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 January 14-15, 2009 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Gaudenzia, Inc. Fountain Springs was found not to be in compliance with the applicable chapters of 28 PA Code which pertain to the facility. Deficiencies were identified during this inspection and plan of correction is due on February 21, 2009.
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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 administrative documentation and discussion with administrative staff, the facility failed to designate a medical director to assume the responsibility of all medical services.
The findings include:
The policy and procedure manual and the physician job description were both reviewed on January 14 and 15, 2009. The facility failed to designate a medical director to assume responsibility for all medical services of the narcotic treatment program. The discussion with the administrative staff confirmed there was no designated medical director for the narcotic treatment program.
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Plan of Correction
Dr. Eric Petterson, M.D. is the designated Medical Director for Gaudenzia Fountain Springs. |
715.6(a)(3)(ii) 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.
(3) The medical director 's responsibilities include the following:
(ii) Supervision of licensed practical nurses if the narcotic treatment program does not employ a registered nurse to supervise the nursing staff. In addition, the medical director in these instances shall ensure that licensed practical nurses adhere to written protocols for dispensing and administration of medication.
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Observations
Based on the review of administrative documentation and interviews with staff, on January 15, 2009, the facility failed to ensure supervision of the licensed practical nurses.
The findings include:
The facility employs four licensed practical nurses (LPN) to provide services to the detoxification unit. The facility did not have a registered nurse or a medical director on staff to supervise the nursing staff. A review of the job description of the treatment physician was conducted on January 15, 2009, did not include supervision of the nursing staff. There was no documentation of the LPNs having received supervision.
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Plan of Correction
Dr. Eric Petterson will assume responsibility for the supervision of the licensed practical nurses. The program will consider a registered nurse for future hire. |
715.6(b)(1-9) LICENSURE Physician Staffing
(b) A narcotic treatment program may employ narcotic treatment physicians to assist the medical director. A narcotic treatment physician 's responsibilities include:
(1) Performing a medical history and physical exam.
(2) Determining diagnosis and determining narcotic dependence.
(3) Reviewing treatment plans.
(4) Determining dosage and all changes in doses.
(5) Ordering take-home privileges.
(6) Discussing cases with the treatment team.
(7) Issuing verbal orders pertaining to patient care.
(8) Assessing coexisting medical and psychiatric disorders.
(9) Treating or making appropriate referrals for treatment of these disorders.
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Observations
Based on the review of administrative documentation and patient records, the facility failed to ensure all required medical responsibilities were communicated to the physician.
The findings include:
The policy and procedure manual and physician's contract with the facility were reviewed on January 15, 2009. The physician's responsibilities noted in the contract with the facility failed to include determining narcotic dependence and diagnosis; assessing coexisting disorders and treating or referring for treatment of these disorders.
Four patient records were reviewed on January 14, 2009. The physician did not document narcotic dependency in patient records # 1, 2, 3 and 4.
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Plan of Correction
The physician's contract with the facility will be revised to include determining narcotic dependence and diagnosis, assessing co-existing disorders, and treating or referring for treatment of these disorders. The physician will document narcotic dependency in all patient records. The Program Director will obtain approval from the Division Director and Regional Director and revise the physician's contract. |
715.6(e) LICENSURE Physician Staffing
(e) A physician assistant or certified registered nurse practitioner may perform functions of a narcotic treatment physician in a narcotic treatment program if authorized by Federal, State and local laws and regulations, and if these functions are delegated to the physician assistant or certified registered nurse practitioner by the medical director, and records are properly countersigned by the medical director or a narcotic treatment physician. One-third of all required narcotic treatment physician time shall be provided by a narcotic treatment physician. Time provided by a physician assistant or certified registered nurse practitioner may not exceed two-thirds of the required narcotic treatment physician time.
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Observations
Based on the review of personnel records, the facility failed to ensure the registered nurse practitioner had a current license.
Findings include:
A review of the personnel record for the registered nurse practitioner on January 14, 2009, revealed the registered nurse practitioner's license expired in April 2008.
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Plan of Correction
The Program Director will ensure that the certified registered nurse practitioner has a current license and a copy of the license is maintained in the personnel records. |
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 patient records, the facility failed to ensure a face to face determination and documentation of the basis for determining current dependency was done prior to the administration of the agent.
The findings include:
Four patient records were reviewed on January 14, 2009. Face to face determination and documentation of current dependency was required in four patient records.
The physician did not document the basis for determining current dependency in patient records # 1, 2, 3 and 4.
The physician did not complete a face to face determination in three of the four records prior to the administration of the agent, # 2, 3 and 4. Patient record # 2 was initially dosed on 8-4-08, but not seen face to face by the physician until 8-5-08. # 3 was dosed on 10-10-08, but not seen face to face by the physician until 10-11-08. # 4 was dosed on 7-25-08 and not seen face to face by the physician until 7-26-08.
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Plan of Correction
A face-to-face determination and documentation of the basis for determining current dependency will be done by the physician prior to the administration of the narcotic treatment agent. This regulation will be reviewed with staff and physician in meeting with the Program Director. The Program Director will obtain written verification from staff that the regulation was reviewed. The Program Director will ensure compliance. |
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 the review of patient records, the facility failed to document physician orders in three of four patient records.
