Every finding on record at Alliant Health Systems, Inc

The following reflects the findings of the California Department of Public Health during a Recertification Survey. Representing the California Department of Public Health: Surveyor # 35893, Health Facilities Evaluator Nurse Surveyor # 22303, Health Facilities Evaluator Nurse Surveyor # 44916, Health Facilities Evaluator Nurse Unduplicated Admissions - 22 Active Patients - 22 Sample Size - 7 Patients Home Visits – 3

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to maintain an accurate, current medication profile for one of seven sampled patients (Patient 6). The patient had an order for Vitamin D3, but it was not observed at the patient's home. This failure resulted in the patient not receiving Vitamin D3 as ordered which had the potential to place the patient at risk for unhealthy bone and teeth. Findings: A review of Patient 6's Patient Information indicated, a start of care (SOC) date of 11/30/20, with a diagnosis that included dementia (loss of mental functions that affect activities of daily living) and hypertension (high blood pressure). During a review of Patient 6's Plan of Care (POC), for the re-certification period from 1/24/22 to 3/24/22, included an order for the certified home health aid (CHHA) to provide services 360 hours per month and the registered nurse (RN) visit 1 hour every 60 days. The CHHA was to observe for fall and ensure safety in activities of daily living. The POC included medications Melatonin (used for insomnia) 3 milligrams (mg-unit of measurement) at bedtime; and Vitamin D3, 125 micrograms (mcg-unit of measurement) once daily. On 2/4/22, at 12 p.m., a home visit was conducted, at Patient 6's residence with the CHHA. During medication reconciliation the Melatonin dosage on the bottle was 5 mg and there was no Vitamin D3. During a concurrent interview with the CHHA she stated the patient care giver could not find the correct dose of Melatonin and the patient ran out of Vitamin D3 two days ago. During an interview. with the Director of Patient Care Services (DPCS), on 2/7/22 at 12:40 p.m., she stated she calls to verify the medications with the caregiver. This is completed as needed and when new medications are prescribed. The HHA's policy and procedure dated 1/22/09 and titled "Administration of Medication Policy" indicated the policy will ensure patient safety. The medications and treatments will be administered as prescribed and will be recorded in the patient's clinical record.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the license nurse failed to obtain an order for a tracheostomy (surgically created hole in the trachea that provides an alternative airway for breathing) tube for one out of seven sampled patients (Patient 1). Patient 1 had tracheostomy tube in her trachea (windpipe) and no physician's order on the patient's record. This deficient practice resulted in the use of tracheostomy tube without a physician order which placed the patient at risk for having an incorrect size of tracheostomy tube that may lead to dislodging and/or other respiratory complications. Findings: A review of Patient 1's clinical record indicated a start of care dated 4/11/19, with primary diagnosis of cerebral palsy (congenital disorder of movement, muscle tone or posture).A review of Patient 1's plan of care from 1/25/22 to 3/25/22, included an order for LVN (license vocational nurse) visits for 160 hours of respite care per month, and the registered nurse (RN) for 1 hour every 60 days. The LVN to do supervision for safety, review of medications, dosages, time of administration , to report adverse reaction, fall/safety, aspiration, safety in activities of daily livings (ADL). On 2/4/22, at 11:45 a.m., a joint home visit was made to Patient 1's residence with LVN 1. Patient 1 was observed lying in bed with a tracheostomy tube (Shiley #8) connected to a ventilator. On 2/4/22, at 11:50 a.m., during an interview with LVN 1, she stated the patient's Shiley #8 tracheostomy tube being changed every two weeks as ordered. A further review of Patient 1's clinical record indicated that there was no physician's order to use a Shiley #8 tracheostomy tube for Patient 1. On 2/7/22, at 11 a.m., during an interview with the DPCS (director of nursing services), she stated she would have to call the physician to get an order for the Shiley #8 tracheostomy tube for Patient 1.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to develop a policies and procedures to address COVID-19 (an acute respiratory illness) and failed to have all staff being fit tested for N 95 respirator. This failure resulted in the HHA's inability to prevent the transmission of COVID-19 which had the potential for the staff to spread infection. Findings: During a review of the infection control policy on 2/7/22 at 1 p.m., the HHA did not have a policy for COVID-19 but had information regarding COVID-19 in a binder. During a concurrent interview with the Director of Patient Care Services (DPCS), she stated a COVID-19 policy would have to create one. The DPCS also could not provide evidence of fit testing for N 95 respirator for all staff but would follow up with her staff. The HHA's policy and procedure dated 1/2/14 and titled "Infection Control/ Exposure Practices" indicated the agency will ensure all staff are knowledgeable of exposure risks and practice infection control measures. The policy also stated that Personal Protective Equipment are required for staff and must be readily available.

