Initial Comments:
Based on the findings of an onsite unannounced Medicare Recertification survey completed on October 17, 2019, Emporium Health Center was found to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 491.12, Subpart A, Conditions for Certification: Rural Health Clinics - Emergency Preparedness.
Plan of Correction:
491.12(d)(1) STANDARD
EP Training Program
Name - Component - 00
§403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1).
*[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:]
(1) Training program. The [facility] must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least every 2 years.
(iii) Maintain documentation of all emergency preparedness training.
(iv) Demonstrate staff knowledge of emergency procedures.
(v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures.
*[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles.
(ii) Demonstrate staff knowledge of emergency procedures.
(iii) Provide emergency preparedness training at least every 2 years.
(iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others.
(v) Maintain documentation of all emergency preparedness training.
(vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and
procedures.
*[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) After initial training, provide emergency preparedness training every 2 years.
(iii) Demonstrate staff knowledge of emergency procedures.
(iv) Maintain documentation of all emergency preparedness training.
(v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures.
*[For PACE at §460.84(d):] (1) The PACE organization must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least every 2 years.
(iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency.
(iv) Maintain documentation of all training.
(v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures.
*[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following:
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of all emergency preparedness training.
(iv) Demonstrate staff knowledge of emergency procedures.
*[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following:
(i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least every 2 years.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment.
(v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures.
*[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following:
(i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least every 2 years.
(iii) Maintain documentation of the training.
(iv) Demonstrate staff knowledge of emergency procedures.
(v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures.
*[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years.
Observations:
Based on review of personnel files (PF), and staff (EMP) interview, the facility failed to ensure staff received annual emergency preparedness training for three (3) of 10 personnel files hired greater than a year (PF8, PF9, & PF10).
Findings included:
Review of personnel files was conducted on October 17, 2019, beginning at 1:15 p.m.
PF8 was hired on 4/11/2016. PF8 completed emergency preparedness training on 4/5/2018 (not annually and greater than 12 months from previous training). There was no training completed on or after April 2019 (to show the annual training requirement was met).
PF9 was hired on 3/31/2014. PF9 completed emergency preparedness training on 8/27/2018. There was no training completed on or after August 2019.
PF10 was hired on 12/16/2013. PF10 completed emergency preparedness training on 9/4/2018. There was no training completed on or after September 2019.
Interview with EMP2 on October 17, 2019, at 2 p.m. confirmed above personnel had not yet completed annual emergency preparedness training.
Plan of Correction:The Chairperson of the Safety Committee at UPMC Cole in conjunction with the Administrative Director of the clinic will update the UPMC Cole Emergency Management Plan/Policy by December 2, 2019. The updated policy will include the requirement that all new staff, individuals providing on-site services under arrangement, and volunteers, consistent with their expected roles will receive initial training in emergency preparedness as part of their orientation process; all existing staff, individuals providing on-site services under arrangement, and volunteers, consistent with their expected roles will receive training annually, annual training will occur between September 1-30. Existing clinic staff, individuals providing on-site services under arrangement, and volunteers consistent with their expected roles will be educated on the new policy, receive and complete emergency preparedness training by December 2, 2019. The new policy will be monitored for a minimum 90 days from the time the plan of correction is approved or until the clinic achieves 100% compliance with the training requirements. Ongoing monitoring will occur annually each October via completion of the emergency preparedness checklist.
491.12(d)(2) STANDARD
EP Testing Requirements
Name - Component - 00
§416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2).
*[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]:
(2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following:
(i) Participate in a full-scale exercise that is community-based every 2 years; or
(A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or
(B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed.
*[For Hospices at 418.113(d):]
(2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following:
(i) Participate in a full-scale exercise that is community based every 2 years; or
(A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or
(B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or
(B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed.
*[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):]
(2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or
(B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed.
*[For PACE at §460.84(d):]
(2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or
(B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed.
*[For LTC Facilities at §483.73(d):]
(2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise.
(B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed.
*[For ICF/IIDs at §483.475(d)]:
(2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or.
(B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed.
*[For HHAs at §484.102]
(d)(2) Testing. The HHA must conduct exercises to test the emergency plan at
least annually. The HHA must do the following:
(i) Participate in a full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or.
(B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed.
*[For OPOs at §486.360]
(d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following:
(i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event.
(ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed.
*[ RNCHIs at §403.748]:
(d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following:
(i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed.
