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Pennsylvania Department of Drug & Alcohol Programs
Inspection Results

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CLEAR CHOICES, LLC
373 CLEVELAND STREET
ROCHESTER, PA 15074

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Survey conducted on 04/16/2013

INITIAL COMMENTS
 
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 April 15-16, 2013 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Innovative Recovery Solutions, 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.
 
Plan of Correction

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).
Observations
Based on a review of the patient records, the facility failed to document a release of information form signed by the patient prior to the disclosure of information in three of eight patient records.



The findings include:



Twelve patient records were reviewed on April 16, 2013. Three of the eight patient records did not include documentation of a consent to release information form prior to the release of information to a referring agency.



Patient record #4 - The patient was admitted to treatment on 2-8-2013. Information regarding the patients admission date and date of the first dose was faxed to the referring facility on 2-12-2013, but a release of information form was not signed by the patient prior to the disclosure.



Patient record #5 - The patient was admitted to treatment on 1-3-2013. Information regarding the patients admission date and date of the first dose was faxed to the referring facility on 1-3-2013, but a release of information form was not signed by the patient prior to the disclosure.



Patient record #7 - The patient was admitted to treatment on 2-7-2013, and was discharged on 3-20-2013. Information regarding the patients admission date and date of the first dose was faxed to the referring facility on 2-7-2013, but a release of information form was not signed by the patient prior to the disclosure.



The findings were reviewed with the Project Director and were not disputed.
 
Plan of Correction
Facility Director has added an additional release of information form to the intake process which allows for notification to the transferring facility of the patient's successful admission. Facility Director shall train all staff on this additional form by 5/31/13, will maintain documentation of that training on site and will monitor for compliance through random chart audits.

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.
Observations
Based on the review of patient records, the facility granted take home privileges despite the patient not being responsible in handling narcotic drugs in one of three patient records.



The findings include:



Twelve patient records were reviewed on April 16, 2013. Three patient records were reviewed for take home privileges.



Patient record #9 - The patient was admitted to treatment on 2-9-2012. The patient was granted tri-weekly take home privileges on 3-25-2013. The patient had opiate positive urine screens on 1-18-2013 and 1-28-2013. The patient had a prescription validation for a 30 day supply of opiates. The opiate prescription was from 3-28-2013 to April 28, 2013. In addition, the patient did not have an annual physical examination completed by the February 2013 due date.



The findings were reviewed with the Project Director and were not disputed.
 
Plan of Correction
Facility Director shall train staff on appropriately suspending or removing take home status when patients fail to meet the minimum eligibility criteria. Facility Director shall complete this training by 5/31/13 and will maintain documentation of the training on site. Facility Director will monitor staff compliance through random chart audits.

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
Based on a review of patient records, the facility failed to ensure that the narcotic treatment physician is determining the proper dosage level for a patient in five of eight patient records.



The findings include:



Twelve patient records were reviewed on April 16, 2013. Eight patient records were reviewed for medication order and dosage changes which shall be written and signed by the narcotic treatment physician. Patient records # 2, 3, 4, 6 and 9 contained documentation of medication orders that were completed by someone other than the narcotic treatment physician. The nurse completed the form including the increase or decrease dosage, and the physician indicated by his signature and a checkmark if he approved or denied the changes.



Patient record # 2 - The patient was admitted to treatment on 4-10-2010. Medication orders were completed on 12-3-2012, 1-21-2013, 1-31-2013, and 2-13-2013 by someone other than the narcotic treatment physician. The nurse completed the form including the increase or decrease dosage, and the physician indicated by his signature and a checkmark if he approved or denied the change.



Patient record # 3 - The patient was admitted to treatment on 2-7-2013. Medication orders were completed on 2-11-2013, 2-15-2013, 2-18-2013, 2-22-2013, 2-27-2013, 3-4-2013, 3-7-2013, 3-13-2013, 3-20-2013, 3-25-2013 and 4-8-2013 by someone other than the narcotic treatment physician. The nurse completed the form including the increase or decrease in dosage, and the physician indicated by his signature and a checkmark if he approved or denied the changes.



Patient record # 4 - The patient was admitted to treatment on 2-8-2013. A medication order was completed on 3-18-2013 by someone other than the narcotic treatment physician. The nurse completed the form including the increase or decrease dosage, and the physician indicated by his signature and a checkmark if he approved or denied the change.



Patient record # 6 - The patient was admitted to treatment on 12-27-2012, and was discharged on 2-22-2013. Medication orders were completed on 12-30-2012, 1-7-2013, 1-9-2013, 1-10-2013, 1-14-2013, 1-17-2013, 1-28-2013 and 1-31-2013 by someone other than the narcotic treatment physician. The nurse completed the form including the increase or decrease dosage, and the physician indicated by his signature and a checkmark if he approved or denied the change. There was a medication order for an increase to 40 mg on 12-30-2013. A medication order for an increase in dose from 40 mg to 50 mg was not signed or dated by the physician. There was an order on 1-7-2013 to decrease the dose from 50 mg to 25 mg due to AWOL.



Patient record # 9 - The patient was admitted to treatment on 2-9-2012. A medication order was completed on 4-4-2013 by someone other than the narcotic treatment physician. The nurse completed the form including an increase to a 70 mg dose, and the physician indicated a checkmark in the approved section, but his signature was in the denied section.



The findings were reviewed with the Project Director and were not disputed.
 
Plan of Correction
Facility Director shall train staff including the Medical Director on documenting patient's new dose or new dosing days on the current form in addition to approving or denying the request with his signature and date. Facility Director shall complete this training by 5/31/13 and will maintain documentation of the training on site. Facility Director will monitor compliance through random chart audits.

 
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