Every finding on record at The Tombigbee Health Care Authority

A recertification survey was conducted on 1/7/25 to 1/9/25 at Bryan W. Whitfield Memorial Hospital Home Health. Standard level deficiencies were cited and will require a plan of correction.

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), §485.542(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 review of Emergency Preparedness (EP) documentation, agency policy, and interview with staff, it was determined the agency failed to ensure their comprehensive EP plan/program was updated and reviewed biennially (every two years) to comply with the Federal EP requirements. This had the potential to negatively affect all staff and patients served by this agency. Findings include: Agency Policy: Emergency Preparedness Plan Policy Number: None Listed Date Updated: August 2019 Review of the EP documentation for the home health agency revealed the last update was August 2019. An interview was conducted on 1/9/25 at 9:15 AM with Employee Identifier (EI) # 1, Director, who confirmed there was no documentation the EP program/plan had been updated and reviewed every two years as required.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on review of Emergency Preparedness documentation and staff interview it was determined the agency failed to complete a facility-based and community-based all hazards risk assessment every two years. This had the potential to negatively affect all patients, and staff served by this agency. Findings include: Review of EP documentation revealed no documentation of a facility-based and community-based all hazards risk assessment for the years 2020, 2021, 2022, 2023, or 2024. An interview was conducted on 1/9/25 at 9:15 AM with Employee Identifier (EI) # 1, Director, who confirmed the agency failed to complete a facility-based and community-based all hazards risk assessment for the years 2020, 2021, 2022, 2023, and 2024.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on review of documents provided for the Emergency Preparedness (EP) program policies and procedures and staff interview, it was determined the agency failed to ensure policies and procedures were reviewed and updated every two years. This had the potential to negatively affect all patients and staff served by the agency. Findings include: Review of EP policies and procedures revealed the last update was August 2019. An interview was conducted on 1/9/25 at 9:15 AM with Employee Identifier # 1, Director, who confirmed policies and procedures had not been reviewed and updated every two years since August, 2019.

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), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on review of Emergency Preparedness (EP) documentation and staff interview, it was determined the agency failed to ensure annual testing of the EP program had been completed, documented and analyzed. This had the potential to negatively affect all patients and staff served by this agency. Findings include: Review of EP documentation revealed no documentation annual testing of the EP program had been completed, documented or analyzed. There was no documentation of any community or facility based exercises, actual events, and no documentation of any table top exercises for the years 2020, 2021, 2022, 2023, and 2024. An interview was conducted on 1/9/25 at 9:15 AM with Employee Identifier # 1, Director, who confirmed there was no documentation of any exercises of any kind documented for the years 2020, 2021, 2022, 2023, or 2024.

A recertification survey was conducted 1/7/25 to 1/9/25 at Bryan W. Whitfield Memorial Hospital Home Health. Standard level deficiencies were cited and will require a plan of correction.

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 review of agency policy and procedure, medical record (MR) reviews, and interviews, it was determined the agency failed to ensure each patient was provided the State toll free home health telephone hot line number. This affected three of three Home Visit (HV) patients including HV # 1, HV # 2, and HV # 3, four of four MR's reviewed including MR # 1, MR # 2, MR # 3, and MR # 4, and had the potential to affect all patients served by this agency. Findings include: Agency Policy: The Patient Bill of Rights and Responsibilities Policy Number: Not Listed Revised: January 2023 ...Federal law requires that all individuals receiving home care services be informed of their rights as a patient... 18. Be advised of the telephone number and hours of operation of the state's hotline, which receives questions and complaints..Telephone number 1-800-356-9596... 1. Seven of seven MRs reviewed revealed no documentation the patients had received the state's hotline number. This included three home visits. There was no documentation of the state's hotline number in the patient's home folders, reviewed during the home visits. An interview was conducted on 1/8/25 at 3:10 PM with Employee Identifier # 1, Director, who confirmed the State hotline number had not been provided to patients. EI # 1 further stated that none of the current 70 patients had been provided with the State hotline number.

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 review of medical records (MRs), observations, agency policy and interviews with staff, it was determined the agency failed to ensure medications were reconciled in two of three Home Visits (HV) conducted. This affected HV # 3, HV # 1 and had the potential to negatively affect all patients served by this agency. Findings include: Agency Policy: Medication Management and Reconciliation Policy Number: None Listed Date Revised: 01/2023 A medication profile is completed at the time of the patient's admission. ...2. When a new medication is ordered, the medication is added to the medication profile along with the appropriate information. ...5. All skilled nurses are to review the patient medication profile list at each skilled nurse visit and document any new or changed medications. ...10. Medications are monitored and reconciled by the RN's, but other disciplines may review medications/medication list with the patient/caregiver and notify the skilled nurse if any discrepancies are noted. 2. HV # 1 was admitted to the agency on 6/28/24 and recertified for continued care from 12/25/24 to 2/22/25 with the diagnosis of Foot Drop. A HV was conducted on 1/7/25 at 1:45 PM with EI # 5, Licensed Physical Therapy Assistant (LPTA). A comparison was made between the MP at the Assisted Living Facility (ALF) and the MP dated 1/7/25 provided from the agency prior to the HV. The following medications were listed on the MP for the ALF as current, but not listed on the MP for the agency: a. Coricidin Hbp (brand name) 200 mg / 10 mg Softgel, take one capsule by mouth once a day as needed for congestion, start date of 10/18/24. b. Meclizine 12.5 mg tablet, take one tablet by mouth three times a day as needed for dizziness, start date 10/28/24. The Following medications were listed on the agency MP dated 1/7/25, and not on the ALF MP as current: a. Colchicine 0.6 mg, take one tablet daily, start 6/28/24. b. Loratadine 10 mg, take one tablet daily as needed, start 6/28/24. An interview was conducted on 1/8/25 at 3:51 PM with EI # 1, who confirmed the agency staff failed to ensure medications were reconciled and all current medications were included on the MP. 1. HV # 3 was admitted to the agency on 2/1/24 and recertified for continued care from 11/27/24 to 1/25/25 with the diagnosis of Epilepsy, Unspecified, not Intractable. Review of the Home Health Certification (HHC) and Plan of Care (POC) for the dates of 11/27/24 to 1/25/25 revealed physician's orders for the Skilled Nurse (SN) to visit one time a week for nine weeks. A home visit was conducted on 1/7/25 at 1:19 PM with Employee Identifier (EI) # 4, Home Health Aide (HHA). A comparison was made between medications observed in the home and the Medication Profile (MP) dated 1/7/25 provided from the agency prior to the HV. The following medications were in the home, but were not listed on the MP: a. Hydrochlorothiazide 12.5 mg (milligram) take one daily. Filled on 12/8/24. b. Levetiracetam 500 mg take at bedtime. Filled on 12/11/24. c. Protonix 40 mg take one daily. Filled on 12/21/24. An interview conducted on 1/8/25 at 3:39 PM with EI # 1, Director, confirmed the agency staff failed to ensure medications were reconciled and all current medications were included on the MP.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on Medical Record (MR) review, agency policy and procedure, and interviews it was determined the Home Health Agency failed to ensure the staff notified the physician of changes in the patient's condition per agency policy, which included an increase in wound size. This did affect one of 3 Home Visits conducted including (HV) # 2, and had the potential to negatively affect all patients served by the agency. Findings include: Physician Communication Date: October 2013 Policy: It is the policy of this Agency to establish and maintain ongoing communication with the physician or outside entities to ensure safe and appropriate care for the patient. Purpose: To promote ongoing communication between the agency staff, physician, or other designated providers... Procedure: The agency will contact the patient's physician:... b. When there are changes in the patient's condition... 2. All conferences or attempts to communicate with the physician will be documented on the proper form and included in the patient's agency clinical record... HV # 2 was admitted to the agency on 11/30/2023 and recertified for care 11/24/24 to 1/22/24 with a primary diagnosis of Peripheral Vascular Disease. Review of the Home Health Certification and Plan of Care dated 11/24/24 to 1/22/24, revealed: Skilled Nurse (SN) visits one every week for nine weeks. Wound Care Right Heel- Per Visit... assess wound, change daily. Caregiver (CG) to change on days no SN visit. Review of the MR revealed a SN visit dated 11/27/24. The SN documented the wound size of the right (R) heel pressure ulcer (PU) as 2 inches (in) x (by) 2 in. Review of the SN visit note dated 12/4/24 revealed the SN documented the wound size of the R heel PU as 2 in x 2.5 in. There was no documentation the SN notified the physician of the increase in the patient's wound size. Review of the SN visit note dated 12/11/24 revealed the SN documented the wound size of the R heel PU as 2.5 in x 2.5 in. There was no documentation the SN notified the physician of the increase in the patient's wound size. Review of the SN visit note dated 12/17/24 revealed the SN documented the wound size as 2.5 in x 3 in. There was no documentation the SN notified the physician of the increase in the patient's wound size. An interview was conducted on 1/8/24 at 3:24 PM with Employee Identifier # 1, Director, who confirmed there was no documentation the physician was notified of the changes in the patient's condition per agency policy.