The following reflects the findings of the California Department of Public Health during a complaint validation survey from July 20, 2021 through July 22, 2021. Representing the California Department of Public Health: Surveyor ID # 22303, RN, Health Facilities Evaluator Nurse Surveyor ID # 36459, RN, Health Facilities Evaluator Nurse Surveyor ID # 43979, RN, Health Facilities Evaluator Nurse Sample Size: 3 Home Visit: 2

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health agency (HHA) failed to meet the Condition of Participation for Establishment of The Emergency Program as follows: 1. The HHA failed to develop and maintain an emergency preparedness plan that is reviewed and updated at least every two years. (Refer to E 004) 2. The HHA failed to develop and maintain a training program for the agency staff to ensure each employee was able to perform their duties in the event of an emergency or disaster. (Refer to E 0037) 3. The Home Health Agency (HHA) failed to conduct testing activities for the agency's Emergency Preparedness Program to ensure the agency staff were aware of their duties in the event of an emergency or disaster. (Refer to E 0039) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (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 all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [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. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to develop and maintain an emergency preparedness plan that had been reviewed and updated at least every two years. This failure placed all the staffs and patients' safety at risk for danger during an emergency or a disaster. Findings: On 7/22/2021 at 3:10 p.m., the agency's Emergency Preparedness Program was requested. A binder titled, "Emergency Management Plan," was provided by the Administrator (ADM) that t did not indicate documentations or logs that the Emergency Preparedness Program was reviewed and revised every two years. During an interview with the Administrator (ADM) on 7/22/2021 at 4:00 p.m., he stated that the Emergency Preparedness Program was reviewed and revised annually. However, Administrator was unable to provide documented evidence to show that the Emergency Preparedness Program had been reviewed and revised annually. A review of the agency's policy and procedure titled, "Emergency and Disaster Preparedness Plan Policy," dated 1/22/2009, indicated that "The effectiveness of the Emergency Preparedness Plan is evaluated by not only reviewing the plan but by also conducting an Emergency Preparedness Drill at a minimum annually. It also indicated that "The Emergency Preparedness Plan is evaluated by the Quality Management Department. The evaluation of the plan will consider the results of the Emergency Preparedness Drill, and any new information that is available."

EP Training Program CFR(s): 484.102(d)(1) §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), §485.625(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, "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. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to develop and maintain an emergency preparedness training to all staff. This failure placed all staff and patients' safety at risk, and a delayed response when staff were not trained to respond to a disaster or to an emergency situation. Findings: On 7/22/2021 at 3:10 p.m., the agency's Emergency Preparedness Program was requested. A binder titled, "Emergency Management Plan," was provided by the Administrator (ADM) however, it did not indicate any documentations of staffs' training regarding emergency preparedness. During an interview with the Administrator (ADM) on 7/22/2021 at 4:00 p.m., he stated that staffs are provided training regarding emergency preparedness. However, the Administrator was not able to provide any documentations that emergency preparedness training and education for staff had been conducted monthly. A review of the agency's policy and procedure titled, "Emergency and Disaster Preparedness Plan Policy," dated 1/22/2009, indicated that "The effectiveness of the Emergency Preparedness Plan is evaluated by not only reviewing the plan but by also conducting an Emergency Preparedness Drill at a minimum annually. The policy and procedure further indicated that "The Emergency Preparedness Plan is evaluated by the Quality Management Department. The evaluation of the plan will consider the results of the Emergency Preparedness Drill, and any new information that is available."

EP Testing Requirements CFR(s): 484.102(d)(2) §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), §485.625(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, 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. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to conduct exercises to test the agency's emergency plan annually to ensure all staff were prepared of their duties in the event of an emergency or a disaster. This failure placed all staff and patients' safety at risk, and a delayed response when staffs are not trained to respond to a disaster or to an emergency situation. Findings: On 7/22/2021 at 3:10 p.m., the agency's Emergency Preparedness Program was requested. A binder titled, "Emergency Management Plan," was provided by the Administrator (ADM) that indicated the agency had conducted emergency preparedness drills on 9/19/2013 and 8/27/2014. No other emergency preparedness drill was documented. During an interview with the Administrator (ADM) on 7/22/2021 at 4:00 p.m., he stated that the last drill conducted by the agency was before the pandemic. However, when asked, the Administrator was unable to provide any documentations of an emergency preparedness drill conducted before the pandemic. A review of the agency's policy and procedure titled, "Emergency and Disaster Preparedness Plan Policy," dated 1/22/2009, indicated that "The effectiveness of the Emergency Preparedness Plan is evaluated by not only reviewing the plan but by also conducting an Emergency Preparedness Drill at a minimum annually. The policy and procedure also indicated that "The Emergency Preparedness Plan is evaluated by the Quality Management Department. The evaluation of the plan will consider the results of the Emergency Preparedness Drill, and any new information that is available."