The findings include:
Four patient records were reviewed on January 14, 2009. Physician orders, signed and dated, were required in four patient records.
The physician did not write and sign an order for Suboxone for patient # 2.
The physician did not date the written order for Suboxone for patient # 3, and a copy of the patient's prescription was not in the record.
Record # 4 contained documentation of a verbal order, but the physician did not sign and date the documentation, required within 24 hours of the verbal order.
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Plan of Correction
Physician orders will be documented, per regulation, in all patient records. The physician will write, date, and sign all orders. A copy of the prescription will be kept in the patient record. All verbal orders will be signed and dated by the physician within twenty-four (24) hours of the verbal order. The nursing staff on duty will ensure that the physician writes, signs, and dates all orders per regulation. The Program Director will review this policy with staff in meeting and with physician. The Program Director will obtain written verification that the policy was reviewed with staff. |
715.17(c)(3)(i-v) 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:
(3) Inspection of storage areas. A narcotic treatment program shall inspect all drug storage areas and the dispensing station at least quarterly to ensure that the areas are maintained in compliance with Federal, State and local laws and regulations. A narcotic treatment program shall develop and implement written policies and procedures regarding who performs the inspections, how often, and in what manner the inspections are to be documented. The policies and procedures shall include the following:
(i) Disinfectants and drugs for external use shall be stored separately from oral and injectable drugs.
(ii) Drugs requiring special conditions for storage to insure stability shall be properly stored.
(iii) Outdated and contaminated drugs shall be removed and destroyed according to Federal and State regulations.
(iv) Administration of controlled substances shall be documented.
(v) Controlled substances and other abusable drugs shall be stored in accordance with Federal and State regulations.
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Observations
Based on the review of administrative documentation, the facility failed to ensure all quarterly inspections were completed.
The findings include:
The documentation of the quarterly reviews of the medication storage areas was reviewed on January 14, 2009. The facility did not document an inspection of the medication area due in November 2008. The last documented inspection was completed August 28, 2008.
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Plan of Correction
Reviews of the medication area will be conducted quarterly. Documentation of the reviews will be maintained in a file in medication area. The Program Director will ensure compliance. |
715.17(c)(4)(i-viii) 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:
(4) Method for control and accountability of drugs. A narcotic treatment program shall develop and implement written policies and procedures regarding who is authorized to remove drugs from the storage area and the method for accounting for all stored drugs. An agent or other drug prescribed or administered shall be documented on an individual medication record or sheet in a manner sufficient to maintain an accurate accounting of medication at all times and shall include:
(i) The name of the medication.
(ii) The date prescribed.
(iii) The dosage.
(iv) The frequency.
(v) The route of administration.
(vi) The date and time administered.
(vii) The name of the person administering the medication.
(viii) The take-home schedule, if applicable.
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Observations
Based on the review of administrative documentation and patient records, the facility failed to maintain an accurate accounting of the medication at all times.
The findings include:
Four patient records were reviewed on January 14, 2009 and the policy manual was reviewed on January 15, 2009. The policy manual under medication control stated the physician will write an individual prescription for each patient under his or her own license and a copy of said prescription will be placed in the patient ' s chart in an effort to show an account of the amount of narcotics to be accounted for. There was no copy of a written prescription in records # 2, 3 and 4. In addition, the medication control form in each record was not completely filled out with all the information regarding the initial amount ordered or the starting count.
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Plan of Correction
The facility will maintain an accurate accounting of the medication at all times. The physician will write an individual prescription for each narcotic for each patient. A copy of the prescription will be placed in the patient record. The medication control forms will be completely filled out including the initial amount ordered or starting count. Program Director will review, upon client admission, that the physician wrote an individual prescription for suboxone for each patient and copy of prescription was filed in the patient's chart. Program Director will review medication count sheets regularly to ensure proper completion. This procedure will be reviewed with staff and physician in meeting with Program Director. The Program Director will obtain written verification that this policy was reviewed with staff. The Program Director will be responsible for ensuring compliance regarding these procedures. |
709.14(b)(4) LICENSURE Subchapter B.Licensing Procedures.Restriction
709.14. Restriction on license.
(b) The licensee, using Department forms, shall notify the Department within 90 days of the occurrence of any of the following conditions:
(4) Change in activity/discontinuance of an activity.
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Observations
Based on discussion with facility administrative staff and observation by the licensing specialist, the facility failed to formally notify the Department of the temporary discontinuance of the licensed detoxification activity.
The findings include:
On January 14, the licensing specialist arrived at approximately 10:15 AM to conduct a detoxification activity monitoring for the use of a narcotic agent. Construction vehicles and construction activity was noted on the outside of the facility, including a temporary entrance to the unit being monitored. Administrative staff reported the detoxification unit was under construction and they were not receiving any patients for that level of care until all of the construction for the unit was completed. The rooms were empty of any and all furniture or lighting. There was no heat in the section during this time. Administrative staff reported this construction had been going on for several months, and they were therefore unable to accept any patients for narcotic detoxification. .
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Plan of Correction
The Department will be notified by the Program Director of any change/discontinuance of activity. The notification will occur within ninety (90) days of the occurrence. |