Documentation of competency evaluation CFR(s): 484.80(c)(5) The HHA must maintain documentation which demonstrates that the requirements of this standard have been met. This ELEMENT is not met as evidenced by: Based on review of personnel records, job descriptions, agency policy, and interviews, it was determined the agency failed to to ensure annual competencies were performed. This deficient practice did affect Employee Identifier (EI) # 4, Certified Nursing Assistant (CNA), one of two CNA's employed by the agency and had the potential to affect all patients served by the agency. Findings Include: Agency Policy and Procedure: Home Care Competency Updated: January 2018 Policy: The competency of Home Care employees shall be validated on initial employment and annually thereafter. It shall be appropriate to the scope of care provided by the organization based on patient needs, level of care required and applicable laws, regulations and/or certifications. Purpose: To provide documented evidence that home care staff members are competent to perform the skills required and understand the concepts necessary for community health nursing... Review of the employee file of EI # 4, Certified Nursing Assistant it was revealed the last competency skills were performed in 2022. An interview was conducted on 1/8/25 at 3:00 PM with EI # 1, Director, who confirmed the agency failed to assess annual competencies for the CNA in 2023 and 2024.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This ELEMENT is not met as evidenced by: Based on review of Medical Records (MR), agency policy, and interviews with the staff, it was determined the agency failed to complete a supervisory assessment of the Home Health Aide (HHA) services being provided no less frequently than every 14 days. This affected one of two patients receiving HHA services, including Home Visit (HV) # 3, and had the potential to negatively affect all patients receiving HHA services. Findings include: Agency Policy: Home Health Aide Supervision Policy Number: None Listed Revised Date: 01/2023 Purpose: To assure the appropriateness of home health aide services and to maintain quality of care. Policy: ...The registered nurse (RN) will schedule home health aide supervisory visits at least every fourteen (14) days....The RN makes an onsite home supervisory visit to assess relationships and determine whether goals are being met. HV # 3 was admitted to the agency on 2/1/24 and recertified for continued care from 11/27/24 to 1/25/25 with the diagnosis of Epilepsy, Unspecified, not Intractable. Review of the Home Health Certification (HHC) and Plan of Care (POC) for the dates of 11/27/24 to 1/25/25 revealed physician's orders for the Skilled Nurse (SN) to visit one time a week for nine weeks. HHA to visit one time a week for one week, then two times a week for eight weeks. Review of the MR revealed HHA visits for 12/17/24, 12/23/24, 12/27/24, 12/31/24 and 1/3/25 were completed by the HHA. Further review of the MR revealed one SN Supervisory visit was completed on 12/19/24, for the recertification period from 11/27/24 to 1/25/25. There was no documentation of onsite HHA supervisory assessment visits for the recertification period. An interview was conducted on 1/8/25 at 3:39 PM with Employee Identifier # 1, Director, who confirmed the agency failed to complete HHA supervisory assessments every 14 days.

Based on the recertification survey conducted on 10/12/21 to 10/14/21, Bryan W. Whitfield Memorial Hospital Home Health was in substantial compliance with the Emergency Preparedness regulations.

A recertification survey was conducted on 10/12/21 to 10/27/21 and Condition Level deficiencies were cited under: 484.70 Infection prevention and control 484.110 Clinical records

