Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed July 24, 2024, Momentum Therapeutics 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 485.727, Subpart H, Conditions of Participation for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services - Emergency Preparedness.
Plan of Correction:
485.727(a)(1)-(2) STANDARD
Plan Based on All Hazards Risk Assessment
Name - Component - 00
§403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2)
[(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:]
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.*
(2) Include strategies for addressing emergency events identified by the risk assessment.
* [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care.
*[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following:
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents.
(2) Include strategies for addressing emergency events identified by the risk assessment.
*[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients.
(2) Include strategies for addressing emergency events identified by the risk assessment.
Observations:
Based on review of facility policy, facility's emergency preparedness plan and emergency preparedness binder, and staff (EMP) interview, the facility failed to document a facility-based and community-based risk assessment, utilizing an all-hazards approach at least every 2 years since 2020.
Findings included:
Review of facility policy on July 24, 2024, at 11 a.m. showed:
"EPP 22.0 EMERGENCY PREPAREDNESS PLAN ... Attempts shall be made to be involved in a full-scale exercise which includes multiple agencies, jurisdictions, and disciplines in the community. Documentation of contact with local, state and healthcare coalitions shall be kept and include date, personnel contacted, agency and content of conversation. If this is not possible (i.e.-the EMA is not planning an all-community exercise), Momentum Therapeutics shall conduct a facility exercise that assesses the facility's response to an emergency and the impact the emergency has on facility functions and operations. This facility exercise shall require full activation of Momentum's emergency plan. This exercise shall also demonstrate how risks are identified in the Risk Assessment."
"EPP 2.0 Risk Assessment ... The following methods were used to identify and prioritize risks at Momentum Therapeutics. These include: Greenville office: Incorporating Mercer county's current Hazard Ranking into the plan collecting existing information about workplace hazards (see Addendum #2). Linesville Office: [NOW CLOSED since approximately 2021] Incorporating Crawford County's current Hazard Ranking into the plan Collecting existing information about workplace hazard (see Addendum #2). All offices: Brain-storming with employees; Reviewing OSHA 300 forms; Workers' comp reports; Reviewing QI Committee minutes; Mercer [County] 2018 Hazard Mitigation Plan Draft. Inspecting the workplace for safety hazards. Including equipment and physical plant ... Potential hazards included were housekeeping, slip/trip/falls, electrical, equipment operation & design, equipment maintenance, fire protection, workplace violence, and ergonomic problems. Identifying health hazards. Including gases, chemicals, biological (e.g.- molds, infectious diseases), physical (e.g.-noise, heat); Identifying hazards associated with non-routine situations (e.g. fires, chemical exposures, hazardous material exposures) ... Each hazard prioritized, based on severity of potential outcomes, likelihood of event, number of people potentially involved, and a risk level assigned. Specific vulnerabilities were considered. For example, patients tend to be elderly (approximated 60% of clients). With this comes decreased mobility, potential confusion, decreased senses (sight, hearing)."
Review of facility's emergency preparedness plan on July 24, 2024, at 11 a.m. showed the agency's plan contained no documented facility and community-based risk assessment using an all-hazards approach since the year 2020.
Interview with EMP1 (owner/administrator) on July 24, 2024, at 11:30 a.m. confirmed findings.
Plan of Correction:POC E 0006
Momentum Therapeutics Safety Committee, consisting of EEP Manager, Assistant EEP Manager, and staff members PTA, and Billing Supervisor, met on 7/31/24 to review Momentum Therapeutics Emergency Preparedness Plan. The Plan was reviewed and changes were made due to the closing of satellite office and upcoming personnel changes made due to upcoming retirements. The plan will be reviewed yearly going forward which will be scheduled on the yearly calendar by EEP manager. To ensure that this yearly meeting is scheduled and carried out, a checklist was devised by the Safety Committee. This checklist will include yearly drills, Emergency Preparedness Table Top Exercises, and /or workshops completed, as well as Safety Committee Meetings and updates of Risk Assessment. This checklist has now been added to Momentum Therapeutics quarterly, 6-month, and yearly checklist that Momentum's QA committee reviews quarterly. This will ensure a check and balance of The EPP committee by the QA committee.
