INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection and inspection conducted for the approval to use a narcotic agent, specifically Methadone, in the treatment of narcotic addiction. This inspection was conducted on May 6 & 7, 2015 by staff from the Department of Drug and Alcohol Programs, Program Licensure Division. Based on the findings of the on-site inspection, New Directions Healthcare, LLC 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.
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Plan of Correction
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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:
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Observations
Based on a review of client records, the facility failed to obtain an informed and voluntary consent for the disclosure of information which included: the name of the person, agency or organization to whom the disclosure is made; the specific information to be released; the purpose of the disclosure and the event or condition upon which the consent will expire, in six of six client records.
The findings include:
Six client records were reviewed on May 6 &7, 2015. Six client records required documentation of an informed and voluntary consent which included all required components. The facility did not document an informed and voluntary consent, with all the required components, in client records # 1, 2, 3, 4, 5 and 6.
Client #1 was admitted on March 4, 2015. Two consents were signed by the client on March 4, 2015; however, the consents did not include all required components. The consent for the emergency contact did not include a recipient. The consent for billing did not include a recipient, the information to be released and an expiration date.
Client #2 was admitted on March 2, 2015. Two consents were signed by the client on March 2, 2015; however, the consents did not include all required components. The consent for the emergency contact did not include a recipient. The consent for billing did not include a recipient, the information to be released and an expiration date.
Client #3 was admitted on January 7, 2015. Two consents were signed by the client on January 7, 2015; however, the consents did not include all required components. The consent for the emergency contact did not include a recipient. The consent for billing did not include a recipient, the information to be released and an expiration date. One additional release, dated January 7, 2015 was blank, other than the client's name, client's signature and witness signature. The recipient, information to be released, purpose for the release and the expiration date were not completed.
Client #4 was admitted on March 3, 2015. Two consents were signed by the client on March 3, 2015; however, the consents did not include all required components. The consent for the emergency contact did not include a recipient. The consent for billing did not include a recipient, the information to be released and an expiration date.
Client #5 was admitted on January 19, 2015. Two consents were signed by the client on January 19, 2015; however, the consents did not include all required components. The consent for the emergency contact did not include a recipient. The consent for billing did not include a recipient, the information to be released and an expiration date.
Client #6 was admitted on January 5, 2015. Two consents were signed by the client on January 5, 2015; however, the consents did not include all required components. The consent for the emergency contact did not include a recipient. The consent for billing did not include a recipient, the information to be released and an expiration date.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
New Directions Healthcare has instituted a policy that all consents,including all required components will be signed by the client upon admission. New Directions Healthcare will add the informed and voluntary informed consents as part as the Patient Admission Checklist. The Facility Director will ensure that all voluntary and informed consents will have all the required components,including all emergency consents will include a recipient, the information to be released and an expiration date. The consents for billing to include a recipient, the information to be released and an expiration date. The Facility Director will ensure that all voluntary and informed consents will be completed and include all required components. The Facility Director will be responsible for implementing the corrective action and ensuring this does not happen in the future. All patient's release of information forms and consents: emergency and billing and rois were all re-signed by the patient as of 5/27/2015 by the patient. The Facility Director had staff training and will be conducting random monthly audits of patient"s charts.
Corrected the date of re-signed by 05/27/2015 on 6/15/2015 |
709.28(d) LICENSURE Confidentiality
709.28. Confidentiality.
(d) A copy of a client consent shall be offered to the client and a copy maintained in the client records.
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Observations
Based on a review of client records, the facility failed to document that a copy of a client consent was offered to the client in five of six client records.
The findings include:
Six client records were reviewed on May 6 & 7, 2015. A copy of each client consent is to be offered to every client. There was no documentation that a copy of client consent was offered in client records #1, 2, 3, 5 and 6.
Client # 1 was admitted on March 4, 2015. Two consents signed by the client on that same date did not include documentation that a copy was offered.
Client # 2 was admitted on March 2, 2015. Two consents signed by the client on that same date did not include documentation that a copy was offered.
Client # 3 was admitted on January 7, 2015. One consent signed by the client on that same date did not include documentation that a copy was offered.