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 observations, agency medication reconciliation requirements, medical record (MR) reviews, patient, and staff interviews, it was determined the agency failed to ensure the medication profile addendum was updated with all current patient medications. This affected HV (Home Visit) # 2, HV # 3, in 2 of 3 HV’s performed and had the potential to affect all patients admitted to the agency. 2. HV # 3 was admitted to the agency on 12/20/19 with diagnoses including Type 2 Diabetes Mellitus without Complications, and Vitamin D Deficiency. A HV was conducted on 10/13/21 at 8:55 AM with EI # 5, Home Health Aide, to observe care provided. During the HV, a review of the medications listed on the Medication Profile provided by the agency prior to the visit, was compared to the medications found in the home with the patient's caregiver (cg). The following discrepancies were observed: a. Lumigan 0.01% ophthalmic (eye) drops, 1 drop at bedtime, was listed on the Medications sheet. The patient's cg stated he/she had stopped using the eye drops about 2 months ago. b. Vitamin D3 50 mcg (micrograms) (2000 units) oral capsule, 1 capsule daily was listed on the Medications sheet. A bottle of Vitamin D 25 mcg OTC (over the counter) was observed in the home. The patient's cg stated he/she had purchased the bottle about 2 months ago. In an interview conducted 10/14/21 at 12:40 PM with EI # 1, it was confirmed the Medication Profile was not updated per policy. Findings include: Agency Document Titled, Interim Record Review-Medication Reconciliation (No Date) …6.0 Medication Reconciliation 6.1 Medication profile addendum completed on admission 6.2 SN (skill nurse) documents at each visit routine meds reviewed/checked for new treatment. 6.3 Medication profile addendum updated as appropriate… 1. A HV was conducted on 10/12/21 at 1:30 PM with EI (Employee Identifier) # 3, Licensed Physical Therapy Assistant (LPTA) for HV # 2. During the HV, a review of the patient’s medications was conducted with assisted living staff (ALF), the patient and EI # 3. The ALF had pre-packaged patient medications confirmed by HV # 2 and included the following: Acetaminophen 500 mg (milligrams) 1-2 tablets (tabs) by mouth every 6 hours as needed (prn) for pain. Date 7/30/21. Natural Relaxant Formula 303 prn do not exceed 12 tabs in 24 hours. Date 7/30/21. Triple Antibiotic ointment apply to right hand incision daily, in use since 10/5/21 following cyst removal. Review of the agency Medication Profile dated 10/12/21 failed to include Acetaminophen, Natural Relaxant Formula, and Triple Antibiotic Ointment. In an interview on 10/14/21 at 12:21 PM, EI # 1, Director, Clinical Manager, confirmed staff failed to ensure the Medication Profile was current and accurate and all medications in use were documented in the medical record.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on medical record (MR) review and staff interview, it was determined the agency failed to ensure staff completed a summary of the care at discharge and submitted the discharge summary documentation to the patient’s physician. This affected MR # 3 in 1 of 2 agency discharge records reviewed and had the potential to affect all patients discharged from the agency. Findings include: 1. MR # 3 was admitted to the agency on 6/9/21 to 8/7/21 with diagnoses including Type 2 Diabetes Mellitus with foot ulcer. Review of the 8/8/21-10/6/21 Home Health Certification and Plan of Care revealed Registered Nurse visits were ordered 3 times a week for 9 weeks for wound care. MR review revealed documentation for a Non-Visit Discharge dated 8/30/21. The discharge disposition documentation revealed the discharge date was 8/30/21 and the patient remained in the community. Written questions submitted to EI (Employee Identifier) # 1, Director, Clinical Manager on 10/13/21 included a request for the completed discharge summary. In an interview on 10/14/21 at 12:47 PM, EI # 1 presented a document titled, “Discharge Summary Report” dated 8/31/21. The documentation revealed MR # 3 was discharged from home health services at this time per her/his request. There was no documentation of the course of care/treatment provided, goals met/not met at discharge and how continued needs were to be met. EI # 1 confirmed no discharge summary was completed and submitted to the patient's physician.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on medical record (MR) reviews and staff interviews, it was determined the agency failed to ensure an individualized Plan of Care (POC) was developed with all required elements to meet the needs of: 1. A patient with PT (Physical Therapy) service orders. 2. A patient with a suprapubic catheter. This affected HV (home visit) # 2 in 1 of 2 records reviewed with PT services and MR # 1 in 1 of 1 record reviewed with a suprapubic catheter and had the potential to affect all patients admitted to the agency. Findings include: 1. HV # 2 was admitted to the agency on 8/13/21 with diagnoses including Valgus deformity, not elsewhere classified, right knee and Essential Hypertension. Review of the Home Health Certification (HHC) and POC dated 8/13/21 to 10/11/21 revealed physician orders effective 8/16/21-8/22/21 for 1 PT visit every week for 1 week. There were no PT interventions, education, goals, rehabilitation potential, and no discharge plans documented on the 8/13/21 HHC/POC. Further record review revealed a PT visit order dated 8/16/21 for PT 2 visits every week for 8 weeks. There were no PT interventions, education, goals, rehabilitation potential, and no discharge plans documented on the 8/16/21 PT visit order. The PT POC failed to include all required elements of an individualized POC. An interview was conducted on 10/14/21 at 12:21 PM with Employee Identifier (EI) # 1, Director, Clinical Manager, who confirmed the PT POC failed to include patient-specific PT interventions, education, measurable outcomes/goals, rehabilitation potential, and discharge plans. 2. MR # 1 was admitted to the agency on 12/28/13 with diagnoses including Benign Prostatic Hyperplasia, Encounter for fitting and adjustment of Urinary Device and Essential Hypertension. Review of the HHC and POC dated 9/17/21 to 11/15/21 revealed physician orders to “perform urinary catheter care as ordered.” There were no physician orders for how the urinary catheter care was to be performed, what antiseptic/ cleaning solution was to be used, the frequency urinary catheter care was to be performed and who was to perform urinary catheter care. In an interview conducted on 10/14/21 at 12:00 PM, EI # 1 confirmed the 9/17/21 POC developed failed to include patient-specific interventions for urinary catheter care.

