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 October 3, 2011 through October 4,2 011 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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715.9(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 of eligibility prior to administration of an agent, specifically Suboxone, in one of six patient records.
The findings include:
Six patient records were reviewed October 4, 2011. All patient records were reviewed for documentation of verification of eligibility for services, specifically, that the patient had reached 18 years of age. The facility failed to verify that the patient was 18 years of age in client record # 1.
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Plan of Correction
1.Currently the admissions staff is verifying the identity of the patient prior to the patient being admitted to Malvern; however, they are not consistently placing a photo copy of the patient's identification in the patient's medical record. The Admissions Manager will inform all admissions staff that they are to make a photo copy of the patient's photo identification and immediately place it in the patient's medical record. This communication to admissions staff will be completed by November 3, 2011 and will be documented.
2.The Medical Records Coordinator will monitor medical records through monthly reviews to ensure the photo copy of the patient's photo identification is in the medical record. Medical record reviews will be implemented beginning with November admissions.
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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 verify the identity of the patient prior to the administration of an agent in one of six patient records.
The findings include:
Six patient records were reviewed on October 4, 2011. All patient records were reviewed for patient identity information. The facility failed to obtain a copy of the patient's photo identification card in patient record # 1.
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Plan of Correction
1.Currently the admissions staff is verifying the identity of the patient prior to the patient being admitted to Malvern; however, they are not consistently placing a photo copy of the patient's identification in the patient's medical record. The Admissions Manager will inform all admissions staff that they are to make a photo copy of the patient's photo identification and immediately place it in the patient's medical record. This communication to admissions staff will be completed by November 3, 2011 and will be documented.
2.The Medical Records Coordinator will monitor medical records through monthly reviews to ensure the photo copy of the patient's photo identification is in the medical record. Medical record reviews will be implemented beginning with November admissions.
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715.11 LICENSURE Confidentiality of patient records
A narcotic treatment program shall physically secure and maintain the confidentiality of all patient records in accordance with 42 CFR 2.22 (relating to notice to patients of Federal confidentiality requirements) and § 709.28 (relating to confidentiality).
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Observations
Based on the review of client records, the consent to release information forms to the funding sources exceeded 4 Pa. Code Subsection 255.5 (b) in 8 of 14 client records.
The findings include:
Based on the review of records on October 4, 2011, the facility failed to ensure that the information disclosed to the funding source did not exceed 4 Pa Code Subsection 255.5 (b). In client records # 2, 3, 4, , 5 and 6, release forms for funding sources documented that the face sheet could be released to the insurance company. The face sheet contained the following information that exceeded 255.5 (b); treatment history, emergency contact, medical history, medication, psychiatric history, living situation and legal information.
This is a repeat citation from the licensing visits conducted on May 16-18, 2011 and May 3-4, 2010. This was also cited during an unannounced follow-up inspection on November 16, 2010.
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Plan of Correction
1.Malvern Institute staff will be re-educated on PA Regulation 4 Pa. Code 255.5 (b) and limits of disclosure. The Quality/Regulatory Compliance Manager will develop an educational training for staff on 4 Pa. Code 255.5 (b) and limits of disclosure. All staff responsible for releasing confidential information will receive this training by November 3, 2011.
2.The release of information consents will be revised as to ensure PA Regulation 4 Pa. Code 255.5 (b) and limits of disclosure are met. This item will be completed by November 14, 2011.
3.The Medical Records Coordinator will monitor medical records through monthly reviews to ensure all staff are utilizing the revised consents and to ensure information disclosed to funding sources does not exceed 4 Pa Code 255.5. Medical record reviews will be implemented beginning with November admissions.
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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 , the program failed to complete an initial drug-screening urinalysis in two of six records.
The findings include:
Six patient records were reviewed on October 4, 2011. The program used an instant urine drug screen test result prior to the administration of a narcotic, specifically Suboxone, in patient records # 4 and 6. This is not a Clinical Laboratory Improvement Amendments of 1998 (CLIA) approved laboratory. The facility did obtain urinalysis test results from the laboratory after the patient's initial dose.
Patient # 4 was admitted on August 8, 2011. The patient had an instant drug screen completed on October 8, 2011. The CLIA approved test results were received by the facility on August 10, 2011 at 8:03 a.m. The patient received their first dose of Suboxone on August 9, 2011 at 9:30 a.m., prior to receiving the results from the laboratory.
Patient # 6 was admitted on September 7, 2011. The patient had an instant drug screen completed on September 7, 2011. The CLIA approved test results were received by the facility on September 9, 2011 at 7:48 a.m. The patient received their first dose of Suboxone on September 8, 2011 at 3:00 p.m., prior to receiving the results from the laboratory.
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Plan of Correction
1. Beginning November 10, 2011 Malvern's contract lab will be picking up urines on a daily basis and Malvern will then receive the drug-screening urinalysis results each morning by 10am. Patients will not receive their first dose of Suboxone until the UDS results are received from the lab.
