Initial Comments:
A recertification survey visit was conducted on March 16 and March 17, 2022. The purpose of this visit was to determine compliance with the requirements of 42 CFR, Part 441.184, Subpart D Emergency Preparedness regulations for Medicare and Medicaid participating providers and suppliers.
Plan of Correction:
441.184(b) STANDARD
Development of EP Policies and Procedures
Name - Component - 00
§403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b).
(b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years.
*[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually.
*Additional Requirements for PACE and ESRD Facilities:
*[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years.
*[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area.
Observations:
Based on review of facility documentation, and interview with administrative staff, the facility failed to develop policies and procedures based on the emergency plan, risk assessment and communication plan for each specific facility.
Findings include:
A review of facility documentation regarding the Emergency Preparedness plan was reviewed on 03/16/2022, between 11:00 AM and 1:00 PM. This review revealed that this plan did not include policies based on the facility and community based risk assessment and communication plan, utilizing an all hazards approach. Interview with the Senior Director of Administration, Quality and Compliance on 03/17/2022 at approximately 11:00 AM confirmed that the facility's plan did not include a written policy addressing the facility's emergency plan.
Plan of Correction:The Quality Manager will develop a written policy related to CVCA's Emergency Operations Plan by 5/15/22. The Quality Manager will review progress on completing the required policy with the Senior Director, Administration, Quality and Compliance weekly during individual supervision.
CVCA's Emergency Operations Plan and all related policies will be reviewed and updated as needed annually, during the third quarter of each year (April – June). The Senior Director, Administration Quality and Compliance is responsible for ensuring this occurs.
441.184(b)(1) STANDARD
Subsistence Needs for Staff and Patients
Name - Component - 00
§403.748(b)(1), §418.113(b)(6)(iii), §441.184(b)(1), §460.84(b)(1), §482.15(b)(1), §483.73(b)(1), §483.475(b)(1), §485.542(b)(1), §485.625(b)(1)
[(b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:
(1) The provision of subsistence needs for staff and patients whether they evacuate or shelter in place, include, but are not limited to the following:
(i) Food, water, medical and pharmaceutical supplies
(ii) Alternate sources of energy to maintain the following:
(A) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions.
(B) Emergency lighting.
(C) Fire detection, extinguishing, and alarm systems.
(D) Sewage and waste disposal.
*[For Inpatient Hospice at §418.113(b)(6)(iii):] Policies and procedures.
(6) The following are additional requirements for hospice-operated inpatient care facilities only. The policies and procedures must address the following:
(iii) The provision of subsistence needs for hospice employees and patients, whether they evacuate or shelter in place, include, but are not limited to the following:
(A) Food, water, medical, and pharmaceutical supplies.
(B) Alternate sources of energy to maintain the following:
(1) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions.
(2) Emergency lighting.
(3) Fire detection, extinguishing, and alarm systems.
(C) Sewage and waste disposal.
Observations:
Based on review of the facility emergency preparedness plan, and interview with administrative staff, the facility failed to develop an Emergency Preparedness plan to include policies and procedures that include subsistence needs for staff and residents during an emergency whether they evacuate or shelter in place.
Findings include:
A review of the facility Emergency Preparedness plan was completed on 03/16/2022, between 11:00 AM and 1:00 PM. This review noted that the plan did not address the provision for subsistence needs to include the following:
a. Food and water supplies
b. Medical and pharmaceutical supplies
c. Emergency lighting
d. Sewage and waste disposal
Interview with the Senior Director of , Administration, Quality and Compliance on 03/17/2022 at approximately 11:00 AM confirmed that the facility's plan did not include all required provisions to be used in the event of an emergency.
Plan of Correction:The Quality Manager will develop written policies related to the provision of subsistence needs and alternative sources of energy in the event the campus needs to evacuate or shelter in place according to the following schedule:
- Food and water supplies – by 5/30/22
- Medical and pharmaceutical supplies - by 8/30/22
- Emergency lighting – by 6/30/22
- Sewage and waste disposal – by 7/30/22
In addition, existing policies related to alternate sources of energy and fire detection, extinguishing and alarm systems will the incorporated into the EOP policy/procedure manual by 9/30/22.
The Quality Manager will consult with CVCA's Emergency Preparedness/Safety Coordinator, Residential Director, Facilities Manager, Assistant Director of Purchasing, Nurse Manager and Medical Director as well as with PHMC's Regional Healthcare Coalition and local township officials when developing policies and procedures.
The Residential Director, COO/CFO and Sr. Director of Administration, Quality and Compliance and will be responsible for reviewing and approving the proposed policies.
