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 Suboxone, in the residential detoxification from opioid dependence. This inspection was conducted on April 9, 2012 through April 10, 2012 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Malvern Institute, 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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715.6(a) LICENSURE Physician staffing
(a) A narcotic treatment program shall designate a medical director to assume responsibility for administering all medical services performed by the narcotic treatment program
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Observations
Based on the review of personnel records and administrative documentation, the facility failed to designated one person as the medical director to assume responsibility for administering all medical services performed by the narcotic treatment program.
The findings include:
The personnel records of the narcotic treatment physicians were reviewed on April 9 and April 10, 2012. Staff interviews revealed that employee # 6 was the facility's Medical Director. However, the review of employee # 6's personnel record revealed that this employee did not have a current job description. The job description in personnel record # 6 was for an Attending Physician and not the Medical Director. The personnel record of employee # 7 was reviewed. Employee # 7 had documentation of a signed job description for Medical Director. The employee record failed to include a current job description for this employee.
A review of the professional service agreement signed between the facility and the President of the group medical practice failed to specifically designate the name of a medical director. There was an addendum to the agreement signed on October 3, 2011 indicating duties that the medical director would provide, however, it did not specifically name a medical director. In this agreement, services provided to the facility are designated as the "group."
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Plan of Correction
A new job description has be written for employee #6 deisgnating this employee as Director of Psychiatric Services.
The professional services agreement will be revised to specifically indicate who the medical director is for Malvern.
The professional services agreement will be reviewed annually to ensure the medical director is specified.
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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 clinical documentation, the facility physician failed to document a face-to-face determination of a patient's current physiological dependence upon a narcotic drug in two of six patient records.
The findings include:
Six patient records were reviewed on April 9 through April 10, 2012. Six patient records were required to include documentation that the narcotic treatment physician made a face-to-face determination of whether an individual was currently physiologically dependent upon a narcotic drug. The narcotic treatment physician failed to document a face-to-face determination in patient records # 1 and 3.
Patient # 1 was admitted on January 8, 2012 and discharged on February 5, 2012. The record failed to contain documentation that the narcotic treatment physician made a face-to face determination of current opiate dependency.
Patient # 3 was admitted on January 14, 2012 and discharged on February 9, 2012. The narcotic treatment physician failed to conduct a face-to-face determination of current dependency. The documentation of current opiate dependency in the patient record was documented as a verbal order given by the narcotic treatment physician to the Certified Registered Nurse Practitioner.
An interview with the Quality Risk Regulatory Compliance Manager confirmed this finding.
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Plan of Correction
The physicans were re-educated on the requirement of making the face-to-face determinations of current dependency prior to administering Suboxone on May 4, 2012. Beginning with May admissions the Asst. Director of Nursing will monitor 100% of patient charts on a weekly basis to ensure the face-to-face determination of current dependency is made by the physician prior to adminstering suboxone. The results of the reviews will be forwarded to the Quality Manager on a weekly basis. |
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, the facility failed to obtain an informed, voluntary, written consent prior to the administration of a narcotic agent, specifically suboxone, for detoxification in one of six records.
The findings include:
Six patient records were reviewed on April 9 through April 10, 2012. All patient records were reviewed for 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 record # 1.
Patient # 1 was admitted on January 8, 2012 and discharged on February 5, 2012. The patient received their initial dose of Suboxone on January 9, 2012 at 6:00 P.M. There was no documentation of an informed, voluntary written consent prior to the administration of a narcotic agent in patient record # 1.
An interview with the Quality Risk Regulatory Compliance Manager confirmed this finding.
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Plan of Correction
Nursing staff will be re-educated on the requirement for all patients receiving suboxone to sign a written consent. The Asst. Director of Nursing will monitor the completion of these consnet through monthly chart reviews starting with May admissions. The completed chart reviews will be forwarded to the Quality Manager on a monthly baisis for review and follow-up as needed. |
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 the facility's policy and procedures, the narcotic treatment program failed to document a consultation between the narcotic treatment physician determining the initial dose and the narcotic treatment physician performing the physical examination in 6 of 6 records.
