Commonspirit Health

“Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient’s eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This Condition is not met as evidenced by: Based on clinical record review and staff interview, it was determined the agency failed to incorporate assessment findings about pain into individualized care planning, resulting in inadequate interventions to meet patient needs. Specifically, assessment data regarding the patient’s condition, preferences, and risks were not utilized in the development or revision of the care plan, leading to inconsistencies in treatment and potential adverse outcomes including distress caused by unnecessary pain, poor treatment compliance, prolonged treatment, failed treatment, infection, rehospitalization and worsening of chronic condition in 5 (#12, #16, #18, #19, #21) of 28 (#1-#28) clinical records reviewed. This Condition, if not corrected, has the potential to affect all patients on current census and any new admissions. Based on Clinical Record Review and staff interview, it was determined the agency failed to incorporate the patient’s strengths, goals, and care preferences into the care planning process, resulting in care that did not align with the patient’s identified needs and measurable outcomes. Specifically, documentation lacked essential information demonstrating the patient’s progress toward achieving their goals, leading to gaps in personalized care delivery and ineffective interventions concerning pain and the treatment and control of pain in 4 (#12, #16, #18, #21) of 28 (#1-#28) clinical records reviewed. Review of Clinical Records #12, #16, #18 and #21 all had the pain vital sign parameter (a certain numeric value on the pain scale in which the physician or patient’s practitioner should be notified as this number would be above the target goal for pain and requires prompt reassessment and attention) set at “>10” or greater than 10. There is no known standard numeric clinical pain assessment tool that go beyond ‘10.’ Clinical Record #19 revealed an order to contact the physician or practitioner for pain “>9” (greater than 9). Surveyor examined Agency Policy concerning assessment of pain. Although it stated each patient was to have a pain assessment, no specific tool was identified for clinicians to use. Agency Staff were asked about use of a standard tool in use by their clinical staff on 05/28/2025. “We don’t have a specific tool.” per Agency Staff #1 at 11:28 AM See G530 for details.”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: During medical record review and staff interview it was determined the Agency failed to ensure comprehensive care planning and coordination in eight (#8, #9, #12, #16, #18) of 28 records reviewed (#1-#28). This resulted in inadequate interventions to address patient needs as well as the ability to assess and measure against identified goals. Specifically, the agency did not develop or implement a care plan that effectively incorporated patient preferences, goals, and measurable outcomes. This failure led to inconsistent disease and health management strategies, compromising the patient’s comfort and overall well-being. This condition, if left uncorrected, has the potential to affect all current and future patients in that the delivery of care or lack thereof can greatly change the course of a patient’s health, quality of life, mental health, and relationships with clinical staff. Findings Follow: 1) Clinical record #8: a. Revealed a Plan of Care with certification dates of 03/06/2025 through 05/04/2025 listed the following diagnosis: Noninfective gastroenteritis and colitis (both are conditions of inflammation in the gastrointestinal tract) and Adult Failure to Thrive (Adult failure to thrive is a condition characterized by unintentional weight loss, decreased appetite, poor nutrition, and reduced physical activity. It often affects older adults and can result from chronic illnesses, depression, cognitive decline, social isolation, or inadequate medical care. One of the diagnostic criteria is the patient must have exceeded 5% of total body weight loss) b. An admission assessment weight on 03/06/2025 of 91.2 pounds. c. No order for weight monitoring of this patient was obtained. d. No other weights were recorded for this patient. 2) Clinical Record #9: a. Revealed a document titled Home Health Certification and Plan of Care (POC) with certification dates of 05/25/2025 though 07/23/25. b. Home-visit was conducted on 05/28/25 at 3:10 PM. Surveyor observed patient with a PEG tube (Percutaneous Endoscopic Gastrostomy tube). A medical device used for long-term enteral feeding when a person cannot eat or swallow safely. It is inserted directly into the stomach through the abdominal wall) c. POC had no practitioner orders concerning the PEG. 3) Clinical Record #12: a. Revealed a Home Health Plan of Care with certification dates from 05/18/2025 through 07/16/2025 showed a physician order to contact the physician when the patients pain level is “>10”. There is not a standard, numeric clinical tool that measures pain greater than ‘10’ 4) Clinical Record #16 a. Revealed a document titled Home Health Certification and Plan of Care with Certification dates from 04/03/2025 through 06/01/2025 listing a physician’s order to report to practitioner a temperature less than 95 degrees or above 101.1 degrees. b. The visit calendar showed patient was seen by clinicians 7 times through this time period. The patient’s temperature was recorded only on 04/08/2025 and 04/18/2025 c. A medication profile listing Oxycodone (a strong pain reliever), Gabapentin (a medication used to alleviate nerve pain), Diazepam (used for muscle spasms) and cyclobenzaprine (muscle relaxer) d. The POC showed an order to “report vital signs falling outside the following established parameters” with a directive to report a pain level of “>10” (greater than 10). There is no known standardized numeric clinical pain