The following reflects the findings of the California Department of Public Health during an abbreviated survey from July 20 to July 22, 2021; and August 13 to August 17, 2021. Complaint Number: CA00742260 Representing the California Department of Public Health: Surveyor ID # 22303, RN, Health Facilities Evaluator Nurse Surveyor ID # 36459, RN, Health Facilities Evaluator Nurse Surveyor ID # 43979, RN, Health Facilities Evaluator Nurse Sample Size: 3 Home Visit: 2 On 8/13/2021, at 5:22 p.m., an Immediate Jeopardy (IJ - a situation in which the agency's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident) was called in the presence of the agency's Administrator for the agency failed to ensure LVN 1 providing supervision to Patient 1 that resulted in Patient 1's death. On 8/17/2021, at 6:22 p.m., IJ was removed in the presence of the Administrator and the Director of Patient Care Services (DPCS) when the agency submitted an acceptable Plan of Action (POA).

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) agency failed to meet the Condition of Participation for Patient Rights when: 1. The agency failed to provide safety and supervision to prevent harm and severe injuries up to death to one of three sampled patients,(Patient 1). (Refer to G430) 2. The agency failed to immediately report to the California Department of Public Health (CDPH) the incident of neglect that resulted to a patient's death for one of three sampled patients, (Patient 1). (Refer to G488) The cumulative effect of these systemic practices resulted in the home health agency's inability to provide the services that meet the patient's needs and safety. The agency failed to ensure the provision of quality and safe health care to the patient.

Be free from abuse CFR(s): 484.50(c)(2) Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property; This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure one of three sampled patients (Patient 1) was free from neglect from Licensed Vocational Nurse 1 (LVN 1) by failing to: Ensure LVN 1 did not leave Patient 1's house during assigned work hours on 5/6/2021. LVN 1 was assigned to provide care to Patient 1, who required supervision for fall prevention and seizure (sudden, uncontrolled electrical disturbance in the brain) precaution due to Patient 1's medical conditions. This deficient practice resulted in Patient 1 was found lying on the floor in his house unresponsive and with no pulse when LVN 1 returned to the house at 11 a.m. on 5/6/2021. The paramedics later pronounced Patient 1 dead at 12 p.m. on 5/6/2021. On 8/13/2021, at 5:22 p.m., an Immediate Jeopardy (IJ a situation in which the agency's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident) was called in the presence of the agency's Administrator for the agency failed to ensure LVN 1 providing supervision to Patient 1 that resulted in Patient 1's death. On 8/17/2021, at 6:22 p.m., IJ was removed in the presence of the Administrator and the Director of Patient Care Services (DPCS) when the Administrator submitted an acceptable Plan of Action (POA). The survey team verified and confirmed on site the implementation of the acceptable POA which included the following summarized actions: 1. The Administrator met with LVN 1 on 5/11/2021 to review the policy and procedure regarding patient abandonment and neglect, restraint and containment fall risk prevention and meal on duty. 2. The Administrator and DPCS met on 8/14/2021 to 8/16/2021 and reviewed the agency's policy and procedure regarding patient abandonment and neglect, restraint, and containment, fall risk prevention and meal on duty. 3. The DPCS conducted an in service on 8/14 2021 to 8/16/2021 for all nursing staff regarding patient abandonment and neglect, restraint and containment, fall risk prevention and meal on duty policies and procedures. 4. The Administrator contacted family members of patients who are cognitively impaired, currently using wheelchairs and have impaired movement, regarding safe use of wheelchairs and medical equipment. Administrator also reviewed fall safety precautions with caregiver and discussed regarding nurse's not being able to leave the patient's home at any time during their shift. 5. The DPCS will complete personal emergency communication forms for all patients and a copy will be left at patient's home and in the office chart. 6. The Administrator initially reported the incident to San Gabriel/Pomona Regional Center on 5/6/2021 via email. California Department of Health (Sacramento) was contacted, and the incident was reported. Department of Public Health were also contacted. 7. The Administrator contacted the West Covina Police Department to request copy of the report but was informed that the "report can only be release to the next of kin." 8. A copy of the on location personal leave policy and the emergency communication sheet will be added to patient's home chart. 9. LVN 1 currently on suspension, pending the results of the investigation. 