There was discussion by the safety committee of potential hazards existing at the facility and surrounding community using the 2023 Mercer Co PA Hazard Mitigation Plan. Hazards were assessed using Hazard Ranking Based on Risk Factor Methodology and All Hazards Approach. The safety committee discussed probability of hazard, impact of event on facility, staff and patients, as well as community. Each hazard was given strategic consideration and a plan made based on All Hazards Approach per risk assessment. Each hazard was prioritized, based on severity of potential outcomes, likelihood of event, number of people potentially involved, and a risk level assigned as well as a plan for either Evacuation or Shelter in place (All Hazards Approach). The Risk Assessment shall be updated every 2 years using any updates of the Mercer Co. PA Hazard Mitigation Plan and staff discussion. This will be scheduled on the yearly event calendar as well as being on the yearly checklist which is monitored by Momentum Therapeutics QA committee.
485.727(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, the facility's emergency preparedness plan and emergency preparedness binder, and staff (EMP) interview, the facility failed to conduct an exercise to test, evaluate, and revise its emergency plan annually since 2020.
Findings included:
Review of facility policy on July 24, 2024, at 11 a.m. showed, "EPP 22.0 EMERGENCY PREPAREDNESS PLAN ... Attempts shall be made to be involved in a full-scale exercise which includes multiple agencies, jurisdictions, and disciplines in the community. Documentation of contact with local, state and healthcare coalitions shall be kept and include date, personnel contacted, agency and content of conversation. If this is not possible (i.e.-the EMA is not planning an all-community exercise), Momentum Therapeutics shall conduct a facility exercise that assesses the facility's response to an emergency and the impact the emergency has on facility functions and operations. This facility exercise shall require full activation of Momentum's emergency plan. This exercise shall also demonstrate how risks are identified in the Risk Assessment. An after action report shall be completed. It shall include identifying improvement needs. Aspects of the AAR shall include what occurred, what went well and what didn't go well, a plan with timelines for incorporating necessary improvement. A response to an actual emergency meets the annual exercise requirement."
Review of facility's emergency preparedness plan on July 24, 2024, at 11 a.m. showed the facility had not exercised its plan since the 2020 Covid-19 pandemic.
Moreover, there was nothing to show that the facility participated in a full-scale exercise that was community-based or individual facility based functional exercise, a mock disaster drill, a tabletop exercise, or workshop that was led by a facilitator and included a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge the emergency plan since the 2020 Covid-19 pandemic.
Interview with EMP1 (owner/administrator) on July 24, 2024, at 11 a.m. confirmed above findings.
Plan of Correction:POC E 0039
The Emergency Preparedness Plan Manager has contacted county (County Emergency Management, Director of Public Safety) and local officials (Hempfield Police Department) as well as NWPA Coalition's Emergency Preparedness Director and will be on mailing list for any upcoming community based exercises / drills. Momentum Therapeutics participated in a table top exercise to reinforce our emergency protocols involving "Active Shooter" scenario. An officer of Hempfield Police Department led this exercise on 8/14/24. Documentation of this exercise has been recorded in Momentum Therapeutics' EPP binder. On 8/5/24 a fire drill was performed at Momentum Therapeutics to reinforce emergency protocols and after action review was also performed.
As decided in the last EPP meeting, held on 7/31/24, EPP manager and Assistant Manager will be responsible for the yearly review and update of the Emergency Preparedness Plan. EPP manager and EPP Assistant Manager will be responsible for training, testing, drills, table top exercise / workshops and review. EPP Manager and EPP Assistant Manager will be responsible for scheduling these meetings and ensuring that it is added to Momentum Therapeutics' annual calendar to ensure annual completion of drills and reviews. These drills, table top exercises and or community based drills will be documented and record kept of these events in EPP binder. Each drill will have a post drill meeting to analyze the facilities response and performance to each event and EPP will be revised as needed. To ensure that these drills are completed on a yearly basis, a check list has been added to Momentum Therapeutics QA quarterly, 6 month, and yearly list. QA committee meet quarterly to review QA measures and will monitor performance of EPP plan and drills after the "After Action Report" is completed.
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed July 24, 2024, Momentum Therapeutics was found to be in compliance with the requirements of 42 CFR, Part 485, Subpart H, Conditions of Participation for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services.
Plan of Correction:
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