Every finding on record at Comanche County Hospital Authority

The Oklahoma State Department of Health conducted an unannounced Medicare Emergency Preparedness Program survey at the agency on 02/01/24 to 02/02/24. Standard deficiencies were cited as a result of the Emergency Preparedness Program survey. Glossary: PHI Protected Health Information

Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility's needs in the event of an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure contact information for an integrated emergency preparedness response with Federal, State, Tribal, Regional and Local emergency management officials for all patients and employees. Findings: A review of administrative records showed no resource contact information for an integrated emergency preparedness response with Federal, State, Tribal, Regional and Local emergency management officials for the agency were in place. On 02/02/24 at 3:00 p.m., Staff B stated the agency did not have an Emergency Preparedness Plan with resource contact information for an integrated emergency preparedness response with Federal, State, Tribal, Regional and Local emergency management officials for the agency.

Methods for Sharing Information CFR(s): 484.102(c)(4)-(5) §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.542(c)(4)-(6), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(6). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (4) A method for sharing information and medical documentation for patients under the [facility's] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility's] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI's care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure administrative policies and procedures related to an Emergency Preparedness Plan dissemination of PHI during plan activation for all patients and employees. Findings: A review of administrative records showed no administrative policies and procedures related to an Emergency Preparedness Plan dissemination of PHI during plan activation for the agency. On 02/02/24 at 3:00 p.m., Staff B stated the agency did not have an Emergency Preparedness Plan with administrative policies and procedures dissemination of PHI during plan activation in place.

The Oklahoma State Department of Health conducted an unannounced Medicare re-certification survey at the agency on 02/01/24 to 02/02/24. An entrance conference was conducted with Staff A, B and C. The survey process was explained. Questions were answered. Staff A and B were identified as the contact persons for administrative and clinical issues. Findings were discussed during an informal exit conference with Staff A, B and C. Standard level deficiencies were cited as a result of the survey. Glossary: CHHA certified home health aide EP Emergency Preparedness HHA Home Health Agency PIP Performance Improvement Project PT Physical therapy POC Plan of Care PHI Protected Health Information QAPI Quality Assessment and Performance Improvement SN skilled nurse PRN as needed

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 record review and interview, the agency failed to ensure individualized patient POC included: 1. Interventions and related goals for skilled diagnosis for two (Patients #2 and #3) of 17 patients; 2. Pain reporting parameters for physician notification and goals for three (Patients #2, 7 and 11) of 17 patients; 3. SN wound care interventions and related goals for two (Patients #6 and #10) of 17 patients; 4. SN catheter treatment/interventions or last changed/treatment due date and related goals for two (Patients #8 and #12) of 17 patients; 5. Skilled interventions and related goals for medication compliance for one (Patient #9) of 17 patients; 6. Identification of wound site for two (Patients #10 and #12) of 17 patients and; 7. Identification of PICC line site for one (Patient #10) of 17 patients. Findings: Patient #2 A review of the POC dated 12/11/23 to 02/08/24 showed a primary diagnosis of urinary tract infection and orders for SN discipline to assess, monitor and instruct on patient’s pain level every visit. POC documentation showed no interventions or related goals for urinary tract infection and no pain reporting parameters for physician notification. SN visits conducted on 12/13/23 pain level of 8, 12/20/23 pain level of 7, 12/27/23 pain level of 5, 01/03/24 pain level of 4, 01/10/24 pain level of 9, 01/15/24 pain level of 6, 01/24/24 pain level of 4 and on 01/31/24 no documented pain level. Documentation showed no physician notifications and no change in orders. On 02/02/24 at 11:45 a.m., Staff A stated the POC for patient #2 had no interventions and goals for urinary tract infection and no physician pain reporting parameters. Patient #3 A review of the POC dated 12/24/23 to 02/21/24 showed a primary diagnosis of unspecified open abdominal wound and orders for SN discipline to assess, monitor the wound site every visit. POC documentation showed no related goals for unspecified open abdominal wound. SN visit was conducted on 01/08/24 and missed (refused SN visits) on 01/05/24, 01/15/24 and 01/22/24. Documentation showed no physician notifications related to the POC and no change in orders. On 02/02/24 at 11:49 a.m., Staff A stated the POC for patient #3 had