INITIAL COMMENTS
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This report is a result of 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 February 23, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Penn Foundation for Mental Health, Inc. was found not to be compliance with the applicable chapters of 28 PA Code which pertain to the facility. Deficiencies were identified during this inspection and a plan of correction is due on April 2, 2011.
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Plan of Correction
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715.9(a)(1) 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:
(1) Verify that the individual has reached 18 years of age.
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Observations
Based on the review of patient records, the facility failed to document verification that the individual has reached 18 years of age in five of five patient records.
The findings include:
Five patient records were reviewed September 9, 2010. Five patient records were reviewed for documentation of verification that the individual has reached 18 years of age. Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. Five patient records did not include the documentation to verify age, # 1, 2, 3, 4 and 5. These records contained documentation of admission but there was no information that verified the age of the patients at the time of their respective admissions.
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Plan of Correction
During our recent site visit, it was explained to us that we needed to verify a client's age prior to start of suboxone. All admissions are processed through our intake office, so the intake workers were met with and it was explained to them that they are to tell clients who have any history of opiate use, that they must present to treatment with proof of ID and age. This will be added to the intake sheet as a question - do you have proof of ID and age? If a client does not have a driver's license we will accept alternative forms of ID, ie birth certificate, prison ID, etc. If a client is not able to produce any proof of age, that client will not be eligible for suboxone treatment. |
715.9(a)(2) 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:
(2) Verify the individual 's identity, including name, address, date of birth, emergency contact and other identifying data.
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Observations
Based on the review of patient records, the facility failed to document verification of the individual's identity in five of five patient records.
The findings include:
Five patient records were reviewed September 9, 2010. Five patient records were reviewed for documentation of verification of identity. Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. Five patient records did not include documentation to verify identity, # 1, 2, 3, 4 and 5. These records contained documentation of admission but there was no information that verified the identity of the patients at the time of their respective admissions.
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Plan of Correction
During our recent site visit, it was explained to us that we needed to verify a client's identity prior to start of suboxone. All admissions are processed through our intake office, so the intake workers were met with and it was explained to them that they are to tell clients who have any history of opiate use, that they must present to treatment with proof of ID and age. This will be added to the intake sheet as a question - do you have proof of ID and age? If a client does not have a driver's license we will accept alternative forms of ID, ie birth certificate, prison ID, etc. If a client is not able to produce any proof of ID, that client will not be eligible for suboxone treatment. |
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 5 patient records on February 23, 2011, the narcotic treatment program failed to have a narcotic treatment physician make a face-to face determination and document in the patient's record the basis for determining an individual's physiological dependence upon a narcotic drug in 1 of 5 records.
Findings:
Five patient records were reviewed on February 23, 2011.
In patient records # 5 there was no documentation verifying that the narcotic treatment physician made a face-to-face determination of the patient's physiological dependence upon a narcotic drug. Documentation in the patient record revealed that the patient had been admitted into treatment following a verbal order from the physician.
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Plan of Correction
During our recent site visit, it was discovered that there was an instance when a client was started on suboxone via verbal order. The regulation stating that a face to face determination must take place was reviewed with the medical director of the Recovery Center and the head nurse. It was made clear to the psychiatrist that verbal orders are not acceptable to start suboxone. This was also discussed with the facility director and Penn Foundation medical director to assure that everyone understands the regulation. NTP is aware and will not prescribe suboxone without a face to face determination of psychiological dependence on a narcotic drug. |
715.12(1-5) LICENSURE Informed patient consent
A narcotic treatment program shall obtain an informed, voluntary, written consent before an agent may be administered to the patient for either maintenance or detoxification treatment. The following shall appear on the patient consent form:
(1) That methadone and LAAM are narcotic drugs which can be harmful if taken without medical supervision.
(2) That methadone and LAAM are addictive medications and may, like other drugs used in medical practices, produce adverse results.
(3) That alternative methods of treatment exist.
(4) That the possible risks and complications of treatment have been explained to the patient.
(5) That methadone is transmitted to the unborn child and will cause physical dependence.
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Observations
Based on a review of patient records and an interview with the facility director, the facility failed to obtain an informed, voluntary, written consent prior to the administration of a narcotic agent for maintenance treatment.
The findings include:
Five patient records were reviewed on February 23, 2011. Five patient records required the completion of an informed, voluntary written consent prior to the administration of a narcotic agent. The facility failed to document the completion of an informed, voluntary, written consent prior to the administration of a narcotic agent in patient records # 1 and 2.
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Plan of Correction
During our recent site visit, we were made aware that during some instances, we were not obtaining an informed, voluntary, written consent prior to administration of suboxone. A meeting was held with the medical director of the Recovery Center. It was explained by the medical director that there was a misunderstanding regarding the informed consents. NTP is now aware that informed consent must be signed prior to administration of suboxone on all clients, regardless of any circumstances. NTP and medical director, along with facility director, are all aware of this regulation now. Informed consent will be printed out by NTP and thoroughly explained to all clients prior to the administration of a narcotic agent. POC will be monitored by medical director of Penn Foundation and Recovery Center director. |
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 patient records and an interview with administrative staff, the facility failed to ensure that the patient was initially dosed following the completion of a drug-screen urinalysis in four of five patient records.