10. The Designee will visit patient home one time per month to evaluate medical equipment in the patient home. Designee will notify the Durable Medical Equipment company by phone if any equipment needs repairs. The Designee will submit a written report to the office, notify patient's family and fax negative findings to Medical Doctor's office for equipment orders if needed. Findings: A review of Patient 1's Plan of Care (POC) for the certification period of 3/19/2021 to 5/17/2021 indicated a start of care date of 10/7/2017, with diagnosis of severe intellectual disability. Patient 1's POC indicated an order for Licensed Vocational Nurse 240 hours per month, 28 hours for respite care (interval care) and Registered Nurse one hour every 60 days for reassessment of Plan of Care and skilled nurse (SN) supervisory visit. The POC indicated a 24 hour supervision for safety measures/fall prevention, aspiration (breathing in a foreign object) and seizure precautions. A review of Patient 1's Communication Note, dated 5/6/2021, indicated at approximately 10 a.m., Licensed Vocational Nurse 1 left Patient 1 with a family member and returned back to the patient's home at approximately 11 a.m. The Communication Note indicated when LVN 1 returned to Patient 1's home, LVN 1 found Patient 1 lying on the floor not breathing. Patient 1's skin was pale, and blood was noted on his face and neck. LVN 1 was unable to find a pulse. The Communication Note further indicated Patient 1's family member told LVN 1 that Patient 1 got caught on his wheelchair's seatbelt. Patient 1 was pronounced dead by the paramedics at approximately 12 p.m. A review of Patient 1's Physician Order dated 5/6/2021, indicated that Patient 1 expired at home and was discharged from the agency. A review of Patient 1's Skilled Nurse Discharge Summary, dated 5/6/2021, indicated Patient 1 was discharged from all services because Patient 1 expired. During an interview with the Administrator on 7/20/2021, at 12:30 p.m., he stated LVN 1 was on duty on 5/6/2021 and should have stayed with Patient 1. The Administrator stated that when the nurses are on duty, they cannot leave the patients at all. The Administrator further stated that LVN 1 was suspended and that she has not seen any patients since Patient 1's incident on 5/6/2021. During an interview with Licensed Vocation Nurse 1 on 7/21/2021, at 9:26 a.m., LVN 1 stated that her shift on 5/6/2021 was from 7 a.m. to 5 p.m. LVN 1 stated that she left Patient 1 in his wheelchair with his seatbelt on in the family room because Patient 1 ambulates (walks) and has drop seizures (type of seizure that causes sudden loss of muscle strength or tone which can cause a person to fall to the ground). LVN 1 stated Patient 1 needs to be supervised due to his medical condition. LVN 1 stated she left Patient 1's home at around 10 a.m. on 5/6/2021 for 45 minutes to one hour so that she could go to the office to pick up more route sheets (form to record home visits) and her paycheck. LVN 1 further stated that when she returned to Patient 1's home, she noticed the door was open and Patient 1's family member was running and yelling her name. LVN 1 further stated that when she got inside the home, she found Patient 1 lying on the floor on his back, pale, and blood was noted on his nose and mouth. LVN 1 stated she started cardiopulmonary resuscitation (CPR, a medical procedure involving repeated compression of a patient's chest, performed to restore the blood circulation and breathing of a person who has suffered sudden loss of heart function) and told Patient 1's family member to call 911 (emergency service). During an interview with Director of Patient Care Services (DPCS) on 7/21/2021, at 11:55 a.m., the DPCS stated LVN 1 was on duty on the day of Patient 1's incident and the expectation was for LVN 1 to stay at Patient 1's home for the entire shift and to take her breaks at the patient's home. During an interview with the Administrator on 7/21/2021, at 12:10 p.m., he stated that employees signed a meal waiver upon hire indicating that if they work eight hours or more, they cannot leave the patient's home for breaks and that employee has to bring their food and eat at the patient's home. A review of the agency's "On Duty Meal Period" form, found in LVN 1's employee file, indicated LVN 1 acknowledged and signed the form on 11/11/2017. The form indicated that "The Employee and the Employer agree that the nature of the Employee's work prevents the Employee from being relieved of all duty during the Employee's meal period and that the Employee shall work on duty meal period that shall be paid for by the Employer." A review of the agency's policy and procedures titled, "Abuse Policy," dated 1/22/2009, indicated that the purpose of the policy and procedure is "To protect the health and well being of the patients and families being serviced by the Agency." The policy and procedures further indicated that the definition of neglect is "The absence or omission of essential services to the degree that it harms or threatens with harm the physical or emotional health of a child or disabled adult." On 8/13/2021, at 5:22 p.m., an Immediate Jeopardy (IJ a situation in which the agency's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident) was called in the presence of the agency's Administrator for the agency failed to ensure LVN 1 providing supervision to Patient 1 that resulted in Patient 1's death. On 8/17/2021, at 6:22 p.m., IJ was removed in the presence of the Administrator and the Director of Patient Care Services (DPCS) when the agency submitted an acceptable Plan of Action (POA).