441.184(b)(2) STANDARD
Procedures for Tracking of Staff and Patients
Name - Component - 00
§403.748(b)(2), §416.54(b)(1), §418.113(b)(6)(ii) and (v), §441.184(b)(2), §460.84(b)(2), §482.15(b)(2), §483.73(b)(2), §483.475(b)(2), §485.542(b)(2), §485.625(b)(2), §485.920(b)(1), §486.360(b)(1), §494.62(b)(1).
[(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:]
[(2) or (1)] A system to track the location of on-duty staff and sheltered patients in the [facility's] care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the [facility] must document the specific name and location of the receiving facility or other location.
*[For PRTFs at §441.184(b), LTC at §483.73(b), ICF/IIDs at §483.475(b), PACE at §460.84(b):] Policies and procedures. (2) A system to track the location of on-duty staff and sheltered residents in the [PRTF's, LTC, ICF/IID or PACE] care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the [PRTF's, LTC, ICF/IID or PACE] must document the specific name and location of the receiving facility or other location.
*[For Inpatient Hospice at §418.113(b)(6):] Policies and procedures.
(ii) Safe evacuation from the hospice, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s) and primary and alternate means of communication with external sources of assistance.
(v) A system to track the location of hospice employees' on-duty and sheltered patients in the hospice's care during an emergency. If the on-duty employees or sheltered patients are relocated during the emergency, the hospice must document the specific name and location of the receiving facility or other location.
*[For CMHCs at §485.920(b):] Policies and procedures. (2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
*[For OPOs at § 486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records.
*[For ESRD at § 494.62(b):] Policies and procedures. (2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and needs of the patients.
Observations:
Based on a review of the facility emergency preparedness plan, and interview with administrative staff, the facility failed to develop an Emergency Preparedness (EP) plan to include a system to track the location of on-duty staff and sheltered residents int he facility's care during an emergency to include the specific name and location of an alternate facility if relocation is utilized.
Findings include:
A review of the facility Emergency Preparedness plan was completed on 03/16/2022 between 11:00 AM and 1:00 PM. This review revealed that the plan did not include a system to track on-duty staff and residents to include the specific name and location of an alternate facility if relocation is utilized. Interview with the Senior Director of Administration, Quality and Compliance on 03/17/2022 at approximately 11:00 AM confirmed the facility's plan did not include a policy for tracking staff in the event of an emergency to include the specific name and location of an alternate facility if relocation is utilized.
Plan of Correction:Plan of Correction:
The Quality Manager will develop written policies and procedures related to tracking the location of on-duty staff and sheltered residents in the event the campus needs to evacuate or shelter in place by 11/30/22. The written policy will include the requirement that the specific name and location of the receiving facility or other location be documented.
The Quality Manager will consult with CVCA's Emergency Preparedness/Safety Coordinator, Residential Director, Facilities Manager, Assistant Director of Purchasing, Nurse Manager and Medical Director as well as with PHMC's Regional Healthcare Coalition and local township officials when developing policies and procedures.
The Residential Director, COO/CFO and Sr. Director of Administration, Quality and Compliance and will be responsible for reviewing and approving the proposed policies.
The Quality Manager will review progress on completing the required policy with the Senior Director, Administration, Quality and Compliance weekly during individual supervision.
CVCA's Emergency Operations Plan and all related policies will be reviewed and updated as needed annually, during the third quarter of each year (April – June). The Senior Director, Administration Quality and Compliance is responsible for ensuring this occurs.
441.184(b)(5) STANDARD
Policies/Procedures for Medical Documentation
Name - Component - 00
§403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.542(b)(5), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4).
[(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:]
[(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records.
*[For RNHCIs at §403.748(b) and REHs at §485.542(b):] Policies and procedures. (5) A system of care documentation that does the following:
(i) Preserves patient information.
(ii) Protects confidentiality of patient information.
(iii) Secures and maintains the availability of records.
*[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records.
Observations:
Based on review of the facility emergency preparedness plan, and interview with administrative staff, the facility failed to develop an Emergency Preparedness (EP) plan to include a system to maintain and secure medical documentation.
Findings include:
A review of the facility Emergency Preparedness plan was completed on 03/16/2022 between 11:00 AM and 1:00 PM. This review revealed that the plan did not include a system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records.
Interview with the Senior Director of Administration, Quality and Compliance on 03/17/2022 at approximately 11:00 AM confirmed the facility's plan did not include a policy for maintaining and securing residents records.
Plan of Correction:The Quality Manager will develop written policies and procedures related to systems of medical documentation that preserve resident information, protects confidentiality of resident information and secures and maintains availability of records by 10/30/22.
The Quality Manager will consult with CVCA's Emergency Preparedness/Safety Coordinator, Residential Director, Facilities Manager, Assistant Director of Purchasing, Nurse Manager and Medical Director as well as with PHMC's Regional Healthcare Coalition and local township officials when developing policies and procedures.
