Every finding on record at All Care Home Health Provider

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey. Complaint: 2573178 Census: 1,102 Unduplicated admissions: 5,572 Sample Size: 17 Home Visits: 6 The following Conditions of Participation (COP) are not met: 484.55 Condition of Participation: Comprehensive Assessment of Patients 484.60 Condition of Participation: Care Planning, Coordination of Services, and Quality of Care 484. Condition of Participation: Clinical Records

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 observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Comprehensive Assessment of Patients as follows: 1.The HHA failed to ensure the comprehensive assessment included a complete physical assessment for two of seventeen sampled patients (Patient 3, Patient 12). This deficient practice resulted in Patients not receiving care according to the HHA’s procedures, which had the potential to result in complications and health status decline. (Refer G528). 2. The HHA failed to review and document all the medications and treatments the patient was currently using for six of seventeen sampled patients (Patient 2, Patient 3, Patient 6, Patient 8, Patient 12, Patient 14). This deficient practice placed the patients at risk of drug-to-drug interaction and harm by not knowing which medications the patients were taking. (Refer to G536). 3. The HHA failed to ensure the comprehensive assessment for one of seventeen sampled patients (Patient 12) accurately reflected the primary care doctor responsible for the patients care. This deficient practice has the potential for delay of care by not knowing which doctor to contact in case there was a change of condition. (Refer to G538). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with the Federal regulations for Comprehensive Assessment of patients to ensure home health care benefits are verified for eligibility to patients provided home health services.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: (1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to ensure the comprehensive assessment included a complete physical assessment for two of seventeen sampled patients (Patient 3, Patient 12). This deficient practice has the potential risk to result in patients not receiving the care and services identified in the assessment and plan of care leading to complications and health status decline. A record review of Patient 12’s Patient Profile sheet indicated a start of care date of 10/7/2024, with diagnoses including encounter for attention to colostomy (a surgically created opening of the large intestine that allows stool to exit through outside of the belly). During a concurrent observation and interview at the home visit on 11/18/2025, at 10:07 a.m., with Licensed Vocational Nurse 4 (LVN 4), LVN 4 provided colostomy care to Patient 12. An observation of the colostomy care indicated LVN 4 did not measure Patient 12’s stoma (the opening of the intestine through the belly). LVN 4 stated she knew the size of the stoma due to the frequent visits, and that was the reason why LVN 4 was not measuring it today. Continued observation of the colostomy care indicated LVN 4 cleaned the stoma and surrounding skin with soap (from the soap dispenser in the bathroom) and water. During the colostomy care Patient 12 stated he had gained some weight and the weight gain was making his stoma feel uncomfortable. Patient 12 stated he was working on losing weight so his stoma doesn’t stretch. During a concurrent interview and record review on 11/18/2025, at 10:43 a.m., with LVN 4, LVN 4 reviewed Patient 12’s record titled Plan of Care, dated 10/22/2025 to 12/20/2025. The record indicated, “Colostomy care-every Tuesday and Friday”. No other instructions for colostomy care were indicated. LVN 4 stated the plan of care was supposed to have instructions for stoma care, so everyone could follow the same treatment and nursing staff know what do to. A record review of the HHA’s document titled, Colostomy Care, dated 11/19/2025, indicated, “Step-By-Step Colostomy Care…5. Cleanse stoma and peristomal skin gently with warm water; pat dry”. Further review of the record did not indicate instructions for using soap to clean the stoma and surrounding skin. During an interview on 11/19/2025, at 10:58 a.m., with the DPCS, the DPCS stated that nurses were supposed to provide colostomy care according to the policy, unless the doctor specified the orders. If there were no specific orders to follow, it could lead to possibly harming the patient by not giving the proper treatment. During an interview on 11/19/2025, at 12:18 p.m., the DPCS stated Patient 12 did not have a specific order for colostomy care. The expectation was for the nurses to follow the HHA’s policy on colostomy care. During a concurrent interview and record review on 11/19/2025, at 12:58 p.m., with the DPCS, the DPCS reviewed the HHA’s document titled, Colostomy Care, dated 11/19/2025. The document indicated, “Documentation must include: Stoma size, color, output characteristics…type of appliance used and wear time…”. The DPCS stated the purpose of taking the stoma size was to make sure the pouch (collection device) was the appropriate size for the patient, to prevent skin irritation. The stoma size should be getting smaller, indicating there is no complications. The DPCS stated there was a conflict between what the policy indicated and what the nurses were expected to do because the HHA did not expect the nurses to measure the stoma, as indicated in the policy. The DPCS stated measuring the stoma was best practices, because its for the patient safety, better health outcomes, and have to monitor the size to prevent complications. In reference to documentation of type of appliance, the DPCS stated this was important because this specified what specific pouch was needed for the patient and to monitor the continued use of the appropriate pouch. During a concurrent interview and record review on 11/19/2025, at 1:08 p.m., with the DPCS, the DPCS reviewed Patient 12’s record titled, OASIS Nurse Recertification, dated 10/17/2025. The DPCS stated there was no stoma size, type of appliance, wear time, output characteristics documented. The purpose of monitoring output characteristics was to differentiate, to report abnormalities, unusual output, which can mean complications. The DPCS stated the purpose of the recertification assessment was a comprehensive assessment to identify the needs of the patient, to develop the plan of care. During a record review of the agency’s policy and procedure, titled “Ongoing Assessment” undated, the policy and procedure indicated, “During each home visit, the clinician or other discipline will re-evaluate the patient according to the problems identified during the initial visit and subsequent visits. Using the standards of care identified by the organization, the clinician will reassess the patient (as appropriate) for: A. Blood pressure, pulse, respirations, temperature B. Weight (once each week, if indicated by disease) C. Pain