Client # 5 was admitted on January 19, 2015. One consent signed by the client on that same date did not include documentation that a copy was offered.
Client # 6 was admitted on January 5, 2015. One consent signed by the client on that same date did not include documentation that a copy was offered.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
New Directions Healthcare has instituted a policy that all consents will be offered to the client and will be documented on the consent if patient accepted or declined consent and patient will be required to initial. New Directions Healthcare has added documentation that all consents were offered and if was accepted or declined by the patient as part as the Patient Admission Checklist. The Facility Director will ensure that all consents are offered to all clients, clients then initial if accepted or declined. The Facility Director will ensure that all clients consents will be offered to client and properly documented on the consent. The Facility Director will be responsible for implementing the corrective action and ensuring this does not happen in the future. All patients forms and releases were re-signed by the patient as of 5/27/2015. All procedures were reviewed in the staff meeting May 27, 2015. The Facility Director will be do monthly review of patient's chart to ensure all forms are properly completed and forms are documented that was offered or declined by patient and patient to initial each form. |
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 five of six patient records.
The findings include:
Six patient records were reviewed on May 6 & 7, 2015. Six 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, 3, 4, 5 and 6.
Patient # 1 was admitted on March 4, 2015. The Certified Registered Nurse Practitioner completed the face to face determination of dependency on March 4, 2015 and the patient's initial dose was given that same day. The narcotic treatment physician co-signed the face to face determination on March 4, 2015.
Patient # 3 was admitted on January 7, 2015. The Certified Registered Nurse Practitioner completed the face to face determination of dependency on January 7, 2015 and the patient's initial dose was given that same day. The narcotic treatment physician co-signed the face to face determination on January 7, 2015.
Patient # 4 was admitted on March 3, 2015. The Certified Registered Nurse Practitioner completed the face to face determination of dependency on March 3, 2015 and the patient's initial dose was given on March 7, 2015. The narcotic treatment physician co-signed the face to face determination on March 3, 2015.
Patient # 5 was admitted on January 19, 2015. The Certified Registered Nurse Practitioner completed the face to face determination of dependency on January 19, 2015 and the patient's initial dose was given that same day. The narcotic treatment physician co-signed the face to face determination on January 19, 2015.
Patient # 6 was admitted on January 5, 2015. The Certified Registered Nurse Practitioner completed the face to face determination of dependency on January 5, 2015 and the patient's initial dose was given that same day. The narcotic treatment physician co-signed the face to face determination on January 5, 2015.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The face to face will be conducted by the Narcotic Treatment Physician, not merely signed by the Physician. All face to face determination of dependency will be signed by the narcotic treatment physician prior to administration of an agent. The Narcotic Treatment Physician, who is also the Project Director will be responsible for implementing the corrective action and ensuring this does not happen in the future. This action was already citated, previously corrected and approved as of May 15,2015. The Project Director will randomly review patient record monthly to ensure that this does not reoccur. |
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 six of six patient records. A complete drug screen includes receiving the results from a CLIA and Department of Health approved laboratory.
The findings include:
Six patient records were reviewed on May 6 & 7, 2015. Six patient records were reviewed for documentation of a completed initial drug-screening urinalysis. There was no documentation of a completed initial drug-screening urinalysis by a CLIA and Department of Health approved laboratory in patient records # 1, 2, 3, 4, 5 and 6.
Patient # 1 was admitted on March 4, 2015. The initial urinalysis was completed on March 4, 2015 using the dip stick method. There was no documentation of urinalysis results from an outside CLIA and Department of Health approved laboratory in patient record #1.
Patient # 2 was admitted on March 2, 2015. The initial urinalysis was completed on March 3, 2015 using the dip stick method. There was no documentation of urinalysis results from an outside CLIA and Department of Health approved laboratory in patient record #2.
Patient # 3 was admitted on January 7, 2015. The initial urinalysis was completed on January 7, 2015 using the dip stick method. There was no documentation of urinalysis results from an outside CLIA and Department of Health approved laboratory in patient record #3.
