INITIAL COMMENTS |
This report is a result of an on-site licensure renewal inspection and inspection conducted for the approval to use a narcotic agent, specifically Methadone, in the treatment of narcotic addiction. This inspection was conducted on April 15 and 16, 2014, by staff from the Department of Drug and Alcohol Programs, Program Licensure Division. Based on the findings of the on-site inspection, Williamsport Family Medical Center was found not to be in compliance with the applicable chapters of 4 PA Code and 28 PA Code which pertain to the facility. The following deficiencies were identified during this inspection: |
Plan of Correction
|
705.24 (1) LICENSURE Bathrooms.
705.24. Bathrooms.
The nonresidential facility shall:
(1) Provide bathrooms to accommodate staff, clients and other users of the facility.
|
Observations Based on observation during the physical plant inspection, the facility failed to ensure that the hot water temperature did not exceed 120F. The findings included:The physical plant inspection took place on April 15, 2014, at approximately 3 p.m. The water temperature was tested in the rear bathroom. The temperature read 130F. The facility director reported having checked and received a lower temperature. The temperature was tested on April 16, 2014, at 10:10 a.m. with the facility director. The Department staff used a thermometer in the water that tested over 130 degrees and the facility director used a digital scanner that read 120.4 degrees.
|
Plan of Correction On April 29, 2014, the landlord was contacted by the Facility Director regarding the water temperature. A work order was initiated to adjust the water temperature below 120 degrees as indicated by the regulation. This work order will be fulfilled by May 9, 2014. Facility Director will take monthly readings of water temperature for the next year to insure compliance. |
705.28 (d) (1) LICENSURE Fire safety.
705.28. Fire safety.
(d) Fire drills. The nonresidential facility shall:
(1) Conduct unannounced fire drills at least once a month.
|
Observations Based upon the review of the fire drill log, the facility failed to document a fire drill at least once a month, during normal staffing conditions, on different days of the week and times of the day, and to set off a fire alarm or smoke detector during each fire drill.The findings included:Fire drill logs for the time period of August 2013 to March 2014 were reviewed. The facility failed to document a fire drill during the month of September 2013. The facility hours are documented from 5:30 a.m. to 1:30 p.m. with most patients receiving services before 8 a.m. The facility failed to document a drill prior to 9:12 a.m. The facility is open 7 days per week. The facility failed to documented drills occurring on any days other than Tuesday and Wednesday. The facility failed to document if the fire alarm or smoke detector was set off during the months of November 2013 and December 2013. The findings were reviewed and confirmed by the facility director.
|
Plan of Correction Facility Director in conjunction with the Safety Officer revised the fire drill schedule so that drills occur on varying days and times throughout the year. This schedule is in effect beginning May 2014. The company QI Director provided WFMC with an updated Emergency Drill Report & Fire Drill Report that insures proper documentation of functional fire alarm and smoke detector system. These forms are currently in use. At the end of the month, the Facility Director and Safety Officer will review the next months schedule of drills. Once a drill has occurred, the Facility Director will review it for accurate completion and sign off to ensure deficiency does not occur in the future. |
709.28(c) LICENSURE Confidentiality
709.28. Confidentiality.
(c) The project shall obtain an informed and voluntary consent from the client for the disclosure of information contained in the client record. The consent shall be in writing and include, but not be limited to:
|
Observations Based on the review of patient records, the facility failed to ensure that an informed and voluntary consent to release information was obtained in four of eight patient records reviewed. Additionally, the facility failed to adhere to 4 Pa Code 255.5 in one of eight records reviewed. The findings included:Eight patient records were reviewed during the on-site inspection. All patient records were reviewed for consents to release information documentation. The facility failed to ensure that an informed and voluntary consent to release information was obtained in four patient records reviewed, # 1, 2, 7 and 8. Additionally, the facility did not adhere to 4 Pa code 255.5 in record # 7.Patient record # 1 contained a consent to release information dated 9/23/2013, addressed to a family member that identified the information to be disclosed as "anything" and failed to identify the purpose for the release. Patient record # 2 contained two consents to release information dated 10/21/2013, addressed to other treatment programs that failed to identify the information to be released. Patient record # 7 contained a consent to release information dated 3/27/2014, addressed to a legal entity that identified the information to be released to include lab results, urinalysis results and dosing changes/history. Additionally, correspondence with the legal entity dated 4/7/2014, included the urinalysis results and dosing attendance. The information disclosed exceeds 4 Pa. Code 255.5 (b).4 Pa. Code 255.5 (b) states:(b) Restrictions. Information released to judges, probation or parole officers,insurance company health or hospital plan or governmental officials, under subsection(a)(1), (2), (4), (7) and (8), is for the purpose of determining the advisabilityof continuing the client with the assigned project and shall be restricted tothe following:(1) Whether the client is or is not in treatment.(2) The prognosis of the client.(3) The nature of the project.(4) A brief description of the progress of the client.(5) A short statement as to whether the client has relapsed into drug, oralcohol abuse and the frequency of such relapse.Patient record # 8 contained a consent to release information dated 3/27/2014, addressed to a funding source that failed to identify the information to be released. The information was reviewed and confirmed with the facility director.
