, using the dip stick method which had a positive result. There was no documentation that the results were forwarded to a CLIA and Department of Health approved laboratory for confirmation of the results.
Patient # 2 was admitted as a transfer on 2/27/15. The initial urinalysis, was completed on 2/27/15, using the dip stick method which had a positive result. There was no documentation that the results were forwarded to a CLIA and Department of Health approved laboratory for confirmation of the results.
These finding were discussed with facility staff during the complaint investigation.
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Plan of Correction
New Directions Healthcare will document in every patient's chart a confirmatory urine sent to an approved Department of Health lab for confirmation of results. All confirmation results will be scanned into every patient's EMR.
5/4/2015-The Project Director has requested an appeal and exception to this citation and statute. The Project Director to submit a letter asking for exception to regulation. Letter will be send to DDAP.
5/5/2015-New Directions Healthcare has instituted a policy that methadone will not be administered until a confirmation is back and results are scanned into the patients chart. New Directions Healthcare has requested an exception to this policy for pregnant opioid patients only. This request has been sent by certified mail to DDAP. The Project Director who is also the Narcotic Treatment Physician is responsible for implementing this change and will ensure this does not reoccur.
5/12/2015-New Directions Healthcare has instituted a policy that methadone will not be administered until a drug screen urine confirmation is back from an outside CLIA and Department of Health approved lab and results are scanned into the patient's chart. The Project Director who is also the Narcotic Treatment Physician is responsible for implementing this change and will ensure this does not reoccur. New Directions Healthcare will comply with the regulation as written until a determination regarding the exception request has been rendered and if that exception request is denied, New Directions Healthcare will adhere prescriptively to the regulation.
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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 patient records, the facility failed to document that the narcotic treatment physician determined the proper dosage level for a patient in one of two patient records reviewed.
The findings include:
Three patient records were reviewed on April 1, 2015. Two patient records were reviewed for documentation that the narcotic treatment physician determined the proper dosage level for a patient. There was no documentation in patient #1 that the narcotic treatment physician determined the proper dosage level.
Patient # 1 was admitted on December 12, 2014. There was documentation that the Certified Nurse Practitioner ordered a dose decrease from 45 to 40 mgs on December 17, 2014. There was also documentation that the Certified Nurse Practitioner ordered a dose increase from 40 to 45 mgs on December 29, 2014. There was no documentation that the narcotic treatment physician determined the dosage level.
These findings were reviewed with facility staff during the complaint investigation.
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Plan of Correction
On review of patient #1 it was determined that the Narcotic Treatment Physician did discuss with the examiner on 12/12/2014. The record of that was not properly sent to the Narcotic Treatment Physician for signature because of a programming issue in the EMR software. We found that error on our own and had the software corrected. The correction was accomplished on 1/9/2015. All previous notes were signed by the Narcotic Treatment Physician electronically on 1/9/2015. Going forward all medication orders are signed electronically by the physician in a timely fashion.
5/4/2015-The Narcotic Treatment Physician will determine the dose and any changes in dose of methadone. The Narcotic Treatment Physician will document in EMR the initial dose of methadone and any changes in doses of methadone. Verbal orders will be confirmed in EMR by checking a box indication verbal orders and read back to the Narcotic Treatment Physician for verification. The Narcotic Treatment Physician will be responsible for implementing the corrective actions and ensuring this does not happen in the future. Submitted by Kara Bennett CRNP, fACILTY |
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 records, the facility failed to ensure the physician documented in the patient record the rationale for granting take home medication in two of two patient records.
The findings include:
Three patient records were reviewed on April 1, 2015. Two patient records were reviewed for take home medication documentation. Patient records # 1 and 2 did not include documentation of the physician's rationale for granting the take home medication.
Patient #1 was admitted as a transfer on 12/12/14. The patient was granted 2 day take- home medication bottles. There was no documentation of the physician's rationale for granting the take home medication.
Patient # 2 was admitted as a transfer on 2/27/15. The patient was granted 2 day take- home medication bottles. There was no documentation of the physician's rationale for granting the take home medication.
These finding were discussed with facility staff during the complaint investigation.
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Plan of Correction
New Directions Healthcare has instituted a policy of a Take Home Checklist that documents all 8 take home criteria. The document is reviewed and approved or disapproved by the narcotic treatment physician, signed and scanned into the EMR. New Directions Healthcare is reviewing all patients currently with take homes and ensuring that this document is completed on all patients, and is scanned into EMR.
5/4/2015 The Narcotic Treatment Physician will document the rationale for allowing take home bottles in EMR. The 8 point take home criteria will be signed electronically by the Narcotic Treatment Physician in patient's EMR, either approving or disapproving the take home and stating rationale for allowing take homes. The Narcotic Treatment Physician will be responsible for implementing this corrective action and ensuring this does not happen in the future. submitted by Kara Bennett, CRNP, Facility Director. |