The Residential Director, COO/CFO and Sr. Director of Administration, Quality and Compliance and will be responsible for reviewing and approving the proposed policies.
The Quality Manager will review progress on completing the required policy with the Senior Director, Administration, Quality and Compliance weekly during individual supervision.
CVCA's Emergency Operations Plan and all related policies will be reviewed and updated as needed annually, during the third quarter of each year (April – June). The Senior Director, Administration Quality and Compliance is responsible for ensuring this occurs.
441.184(b)(7) STANDARD
Arrangement with Other Facilities
Name - Component - 00
§403.748(b)(7), §418.113(b)(5), §441.184(b)(7), §460.84(b)(8), §482.15(b)(7), §483.73(b)(7), §483.475(b)(7), §485.625(b)(7), §485.920(b)(6), §494.62(b)(6).
[(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:]
*[For Hospices at §418.113(b), PRFTs at §441.184,(b) Hospitals at §482.15(b), and LTC Facilities at §483.73(b):] Policies and procedures. (7) [or (5)] The development of arrangements with other [facilities] [and] other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of services to facility patients.
*[For PACE at §460.84(b), ICF/IIDs at §483.475(b), CAHs at §486.625(b), CMHCs at §485.920(b) and ESRD Facilities at §494.62(b):] Policies and procedures. (7) [or (6), (8)] The development of arrangements with other [facilities] [or] other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of services to facility patients.
*[For RNHCIs at §403.748(b):] Policies and procedures. (7) The development of arrangements with other RNHCIs and other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of non-medical services to RNHCI patients.
Observations:
Based on a review of the facility emergency preparedness plan, and interview with administrative staff, the facility failed to develop an Emergency Preparedness (EP) plan to include the development of arrangements with other Psychiatric Residential Treatment Facilities for under age 21 (PRTF) facilities and providers to receive residents in the event of limitations or cessation of operations to maintain continuity of service.
Findings include:
A review of the facility Emergency Preparedness plan was completed on 03/16/2022 between 11:00 AM and 1:00 PM. This review revealed that the Emergency Preparedness plan did not include arrangements with other PRTF facilities and providers to receive residents in the event of limitations or cessation of operations to maintain continuity of service.
Interview with the Senior Director of Administration, Quality and Compliance on 03/17/2022 at approximately 11:00 AM confirmed that the facility's plan did not include arrangements with other facilities in the event of an emergency.
Plan of Correction:The Emergency Preparedness/Safety Coordinator will connect with the Southeast Region Health Care Coalition and at least two other PRTFs in the region to explore potential relocation options by 5/30/22.
In collaboration with the Chief Executive Officer, Chief Operations Officer and Residential Director the Emergency Preparedness/Safety Coordinator will establish a written memorandum of understanding with another PRTF or provider to receive residents in the event of limitations or cessation of operations to maintain the continuity of services to residents by 9/30/22.
The Sr. Director of Administration, Quality and Compliance will develop a timeline of activities associated with this Correction Plan which will be monitored quarterly.
441.184(c) STANDARD
Development of Communication Plan
Name - Component - 00
§403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c).
(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities].
Observations:
Based on a review of the facility emergency preparedness plan, and interview with administrative staff, the facility failed to develop an Emergency Preparedness (EP) plan communication plan that complies with Federal, State and local laws.
Findings include:
A review of the Emergency Preparedness plan was completed on 03/16/2022 between 11:00 AM and 1:00 PM. This review revealed that this plan did not include a written Communication Plan that complies with Federal, State and local laws. Interview with the
Senior Director of Administration, Quality and Compliance on 03/17/2022 at approximately 11:00 AM confirmed that the facility's plan did not include a written communication plan.
Plan of Correction:The Quality Manager will develop written communication plan that complies with Federal, State and local laws by 12/30/22.
The Quality Manager will consult with CVCA's Emergency Preparedness/Safety Coordinator, Residential Director, Facilities Manager, Assistant Director of Purchasing, Nurse Manager and Medical Director as well as with PHMC's Regional Healthcare Coalition and local township officials when developing policies and procedures.
The Residential Director, COO/CFO and Sr. Director of Administration, Quality and Compliance and will be responsible for reviewing and approving the proposed policies.
The Quality Manager will review progress on completing the required policy with the Senior Director, Administration, Quality and Compliance weekly during individual supervision.
CVCA's Emergency Operations Plan and all related policies will be reviewed and updated as needed annually, during the third quarter of each year (April – June). The Senior Director, Administration Quality and Compliance is responsible for ensuring this occurs.
441.184(d) STANDARD
EP Training and Testing
Name - Component - 00
§403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d).
*[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years.
*[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually.
*[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i).
*[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years.
