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Pennsylvania Department of Drug & Alcohol Programs
Inspection Results

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NEW DIRECTIONS HEALTHCARE, LLC
306 WEST 11TH STREET
ERIE, PA 16501

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Survey conducted on 07/08/2015

INITIAL COMMENTS
 
This report is a result of an onsite follow-up inspection regarding the plans of correction for the May 7, 2015 licensure renewal inspection. The follow-up inspection was conducted on July 8, 2015 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the onsite follow-up inspection, 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 inspection.
 
Plan of Correction

709.28(c)  LICENSURE Confidentiality

709.28. Confidentiality. (c) The project shall obtain an informed and voluntary consent from the client for the disclosure of information contained in the client record. The consent shall be in writing and include, but not be limited to:
Observations
Based on a review of client records, the facility failed to obtain an informed and voluntary consent prior to disclosure which included the specific information to be released and the purpose of the disclosure in four of four client records.



The findings include:



The consents for disclosure of information were reviewed in four client records on July 8, 2015. The facility did not document an informed and voluntary consent in client records # 1, 2, 3 and 4.





Client #1 was admitted on June 1, 2015. Three consents were signed by the client on June 1, 2015 - one for a funding source and two for laboratories.

The consent for the funding source did not include the specific information to be released. "Billing Information" was handwritten under information to be released, but does not indicate the specific information to be released.

The consents for the laboratories did not include the specific information to be released and a relevant purpose. "Billing Information" was handwritten under information to be released, but does not indicate the specific information to be released. The consents documented "Utilization review / billing" as the purpose, but this is not a relevant purpose for a laboratory. Laboratory results were noted in the record.





Client #2 was admitted on June 9, 2015. Three consents were signed by the client on June 8, 2015 - one for a funding source and two for laboratories.

The consent for the funding source did not include the specific information to be released. "Billing Information" was handwritten under information to be released, but does not indicate the specific information to be released.

The consents for the laboratories did not include the specific information to be released and an relevant purpose. "Billing Information" was handwritten under information to be released, but does not indicate the specific information to be released. The consents documented "Utilization review / billing" as the purpose, but this is not a relevant purpose for a laboratory. Laboratory results were noted in the record.





Client #3 was admitted on June 24, 2015. Three consents were signed by the client on June 22, 2015 - one for a funding source and two for laboratories.

The consent for the funding source did not include the specific information to be released. "Billing Information" was handwritten under information to be released, but does not indicate the specific information to be released.

The consents for the laboratories did not include the specific information to be released and a relevant purpose. "Billing Information" was handwritten under information to be released, but does not indicate the specific information to be released. The consents documented "Utilization review / billing" as the purpose, but this is not a relevant purpose for a laboratory. Laboratory results were noted in the record.





Client #4 was admitted on June 15, 2015. Two consents for laboratories were signed by the client on June 12, 2015. The consents for the laboratories did not include the specific information to be released and an relevant purpose. "Billing Information" was handwritten under information to be released, but does not indicate the specific information to be released. The consents documented "Utilization review / billing" as the purpose, but this is not a relevant purpose for a laboratory. Laboratory results were noted in the record.



These findings were reviewed with facility staff during the licensing process.
 
Plan of Correction
New Directions Healthcare has changed all insurance billing and lab release of information to all patients' chart as follows: all insurance companies ROI has checkmarked the following information to be released: whether the client is in treatment, demographics, nature of project, a brief statement regarding relapse and the frequency of relapse, diagnosis and dates of treatment. The stated purpose of disclosure is utilization review/billing. All lab ROI's have checkmarked the following information to be released: whether the client is in treatment, demographics-name, date of birth, ssn and address and copy of insurance card if applicable. The purpose of the disclosure is urine drugs screens and lab testing. The Facility Director has already changed the consents of as 8/01/2015-all patients have a new signed ROIS of labs and insurance ROI. The Facility Director will ensure that the corrective action is implemented and will do monthly QA on all new patient charts. Also, this will be imported as a computer document.