status, when applicable, including:1.Responses to pain intervention(s) 2. Progress toward pain management goals, including functional ability 3. Side effects of treatment 4. Risk factors for adverse events caused by the treatment D. Breath sounds E. Skin integrity F. Bowel sounds; elimination (urinary arid bowel) G. Appetite/diet, nutritional status H. Mental status I. Functional status J. Safety/home environment K. Patient and family/caregiver support”. A.During a record review of Patient 3’s Patient Profile sheet indicated a start of care date of 07/23/2025, with diagnoses including post laminectomy syndrome (is characterized by a persistent back or neck pain after spine surgery, sometimes accompanied by radiating pain, numbness, or weakness in the extremities). During a concurrent observation and interview on 11/18/2025 at 11:10 a.m. with Family Member 2 (FM 2), a photo was observed on FM 2’s cellular phone dated 10/28/2025 with an image of Patient 3, with a raised bump on the right side of the forehead with redness. FM 2 stated, “Patient 3 had a fall at the doctor’s office in October, based on this image it was October 28th, 2025. It was a pretty bad fall. We are lucky it happened at the doctors office and they took imaging.” During a interview and record review on 11/19/2025 at 1:55 pm with DPCS, Patient 3’s medical record was reviewed. There was no documented evidence of any falls in the communication log or documentation by the physical therapist and occupational therapist notes following 10/28/2025, dated 10/29/2025, 10/30/2025, 11/03/2025, 11/06/2025, 11/07/2025, 11/11/2025. The DPCS stated, “I don’t see any documentation Patient 3 had a fall. It is important to report falls, because it is part of the comprehensive ongoing assessment, and so we can notify the physician and monitor the progress of the patient and make sure they are okay.”

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to review and document all the medications and treatments the patient was currently using for six of seventeen sampled patients (Patient 2, Patient 3, Patient 6, Patient 8, Patient 12, Patient 14). This deficient practice placed the patients at risk of drug-to-drug interaction and harm by not knowing which medications the patients were taking. A record review of Patient 12’s Patient Profile sheet indicated a start of care date of 10/7/2024, with diagnoses including encounter for attention to colostomy (a surgically created opening of the large intestine that allows stool to exit through outside of the belly). During a concurrent observation, interview, and record review at the home visit on 11/18/2025, with Licensed Vocational Nurse 4 (LVN 4), LVN 4 reviewed the medication Patient 12 was taking using record titled, Medication Profile, dated 10/17/2025. LVN 5 stated the following medications were at home, patient reported taking, but was not listed: Atorvastatin (used to lower cholesterol (fat) levels in the blood) 10 mg (mg-milligram, unit of measurement) 1 tablet by mouth at bedtime. Triamcinolone (treats skin discomfort such as redness, itching) 0.1% (%-percent) ointment (cream). Apply and gently massage into affected are twice daily. Omega 3 (a supplement). 1000 mg capsule. 1 capsule daily. Vitamin D 3(a supplement). 50 mcg (mcg-micrograms, unit of measurement). 1 tablet daily. LVN 4 stated the medication Zofran (used to treat nausea) listed had the wrong dose documented. The medication profiled indicated Zofran 4 mg. Patient 12’s Zofran label read Zofran 8 mg 1 tablet every 8 hours as needed. During an interview on 11/18/2025, at 10:43 a.m., with LVN 4, LVN 4 stated the nurse needed to review the medications and update the medication profile every visit. The importance of reviewing medications was so the nursing staff could follow the patients treatment, to ensure the medication was effective, monitor for medication side effects, and educate the patient/family on medication use. A record review of Patient 12’s Plan of Care, dated 10/22/2025 to 12/20/2025, indicated the skilled nurse was visiting the patient twice a week for colostomy care. A record review of Patient 14’s Patient Profile sheet indicated a start of care date of 8/14/2025 with diagnoses including essential hypertension (high blood pressure). During a concurrent observation, interview, and record review at the home visit on 11/18/2025, with Licensed Vocational Nurse 5 (LVN 5), LVN 5 reviewed the medication Patient 14 was taking using record titled, Medication Profile, dated 8/14/2025. The following medications were at Patient 14’s home, Patient 14 reported taking, and were not listed on the mediation profile: Gabapentin (treats nerve pain) 200 mg, 1 capsule every day. The medication label indicated it was filled on 9/25/2025. Tamsulosin (treatment of prostate issues) 0.4 mg, 1 capsule by mouth every day. The medication label indicated it was filled on 9/25/2025. Tylenol 500 mg as needed. Patient 14 stated to LVN 5 he was taking the medication 2 to 3 times daily. LVN 5 stated Patient 14 did not tell LVN 5 Patient 14 was taking the medications listed above. During a record review of the agency’s policy and procedure, titled “Medication Profile” , undated, the policy and procedure indicated, “ Upon admission to the organization, the admitting clinician will initiate a medication profile to document the current medication regimen, including name, drug classification, date prescribed/discontinued, dose, strength, route, frequency, date and time of administration and any drug or food allergies. A drug regimen review will be performed at the time of admission, when updates to the comprehensive assessments are performed, when care is resumed after a patient has been placed on hold, and with the addition of a new medication. A. The review will be performed by qualified personnel and will identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, significant side effects, significant drug interactions, duplicative drug therapy, and noncompliance with drug therapy. During subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver, as well as other clinicians, understand the medication regimen. This includes, but will not be limited to: A. Using the medication profile, in conjunction with other pertinent data, to evaluate the use of the drugs in the home setting...” b. During a record review of Patient 6’s “Plan of Care” dated 10/24/2025 to 12/22/2025, indicated a start of care date of 8/22/2025 with a primary diagnosis of an encounter for fitting and adjustment of urinary device. During a joint home visit, on 11/18/2025 at 9:30 a.m. with the Licensed Vocational Nurse (LVN 2) at Patient 6’s residence, Patient 6 was observed lying down in the couch with walker next to the couch. During a review of Patient 6’s current medication, on 11/18/2025 at 10:26 a.m. with LVN 2, the following medications were not available in Patient 6’s residence but listed in Patient 6’s medication list provided by the HHA: - Metoprolol Succinate Extended Release (used treat several cardiovascular conditions by lowering heart rate