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 review of medical records (MR), agency policies and procedure, and staff interviews, it was determined the agency failed to ensure the staff: 1. Provided wound care according to physician's orders. 2. Followed the PT (physical therapy) visit frequency orders and notified the physician when visits were missed and not provided per physician orders. 3. Notified the physician when the pulse (heart rate-[HR]), blood pressure (BP) and pain assessment findings were outside physician ordered parameters. This deficient practice affected 2 of 7 records reviewed including MR # 3, Home Visit (HV) # 2, and had the potential to negatively affect all patients serviced by the agency. Findings include: Agency Policy: Subject: Physician Orders Dated: 12/2017 Policy: …Medications and treatments are administered by Agency staff only as ordered by the physician… Procedure: Orders for patient care are obtained from the physician, either verbally or in writing…Faxed signatures are acceptable… Agency Policy: Subject: Missed Visits Updated: 8/2019 Policy: …In the event that a…scheduled visit is missed…visit will be rescheduled….otherwise requested by the patient to omit the visit…The physician will be notified of the missed visit…and a record kept in the patient’s medical chart… 1. MR # 3 was admitted to the agency on 6/9/21 with diagnoses including Type 2 Diabetes Mellitus with foot ulcer. Review of the 6/9/21 to 8/7/21 HHC (Home Health Certification) and Plan of Care (POC) revealed RN (Registered Nurse) visits were ordered 2 visits every week for 9 weeks. MR review revealed a faxed physician order dated 7/26/21 which included the following wound care orders: Patient requests HH (home health) to visit 8/2/21 due to not having a wound care appointment that day. Wound # 2-left (L) foot, second toe, Wound # 3-(L) foot, third toe, and Wound # 4-(L) foot, fourth toe: cleanse wounds with vashe wound cleanser, apply drawtec (dressing) to wound, cut dermafoam and place between all toes (on the) (L) foot and secure with dressing with roll gauze and paper tape. Record review revealed no documentation a HH visit was completed/attempted on 8/2/21 per patient request and no documentation why the 8/2/21 visit was not completed. MR review revealed the 8/3/21 HH Recertification visit completed by the RN revealed documentation the (L) foot second and third toe wounds were cleansed with vashe, foam was cut, medihoney applied to foam, foam was placed between all toes (L) foot, drawtech was applied over wound bed to the (L) foot second toe, folded 4 x (by) 4 (gauze) was placed over the end of toes, then wrapped with kerlix and secured with paper tape. There was no physician order for medihoney application, and no documentation wound care was performed to wound # 4, the fourth toe (L) foot wound. Staff failed follow the 7/26/21 wound care orders. Record review revealed a faxed physician order dated 8/3/21 which included the following wound care orders: Wound # 2-(L) foot, second toe, and Wound # 4-(L) foot, fourth toe: cleanse wounds with vashe wound cleanser, apply promogran prisma ag (silver) to wound bed, cut dermafoam and place between all toes (L) foot and secure with dressing with roll gauze and paper tape. Review of next Nurse Visit dated 8/6/21 revealed the (L) foot second and third toe wounds were cleansed with vashe, foam cut, medihoney applied to foam, a piece (foam) was placed between (L) foot toes, apply (applied) drawtech over wound bed to the (L) second toe, folded 4 x (by) 4 (gauze) placed over ends of toes, wrapped with kerlix and secured with paper tape. Staff failed to follow physician wound care orders dated 8/3/21 and apply promogran prisma ag to the wounds. There was no documentation wound care was provided to wound # 4. In an interview on 10/14/21 at 12:47 PM, EI (Employee Identifier) # 1, Director, Clinical Manager confirmed staff failed to follow physician orders for wound care. 2. HV # 2 was admitted to the agency on 8/13/21 for PT services with diagnoses including Valgus deformity, not elsewhere classified, right knee and Essential Hypertension. Review of the HHC and POC dated 8/13/21 to 10/11/21 revealed physician notification orders which included, monitor and report pain level (0-10 with 10 being the worst ) 8/10 pain, BP > (greater than) 170/100, and HR 8/10. Review of the PT visit dated 10/7/21 revealed the sitting BP was 171/81 pre-exercise. There was no documentation the BP was re-assessed and within an acceptable range during the PT visit. There was no documentation the physician was notified the BP was greater than 170. In an interview conducted on 10/14/21 at 12:21 PM, EI # 1 presented electronic record scheduling documentation for PT visits not provided due to COVID (coronavirus)-19 exposure/illness at the patient's residence. EI # 1 confirmed staff failed to document the physician was notified when PT visits were not performed as ordered and when the pulse, BP, and pain were outside ordered parameters.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on staff interviews, medical record (MR) and agency policy and procedure review, it was determined the agency failed to ensure PT (physical therapy) services were coordinated and delivered to meet patient needs. This affected HV( home visit) # 2, in 1 of 2 record reviews with PT services ordered and had the potential to affect all patients who required HH (home health) PT. Findings include: Agency Policy: Reference # (number) 10026 (No Effective/Revised Date documented) Policy: This organization shall coordinate its care and/or services with all...patient's physicians involved in the plan of care (POC) when...services supplied is under the order of the physician. Procedure: ...The organization shall communicate with the patient's physician(s) when: ...A delay is anticipated in initiating prescribed care or services to the patient ...There is any significant information concerning the patient's care or services During the entrance conference interview on 10/12/21 at 10:10 AM, EI (Employee Identifier) # 1, Director, Clinical Manager, reported the hospital PT’s are available for HH agency visits 2 times a week and the HH agency also has a PT on contract. EI # 1 reported when a PT referral is made, PT evaluations were usually conducted in 2-3 days. 1. HV # 2 was admitted to the agency on 8/13/21 with diagnoses including Valgus deformity, not elsewhere classified, right knee and Essential Hypertension. MR review revealed faxed documentation following an 8/10/21 physician office visit that included a physician's order dated 8/11/21 to “…evaluate for PT, HX CVA (history of cerebrovascular vascular accident).“ There were no additional orders for care included. Record review revealed the Registered Nurse (RN) completed a Nursing Admission Visit on 8/13/21. Further record review revealed the PT completed a HH PT Admission Visit on 8/17/21, which was 6 days after the PT evaluation order was received. There was no MR documentation why there was a 6 day delay in PT service initiation. Written questions were submitted on 10/12/21 regarding the reason for the delay in PT services and on 10/14/21 at 8:30 AM, the surveyor requested the agency policy for the timeframe from referral to PT evaluation completion. In an interview on 10/14/21 at 12:21 PM, EI # 1 reported the RN goes in the home, admits the patient to the HH care then PT services were scheduled. EI # 1 confirmed there was no documentation coordination of care was performed, the physician and the patient were notified and agreeable to the 6 day delay in PT services following the physician PT referral. No policy for PT evaluation completion was provided.