Observations:
Based on a review of the facility emergency preparedness plan, and interview with administrative staff, the facility failed to develop an Emergency Preparedness (EP) plan training program that is based on the emergency plan, risk assessment, policies and procedures, and communication plan.
Findings include:
A review of the facility Emergency Preparedness plan was completed on 03/16/2022 between 11:00 AM and 1:00 PM. This review noted that there was no training program that includes 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. Interview with the Senior Director of Administration, Quality and Compliance on 03/17/2022 at approximately 11:00 AM confirmed the facility's plan did not include a training program.
Plan of Correction:The Training Manager will develop an Emergency Preparedness (EP) plan training program that is based on the emergency plan, risk assessment, policies and procedures, and communication plan by 3/15/23.
The Training Manager will collaborate with the Quality Manager, Emergency Preparedness/Safety Coordinator, Residential Director, Education Director and local Township Officials to develop the training plan.
The Sr. Director of Administration, Quality and Compliance will develop a timeline of activities associated with this Correction Plan which will be monitored quarterly.
441.184(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 the facility emergency preparedness plan, and interview with administrative staff, the facility failed to develop an Emergency Preparedness (EP) training plan based on the emergency plan, risk assessment, policies and procedures, and communication plan, affecting the entire facility.
Findings include:
A review of the Emergency Preparedness plan was completed on 03/16/2022 between 11:00 AM and 1:00 PM. This review revealed that the plan did not include written policies and procedures identifying its training program for all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
Interview with the Senior Director of Administration, Quality and Compliance on 03/17/2022 at approximately 11:00 AM, confirmed the facility's plan did not include a written emergency training program.
Plan of Correction:The Training Manager will develop an Emergency Preparedness (EP) plan training program that is based on the emergency plan, risk assessment, policies and procedures, and communication plan by 3/15/23. Staff will be required to demonstrate knowledge of emergency procedures following completing the training through a written test.
The Training Manager will collaborate with the Quality Manager, Emergency Preparedness/Safety Coordinator, Residential Director, Education Director and local Township Officials to develop the training plan.
The Quality Manager and Training Manager will develop written policies and procedures identifying CVCA's training program for all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles by 3/31/23.
Campus specific emergency preparedness training will be incorporated into new hire orientation during the first orientation session in April 2023. All current PRTF staff will be required to complete campus specific emergency preparedness training during the month of April 2023. Documentation regarding all training completed will be maintained in CVCA's electronic learning management system.
The Training Manager will monitor completion of required training in the learning management system.
Initial Comments:
A recertification survey visit was conducted on March 16 and March 17, 2022. The purpose of this visit was to determine compliance with the requirements of 42 CFR, Part 483, Subpart G regulations for Psychiatric Residential Treatment Facilities for residents under the age of 21. The census at the time of the visit was six, and the sample consisted of four residents.
Plan of Correction:
483.358(a) STANDARD
ORDERS FOR USE OF RESTRAINT OR SECLUSION
Name - Component - 00
Orders for restraint or seclusion must be by a physician, or other licensed practitioner permitted by the State and the facility to order restraint or seclusion and trained in the use of emergency safety interventions. Federal regulations at 42 CFR 441.151 require that inpatient psychiatric services for beneficiaries under age 21 are provided under the direction of a physician.
Observations:
Based on record review and interview with administrative staff, the facility failed to ensure orders for restraints were ordered by a physician or other licensed practitioner permitted by the State and the facility for two of three sample Resident who were restrained. This practice is specific to Resident #1 and #2.
Findings include:
A review of the records for Resident #1 and Resident #2 was completed on 03/16/2022 from approximately 9:00 AM to 12:00 AM and on 03/17/2022 from approximately 9:00AM until 11:00 AM.
Individual #1
A review of the record for Resident #1 revealed that she was restrained on 11/11/2021. This restraint was noted on a document titled, "Critical Incident Report".
This report indicates that Resident #1 was restrained using "interventions when 2 individuals fighting" restraint for a total of 2 minutes from 7:51 PM until 7:53 PM. Further review of this information noted that there was no evidence that a physician, or other licensed practitioner permitted by the State had ordered the use of this restraint.
Individual #2
A review of the record for Resident #2 revealed that she was restrained on 01/27/2022. This restraint was noted on the "Critical Incident Report". This report indicates that Resident #2 was restrained using a "bear hug control" restraint which started at 3:06 PM. Further review of this information noted that there was no evidence that a physician, or other licensed practitioner permitted by the State had ordered the use of this restraint.
Interview with the Senior Director of Administration, Quality & Compliance on 03/16/2022, at approximately 10:45 AM and on 03/17/2022 at approximately 10:00 AM, confirmed that the facility was unable to verify that a physician's orders were obtained for the use of the above mentioned restraints.