Patient # 4 was admitted on March 3, 2015. The initial urinalysis was completed on March 3, 2015 using the dip stick method. There was no documentation of urinalysis results from an outside CLIA and Department of Health approved laboratory in patient record #4.
Patient # 5 was admitted on January 19, 2015. The initial urinalysis was completed on January 19, 2015 using the dip stick method. There was no documentation of urinalysis results from an outside CLIA and Department of Health approved laboratory in patient record #5.
Patient # 6 was admitted on January 5, 2015. The initial urinalysis was completed on January 5, 2015 using the dip stick method. There was no documentation of urinalysis results from an outside CLIA and Department of Health approved laboratory in patient record #6.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
New Directions Healthcare has instituted a policy that methadone will not be administered until a confirmation is back from an outside CLIA and Department of Health approved lab 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. 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. This was corrected as of 5/5/2015 and was a previous citation that was re-submitted and approved as of 5/15/2015. All staff have been thoroughly trained in this procedure in May 4 2015 staffing. |
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 six of six patient records reviewed.
The findings include:
Six patient records were reviewed on May 6 & 7, 2015. Six 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 records # 1, 2, 3, 4, 5 and 6 that the narcotic treatment physician determined the proper dosage level.
Patient # 1 was admitted on March 4, 2015. The patient's first dose was on March 4, 2015. There was no initial order for methadone signed by the narcotic treatment physician in patient record #1.
Patient # 2 was admitted on March 2, 2015. The patient's first dose was on March 2, 2015. There was no initial order for methadone signed by the narcotic treatment physician in patient record #2.
Patient # 3 was admitted on January 7, 2015. The patient's first dose was on January 7, 2015. There was no initial order for methadone signed by the narcotic treatment physician in patient record #3.
Patient # 4 was admitted on March 3, 2015. The patient's first dose was on March 7, 2015. There was no initial order for methadone signed by the narcotic treatment physician in patient record #4.
Patient # 5 was admitted on January 19, 2015. The patient's first dose was on January 19, 2015. There was no initial order for methadone signed by the narcotic treatment physician in patient record #5.
Patient # 6 was admitted on January 5, 2015. The patient's first dose was on January 5, 2015. There was no initial order for methadone signed by the narcotic treatment physician in patient record #6.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Project Director in reviewing the charts with the Facility Director discovered a process error in our computer software. The Narcotic Treatment Physician was entering the orders in the wrong screen in the EMR, thus not generating a physician order. Procedures were reviewed with the Narcotic Treatment Physician, Facility Director and EMR company. All orders will be entered in the appropriate order set which will generate a physician order to be signed and time stamped by the Narcotic Treatment Physician. The Project Director is responsible to ensure ongoing implementation of this process and will ensure that this does not reoccur in the future. The plan of correction was implemented as of May 4, 2015. This was a previous citation that was cited, resubmitted and approved already as of 5/5/2015. The Project Director will be conducting monthly random audits of all patient's charts to ensure that this does not re-occur. The Project Director will provide staff training to other Narcotic Treatment Physicians. |
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.
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Observations
Based on a review of patient records, the facility failed to document the physician's determination of subsequent dose and schedule in two of two patient records.
The findings include:
Six patient records were reviewed on May 6 & 7, 2015. Two of the patients reviewed had an alternate dosing schedule with take home privileges. Patient records # 2 and 4 did not include documentation of the physician's determination of subsequent dose and schedule.
Patient #2 was admitted on March 2, 2015 as a transfer and was given two take home medication bottles on March 14, 2015. There was no physician order documenting the alternate dosing schedule to include take home privileges.
Patient # 4 was admitted on March 3, 2015 as a transfer. Patient was admitted with 6-day take home privileges and according to dosing history, the privileges were continued at the current facility. There was no physician order documenting the alternate dosing schedule to include take home privileges.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
In review of the charts with the Project Director and Facility Director, discovered there was a process error for physician's determination of subsequent dose and schedule. The Narcotic Treatment Physician was entering the orders in the wrong screen in the EMR,thus not generating a physician order. Procedures were reviewed between the Project Director, Facility Director and EMR company. This was corrected by the Project Director. All orders will be entered in the appropriate order set which will generate a physician order to be signed and time stamped by the Narcotic Treatment Physician.