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 agency policy, observation and interview, it was determined the agency failed to ensure the staff followed their own policy for COVID-19 screening and had an ongoing Infection Prevention and Control program. This had the potential to negatively affect all patients who were admitted to this home health agency. Refer to G682 and G684 for individual findings.

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 observations during HV (home visits), review of agency policies, the Mosby’s Manual of Home Health (HH) Nursing Procedures, medical record (MR) reviews and staff interviews, it was determined the agency failed to ensure staff followed agency infection control (IC) policies and procedures and accepted IC practice standards and: 1. Conducted COVID (coronavirus)-19 screenings prior to all HV’s. 2. Notified the physician and agency staff after a patient reported testing positive for COVID-19. 3. Performed and documented suprapubic catheter changes and catheter care per agency policy and procedure and standards of IC practice. 4. Performed hand hygiene per policy. This affected 3 of 3 HV’s conducted and 1 of 1 record reviews with a urinary catheter which included HV # 2, MR # 1, HV # 3, and HV # 1. # 4. HV # 1 was admitted to the agency on 9/29/21 with diagnosis including Cutaneous Abscess of Groin and Local Infection of the Skin and Subcutaneous Tissue, Unspecified. A HV was conducted on 10/12/21 at 3:20 PM with EI # 6, Registered Nurse, to observe care provided. During the visit, the surveyor observed EI # 6 perform hand hygiene, don gloves, remove soiled dressing and packing from wound bed and without performing hand hygiene or changing gloves, applied lidocaine to the wound bed with a Q-tip, measured the wound and opened clean supplies. Prior to the end of the visit, the surveyor asked the patient if anyone from the home health agency had contacted him/her prior to the nurse visit to perform a Covid-19 screening. The patient stated no one from the agency had called to perform a Covid screening. In an interview conducted 10/14/21 at 12:00 PM, EI # 1 confirmed the nurse did not perform hand hygiene per policy and there was no documentation of a Covid Screening prior to the visit. 3. HV # 3 was admitted to the agency on 12/20/19 with diagnoses including Type 2 Diabetes Mellitus without Complications, and Vitamin D Deficiency. A HV was conducted on 10/13/21 at 8:55 AM with EI # 5, Home Health Aide, to observe care provided. During the visit, the patient's caregiver was asked if anyone from the home health agency had contacted him/her prior to the aide visit to perform a Covid-19 screening. The caregiver stated no one from the agency had called to perform Covid screening. In an interview conducted 10/14/21 at 1:07 PM, EI # 1 confirmed there was no documentation of Covid Screening prior to the visit. Findings include: Agency Policy: Updated: 4/27/2020 Subject: Coronavirus (COVID-19) Screening Questions In order to protect staff and patients, WRH (Whitfield Regional Hospital) HH will ask the following questions to screen for the novel coronavirus…These questions will be asked over the phone before visiting the patient. If there is no answer on the phone…the same questions are to be asked before entering the home… 1. Have you or anyone in your household traveled to or been on close contact with anyone who has traveled to…China…in the past 14 days? 2. Have you or anyone in the household experienced a fever, cough, shortness of breath, chills,…shaking with chills, muscle pain, headache, sore throat new loss of taste or smell over the last 14 days? 3. Have you or anyone in the household been around or exposed to anyone exhibiting the above-named signs and symptoms in the last 14 days? If the patient answers no…Provide care…. If the patient answers yes to any of the above questions…. 1. Do not provide care...leave the home. 2. Contact the patient's primary care physician for further orders... Agency Policy: Date: March 13, 2020 ...Guidance for Infection Control and Prevention Related to COVID-19. For ill patients, the home health agency must...place a mask over the patient's nose...mouth if not already done. Staff must inform the agency clinical manager (CM) about the presence of a person investigation...for COVID-19. The CM will inform...Hospital Quality Control Director who will...notify...state public health authorities as per protocol. Agency Policy: Section: 5-14_RN (Registered Nurse) No Date documented Subject: Genitourinary: Re-insertion of Suprapubic Catheter ...Equipment: Catheter insertion tray: Sterile gloves Prepping balls Antimicrobial solution …Sterile lubricating jelly …Normal saline, sterile water or prescribed… Procedure: 1. Adhere to Universal Precautions. …5. Remove present dressing, assessing skin, and note any drainage or odor. 6. Cleanse around cystoscopy opening…using normal saline, sterile water, or any prescribed solutions. 8. Prepare catheter tray…Remove gloves. Don sterile gloves. 10. Cleanse suprapubic opening…using at least 3 prepping balls… After Care: 1. Document in…patient’s record: a. Procedure and observations b. Catheter size and balloon size… Mosby’s Manual of Home Health Nursing Procedures Second Edith Part 1, Chapter (CH) 1 Infection Control (IC) Procedures pages (pg.) 5-7 ...Gloves …Sterile disposable nonlatex gloves are to be worn using certain clinical procedures that require sterile technique (e.g. [example is] during…inserting a urinary catheter)… Documentation Guidelines Document…on the visit report… Implementation of Standard Precautions… Part III Medical-Surgical Care pgs. 294-295 Suprapubic Catheter Care General Information The suprapubic catheter is inserted into the bladder through a permanent opening in the abdominal wall…surgically created to provide an alternate path for urine flow from the bladder. Catheter Change Equipment 1. Sterile catheter... 2. Sterile catheter tray 6. Soap and warm water… 7. Disposable nonsterile and sterile gloves…(see IC) Procedure …8. Gently and slowly remove the catheter... 9. Gently wash the peristomal area with soap and water…Rinse and pat dry. 10. Inspect the stoma site for redness or drainage… 12. Open the catheter using a sterile technique. 13. Open the sterile wrap…provide a sterile field. 14. Don sterile gloves. …17. Pour antiseptic solution over cotton balls. 18. Use forceps…pick up cotton balls…cleanse the stoma and surrounding area…on ball per wipe... 19…gently insert the catheter into the stoma… 20. Inflate the bulb of the catheter with 5 to 10 ml of sterile normal saline or water… Documentation Guidelines Document the following on the visit report: The procedure...patient toleration...Catheter size…Condition of the stoma site... Implementation of Standard Precautions… 1. Record review revealed HV # 2 was admitted to the agency on 8/13/21 by the RN with diagnoses including Valgus deformity, not elsewhere classified, right knee and Essential Hypertension. Review of the physician orders effective the week of 8/16/21 revealed PT visits 2 every week for 8 weeks were ordered, however, there were no PT visit documentation completed the week of 9/6/21-9/12/21. Written questions were submitted on 10/12/21 for PT visit documentation for the week of 9/6/21. In an interview on 10/14/21 at 12:21 PM, EI (Employee Identifier) # 1, Director, Clinical Manager, verified the staff failed to follow the agency COVID-19 screening policy and perform a COVID-19 screening prior to the 10/12/21 HV. In addition, EI # 1 reported the week of 9/6/21 the ALF was not allowing visitors due to COVID cases and 2 PT visits were missed. At 1:38 PM, during review of the electronic record scheduling documentation for missed visits, EI # 1 reported the LPTA (Licensed Physical Therapy Assistant) documented on 9/7/21 a PT missed visit, reason was ALF COVID-19 exposure and on 9/9/21 documented a missed PT visit, the patient tested positive COVID-19. EI # 1 reported to the surveyor she/he was not notified the HH patient was COVID-19 positive. EI # 1 confirmed there was no documentation agency staff notified the patient’s primary care physician of the positive COVID-19 results per the agency COVID-19 policy. On 10/15/21 at 10:38 AM in a phone interview, EI # 3, LPTA reported he/she notified HH nursing staff and the Registered PT that HV # 2 tested positive for COVID-19. EI # 3 confirmed this was no documented in the MR and there was no documentation the patient's physician was notified. On 10/14/21 at 1:30 PM, a HV was conducted with EI # 3, (LPTA) for HV # 2. In an interview on 10/14/21 at 1:33 PM outside the patient's residence, an assisted living facility (ALF), the surveyor greeted EI # 3 and explained the HV purpose. The surveyor asked EI # 3 if he/she had conducted COVID screening over the phone before arrival? EI # 3 reported he/she had not conducted a COVID phone screening. EI # 3 reported the RN (Registered Nurse) conducted a COVID screening on the initial visit (8/13/21). Upon entering the ALF lobby, EI # 3 and the surveyor were greeted by ALF staff who provided instructions for temperature checks and completion of the facility COVID screening documentation. EI # 3 did not ask the ALF staff if there were persons under investigation or COVID-19 positive patients at the ALF and no COVID-19 screening was conducted. Next, EI # 3 entered HV # 2’s room, introduced the surveyor and explained the visit purpose to the patient. EI # 3 failed to conduct COVID-19 screening before entering the patient’s room and performing the HV. 2. MR # 1 was admitted to the agency on 12/28/13 and recertified for continued care on 9/13/21 for the HHC (Home Health Certification) and POC (Plan of Care) period 9/17/21 to 11/15/21. Review of 9/17/21 HHC and POC included diagnoses of Benign Prostatic Hyperplasia, Encounter for fitting and adjustment of Urinary Device and Essential Hypertension with physician orders for urinary suprapubic catheter change every 3 weeks and PRN (as needed) and perform urinary catheter care as ordered. Record review revealed a nurse visit dated 9/17/21 with documentation, the 16 French (FR) suprapubic catheter was obstructed, and not draining. The nurse documented, cleaned (stoma) using betadine, and completed a urinary catheter change using a 16 fr 5 ml (millimeter) balloon size, suprapubic catheter change(d) with no complications, patient tolerated (procedure) well. There was no documentation what IC precautions, if any, was taken during the procedure and the condition of the stoma site was not documented. MR review revealed a nurse visit dated 10/4/21 and the nurse documented, change(d) 16 fr suprapubic catheter every 3 weeks and PRN, no complications, patient tolerated well. There was no documentation what IC precautions, if any, was taken during the procedure. The condition of the stoma site and the catheter bulb balloon size was not documented. In an interview conducted 10/14/21 at 12:00 PM, EI # 1 confirmed staff failed to follow the agency policy and accepted IC practice standards for care of a suprapubic catheter.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on policy and procedure review and staff interviews, it was determined the agency failed to identify, track and trend infections for staff and patients. This deficient practice had the potential to effect all staff and all patients served by the agency. Agency Policy: Infection Control Plan Policy Reviewed Date: March 2021 Purpose: The infection Control Surveillance, Prevention and Control Program is a plan of action designed to identify infections that occur in patients and staff that have the potential for disease transmission, and recommend risk reduction practices by integrating principles of infection control into all direct and indirect standards of practice.... Procedure: A. Program Values...The infection Control Program ...address the integrated facets of surveillance (observation, monitoring and evaluation);...These include activities related to: a. Identifying, managing, reporting and following up on persons with reportable and/or transmissible diseases. b. Identifying specific infections in patients that are present on admission or that occur after admission, and infections in staff that are present on employment or that occur as a result of exposure. c. Managing risk (perceived or real), and complying with mandates listed under the umbrella of infection control by licensing and accrediting agencies. d. Measuring and monitoring program effectiveness and, when indicated, expanding activities associated with health and safety and quality improvement. 1. Review of the agency Infection Control Program revealed no documentation of tracking patients for confirmed or PUI (Persons Under Investigation) COVID-19 infections, and no documentation of tracking staff for confirmed or PUI COVID-19 infections. Further review of the infection control program and interview with EI (Employee Identifier) # 1, Director, Clinical Manager for the agency revealed that data on COVID-19 infections is not collected and used as a basis to improve and prevent infectious disease transmission. An interview conducted on 10/13/21 at 3:00 PM with EI # 1, Director, Clinical Manager confirmed the agency had at least 2 known employees who had performed work in the agency with confirmed COVID-19 infections along with an unknown number of patients with confirmed COVID-19 infections, but no documentation of tracking and trending of COVID-19 infections for patients and staff to improve and prevent infectious disease transmission.

Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA's policies and procedures. This STANDARD is not met as evidenced by: Based on personnel record documentation, agency policy and procedure, medical record (MR) review, and staff interview, it was determined the agency failed to ensure the: 1. Nurse was deemed competent by the ABON (Alabama Board of Nursing) approved standardized procedure for PICC (Peripherally Inserted Central Catheter) line removal. 2. Nurse competency documentation was complete and accurate for RN (Registered Nurse) skills validation. This affected 3 of 3 RN personnel records reviewed which included 1 of 1 RN who performed PICC removal for MR # 2 for 1of 1 record reviews with a PICC. This had the potential to negatively affect all patients serviced by this agency who received intravenous access therapies. Findings include: Agency Policy: Updated: August 2019 Subject: Home Care Competency Policy: The competence of Home Care employees shall be validated on initial employment and annually thereafter. It shall be appropriate to the scope of care provided by the organization based on patient needs, level of are required and applicable laws. Regulations, and/or certifications. Purpose: To provide documented evidence that home care staff members are competent to perform the skills required and understand the concepts necessary for community health nursing. …Validation of performance may be in the form of written exam, return demonstration, self-learning module, or direct observation of practice skills. Agency Manager or …designee will verify…the competency status of the employee is current, and documentation of satisfactory performance is noted on the required documents… Documentation: …Orientation Checklist Skills Record Home Care Orientation and checklist 1. MR # 2 was admitted to the agency on 9/2/2020 with diagnosis including Osteomyelitis, Unspecified. Review of Physician Orders dated 8/6/21 revealed orders for SN (Skilled Nurse) to discontinue the PICC line due to completion of antibiotic therapy. Review of the Nursing Regular Visit note by EI (Employee Identifier) # 4, RN, dated 8/9/21 revealed PICC line discontinued with catheter intact. Review of the agency Standardized Procedure Application dated 12/15/2016, submitted by the hospital to the Alabama Board of Nursing revealed required validation of PICC Line Removal by an RN who has completed an ABN (Alabama Board of Nursing) approved provider in-service on Central Venous Access Devices with PICC line removal. Review of EI # 4's personnel record revealed no competency validation documented for removal of a PICC line. An interview conducted on 10/14/21 at 12:00 PM with EI # 1 confirmed EI # 4 did not complete a competency validation for PICC line removal prior to performing a PICC line removal in the home. On 10/14/21 at 10:45 AM, review of 3 personnel records for RN's, EI (Employee Identifier) # 1, Director, Clinical Manager, EI # 4, RN and EI# 6, RN all included a document titled, Skills Competency Form. 2. Review of EI # 1 personnel record revealed the date of hire (DOH) was 5/15/03. EI # 1's Skills Competency Form revealed a self-competency rating, “feel comfortable doing” and “competency met” documented in all 7 evaluation areas. There was no documentation of the method of skills validation, whether by direct observation of practice skills, return demonstration, or self-learning module. EI # 1 signed and dated the Skills Competency Form 11/30/2020. There was no date the skills were evaluated and no preceptor initials/date documented on the Skills Competency Form. 3. Review of EI # 4, RN personnel record documentation revealed DOH was 3/27/12 and EI # 6, RN, DOH was 11/21/08. EI # 4 and EI # 6’s Skills Competency Form revealed a self-competency rating, “feel comfortable doing” and “competency met” documented in all 7 evaluation areas. There was no documentation of the method of skills validation, whether a direct observation of practice skills, return demonstration, or self-learning module. The preceptor initials/date 11/19/2020 and 11/20/2020 were documented at the top of each page and a line was drawn from the top of each page to the bottom. There was no date documented for validation of the required skills for EI # 4 and EI # 6. 4. In addition, the HH agency RN competency validation failed to include a clinical skills evaluation/validation for a PICC. In an interview on 10/14/21 at 11:53 AM, EI # 1 stated the date(s) entered on competency form was the date “I filled out the form” and not the date the evaluator determined the RN competent in the specific skill/task. EI # 1 reported the agency provides care to patients who require infusion services including care of PICC line. EI # 1 confirmed PICC removal in the home was not part of the agencies current program competency, the agency competency validation documentation was not accurate, complete, and inclusive for the scope of care provided at the agency including removal of a PICC.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on review of agency policies, medical records (MR), and staff interviews, it was determined the staff failed to follow the agency policies and: 1. Perform and document case management review of all patients no less than every 60 days per agency policy. 2. Perform and document wound assessments every visit and wound measurements at least weekly per agency policy. This affected 2 of 7 records reviewed which included HV (home visit) # 2 and MR # 1 and had the potential to affect all patients admitted to the agency. Findings include: Agency Policy: Case Conference Updated: August 2019 Subject: Case Conference A…in order to promote open communication, Case Conference will be conducted on all active patients no less than 60 days…whenever problems arise. B. The RN (Registered Nurse) responsible for the patient will complete the case conference form indicating goals met…current problems and further needs… C. Each patient’s care management will be discussed… D. All disciplines…involved in care…attend…provide information… Agency Policy: Subject: Wound Assessment Date: October 1992 Wound Assessment Purpose: To provide guidelines for wound assessment…to accurately…consistently document wound characteristics. …Wounds…assessed with each dressing change. Measurements in centimeters of width, length, depth (full thickness or partial thickness)…documented at least weekly. Wound assessments…include location, measurement, shape, color of wound bed, base of necrotic tissue, exudate (amount), skin color surroundings wound…tissue edema, tissue induration, odor (description), presence of granulation tissue. Measure wound head to toe… Documentation: Document date and time of assessment and any wound care performed. Documentation of the assessment should include location, measurements (weekly), shape, and color of wound base, necrotic tissue, any exudate, tissue edema, presence of granulation or epithelization, odor, and any other pertinent information… 1. HV # 2 was admitted to the agency on 8/13/21 with diagnoses including Valgus deformity, not elsewhere classified, right knee and Essential Hypertension. Record review revealed a Home Health Certification (HHC) and Plan of Care (POC) dated 8/13/21-10/11/21 with nurse orders 8/12/21-8/15/21 for 1 visit every week for 1 week, and PT (Physical Therapy) orders effective 8/16/21-8/22/21 for 1 (PT visit) every week for 1 week. MR review revealed the PT Admission visit was completed on 8/17/21 with PT visit orders for 2 visits every week for 8 weeks. Further record review revealed a HH (Home Health) Recertification Visit dated 10/8/21 completed by the nurse. There were no plans for continued nurse care documented. In addition, the MR included a PT order dated 10/12/21 for 2 PT visits every week for 9 weeks. There was no case management documentation and no evidence of team member communication documented for this active patient with continued care needs. Further review revealed the Revised HHC and POC dated 10/12/21-12/10/21 for PT visits 2 every week for 9 weeks. On 10/13/21 which was day 61, the surveyor requested documentation for the case conference/interdisciplinary communication completed by disciplines involved in the patient care. In an interview conducted on 10/14/21 at 12:21 PM, EI (Employee Identifier) # 1, Director, Clinical Manager confirmed no case management documentation was completed. 2. MR # 1 was admitted to the agency on 12/28/13 and recertified for continued care on 9/13/21 for the period dated 9/17/21 to 11/15/21. There was no documentation staff conducted case management for this active patient at least every 60 days prior to 9/17/21 and reviewed goals met/unmet, current problems and continued care needs. Review of HHC and POC dated 9/17/21-11/15/21 included diagnoses of Benign Prostatic Hyperplasia, Encounter for fitting and adjustment of Urinary Device and Essential Hypertension with physician orders for nurse visits 1 time a week for 9 weeks and wound care to the right (R) leg with wound cleanser, xeroform dressing, 4 x (by) 4 gauze wrap, kerlix gauze and tape ordered every nurse visit. Record review revealed weekly nurse visits dated 9/20/21 and 9/27/21. The dressing condition was intact/dry, and no drainage was documented. There was no wound site assessment documentation of the wound shape, wound bed color, presence/absence of necrotic tissue, skin color surrounding the wound, tissue edema, tissue induration, odor, and the presence of granulation tissue documented. MR reviewed revealed the 10/4/21 and 10/11/21 weekly nurse visit documentation included right lower leg wound measurements and on 10/4/21, the nurse documented exudate was “none”. However, the nurse described exudate as “serosanguinous”. There was no wound site assessment documentation of the wound shape, the wound bed color, presence/absence of necrotic tissue, skin color surrounding the wound, tissue edema, tissue induration, odor, and the presence of granulation tissue documented on the nurse visits dated 10/4/21 and 10/11/21. Staff failed follow the wound assessment policy, perform, and document wound assessments. On 10/13/21 the surveyor submitted a written request for the most current case conference and wound assessment documentation. In an interview conducted 10/14/21 at 12:00 PM, EI # 1 confirmed staff failed to follow the agency case conference and wound assessment policy.