assessment tool that has values above ‘10’ 5) Clinical Record #18 a. Document titled Home Health Certification and Plan of Care with certification dates from 04/01/2025 through 05/30/2025 revealed a physician’s order for “Skilled nurse to initiate telemonitoring service for daily vital signs.” There was no other documentation of the tele health equipment being delivered, set up, patient and family teaching concerning the devices or a physician’s order to discontinue/disregard the telemonitoring. b. A physician’s order of “licensed professional to report vital signs falling outside the following established parameters. Pain >10”. There is no known standardized numeric clinical pain assessment tool that has values above ‘10’ 6) Clinical Record #19 a. Document titled Home Health Plan of Care with Certification dates from 02/04/2025 through 04/04/2025 revealed an order reading, “Licensed professional to report vital signs falling outside the following established parameters Pain >9”. According to Kaiser Permanente 10 Levels Of Pain: A Detailed Scale Description Guide A pain level of 9 on the 0-10 pain scale represents severe pain that is almost unbearable and completely disrupts a person’s ability to function. It is intense, persistent, and overwhelming, often requiring strong pain management interventions. At this level, emergency medical care or powerful pain relief treatments (such as opioids, nerve blocks, or specialized therapies) may be necessary. It is one step below 10, which is described as the worst pain imaginable. The known standardized numeric clinical pain assessment tools have no values above ‘10’ 7) Clinical Record #20 a. Revealed a document titled Home Health Plan of Care with certification dates from 03/10/2025 through 05/08/2025.with a diagnosis of “Pressure Ulcer of Right hip, Unstageable” (An unstageable pressure ulcer is a type of pressure injury where the full extent of tissue damage cannot be determined because the wound is covered by necrotic tissue, eschar (a thick, black or brown scab), or slough (soft, yellow or tan tissue). b. Physician ordered “Skilled Nurse to perform wound care to unstageable pressure ulcer to right hip. Cleanse wound with wound cleanser, apply Xeroform (Xeroform is a type of sterile wound dressing made of fine-mesh gauze impregnated with petrolatum and 3% bismuth tribromophenate. It is non-adherent, meaning it won’t stick to the wound, which helps minimize pain during dressing changes), to wound bed, and cover with 4x4 (4 centimeters by 4 centimeters square) Mepilex (a soft foam type dressing with self-adhesive edges) c. Skilled Nurse Visit Note dated 03/19/2025 with documentation of wound care “not provided due to supplies being low” d. A clinical communication note from SN (skilled nurse) attempting to set up a visit time for patient on 03/21/25. SN documented the family asked the nurse if SN had wound care supplies to bring to patient’s home. When SN said no, they did not have the specific physician ordered supplies, the family refused the visit. e. the patient record showed a supply order was made for this patient on 03/21/25. f. Patient family continued to refuse any visits from clinicians due to lack of supplies. 8) Clinical Record #21 a. Revealed a document titled Home Health Plan of Care with Certification dates from 03/13/2025 through 05/11/2025 showed an order reading “Licensed professional to report vital signs falling outside the following established parameters Pain >10”. There is not a standard, numeric clinical tool that measures pain greater than ‘10’ 9. Review of Clinical Records and staff interview, it was determined the Agency failed to develop and implement a comprehensive plan of care that accurately reflected the patient’s “Patient-specific measurable outcome” for 4 (#12, #16, #18, #21) of 28 (#1-#28), needs, goals, and physician-ordered interventions. Specifically, the agency did not ensure proper coordination of services, leading to inconsistencies in care delivery and potential risks to patient safety and well-being. Based on review of clinical records and staff interview, it was determined the Agency failed to develop and implement a comprehensive plan of care that accurately reflected the patient’s “Patient-specific measurable outcome” for 4 (#12, #16, #18, #21) of 28 (#1-#28), needs, goals, and physician-ordered interventions. Agency Representatives were asked for additional information. None was provided. See G572 for details.”

“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 Clinical Record review, it was determined the Agency failed to implement infection prevention and control procedures in 3 (#13, #14, #15) of 7 (#9-#15) of home visits observed. Specifically, the agency staff did not adhere to accepted standards of practice, including the use of standard precautions, surveillance, leading to gaps in infection control measures and potential harm to patient safety. This deficient practice had the potential to affect all patients, staff members, family and others, and can lead to complications, hospitalizations, and delayed healing. Clinical Record/Patient #13 A home visit was conducted on 05/29/2025 at 11:33 AM. SN (Skilled Nurse) was to perform a catheter change. Surveyor observed SN pulled the bedding down off the patient’s midsection and groin area. SN then exclaimed “Oh, I didn’t know it was a suprapubic catheter. I’ve never done (changed) one before.” SN required verbal queues from Agency Staff #1 to remove old catheter. Post removal, SN continued to rely on Agency Staff #1 to provide instruction as each step of the skill was attempted and then completed. Agency Staff #1 was required to open sterile packages and instruct SN on how to remove the items from packaging. SN would not have been able to complete the skill without assistance. The surveyor asked Agency Staff #1 about the home visit. Agency Staff #1 stated, “It was her first suprapubic catheter change.” Clinical Record/Patient #14 A home visit was conducted on 05/29/2025 at 1:02 PM. SN was to perform a PICC (Peripherally Inserted Central Catheter) sterile dressing change. SN gathered a sterile dressing change kit (specifically made for this procedure), a clean plastic bag with face mask in it. Patient #14 sat upright on the edge of the bed. SN performed hand hygiene. Opened the PICC dressing kit in such a way as to create a sterile field by using the package. SN performed hand hygiene again, donned clean gloves and began rearranging items in the sterile PICC dressing kit contaminating the contents. SN then returned focus to patient #14, and removal of the current dressing. SN was observed pulling the dressing away from patient’s skin, yet dressing was still adhered to the PICC line and began pulling the line out of the patients arm approx. 