State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This ELEMENT is not met as evidenced by: Based on observations, interview, and record review, the facility failed to provide the toll-free home health telephone hot line to one of three sampled patients, (Patient 2). This failure had the potential that complaints or concerns of the patients who are under the agency's care will not be reported timely to the appropriate authorities. Findings: A review of Patient 2's Patient Information, dated 9/14/2018, indicated a start of care (SOC) date of 9/14/2018, with diagnoses that included Cerebral Palsy (a congenital disorder of movement, muscle tone, or posture). A review of Patient 2's Plan of Care (POC), dated 6/29/2021, indicated a certification period from 6/29/2021 to 8/27/2021. An order for skilled nurse (SN) is to visit 40 hours/week for respite care. SN is to assess the activities of daily living (ADLs) and home safety, knowledge on disease process and management, medication knowledge and compliance. Instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). A review of the Patients 2's Comprehensive Adult Nursing Assessment (to determine the need for nursing services), dated 6/25/2021, indicated Patient 2 had history of Epilepsy (seizures), unspecified, not intractable, without status epilepticus. There were no medication changes that occurred. License Vocational Nurse (LVN) was to continue to instruct Primary Care Giver (PCG) on new or change in medications, functions, dosages, times of administration, s/s (signs and symptoms) of adverse reactions to report. (What is the significance of the above report to the deficient practice?) On 7/20/2021, at 1 p.m., a home visit was conducted at Patient 2's residence. Patient 2 was observed sitting on the wheelchair in the living room with Licensed Vocational Nurse 2 (LVN 2) and Family Member 2 (FM 2) by the side. During an interview on 7/20/2021, at 1:15 p.m., LVN 2 stated she was unable to locate Patient 2's current medication record or POC. LVN 2 was carrying a copy of Patient 2's POC dated 2019. LVN 2 was able to locate the agency's folder, but was unaware of the agency's toll-free hotline number or the need to inform Patient 2's family member. (Empathy's father. (??) What is the agency's policy indicates on how to provide the toll free telephone hot line? Was the family member interviewed reagrding the toll free hot line?

Immediate reporting of abuse by all staff CFR(s): 484.50(e)(2) Any HHA staff (whether employed directly or under arrangements) in the normal course of providing services to patients, who identifies, notices, or recognizes incidences or circumstances of mistreatment, neglect, verbal, mental, sexual, and/or physical abuse, including injuries of unknown source, or misappropriation of patient property, must report these findings immediately to the HHA and other appropriate authorities in accordance with state law. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to immediately report to the appropriate authorities an incident of neglect that resulted to a patient's death for one of three sampled patients (Patient 1). This failure resulted in the local Department of Public Health and other appropriate authorities were not made aware of the incident. This failure also had the potential that safety measures to prevent further neglect, harm and injuries to other patients will not be implemented as soon as possible. Findings: A review of Patient 1's Plan of Care for the certification period of 3/19/2021 to 5/17/2021 indicated a start of care date (SOC) of 10/7/2017, with diagnosis of severe intellectual disability. Patient 1's Plan of Care indicated an order for Licensed Vocational Nurse (LVN) 240 hours per month, 28 hours for respite care, and Registered Nurse (RN) one hour every 60 days for reassessment of Plan of Care and skilled nurse (SN) supervisory visit. A review of Patient 1's Plan of Care under neurological (cognition) status further indicated 24 hour supervision for safety measures/fall prevention, aspiration (foreign objects that entered the lungs or airway) and seizure (uncontrolled twitching, stiffness or limpness) precautions. A review of Patient 1's Physician Order dated 5/6/2021 indicated that Patient 1 had been discharged from the agency. The Physician Order under communication note indicated that Patient 1 expired (died) at home. A review of Patient 1's SN Discharge (DC) Summary dated 5/6/2021 indicated that patient was discharged from all services and reason for discharge indicated that patient no longer meets Home Health Criteria because patient expired. A review of Patient 1's Communication Note dated 5/6/2021at 6 a.m. to 5 p.m., indicated that at approximately 10:00 a.m. LVN 1 left patient with a family member and returned back to patient's home at approximately 11:00 a.m. Communication Note further indicated that upon LVN 1's return to Patient 1's home, LVN 1 found Patient 1 lying on the floor not breathing, skin pale, blood on his face and neck. LVN 1 was unable to locate a pulse. Communication Note further indicated that family member had told LVN 1 that Patient 1 got caught on his seatbelt while seated on his wheelchair. Communication Note further indicated that Patient 1 was pronounced dead at approximately 12:00 p.m. A review of Patient 1's Communication Note dated 5/6/2021 at 4 p.m. to 5 p.m., indicated that appropriate communication regarding incident reporting were made to all relevant agencies regarding Patient'1 death. The Communication Note further indicated that the agency notified and filed a Special Incident Reports (SIRs report that is filed with the regional center whenever a person served by the regional center is involved in an unusual event) with the Regional Center and also reported to the Department of Public Health, Sacramento. During an interview with the Administrator (ADM) on 7/20/2021 at 3:35 p.m. and 7/21/2021 at 3:38 p.m., he stated that he notified