|
Plan of Correction On April 17, 2014, Facility Director conducted training with staff on confidentiality and proper documentation on releases of information. Provided examples of proper vs improper completion of these forms. Also reviewed 4 Pa Code 255.5 regarding information that can be released to treatment providers vs other entities. This will be monitored by the Facility Director through the monthly chart review process starting May 2014. |
715.6(d) LICENSURE Physician Staffing
(d) A narcotic treatment program shall provide narcotic treatment physician services at least 1 hour per week onsite for every ten patients
|
Observations Based on the review of administrative documentation, the facility failed to provide at least one hour of physician time a week, on site, for every ten patients.The findings included:Physician time sheets and census reports for the months of December 2013, January 2014, February 2014 and March 2014, were reviewed on April 15, 2014. There were insufficient onsite physician hours during December 2013, February 2014, and March 2014. During the week of December 2-8, 2013, the census was 48 patients and 4.5 physician hours were documented as provided to the facility's patients during this time period. Physician hours required were 4.8 per week.During the week of February 3-9, 2014, the census was 92 patients and 9 physician hours were documented as provided to the facility's patients during this time period. Physician hours required were 9.2 per week.During the week of February 10-16, 2014, the census was 101 patients and 5 physician hours were documented as provided to the facility's patients during this time period. Physician hours required were 10.1 per week.During the week of February 17-23, 2014, the census was 101 patients and 5 physician hours were documented as provided to the facility's patients during this time period. Physician hours required were 10.1 per week.During the week of February 24 - March 2, 2014, the census was 104 patients and 5 physician hours were documented as provided to the facility's patients during this time period. Physician hours required were 10.4 per week.During the week of March 3-9, 2014, the census was 104 patients and 5 physician hours were documented as provided to the facility's patients during this time period. Physician hours required were 10.4 per week.The findings were reviewed and confirmed with the facility director.
|
Plan of Correction the Facility Director will ensure that the proper doctor patient ratio is followed on a weekly basis. As March 13, 2014, a Physician Assistant was hired to supplement the Medical Director's hours on a weekly basis. The number of doctor/PA hours will be adjusted according to census needs weekly. The Facility Director will review weekly enrollment and doctor/PA schedule with Assistant Regional Director to ensure time is consistent with program enrollment to ensure deficiency doesn't occur in the future. |
715.9(c) LICENSURE Intake
(c) If a patient was previously discharged from treatment at another narcotic treatment program, the admitting narcotic treatment program, with patient consent, shall contact the previous facility for the treatment history.
|
Observations Based on a review of patient records, the facility failed to ensure that the previous narcotic treatment facility was contacted in one of one patient record. The findings included:Eight patient records were reviewed during the on-site inspection. One patient record contained information of the patient having previously being a patient at another narcotic treatment program. Patient record # 6 did not contain documented contact of the previous narcotic treatment program for the treatment history or a consent to release client information form for the previous provider.The findings were reviewed and confirmed with the facility director.
|
Plan of Correction The Facility Director provided education on April 17, 2014 to staff regarding request for information from a patient's prior OTP treatment episode. Monitoring will occur through weekly chart reviews of intake/orientation documentation. |
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.
|
Observations Based on the review of patient records, the facility failed to document a complete initial drug-screening urinalysis prior to the administration of a narcotic agent in two of eight records reviewed.The findings included:Eight patient records were reviewed during the on-site inspection. All patient records were reviewed for a complete initial drug-screening urinalysis prior to the administration of a narcotic agent. Patient records # 1 and 3 had documentation of the patient receiving an initial dose prior to the completion of a drug-screening urinalysis. Patient # 1 was admitted on September 23, 2013, and received an initial dose of 30 mg of Methadone on September 23, 2013. An instant drug test was used on admission. A complete initial drug-screening urinalysis was documented on 9/25/2013, and reviewed by the physician on 10/28/2013.Patient # 3 was admitted on September 9, 2013, and received an initial dose of 30 mg of Methadone on September 9, 2013. An instant drug test was used on admission. A complete initial drug-screening urinalysis was documented on 9/12/2013, and reviewed by the physician on 9/30/2013.This findings were discussed and confirmed with the facility director.