The findings include:
Six patient records were reviewed on April 9 through April 10, 2012. In patient records # 1, 2, 3, 4, 5, and 6, the narcotic treatment physician determining the initial dose was not the person that conducted the patient examination. The narcotic treatment physician failed to document the consultation with the narcotic treatment physician completing the examination. Additionally, the facility's policy and procedure was reviewed. The policy stated, "The narcotic treatment physician shall determine the proper dosage level for a patient, except if the narcotic treatment physician determining the initial dose is not the narcotic treatment physician who conducted the face-to-face 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." The policy does not meet the regulation by ensuring that a consultation takes place between the narcotic treatment physician that conducted the patient examination and the narcotic treatment physician that is determining the initial dose.
Patient # 1 was admitted on January 18, 2012. A review of documentation in the record indicated that the Certified Registered Nurse Practitioner completed the patient physical examination on January 9, 2012. The record did not contain documentation of a consultation between the narcotic treatment physician and the CRNP prior to the first dose of Suboxone on January 9, 2012 at 6:00 p.m.
Patient # 2 was admitted on January 23, 2012. A review of documentation in the record indicated that the patient physical examination was completed by the Certified Registered Nurse Practitioner (CRNP) on January 24, 2012. The narcotic treatment physician that determined the initial dose failed to document a consultation with the CRNP who completed the patient examination prior to the patient's initial dose of Suboxone. The patient received their first dose of Suboxone on January 24, 2012 at 6:00 p.m.
Patient # 3 was admitted on January 14, 2012. A review of documentation in the record indicated the patient physical examination was completed by the Certified Registered Nurse Practitioner (CRNP) on January 16, 2012. The documentation in the record indicated that the narcotic treatment physician provided a verbal order to induct the patient with Suboxone. There is no indication in the record that the narcotic treatment physician met with the patient prior to induction.
Patient # 4 was admitted on April 4, 2012 . Documentation in the patient record indicated the patient physical examination was completed by the Certified Registered Nurse Practitioner (CRNP) on April 5, 2012. The documentation revealed that the narcotic treatment physician indicated on the patient physical examination that she agreed with the findings of the CRNP, however, the record failed to document a consultation between the person who did the patient physical examination and the narcotic treatment physician.
Patient # 5 was admitted on April 5, 2012. Documentation in the patient record indicated the patient physical examination was completed by the Certified Registered Nurse Practitioner (CRNP) on April 5, 2012. The documentation revealed that the narcotic treatment physician indicated on the patient physical examination that she agreed with the findings of the CRNP, however, the record failed to document a consultation between the person who did the physical examination and the narcotic treatment physician.
Patient # 6 was admitted on April 8, 2012. Documentation in the patient record indicated the patient physical examination was completed by the Certified Registered Nurse Practitioner (CRNP) on April 8, 2012. The narcotic treatment physician that determined the initial dose failed to document a consultation with the CRNP who completed the patient examination prior to the patient's initial dose of Suboxone. The patient received their first dose of Suboxone on April 8, 2012 at 3:30 p.m.
An interview with the Quality Risk Regulatory Compliance Manager confirmed this finding.
This is a repeat citation from the October 3 through October, 4, 2011 Suboxone monitoring inspection.
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Plan of Correction
Beginning May 20, 2012 the physician who is completing the physical examination will be the same physician prescribing the initial dose of suboxone. This new process will eliminate the need for there to be a consultation between two physicians.
The Asst. Director of Nursing will monter this new process on a weekly basis starting with new admissions admitted after May 20, 2012. |
715.23(e) LICENSURE Patient records
(e) Patient file records, information and documentation shall be legible, accurate, complete, written in English and maintained on standardized forms or electronically.
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Observations
Based on the review of patient records, the facility failed to ensure that all documentation was legible.
The findings include:
Six patient records were reviewed on April 9 through April 10, 2012. The documentation included in the medical records did not have legible signatures and handwriting by the Certified Registered Nurse Practitioners and narcotic treatment physicians.
The licensing specialist requested a signature authentication page and one was provided. However, even with this tool the writer was unable to determine who signed the entries in the medical record. The Director of Nursing had to be utilized to help decipher the penmanship.