and blood pressure), 25 milligrams (mg – unit of measurement), 0.5 tablet daily - Linzess ( used to treat specific chronic constipation)145 microgram (mcg – unit of measurement), 1 capsule daily - Senna (used on a short-term basis to treat constipation) 8.6 mg tablet, 1 tablet daily - Trazodone (used to treat major depressive disorder) 50 mg tablet, 1 tablet as needed - Tolterodine Extended Release (used to treat symptoms of an overactive bladder), 4 mg capsule, 1 capsule daily - Crestor (used to lower bad cholesterol) 40 mg tablet, 1 tablet daily - Acetaminophen (used to relieve mild to moderate pain and reduce fever) 500 mg tablet, 1 tablet as needed evert 6 hours - Lidocaine Patch (used to provide temporary relief of pain by numbing the nerves in a specific area), 1 Patch as needed c. During a record review of Patient 7’s “Plan of Care” dated 10/23/2025 to 12/21/2025, indicated a start of care date of 10/23/2025 with a primary diagnosis of type 2 diabetes mellitus (high blood sugar levels) without complications. During a joint home visit, on 11/18/2025 at 10:35 a.m. with the Physical Therapist (PT) at Patient 7’s residence, Patient 7 was observed sitting down in by the dining table. During a review of Patient 7’s current medication, on 11/18/2025 at 11:20 a.m. with PT, the following medications were not available in Patient 7’s residence but listed in Patient 7’s medication list provided by the HHA: - Vitamin D3 (supplement) mcg (1,000 units), 1 tablet daily - Carvedilol (used to treat high blood pressure). 6.25 mg tablet, 1 tablet daily During a review of Patient 7’s current medication, on 11/18/2025 at 11:20 a.m. with PT, the following medications were not available in Patient 7’s residence but listed in Patient 7’s medication list provided by the HHA: - Glipizide Extended Release (used to treat high blood sugar levels), 5 mg tablet, 1 tablet daily - Trazadone 50 mg tablet, 1 tablet daily at bedtime - Carvedilol 12.5 mg tablet, 1 tablet twice a day - Vitamin D3 125 mg (5,000 units), 1 tablet daily - Acetaminophen 500 mg tablet - Koi CBD (Cannabidiol - non-psychoactive compound found in cannabis plants that has potential medical applications like reducing anxiety and pain), 1500 mg Roll-on Gel - Koi CBD Balm 3000mg During an interview, on 11/19/2025 at 12:25 p.m., with the Director of Patient Care Services DPCS, the DPCS stated that medication reconciliation should be done every visit. DPCS stated that it is important for medication reconciliations to be done every visit to make sure patient is educated on new medications and staff check to make sure there are no discontinued medications. A. During a record review of Patient 2’s Patient Profile sheet indicated a start of care date of 11/08/2024, with diagnoses including other artificial opening of urinary tract status (Refers to the presence of a surgically created opening in the urinary tract for draining urine). During a concurrent interview and record review on 11/18/2025 at 9:50 am with Licensed Vocational Nurse 1 (LVN 1) at Patient 2’s residence, LVN 1 reviewed the medication Patient 2 was taking using record titled, Medication Profile, dated 09/03/2025-11/08/2025. LVN 1 stated the following medications were at home reflecting the dosage and frequency patient reported taking, but listed at different dosage and frequency on the Medication Profile: Lasin 20 mg tablet 1 tablet taken daily except for Monday, Wednesday, and Friday 2 tablets taken by patient, but listed as take one tablet every Monday Wednesday and Friday on the medication profile PreserVision Areds 2N/A (a supplement) 2 tablets daily, but listed as take one tab daily on medication profile Creon 24,000 units capsule takes two daily with meals, but listed as there is 36,000 units on the medication profile Sodium Bicarbonate (used for heartburn) 650mg takes three times a day, but listed as take three times weekly every Monday Wednesday and Friday on the medication profile Lokelma 10 gram powder (used to treat high potatssium levels) t packet takes three times weekly, but listed as take one packet three times daily on the medication profile Iron 325 mg (supplement) takes 1 tablet once a day, but listed as take one tablet 3 times weekly on medication profile Vitamin D 3 (supplement) 25mcg, takes once a day but listed on the medication profile as 50mcg LVN 1 stated, “medication reconciliation needs to be done by nursing staff on every visit. This was missed. It is important to do it so we can update the agency and the doctor on the patients current meds.” During an interview and record review on 11/19/2025 at 1:00 pm with DPCS, DPCS stated “medication reconciliation is supposed to be done every visit, this includes physical therapists as well nurses. They are supposed to do it on every visit. This was missed for these patients.” B. During a record review of Patient 3’s Patient Profile sheet indicated a start of care date of 07/23/2025, with diagnoses including post laminectomy syndrome (is characterized by a persistent back or neck pain after spine surgery, sometimes accompanied by radiating pain, numbness, or weakness in the extremities). During a concurrent interview and record review on 11/18/2025 at 10:55 am with Registered Nurse 1 (RN 1), at Patient 3’s residence, RN 1 reviewed the medication Patient 3 was taking using record titled, Medication Profile, dated 07/23/2025-09/18/2025. RN 1 stated the following medications were at home, patient reported taking, but was not listed: -Diclofenac sodium (an anti-inflammatory medication) 75mg, take 1 tablet by mouth twice daily as needed no indication for reason date filled 11/11/2025 -Lisinopril 10mg (a medication to lower elevated blood pressure) take 1 tablet by mouth daily date filled 7/24/2025 -Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic solution (used to treat elevated pressure inside the eye) USP (united states pharmacopeia, it signifies that the product meets the stringent quality standards for identity, strength, purity, and performance) 2% /0.5% one drop in each eye daily -Brimonidine Tartrate ophthalmic solution 0.2% one drop in each eye daily. The following medications were listed on the medication profile but not available in Patient 3’s residence: -Bisoprolol fumarate (a medication to lower blood pressure) 5mg tablet take 1 tablet by mouth daily -Norco 5mg/325 mg tablet (pain medication) 1 tablet as needed every 6 hours for pain -Gabapentin 100 mg (medication for nerve pain) 2 tablets twice a day RN 1 stated, “this was missed by the physical therapist. Medication reconciliation needs to be done on every visit by physical therapists, occupational therapists and nurses. This is very important so we can keep track of all the current medications the patient has and communicate with the physician.” During an interview and record review on 11/19/2025 at 1:00 pm with DPCS, DPCS stated “medication reconciliation is supposed to be done every visit, this includes physical therapists as well nurses. They are supposed to do it on every visit. This was missed for these patients.”