Observations:
Based on review of facility policy and procedure, documentation, and staff (EMP) interviews, the facility failed to conduct exercises to test the emergency plan at least annually. The facility failed to conduct a full-scale community based exercise or facility based exercise. The facility failed to conduct an additional exercise to include a second full-scale community or facility based exercise, and a table top exercise designed to challenge the emergency plan. The facility failed to analyze its response to drills, tabletop exercises, and emergency events.
Findings included:
Review of facility policy and procedure on October 16, 2019, at 2:23 p.m. showed, "UPMC | Cole ... Emergency Management Plan Policy ... Purpose The Emergency Management plan, ... is designed , taught, implemented, measured, changed and improved to ensure effective response to disaster or emergency affecting the environment of care. ... Emergency preparedness drills occur at least semi-annually. All emergency preparedness activations are critiqued to identify deficiencies and opportunities for improvement. Based on the event critiques and After Action Report will be completed by the Incident Command Team."
Review of facility documentation on October 16, 2019, at 3 p.m. showed facility last conducted a disaster drill on June 20, 2018. The facility did conduct fire drills on 9/11/2019, 4/11/2019, 1/3/2019, 10/18/2018, and 7/19/2018, but there was nothing to show these facility based drills were full-scale, or that the facility analyzed its response to the drills. For instance, documentation for the 9/11/2019 drill showed, "Area: Waiting room/lobby Type of Fire: Drill ... Action Taken: Initiated drill Comments/ Suggestions: Good Drill."
Interview with EMP1 on October 16, 2019, at 1:45 p.m. confirmed above findings.
Interview with EMP2 on October 17, 2019, at 9:15 a.m. confirmed above findings. EMP2 noted the full-scale exercises have been missed due to being repeatedly cancelled and rescheduled.
Plan of Correction:The Chairperson of the Safety Committee at UPMC Cole in conjunction with the Administrative Director of the clinic will update the UPMC Cole Emergency Management Plan/Policy by December 2, 2019. The updated policy will be specific to the Emporium clinic and community. The update will address findings from the clinics hazard vulnerability assessment and will include the requirement for annual full-scale community-based emergency drills and a minimum of one emergency drill occurring at the Emporium clinic. Education for clinic staff, individuals providing on-site services under arrangement, and volunteers will be completed by December 16, 2019. The full-scale community-based emergency drill and a minimum of one additional emergency drill will occur on or before January 15, 2020. Compliance with the RHC emergency drills will be monitored by the UPMC Safety Committee through inclusion as a standing agenda item at their bi-monthly meetings. Ongoing monitoring will occur annually each October via completion of the emergency preparedness checklist.
491.12(e) STANDARD
Integrated EP Program
Name - Component - 00
§416.54(e), §418.113(e), §441.184(e), §460.84(e), §482.15(f), §483.73(f), §483.475(e), §484.102(e), §485.68(e), §485.542(f), §485.625(f), §485.727(e), §485.920(e), §486.360(f), §491.12(e), §494.62(e).
(e) [or (f)]Integrated healthcare systems. If a [facility] is part of a healthcare system consisting of multiple separately certified healthcare facilities that elects to have a unified and integrated emergency preparedness program, the [facility] may choose to participate in the healthcare system's coordinated emergency preparedness program.
If elected, the unified and integrated emergency preparedness program must- [do all of the following:]
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance [with the program].
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include the following:
(i) A documented community-based risk assessment, utilizing an all-hazards
approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan, and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
Observations:
Based on review of facility policy and procedure, documentation, and staff (EMP) interview, the integrated healthcare system failed to ensure its plan accounted for each separately certified facility's unique circumstances, patient populations, and services offered. The integrated healthcare system failed to demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and was in compliance with its emergency preparedness plan.
Findings included:
Review of facility policy and procedure on October 16, 2019, at 2:23 p.m. showed, "UPMC | Cole ... Emergency Management Plan Policy ... Purpose The Emergency Management plan, ... is designed , taught, implemented, measured, changed and improved to ensure effective response to disaster or emergency affecting the environment of care. ... Emergency preparedness drills occur at least semi-annually. All emergency preparedness activations are critiqued to identify deficiencies and opportunities for improvement. Based on the event critiques and After Action Report will be completed by the Incident Command Team. ... Response Notifying external authorities of emergencies, ... The local Fire Departments, Ambulance Associations and the Potter County EMA Office are notified of any emergency situation by the Hospital switchboard operator via 911 by order of the incident commander, Liaison Officer, Maintenance Director, House Supervisor, or Administrator on call." There was no mention in the plan concerning the rural health clinic (facility), and its location Cameron County.