0.5 cm before the patient noticed and stopped the SN. The surveyor observed patient # 14 push the PICC line back under the skin. Based on “Guidelines for the Prevention of Intravascular Catheter-related Infections” this is contraindicated as the area just under the skin where the PICC is placed can become infected as well as potentiating a systemic infection by allowing bacteria and contaminates to travel along the PICC line itself causing insertion site infection, systemic or whole-body infections SN did not don a face mask, nor did SN instruct patient to wear a mask during the dressing change. This allowed for both nurse and patient to breathe on skin surrounding PICC and PICC itself during exposure to air. It is standard nursing practice to wear a mask during PICC care, and one is provided in the PICC dressing change kit for this reason. According to “PICC Dressing Change” instructions at Lecturio Nursing, it is also recommended that the patient either have their face turned away from the PICC site while care is being performed or be offered a mask to wear to avoid respiratory contamination. SN began cleaning the PICC site with the Chlorhexidine (a strong germicide) solution included in the kit. SN then allowed the site to dry but would periodically touch near the PICC to assure the skin was dry enough for the transparent dressing to adhere to the patient’s skin. SN put a bio-patch (a small foam like disc treated with antibacterial agents), then a transparent dressing. Immediately after the home visit, the surveyor asked Agency Staff #1 the SN execution of PICC care. Per Agency Staff #1, “I’ve never seen it (PICC care) done like that before.” On 05/29/2025 the surveyor requested skills documentation for SN providing PICC care. Per Agency Staff #, “We don’t have it.” On 06/02/2025 the surveyor requested skills documentation for SN providing PICC care. Per Agency Staff #2, “We are getting an educator soon and will be getting this taken care of. We have pulled that nurse from all sterile procedures for now.” During Record Review of Patient #15, a document titled Home Health Plan of Care with certification dates of 04/21/2025 through 06/19/2025 revealed a physician’s order to “Perform (PICC) dressing changes to site weekly (every seven days) and PRN (as needed) for loose or soiled dressing.” Client calendar from same certification period shows PICC dressing changes on 4/23/25, then 8 days later 03/31/25. There is another incidence of the PICC dressing being completed later than ordered on 05/21/2025 and then 8 days later on 05/29/2025. Best practice “Guidelines for the Prevention of Intravascular Catheter-related Infections” direct healthcare personnel to change a PICC site dressing every 5-7 days. Clinical Record/Patient #15 On 05/28/2025 at 1:17 PM, a home visit was conducted to observe wound care. Skilled Nurse (SN) was wearing an electronic tablet on a strap across the right shoulder and the tablet was hanging from the nurses left hip area. SN adjusted the device and strap and performed hand hygiene. SN donned clean gloves and removed the soiled dressing from patient #15’s right foot. The soiled dressing was then discarded in the regular trash. According to the EPA (Environmental Protection Agency) Professional Brochure ‘Disposal Tips for Home Health Care’, it is recommended that soiled bandages be placed in securely fastened plastic bags before placing in the garbage with other trash. While still wearing contaminated gloves, SN readjusted the tablet hanging from the left hip as it had rotated towards the front/working area of the nurse. The SN grabbed the strap at SN chest level & moved the device towards the nurses back, touching the strap, SN uniform and tablet several more times before removing the contaminated gloves. SN then performed hand hygiene, donned clean gloves and began cleaning the wound. As the nurse bent towards the foot (wound), the tablet on the strap fell forward towards the working area and the SN would adjust this several more times going from wound to tablet to supplies and back. This not only contaminated the SN clothing, the strap SN uses for carrying the tablet, but also all patient dressing items. According to the CDC’s (Center for Disease Control) hand hygiene recommendations for correct procedures. Hand Hygiene should be performed: • Before and after contact with a patient; • Before performing an aseptic task (e.g., insertion of IV, preparing an injection, performing wound care); • After contact with blood, body fluids or contaminated surfaces; • After contact with the patient’s immediate environment; • When moving from a contaminated body site to a clean body site during patient care; and • After removal of personal protective equipment (e.g., gloves, gown, facemask). Based on Home Visits and Surveyor Observation, it was determined that Agency Staff did not adhere to known Infection prevention standards that markedly reduce the potential for infections in three (#13, #14, #15) of seven (#9-#15) home visit observations. This failed practice, if not corrected, has the potential to affect all patients on current and future census as well as