no SN interventions and goals for unspecified open abdominal wound. Patient #6 A review of the POC dated 12/11/23 to 02/08/24 showed a primary diagnosis of stage 2 pressure ulcer sacral region and orders for SN for wound care to buttocks and assessment of stage 2 pressure ulcer sacral region every visit. POC documentation showed no wound site care and no related goals for buttocks or stage 2 pressure ulcer sacral region. SN visit were conducted on 12/15/23, 12/18/23, 12/27/23, 01/03/24, 01/08/24, 01/05/24, 01/24/24 and on 01/29/24 documentation showed no wound site assessments or wound site care was conducted. Documentation showed no physician notifications related to the POC and no change in orders. On 02/02/24 at 12:04 p.m., Staff A stated the POC for patient #6 had no SN interventions and goals for wound care to buttocks and assessment of stage 2 pressure ulcer sacral region. Patient #7 A review of the POC dated 12/08/23 to 02/05/24 showed orders for SN discipline to assess, monitor and instruct on patient’s pain level every visit. POC documentation showed no pain reporting parameters for physician notification. SN visits conducted on 12/13/23 pain level of 5, 12/27/23 pain level of 8, 01/03/24 pain level of 10 and on 01/31/24 pain level of 5. Documentation showed no physician notifications and no change in orders. On 02/02/24 at 12:15 p.m., Staff A stated the POC for patient #7 had no physician pain reporting parameters. Patient #8 A review of the POC dated 01/05/23 to 03/04/24 showed orders for SN visit frequency one time a month for three months as needed for Foley catheter. POC documentation showed no catheter treatment interventions, Foley catheter type or size, no last changed or treatment intervention change due date and showed no SN goals related to Foley (urinary) catheter management. Documentation showed SN visits were conducted on 01/12/24 (documentation showed Foley catheter changed using 16 French/10 cubic centimeter catheter, no orders), 01/09/24 and on 01/26/24. Documentation of showed no physician notification and no changes in orders. On 02/02/24 at 12:18 p.m., Staff A stated the POC for patient #8 had no catheter treatment interventions, Foley catheter type or size, no last changed or treatment intervention change due date and showed no SN goals related to Foley (urinary) catheter management. Patient #9 A review of the POC dated 01/07/24 to 03/06/24 showed a primary diagnosis of pneumonia and orders for SN to assess, monitor and instruct on patient’s medication compliance every visit. POC documentation showed no interventions or related goals for medication compliance. SN visits were conducted on 01/11/24, 01/18/24 and on 01/24/24. Documentation showed no physician notifications and no change in orders. On 02/02/24 at 12:20 p.m., Staff A stated the POC for patient #9 had no interventions and goals for medication compliance. Patient #10 A review of the POC dated 12/25/23 to 02/22/24 showed a primary diagnosis of stage 4 pressure ulcer sacral region and orders for SN for weekly dressing change to midline port, draw lab as ordered and SN to assess and evaluate wounds at each dressing change. POC documentation showed no wound site care and no related goals for stage 4 pressure ulcer sacral region. SN visit documentation showed the patient had a PICC line in place but did not document the site location (not a midline port) and documented a wound site to the right buttock (not sacrum). Documentation showed no physician notifications related to the POC and no change in orders. On 02/02/24 at 12:21 p.m., Staff A stated the POC for patient #10 showed no wound site care and no related goals for stage 4 pressure ulcer sacral region and documented weekly dressing change to midline port, not PICC line and showed no order for PICC line management, dressing changes or lab draws via the PICC line. Patient #11 A review of the POC dated 01/25/24 to 03/24/24 showed orders for SN discipline to assess, monitor and instruct on patient’s pain level every visit. POC documentation showed no pain reporting parameters for physician notification. SN visits conducted on 02/01/24 pain level of 8. Documentation showed no physician notifications and no change in orders. On 02/02/24 at 12:25 p.m., Staff A stated the POC for patient #11 had no physician pain reporting parameters. Patient #12 A review of the POC dated 12/31/23 to 02/28/24 showed a diagnoses of stage 3 pressure ulcer left buttock and Stage 2 pressure ulcers to bilateral heels and orders for SN for three times weekly dressing changes and SN to change Foley catheter one time a month with a SN visit frequency of three times a week for eight weeks, then two times a week for one week. POC showed no documentation of wound site identification for Wound Vac use and showed no catheter treatment interventions, Foley catheter type or size, no last changed or treatment intervention change due date and showed no SN goals related to wound sites or Foley (urinary) catheter management. Documentation showed SN visits were conducted on 01/01/24, 01/05/24, 01/08/24, 01/10/24, 01/15/24, 01/17/24, 01/19/24 (documentation showed an indwelling Foley catheter change using an 18 French/10 cubic centimeter Foley catheter), 01/23/24 and on 01/27/24. Documentation showed no physician notification and no changes in orders. On 02/02/24 at 12:30 p.m., Staff A stated the POC for patient #12 identified no site for Wound Vac use and showed no catheter treatment interventions, Foley catheter type or size, no last changed or treatment intervention change due date and showed no SN goals related to Foley (urinary) catheter management.