Plan of Correction:1. NA – Orders were not received
2. During the month of April, the Quality Manager will review the last six months of restraint documentation for Thistle residents to identify other individuals having the potential to be affected by the same deficient practice.
3. The Medical Director or designee will retrain Thistle staff members regarding restraint protocols, including the need to obtain orders, by 5/15/22.
4. The Quality Manager will review completed restraint packets on a daily basis (Monday- Friday) to ensure they include written orders. If an order is missing, the Quality Manager will notify licensed clinicians via Teams and will follow up to ensure the order is written.
5. The Medical Director and Residential Director will review overall restraint protocol compliance rates during weekly leadership meetings and will address areas of non-compliance with relevant staff as needed.
483.358(f) ELEMENT
ORDERS FOR USE OF RESTRAINT OR SECLUSION
Name - Component - 00
Within 1 hour of the initiation of the emergency safety intervention a physician, or other licensed practitioner trained in the use of emergency safety interventions and permitted by the state and the facility to assess the physical and psychological wellbeing of residents, must conduct a face-to-face assessment of the physical and psychological wellbeing of the resident, including but not limited to-
(1) The resident's physical and psychological status;
(2) The resident's behavior;
(3) The appropriateness of the intervention measures; and
(4) Any complications resulting from the intervention.
Observations:
Based on a review of facility documents and interview with administrative staff, the facility failed to ensure that within one hour of the initiation of the emergency safety intervention a physician or other licensed practitioner trained in the use of emergency safety interventions (ESI) and permitted by the state and the facility to assess the physical and psychological well-being of residents, must conduct a face-to-face assessment of the physical and psychological well-being of the Resident. This practice is specific to Residents #1 and #3..
Findings include:
A review of Resident #1 and #3's records was completed on 03/16/2022 and 03/17/2022 from approximately 9:45 AM to 12:30 PM and 8:45 AM to 11:00 AM respectively. This review noted that a face to face assessment of physical and psychological well-being of the resident was not conducted within one hour after the restraint. The following is exemplary of that practice:
Resident #3:
A review of Resident #3's record revealed that this resident was restrained on 11/11/2021 at 5:03 PM. This incident was documented on a form titled Critical Incident Report packet dated 11/11/2021. Further review of this packet revealed that there was no evidence that a physical and psychological well-being assessment was completed until 7:20 PM
Interview with the Senior Director of Administration, Quality & Compliance on 03/17/2022 at approximately 10:20 AM confirmed that the face to face medical assessment was not conducted within one hour post restraint.
Plan of Correction:
1. NA – Assessments were not completed within the required timeframe.
2. During the month of April, the Quality Manager will review the last six months of restraint documentation for Thistle residents to identify other individuals having the potential to be affected by the same deficient practice.
3. The Medical Director or designee will retrain Thistle and nursing staff members regarding restraint protocols, including the need to assess the physical and psychological wellbeing of residents within one hour of the initiation of a restraint, by 5/15/22. Staff will be reminded that residents must be taken to an Urgent Care facility or Emergency Room if CVCA nursing staff is not available to complete the required assessments.
4. The Quality Manager will review completed restraint packets on a daily basis (Monday- Friday). The Quality Manager will notify the Medical Director and Nurse Manager via Teams if expected assessments were not completed within one hour of initiation of the restraint.
5. The Medical Director and Residential Director will review overall restraint protocol compliance rates during weekly leadership meetings and will address areas of non-compliance with relevant staff as needed.
483.358(h)(2) ELEMENT
ORDERS FOR USE OF RESTRAINT OR SECLUSION
Name - Component - 00
[Documentation must include] the time the emergency safety intervention actually began and ended.
Observations:
Based on record review and interview with administrative staff, the facility failed to document the time emergency safety interventions actually began and ended for one of three sample Residents who were restrained. This practice is specific to Resident #2.
Findings include:
A review of the record of Resident #2 completed on 03/16/2022 between 9:00 AM and 12:30 AM, revealed a document titled Critical Incident Report dated 01/27/2022. Continued review of this report notes that Resident #2 was restrained on 01/27/2022 starting at 2:55 PM and again restrained on 01/27/2022 starting at 3:06 PM. Further review of this restraint report revealed the "Personal Emergency Invention Report", dated 01/27/2022. This report notes that the start and end time of this restraint was from 3:00 PM until 3:07 PM. There was no evidence that the actual start time and end time of both restraint were documented.
Interview with the Senior Director of Administration, Quality & Compliance on 03/16/2022, at approximately 10:45 AM confirmed that the start time for the first restraint was not the same time as documented on the Critical Incident Report and that the end time was for both restraints.
Plan of Correction:
1. NA – Beginning and ending times were not documented at the time of the personal emergency intervention. Staff is unable to recall specific beginning and ending times.