2. On November 9, 2011, all physicians and nurses will be informed of the requirement for receipt of UDS results prior to dosing.
3. The Assistant Director of Nursing will monitor medical records through monthly reviews to ensure the UDS results are received prior to dosing Suboxone. Medical record reviews will be implemented beginning with November admissions.
4. Malvern Institute will request an exception to PA Code 715.14(a) in order to utilize the "dipstick" measure for initial urinalysis drug screening. The letter of exception will be completed by November 14, 2011. |
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, 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 2 of 6 records, as required.
The findings include:
Six patient records were reviewed on October 4, 2011. In patient records # 3 and 6, the narcotic treatment physician determining the initial dose failed to document the consultation with the narcotic treatment physician completing the physical examination.
An interview with the Quality Risk Regulatory Compliance Manager confirmed this finding.
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Plan of Correction
1. All physicians will be educated on the requirement for the physician who is ordering the first dose of Bupronorphine to consult with the physician who completed the physical examination. This education will be completed by November 3, 2011 and will be documented.
2. The Buprenorphine Detox Protocol form will be revised to include a section for the physician to document the consultation.
3. The Assistant Director of Nursing will monitor medical records through monthly reviews to ensure the consultation between the ordering physician and physician completing the physical examination is documented. Medical record reviews will be implemented beginning with November admissions.
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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, the facility failed to ensure the physician or certified registered nurse practitioner signed and dated the verbal order within 24 hours in three of three patient records reviewed.
The findings include:
Six patient records were reviewed October 4, 2011. Three records contained documentation of a physician or certified registered nurse practitioner's (CRNP) verbal orders. According to the facility's policy, the prescribing physician and/or CRNP's name must be documented with the orders (written by the licensed nurse taking the order) . The orders must be authenticated in writing by the physician no later than 24 hours. The facility failed to sign off on verbal orders within 24 hours in patient records # 3, 5, and 6.
Patient # 3 was admitted on September 30, 2011. There was a verbal order documented on the Physician's Admission order sheet from the narcotic treatment physician on 9/30/2011. The narcotic treatment physician failed to sign off on the orders as of October 4, 2011.
Patient # 5 was admitted on July 21,2011. There was a verbal order documented on the Physician's Admission order sheet that was received from the Certified Registered Nurse Practitioner (CRNP) on July 21, 2011. The CRNP did not sign off on the order as of October 4, 2011.
Patient # 6 was admitted on September 7, 2011. On 9/11/2011 a verbal order was received from the Certified Registered Nurse Practitioner (CRNP), the CRNP failed to sign off on this order within 24 hours, as required.
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Plan of Correction
1. Physicians and CRNP's will be re-educated on the requirement for verbal order authentication to be completed in writing within 24 hours. This education will be completed by November 3, 2011 and will be documented.
2. Nursing is now flagging all verbal orders for physician signature within 24 hours.
3. The Assistant Director of Nursing will monitor medical records through monthly reviews to ensure all verbal orders are authenticated within 24 hours by a physician. Medical record reviews will be implemented beginning with November admissions.
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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 observation, the facility failed to ensure that administering and dispensing of medications were conducted in a manner that protected patients from disruption or annoyance from other individuals.
The findings include:
At approximately 11:05 a.m. the licensing specialist observed a patient being dosed with suboxone. While this patient was being dosed, there was another patient in the same area that was being assessed by a nurse. This other patient also received medications. The dosing was not completed in a manner that the patient was protected from disruption or annoyance from other individuals.
This finding was confirmed by the Quality Risk Regulatory Compliance Manager who was also present when the dose monitoring was being conducted.
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Plan of Correction
1. Nursing staff will be re-educated on the requirement for only having one patient in the dosing area at a time when dosing suboxone. This education completed by November 1, 2011 and will be documented.
2. The Assistant Director of Nursing will monitor suboxone dosing on a weekly basis at random times of day to ensure that no other patients are present in the nursing station while a patient is receiving suboxone. This monitoring will begin on November 7, 2011 and will be documented. This monitoring will continue for a period of four weeks.
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715.17(c)(2) 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:
(2) Drug storage areas. A narcotic treatment program shall develop and implement written policies and procedures regarding storage of medications and access to the medication storage area. Agents shall be stored in a locked safe that has been approved by the DEA under 21 CFR 1301.72 and 1301.74 (relating to physical security controls; and other security controls).
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Observations
Based on a nursing station inspection , the facility failed to obtain permission prior to storage of materials other than the controlled agent required to be stored in the double locked controlled substance box.
The findings include:
An inspection of the medication storage and dosing area was conducted on October 4, 2011 at approximately 10:30 a.m. The double locked controlled substance box was opened and the contents reviewed. The contents included patient medications other than the controlled agent used for dispensing purposes. The findings were discussed with the assistant director of nursing, quality risk regulatory compliance manager, and facility director.