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure: 1. Physician ordered SN for indwelling urinary catheter treatment interventions for two (Patients #8 and #12) of 17 patients and; 2. Physician ordered wound site care and dressing materials for one (Patient #10) of 17 patients. Findings: Patient #8 A review of the POC dated 01/05/23 to 03/04/24 showed orders for SN visit frequency one time a month for three months as needed for Foley catheter. POC documentation showed no orders for catheter treatment interventions, Foley catheter type or size, no last changed or treatment intervention change due date related to Foley (urinary) catheter management. Documentation showed SN visit was conducted on 01/12/24 (documentation showed Foley catheter changed using 16 French/10 cubic centimeter catheter, no orders). Documentation showed no physician notification and no changes in orders. On 02/02/24 at 12:18 p.m., Staff A stated the POC for patient #8 had no catheter treatment interventions, Foley catheter type or size, no last changed or treatment intervention change due date related to Foley (urinary) catheter management. Patient #10 A review of the POC dated 12/25/23 to 02/22/24 showed a primary diagnosis of stage 4 pressure ulcer sacral region and orders for SN for weekly dressing change to midline port, draw lab as ordered and SN to assess and evaluate wounds at each dressing change. POC documentation showed no wound site care and related dressing materials for stage 4 pressure ulcer sacral region. SN visit documentation showed the patient had a PICC line in place but did not document the site location (not a midline port) and documented a wound site to the right buttock (not sacrum). Documentation showed wound site assessment and care to right buttock (not sacrum) using normal saline, Vashe cleanser, iodoform packing and covered with a sacral dressing pad (no orders on the POC and no order attachments in the clinical record) during SN visits on 12/27/23, 12/29/23, 01/02/24, 01/03/24, 01/05/24, 01/07/24. Documentation showed lab draws via PICC line on 01/04/24, 01/15/24 and on 01/25/24. Documentation showed no identified site of the PICC line and showed no orders on POC or attached in the clinical record for PICC line management, dressing changes or lab. Documentation showed no physician notifications related to the POC and no change in orders. On 02/02/24 at 12:21 p.m., Staff A stated the POC for patient #10 showed no wound site care with related dressing materials and showed no order for PICC line management, dressing changes or lab draws via the PICC line. Patient #12 A review of the POC dated 12/31/23 to 02/28/24 showed a primary diagnosis of stage 3 pressure ulcer left buttock, Stage 2 pressure ulcers to bilateral heels with a SN visit frequency of three times a week for eight weeks, then two times a week for one week. POC review showed no documentation of catheter treatment interventions, Foley catheter type or size, no last changed or treatment intervention change due date for Foley (urinary) catheter management. Documentation showed during SN visits conducted on 01/19/24 (documentation showed an indwelling Foley catheter change using an 18 French/10 cubic centimeter Foley catheter). Documentation showed no physician notification and no changes in orders. On 02/02/24 at 12:30 p.m., Staff A stated the POC for patient #12 showed no catheter treatment interventions, Foley catheter type or size, no last changed or treatment intervention change due date for Foley (urinary) catheter management.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure care was coordinated between the agency and physician for four (Patient #1, 3, 6 and #7) of 17 patients. Findings: Patient #1 A review of a POC dated 12/22/23 to 02/19/24 showed a SN visit frequency of two times a week for one week, then six times a week for eight weeks for SN to conduct wound site assessment and care. Documentation showed missed SN visits on 12/24/23, 12/28/23, 01/02/24, 01/04/24 and on 01/21/24. Documentation showed no follow up physician communications or coordination of care notes for continued missed SN visits and showed no changes in orders. On 02/02/24 at 11:45 a.m., Staff A stated the staff did not follow up with the physician for continued missed SN visits for Patient #1. Patient #3 A review of the POC dated 12/24/23 to 02/21/24 showed a SN visit frequency of one time a week for eight weeks for SN to set up medication planners and assess medication compliance. Documentation showed missed SN visits on 01/05/24 and on 01/15/24. Documentation showed no follow up physician communications or coordination of care notes for missed SN visits and showed no changes in orders. On 02/02/24 at 11:50 a.m., Staff A stated the staff did not follow up with the physician for missed SN visits to set up patient medication planners and assess medication compliance for Patient #3. Patient #6 A review of the POC dated 12/11/23 to 02/08/24 showed a Sn visit frequency of two times a week for one week, then two times a week for eight weeks for SN to conduct wound site assessment care to buttocks and stage 2 pressure ulcer sacral region every visit. Further review of the clinical record showed a physician’s order for lab work venipuncture and urine collection to be completed on 12/15/23. Documentation showed during SN visit on 12/15/23 SN collected a urine sample only and on SN visit dated 12/18/23 performed the venipuncture lab draw and during SN visit conducted on 01/15/24 the patient reported an unwitnessed fall and had a blood pressure of 98/69 at the time of the visit. Documentation showed no follow up physician communications or coordination of care notes for delayed venipuncture lab draw and report of an unwitnessed fall and a blood pressure of 98/69; and showed no changes in orders. On 02/02/24 at 12:04 p.m., Staff A stated the staff did not follow up with the physician for delayed venipuncture lab draw and reported an unwitnessed fall and had a blood pressure of 98/69 at the time of the visit for Patient #6. Patient #7 A review of the POC dated 12/08/23 to 02/05/24 showed orders for SN visit frequency of one time a week for nine weeks. Documentation showed a missed SN visit on 01/17/24 (patient requested a visit on 01/19/24). Documentation showed no attempt to make up the visit, no physician notifications and no change in orders for patient #7. On 02/02/24 at 12:15 p.m., Staff A stated the documentation for patient #7 showed no attempt to make up the visit and no physician notification of the missed visit.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure patient centered QAPI Program activities that identified actions and self-monitoring efforts to identify problems, improve care, services and operations for all patients and employees. Findings: A review of QAPI Program documents showed no patient centered QAPI Program activities that identified actions and interventions or self-monitoring efforts and opportunities to identify problems, improve care, services and operations for calendar years 2022 and 2023. On 02/02/24 at 3:00 p.m., Staff A stated QAPI program documentation for calendar years 2022 and 2023 showed no ongoing QAPI program activities that identified actions and interventions for self-monitoring efforts and opportunities to identify problems to improve care, services and operations of the agency.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure: intervention activities; analysis of data; follow up; PIP status for the agency in calendar years 2022 and 2023 for all patients and employees. Findings: A review of QAPI Program documentation showed no intervention activities, analysis of data and no follow up or PIP status designation for the agency in calendar year 2022 and 2023. On 02/02/24 at 3:00 p.m., Staff A stated the agency had no PIP documentation which showed intervention activities, analysis of data, follow up or PIP status designation in calendar years 2022 and 2023.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body oversite of the conduction of patient centered QAPI program plan and agency evaluation for all patients and employees. Findings: A review of governing body meeting minutes dated 03/14/22 and 03/27/23 showed no review of : QAPI program data which included approving activities for the next year calendar year and no review of an agency evaluation for calendar years 2022 and 2023. On 02/02/24 at 3:00 p.m., Staff A stated documentation showed no review of QAPI program data and showed no review of an agency evaluation for calendar years 2022 and 2023.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure: SN conducted visit frequency as ordered on the POC for four (Patients #1, 5, 7 and 12) of 17 patients; PT conducted an evaluation as ordered for one (Patient #4) of 17 patients; SN conducted wound site assessment and care ordered on the POCs for three (Patients #6, 10 and #12) of 17 patients; SN notified the physician of heart rate outside of reporting parameters as ordered on the POC for one (Patient #8) of 17 patients; SN notified the physician for blood pressure reading outside of reporting parameters as ordered on the POC for two (Patients #8 and #11) of 17 patients and; SN conducted port care ordered on the POCs for one (Patient #10) of 17 patients. Findings: Patient #1 A review of a POC dated 12/22/23 to 02/19/24 showed a SN visit frequency of two times a week for one week, then six times a week for eight weeks for SN to conduct wound site assessment and care. Further review of clinical ocumentation showed missed SN visit on 01/29/24 (marked as not due yet). Documentation showed no patient refusal of care, physician communications or coordination of care notes or changes in orders. On 02/02/24 at 11:45 a.m., Staff A stated the SN visit on 01/29/24 for Patient #1 should have been documented as completed or showed physician notification of missed/refused SN visit. Patient #4 A review of a POC dated 01/17/24 to 03/16/24 showed orders for a one week one PT evaluation and treatment. Documentation showed no PT evaluation from 01/17/24 to date of record review on 02/01/24. Documentation showed no patient refusal of