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to ensure the comprehensive assessment for one of seventeen sampled patients (Patient 12) accurately reflected the primary care doctor responsible for the patient's care. This deficient practice has the potential for delay of care by not knowing which doctor to contact in case there was a change of condition. A record review of Patient 12’s Patient Profile sheet indicated a start of care date of 10/7/2024, with diagnosis including encounter for attention to colostomy (a surgically created opening of the large intestine that allows stool to exit through outside of the belly). During an interview at the home visit on 11/18/2025, at 9:50 a.m., Patient 12 stated he had a new primary care doctor since (Medical Doctor 2-MD 2) 10/18/2025 because his previous doctor (Medical Doctor 1-MD 1) had stopped taking his health insurance in September 2025. During a concurrent interview and record review on 11/19/2025, at 1:08 p.m., with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 12’s record titled, OASIS Nurse Recertification, dated 10/17/2025. The record indicated MD 1 was the Physician (Doctor) Signing Plan of Care. During an interview on 11/19/2025, at 1:15 p.m., with the DPCS, the DPCS it was important to ensure the correct doctor was in the comprehensive assessment so if there were abnormal findings with the patient, the right doctor would be called so the patient can be treated right away. A record review of the HHA’s undated document titled, Ongoing Assessments, indicated, “Based on the findings of the reassessment, additional order will be generated and forwarded to the physician (doctor)…for signature(s).”

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: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation regarding Care Planning, Coordination, and Quality of Care was met as follows: 1. The HHA failed to ensure the Plan of Care (POC) was followed for three of seventeen sampled patients (Patient 12, Patient 14, Patient 16). This failure placed patients at risk for health status decline by not providing the services as indicated in the POC (Refer to G572). 2. The HHA failed to include information required in the plan of care for two of seventeen sampled patients (Patient 2, Patient 12). This failure had the potential to result in patients not receiving the identified needs and services, and have a decline in health status, that could affect their quality of care and well-being. (Refer to G574). 3. The HHA failed to ensure the physician reviewed and revised five of seventeen sample patients (Patient 1, Patient 2, Patient 14, Patient 15, and Patient 17) individualized plan of care. This failure had the potential to result in Patient receiving inappropriate or lacking appropriate services. (Refer to G588). 4. The HHA failed to provide written information regarding the plan of care and medication list for one of seven patients (Patient 12). This deficient practice resulted in patients and their representatives not knowing their care team or their treatment course. (Refer to G612). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure highest quality health care is provided to patients assessed to receive home health services.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Plan of Care (POC) was followed for five of seventeen sampled patients (Patient 7, Patient 10, Patient 12, Patient 14, Patient 16). This failure placed patients at risk for health status decline by not providing the services as indicated in the POC. A record review of Patient 12’s Patient Profile sheet indicated a start of care date of 10/7/2024, with diagnoses including encounter for attention to colostomy (a surgically created opening of the large intestine that allows stool to exit through outside of the belly). During a concurrent observation and interview at the home visit on 11/18/2025, at 10:07 a.m., with Licensed Vocational Nurse 4 (LVN 4), LVN 4 provided colostomy care to Patient 12. An observation of the colostomy care indicated LVN 4 did not measure Patient 12’s stoma (the opening of the intestine through the belly). LVN 4 stated she knew the size of the stoma due to the frequent visits, and that was the reason why LVN 4 was not measuring it today. Continued observation of the colostomy care indicated LVN 4 cleaned the stoma and surrounding skin with soap (from the soap dispenser in the bathroom) and water. During the colostomy care Patient 12 stated he had gained some weight, and the weight gain was making his stoma feel uncomfortable. Patient 12 stated he was working on losing weight, so his stoma doesn’t stretch. During a concurrent interview and record review on 11/18/2025, at 10:43 a.m., with LVN 4, LVN 4 reviewed Patient 12’s record titled Plan of Care, dated 10/22/2025 to 12/20/2025. The record indicated, “Colostomy care-every Tuesday and Friday”. During an interview on 11/19/2025, at 10:58 a.m., with the Director of Patient Care Services (DPCS), the DPCS stated that nurses were supposed to provide colostomy care according to the policy, unless the doctor specified the orders. If there were no specific orders to follow, it could lead to possibly harming the patient by not giving the proper treatment. During an interview on 11/19/2025, at 12:18 p.m., the DPCS stated Patient 12 did not have a specific order for colostomy care. The expectation was for the nurses to follow the HHA’s policy on colostomy care. A record review of the HHA’s document titled, Colostomy Care, dated 11/19/2025, indicated, “Step-By-Step Colostomy Care…5. Cleanse stoma and peristomal skin gently with warm water; pat dry….Measure stoma and cut appliance opening to appropriate size…” Further review of the record did not indicate instructions for using soap to clean the stoma and surrounding skin. During a concurrent interview and record review on 11/19/2025, at 12:58 p.m., with the DPCS, the DPCS reviewed the HHA’s document titled, Colostomy Care, dated 11/19/2025. The document indicated, “Documentation must include: Stoma size, color, output characteristics…type of appliance used and wear time…”. The DPCS stated the purpose of taking the stoma size was to make sure the pouch (collection device) was the appropriate size for the patient, to prevent skin irritation. The stoma size should be getting smaller, indicating there were no complications. The DPCS stated measuring the stoma was best practices, because its for the patient safety, better health