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Plan of Correction
1. All other controlled substances were moved to a separate double locked box during the inspection. The reviewer re-inspected the medication storage area and verified that suboxone was stored separately in a double locked box. Suboxone continues to be stored in a separate double locked box. This item was completed on October 3, 2011.
2. This requirement will be added to the monthly pharmacy inspections in order to ensure continued compliance. This item will be added to pharmacy inspections starting with the November inspection.
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715.23(b)(14) LICENSURE Patient records
(b) Each patient file shall include the following information:
(14) Case consultation notes regarding the patient.
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Observations
Based on the review of patient records, the facility documented a case consultation that had inaccurate information reflected on the document.
The findings include:
A review of patient record # 3 documented a case consultation that was conducted on October 3, 2011. It was determined that the form that was being used for the case consultation was pre-populated to include staff in attendance that were previously a part of the clinical team. However, some of the employees that were marked as present were no longer employees of the project.
An interview with the Quality Risk Regulatory Compliance Manager confirmed that there were employees marked as present in the case consultation meeting held on October 3, 2011 that were no longer employed with the project.
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Plan of Correction
1. The case consultation note was revised on October 4, 2011 to remove all pre-preprinted counselor names. The case consultation note was revised to include blank signature lines for all counselors in attendance at case consultation to sign. The revised case consultation note was implemented on October 5, 2011.
2. The Clinical Supervisors will monitor medical records through monthly reviews to ensure all counselors are utilizing the revised case consultation note. Medical record reviews will be implemented beginning with November admissions.
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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 the review of patient records, the facility failed to document a timely discharge summary in two of three records.
The findings include:
Six patient records were reviewed on October 4, 2011. Three patients were discharged from the program and required a discharge summary within seven days from the date of discharge. Patient record # 5's discharge summary was completed late, and patient record # 6 failed to have a discharge summary documented in the record.
Patient # 5 was admitted to the program on July 21, 2011 and discharged on August 11, 2011. The project completed the discharge summary on August 23, 2011. This was five days late.
Patient # 6 was admitted on September 7, 2011 and discharged on September 22, 2011. The facility failed to document a discharge summary for this patient record as of October 4, 2011.
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Plan of Correction
1. Counselors will be re-educated on the requirement for discharge summaries to be completed within 7 days of discharge. This education will be documented. This item will be completed by November 7, 2011.
2. The Medical Records Coordinator will monitor medical records through monthly reviews to ensure all discharge summaries are being completed within 7 days of discharge. Medical record reviews will be implemented beginning with November admissions.
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715.28(c)(1-5) LICENSURE Unusual incidents
(c) A narcotic treatment program shall file a written Unusual Incident Report with the Department within 48 hours following an unusual incident including the following:
(1) Complaints of patient abuse (physical, verbal, sexual and emotional).
(2) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.
(3) Significant disruption of services due to a disaster such as a fire, storm, flood or other occurrence.
(4) Incidents with potential for negative community reaction or which the facility director believes may lead to community concern.
(5) Drug related hospitalization of a patient.
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Observations
Based on the review facility documentation that included incident reports and the facility's policy and procedures, the facility failed to provide documentation of incident reports involving a drug related hospitalization of a patient to the Department. The facility's policy failed to include that incident reports must be forwarded to Department with 48 hours of the incident occurrence.
The findings include:
During the October 3, 2011 and October 4, 2011 Suboxone monitoring, the facility had documentation of an incident report that identified a patient was transported and admitted to the hospital due to use of heroin while in the program. On May 17, 2011 a tech found a patient locked in their bathroom. The tech had heard snoring and gurgling noises coming from the bathroom. The tech was able to unlock the bathroom door and found the patient in the bathroom with a loaded syringe and a bundle of heroin lying next to him. According to the incident report 911 was called and the patient was transported to the Emergency Room and admitted. The facility failed to provide the Department with written report that provided an account of the patient's hospitalization.
According to the facility's policy, all incident reports shall be forwarded to the Pennsylvania Department of Health, as appropriate. The policy failed to include that unusual incident reports must be filed with the Department with 48 hours following the unusual incident.
The facility was previously cited for not reporting unusual incidents during the July 8, 2011 complaint investigation. This is a repeat citation.
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Plan of Correction
1. Malvern's policy on incident reporting will be revised to include the requirement for all unusual incidents to be reported to the Department within 48 hours following the incident.
2. The Quality/Regulatory Compliance Manager will notify all staff of the unusual incidents that must be reported as defined in Chapter 715, standard #715.28. This notification to staff will be sent by November 3, 2001 and will be documented.
3. The Quality/Regulatory Compliance Manager will submit all required Unusual Incident Reports to the Department as required. This item will be completed ongoing as unusual incidents are reported.
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