-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 and dosing schedule. The Project Director will be responsible for implementing the corrective action and ensuring this does not reoccur. This was already cited, corrected, resubmitted and approved as of 5/5/2015. The Project Director will conduct monthly audits of 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 a review of patient records, the facility failed to document a psychosocial evaluation in two of six patient records.
The findings include:
Six patient records were reviewed on May 6 & 7, 2015. All patient records are required to have documentation of a psychosocial evaluation. Patient records #1 and 4 did not include documentation of a psychosocial evaluation.
Patient #1 was admitted on 3/4/15. As of the time of the inspection, there was no psychosocial evaluation documented for patient #1.
Patient #4 was admitted on 3/3/15. As of the time of the inspection, there was no psychosocial evaluation documented for patient #4.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
In review with the licensing specialist, client #1 and #4 had a psychosocial evaluation completed on the clients date of admission but did not have a narrative summary at the end of the evaluation summarizing all obtained information. This was later found to be from a processing error in the EMR because the summary did not appear at the end of the psychosocial evaluation. New Directions Healthcare has instituted a policy that all psychosocial are completed and signed and time stamped which will complete the document in the EMR. The Facility Director has implemented this change and will be responsible for ensuring this does not reoccur in the future. This was reviewed with the staff in the May 11,2015 staff. All patients admitted have documentation of a psychosocial evaluation. A chart audit was completed of all patients as of May 27, 2015 and all patients have had had a completed psychosocial evaluation. The Facility Director will conduct monthly audits of patient charts to ensure that all patients have a psychosocial evaluation. |
709.91(b)(6) LICENSURE Intake and admission
709.91. Intake and admission.
(b) Intake procedures shall include documentation of:
(6) Psychosocial evaluation.
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Observations
Based on a review of client records, the facility failed to document a psychosocial evaluation in two of six client records.
The findings include:
Six client records were reviewed on May 6 & 7, 2015. All client records are required to have documentation of a psychosocial evaluation. Client records #1 and 4 did not include documentation of a psychosocial evaluation.
Client #1 was admitted on 3/4/15. As of the time of the inspection, there was no psychosocial evaluation documented for client #1.
Client #4 was admitted on 3/3/15. As of the time of the inspection, there was no psychosocial evaluation documented for client #4.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
In review with the licensing specialist, client #1 and #4 had a psychosocial evaluation completed on the clients date of admission but did not have a narrative summary at the end of the evaluation summarizing all obtained information. This was later found to be from a processing error in the EMR because the summary did not appear at the end of the psychosocial evaluation. New Directions Healthcare has instituted a policy that all psychosocial are completed and signed and time stamped which will complete the document in the EMR. The Facility Director has implemented this change and will be responsible for ensuring this does not reoccur in the future.
This was reviewed with the staff in the May 11,2015 staff. All patients admitted have documentation of a psychosocial evaluation. A chart audit was completed of all patients as of May 27, 2015 and all patients have had had a completed psychosocial evaluation. The Facility Director will conduct monthly audits of patient charts to ensure that all patients have had a psychosocial evaluation. |
709.93(a) LICENSURE Client records
709.93. Client records.
(a) There shall be a complete client record on an individual which includes information relative to the client's involvement with the project. This shall include, but not be limited to, the following:
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Observations
Based on a review of client records, the facility failed to document a complete client record including client- related correspondence in six of six client records.
The findings include:
Six client records were reviewed on May 6 & 7, 2015. A record of client- related correspondence is required in all client records. Client records #1, 2, 3, 4, 5 and 6 did not include a record of client related correspondence.
None of the client records reviewed had a correspondence log or fax confirmation sheets, copies of letters, etc.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
New Directions Healthcare has instituted a policy that will scan all patient correspondence logs, fax confirmation sheets, letters in to the patient's EMR. The Facility Director has implemented this change and will be responsible for ensuring this does not reoccur in the future. Fax Confirmation sheets has been implemented as of May 18,2015. This was reviewed on May 18 staffing. Patient charts will be randomly audited monthly by the Facility Director to ensure this. |