Interview with EMP2 on October 17, 2019, at 2:30 p.m. confirmed facility operates as part of a integrated health care system. EMP2 confirmed facility is owned by UPMC Cole (hospital) which is located 30 minutes away, and that facility uses the hospital's emergency preparedness plans and procedures. Review of Google Maps on October 17, 2019, at 3:45 p.m. showed UPMC Cole is 27 miles north of the facility in neighboring Potter County.
The integrated healthcare system failed to ensure that facility conducted drills semi-annually, and failed to ensure staff received annual emergency preparedness training. Cross reference Tags E0037, and E0039 for more information.
Plan of Correction:The Chairperson of the Safety Committee at UPMC Cole in conjunction with the Administrative Director of the clinic will update the UPMC Cole Emergency Management Plan/Policy by December 2, 2019. The updated policy will be specific to the Emporium clinic and community. The update will address findings from the clinics hazard vulnerability assessment and will include the requirement for annual full-scale community-based emergency drills and a minimum of one emergency drill occurring at the Emporium clinic. Education for clinic staff, individuals providing on-site services under arrangement, and volunteers will be completed by December 16, 2019. Compliance with the RHC emergency drills will be monitored by the UPMC Safety Committee through inclusion as a standing agenda item at their bi-monthly meetings. Ongoing monitoring will occur annually each October via completion of the emergency preparedness checklist.
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed October 17, 2019, Emporium Health Center was found to have the following standard level deficiency that was determined to be in substantial compliance with the following requirement of 42 CFR, Part 405, Subpart X and 42 CFR, Part 491.1 - 491.12, Subpart A, Conditions for Certification: Rural Health Clinics.
Plan of Correction:
491.6(b)(1) STANDARD
MAINTENANCE
Name - Component - 00
All essential mechanical, electrical, and patient-care equipment is maintained in safe operating condition;
Observations:
Based on review of facility documentation, observation, and staff (EMP) interview, the facility failed to ensure electrical, and patient-care equipment was maintained in a safe operating condition. The facility failed to ensure the specimen freezer's temperature was in range, and failed to ensure clean items were not stored in regulated waste containers (dirty).
Findings included:
Review of facility policy and procedure on October 17, 2019, at 9 a.m. showed:
"UPMC | Cole ... Bloodborne Pathogen Exposure Control Plan ... Engineering Controls and Work Practices ... Specimens of blood or other potentially infectious material shall be properly containerized in a biohazard-labeled container which prevents leakage during the collection, processing, storage and transport of the specimen. ... Labels The following labeling method is used in this facility: ... Regulated waste ... Red Biohazard Bag ... Contaminated Sharps Biohazard Label."
"UPMC | Cole ... Waste Management - Medical/Infectious Waste Disposal Purpose: Follow appropriate procedures for collection, transport, removal and disposal of the medical/infectious waste stream. ... Procedure: Required Action Steps 1. All medical infectious waste will be discarded into appropriate was receptacle labeled as "biohazard" and placed throughout the facility for this purpose."
Observation in patient treatment room with EMP1 on October 16, 2019, at 11:41 a.m. revealed sterilized instruments hanging on the wall and available for use. On the counter below the sterilized instruments was a red "biohazard" container. The container had a lid labeled "Emporium." The container had a small white tag affixed to it that read, "Clean." The biohazard container contained two (2) sterilized instrument ready for patient use. Interview with EMP1 at time of observation confirmed findings. EMP1 noted that facility's used instruments are transported to the hospital (this is a hospital based facility) in the red container where they are sterilized. The sterilized instruments are then returned to the facility in a red biohazard container labeled "Clean" per the white tag placed on them. Facility policy and procedure made no mention of storing or transporting clean/sterilized items in red biohazard / regulated waste containers.