|
Plan of Correction As of October 2013, the intake lab was changed to Quest Diagnostics to ensure a 24hr return on drug screen results. No patient will be admitted to services prior to completion of the intake process including review of intake urine test results by the Medical Director. Facility Director will monitor all intake processes to ensure compliance with this regulation. |
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.
|
Observations Based on the review of patient records, the facility failed to ensure that the narcotic treatment physician determined the proper dosage level in three of eight patient records. Additionally, the narcotic treatment physician must document orders in accordance with applicable Federal and State Statues and regulations.The findings included:Eight patient records were reviewed during the on-site inspection. All patient records were reviewed for the physician's documentation in determining the proper dose, specifically, # 1, 2 and 3 had orders documented for determining the patient's dose for multiple days without physician assessment. Patient # 1 was admitted on September 23, 2013, and received an initial dose of 30 mg of Methadone on September 23, 2013. Documented in the patient record was an order dated September 23, 2013 for Methadone 30 mg. The physician order log noted the patient was to receive 40 mg on September 24, 2013, and 45 mg on September 25, 2013. The patient completed an assessment with the nurse on September 24, 2013, with an identified dose of 30 mg. The physician signed the assessment on September 30, 2013, identifying no adjustment; however, the order log and the dosing history identified the patient was increased to 40 mg. The patient completed an assessment with the nurse on September 25, 2013, with an identified dose of 40 mg. The physician signed the assessment on September 30, 2013, identifying no adjustment; however, the order log and the dosing history identified the patient was increased to 45 mg. There was no documentation that the narcotic treatment physician used the assessment of the patient to determine if an increase in the patient's dose was needed. Patient # 2 was admitted on September 23, 2013, and received an initial dose of 30 mg of Methadone on September 23, 2013. Documented in the patient record was an order dated September 23, 2013 for Methadone 30 mg. The physician order log noted the patient was to receive 40 mg on September 24, 2013, and 50 mg on September 25, 2013. The patient completed an assessment with the nurse on September 24, 2013, with an identified dose of 30 mg. The physician signed the assessment, identifying no adjustment; however, the order log and the dosing history identified the patient was increased to 40 mg. The patient completed an assessment with the nurse on September 25, 2013, with an identified dose of 40 mg. The physician signed the assessment, identifying no adjustment; however, the order log and the dosing history identified the patient was increased to 50 mg. There was no documentation that the narcotic treatment physician used the assessment of the patient to determine if an increase in the patient's dose was needed. Patient # 3 was admitted on September 9, 2013, and received an initial dose of 30 mg of Methadone on September 9, 2013. Documented in the patient record was an order dated September 9, 2013 for Methadone 30 mg. The physician order log noted the patient was to receive 40 mg on September 10, 2013, and 50 mg on September 11, 2013. The patient completed an assessment with the nurse on September 10, 2013, with an identified dose of 30 mg. The physician signed the assessment, identifying no adjustment; however, the order log and the dosing history identified the patient was increased to 40 mg. The patient completed an assessment with the nurse on September 11, 2013, with an identified dose of 40 mg. The physician signed the assessment, identifying no adjustment; however, the order log and the dosing history identified the patient was increased to 50 mg. There was no documentation that the narcotic treatment physician used the assessment of the patient to determine if an increase in the patient's dose was needed. An interview was conducted with the facility director and confirmed that the physician did not assess the patient prior to the requested dose increases.
|
Plan of Correction Medical Director and Facility Director established the following protocol for induction: The Medical Director will determine initial dose after his face to face assessment of the patient upon intake. Patients will submit dose assessment forms daily to nurses thereafter. The Medical Director will be notified (via telephone, should he be off-site) of the patient's symptoms and make a determination of dose adjustment, if necessary, through verbal order. Verbal orders will be signed by the physician within 24 hours. Facility Director will monitor medical charts to ensure that this protocol is being followed. |
715.21(1)(i-iv) LICENSURE Patient termination
A narcotic treatment program shall develop and implement policies and procedures regarding involuntary terminations. Involuntary terminations shall be initiated only when all other efforts to retain the patient in the program have failed.
(1) A narcotic treatment program may involuntarily terminate a patient from the narcotic treatment program if it deems that the termination would be in the best interests of the health or safety of the patient and others, or the program finds any of the following conditions to exist:
(i) The patient has committed or threatened to commit acts of physical violence in or around the narcotic treatment program premises.