potentially affecting staff and their families. Based on Home Visit Observation and Agency Staff interviews, it was determined the Agency did provide infection control education to staff. This standard, if not corrected, affected 3 (#13, #14, #15) of seven home visits observed and poses a risk of infection to all current and future patients as well as clinicians’ and their families by spread of infection causing increased complications to patients, prolonged home health services, rehospitalizations and treatment failures. Agency Representatives were asked to provide continuing education, and skills check off for Skilled Nurses observed during home visits. On 05/29/2025 the surveyor requested skills documentation for SN providing PICC care. Per Agency Staff #1, “We don’t have it.” On 6/2/25 at 1:15 PM, Agency staff #2 was asked to provide skills validation proof for Skilled nurses. Surveyor was told, “We are getting an educator soon and will be getting this taken care of. “”

“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 clinical record review, staff interview and review of agency policy, it was determined that the agency failed to follow its own policy of timeframes for documentation of skilled visits in three (#15, #20, #21) of 28 (#1-#28) clinical records reviewed. This condition, if left unresolved, had the potential to affect all patients on census in that delay of documentation could result in missed opportunities to create a clear and accurate clinical picture of how the individual patient is progressing which could cause a delay in detection of complications, poor coordination of care, lack of timely intervention and complications leading to rehospitalization, prolonged course of home health, increase in medical costs and poor outcomes up to and including death. Findings follow: A document titled, “Focus On Care” , with subject as “Clinical Documentation- Timely Submission Requirements” reads, “a. After patient care has been rendered, documentation will be entered into the patient medical record: Same day, or Next day by 9:00 AM (local agency time zone)” Clinical Record #15 showed the following: A visit note report dated 4/24/25 showed in home visit time beginning at 4/24/25 at 11:40 AM. The visit note was completed & synched (electronically sent) back to the EMR (electronic medical record) on 4/30/24 at 11:45 AM seven days past the policy requirement. Clinical Record #20 Revealed an OASIS start of care dated 3/10/25 at 10:14. The visit note was completed & synched back to the EMR on 3/16/25 at 1:45 PM six days past the policy requirement. A visit Note Report dated 3/19/25 and started at 10:38 AM. The visit note was completed and synched back to the EMR on 3/24/25 at 10:17 AM five days past the policy requirement. Clinical Record #21 Showed a Visit Note Report dated 3/17/25 and visit started at 3:04 PM. The Visit note was completed and synched back on 3/23/25 at 1:16 PM six days past the policy requirement. A visit Note Report dated 3/24/25 and visit time started at 10:33 AM. The visit note was completed and synched back to the EMR on 3/31/25 at 9:22 AM seven days past the policy requirement. Agency Representative #2 confirmed the late documentation and stated, “I have done some counselling recently about the late documentation issue.””

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Review of Clinical Records and staff interview, it was determined the Agency failed to develop and implement a comprehensive plan of care that accurately reflected the patient’s “Patient-specific measurable outcome” for 4 (#12, #16, #18, #21) of 28 (#1-#28), needs, goals, and physician-ordered interventions. Specifically, the agency did not ensure proper coordination of services, leading to inconsistencies in care delivery and potential risks to patient safety and well-being. Findings Follow: During Clinical Record Review, it was determined the agency failed to assure an individualized pain parameters for Clinical Records #12, #16, #18 & #21. All showed practitioners orders of a pain scale parameter to “report vital signs falling outside the following established parameters...pain >10”. (greater than ten) There is no known standardized clinical assessment tool that scores pain beyond a numeric rating of ten (10).”

“Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This Standard is not met as evidenced by: Based on Clinical record review, staff interview and home visits, it was determined the agency failed to provide written information and instructions specific to the patients and their caregivers in 5 (#10, #12, #13, #13, #14, #15) of 7 (#9-#15) home visits conducted. This failed practice, if left uncorrected, had the potential to affect all patients on census, in that, the lack of written education prevents and impairs the patient and family’s ability to play an integral part of patient centered care. Clinical Record/Patient #10 Home Visit: Conducted on 5/29/2025 at 2:15 PM. Inspection of home folder had no evidence of POC (Plan of Care), Medication list or current wound care instructions or home exercise program/physical therapy teaching. Clinical Record/Patient #12 Home Visit: Conducted 05/29/2025 at 12:35 PM. Home folder showed no POC, no medication list. Clinical Record/Patient #13 Home Visit: Conducted on 05/29/2025 at 11:33 AM, Inspection of home folder showed no evidence of POC, patient medication list. Clinical Record/Patient #14 Home Visit: Conducted on 05/29/2025 at 1:02 PM. Home folder showed no evidence of medication list, current POC or additional wound care orders. Clinical Record/Patient #15 Home Visit: Conducted 05/28/2025 at 1:17 PM. Upon inspection of contents of the home folder, no evidence of POC, or patient medication list was not located. During interview with Agency Staff #1 05/29/2025 at 3:23 PM, “We mail the medication lists and POC (Plan of Care) to the patient’s homes, we give copies to the clinicians as well but they never make it to the folders.””