outcomes, and have to monitor the size to prevent complications. B. A record review of Patient 14’s Patient Profile sheet indicated a start of care date of 8/14/2025 with diagnoses including essential hypertension (high blood pressure). During an observation of the home visit on 11/18/2025, at 12:00 p.m., with Licensed Vocational Nurse 5 (LVN 5), LVN 5 provided wound care to Patient 14’s left lower leg. An observation of Patient 14’s wound indicated an open wound. During the wound care, LVN 5 did not measure the wound. A record review of Patient 14’s document titled, Plan of Care, dated 10/13/2025 to 12/11/2025, indicated integumentary (skin) interventions included assessment of the wound. During an interview on 11/20/2025, at 10:30 a.m., with the DPCS, the DPCS stated the wound was supposed to be measured, as part of the assessment, every week. Assessment of the wound included characteristics and wound description. The DPCS stated the purpose of the wound assessment was to see if there were signs of infection, determine if the wound is improving, or if there was something that needed to be reported to the doctor. If these things were not assessed, the patient was put at risk of infection. Infection could lead to sepsis (blood infection, affecting the entire body), which could lead to harm and hospitalization. During a concurrent interview and record review on 11/20/2025, at 10:38 a.m., with the DPCS, the DPCS reviewed Patient 14’s Skilled Nurse Visit Notes, for the weeks of 10/13/2025, 10/19/2025, 10/26/2025, and 11/2/2025. The DPCS stated Patient 14’s wound had not been measured. C. A record review of Patient 16’s document titled Face Sheet indicated a start of care date of 7/26/2025, with diagnoses including essential hypertension (high blood pressure). During a concurrent interview and record review on 11/20/2025, at 11:13 a.m., with the DPCS, the DPCS reviewed Patient 16’s referral for HHA services, dated 7/26/2025. The record indicated, “Note that this member is limited English proficient and will require language assistance.” The DPCS stated the HHA did not provide language services for Patient 16. The importance of providing language services was so the HHA could get all the concerns of the patient, so the patient can have better health outcomes. The DPCS then reviewed Patient 16’s record titled, Plan of Care, dated 7/26/2025 to 9/23/2025. The DPCS stated the referral order for language services was not followed and was not included in Patient 16’s plan of care. C2. During a concurrent interview and record review on 11/20/2025, at 11:20 a.m., with the DPCS, the DPCS reviewed Patient 16’s, Plan of Care, dated 7/26/2025 to 9/23/2025. The record indicated the skilled nurse was to visit the patient two times a week, beginning on 7/29/2025, for wound care. The DPCS reviewed Patient 16’s medical records and stated there was only 1 nursing note documented on 7/31/2025. The DPCS stated there was no other notes to indicate what happened, the reason why services were not provided twice a week. The DPCS stated the visiting nurse entered a note on 11/17/2025 to indicate Patient 16 had refused services. The DPCS stated the note did not indicate when the patient refused nursing visits. A record review of the HHA’s undated document titled, Care Planning Process, indicated, “Based on the assessment and conclusions, the plan of care will include, but not limited to…Specific services and treatment to be provided…Actions to be taken to meet the patient goals…”. a. During a record review of Patient 7’s “Plan of Care” dated 10/23/2025 to 12/21/2025, indicated a start of care date of 10/23/2025 with a primary diagnosis of type 2 diabetes mellitus (high blood sugar levels) without complications. The plan of care indicated to notify the MD (Doctor of Medicine) if blood sugar is greater than 300mg/dl or less than 60 mg/dl. A review of Patient 7’s clinical record indicated that there is no documentation during visits regarding Patient 7’s blood sugar being checked and monitored. During an concurrent interview and record review, on 11/19/2025 at 12:25 p.m. and 1:14 p.m., with the Director of Patient Care Services (DPCS), the DPCS stated that Patient 7 did not have any documentation regarding blood sugar. DPCS stated that staff should document in their notes regarding Patient 7’s blood sugar. DPCS stated that it is important to document patient’s blood sugar so that it can be reported to the primary care physician if blood sugar is low or high. b. During a record review of Patient 10’s “Plan of Care” dated 10/25/2025 to 12/23/2025, indicated a start of care date of 10/25/2025 with a diagnosis of dementia (decline in mental ability that interferes with daily life, affecting memory, thinking, and judgment) and type 2 diabetes mellitus. The plan of care indicated to notify the MD if blood sugar is greater than 300mg/dl or less than 60 mg/dl. The plan of care further indicated that Physical Therapist (PT) treatment plan included evaluation with an effective date 0f 10/25/2025 and PT and PT Aide one time a week for one week starting 10/27/2025. A review of Patient 10’s clinical record indicated that there is no documentation regarding Patient 10’s blood sugar being checked and monitored. Further review of Patient 10’s clinical record further indicated that there was no documentation that PT had visited Patient 10. During a concurrent interview and record review, on 11/19/2025 at 1:14 p.m., with the DPCS, the DPCS stated that Patient 10 did not have any documentation regarding blood sugar. DPCS stated that it is important to document patient’s blood sugar so that it can be reported to the primary care physician if blood sugar is low or high. During an interview, on 11/19/2025 at 1:55 p.m., with the Licensed Vocational Nurse (LVN 3), LVN 3 stated that there was no documentation indicating the physician was notified and aware regarding Patient 10’s delay in PT due to family members request for Spanish speaking PT prior to 11/19/2025. During a concurrent interview and record review, on 11/19/2025 at 2:39 p.m., with the DPCS, the DPCS stated Patient 10 had a PT evaluation on 11/18/2025. DPCS stated that there was no documentation prior to 11/17/2025 regarding reason for Patient 10’s delay in PT services. DPCS stated that within 24 to 48 hours physician is to be notified if a visit has not been made. DPCS stated that the goal is to send PT right away for better health care outcome and prevent rehospitalization.