The findings included:
Five patient records were reviewed on February 23, 2011. Five patient records were reviewed for drug screen urinalysis results prior to a patient's initial dose. Per regulation, a narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter. The facility failed to document the completion of a drug screen urinalysis prior to dosing in patient record # 1, 2, 3 and 4.
Staff were interviewed at the time of the monitoring. They confirmed they were out of compliance.
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Plan of Correction
It was discovered during this site visit that an initial urine drug screen was not consisitently being done on clients prior to suboxone induction. Addiction technicians are responsible for admitting all clients. A new policy and procedure will be written for inpatient stating that every client admitted with a history of opiate use, will receive a urine drug screen upon admission. All addiction techs will be met with in a staff meeting and they will be informed of this new p&p. A follow up email will also be sent to ensure that every staff member receives the message that a UDS is to be given at time of admission. Penn Foundation has submitted a waiver to DOH to allow on-site dip stick testing and we are awaiting determination of that waiver. While we await determination of the waiver, the Recovery Center will make ongoing efforts to meet this regulation. Director of inpatient will oversee this POC. |
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 a review patient records and a staff interview, the narcotic treatment program failed to document the consultation between the narcotic treatment physician determining the initial dose and the narcotic treatment physician performing the physical examination in one of five patient records.
Findings:
Five patient records were reviewed on February 23, 2011. In patient records #1, the narcotic treatment physician determining the initial dose failed to document the consultation with the physician narcotic who completed the physical examination.
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Plan of Correction
It was discovered during the site visit that our NTP was not documenting the consultation with the medical doctor doing the history and physical. Our NTP uses a form documenting a client's current addiction and need for suboxone treatment. On this form, we have added a statement stating that the pysical has been reviewed and has been accepted by the NTP. The NTP physician will sign this form prior to a client beginning suboxone treatment. Medical Director of Penn Foundation will oversee this POC. |
715.17(b) LICENSURE Medication control
(b) A narcotic treatment program shall develop policies and procedures regarding verbal medication orders, including the issuing and receiving of orders, identifying circumstances when orders are appropriate and documenting orders, in accordance with applicable Federal and State statutes and regulations.
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Observations
Based on the review of patient records and discussion with staff, the facility failed to ensure the physician dated the signature after submitting a verbal order in two of five patient records.
The findings include:
Five patient records were reviewed February 23, 2011. Three records contained documentation of a physician's verbal orders. In patient record # 1, a verbal order was issued on October 1, 2011 and not signed until October 4, 2011. In patient record # 5, there was a verbal order signed by the physician but there was no date on the document to verify that the order had been signed within 24 hours of issuance.
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Plan of Correction
Nursing and medical staff were met with on March 30th to discuss this non-compliance. Nurses have been instructed to have physician sign all verbal orders within 24 hours. Nursing and NTP are aware of this regulation and understand. Medical Director of Penn Foundation and Director of Inpatient will oversee this POC. |
715.23(b)(6) LICENSURE Patient records
(b) Each patient file shall include the following information:
(6) Results of laboratory tests or other special examinations given by the narcotic treatment program.
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Observations
Based on a review of patient records and an interview with administrative staff, the facility failed to document the results of laboratory tests in four of five patient records.
The findings include:
Five patient records were reviewed on February 23, 2011. Five patient records were reviewed for the results of laboratory tests; specifically a serology test. Per regulation, each patient file shall include the results of laboratory tests or other special examinations given by the narcotic treatment program. The facility failed to document the results of a serology test in patient records # 1, 2, 3 and 4.
Discussions with treatment staff revealed that serology testing was not performed on all patients at the time of their admission into treatment.
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Plan of Correction
It was noted during the site visit that serology testing was not being done on clients. Penn Foundation does do serology testing on client who are exhibiting symptoms of disease and when indicated by the family practice physician or NTP, however Penn Foundation does not routinely do serology testing on clients without orders from a physician. A new policy and procedure will be written to explain that this testing is not routinely done on clients due to the fact that we are not a medical facility, the financial cost and the safety of our staff, we do not believe it is safe to transport actively detoxing clients to a lab while alone in a car with a technician. The policy and procedure will also explain that this test will be performed when indicated by the family practice physician, NTP or if client is exhibiting active symptoms. |
715.23(b)(23) LICENSURE Patient records
(b) Each patient file shall include the following information:
(23) Discharge summary.
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Observations
Based on a review of patient records and staff interviews, the facility failed to document discharge summaries within the facility's stated policy in 2 of five patient records.
The findings include:
Five patient records were reviewed February 23, 2011. Three patient records were reviewed for complete discharge summaries. The facility policy regarding the completion of discharge summaries stipulated that summaries should be completed within one week of discharge. Patient records # 3 and 5 were not competed within that time frame.
Patient # 3 was discharged on November 18, 2010; the discharge summary was completed on January 24, 2011.
Patient # 5 was discharged on October 8, 2010; the discharge summary was completed on December 13, 2010.
Interviews with facility staff confirmed the time frames for discharge summary completion was one week following discharge.
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Plan of Correction
It was discovered during the site visit that discharge summaries were being comleted late. Inpatient director will have a meeting with all inpatient clinicians and outpatient director will do the same with all outpatient clinicians. Directors will go over the Penn Foundation policy and procedure stating that discharge summaries are to be completed within one week. Clinicians are expected to follow this policy and procedure. POC will be monitored by chart check and via computer tracking system. Director of Inpatient/Outpatient will oversee this POC. |