“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 home visits and surveyor observation, it was determined that agency staff did not adhere to infection prevention precautions in three (#13, #14, #15) of seven (#9-#15) home visit observations. This failed practice, if not corrected, has the potential to affect all patients on current and future census in that, infections can complicate already health compromised patients. Findings follow: Clinical Record/Patient #13 A home visit was conducted on 05/29/2025 at 11:33 AM. SN (Skilled Nurse) was to perform a catheter change. Surveyor observed SN pulled the bedding down off the patient’s midsection and groin area. SN then exclaimed “Oh, I didn’t know it was a suprapubic catheter. I’ve never done (changed) one before.” SN required verbal queues from Agency Staff #1 to remove old catheter. Post removal, SN continued to rely on Agency Staff #1 to provide instruction as each step of the skill was attempted and then completed. Agency Staff #1 was required to open sterile packages and instruct SN on how to remove the items from packaging. SN dependence on Agency Staff #1 continued though out the skill. Immediately after exiting the home, surveyor asked Agency Staff #1 about the home visit. Agency Staff #1 stated, “It was her first suprapubic catheter change.” Clinical Record/Patient #14 A home visit was conducted on 05/29/2025 at 1:02 PM. SN was to perform a PICC (Peripherally Inserted Central Catheter) sterile dressing change. SN gathered a sterile dressing change kit (specifically made for this procedure), a clean plastic bag with face mask in it. Patient sat upright on the edge of the bed. SN Performed hand hygiene. Opened the PICC dressing kit in such a way as to create a sterile field by using the package. SN performed hand hygiene again, donned clean gloves and began rearranging items in the sterile PICC dressing kit contaminating the contents. SN then returned focus to patient #14, and removal of the current dressing. SN was observed pulling the dressing away from patient’s skin, yet dressing was still adhered to the PICC line and began pulling the line out of the patients arm approx. 0.5 cm before the patient noticed and stopped the SN. The surveyor observed patient # 14 push the PICC line back under the skin. Based on “Guidelines for the Prevention of Intravascular Catheter-related Infections” this is contraindicated as the area just under the skin where the PICC is placed can become infected as well as potentiating a systemic infection by allowing bacteria and contaminates to travel along the PICC line itself causing insertion site infection, systemic or whole-body infections. SN did not don a face mask, nor did SN instruct patient to wear a mask during the dressing change. This allowed for both nurse and patient to breathe on skin surrounding PICC and PICC itself during exposure to air. It is standard nursing practice to wear a mask during PICC care, and one is provided in the PICC dressing change kit for this reason. According to “PICC Dressing Change [+ Free Cheat Sheet]” at | Lecturio Nursing, it is also recommended that the patient either have their face turned away from the PICC site while care is being performed or be offered a mask to wear to avoid respiratory contamination. SN began cleaning the PICC site with the Chlorhexidine (a strong germicide) solution included in the kit. SN then allowed the site to dry but would periodically touch near the PICC to assure the skin was dry enough for the transparent dressing to adhere to the patient’s skin. SN put a bio-patch (a small foam like disc treated with antibacterial agents), then a transparent dressing. Immediately after the home visit, the surveyor asked Agency Staff #1 about SN execution of PICC care. Per Agency Staff #1, “I’ve never seen it (PICC care) done like that before.” On 05/29/2025 the surveyor requested skills documentation for SN providing PICC care. Per Agency Staff #, “We don’t have it.” On 06/02/2025 the surveyor requested skills documentation for SN providing PICC care. Per Agency Staff #2, “We are getting an educator soon and will be getting this taken care of. We have pulled that nurse from all sterile procedures for now.” Clinical Record/Patient #15 During Record Review, a document titled Home Health Plan of Care with certification dates of 04/21/2025 through 06/19/2025 revealed a physician’s order to “Perform (PICC) dressing changes to site weekly (every seven days) and PRN (as needed) for loose or soiled dressing.” Client calendar from same certification period shows PICC dressing changes on 4/23/25, then 8 days later 03/31/25. There is another incidence of the PICC dressing being completed later than ordered on 05/21/2025 and then 8 days later on 05/29/2025. Best practice “Guidelines for the Prevention of Intravascular Catheter-related Infections” found at NIH (National Institute of Health), direct healthcare personnel to change a PICC site dressing every 5-7 days. Clinical Record/Patient #15 On 05/28/2025 at 1:17 PM, a home visit was conducted to observe wound care. Skilled Nurse (SN) was wearing an electronic tablet on a strap across the right shoulder and the tablet was hanging from the nurses left hip area. SN adjusted the device and strap and performed hand hygiene. SN donned clean gloves and removed the soiled dressing from patient #15’s right foot. The soiled dressing was then discarded in the regular trash. According to the EPA (Environmental Protection Agency) Professional Brochure ‘Disposal Tips for Home Health Care’, it is recommended that soiled bandages be placed in securely fastened plastic bags before placing in the garbage with other trash. While still wearing contaminated gloves, SN readjusted the tablet hanging from the left hip as it had rotated towards the front/working area of the nurse. The SN grabbed the strap at SN chest level & moved the device towards the nurses back, touching the strap, SN uniform and tablet several more times before removing the contaminated gloves. SN then performed hand hygiene, donned clean gloves and began cleaning the wound. As the nurse bent towards the foot (wound), the tablet on the strap fell forward towards the working area and the SN would adjust this several more times going from wound to tablet to supplies and back. This not only contaminated the SN clothing, the strap SN uses for carrying the tablet, but also all patient dressing items. According to the CDC’s (Center for Disease Control) hand hygiene recommendations for correct procedures. Hand Hygiene should be performed: • Before and after contact with a patient; • Before performing an aseptic task (e.g., insertion of IV, preparing an injection, performing wound care); • After contact with blood, body fluids or contaminated surfaces; • After contact with the patient’s immediate environment; • When moving from a contaminated body site to a clean body site during patient care; and • After removal of personal protective equipment (e.g., gloves, gown, facemask). On 05/29/2025 the surveyor requested skills documentation for SN providing PICC care. Per Agency Staff #1, “We don’t have it.” On 6/2/25 at 1:15 PM, Agency staff #2 was asked to provide skills validation proof for Skilled nurses. Surveyor was told, “We are getting an educator soon and will be getting this taken care of.””

“Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This Standard is not met as evidenced by: Based on home visit observation and agency staff interviews, it was determined the agency did not provide infection control education to 3 (#4, #5, #6) of 4 (#4 - #7) Skilled Nurses (SN) observed. This failure to provided required education, if not corrected, affected 3 (#13, #14, #15) of seven home visits observed and poses a risk of infection to all current and future patients as well as clinicians’ and their families by spread of infection causing increased complications to patients, prolonged home health services, rehospitalizations and treatment failures. Findings follow: Clinical Record/Patient #13 A home visit was conducted on 05/29/2025 at 11:33 AM. Review of Patient’s clinical record revealed an order for the SN (Skilled Nurse) to perform a catheter change. Surveyor observed SN pulled the bedding down off the patient’s midsection and groin area. SN then exclaimed “Oh, I didn’t know it was a suprapubic catheter. I’ve never done (changed) one before.” SN required verbal queues from Agency Staff #1 to remove old catheter. Post removal, SN continued to rely on Agency Staff #1 to provide instruction as each step of the skill was attempted and then completed. Agency Staff #1 was required to open sterile packages and instruct SN on how to remove the items from packaging. SN continued to rely on physical assistance and verbal ques from Agency Staff #1,and was eventually able to complete the skill. The surveyor asked Agency Staff #1 about the home visit. Agency Staff #1 stated, “It was her first suprapubic catheter change.” Clinical Record/Patient #14 A home visit was conducted on 05/29/2025 at 1:02 PM. SN was to perform a PICC (Peripherally Inserted Central Catheter) sterile dressing change. Surveyor observed as SN gathered a sterile dressing change kit (specifically made for this procedure), a clean plastic bag with face mask in it. Patient sat on edge of bed. SN performed hand hygiene. Opened the PICC dressing kit in such a way as to create a sterile field by using the package. SN performed hand hygiene again, donned clean gloves and began rearranging items in the sterile PICC dressing kit contaminating the contents. SN then returned focus to patient #14, and removal of the current dressing. SN was observed pulling the dressing away from patient’s skin, yet dressing was still adhered to the PICC line and began pulling the line out of the patients arm approx. 0.5 cm before the patient noticed and stopped the SN. The surveyor observed patient # 14 push the PICC line back under the skin. Based on “Guidelines for the Prevention of Intravascular Catheter-related Infections” at NIH (National Institute of Health), is contraindicated as the area just under the skin where the PICC is placed can become infected as well as potentiating a systemic infection by allowing bacteria and contaminates to travel along the PICC line itself causing insertion site infection, systemic or whole-body infections SN did not don a face mask, nor did SN instruct patient to wear a mask during the dressing change. This allowed for both nurse and patient to breathe on skin surrounding PICC and PICC itself during exposure to air. It is standard nursing practice to wear a mask during PICC care and one is provided in the PICC dressing change kit for this reason. According to “ PICC Dressing Change [+ Free Cheat Sheet] “ at | Lecturio Nursing, it is also recommended that the patient either have their face turned away from the PICC site while care is being performed or be offered a mask to wear to avoid respiratory contamination. SN began cleaning the PICC site with the Chlorhexidine (a strong germicide) solution included in the kit. SN then allowed the site to dry but would periodically touch near the PICC to assure the skin was dry enough for the transparent dressing to adhere to the patient’s skin. SN put a bio-patch (a small foam like disc treated with antibacterial agents), then a transparent dressing. Immediately after the home visit, the surveyor asked Agency Staff #1 about the SN execution of PICC care. Per Agency Staff #1, “I’ve never seen it (PICC care) done like that before.” Clinical Record review revealed a document titled Home Health Plan of Care with certification dates of 04/21/2025 through 06/19/2025 revealed a physician’s order to “Perform (PICC) dressing changes to site weekly (every seven days) and PRN (as needed) for loose or soiled dressing.” Client calendar from same certification period shows PICC dressing changes on 4/23/25, then 8 days later 03/31/25. There is a second incidence of the PICC dressing being completed later than ordered on 05/21/2025 and then 8 days later on 05/29/2025. Best practice “Guidelines for the Prevention of Intravascular Catheter-related Infections” at NIH direct healthcare personnel to change a PICC site dressing every 5-7 days. On 05/29/2025 at 3:00PM, the surveyor requested skills documentation for SN providing PICC care. Per Agency Staff #, “We don’t have it.” On 06/02/2025 at 1:15 PM, the surveyor requested skills documentation for SN providing PICC care. Per Agency Staff #2, “We are getting an educator soon and will be getting this taken care of. We have pulled that nurse from all sterile procedures for now.” Clinical Record/Patient #15 On 05/28/2025 at 1:17 PM, a home visit was conducted to observe wound care. Skilled Nurse (SN) was wearing an electronic tablet on a strap across the right shoulder and the tablet was hanging from the nurses left hip area. SN adjusted the device and strap and performed hand hygiene. SN donned clean gloves and removed the soiled dressing from patient #15’s right foot. The soiled dressing was then discarded in the regular trash. According to the EPA (Environmental Protection Agency) Professional Brochure ‘Disposal Tips for Home Health Care’, it is recommended that soiled bandages be placed in securely fastened plastic bags before placing in the garbage with other trash. While still wearing contaminated gloves, SN readjusted the tablet hanging from the left hip as it had rotated towards the front/working area of the nurse. The SN grabbed the strap at SN chest level & moved the device towards the nurses back, touching the strap, SN uniform and tablet several more times before removing the contaminated gloves. SN then performed hand hygiene, donned clean gloves and began cleaning the wound. As the nurse bent towards the foot (wound), the tablet on the strap fell forward towards the working area and the SN would adjust this several more times going from wound to tablet to supplies and back. This not only contaminated the SN clothing, the strap SN uses for carrying the tablet, but also all patient dressing items. According to the CDC’s (Center for Disease Control) hand hygiene recommendations for correct procedures. Hand Hygiene should be performed: • Before and after contact with a patient; • Before performing an aseptic task (e.g., insertion of IV, preparing an injection, performing wound care); • After contact with blood, body fluids or contaminated surfaces; • After contact with the patient’s immediate environment; • When moving from a contaminated body site to a clean body site during patient care; and • After removal of personal protective equipment (e.g., gloves, gown, facemask). Agency Representatives were asked to provide continuing education and skills check off for Skilled Nurses observed during home visits. On 05/29/2025at 3:00 PM, the surveyor requested skills documentation for SN providing PICC care. Per Agency Staff #1, “We don’t have it.” On 6/2/25 at 1:15 PM, Agency staff #2 was asked to provide skills validation proof for Skilled nurses. Surveyor was told, “We are getting an educator soon and will be getting this taken care of. We have pulled that nurse from all sterile procedures for now.””