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 interview and record review, the Home Health Agency (HHA) failed t include information required in the plan of care for two of seventeen sampled patients (Patient 2, Patient 12). This failure had the potential to result in patients not receiving the identified needs and services, and decline in health status, that could affect their quality of care and well-being. B. A record review of Patient 12’s Patient Profile sheet indicated a start of care date of 10/7/2024, with diagnoses including encounter for attention to colostomy (a surgically created opening of the large intestine that allows stool to exit through outside of the belly). During a concurrent observation and interview at the home visit on 11/18/2025, at 10:07 a.m., with Licensed Vocational Nurse 4 (LVN 4), LVN 4 provided colostomy care to Patient 12. An observation of the colostomy care indicated LVN 4 did not measure Patient 12’s stoma (the opening of the intestine through the belly). LVN 4 stated she knew the size of the stoma due to the frequent visits, and that was the reason why LVN 4 was not measuring it today. Continued observation of the colostomy care indicated LVN 4 cleaned the stoma and surrounding skin with soap (from the soap dispenser in the bathroom) and water. During the colostomy care Patient 12 stated he had gained some weight and the weight gain was making his stoma feel uncomfortable. Patient 12 stated he was working on losing weight so his stoma doesn’t stretch. During a concurrent interview and record review on 11/18/2025, at 10:43 a.m., with LVN 4, LVN 4 reviewed Patient 12’s record titled Plan of Care, dated 10/22/2025 to 12/20/2025. The record indicated, “Colostomy care-every Tuesday and Friday”. No other instructions for colostomy care were indicated. LVN 4 stated the plan of care was supposed to have instructions for stoma care, so everyone could follow the same treatment and nursing staff know what do to. During an interview on 11/19/2025, at 10:58 a.m., with the DPCS, the DPCS stated that nurses were supposed to provide colostomy care according to the policy, unless the doctor specified the orders. If there were no specific orders to follow, it could lead to possibly harming the patient by not giving the proper treatment. During a concurrent interview and record review on 11/19/2025, at 12:18 p.m., with the DPCS, the DPCS reviewed Patient 12’s record titled, Optum, dated 10/25/2024. The record indicated “Ostomy mgt. (management)/teaching”. The DPCS stated the order needed to be specific to what needed to be done. The importance of having a specific order was to provide the right treatment so nothing happens to the patient. During a concurrent interview and record review on 11/19/2025, at 12:58 p.m., with the DPCS, the DPCS reviewed the HHA’s document titled, Colostomy Care, dated 11/19/2025. The document indicated, “Documentation must include: Stoma size, color, output characteristics…type of appliance used and wear time…”. The DPCS stated the purpose of taking the stoma size was to make sure the pouch (collection device) was the appropriate size for the patient, to prevent skin irritation. The stoma size should be getting smaller, indicating there is no complications. The DPCS stated there was a conflict between what the policy indicated and what the nurses were expected to do because the HHA did not expect the nurses to measure the stoma, as indicated in the policy. The DPCS stated measuring the stoma was best practices, because its for the patient safety, better health outcomes, and have to monitor the size to prevent complications. In reference to documentation of type of appliance, the DPCS stated this was important because this specified what specific pouch was needed for the patient and to monitor the continued use of the appropriate pouch. During a concurrent interview and record review on 11/19/2025, at 1:05 p.m., with the DPCS, the DPCS reviewed Patient 12’s Skilled Nurse Visit notes for the current certification period dated 10/22/2025 to the present time. The DPCS stated the nursing notes did not indicate the stoma size, type pf appliance used, wear time, and characteristics were documented. B2: During an interview at the home visit on 11/18/2025, at 9:50 a.m., Patient 12 stated he had a new primary care doctor since (Medical Doctor 2-MD 2) 10/18/2025 because his previous doctor (Medical Doctor 1-MD 1) had stopped taking his insurance in September 2025. During a concurrent interview and record review on 11/19/2025, at 1:08 p.m., with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 12’s record titled, Plan of Care, dated 10/22/2025 to 12/20/2025. The record indicated MD 1 was the attending Physician (Doctor) Plan of Care. During an interview on 11/19/2025, at 1:15 p.m., with the DPCS, the DPCS stated the importance of ensuring the right doctor was documented on the plan of care was to make sure the right doctor was notified if there were abnormal findings to report, so the patient can be treated right away. During a record review of the agency’s policy and procedure, titled “Care Planning Process” undated, the policy and procedure indicated, “ The patient-specific clinical plan of care includes all pertinent diagnoses, mental status, types of services/equipment, frequency of visits, goals and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, treatments, safety measures, instructions, discharge plan...” the policy and procedure further indicated, “Based on the assessment and conclusions, the plan of care will include, but not be limited to: A. Patient specific interventions and education B. All patient care orders from all physicians involved in the plan of care, including verbal orders C. Identified patient problems and needs, including functional limitations, activities permitted, nutritional requirements D. Reasonable, measurable, and individualized goals and outcomes identified by the organization and the patient anticipated to occur as a result of implementing and coordinating the plan of care E. Specific services and treatments to be provided, including services furnished via telecommunication systems (if appropriate) F. Actions to be taken to meet the patient goals G. Type, including identifying the responsible discipline(s), frequency, and duration of above actions... 