Documentation of competency evaluation CFR(s): 484.80(c)(5) The HHA must maintain documentation which demonstrates that the requirements of this standard have been met. This ELEMENT is not met as evidenced by: Based on agency policy and procedure, personnel record review, and staff interview, it was determined the agency failed to ensure HHA (Home Health Aide) competency evaluation documentation was complete, and accurate for HHA skills validation. This affected 1 of 1 HHA personnel records reviewed and had the potential to affect all patients with HHA services. Findings include: Agency Policy: Updated: August 2019 Subject: Annual HHA Competency Evaluation …Policy The agency ensures…all HHA’s remain competent relative to knowledge and performance in all areas where their skills/tasks are required to provide care in the …patient’s home. Procedure Each HHA receives an on-site skill assessment in a…patient’s home conducted by a registered nurse (RN)…and skills demonstration must include a minimum of…Bed bath, sponge, tub, or shower bath…shampoo…nail and skin care…oral hygiene…toileting and elimination…safe transfer technique and ambulation… A written competency evaluation may be administered by a RN annually as…necessary… 1. On 10/14/21 at 10:45 AM, review of 1 of 1 agency HHA personnel records included EI (Employee Identifier) # 5, HHA, date of hire 5/8/01. EI # 5's personnel record documentation included handwashing, bag and aseptic competency validated completed by observation. In addition, there was a document titled, Skills Competency Form: HHA included in the personnel record. Review of EI # 5'sHHA Skills Competency Form revealed a self-competency rating, “feel comfortable doing” and “competency met” documented in the 7 evaluation areas. There was no method of skills validation and the date the skills were validated was not documented. The preceptor initials and the date 11/20/2020 was documented at the top of each page and a line was drawn from the top of each page to the bottom. There was no date documented that the skills were evaluated and competency validated. There was no documentation the skills competency were validated by an observation of care. In an interview on 10/14/21 at 11:53 AM, EI # 1, Director, Clinical Manager reported 11/20/2020 was the date “I filled out the form ", and there was no documentation HHA skill competency was evaluated by observation. EI # 1 confirmed the HHA Skills Competency Form and the competency skills documentation was not accurate and complete.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on review of the medical record (MR), policy and procedure, and interview with staff it was determined the Home Health Aide (HHA) failed to follow the Plan of Care prepared by the Registered Nurse (RN) for 1 of 2 active records reviewed with aide services. This affected Home Visit (HV) # 3 and had the potential to negatively affect all patients served by the agency. Findings include: Agency Policy: Plan of Care Policy Number: None Updated: 8/2019 Policy: ...1. A written Plan of Treatment (485) that conforms with the physician's orders will be developed for each home care patient and will include, but not limited to, the following: ...E. Types and frequency of services to be provided... ...5. Each patient is reassessed by a skilled nurse as per the plan of treatment... ...D. A review of the HHA Plan of Care (POC) as indicated... ...F. The HHA is responsible for notifying the RN responsible for the patient's care of any changes, abnormal VS (vital signs), and/or pertinent information related to the patient as well as the proper documentation to include the name and title of person notified, with the date and time. 1. HV # 3 was admitted to the agency on 12/20/19 with diagnoses including Type 2 Diabetes Mellitus without Complications, and Vitamin D Deficiency. Review of the Home Health Certification and Plan of Care dated 8/11/21 to 10/9/21 revealed orders including HHA frequency: 1 every Week for 1 Week, 2 every Week for 8 Weeks. Review of the Aide Assignment Sheet (no date) revealed assigned tasks from the skilled nurse (SN) including Shampoo, Oral Care, and Denture Care to be performed each visit. Review of the Aide Regular Visit Notes dated 8/11/21 to 10/13/21 revealed the HHA documented, "Refused Shampoo" on 14 of 18 visits, "Refused Oral Care" on 4 of 18 visits, "Refused Denture Care" on 9 of 18 visits. There was no documentation the HHA notified the RN of tasks not completed. In an interview conducted 10/14/21 at 12:40 PM with Employee Identifier (EI) # 1, Director/Clinical Manager, EI # 1 confirmed there was no documentation the SN was notified of assigned tasks not completed, and should have been.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on review of agency policy, observation and interview, it was determined the agency failed to protect the medical records, protect authenticated documents, and document assessments. This had the potential to negatively affect all patients who were admitted to this agency. Refer to G1010 and G1028 for individual findings.