“Investigate complaints made by patient CFR(s): 484.50(e)(1)(i) The HHA must— (i) Investigate complaints made by a patient, the patient’s representative (if any), and the patient’s caregivers and family, including, but not limited to, the following topics: (A) Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately; (B) Mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of patient property by anyone furnishing services on behalf of the HHA. This Element is not met as evidenced by: Based on review of agency documentation, clinical records and staff interview, the agency failed to investigate complaints in 7 (#1, #20, #21, #23, #24, #25, #26) of 28 (#1 - #28) clinical records reviewed. This deficient practice had the potential to negatively affect any patient current or future who complains about Agency services, clinicians or care and supplies and limited the agency in providing an appropriate response to complaints. Findings follow: A document titled “Complaints Activity Listing” printed 5/28/25 at 1:06 PM, Revealed seven complaints for Clinical Records #1, #20, #21, #23, #24, #25, #26 from dates 08/06/2024-05/28/2025. The Agency showed no investigation or resolution documentation. Agency staff were asked to provide additional information. None was forthcoming.”

“Strengths, goals, and care preferences CFR(s): 484.55(c)(2) The patient’s strengths, goals, and care preferences, including information that may be used to demonstrate the patient’s progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the HHA; This Element is not met as evidenced by: Based on Clinical Record Review and staff interview, it was determined the agency failed to incorporate the patient’s strengths, goals, and care preferences into the care planning process, resulting in care that did not align with the patient’s identified needs and measurable outcomes. Specifically, documentation lacked essential information demonstrating the patient’s progress toward achieving their goals, leading to gaps in personalized care delivery and ineffective interventions concerning pain and the treatment and control of pain in 4 (#12, #16, #18, #21) of 28 (#1-#28) clinical records reviewed. By not providing a measurable goal for pain, the Agency placed these patients in a passive, recipient role and did not allow these patients or their physicians to take an active role in their care by setting a patient specific objective with both patients and physicians. This deficient practice, if not corrected, has the potential to affect all patients currently on census and any future admissions. Clinical Records #12, #16, #18 and #21 revealed plan of care pain parameter goal set at “>10” (greater than 10). There is no known current, standardized numeric clinical pain assessment tool scoring past “10”. Agency staff were asked about a pain assessment tool used by the clinical staff. on 05/28/2025 at 9:36 AM, agency staff #3 stated, “Not that I know of.””

“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 clinical record review, staff interview and patient home visit, it was determined the agency failed to assure Medical Marijuana was included in a review for all other Patient medications 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 in one #12 of 28 records reviewed (#1-#28). This failed practice, if not corrected, has the potential to affect all patients on census who use medical marijuana for therapeutic symptom control in that if left unlisted, a complication, synergistic effect, failed drug therapy or interactions with other medications the patient may be taking leading to complications with treatment and rehospitalization risk. A home visit was conducted on 05/29/2025 at 11:33 AM for patient #12. Surveyor observed a Medical Marijuana vape. (a small battery-operated device someone can ‘smoke’ like a cigarette but the contents of the device has vapor instead of smoke). Upon questioning, the patient stated it belonged to them and was used to control pain. Patient #12 went on to express its effectiveness with controlling pain and the frequency of use. Upon record review a document was revealed titled “Patient Medication Record.” Medical Marijuana was not listed. On 05/29/2025 at 3:00 PM, Agency staff were asked to provide additional information. None was forthcoming.”

