INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection and an on-site inspection conducted for the approval to use a narcotic agent, specifically buprenorphine, in the treatment of narcotic addiction. This inspection was conducted on November 21-22, 2016 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Pyramid Healthcare, Inc- Pyramid Pittsburgh was found not to be in compliance with the applicable chapters of 28 PA Code which pertain to the facility.
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Plan of Correction
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709.28 (c) (1) 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 must be in writing and include, but not be limited to:
(1) Name of the person, agency or organization to whom disclosure is made.
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Observations
The facility failed to obtain informed and voluntary consent forms for the disclosure of information contained in the client record in ten of ten client records reviewed on November 21-22, 2016.
Ten client records were reviewed. Ten records required an informed and voluntary consent to release client information. The facility failed to obtain an informed and voluntary consent to release information in client records # 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10.
The consent to release information form states that revocation must be in writing. 42 CFR Part 2, Subpart C, subsection 2.31 (a) Required elements, specifies that the following information must be included on the written consent: "(8) A statement that the consent is subject to revocation at any time except to the extent that the program or person which is to make the disclosure has already acted in reliance on it." Therefore, as per 42 CFR, Part 2, Subpart C, subsection 2.31 (a)(8) the consent to release client information form can be revoked by the client at any time and there is no restriction on the manner in which they may revoke it. The facility failed to adhere to the requirements outlined in the federal confidentiality regulations by requiring the clients to revoke consent forms in writing.
In addition, consents to release information to criminal justice authorities were observed to include a statement that the consent could not be revoked. There were no court orders mandating treatment documented for these clients and therefore, the consents could be revoked verbally or in writing at any time.
These findings were discussed with facility staff during the licensing process.
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Plan of Correction
VP of Clinical Services revised consents on November 28, 2016 to ensure that all consents contain appropriate elements of a valid consent, inlcudng acknowledgement that a copy was offered to the client as well as the ability to revoke consents verbally or in writing. Criminal Justice consent was revised to eliminate statement that consent cannot be revoked. All staff members who deal directly with consents will receive additional training on revisions and completion of consents. Training will be concluded by February 2017. Completion of training will be verified by post test completion and monitored by Human resources Coordinators. |
709.28 (c) (2) 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 must be in writing and include, but not be limited to:
(2) Specific information disclosed.
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Observations
The facility failed to document that a copy of signed consents were offered to the client in ten of ten client records reviewed on November 21-22, 2016.
Ten client records were reviewed. All ten client records included at least one signed consent in which the client was not offered a copy.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
VP of Clinical Services revised consents on November 28, 2016 to ensure that all consents contain appropriate elements of a valid consent, inlcudng acknowledgement that a copy was offered to the client as well as the ability to revoke consents verbally or in writing. All staff members who deal directly with consents will receive additional training on revisions and completion of consents. Training will be concluded by February 2017. Completion of training will be verified by post test completion and monitored by Human resources Coordinators. |
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
The facility failed to document that the narcotic treatment physician made 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 in four of ten patient records reviewed on November 21-22, 2016.
Ten patient records were reviewed. Ten patient records required a face to face determination. Patient records # 4, 5, 6 and 7 did not document that a narcotic treatment physician made a face-to-face determination of dependency.
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
The Documentation of Addiction form used prior to the inspection on November 21-22 2016 has been revised by Director of Nursing and Medical Directors to state that the physician's evaluation with the client is in a face to face matter. The new form was developed, and approved by VP of Clinical Services on December 21, 2016 and will be put into place companywide on December 26, 2016. Director Of Nursing and Nurse Manager will ensure the new forms are placed in all new charts. Completion of form will be monitored on the monthly chart monitoring of open and closed charts, which is completed by Psych nurse. Chart monitor will ensure that all the required information is on the form and the form is signed and dated by the prescribing provider. |
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
The facility failed to obtain a complete drug screen urinalysis prior to the administration of Suboxone, a narcotic agent, in two of four patient records reviewed on November 21-22, 2016.
Ten patient records were reviewed for documentation of an initial drug-screening urinalysis. In patient records # 4 and 7, the patient received the first dose of Suboxone prior to the facility receiving the results of the initial urinalysis.
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
Clients admitted into the NTP and ordered suboxone inpatient have an initial UDS completed by nursing staff, and the prescribing physician reviews the results prior to ordering suboxone. These clients will continue to receive at least monthly UDS during treatment and random screens if needed. Psych nurse monitors to make sure all clients receive their screens and the results are provided to the physician to review.
In addition, the new Documentation of Addiction form now confirms documentation of the UDS on that form to ensure results are |
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
The facility physician failed to adhere to the dosing protocol listed on the medication by ordering that single dose Suboxone film be halved in one of four patient records reviewed on November 21-22, 2016.
Ten patient records were reviewed. Ten patient records had either subutex or suboxone prescriptions. Medication packaging identifies Suboxone as a single dose medication. Copies of the Suboxone prescriptions were reviewed. Patient # 7 had instructions to split the single dose Suboxone films.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Beginning January 1, 2017 Education and training will be provided on a continuous basis to all medical staff-prescribing providers as well as nursing staff administering medications. Director of Nursing and Nurse manager will facilitate training for nurses and providers, ensure training gets done, keep documentation of training, and monitor that all staff in these instances are trained. Education will ensure that suboxone films may not be cut or divided in any way. It will also include information for prescribers so they do not order suboxone to be cut or divided in any way. It will be reviewed with nursing staff that they are not permitted to cut or divide or administer suboxone films that have been cut or divided. If the appropriate dosage of suboxone films are not available, the pharmacy will be contacted to make an emergency delivery of the appropriate dose to the facility as soon as possible. |
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
The facility failed to document a complete client record which included case consultation notes and a discharge summary, in one of three client records reviewed on November 21-22, 2016.
Ten client records were reviewed. Three were reviewed as discharged clients.
Client # 9 was discharged on September 14, 2016. There was no documentation of case consultation notes or of a discharge summary.
These findings were reviewed with facility staff during the licensing inspection.
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Plan of Correction
Effective Tuesday, December 27th 2016 Clinical Supervisors will pass out form detailing clinical documentation deadlines to all clinical staff during treatment team meeting. This form includes due dates for treatment plans, case consults, discharge summaries and treatment plan updates. They will review clinical timeframes and reiterate timely documentation. Clinical supervisors will review clinicians paperwork weekly to ensure that timeframes are being met and that all clinical paperwork, including treatment plans, treatment plan updates, individual and group notes and case consults and discharge summaries are being completed. Clinical supervisors will address counselors during bi weekly supervision on any deficient clinical paperwork. Any counselors requiring more supervision will be met with accordingly. Interim Program Director will meet bi weekly with Clinical Supervisors to ensure charts are being monitored and supervision is being completed and clinical paperwork is being done. |