6. The plan of care will be based upon the physician's (or allowed practitioner's) orders and will encompass the equipment, supplies, and services required to meet the patient's needs.” A. During a record review of Patient 2’s Patient Profile sheet indicated a start of care date of 11/08/2024, with diagnoses including other artificial opening of urinary tract status (Refers to the presence of a surgically created opening in the urinary tract for draining urine). During a record review of Patient 2’s POC dated 09/03/2025 to 11/02/2025, recertified on 11/08/2025, the POC indicated, “Assess/Perform/Instruct Patient /patient caregiver :Urostomy (a surgically created opening in the abdomen that reroutes urine from the body without going through the bladder) Care effective 932025 assess genitourinary status start effective date 9/3/2025 skilled nurse continued to instruct patient/patient caregiver care of urostomy equipment and supplies start effective date 9/3/2025. There is no documented evidence in the POC of how often and how the urostomy care needs to be done, what supplies need to be used during urostomy care, or what signs and symptoms needs to be assessed for the urostomy. During an interview on 11/19/2025 at 10:45am with DPCS, the DPCS stated “the urostomy order doesn’t list what the clinician needs to do specifically, they just follow routine urostomy care, but the order and the plan of care should be very specific to the care. It should list detail of what needs to be done to the stoma site. How often care needs to be provided to the urostomy, what supplies need to be used during the care and what signs and symptoms needs to be assessed by the skilled nurse. This is important because nurses need to know what order to follow to keep the patient safe and away from harm.” During a record review of the agency’s policy and procedure, titled “Care Planning Process” undated, the policy and procedure indicated, “ The patient-specific clinical plan of care includes all pertinent diagnoses, mental status, types of services/equipment, frequency of visits, goals and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, treatments, safety measures, instructions, discharge plan...” the policy and procedure further indicated, “Based on the assessment and conclusions, the plan of care will include, but not be limited to: A. Patient specific interventions and education B. All patient care orders from all physicians involved in the plan of care, including verbal orders C. Identified patient problems and needs, including functional limitations, activities permitted, nutritional requirements D. Reasonable, measurable, and individualized goals and outcomes identified by the organization and the patient anticipated to occur as a result of implementing and coordinating the plan of care E. Specific services and treatments to be provided, including services furnished via telecommunication systems (if appropriate) F. Actions to be taken to meet the patient goals G. Type, including identifying the responsible discipline(s), frequency, and duration of above actions... 6. The plan of care will be based upon the physician's (or allowed practitioner's) orders and will encompass the equipment, supplies, and services required to meet the patient's needs.”

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the physician reviewed and revised seven of seventeen sample patients (Patient 1, Patient 2, Patient 8, Patient 9, Patient 14, Patient 15, and Patient 17) individualized plans of care. This failure had the potential to result in Patient receiving inappropriate or lacking appropriate services. C. A record review of Patient 14’s Patient Profile sheet indicated a start of care date of 8/14/2025 with diagnoses including essential hypertension (high blood pressure). During a concurrent interview and record review with the DPCS, on 11/20/2025, at 10:20 a.m., the DPCS reviewed Patient 14’s records titled, Plan of Care, dated 8/14/2025 to 10/12/2025 and 10/13/2025 to 12/11/2025. The records did not indicate a doctor’s signature. The DPCS stated the documents were supposed to be signed by the doctor because of the rules and regulations. The signature indicated the doctor acknowledged was the primary doctor and responsible for the care of the patient. The doctor signature validated the specific treatment needed for the patient. The DPCS stated the plan of care was supposed to be signed within 30 days of admission. The risk of not signing the plan of care was the doctor not knowing what services had been provided to the patient. D. A record review of Patient 15’s record titled, Face Sheet, indicated a start of care date of 9/20/2025, with diagnoses including essential hypertension (high blood pressure). During a concurrent interview and record review with the DPCS, on 11/20/2025, at 10:52 a.m., the DPCS reviewed Patient 15’s records titled, Plan of Care, dated 9/20/2025 to 11/18/2025. The DPCS stated the plan of care had not been signed by the doctor. E. A record review of Patient 17’s record titled, Face Sheet, indicated a start of care date of 12/13/2023, with diagnoses including difficulty in walking. During a concurrent interview and record review with the DPCS, on 11/20/2025, at 12:00 p.m., the DPCS reviewed Patient 17’s records titled, Plan of Care, dated 12/13/2023 to 2/10/2024. The DPCS stated the plan of care had not been signed by the doctor. During a record review of the agency’s policy and procedure, titled “Care Planning Process” undated, the policy and procedure indicated, “All clinicians including the physician (or allowed practitioner} involved in the patient's care, either directly or indirectly, will contribute to the plan of care. The plan of care shall be signed by a Doctor of Medicine, osteopathy, or podiatric medicine, or an allowed practitioner acting within the scope of a state license, certification or registration.” During a record review of Patient 8’s “Plan of Care” dated 10/16/2025 to 