(ii) The patient possessed a controlled substance without a prescription or sold or distributed a controlled substance, in or around the narcotic treatment program premises.
(iii) The patient has been absent from the narcotic treatment program for 3 consecutive days or longer without cause.
(iv) The patient has failed to follow treatment plan objectives.
|
Observations Based on the review of patient records, the facility failed to restrict the reasons for involuntary termination to those allowed by regulation in two of two patient records.The findings included:Eight patient records were reviewed during the on-site inspection. Two patient records were reviewed for involuntary or therapeutic discharge, specifically client records # 3 and 4. Patient # 3 was admitted on September 9, 2013 and discharged on January 16, 2014. The patient received a Non-compliance Notice on October 21, 2013, that stated the plan of corrective action was to follow up with the assistance office to get medical assistance and to pay the total due in order to return to treatment. The facility failed to restrict the reason for involuntary termination to those permitted by regulation.Patient # 4 was admitted on October 8, 2013 and discharged on November 1, 2013. The patient record contained a Non-compliance Notice dated January 15, 2014, that stated the reason for discharge as not meeting treatment guidelines, missing dosing continually, missing groups and individual sessions and continued drug use. The facility failed to restrict the reason for involuntary termination to those permitted by regulation. Additionally, the patient did not attend the program on 1/15/2014. The patient did not receive the notification as the original and copy of the Notice were still in the patient record.
|
Plan of Correction On April 17, 2014, The Facility Director provided education to the staff regarding appropriate reasons for involuntary termination of services according to the regulation. To ensure compliance all potential administrative discharges will be reviewed with the Facility Director for appropriateness. |
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.
|
Observations Based on the review of administrative documentation, the facility failed to file a written Unusual Incident Report with the Department within 48 hours following an unusual incident with the potential for negative community reaction.The findings included:Administrative documentation that included the unusual incident reports was reviewed April 16, 2014. It was noted the facility had documentation of an incident that identified that a patient had been observed dipping his son's pacifier in the patient's rinsed dosing cup. Child Line was contacted. The documentation included information of the investigation and who was involved. This unusual incident was not reported to the Department as required. The findings were confirmed with facility director.
|
Plan of Correction Under the supervision of the Corporate QI Director and Regional Director, all documentation regarding unusual incidents will be sent to the Division of Licensing per regulation. On-going monitoring will be provided quarterly by Assistant Regional Director and Regional Director. |
709.91(b)(6) LICENSURE Intake and admission
709.91. Intake and admission.
(b) Intake procedures shall include documentation of:
(6) Psychosocial evaluation.
|
Observations Based on the review of patient records, the facility failed to document a psychosocial evaluation that included an assessment of the patient's assets, strengths and/or coping mechanisms. The facility also failed to document a psychosocial evaluation in four of seven patient records. The findings included:Eight patient records were reviewed during the on-site inspection. Seven patient records were reviewed for the documentation of a psychosocial evaluation. The facility failed to document a psychosocial evaluation that included an assessment of the patient's assets, strengths and/or coping mechanisms in client records # 3, 4, and 5. The facility failed to document a psychosocial evaluation in client record # 7.Patient # 3 was admitted on September 9, 2013, and discharged on November 1, 2013. The record included a psychosocial evaluation that was completed on October 7, 2013. The facility failed to include a clinical evaluation of the patient's assets and strengths on the psychosocial evaluation.Patient # 4 was admitted on October 8, 2013, and discharged on January 16, 2014. The psychosocial evaluation was completed on November 7, 2013. The facility failed to include a clinical evaluation of the patient's coping mechanisms on the psychosocial evaluation.Patient # 5 was admitted on January 16, 2014 and the psychosocial evaluation was documented on February 12, 2014. The facility failed to include a clinical evaluation of the patient's coping mechanisms on the psychosocial evaluation.Patient # 7 was admitted on February 27, 2014. The psychosocial evaluation was due by March 29, 2014. As of the time of the review, the facility had failed to document a psychosocial evaluation. The findings were reviewed with and confirmed by the facility director.
|
Plan of Correction On April 17, 2014, The Facility Director provided education to staff regarding content of psychosocial evaluation. Addition training will be provided on May 21, 2014 by Assistant Regional Director regarding proper documentation of evaluation. Facility Director will review each evaluation prior to inclusion in the patient chart. Facility Director will monitor completion of evaluations within appropriate timeframes to ensure compliance on a weekly basis. |