INITIAL COMMENTS
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This report is a result of an on-site follow up inspection pertaining to the plans of correction for a complaint investigation for the ARS of Lancaster, LP. This follow-up inspection was conducted on October 14, 2011, by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site follow-up inspection, A.R.S. of Lancaster, LP was found not to be 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)(3) 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:
(3) Obtain a drug use history and current drug use status of the individual.
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Observations
Based on the review of patient records, the facility failed to follow their plan of correction for documentation of drug use history and current drug status.
The findings include:
On October 14, 2011, a review of seven patient records found that the admitting physician did not sign and date the nursing assessment and biopsychosocial assessment prior to admitting the patient in all records reviewed. The plan of correction, submitted on July, 26, 2011, stated current drug use and drug use history will be documented within the Nursing Assessment and Biopsychosocial assessment. Within the plan of correction, these documents will be reviewed by the admitting physician with signature and date prior to the patient's admission.
Patient # 1 was admitted on September 13, 2011. A review of the patient record revealed the admitting physician did not date the signature on the nursing assessment prior to admitting the patient and the biopsychosocial assessment was signed and dated on September 20, 2011.
Patient # 2 was admitted on September 22, 2011. A review of the patient record revealed the biopsychosocial assessment was signed and dated October 11, 2011.
Patient # 3 was admitted on August 24, 2011. A review of the patient record revealed the admitting physician did not date the signature on the nursing assessment prior to admitting the patient and the biopsychosocial assessment was signed and dated on August 30, 2011.
Patient # 4 was admitted on September 6, 2011. A review of the patient record revealed the admitting physician did not date the signature on the nursing assessment prior to admitting the patient and the biopsychosocial assessment was signed and dated on September 20, 2011.
Patient # 5 was admitted on October 5, 2011. A review of the patient record revealed the admitting physician did not date the signature on the nursing assessment prior to admitting the patient and the biopsychosocial assessment was signed and dated on October 11, 2011.
Patient # 6 was admitted on August 30, 2011. A review of the patient record revealed the admitting physician did not date the signature on the nursing assessment prior to admitting the patient and the biopsychosocial assessment was signed and dated on September 20, 2011.
Patient # 7 was admitted on August 17, 2011. A review of the patient record revealed the admitting physician did not date the signature on the nursing assessment prior to admitting the patient and the biopsychosocial assessment was signed and dated on August 23, 2011.
The lack of documentation was addressed with the project director and it was confirmed that the plan of correction had not been met.
This was a repeat citation from the complaint generated on-site investigation conducted on July 5, 2011, by staff from the Division of Drug and Alcohol Program Licensure.
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Plan of Correction
ARS has modified nursing assessment and the biopsychosocial assessment to improve the documentation of both drug use history and current drug use status. In addition a separate space has been included on both assessments for admitting physician to sign and date signifying review of the assessments prior to admission. Both physicians will be trained on the use of the new assessments prior to the implementation of these new forms on or before November 8, 2011. This will ensure that the physicians always properly document their review of drug use history and current drug use status prior to admission. Nursing staff and our physician assistant will be trained regarding the use of the new nursing assessment and all clinical staff will be trained on the use of the new biopsychosocial assessment to ensure that the assessments are completed correctly. This training will be completed on or before November 8, 2011.
Nursing staff and the physician assistant will also be trained on or before November 8, 2011 to incorporate the review of both the nursing and biopsychosocial assessments for physician signature and date into the already occurring audit procedure that the Director of Nursing or Charge Nurse performs to ensure all admission requirements have been performed and documented prior to medicating new patients.
The clinical supervisor and project/facility director will also be trained on or before November 8, 2011 regarding these new procedures to ensure that the on-going chart audit process already in place at the facility includes reviewing the documentation to ensure compliance with these new procedures.
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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 document the consultation between the narcotic treatment physician determining the initial dose and the narcotic treatment physician performing the physical examination.
The findings include:
Seven patient records were reviewed on October 14, 2011. The facility failed to document the consultation between the narcotic treatment physician determining the initial dose and the narcotic treatment physician performing the physical examination in four of seven records.
Patient # 2 was admitted on September 22, 2011. A review of the patient record revealed the physician assistant (PA-C) did the physical exam on September 22, 2011, with no record of consult with the narcotic treatment physician determining the initial dose.
Patient # 4 was admitted on September 6, 2011. A review of the patient record revealed the physician assistant (PA-C) did the physical exam on September 6, 2011, with no record of consult with the narcotic treatment physician determining the initial dose and no date of signature by the narcotic physician.
Patient # 6 was admitted on August 30, 2011. A review of the patient record revealed the physician assistant (PA-C) did the physical exam on August 30, 2011, with no record of consult with the narcotic treatment physician determining the initial dose and no date of signature by the narcotic physician.