Contents of clinical record CFR(s): 484.110(a) Standard: Contents of clinical record. The record must include: This STANDARD is not met as evidenced by: Based on agency policy, medical record (MR) reviews, and staff interviews, it was determined the agency failed to ensure staff followed the agency pain management policy, performed pain assessments/re-assessments, and documented the assessment findings in the MR. This affected MR # 1, HV (Home Visit) # 2, MR # 2 in 3 of 7 MR reviews and had the potential to affect all patients admitted to the agency. 3. MR # 2 was admitted to the agency on 9/20/2020 with diagnosis including Osteomyelitis, Unspecified. Review of the Home Health Certification and Plan of Care dated 8/28/21 to 10/26/21 revealed SN to monitor and report abnormal VS to MD (Medical Doctor) such as Pain level (0-10 with 10 being the worst) 8/10 (8 out of 10). Review of the Nursing Regular Visit notes dated 8/31/21, 9/13/21, 9/27/21 and 10/12/21 revealed no pain assessment completed by the nurse. Review of the HH LPTA (Home Health Licensed Physical Therapy Assistant) Regular Visit note dated 9/16/21 revealed the "Patient reports pain in left shoulder and all over 8/10 (8 out of 10 on a scale of 1 to 10). Further review of the HHLPTA Visit note revealed no documentation the pain was reported to the nurse and/or physician. An interview conducted on 10/14/21 at 12:00 PM with EI # 1 confirmed there was no documentation the nurse assessed the patients pain on visits dated 8/31/21, 9/13/21, 9/27/21 and 10/12/21 and there was no documentation the LPTA reported the patient's pain level of 8/10 on 9/16/21. Findings include: Agency Policy: Subject: Pain Management Date: October 2013 Purpose: It is the policy…to respect and support the patient’s…right to optimal pain assessment and management. Patients will be assessed at the time of admission and on every visit thereafter. Should the patient complain, or exhibit signs…of pain, that are not being controlled by…the currently prescribed medication, the physician will be notified for his/her awareness and/or the patient will be advised to see the MD (medical doctor) for further evaluation. Pain Assessment …It is the responsibility of the nurse and physical therapist…assistant to reassess the patient for pain on each home visit…Each site of pain…assessed and documented separately…Pain Scales…will be assessed using a pain scale 0 to 5…0 being the least pain and 5 being the worst pain… 1. MR # 1 was admitted to the agency on 12/28/13, recertified for continued care on 9/13/21 for the HHC (Home Health Certification) and POC (Plan of Care) period 9/17/21 to 11/15/21 with diagnoses including Benign Prostatic Hyperplasia, Encounter for fitting and adjustment of Urinary Device and Essential Hypertension. Review of the 9/13/21 HHC/POC effective 9/17/21-11/15/21 included physician orders for the SN (skill nurse) to monitor and report abnormal VS (vital signs) and pain level (0-10 with 10 being the worst) 8/10. Review of the Nurse Visits dated 9/17/21, 9/20/21, 9/27/21, 10/4/21 and 10/11/21 failed to reveal the SN completed pain assessments and documented the pain assessment findings. In an interview conducted 10/14/21 at 12:00 PM, EI (Employee Identifier) # 1, Director, Clinical Manager confirmed there was no documentation staff performed pain assessments and documented pain assessment findings in the patient’s record. 2. HV # 2 was admitted to the agency on 8/13/21 with diagnoses including Valgus deformity, not elsewhere classified, right knee and Essential Hypertension. Record review revealed a HHC and POC dated 8/13/21-10/11/21 and Health Management Orders which included physician notification effective 8/13/21-10/11/21, report pain level (1-10 with 10 being the worst) 8/10. Review of the 8/13/21 Nursing Admission Visit revealed HV # 2 experienced pain which interfered with activity and occurred less often than daily. The pain assessment documentation failed to include a pain site and there was no pain scale assessment documented. Review of the LPTA (Licensed Physical Therapy Assistant) Visit documentation dated 9/16/21 revealed the patient was experiencing right (R) shoulder pain but there was no pain scale assessment documented. MR review revealed a LPTA Visit dated 9/21/21 with pain assessment documentation that the patient began to complain of increased (R) knee pain. There was no pain scale rating documented. Further review of the 9/21/21 LPTA pain assessment documentation revealed pain in the shoulder was 10/10 and using OTC (over the counter) RX (prescription) to manage pain. There was no documentation the pain assessment greater than 8/10 was re-assessed and found to be less than 8 during the visit. There was no documentation the physician was notified and/or the patient advised to see the MD for further evaluation per the agency pain assessment policy. Review of the LPTA Visits dated 9/28/21 and 9/30/21 revealed the patient reported (R) right upper and lower extremity pain, but no pain scale assessment was documented. MR review revealed a Nurse Visit dated 9/30/21 and no pain assessment was documented. Record review revealed a Physical Therapy Re-assessment Visit conducted on 10/7/21 and there was no pain assessment documentation. Review of the 10/8/21 Nurse Recertification Visit revealed HV # 2 experienced pain which interfered with activity and occurred less often than daily. The pain assessment failed to include the site of the pain and no pain scale assessment was documented. In an interview on 10/14/21 at 12:21 PM, EI # 1 confirmed staff failed to perform and document pain assessment findings per the agency pain management policy.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on review of medical records (MR), observation of agency medical record storage area, review of agency policies and procedures and staff interviews, it was determined the agency failed to ensure: 1. Medical records were secure from unauthorized use. 2. Authenticated documents were corrected with an addendum per policy. This deficient practice did affect MR # 4 and Home Visit (HV) # 1 and had the potential to affect all patient's medical records stored in the medical records storage area. Agency Policy: Privacy and Confidentiality of information Policy Number: 6005 Policy Revised Date: (Not Dated) Policy: ...Home Health Agency (HHA) operates in accordance with the HIPAA (Health Insurance Portability and Accountability Act) Privacy Rule of 1996. Confidentiality of data and information within the HHA (Home Health Agency) applies across all systems... as well as to clinical/service... All patients' personal health information...is considered confidential and will be disclosed at the direction of Administration only when authorized to do so by the patient necessary to carry out the day to day business activities.... Home care medical records,...shall be protected from loss, alteration, unauthorized use or damage and stored in a locked, secure location.... Information regarding patients shall not be displayed in areas that are available to the public and/or unauthorized staff. Safeguarding of Records: ...Records should not be left in unattended areas accessible to unauthorized individuals. Agency Policy: Confidentiality of the Medical Record Policy Number: 6007 Policy Revised Date: (Not Dated) Policy: ...The medical records are stored in a locked file away from public access. Lists of patients and patient information must be sequestered and protected from the view of those not involved in care. Agency Policy: Electronic Medical Record Addendum Policy Date: January 2018 Policy: Addendum: New documentation used to add information to an original entry. Addenda shall include the current date and reason for the additional information being added to the medical record. Example of documentation errors that are corrected by addendum include, but not limeted to, wrong date, ...incomplete documents or other errors.... Once a document has been signed (authenticated), the only way to correct or revise the documentation is to provide an addendum. Procedure: The following information must be documented by the provider when completing an addendum to the medical record: Patient name Date of service Medical Record Number Original report the addendum is to be attached to Date and time of the addendum Reason for the additional information being added Authentication by the provider 1. A tour of the agency was conducted on 10/14/21 at 10:00 AM to observe the medical record storage room. The medical records room was observed down a hallway and located in an area of the building leased by another company which was separate from the agency. The door to the medical records room was left unlocked and unattended by agency staff and not safeguarded against loss or unauthorized use. An interview conducted on 10/14/21 at 10:00 AM with EI # 1 confirmed the medical records room was left unlocked and unobserved by the agency staff in an area leased by another company and not safeguarded against loss or unauthorized use. 2. MR # 4 was admitted to the agency on 7/3/21 with diagnosis including Chronic Kidney Disease, Stage 4 (Severe) and Hyperkalemia. Review of the Admission Service Agreement for Home Health form presented to the surveyor for review on 10/12/21 was undated by the patient representative and undated and unsigned by the nurse. During an interview conducted on 10/14/21, with EI # 1, Director, Clinical Manager, the surveyor was presented with another Admission Service Agreement for Home Health form which was dated 7/3/21 next to the patient representative's signature and signed and dated 7/3/21 by EI (Employee Identifier) # 6 RN (Registered Nurse). Further review of the clinical record and Admission Service Agreement for Home Health form revealed the clinical record contained only one Admission Service Agreement for Home Health form which was now signed and dated the day of admission. An interview conducted on 10/14/21 at 12:00 PM with EI # 6 confirmed the Admission Service Agreement for Home Health form was altered on 10/13/21 to add the date of 7/3/21 next to the patient representative's signature, EI# 6's signature as admitting clinician and the date of 7/3/21 next to EI # 6's signature. Further interview with EI # 1, Director, Clinical Manager confirmed the form was not completed correctly on admission and was altered after admission and should not have been. 3. HV # 1 was admitted to the agency on 9/29/21 with diagnosis including Cutaneous Abscess of Groin and Local Infection of the Skin and Subcutaneous Tissue, Unspecified. Review of the Admission Service Agreement for Home Health form presented to the surveyor for review on 10/12/21 was not dated by the patient representative and incorrectly dated 9/2 by the admitting clinician. During an interview conducted on 10/14/21 at 12 PM, with EI # 1, Director, Clinical Manager, the surveyor was presented with another Admission Service Agreement for Home Health form which was now dated 9/29/21 next to the patient representative's signature and the date was entered to include the correct day and year by EI # 6's signature as admitting Clinician on the form. Further review of the clinical record and Admission Service Agreement for Home Health form revealed the clinical record contained only one Admission Service Agreement for Home Health form which was now dated the day of admission. An interview conducted on 10/14/21 at 12:00 PM with EI # 6 confirmed the Admission Service Agreement for Home Health form was altered on 10/13/21 to correct the date of 9/2 which was incorrectly entered by the admitting clinician, to the correct date of 9/29/21 next to EI # 6's signature and add the date of 9/29/21 next to the patient representative's signature. Further interview with EI # 1, Director, Clinical Manager confirmed the form was not completed correctly on admission and was altered after admission and should not have been.