2. During the month of April, the Quality Manager will review the last six months of restraint documentation for Thistle residents to identify other individuals having the potential to be affected by the same deficient practice.
3. The Medical Director or designee will retrain Thistle staff members regarding restraint protocolsby 5/15/22. Documentation requirements, including the need to complete separate restraint reports with specific beginning and ending times for each restraint that is placed, will be reviewed.
4. The Quality Manager will review completed restraint packets on a daily basis (Monday- Friday) and will provide feedback related to compliance with regulations to Supervisors and Directors via a channel in Microsoft Teams. If a restraint report is missing beginning and/or ending times, the Supervisor will ensure that the staff involved in the restraint makes this correction. The Supervisor will confirm that the restraint report was completed by replying to the Quality Manager's notification in Microsoft Teams.
5. The Medical Director and Residential Director will review overall restraint protocol compliance rates during weekly leadership meetings and will address areas of non-compliance with relevant staff as needed.
483.366 STANDARD
NOTIFICATION OF PARENT(S) OR LEGAL GUARDIAN
Name - Component - 00
If the resident is a minor as defined in this subpart:
483.366(a) The facility must notify the parent(s) or legal guardian(s) of the resident who has been restrained or placed in seclusion as soon as possible after the initiation of each emergency safety intervention.
Observations:
Based on record review and interview with administrative staff, the facility failed to notify the parents of a resident who had been restrained after the initiation of an emergency safety intervention for one of three sample residents. This is specific to Resident #3.
Findings include:
A review of Resident #3's record revealed a document titled, [agency name] Personal Emergency Intervention, dated 11/21/2021. This document noted that Resident #3 was restrained on 03/21/2021. Further review of the document titled, [agency name] CIR Notification, Session Information, dated 11/22/2021 revealed the parents were not notified.
Interview on 03/16/2022 at 11:45 AM and again on 03/17/2022 at 9:10 AM with Sr. Director, Administration, Quality & Compliance confirmed Resident #3's parents should have been notified of the above restraint.
Plan of Correction:1. The Director of Social Services or designee will notify the residents' parents/legal guardians of the restraints by 4/15/22.
2. During the month of April, the Quality Manager will review the last six months of restraint documentation for Thistle residents to identify other individuals having the potential to be affected by the same deficient practice.
3. The Social Services Coordinator will review the list of incident reports in TEAMS daily, notify parent(s)/legal guardian(s) of restraints placed and document the notification on the notification page in the restraint/Critical Incident Report packet. In the absence of the Social Services Coordinator, the assigned social worker will make and document the notifications.
4. The Quality Manager will review completed restraint packets on a daily basis (Monday- Friday) and will provide feedback related to compliance with regulations to Supervisors and Directors via a channel in Microsoft Teams. If a notification was not made, the Social Service Coordinator will contact the parents/legal guardians and confirm that the notification was completed by replying to the Quality Manager's notification in Microsoft Teams.
5. The Medical Director and Residential Director will review overall restraint protocol compliance rates during weekly leadership meetings and will address areas of non-compliance with relevant staff as needed
483.370(a) STANDARD
POST INTERVENTION DEBRIEFINGS
Name - Component - 00
Within 24 hours after the use of the restraint or seclusion, staff involved in an emergency safety intervention and the resident must have a face-to-face discussion. This discussion must include all staff involved in the intervention except when the presence of a particular staff person may jeopardize the wellbeing of the resident. Other staff and the resident's parent(s) or legal guardian(s) may participate in the discussion when it is deemed appropriate by the facility. The facility must conduct such discussion in a language that is understood by the resident and by the resident's parent(s) or legal guardian(s).
The discussion must provide both the resident and staff the opportunity to discuss the circumstances resulting in the use of restraint or seclusion and strategies to be used by the staff, the resident, or others that could prevent the future use of restraint or seclusion.
Observations:
Based on a review of facility documents and interview with administrative staff, the facility failed to ensure that within 24 hours after the use of restraint, staff involved in an emergency safety intervention and the resident must have a face-to-face discussion. This discussion must include all staff involved in the intervention, except when the presence of a particular staff person may jeopardize the well-being of the resident. This practice is specific to
Residents #1, #2 and #3.
Findings include:
A review of three of three sample Resident restraint records noted that the debriefing session between resident and staff involved in the restraint did not occur within the 24 hours after the restraint. Additionally, there was no indication on the report information reviewed that all staff involved in the restraint were included in this debriefing. The following is exemplary of that practice:
Resident #1: (debriefing not conducted within 24 hours.)
A review of the record of Resident #1 completed on 03/16/2021 between 9:45 AM and 12:30 PM revealed that this Resident was restrained on 02/20/2022 at 6:54 PM for a duration of 5 minutes . A review of the facility's restraint packet titled [agency name] personal Emergency Intervention revealed a Staff - child debriefing document. This document notes that this debriefing session occurred on 02/22/2022 at 3:18 PM.