Patient # 7 was admitted on August 17, 2011. A review of the patient record revealed the physician assistant (PA-C) did the physical exam on August 17, 2011, with no record of consult with the narcotic treatment physician determining the initial dose and no date of signature by the narcotic physician.
An interview with the facility's project director confirmed these findings.
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Plan of Correction
The History and Physical Exam form has been modified to include a section within the History and Physical form that will document the narcotic treatment physician consultation with the physician assistant and provide an area for documenting any comments the narcotic treatment physician has pertinent to the consultation with physician assistant.
The Director of Nursing or Charge Nurse will incorporate reviewing the revised History and Physical Exam form into their already occurring audit procedure that the Director of Nursing or Charge Nurse performs to ensure all admission requirements have been performed and documented prior to medicating new patients.
The narcotic treatment physicians, physician assistant, and nursing staff will be trained on the use of the new form and audit procedures on or before November 8, 2011.
The clinical supervisor and project/facility director will also be included in this training to ensure that the existing chart audit process in place at the facility incorporates ensuring the new procedures remain in place and are carried out appropriately.
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715.17(a) LICENSURE Medication control
(a) A narcotic treatment program shall comply with applicable Federal and State statutes and regulations regarding the storing, compounding, administering and dispensing of medication.
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Observations
Based on the review of patient records, the facility failed to ensure that the narcotic treatment physician determined the proper dosage level in two of seven patients. Additionally, the narcotic treatment physician must document orders in accordance with applicable Federal and State regulations and statutes.
The findings include:
Seven patient records were reviewed on October 14, 2011. The patients' initial dose and subsequent dosing orders were reviewed in all records.
In patient record # 3, the patient was administered 30 mg of methadone on admission on August 25, 2011. On this same date, there was an order written to increase dose by 10 mg per day based on withdrawal symptoms.
In patient record # 5, the patient was administered 30 mg of methadone on admission on October 5, 2011. On this same date, there was an order written to increase dose by 5 mg per day based on symptoms of withdrawal.
On September 4, 2007, all narcotic treatment programs were issued a letter regarding methadone dose orders, especially during the induction phase, by the Department of Health & Human Services, Substance Abuse and Mental Health Services Administration: (SAMHSA)
In part, the following is excerpted from the letter:
"Because methadone overdose deaths have occurred in early treatment due to the drug's
cumulative effects of the first several days, it is also important to be cautious when
adjusting the dose. According to the drug labeling, the peak respiratory depressant
effects of methadone typically occur later and persist longer than its peak analgesic effects, which can contribute to cases of iatrogenic overdose, particularly during treatment initiation and dose titration. With repeated dosing, "methadone may be retained in the liver and released slowly, prolonging the duration of action despite low plasma concentrations." The drug labeling also states that "steady-state concentrations are not usually attained until 3 to 5 days of dosing," and that doses "will 'hold' for a longer period of time as tissue stores of methadone accumulate." Therefore, patients should be closely monitored during the induction phase, and the increase in dose should be under the close supervision of a physician as stated in 42 CFR 8.12 (h)(4), ' Dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling'. "
An interview with the facility's project director confirmed these findings.
This was a repeat citation from the complaint generated on-site investigation conducted on July 5, 2011, by staff from the Division of Drug and Alcohol Program Licensure.
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Plan of Correction
The facility has received the September 4, 2007 letter. This letter will be re-reviewed with the facility narcotic treatment physicians on or before November 8, 2011.
A training will be conducted on or before November 8, 2011 with both narcotic treatment physicians, physician assistant, and nursing staff members. This training will include retraining on Federal and State regulations and statutes concerning the documentation of physician orders. The training will be completed on or before November 8, 2011.
The training will include: 1. Communication of the requirement for physicians to only issue admission orders that include dosing instructions for the initial induction dose.
2. Additional dose increases during the induction period may only be ordered after a medical or nursing staff member conducts a face to face assessment of the patient to obtain a COWS score assessment.
3. The COWS score assessment must be reviewed with the physician prior to the physician issuing the dose increase order.
4. The review of the COWS score will be evidenced by COWS score being included on all physician orders during induction period in addition to the actual COWS score assessment being stapled to the physician order.
The facility/project director and clinical supervisor will also be included in this training to ensure that the existing chart audit process in place at the facility incorporates ensuring that the documentation standards remain in place on an ongoing basis.
During the 4 weeks following the training and the re-implementation of these procedures, the director of nursing and either the project/facility director or clinical supervisor will conduct meetings on Tuesdays, Wednesdays, and Thursdays to conduct an audit of all orders that have been issued prior to the previous meeting to ensure that these procedures are consistently in place. If the results of these audits do not yield 100% compliance, this compliance check process will continue for additional 4 week periods until 100% compliance is reached.