care, no physician notifications related to the POC and no change in orders. On 02/02/24 at 11:55 a.m., Staff A stated patient #4 did not have a PT evaluation as ordered on the POC. Patient #5 A review of the clinical record showed a POC dated 12/17/23 to 02/14/24 documented SN visit frequency of two times a week for eight weeks. Documentation showed missed SN visits on 01/29/24 and 01/30/24 (marked as not due yet). Documentation showed no patient refusal of care, physician communications or coordination of care notes or changes in orders. On 02/02/24 at 11:57 a.m., Staff A stated the SN visits on 01/29/24 and 01/30/24 for Patient #5 should have been documented as completed or showed physician notification of missed/refused SN visits. Patient #6 A review of the POC dated 12/11/23 to 02/08/24 showed a primary diagnosis of stage 2 pressure ulcer sacral region and orders for SN for wound care to buttocks and assessment of stage 2 pressure ulcer sacral region every visit. Further review of clinical documentation showed no wound site assessments or care for buttocks or stage 2 pressure ulcer sacral region during SN visits conducted on 12/15/23, 12/18/23, 12/27/23, 01/03/24, 01/08/24, 01/05/24, 01/24/24 and on 01/29/24. Documentation showed no patient refusal of care, physician notifications related to wound site assessments or care and showed no change in orders. On 02/02/24 at 12:04 p.m., Staff A stated SN wound site assessment and care interventions should have been conducted each SN visits for patient #6. Patient #7 A review of the POC dated 12/08/23 to 02/05/24 showed orders for SN visit frequency of one time a week for nine weeks. Further reviw of clinical documentation showed during the week of 01/14/24 to 01/20/24 the patient requested a SN visit on 01/19/24. Documentation showed no visit during that week (one visit ordered, no visit conducted). Documentation showed no physician notifications and no change in orders. On 02/02/24 at 12:15 p.m., Staff A stated the patient #7 should have had a SN visit on 01/19/24 as requested. Patient #8 A review of the POC dated 01/05/23 to 03/04/24 showed orders for SN visit frequency one time a month for three months as needed for Foley catheter with a pulse (heart rate) reporting parameter of less than 65 beats per minute. Further review of clinical documentation showed during SN visits conducted on 01/19/24 a pulse rate of 56 and on 01/26/24 a pulse rate of 55. Documentation showed no physician notification and no changes in orders. On 02/02/24 at 12:18 p.m., Staff A stated the pulse rate reading during SN visits on 01/19/24 and 01/26/24 should have been reported to the physician for patient #8. Patient #10 A review of the POC dated 12/25/23 to 02/22/24 showed a primary diagnosis of stage 4 pressure ulcer sacral region and orders for SN for weekly dressing change to midline port, draw lab as ordered and SN to assess and evaluate wounds at each dressing change. Further review of clinical documentation showed no wound site assessment or wound care during SN visit conducted on 12/26/23, 12/28/23, 12/30/23, 12/31/23, 01/04/24, 01/06/24, 01/09/24, 01/10/24, 01/11/24, 01/13/24, 01/19/24, 01/20/24, 01/21/24, 01/23/24, 01/25/24, 01/27/24 and on 01/28/24 and showed no port (PICC line) assessment or dressing change during the weeks of 12/25/23 to 12/30/23, 12/31/23 to 01/06/24 and 01/21/24 to 01/27/24. Documentation showed no patient refusal of care, no physician notifications related to the POC and no change in orders. On 02/02/24 at 12:21 p.m., Staff A stated: 1. SN visit conducted on 12/26/23, 12/28/23, 12/30/23, 12/31/23, 01/04/24, 01/06/24, 01/09/24, 01/10/24, 01/11/24, 01/13/24, 01/19/24, 01/20/24, 01/21/24, 01/23/24, 01/25/24, 01/27/24 and on 01/28/24 showed no wound site care or assessment and; 2. SN visits during the weeks of 12/25/23 to 12/30/23, 12/31/23 to 01/06/24 and 01/21/24 to 01/27/24 showed no port (PICC line) assessment or dressing change. Patient #11 A review of the POC dated 01/25/24 to 03/24/24 showed orders for SN visit frequency of one time a week for six weeks with a blood pressure reporting parameter of less than 100/75. Review of clinical documentation showed SN visits conducted on 02/01/24 revealed a blood pressure of 99/78. Documentation showed no physician notifications and no change in orders. On 02/02/24 at 12:25 p.m., Staff A stated the physician for patient #11 should have been notified of blood pressure reading during the 02/02/24 SN visit. Patient #12 A review of the POC dated 12/31/23 to 02/28/24 showed a primary diagnosis of stage 3 pressure ulcer left buttock, Stage 2 pressure ulcers to bilateral heels with a SN visit frequency of three times a week for eight weeks, then two times a week for one week. Clinical documentation showed SN visits scheduled on 01/29/24 and 01/31/24 marked as visit not due (two SN visits ordered, no visits conducted) and during SN visit dated 01/23/24 documentation showed no wound site assessment or care. Documentation showed no patient refusal, physician notification and no changes in orders. On 02/02/24 at 12:30 p.m., Staff A stated SN visits for 01/29/24 and 01/31/24 should have been conducted and wound site assessment and care during SN visit on 01/23/24 should have completed for patient #12.

