Every finding on record at Pacific Home Care LLC

EMERGENCY PREPAREDNESS SURVEY The following deficiencies are based on the emergency preparedness survey completed 04/19/23.

Development of Communication Plan CFR(s): 484.102(c) §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]. This STANDARD is not met as evidenced by: Based on record review and staff interview, the agency failed to develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws. This could affect all patients receiving services from the facility. The census was 33. Findings include: Review of the Emergency Preparedness Program last updated 08/03/21, revealed the Communication Plan must include a contact list for Federal, State, tribal, regional, and local emergency preparedness staff. The Communication Plan also will include contact information to identify state and Local officials to request assistance to provide care for homebound patients in need of evacuation. Review of the form titled, Communication Plan: Other Sources of Assistance Contact Information, revealed it was blank. Review of the Emergency Contact Lists revealed contacts for Franklin County Emergency and City of Columbus, not for Cuyahoga County or Cleveland. Per interview on 04/17/23 at 3:46 PM Staff C confirmed there was no contact list for Federal, State, tribal, regional, and local emergency preparedness staff for the Cleveland area.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(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]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and staff interview, the agency failed to maintain an emergency contact list of patients and staff. This could potentially affect all patients receiving services from the agency. The census was 33. Findings include: Review of “Exhibit 3, Notification Call List” revealed a list of telephone numbers of patients and staff for emergency contact is located at the front desk. Interview on 04/17/23 at 3:35 PM with Staff D revealed, “We look in each patient’s record for the emergency contact information”. Interview on 04/17/23 at 3:37 PM with Staff C and E revealed there was no patient or staff emergency contact lists available at the front desk. Interview on 04/17/23 at 3:48 PM with Staff C revealed the employee emergency contact list, located in the Communication Plan, only contained the office staff and not the field staff.

EP Training and Testing CFR(s): 484.102(d) §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. This STANDARD is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure the Emergency Preparedness Plan training and testing program included all staff. This could affect all patients receiving services from the agency. The census was 33. Findings include: Review of the Emergency Operations Plan Training and Testing Program revealed the Agency will ensure that all staff are appropriately trained regarding their roles in the EOP. Training will be documented. Staff will be prepared to assist the Agency in continuing to provide patient care during an emergency. The training program includes individual-based employee response activities in the event of a natural disaster, policies, and procedures regarding how to shelter-in-place, how the Agency manages patient continuity of care and the Agency's risk assessment, including procedures for identified hazards. A review of the training and testing documentation revealed only the office staff were trained and tested. No field staff were trained or tested. Interview on 04/17/23 at 3:18 PM with Staff C confirmed that none of the home health aides that worked with the patients were trained or tested on the Emergency Preparedness Program.

Extended Recertification Survey An entrance conference was conducted on 04/17/23 at 9:30 AM with the Secretary. An exit conference was conducted on 04/19/23 at 2:25 PM with administrative staff. The following deficiencies are based on the extended recertification survey completed 04/19/23. Pacific Home Care LLC 368469, is not in compliance with the requirements at 42 CFR Part 484, Subpart B, C for Home Health Agencies. Pacific Home Care LLC is precluded from providing its own home health aide training and competency testing or competency evaluation program for a period of two years from the date of the receipt of the deficiency report (2567) for this survey

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, record review and staff interview, the agency failed to review all medications the patient is currently using for two of three home visits conducted (Patient #1 and #3). The total sample was seven patients. The census was 33. Findings include: 1. A home visit was made on 04/18/23 at 9:00 AM to observe Staff F with Patient #1. Observation of the medication bottles and labels for Patient #1 revealed Tramadol (pain medication) 50 milligrams (mg) taken twice a day as needed, filled 11/29/22; Melatonin taken as needed (supplement used to help with sleep. Patient #1 stated she had been taking it for one and a half years; Lidocaine Ointment 5% (topical ointment used for pain). Patient #1 stated she had been using it for three years; Vitamin B12 (supplement to help prevent anemia) at bedtime. Patient #1 stated she had taken the supplement "for years." These four medications were missing from the current medication profile last updated 02/22/23. Interview on 04/18/23 at 9:15 AM with Patient #1 confirmed she was currently taking these four medications. Interview on 04/18/23 at 9:30 AM with Staff F confirmed the medications were missing from the medication profile. Review of the medication profile last updated 02/22/23 revealed and order for Synthroid (for hypothyroidism) 100 micrograms (mcg) to be taken daily. Observation of the medication bottle and label revealed the prescription was for Synthroid 125 mcg to be taken daily. This medication was filled 01/30/23 and should have been reviewed during the recertification assessment completed by the Registered Nurse (RN) on 02/22/23. Interview on 04/18/23 at 12:53 PM with Staff B confirmed this medication change had been missed. 2. A home visit was made on 04/18/23 at 11:00 AM to observe Staff G with Patient #3. Observation of the medication bottles and labels for Patient #3 revealed Sumatriptan (helps with cluster headaches) 100 mg to be taken daily as needed and was filled on 03/01/23. Famotidine (for gastroesophageal reflux disease) 20 mg to be taken daily and was filled 01/20/23. These two medications were missing from the current medication profile last updated 03/09/23. Interview on 04/18/23 at 11:25 AM with Patient #3's family member confirmed Patient #3 was currently taking these two medications. Interview on 04/18/23 at 11:33 AM with Staff G confirmed the medications were missing from the medication profile. Review of the medication profile last updated 03/09/23 revealed Vitamin D2 (helps to keep the bones strong) 50,000 International Units (1.25 mg) to be taken weekly. Observation of the medication bottle and label in the patient's home revealed a prescription for Vitamin D3 (bone and muscle strength and immune function) 25 mcg to be taken daily. This medication was filled 01/09/23 and should have been reviewed during the recertification assessment completed by the RN on 03/09/23. Interview on 04/18/23 at 2:34 PM with Staff B confirmed this medication change had been missed.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on review of QSO memo 23-02-ALL Attachment G, review of facility COVID-19 vaccination records, staff interview, and review of facility policy, the home health agency must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases (G687). The cumulative effect of these systemic practices resulted in the agency's inability to ensure that the patients' infection control needs would be met.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on review of QSO memo 23-02-ALL Attachment G, review of facility COVID-19 vaccination records, staff interview, and review of facility policy, the facility failed to ensure 100% of staff were vaccinated and the agency failed to develop a COVID-19 policy. This affected 17 out of 43 staff. This could affect all patients receiving services from the agency. The census was 33. Findings include: Review of QSO memo 23-02-ALL Attachment G, dated 10/26/22, revealed the home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. The policies and procedures must include, at a minimum, the following components: A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the Centers for Disease control (CDC), due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA’s COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; Contingency plans for staff who are not fully vaccinated for COVID-19. On 04/18/23 at 2:05 PM Staff D presented a list of 34 staff. Only 19 staff were marked as COVID vaccine card "received". This was not a complete staff list as the agency had 43 employees. Additionally, this list did not show the vaccine manufacturer, dates of vaccines, boosters, if any, or who had religious or medical exemptions. Interview on 04/18/23 at 2:07 PM with Staff D revealed this was how they monitored the staff for the COVID vaccine. Review of the vaccine status report and confirmed by review of vaccine cards submitted by staff revealed as of 04/19/23 at 1:29 PM, 17 staff were not vaccinated. There were no exemptions or delays as recommended by CDC. The agency’s percentage of vaccinated staff for COVID-19 was 60.5%. Interview on 04/19/23 at 1:44 PM with Staff B confirmed 17 staff were not vaccinated and that there were no approved exemptions. Staff B confirmed the agency did not have a COVID-19 vaccine policy.