the Department of Public Health Sacramento. Administrator further stated that the Department of Public Health Sacramento did not provide any confirmation or documentation regarding incident with Patient 1 and that everything was done through the telephone. A review of the agency's policy and procedure titled, "Abuse Policy," dated 1/22/2009, indicated that "It shall be the policy of this Agency for all staff members to report signs of abuse, neglect, or exploitation observed during the course of providing home care services." It also indicated that if a patient/ staff member reports abuse of a patient by another staff member, it will be reported immediately to their immediate supervisor who will inform the Director Of Patient Care Services and Administrator. The abuse will be reported within 24 hours to Adult Protective Services, and local law enforcement. In addition, "the Administrator will notify the Department of Health Services verbally and in writing i.e. an Incident Report will be completed and faxed to the Department of Health services within 24 hours. A final report of the investigation will be sent to the Department of Health Services within 24 hours of its completion via certified mail.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to: 1. Ensure medication orders were reviewed and administered as per physician's order for one of three sampled patients (Patient 2). 2. Ensure medications were reviewed for its expiration dates for one of three sampled patients, (Patient 3). These failures placed all patients at risk for ineffective drug therapy and adverse drug reactions. Findings: a. During a review of Patient 2's Patient Information, dated 9/14/2018, the Patient Information indicated, a start of care (SOC) date of 9/14/2018, with diagnosis that included Cerebral Palsy (A congenital disorder of movement, muscle tone, or posture). During a review of Patient 2's Plan of Care (POC), dated 6/29/21, the POC indicated, a certification period from 6/29/2021 to 8/27/2021. It also included an order for skilled nurse (SN) to visit of 40 hours/week for respite care. SN to assess activities of daily living and home safety, knowledge on disease process and management, medication knowledge and compliance. Instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). One of the physician's order included in the plan of care dated 2/20/2020 was to administer Divalproex (medicine for epilepsy) sprinkles 125 milligrams (mg) 1 capsule by mouth 2x daily. During a review of the document titled "Comprehensive Adult Nursing Assessment" (to determine the need for nursing services) for Patient 2, dated 6/25/2021, it indicated that Patient 2 had a history of epilepsy (seizures), unspecified, not intractable, without status epilepticus. It did not indicate changes to the medications. LVN (license Vocational Nurse) to continue to instruct PCG (Primary Care Giver) on new/change medications, functions, dosages, times of administration, s/s (sign and symptoms) adverse reactions to report. During a review of Patient 2's Medication Profile, dated 6/25/2021, it indicated a Divalproex sprinkles 125 mg 1 capsule by mouth 2x daily. On 7/20/2021, at 1 p.m., a home visit was conducted at Patient 2's residence. Patient 2 was observed sitting on wheelchair in the living room, LVN 2 and FM 2 by side. During an interview on 7/20/2021 at 1:15 p.m., LVN 2 stated she was unable to locate Patient 2's current medication record or POC. LVN 2 was carrying a copy of Patient 2's POC dated 2019. During an inspection of Patient 2's medications, a long green medicine bottle of Divalproex Sprinkles 125 milligram (mg) indicated to take 2 capsules in the morning and 3 capsules at night. During an interview on 7/20/2021 at 1:30 p.m., FM2 stated, that he administers Divalproex Sprinkles 125mg, 3 capsules in the morning and LVN 2 administers 3 capsules at night. FM 2 stated that LVN 2 is there five days during the week, usually from 11:30 a.m. to 7:30 p.m. During an interview on 7/21/2021 at 12:28 p.m. with Director of Patient Care Services) (DPCS), DPCS stated that LVNs have to follow the six rights in medication administration, check start/stop dates, check time to give medications. Medication sheet must match POC, MD orders, and medication bottle. If there is a discrepancy, LVNs needs to call MD to verify and clarify. If there are any changes to the medications, LVNs should call office and MD's office and are supposed to write in the communication notes to let the office know if there are any changes. DPCS was asked for any communication notes from LVN 2 regarding Patient 2. DPCS stated, there were no communication notes at this time. During an interview on 7/22/2021 at 11:45 a.m., with ADM, ADM stated that every 60 days the Registered Nurse (RN) does the medication reconciliation. The LVNs do the medication reconciliation when they find out medications are being added or taken away. LVNs are to check medications every day to check which medication is current and which is not. The Registered Nurse (RN) should have called the pharmacy and did the full reconciliation of medications. If its not there, we should call the doctor. That's what they should have done. We didn't do it. b. A review of Patient 3's admission record indicated that Patient 3 was admitted to the facility on 8/1/19, with diagnoses that included facioscapulohumeral muscular disease (genetic muscular disorder mild intellectual disabilitiof insulin dependent diabets mellitus (characterized by muscle weakness and wasting). A review of Patient 3's POC from 5/21/21 to 7/21/21, included an order for the LVN visit of 170 hours per month, to observe/assess all body systems focusing on respiratory system. One of the SN intervention was to assess knowledge on disease process and management, medication knowledge and compliance. Instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). A review of physician's order that were included in the POC were