Participate in the HHA's QAPI program; CFR(s): 484.75(b)(8) Participation in the HHA's QAPI program; and This ELEMENT is not met as evidenced by: Based on a record review and interview, the agency failed to ensure multi-disciplined skilled professional staff were available to participate and provide input into the agency’s QAPI program for all patients and employees. Findings: A review of administrative records showed no multi-disciplined skilled professional staff participation in QAPI activities for calendar years 2022 and 2023. On 02/02/24 at 3:00 p.m., Staff A stated documentation showed no evidence of multi-disciplined skilled professional staff participation in ongoing QAPI program activities for the agency.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the development of a home health aide care plan for one (Patient #5) of 17 patients. Findings: Patient #5 A review of the clinical record showed a POC dated 12/17/23 to 02/14/24 documented home health aide visit frequency of two times a week for eight weeks. Documented showed no home health aide care plan for certification period of 12/17/23 to 02/14/24. Documentation showed home health aide visits were completed on 12/19/23, 12/22/23, 12/26/23, 12/29/23, 01/02/24, 01/05/24, 01/09/24, 01/12/24, 01/16/24, 01/19/24, 01/23/24, 01/26/24, and 01/30/24. On 02/02/24 at 11:57 a.m., Staff A stated: 1. The agency only had to do an aide care plan at the time of admission and did not have to update and /or revise the aide care plan every certification period and; 2. The clinical record showed no documented home health aide care plan for 12/17/23 to 02/14/24 certification period.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(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 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 §484.80(g), must make an onsite visit to the patient's home no less frequently than every 14 days. The home health aide does not have to be present during this visit. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure certified home health aide supervisory visits were completed every 14 days for one (Patient #5) of 17 patients. Findings: Patient #5 A review of the POC dated 12/17/23 to 02/14/24 ordered a home health aide visit frequency of two times a week for eight weeks. Further review of clinical documentation showed CHHA supervisory visits were due on 01/02/24 and completed 01/12/24 (10 days late) and due on 01/25/24 (6 days late at the time of review on 02/01/24). Documentation showed no patient refusal, physician notification or change in orders. On 02/02/24 at 11:57 a.m., Staff A stated the CHHA supervisory visits for Patients #5 should be conducted every 14 days.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body oversite of an operating budget, capital expenditure plan and allocation of resources activities for calendar year 2022 and 2023 for all patients and staff. Findings: A review of administrative records showed no governing body over-site for operating budget, capital expenditure plan and allocation of resources activities for calendar year 2022 and 2023. On 02/02/24 at 3:00 p.m., Staff A stated documentation showed no evidence of ongoing governing body oversite or responsibility for the agency’s operating budget and capital expenditure plan for calendar years 2022 and 2023.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record reviews and interview, the agency failed to ensure a completed transfer/discharge summary was provided for one (Patient #13) of 17 patients. Findings: Patient #13 A review of the clinical record documented transfer to inpatient service provider with subsequent discharge from the agency on 09/07/23. Documentation showed no transfer/discharge summary was provided to the inpatient service provider. On 02/02/24 at 12:30 p.m., Staff A stated no transfer/discharge summary was sent to the receiving service provider for Patients #13.

The Oklahoma State Department of Health conducted an unannounced Medicare Emergency Preparedness Program survey at the agency on 02/22/21 to 02/23/21. A standard deficiency was cited as a result of the Emergency Preparedness Program survey.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure emergency preparedness disaster table top exercises and drills conducted for fiscal years 2019 and 2020 documented agency staff participation for 273 patients and all staff members. Findings: A review of administrative records and emergency preparedness records showed no documentation of agency staff participation in disaster table top exercises and drills conducted for fiscal years 2019 and 2020. On 02/23/21 at 9:38 a.m., Staff K stated the agency had no documentation which showed agency staff participation in emergency preparedness disaster table top exercises and drills conducted for fiscal years 2019 and 2020.

The Oklahoma State Department of Health conducted an unannounced Medicare re-certification survey at the agency on 02/22/21 through 02/23/21. An entrance conference was conducted with Staff A. The survey process was explained. Questions were answered. Staff A was identified as the contact person for clinical and administrative issues. Findings were discussed during an informal exit conference with Staff A, B, C, D and E. Standard level deficiencies were cited as a result of the Medicare re-certification survey. Glossary: POC Plan of Care Pts Patients QAPI Quality Assurance Performance Improvement SN Skilled Nurse

