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 residential detoxification from opioid dependence. This inspection was conducted on September 1, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Mirmont Treatment Center 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.
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Plan of Correction
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715.3(a)-(h) LICENSURE Approval of narcotic treatment programs
(a) An entity shall apply for and receive approval as required from the Department, DEA and CSAT or an organization designated by the Substance Abuse and Mental Health Services Administration (SAMHSA), under the authority of section 303 of the Controlled Substances Act (21 U.S.C.A. § 823) and sections 501(d), 509(a), 543, 1923, 1927(a) and 1976 of the Public Health Service Act (42 U.S.C.A. §§ 290aa(d), 290bb-2(a), 290dd-2, 300x-23, 300x-27(a) and 300y-11), prior to offering services within this Commonwealth as a narcotic treatment program. Application for approval shall be made simultaneously to the Department, DEA and CSAT or SAMHSA designee.
(1) The Department will forward a recommendation for approval to the Federal officials after a review of policies and procedures and an onsite inspection by an authorized representative of the Department and after a determination has been made that the requirements for approval under this chapter have been met.
(2) The decision of the Federal officials set forth in 21 CFR Chapter II (relating to Drug Enforcement Administration, Department of Justice) or other Federal statutes shall constitute the final determination on the application for approval by DEA and CSAT or SAMHSA designee.
(b) A narcotic treatment program shall be licensed under the Department's regulations for drug and alcohol facilities in Chapter 157, 704, 705, 709 or 711. When a licensee applies to operate a narcotic treatment program, the history component of the application of the licensee shall include the licensee's record of operation of any facility regulated by any State or Federal entity. A narcotic treatment program may not be recommended for approval unless licensure has been obtained under Chapters 157, 704, 705, 709 or 711.
(c) The Department will grant approval as a narcotic treatment program after an onsite inspection and review of narcotic treatment program policies, procedures and other material, when the Department determines that the requirements for approval have been met.
(d) The Department will inspect a narcotic treatment program at least annually to determine compliance with State narcotic treatment program regulations. This inspection shall consist of an onsite visit and shall include an examination of patient records, reports, files, policies and procedures, and other similar items to enable the Department to make an evaluation of the status of the narcotic treatment program. The Department may inspect the narcotic treatment program without notice during any regular business hours of the narcotic treatment program.
(e) During the inspection process, a narcotic treatment program shall make available to the authorized staff of the Department full and free access to its premises, facilities, records, reports, files and other similar items necessary for a full and complete evaluation. The Department may make copies of materials it deems necessary under 42 CFR 2.53 (relating to audit and evaluation activities) and §§ 709.15 and 711.15 (relating to right to enter and inspect; and right to enter and inspect).
(f) The authorized Department representative may interview patients and staff as part of the inspection process.
(g) The Department may grant approval as a narcotic treatment program after an onsite inspection when the Department determines that a narcotic treatment program satisfies the following:
(1) It has substantially complied with applicable requirements for approval.
(2) It is complying with a plan of correction approved by the Department with regard to any outstanding deficiencies.
(3) Its existing deficiencies will not adversely alter the health, welfare or safety of the facility 's patients.
(h) Notification of deficiencies involves the following:
(1) The authorized Department representative will provide the program director with a record of deficiencies with instructions to submit a plan of correction.
(2) The narcotic treatment program shall complete the plan of correction and submit it to the Department within 21 days after the last day of the onsite inspection.
(3) The Department will not grant approval as narcotic treatment program until the Department receives and approves a plan of correction.
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Observations
Based on the review of administrative documentation, the facility failed to have a current approval from the DEA.
The findings include:
The facility's administrative documentation was reviewed on September 1, 2011. The facility provided a DEA approval certificate that had expired on January 1, 2007. A current DEA certificate for the facility was requested and the facility was unable to produce one. The facility staff did apply for an updated certificate during the inspection. This finding was confirmed by the Director of Quality Improvement.