as follows: a. Sertraline Hydrochloride 50 mg (antidepressant) tablet oral daily b. Loratidine 10 mg one tab daily. (medication to help allergies) c. Trazadone Hydrochloride 50 mg one tab daily (antidepressant) On 7/21/21, at 10:30 a.m., a home visit was conducted at Patient 3's residence with LVN 3. Patient 3 was observed sitting on wheelchair in the living room. At 10:50 a.m., during inspection of Patient 3's actual medication bottles, the following were observed: a. A vial of Sertraline Hydrochloride 50 mg (milligrams) medication with no expiration date and date of refill was 1/14/21. There were 15 tablets remaining in the vial. b. A vial of Loratidine 10 mg medication with no expiration date and date of refill was 1/14/21. There were 20 tablets remaining in the vial. c. A vial of Trazadone Hydrochloride 50 mg medication with no expiration date and date of refill was 1/14/21. There were 18 tablets remaining in the vial. At 11:10 a.m., during an interview with LVN 3 and when asked if he checked the patient's actual medications on his visits, he stated he checks them always. He also stated that he missed looking at the expiration date of medicaton bottles. At 11:20 a.m., during an interview with Patient 3, he stated he mixed all his new medications with the old medications in one medication vial. On 7/21/21 at 1 p.m., during an interview with the DPCS, she stated the LVN's have to follow the six rights, check start/stop dates, check time to give medications and check label on medication vial/bottle. Medication sheet must match POC, MD orders, and medication bottle. If there is a discrepancy, LVNs needs to call MD to verify and clarify. If there are any changes to the medications, LVNs should call the office and MD's office. LVNs are supposed to write in communication notes to let the office know if there were any changes. She also stated that LVN 3 did not report to the agency regarding Patient 1's outdated medication vials with no expiration dates. A review of the agency's policy titled "Administration of Medication" dated 1/22/2009, the Medication Administration Policy indicated, when there is a discrepancy in the medications, the nurse will contact the physician by telephone as soon as possible to verify the medication regimen. The nurse will instruct the patient and family in the correct medication regimen. The nurse will document all telephone conversations and instructions given to the patient and/or family in the patient clinical record. It also indicated that all supplies utilized for medication administration are to be examined for defects and expiration dates.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to review the current Plan of Care for one of three patients (Patient 2). This failure had the potential to cause negative impact to the health and well-being of the affected patient and all the patients under the agency's care. Findings: During a review of Patient 2's Patient Information, dated 9/14/2018, it indicated a start of care (SOC) date of 9/14/2018, with diagnosis that included Cerebral Palsy (A congenital disorder of movement, muscle tone, or posture). During a review of Patient 2's Plan of Care (POC), dated 6/29/21, the POC indicated, a certification period from 6/29/2021 to 8/27/2021. It also included an order for skilled nurse (SN) to visit of 40 hours/week for respite care. SN to assess activities of daily living (ADLs) and home safety, knowledge on disease process and management, medication knowledge and compliance. Instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). During a review of the Patients 2 Comprehensive Adult Nursing Assessment (to determine the need for nursing services), dated 6/25/2021, it indicated that Patient 2 had a history of Epilepsy (seizures), unspecified, not intractable, without status epilepticus. It also indicates there were no medication changes that occurred. LVN (license Vocational Nurse) to continue to instruct PCG (Primary Care Giver) on new/change medications, functions, dosages, times of administration, s/s (sign and symptoms) adverse reactions to report. On 7/20/2021at 1 p.m., a home visit was conducted at Patient 2 residence. Patient 2 was observed sitting on wheelchair in the living room, LVN 2 and FM 2 by side. During an interview on 7/20/2021 at 1:15 p.m., with LVN 2, LVN 2 stated she was unable to locate Patient 2's current medication record or POC. LVN 2 was carrying a copy of Patient 2's POC dated 2019.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to comply with the physician's orders for one of 3 patients (Patient 3) when the oxygen saturation level was not checked as ordered. This deficient practice can result to a delayed intervention and had the potential to cause respiratory distress to the affected patient and the other patients under the agency's care. Findings: A review of Patient 3's admission record indicated Patient 3 was admitted to the facility on 8/1/19, with diagnoses that included facioscapulohumeral muscular disease (genetic muscular disorder mild intellectual disability, insulin dependent diabetes mellitus (characterized by muscle weakness and wasting). A review of Patient 3's plan of care (POC) from 5/21/21 to 7/21/21 included an order for the LVN (license vocational nurse) visit of 170 hours per month, to observe/assess all body systems focusing on respiratory system. One of the physician's order included in the POC was to check oxygen saturation using the pulse oximeter on every visit and/or PRN (as needed) for dyspnea (shortness of breath), to notify physician if pulse oxymeter reading is less than 92 percent. A review of Patient 1's SN Visit Notes dated 6/29/21 to 6/30/21 did not indicate that the LVN checked the patient's oxygen saturation level. During an interview with the Director of Patient Care Services (DPCS) on 7/21/21, at 11:45 a.m., she stated the visiting nurse should be checking the patient's oxygen saturation level on every visit as ordered.