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.
Observations
As a result of a plan of correction follow up inspection conducted on July 8, 2015, there were two areas of non-compliance which were under the same regulation. They are as follows:



1.)

Based on review of the patient records, the facility failed to document the narcotic treatment physician communicated the dose and schedule to the person responsible for the administration of medication in five of five patient records.



The findings include:



Five patient records were reviewed on July 8, 2015. The narcotic treatment physician must communicate the dose and schedule to the person responsible for the administration of medication in all patient records. The five patients reviewed received a take home bottle for July 4, 2015 as the facility was closed for the holiday. There were no orders written for the take home medication. Upon further exploration, it was discovered that all 105 patients were given a take home bottle for July 4, 2015 and there were no orders written for the take home medication.





Patient # 1 was admitted on June 1, 2015. Patient #1 was given a take home bottle for July 4, 2015 and there was no order for this take home bottle documented in patient record #1.



Patient # 2 was admitted on June 9, 2015. Patient #2 was given a take home bottle for July 4, 2015 and there was no order for this take home bottle documented in patient record #2.



Patient # 3 was admitted on June 24, 2015. Patient #3 was given a take home bottle for July 4, 2015 and there was no order for this take home bottle documented in patient record #1.



Patient # 4 was admitted on June 1, 2015. Patient #4 was given a take home bottle for July 4, 2015 and there was no order for this take home bottle documented in patient record #4.



Patient #5 was given a take home bottle for July 4, 2015 and there was no order for this take home bottle documented in patient record #5.





These findings were reviewed with facility staff during the licensing process.









(2.)

Based on a review of patient records, the facility failed to document that each medication order and dosage change was written and signed by the narcotic treatment physician in four of five patient records.



The findings include:



Five patient records were reviewed on July 4, 2015. Four of the patients reviewed had dosage changes that were reviewed. Each medication order and dosage change shall be written and signed by the narcotic treatment physician. Patient records # 1, 2, 3 and 4 contained a standing order that included multiple dosage changes.



Patient #1 was admitted on June 1, 2015. The initial order written on June 1, 2015 stated that patient #1 should have 30 milligrams on June 1, 2015, 35 milligrams on June 2, 2015, 40 milligrams on June 3, 2015 and 45 milligrams on June 4, 2015.



Patient #2 was admitted on June 9, 2015. The initial order written on June 9, 2015 stated that patient #2 should have 30 milligrams on June 9, 2015, 35 milligrams on June 10, 2015, 40 milligrams on June 11, 2015 and 45 milligrams on June 12, 2015.



Patient #3 was admitted on June 24, 2015. The initial order written on June 24, 2015 stated that patient #3 should have 30 milligrams on June 24, 2015, 35 milligrams on June 25, 2015, 40 milligrams on June 26, 2015 and 45 milligrams on June 27, 2015.



Patient #4 was admitted on June 15, 2015. The initial order written on June 15, 2015 stated that patient #4 should have 30 milligrams on June 15, 2015, 35 milligrams on June 16, 2015 and 40 milligrams on June 17, 2015. A second order written on June 18, 2015 stated that the patient should have 45 milligrams on June 18, 2015 and 50 milligrams on June 20, 2015.





These findings were reviewed with facility staff during the licensing process.
 
Plan of Correction
New Directions Healthcare has instituted a policy that all patients receiving take home medication that each patient will have their own order in the chart and not a blanket order for the holiday. The Project Director will ensure that this does not occur again and will put every patient that is receiving a take home medication will have their own order written and signed by the narcotic treatment physician. This policy has already been instituted on 7/9/2015 as this was pointed out during our follow up inspection. This will be monitored by the Facility Director in the monthly QA of patient charts.



New Directions Healthcare has instituted a new policy effective 8/25/2015 that each medication order and dosage change shall be written and signed separately each day by the narcotic treatment physician and not as a standing order in one order. The Project Director is responsible for ensuring implementation of this policy and that this does not reoccur again. The Project Director will also be responsible for training any new physicians. This policy will be a part of our monthly QA checklist of all patients by the Facility Director.

 
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