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Plan of Correction
Mirmont applied on line for their updated DEA facility license September 1, 2011. The DEA sent agents, Thompson and Reed, for a site visit on 9/28/11. They and are processig the appropriate paperwork along with Mirmont. Mirmont should receive thier new facility DEA certification within the next few weeks.
To ensure the DEA certification does not lapsen in the future, arrangements have been made for the DEA to send the renewal notice to the "Medical Director" as a title, not in the name of the Medical Director and also the Director of Performance will keep the renewal notice date on the Mirmont annual calendar of events for monitoring of the renewal process. |
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 the review of patient records, the facility failed to ensure that the narcotic treatment physician made the face-to-face determination of whether an individual is currently physiologically dependent upon a narcotic drug in two of seven patient records..
The findings include:
Seven patient records were reviewed on September 1, 2011. The facility failed to have the physician make the face-to-face determination of whether or not the patient was currently physiologically dependent on a narcotic drug. The certified registered nurse practitioner (CRNP) completed the face-to face documentation, not the physician in patient records # 2 and 6.
Patient # 2 was admitted on February 19, 2011. The CRNP completed the face-to-face on February 19, 2011. The documentation completed by the CRNP was countersigned by the physician; however, the physician did not date his signature. Additionally, there was no documentation by the physician that indicated a face-to-face by the physician had occurred.
Patient # 6 was admitted on August 19, 2011. The face-to-face was documented on August 20, 2011; the documentation indicated that the assessment was conducted by the CRNP.
The Director of Quality Improvement confirmed these findings.
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Plan of Correction
The Medical Director revised the Physician/Nurse Buprenorphine Detox Form, to include the following questions under the question listed below to ensure clear documentation of how the physician completed the evaluation:
1- Was the face-to-face evaluation of the client completed?
a- was the face-to face evaluationcompleted via televideomedicine?
b- If yes, did the physicin give the Buprenorphine dosing orders?
The Medical Director reviewed the revisions with all the physicians, CRNPs and nursing staff on September 21, 2001
The Medical Director has petitioned the State for an exception request for the face-to-face to be completed via teleconference. In the interim, Mirmont's Narcotic Treawtment Physicians will continue to complete the face-to-face interviews in person. |
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 of patient records, the narcotic treatment program failed to provide documentation of the physician's dose determination that was consistent with the regulations in three of seven records.
The findings include:
Seven patient records were reviewed on September 1, 2011. All patient records were required to document the narcotic treatment physician's determination of a dosage level for a patient, which could include a consult between the narcotic treatment physician determining the initial dose and the narcotic treatment physician performing the physical examination.
Patient # 2 was admitted on February 19, 2011. The Certified Registered Nurse Practitioner (CRNP) completed the physical examination on February 19, 2011. The Certified Registered Nurse Practitioner completed the suboxone order sheet on February 19, 2011. This was signed by the CRNP and countersigned by the narcotic treatment physician. The patient record contained a verbal order by the narcotic treatment physician to the CRNP that indicated the patient was to start on a high dose Suboxone protocol at 5 p.m. on February 19, 2011. There was no documentation that specified that the physician had met with and assessed the patient prior to the dose determination.
Patient # 4 was admitted on July 18, 2011. The Certified Registered Nurse Practitioner completed the physical examination July 19, 2011. The narcotic treatment physician completed the face-to-face for the client on July 18, 2011 and indicated that a consultation took place with the clinician who completed the physical examination. This was not able to take place on July 18, 2011 since the physical examination was not completed until July 19, 2011.
Patient # 6 was admitted August 19, 2011. The Certified Registered Nurse Practitioner completed the physical examination on August 20, 2011. The CRNP completed the Suboxone order sheet on August 20, 2011 and indicated that a verbal order from the narcotic treatment physician was received for the Suboxone protocol. There was no documentation that specified that the physician had met with and assessed the patient prior to the dose determination.