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Plan of Correction
On May 4, 2012 the physicians and CRNP's were informed of hte need to improve their handwriting to ensure it is legible.
Additionally Malvern is currently implementing an electronic medical record system which in turn will eliminate most of the handwritten documents. The electronic medical record is scheduled to be fully implemented with all physicians and nurses by June 1, 2012.
Until there is no longer hand written documentation in patient records the Asst. Director of Nursing will monitor the physician and CRNP's handwriting for legibility on a monthly basis through chart reviews. Monthly reviews will be impleted starting with May admissions. |
709.26(d)(3) LICENSURE Personnel Management
709.26. Personnel management.
(d) The personnel records shall include, but not be limited to:
(3) The verification of training experience and professional licensure or registration, where applicable.
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Observations
Based on the review of personnel records, the facility failed to document that each counselor met the qualifications for the position in one of five personnel records reviewed.
The findings included:
Seven personnel records were reviewed on April 9 and 10, 2012. Five of seven personnel records reviewed were counselors and were required to have documentation of degree verification. The facility failed to have documentation of qualifications employee record # 3.
Employee # 3 was recently promoted to counselor assistant. The staff provided a copy of the employee's degree. The degree indicated that the employee had obtained a Bachelor of Arts degree from Millersville University in January of 2011. However, the degree and transcripts that were provided failed to document the concentration of the employee's degree.
This finding was confirmed by the Quality Risk Regulatory Compliance Manager.
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Plan of Correction
On 4/24/12 employee #3's degree was verified with Millersville University. Employee #3 has a degree in psychologoy.
All employee's degree's have been verified for all employee's hired since 4/10/12.
A new hire checklist has been developed to ensure all new employee's have all required documentation completed upon hire including degree verfication. This checklist was implemented with all new hires as of May 1, 2012. |
709.32(b) LICENSURE Medication Control
709.32. Medication control.
(b) Verbal medication orders may be accepted but shall be put in writing and signed within 24 hours thereafter by the prescribing physician.
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Observations
Based on a review of the facility's policy and patient records, the facility failed to ensure that verbal medication orders were put in writing and signed within 24 hours thereafter by the prescribing physician, in two of two patient records. Additionally, the facility's policy on verbal orders did not meet the regulation.
The findings include:
Six patient records were reviewed on April 9 through April 10, 2012. According to the facility's policy, verbal orders may be accepted by the the Registered Nurse or Licensed Nurse Practitioner. The policy stated, "The prescribing physician and/or Certified Registered Nurse Practitioner's name must be documented with the order when a verbal order or telephone order is given. It must be authenticated in writing by a physician no later than 24 hours from the time the orders were originally given." The policy does not meet the regulation requirement of having verbal orders signed by the prescribing physician within 24 hours.
Patient records # 5 and 6 contained documentation of a verbal medication order that was not signed by the prescribing physician within 24 hours.
Patient #5 was admitted on April 5, 2012. Verbal orders contained in the patient record dated April 5, 2012 were given by the physician. Documentation in the patient record revealed that the Certified Registered Nurse Practitioner signed off on the order, not the prescribing physician.
Patient # 6 was admitted on April 7, 2012. Verbal orders contained in the patient record dated April 7, 2012 were given by the Certified Registered Nurse Practitioner. Documentation in the patient record revealed that the Certified Registered Nurse Practitioner signed off on the order, not the prescribing physician.
These findings were confirmed by the Director of Nursing on April 10, 2012 and were not disputed.
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Plan of Correction
On May 4, 2012 all physicians and CRNP's were informed of the requirement for verbal orders to be signed off on by the physician/CRNP who gives the verbal within 24 hours.
A new process will be implemented starting May 20, 2012 to ensure all verbal orders will be signed within 24 hours by the physician/CRNP who gives the verbal order. The new process will be for the nurse to fax the verbal order to the physician or CRNP at the time of the verbal order for their signature. The physician or CRNP will then fax the signed order back to the nurse.
The Asst. Director of Nursing will monitor this new process through weekly chart reviews starting on May 25, 2012. Once completed the weekly reviews will be forwarded to the Quality Manager for review and follow up if needed. |