Interview with the Senior. Director of Administration, Quality & Compliance on 03/17/2022 at approximately 10:30 AM confirmed that this staff-child debriefing was not conducted within 24 hours
Resident #3: (staff involved in restraint not include on the debriefing.)
A review of the record of Resident #3 completed on 03/16/2021 between 9:45 AM and 12:30 PM revealed a document titled Significant Incident Report dated 11/11/2021. This report stated that Resident #3 had been restrained on 11/11/2021 at 5:03 PM for a duration of 2 minutes. A review of the facility's restraint packet titled [agency name] personal Emergency Intervention revealed a document titled Critical Incident Debriefing-Child.
There were no staff names identified on this report who were involved in this restraint.
Interview with the Senior Director of Administration, Quality & Compliance on 03/16/2022 at approximately 10:10 AM and on 03/17/2022 at approximately 9:05 AM confirmed that all staff involved in the restraint were not identified on this debriefing.
Plan of Correction:1. NA – staff-resident debriefings were not completed within 24 hours
2. During the month of April, the Quality Manager will review the last six months of restraint documentation for Thistle residents to identify other individuals having the potential to be affected by the same deficient practice.
3. The Quality Manager is responsible for completing post restraint staff/resident debriefings within 24 hours of restraints that are placed between Sunday and mid-day on Friday. The Senior Director of Administration, Quality and Compliance will review the regulation that these debriefings occurring within 24 hours of restraint being placed during weekly supervision by 4/30/22. The Residential Director will identify a staff member to debrief restraints that are placed after 1:00 p.m. on Fridays and/or on Saturdays by 5/15/22. The Quality Manager will train this staff member on how to complete post-restraint debriefings on or before 5/30/22.
4. Effective immediately, The Senior Director, Administration, Quality and Compliance will review a sample of the Quality Manager's debriefings monthly to monitor whether or not they were completed within 24 hours and included all necessary parties. The Quality Manager will review restraint packets completed over the weekend on Mondays to ensure they include the required debriefings.
5. The Medical Director and Residential Director will review overall restraint protocol compliance rates during weekly leadership meetings and will address areas of non-compliance with relevant staff as needed.
483.370(b) ELEMENT
POST INTERVENTION DEBRIEFINGS
Name - Component - 00
Within 24 hours after the use of restraint or seclusion, all staff involved in the emergency safety intervention, and appropriate supervisory and administrative staff, must conduct a debriefing session that includes, at a minimum, a review and discussion of -
483.370(b)(1) The emergency safety situation that required the intervention, including discussion of the precipitating factors that led up to the intervention;
Observations:
Based on a review of facility documents and interview with administrative staff, the facility failed to ensure that within 24 hours after the use of restraint, all staff involved in the emergency safety intervention, and appropriate supervisory and administrative staff, must conduct a debriefing session to discuss the precipitating factors that lead up to the intervention for 7 out of 9 restraints implemented. This practice is specific to Residents #1,
#2 and #3.
Findings include:
A review of three of three sample Resident restraint records noted that the debriefing session between staff involved in the restraint, and supervisory/administrative staff did not occur within the 24 hours after the restraint. Additionally, there was no indication on the report information reviewed that all staff involved in the restraint were included in this debriefing. The following is exemplary of that practice:
Resident #1: (debriefing not conducted within 24 hours.)
A review of the record of Resident #1 completed on 03/16/2021 between 9:45 AM and 12:30 PM. This review revealed that she was restrained on 11/21/2021 at 6:15 PM for a duration of 10 minutes . A review of the facility's restraint packet titled [agency name] personal Emergency Intervention revealed a Staff debriefing document. This staff debriefing document notes that this staff-administrative debriefing session occurred on 11/29/2021 at 3:06 PM.
Interview with the Senior Director of Administration, Quality & Compliance on 03/17/2022 at approximately 10:30 AM confirmed that this staff-administrative debriefing was not conducted within 24 hours
Resident #3: (staff involved in restraint not include on the debriefing.)
A review of the record of Resident #3 completed on 03/16/2021 between 9:45 AM and 12:30 PM. This review revealed a document titled, Significant Incident Report dated 11/11/2021 which states that Resident #3 had been restrained on 11/11/2021 at 5:03 PM for a duration of 2 minutes A review of the facility's restraint packet titled [agency name] personal Emergency Intervention revealed no evidence that within 24 hours after the use of this restraint a debriefing was conducted between staff involved in the restraint and
appropriate supervisory and administrative staff.
Interview with the Senior Director of Administration, Quality & Compliance on 03/16/2022 at approximately 10:10 AM confirmed the above information
.