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Plan of Correction
The Medical Director revised the Physician/Nurse Buprenorphine Detox Form, to include the following questions under the question listed below to ensure clear documenation of the physician giving the dosing orders:
1- Was the face-to-face evaluation of the client completed?
a- was the face-to face evaluationcompleted via televideomedicine?
b- If yes, did the physicin give the Buprenorphine dosing orders?
The Medical Director reviewed the revisions with all the physicians, CRNPs and nursing staff on September 21, 2001.
The Medical Director has petitioned the State for an exception request for the face-to-face to be completed via teleconference. In the interim, Mirmont' Narcotic Treatment Physicians will continue to complete and document the dosing determinations in person.
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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 the facility's policy and procedures, the facility failed to ensure the physician signed and dated the signature after submitting a verbal order in three of three patient records reviewed.
The findings include:
Seven patient records were reviewed September 1, 2011. According to the facility's policy and procedure, "verbal or telephone orders given must be authenticated in writing by the physician no later than twenty-four hours from the time the order was originally given." Three records contained documentation of a physician's verbal orders. The physician failed to sign off on verbal orders within 24-hours in three of three patient records, # 2, 6, and 7.
Patient # 2 was admitted on February 19, 2011. The Certified Registered Nurse Practitioner (CRNP) documented a verbal order on February 19, 2011 for the patient to start a high dose of suboxone protocol at 5 PM on February 19, 2011. The physician failed to sign and date this verbal order as of the September 1, 2011 inspection. Additionally, a verbal order should not have been written in this situation as the physician would need to meet with the patient prior to determining the dose,
Patient # 6 was admitted August 19, 2011. There was a verbal order from the physician taken by the registered nurse on August 25, 2011. The order stated the patient could have a one time dose of catapress 0.1 mg DO PRN for anxiety. The physician failed to sign and date this verbal order as of the September 1, 2011 inspection.
Patient record # 6 also had a verbal order from the certified registered nurse practitioner on August 26, 2011 at 12 PM for the patient to be given Robaxin 1500 mg PO Q 6 PRN for muscle aches for seven days. The CRNP failed to sign and date this verbal order as of the September 1, 2011 inspection.
Patient # 7 was admitted August 10, 2011. A verbal order from the physician was taken by the certified registered nurse practitioner on August 11, 2011 at 3 PM for the patient to receive Albuterol 0.0083% 2.5 mg/ 3 ml via mini neb x DON. The CRNP failed to sign and date this verbal order as of the September 1, 2011 inspection.
Patient # 7 had a verbal order from the certified registered nurse practitioner on August 11, 2011 stating that it was a clarification order, Keflex 500 mg PO 4X/Day X 7 days for cellulitis. The CRNP failed to sign and date this verbal order as of the September 1, 2011.
Patient # 7 also had a verbal order, issued by the certified registered nurse practitioner on August 11,2 011 at 10:30 PM, for the patient to receive Albuterol 0.0083% 2.5 mg/ 3 ml via mini neb x now for wheezing on right lung. The CRNP failed to sign and date this verbal order as of the September 1, 2011 inspection.
Patient # 7 had a verbal order from the certified registered nurse practitioner on August 16, 2011 to discharge the warm compress to the Right FA. The CRNP failed to sign and date this verbal order as of the September 1, 2011 inspection.
Patient # 7 had a verbal order from the Physician to increase Zoloft 100 mg PO to Qhs per patient request for depression. The physician failed to sign and date this verbal order as of the September 1, 2011 inspection.
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Plan of Correction
The Medical Director and Nurse Manager develpoed a new protocol to ensure that all verbal orders are countersigned and dated by the physician within 24-hrs. The Nurse Manager educated the nursing staff on the new protocol 9/14 - 9/21/2011. The Nurse Manager will monitor compliance with the protocol by completing checks on open charts. The Nurse Manager will also have Medical Records reviewing all closed charts for compliance. The findings will be reported at the quarterly PI meeting.
The protocol is:
1- the nurse completing nightly chart check will pull all charts with verbal orders and place in the medical office for signature.
2- the medical staff will sign and date all verbal orders daily and return the charts for filing. |