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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 a review of patient records, the facility failed to provide documentation of the physician's determinations for dose changes in one patient record.
The findings include:
Seven patient records were reviewed on October 14, 2011. The facility failed to document the physician's determination for a dose change in patient record # 7.
Patient # 7 was administered 30 mg of methadone on August 17, 2011. The patient was subsequently increased 10 mg per day on August 18, 2011 and August 19, 2011. An increase on August 21, 2011, was determined for another 10 mg. On August 22, 2011, the patient submitted a dose evaluation form for an increase in methadone dose. A face to face meeting with the medical director for patient assessment occurred on August 23, 2011, at which time the patient registered physical withdrawal symptoms. The medical director stated the patient would follow the "regular policy for dose increases" and was denied an increase based on facility policy.
On August 26, 2011, a verbal order to increase patient # 7's methadone dose from 60 mg to 70 mg was entered by a narcotic treatment physician. A review of patient record # 7 revealed that the increase was based on the original request submitted by the patient on August 22, 2011. There was no additional documentation in the patient record that identified the physician's rationale for the dose change nor was there any documentation between the physicians who had individually reviewed the patient's care and assessed the patient's dose level. An interview with the administrative staff confirmed there was a second physician involved in the determination of patient # 7's dose changes.
This was a repeat citation from the complaint generated on-site investigation conducted on July 5, 2011, by staff from the Division of Drug and Alcohol Program Licensure.
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Plan of Correction
ARS will conduct training with all medical and nursing staff on or before November 8, 2011. This training will include:
1. Re-education on facility policy and State regulations regarding documentation of the rationale for dose changes particularly as it relates to documentation of dose increase denials and subsequent requests for dosage increases. Narcotic treatment physicians will require a new dose evaluation form or COWS Assessment, when appropriate, to be completed and will have the data reviewed with the physician prior to issuing the order for all dosage increases rather than relying on dose evaluation form or COWS Assessment from a previously denied dosage increase request.
2. When two narcotic treatment physicians are both involved in evaluating or determining a dosage level increase, documentation of the consultation will be required within the physician order that is ultimately issued.
This training will ensure that Narcotic Treatment Physicians will not issue a dosage increase change without ensuring that the rationale of the dosage change is documented through a dose evaluation form, a current COWS Score Assessment, or special physician note explaining circumstances of dosage change. Additionally the training will ensure that both narcotic treatment physicians will understand that documentation of consultation between the 2 physicians is necessary when both physicians are involved in determining a dosage change.
Nursing staff and physician assistant will also be trained on or before November 8, 2011 to ensure this policy is consistently understood. Nurses will be training to not accept orders that do not include the required dose evaluation form or COWS assessment score, when appropriate.
The facility/project director and clinical supervisor will also be trained on this matter on or prior to November 8, 2011 to ensure that the existing chart audit process in place at the facility incorporates ensuring that all physician orders document the rationale for dosage changes and consultations with other narcotic treatment physicians, when required.
During the 4 weeks following the training and the re-implementation of these procedures, the director of nursing and either the project/facility director or clinical supervisor will conduct meetings Tuesdays, Wednesdays, and Thursdays to conduct an audit of all orders that have been issued prior to the previous meeting to ensure that these procedures are consistently in place. If the results of these audits do not yield 100% compliance, this compliance check process will continue for additional 4 week periods until 100% compliance is reached.
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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 patient records, the facility failed to ensure that verbal medication orders were signed within 24 hours by the prescribing physician, in one procedure, in one of seven patient records.
The findings include:
Seven patient records were reviewed patient records were reviewed on October 14, 2011. All verbal medication orders are required to be signed within 24 hours by the prescribing physician. Patient record # 3 contained documentation of a verbal medication order that was issued on August 27, 2011. This order was not signed by the physician until August 29, 2011, more than twenty four hours following the verbal order. Additionally, patient record # 3 contained documentation of a verbal order that was issued by a physician on August 25, 2011 and signed by a second physician within twenty four hours. Only the physician prescribing the verbal order may sign the order.
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Plan of Correction
The appropriate disciplinary action was administered to the part-time dispensing nurse that was involved in this error. The Director of Nursing and Project/Facility Director will continue to monitor this area for compliance utilizing our on-going chart audit process already in place at the facility to ensure all verbal orders are signed within 24 hours of issuance.
Additionally, we communicated with both narcotic treatment physicians to ensure that that they understand that only the physician issuing the verbal order may sign the corresponding order. We will also include education regarding this regulation in our training that will occur on or before November 8, 2011. Our nursing staff, physician assistant, facility/project director, and clinical supervisor will also be trained in this area to ensure that our on-going chart audit process already in place at the facility incorporates checking for compliance with this regulation.
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