Review of facility's October 2019 "Specimen Temperature Recording Log" was conducted on October 17, 2019, at 10 a.m. The log contained temperature ranges to be maintained for the freezer, "Accepted ranges: Freezer -13 F [degrees Fahrenheit] to 23 F." Review of the log's recorded temperatures from 10/1/2019 to 10/9/2019 showed the freezer's temperature was out of range:
10/1 -- 26.1 F (not within -13 F to 23 F)
10/2 -- 27.7 F
10/4 -- 24.8 F
10/5 -- Saturday (closed)
10/6 -- Sunday (closed)
10/7 -- 24.4 F
10/8 -- 26.2 F
10/9 -- 24.8 F
Per procedure outlined on log, "Action for out of range temperatures: 1. If temperature is out of range for less than 30 minutes, adjust temperature of the fridge/freezer. Contact the lab to verify specimen stability. 2. If temperature is out of range for more than 30 minutes, call your supervisor immediately. Contact lab to verify specimen stability. 3. If you are unsure how long the temperature has been out of range, call your supervisor immediately. Contact lab to verify specimen stability. ... 5. Circle any out of range temperatures. Document the date, time, and actions on the back of this form."
Interview with EMP1 on October 17, 2019, at 10:29 a.m. confirmed findings, and nothing to show facility followed steps as outlined above.
Interviews were conducted with EMP1 (manager), EMP2 (director), and EMP6 (quality) on October 17, 2019, at 11:33 a.m. in the patient treatment area containing instruments. At this time, it was confirmed that used instruments and sterilized instruments are transported in the same biohazard container. Surveyor mentioned to the above personnel that red biohazard containers are intended to store regulated waste and not clean items, and asked for confirmation to show the container used by the facility was only used for clean items. EMP1, EMP2, and EMP6 were unable to confirm if the red biohazard container ever contained biohazard or regulated waste (its intended purpose).
Plan of Correction:Quality nurse developed new control logs for the specimen refrigerator that requires staff to indicate Y (yes) or N (no) daily if temperature is in range and includes instructions for staff to follow if temperature is out of range. October 24, 2019 the new control log was put into place with clinic staff receiving training on how to complete the facility name, month and year being recorded, dates the thermometers are due for recalibration, how to document the appropriate day, time (military time), temperature, if the temperature is within range and action steps if the temperature is out of range. The Quality Nurse will review temperature logs once per week for a minimum of 6 (six weeks) or until 100% compliance is attained. Monthly practice that is currently in use checklist will be updated, staff trained and placed into use by 11/30/2019 with question: 'Is specimen refrigerator temperature log completed in its entirety including, facility name, month and year being recorded, dates thermometers are due for recalibration, min/max temperatures and action taken if any temperature logged is out of range?' Monthly staff checklists are reviewed by the practice manager and quality nurse monthly to ensure compliance with any items on checklist, corrective action is addressed immediately when non-compliance is identified.
Each practice will have two instrument transport containers container 1 (newly purchased puncture proof container-not red) will only be used for transport of sterilized (clean) instruments, container 2 (red biohazard puncture proof container) will only be used for transport of used (dirty) instruments. Staff will be educated that 'red' container will always contain used/dirty instruments. Practice will purchase puncture proof transport container to be used for transport of sterilized (clean) instruments from sterile processing to the practice by 11/22/2019. Director of Sterile Processing will update preparation and transport of instruments, equipment to a decontamination area policy will be updated and staff training will occur on the new policy by November 22, 2019. The policy will reflect the new process of:
1. Practice will place used/dirty instruments in a container 2-red biohazard transport container (dirty) to sterile processing for sterilization.
2. Practice will send container 2-red biohazard container and container 1-empty puncture proof transport container to sterile processing for sterilization of dirty instruments
3. Sterile processing will sterilize used/dirty instruments
4. Sterile processing will place sterilized instruments in container 1-clean puncture proof transport container
5. Sterile processing will clean container 2-red biohazard container through Steris cleaning system, clean with enzymatic cleaner and dry using Steris system
6. Sterile processing will return to practice container 1-clean puncture proof transport container containing sterilized instruments and container 2- cleaned red biohazard container to practice
7. Process will restart at step 1 once an instrument is used/dirtied in the practice
The Administrative Manager of the clinic will monitor specimen transports from the clinic for a period of 6 weeks or until 100% compliance is attained. Monthly practice checklist will be updated, staff trained and placed into use by 11/30/2019 with question: 'Sterilized instruments are returned to the practice in a clean puncture proof container that is not red and does not include biohazard symbol?' Monthly staff checklists are reviewed by the practice manager and quality nurse monthly to ensure compliance with any items on checklist, corrective action is addressed immediately when non-compliance is identified.
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