Plan of Correction:1. NA – administrative debriefings with all involved staff and appropriate supervisory and administrative staff were not completed within 24 hours
2. During the month of April, the Quality Manager will review the last six months of restraint documentation for Thistle residents to identify other individuals having the potential to be affected by the same deficient practice.
3. The Quality Manager is responsible for completing post restraint administrative debriefings within 24 hours of restraints that are placed between Sunday and mid-day on Friday. The Senior Director of Administration, Quality and Compliance will review the regulation that these debriefings occurring within 24 hours of restraint being placed during weekly supervision by 4/30/22. The Residential Director will identify a staff member to debrief restraints that are placed after 1:00 p.m. on Fridays and/or on Saturdays by 5/15/22. The Quality Manager will train this staff member on how to complete post-restraint debriefings on or before 5/30/22.
4. Effective immediately, The Senior Director, Administration, Quality and Compliance will review a sample of the Quality Manager's debriefings monthly to monitor whether or not they were completed within 24 hours and included all necessary parties. The Quality Manager will review restraint packets completed over the weekend on Mondays to ensure they include the required administrative debriefings.
5. The Medical Director and Residential Director will review overall restraint protocol compliance rates during weekly leadership meetings and will address areas of non-compliance with relevant staff as needed.
483.376(b) ELEMENT
EDUCATION AND TRAINING
Name - Component - 00
Certification in the use of cardiopulmonary resuscitation, including periodic recertification, is required.
Observations:
Based on review of staff training records, the facility failed to require staff certification in the use of in the use of cardiopulmonary resuscitation, including periodic recertification as required. This practice was specific to 1 of 22 sample employee staff training records which were reviewed.
Findings include:
A review of 22 sample employee training records regarding certification in cardiopulmonary resuscitation (CPR) was completed on 03/17/2022, from approximately 9:30 AM to 11:00 AM. This review revealed that valid certification status for one of these sample employees had expired.
Interview with the Senior Director of Administration, Quality & Compliance on 03/17/2022 at approximately 11:00 AM revealed that the certification for the one employee noted above had expired.
Plan of Correction: 1. The staff member who did not have valid CPR certification at the time of the revalidation survey will complete CPR training on or before 4/15/22.
2. NA – the Department of Health reviewed 100% of records for staff who work in Thistle
3. CPR training/certification dates are tracked in CVCA's electronic learning management system, Relias. The Training Manager will distribute a training calendar and a report of staff in need of CPR training within the next month to all campus directors monthly. Campus directors will be responsible for ensuring staff register and attend CPR training within required timeframes.
4. The Training Manager will monitor training completion dates and will notify Directors if/when staff fail to complete required trainings within expected timeframes.
5. The Residential Director and Medical Director are responsible for monitoring corrective actions.
483.376(f) ELEMENT
EDUCATION AND TRAINING
Name - Component - 00
Staff must demonstrate their competencies as specified in paragraph (a) of this section on a semiannual basis and their competencies as specified in paragraph (b) of this section on an annual basis.
Observations:
Based on review of facility documentation and staff training records, the facility failed to ensure that staff demonstrated their competencies in the use of emergency safety inventions on a semi annual basis. This practice is specific to 8 of 22 staff persons working with the residents of this facility.
Findings include:
A review of the facility documention regarding staff training for emergency safety interventions for the period of March 2021 through March 2022 was completed on 03/17/2022 from approximately 9:30 AM to 11:30 AM. This review revealed that eight (8) facility staff persons completed the annual training regarding the demonstration of the use of emergency safety interventions (ESI). However, further review showed there was no evidence that these same staff demonstrated their competencies on a semiannual basis.
Interview with the Senior Director of Administration, Quality & Compliance on 03/17/2022 at approximately 11:00 AM confirmed that eight (8) facility staff had not completed the emergency invention training on a semi annual basis.
Plan of Correction:1. The eight staff members who did not demonstrate required competencies will do so by 5/15/22. The Training Manager will coordinate with their supervisors to schedule the trainings and will record completions in Relias. Documentation of competency demonstration will be maintained in the employees' paper personnel records.
2. NA – the Department of Health reviewed 100% of records for staff who work in Thistle.
3. Trainers are responsible for completing skills assessments at the conclusion of each restraint training and for documenting staff results. Effective immediately, the Training Manager will ensure that written skills tests are submitted with staff training rosters and are filed in staff members' personnel records.
4. Dates of required trainings/competency tests are maintained in CVCA's electronic learning management system, Relias. The Training Manager will distribute reports from Relias monthly to notify directors and managers of when staff are due to complete semi-annual restraint training/competency testing. Directors and Managers are responsible for ensuring staff complete the training as required.
5. The Residential Director and Medical Director are responsible for monitoring corrective actions.
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