“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 Clinical Record Review and staff interview, it was determined the Agency failed to promptly notify the patient’s physician(s) or allowed practitioner(s) of changes in the patient’s condition or needs that indicated unmet care outcomes or required modifications to the plan of care in 5 (#15, #16, #17, #20, #22) of 28 (#1-#28) Clinical Records reviewed. Specifically, delays in communication resulted in inadequate consultation and consideration to the physicians ordered vital sign parameters or omitting vital signs and treatments causing delay or lack of therapeutic adjustments to treatment, potentially compromising patient safety and well-being.This has the ability ot affect all current patients on census as well as any future patients admitted to the agency. Clinical Record #15 Shows a document titled Home Health Certification and Plan of Care with dates of 04/11/2025-6/09/2025 with a physician’s order “Licensed professional to report vital signs falling outside the following established parameters...Pain >8” Vital Sign Report revealed a single entry for pain on 05/25/2025 A document titled “Wound record Report” revealed: 4/11/25, pain was reported at “9” with a duration of “all the time.”, 4/17/25 pain rated at “8” with duration of “all the time”, 5/9/25 a pain level of “8” with duration of “daily”, 5/21/25 pain reported at “8” with duration of “daily”. There was no evidence of agency staff contacting practitioner about patients’ persistent pain and possible changes needed to assist with control of pain. Clinical Record #16: Showed Clinicians made visits 7 times, but the patient temperature was only recorded on 04/1/25 & 04/18/25. There were no orders to omit checking the patient’s temperature, discontinue checking the temperature or that only specific clinicians were responsible to checking the temperature. Clinical Record #17: Document titled Home Health Certification and Plan of Care with dates from 04/24/2025 through 06/22/2025 revealed a diagnosis of heart failure and a physician’s order for “ Skilled Nurse to observe and assess cardiovascular system to identify changes and intervene to minimize complications and promote self-care management, skilled nurse to provide skilled teaching related to pathophysiology, disease management, weight/edema management...” Daily weights obtained by the patient or by clinician when making a home visit, is an integral part of a standard heart failure patient. According to Daily Weights - American Association of Heart Failure Nurses, “having the patient weight monitoring is important because it Detects fluid overload early – CHF patients often retain fluid due to poor heart function, leading to rapid weight gain, Guides diuretic therapy – Changes in weight help determine if adjustments to diuretics (water pills) are needed, Prevents hospitalizations – Catching weight fluctuations early can prevent severe fluid buildup that may require emergency care, Tracks disease progression – A steady increase in weight may indicate worsening heart failure, while weight loss could signal effective treatment.)” 4/24/25 Admission weight: 146.2 lbs., 4/29/25-weight was not obtained, 5/2/25 weight 148.6 lbs.,5/15/25 two clinicians visited at two different times. One weight was recorded for that day-139 lbs., 5/22/25-no weight recorded, 5/29/25- no weight recorded. Clinical Record #20: Showed a document titled Home Health Certification and Plan of Care with dates from 03/10/25 through 5/8/25. The primary diagnosis for this patient we “Pressure Ulcer or Right Hip, Unstageable” (An unstageable pressure ulcer is a type of pressure injury where the full extent of tissue damage cannot be determined because the wound is covered by necrotic tissue, eschar (a thick, black or brown scab), or slough (soft, yellow or tan tissue). A physician’s order of, “Skilled Nurse to perform/teach wound care to unstageable pressure ulcer to right hip. Cleanse with wound cleanser, apply Xerofoam (Xeroform is a type of sterile wound dressing made of fine-mesh gauze impregnated with petrolatum and 3% bismuth tribromophenate It is non-adherent, meaning it won’t stick to the wound, which helps minimize pain during dressing changes.) to wound bed, and cover with 4x4 (4 centimeters by 4 centimeters square) Mepelex (a type of absorbent foam dressing designed for managing chronic and acute wounds. It is soft and foam-like which helps reduce trauma during dressing changes. Wound care to be performed every other day by caregiver except skilled nursing days.” 3/19/25 a Skilled Nurse (SN) Visit Note showed documentation by SN that wound care was not provided during the visit due to “supplies being low” 3/21/25 A SN documented calling patient caregiver to set up a time for at visit for this day. Caregiver asked nurse if they would be bringing and supplies for the patient’s wound and SN did not have the specific supplies ordered by the doctor. The visit was refused by the caregiver due of lack of wound care supplies. Clinical Record #22: Showed an order to report to practitioner pain “>8” (greater than 8). SVN (skilled visit note) 04/02/25 shows patient reports pain of “8”. There was no evidence in the clinical record of notification to the physician, no documentation of strategies attempted to alleviate the patient’s pain or any teaching.”

“In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This Element is not met as evidenced by: Based on clinical record review, review of a standard publication on pain management, and staff interview, it was determined the agency had not adhered to current clinical practice concerning pain assessment in four (#12, #16, #18, #21) or 28 (#1-#28) clinical records reviewed. This failed practice had the potential to affect all patients on census and future census, in that, not using a current practice for pain assessment and implementing interventions based on those assessments could negatively impact a patient’s healthcare, increase rehospitalization rates, and delay healing. Patients #12, #16, #18, #21 All had orders to notify the physician or practitioner for “pain >10”. There is no known clinical numeric assessment tool for pain that goes beyond “10”. According to NIH (National Institute of Health),”Patient Safety and Quality: An Evidence-Based Handbook for Nurses” When a patient’s pain is well controlled, it leads to significant improvements in their physical, emotional, and overall well-being including Better Mobility & Function, Improved Sleep, Enhanced Mood & Mental Health, Faster Recovery, Better Social Engagement, Improved Appetite & Nutrition and better relationships and trust with healthcare staff. This deficient practice, if not corrected, has the potential to affect all patients on census or future admissions with acute or chronic pain conditions. on 5/28/2025 at 1:00 PM, Surveyor requested the assessment tool used by Agency to assess pain and Agency Staff #3 said, “We don’t have one.””