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure that monthly skilled nurse supervisory visit (to determine if the staff are following the care plan, if the care plan is meeting the patient's needs, if the patient/caregiver is satisfied with the care plan and the performance of the staff) for a Licensed Vocational Nurse (LVN) was done by a Registered Nurse. This failure had the potential that the skills and competence of the staff providing direct patient care are not evaluated properly which can affect the quality of care and nursing services provided to the three (3) of 3 patients under the agency's care. Findings: During a review of Patient 2's Patient Information, dated 9/14/2018, the Patient Information indicated, a start of care (SOC) date of 9/14/2018, with diagnosis that included Cerebral Palsy (A congenital disorder of movement, muscle tone, or posture). During a review of Patient 2's Plan of Care (POC), dated 6/29/21, the POC indicated a certification period from 6/29/2021 to 8/27/2021 that had an order for skilled nurse (SN) to visit of 40 hours/week for respite care. SN to assess activities of daily living (ADLs) and home safety, knowledge on disease process and management, medication knowledge and compliance. Instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). During a review of the Patient 2's Comprehensive Adult Nursing Assessment (to determine the need for nursing services), dated 6/25/2021, it indicated that Patient 2 had history of Epilepsy (seizures), unspecified, not intractable, without status epilepticus. It also indicates there were no medication changes that occurred. LVN to continue to instruct PCG (Primary Care Giver) on new/change medications, functions, dosages, times of administration, s/s (sign and symptoms) adverse reactions to report. During a review of the LVN-LPN supervisory notes for LVN 2 dated 4/27/2021, 2/25/2021, 12/28/2020, and 10/29/2020, it indicated an electronic signature of the Quality Assurance Licensed Vocational Nurse (QA LVN). During a concurrent interview and record review on 7/21/2021 at 1:25 p.m. with DPCS, the LVN-LPN Supervisory Notes for LVN 2 dated 4/27/2021, 2/25/2021, 12/28/2020, and 10/29/2020 indicated the electronic signatures of the QA, which is an LVN. DPCS stated that she does the supervisory LVN notes every 30 days. When asked, DPCS was unable to answer why the electronic signature of the QA LVN personnel had reflected in the document. During a concurrent interview and record review on 7/21/2021 at 1:30 p.m., with ADM, the LVN-LPN Supervisory Notes for LVN 2 dated 4/27/2021, 2/25/2021, 12/28/2020, and 10/29/2020 that indicated the electronic signatures of the QA LVN, ADM stated the QA LVN's electronic signature were there due to her QA status, "she probably printed or reviewed the notes last".

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to: a. Ensure that employees had updated tuberculosis [TB, an infectious bacterial disease characterized by the growth of nodules (tubercles) in the tissues, especially the lungs] screening for six (6) of 10 employees. b. Provide PPD or chest x-ray results for five (5) of eight (8) employees. c. Provided History and Physicals (H&P, a thorough physical exam with a history of medical diagnosis) in four (4) of 8 employees. This deficient practice placed all patients at risk for a potential bacterial infection from an employee that can affect the health and safety of all the patients under the agency's care. Findings: a. A review of Licensed Vocational Nurse 1's (LVN 1) employee record indicated that her last PPD (Purified Protein Derivative, skin test to determine a TB infection) was on 1/23/2020. During an interview with Director of Patient Care Services (DPCS) on 7/21/2021, at 3:25 p.m., she stated that employee PPD should be done yearly. b. During a record review and concurrent interview on 7/22/2021 at 3:30 p.m. with Administrator (ADM), 8 employee personnel records were reviewed. The records for 5 employees did not indicate that a PPD test or chest x-ray was done, and 4 employee records did not indicate that an H&P had been done. When asked, ADM stated that she cannot find the PPD test or chest x-ray of the 5 employees nor the H&P of the 4 employees. A review of the facility's policy and procedure titled, "Employee Health Files", dated 1/22/2009, indicated that all agency employees and contractors with direct patient contact will have a health examination by a licensed and legally authorized practitioners within his or her scope of practice six months prior to employment or within fifteen days of employment. All personnel will have a health examination at least every two years thereafter. It also indicated that upon hire, agency staff providing direct patient care will provide written results of non-reactive PPD or negative chest x-ray in the last year. If the employee does not have the above, agency will provide for a tuberculosis screening which will be administered to all new employees who have direct patient contact and annually thereafter. Employees who present evidence of a previous positive tuberculin skin test, will not be required to undergo the annual tuberculosis screening requirements if a chest x-ray is done every two years and indicates no active disease and the employee completes a TB screening questionnaire annually. It also indicates that the agency will maintain a separate confidential employee health file that will include the health records and pertinent documentation of health examinations for each employee and contractor providing direct patient contact that will include but not limited to the above-described documents.