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 record review and interview, the agency failed to ensure medication embedded wound care supplies were included in the review of medications for potential/adverse effects, drug reactions, side effects, interactions and duplicate drug therapy for three (Pts #2, 7 and #12) of 17 patients. Findings: Patient #2 A review of the plan of care dated 12/11/20 to 02/08/21 documented a principal diagnosis of non-pressure chronic ulcer left leg with venous insufficiency and orders for SN to perform wound site care using Hydrofera Blue (a medication embedded wound care supply material). A review of the clinical record showed no documentation the Hydrofera Blue was added to the medication profile or reviewed for potential/adverse effects, drug reactions, side effects, interactions and duplicate drug therapy. Patient #7 A review of the plan of care dated 11/28/20 to 01/26/21 documented a principal diagnosis of non-pressure chronic ulcer right leg with venous insufficiency and orders for SN to perform wound site care using Aquacel AG (alginate; a medication embedded wound care supply material). A review of the clinical record showed no documentation the Aquacel AG was added to the medication profile or reviewed for potential/adverse effects, drug reactions, side effects, interactions and duplicate drug therapy. Patient #12 A review of the plan of care dated 12/14/20 to 02/11/21 documented a principal diagnosis of non-pressure chronic ulcer of right foot site and orders for home health nursing to perform wound site care using Hydrofera Blue (a medication embedded wound care supply material). A review of the clinical record showed no documentation the Hydrofera Blue was added to the medication profile or reviewed for potential/adverse effects, drug reactions, side effects, interactions and duplicate drug therapy On 02/23/21 at 12:15 p.m., Staff A stated the agency did not list wound care supplies on the patient medication profiles or review medicated wound care supplies for potential/adverse effects, drug reactions, side effects, interactions and duplicate drug therapy.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a discharge oasis were completed on patients discharged from the agency for four (Pts #7, 8, 15 and #17) of 17 patients. Findings: Patient #7 A review of the clinical record showed the patient was discharged from the agency to care of self on 01/20/21. The documentation showed no discharge oasis completed after the patient was discharged from the agency on 01/20/21. Patient #8 A review of the clinical record showed the patient was discharged from the agency to care of self on 08/26/20. The documentation showed no discharge oasis completed after the patient was discharged from the agency on 08/26/20. Patient #15 A review of the clinical record showed the patient was discharged from the agency to a skilled nursing care facility on 01/18/21. The documentation showed no discharge oasis completed after the patient was discharged from the agency on 01/18/21. Patient #17 A review of the clinical record showed the patient was discharged from the agency to hospice care services on 01/19/21. The documentation showed no discharge oasis completed after the patient was discharged from the agency on 01/19/21. On 02/23/21 at 1:20p.m., Staff A stated no discharge oasis was completed for Pt #7, 8, 15 or 17 at the time of discharge from agency services.

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 record review and interview, the agency failed to ensure the individualized patient POC included: 1. Pain reporting ranges for six (Pts #1, 3, 4, 6, 8 and #10) of 17 patients and; 2. Recurring urinary catheter change due dates were documented for two (Pts #6 and #9) of 17 patients. Findings: Patient #1 A review of the plan of care dated 12/05/20 to 02/02/21 documented a principal diagnosis of hypertension. POC orders instructed SN to assess pain location, duration, frequency, character and intensity; and to teach and instruct disease process and progression of pain/symptom management. The POC documented no parameter of pain to report to the physician for further intervention. Patient #3 A review of the plan of care dated 12/11/20 to 02/08/21 documented a principal diagnosis of ataxia and a secondary diagnosis of radiculopathy of the lumbosacral region of the spine. POC orders instructed SN to assess for discomfort or pain, including patient acceptable level of pain. The POC documented no parameter of pain to report to the physician for further intervention. Patient #4 A review of the plan of care dated 01/04/21 to 03/04/21 documented a principal diagnosis of COPD (chronic obstructive pulmonary disease). POC orders instructed SN to assess for discomfort or pain, including patient acceptable level of pain and to report to physician if pain is out of control. The POC documented no parameter of pain to report to the physician for further intervention. Patient #6 A review of the plan of care dated 12/03/20 to 01/31/21 documented a principal diagnosis of urinary retention. POC orders instructed: 1) SN to assess pain location, duration, frequency, character and intensity and to teach and instruct disease process and progression of pain/symptom management and 2) SN to change indwelling Foley catheter every month. POC documentation showed no parameter of pain to report to the physician for further intervention and showed no date the indwelling Foley catheter change was due. Patient #8 A review of the plan of care dated 07/26/20 to 09/23/20 documented a principal diagnosis of COPD and a secondary diagnosis of peri-prosthetic fracture of right shoulder. POC orders instructed SN to assess pain location, duration, frequency, character and intensity to teach and report uncontrolled pain to the physician and to instruct joint distraction for pain management. The POC showed no parameter of pain to report to the physician for further intervention. Patient #9 A review of the plan of care dated 12/04/20 to 02/01/21 documented a principal diagnosis of dementia with urinary tract infection and inflammation. POC orders instructed SN to assess pain location, duration, frequency, character and intensity and to change indwelling Foley catheter every month. The POC documented no parameter of pain to report to the physician for further intervention. Patient #10 A review of the plan of care dated 12/13/20 to 01/31/21 documented a principal diagnosis of Stage III pressure ulcer of the sacrum. POC orders instructed SN to assess pain location, duration, frequency, character and intensity and to teach on pre-medication for pain prior to wound care. The POC documented no parameter of pain to report to the physician for further intervention. On 02/23/21 at 11:55 a.m., Staff A stated: 1. Pain reporting ranges for Pts #1, 3, 4, 6, 8 and #10 should have been documented in their POC's and; 2. Recurring urinary catheter change due dates should have been documented for Pts #6 and #9 in their POC's.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record reviews and interview, the agency failed to ensure SN visits were conducted as ordered by the physician for four (Pts #7, 10, 11 and #12) of 17 patients. Findings: Patient #7 A review of the POC dated 11/28/20 to 01/26/21 showed a SN frequency of daily for 60 days. Clinical documentation showed SN visits performed daily on 11/28/20 through 12/24/20 and 12/26/20 through 01/20/21. Documentation showed no SN visit conducted on 12/25/20 (one missing SN visit.) Documentation showed no physician notification of the missed visit, no change in orders, and no patient or caregiver refusal of the SN visit. Patient #10 A review of the POC dated 12/03/20 to 01/31/21 showed a SN frequency of three times a week for one week, two times a week for seven weeks and then one time a week for one week. Clinical documentation showed during the week of 12/27/20 through 01/02/21 a SN visit conducted on 12/30/20 (one missing SN visit.) Documentation showed no physician notification of the missed visit, no change in orders, and no patient or caregiver refusal of the SN visit. Patient #11 A review of the POC dated 12/18/20 to 02/15/21 showed a SN frequency of two times a week for nine weeks. Clinical documentation showed during the week of 01/10/21 through 01/16/21 no SN visit conducted (one missing SN visit.) Documentation showed no physician notification of the missed visit, no change in orders, and no patient or caregiver refusal of the SN visit. Patient #12 A review of the POC dated 12/14/20 to 02/11/21 showed a SN frequency of three times a week for eight weeks and then two times a week for one week. Clinical documentation showed during the week of 02/10/21 through 02/11/21 one SN visit was conducted on 02/10/21 (one missing SN visit.) Documentation showed no physician notification of the missed visit, no change in orders, and no patient or caregiver refusal of the SN visit. On 02/23/21 at 12:58 p.m., Staff A stated Pts #7, 10, 11 and #12 had missed SN visits and the documentation showed no physician notification of the missed visits, no change in orders, and no patient or caregiver refusals of the SN visits. Staff A further stated the staff should have completed missed visit reports or documented physician notification of why the visits were missed.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure conduction of patient centered QAPI Program activities for all 273 patients and all employees. Findings: A review of administrative records showed no ongoing QAPI program activities, no patient record audits and no quarterly QAPI meetings to improve the care, services, and operations of the agency for calendar years 2019 and 2020. On 02/23/21 at 9:00 a.m., Staff A stated: 1) they had no QAPI documentation which showed QAPI program activities 2) the had no QAPI documentation which included patient record audits and quarterly QAPI committee meetings for calendar years 2019 and 2020.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure governing body oversight of: 1) a patient centered QAPI Program and 2) an operating budget and allocation of resources for calendar years 2019 and 2020 effecting 273 patients and all staff. Findings: A review of administrative records showed no: 1) governing body oversight of an ongoing patient centered QAPI program; 2) QAPI program activities for calendar years 2019 and 2020; 3) governing body oversight of the operating budget and allocation of resources for the agency in calendar years 2019 and 2020. On 02/23/21 at 9:00 a.m, Staff A stated there was no documentation which showed evidence of: 1) governing body oversight of the agency's QAPI program and QAPI program activities for calendar years 2019 and 2020 and 2) governing body discussion of the operating budget or resource allocation needs for the agency for calendar years 2019 and 2020.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure completion of a transfer/discharge summary for six (Pts #7, 8, 12, 15, 16 and #17) of 17 patients. Findings: Patient #7 A review of the clinical record showed the patient was discharged from the agency on 01/20/21. Documentation showed no discharge summary and no physician notification of the discharge. Patient #8 A review of the clinical record showed the patient was discharged from the agency on 08/26/20. Documentation showed no discharge summary and no physician notification of the discharge. Patient #12 A review of the clinical record showed the patient was transferred to in-patient hospital care services on 01/25/21. Documentation showed no transfer summary and no physician notification of the transfer. Patient #15 A review of the clinical record showed the patient was discharged from the agency to skilled nursing facility services on 01/18/21. Documentation showed no discharge summary and no physician notification of the discharge. Patient #16 A review of the clinical record showed the patient was transferred to in-patient hospital care services on 10/04/20. Documentation showed no transfer summary, no in-patient follow up communication, no subsequent discharge assessment and no physician notification of the in-patient hospital transfer. Patient #17 A review of the clinical record showed the patient was discharged from the agency to hospice care services on 01/19/21. Documentation showed no discharge summary and no physician notification of the discharge. On 02/23/21 at 12:25 p.m., Staff A stated Patients #7, 8, 12, 15, 16 and #17 should have had transfer/discharge summaries completed and their physician should have been notified of their transfer/discharge from the agency.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure clinical records were complete for one (Patient #5) of 17 patients. Findings: Patient #5 A review of the clinical record showed incomplete documentation (a blank visit note) of a SN visit conducted on 02/08/21. On 02/23/21 at 12:20 p.m., Staff A stated the SN visit note dated 02/08/21 was completed 02/23/21 but should have been completed after the SN visit on 02/08/21.