12/14/2025, indicated a start of care date of 10/16/2025 with a primary diagnosis of essential hypertension (high blood pressure). The “Plan of Care” indicated that there was no signature from the physician. During a record review of Patient 9’s “Plan of Care” dated 10/15/2025 to 12/13/2025, indicated a start of care date of 8/16/2025 with a primary diagnosis of polyneuropathies (disorders affecting multiple peripheral nerves, causing symptoms like numbness, tingling, pain, and weakness, often starting in the feet and hands). The “Plan of Care” indicated that there was no signature from the physician. During a concurrent interview and record review on 11/20/2025 at 11:45 am with DPCS, the DPCS stated that Patient 8 and Patient 9’s plan of care were not signed. DPCS stated that there is a 30 day timeframe for signing the plan of care. DPCS stated that it is important for the physician to signed the plan of care so that the physician is aware what the specific care and treatment the patients are being provided. A.During a record review of Patient 1’s Patient Profile sheet indicated a start of care date of 07/09/2025, with diagnoses including retention of urine (a condition Resulting in the inability to completely empty the bladder). During a concurrent interview and record review on 11/20/2025 at 11:43 am with DPCS Patient 1’s medical record was reviewed. The Plan of Care dated 07/09/2025 to 09/06/2025 was not signed. The DPCS stated, “the MD has 30 days to sign the Plan of Care and Physician orders. It is important for the physician to see the plan of care and sign it because the physician needs to be aware and approve of the plan of care and orders.” B. During a record review of Patient 2’s Patient Profile sheet indicated a start of care date of 11/08/2024, with diagnoses including other artificial opening of urinary tract status (Refers to the presence of a surgically created opening in the urinary tract for draining urine). During a concurrent interview and record review on 11/20/2025 at 11:50 am with DPCS Patient 2’s medical record was reviewed. The Plan of Care dated 09/03/2025 to 11/02/2025 was not signed. The DPCS stated, “the MD has 30 days to sign the Plan of Care and Physician orders. It is important for the physician to see the plan of care and sign it because the physician needs to be aware and approve of the plan of care and orders.” During a record review of the agency’s policy and procedure, titled “Care Planning Process” undated, the policy and procedure indicated, “All clinicians including the physician (or allowed practitioner} involved in the patient's care, either directly or indirectly, will contribute to the plan of care. The plan of care shall be signed by a Doctor of Medicine, osteopathy, or podiatric medicine, or an allowed practitioner acting within the scope of a state license, certification or registration.”

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 interview and record review, the Home Health Agency (HHA) failed to provide written information regarding the plan of care and medication list for two of seven patients (Patient 7 and Patient 12). This deficient practice resulted in patients and their representatives not knowing their care team or their treatment course. A record review of Patient 12’s Patient Profile sheet indicated a start of care date of 10/7/2024, with diagnoses including encounter for attention to colostomy (a surgically created opening of the large intestine that allows stool to exit through outside of the belly). During a concurrent observation and interview at the home visit on 11/18/2025, at 10:20 a.m., with Licensed Vocational Nurse 4 (LVN 4), LVN 4 reviewed the contents of the agency folder (information required to be given to the patient). There was no plan of care (POC) and medication list in Patient 12’s home. LVN 4 stated she brought the POC and medication list to the patients home today, 11/18/2025. Patient 12 stated he had never received a copy of the POC and medication list. A record review of the HHA’s undated document titled, Care Planning Process, indicated, “The organization shall provide the patient and caregiver with a copy of written instructions outlining: A. Visit schedule, including frequency of visits…Patient medication schedule/instructions, including medication name…” a. During a record review of Patient 7’s “Plan of Care” dated 10/23/2025 to 12/21/2025, indicated a start of care date of 10/23/2025 with a primary diagnosis of type 2 diabetes mellitus (high blood sugar levels) without complications. During a joint home visit, on 11/18/2025 at 10:35 a.m. with the Physical Therapist (PT) at Patient 7’s residence, Patient 7 was observed sitting down in by the dining table. During a concurrent observation and interview at the home visit on 11/18/2025, at 11:20 a.m., with PT, PT reviewed the contents of Patient 7’s agency folder (information required to be given to the patient). There was no plan of care (POC) and medication profile found in Patient 7’s home. During an interview, on 11/19/2025 at 12:25 p.m., with the Director of Patient Care Services (DPCS), the DPCS stated that an updated copy of the plan of care and medication profile should be in the patient’s home. DPCS stated that it is important to have a copy of the updated plan of care and medication profile in the patient’s home so that the patient and family are aware of any new orders.

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 interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation regarding Clinical Records was met as follows: 1.The HHA failed to ensure one of seventeen sampled patients (Patient 1) clinical records included all the necessary forms. This failure resulted in an incomplete clinical record. (Refer to G1012). 2. The HHA failed to send all necessary medical information to the primary care practitioner within 5 days of discharge for two of seventeen sampled patients (Patient 15 and Patient 16). This deficient practice resulted in the primary care practitioner not receiving information regarding the services and care provided by the HHA. (Refer to G1022). 3. The HHA failed to ensure patient care records were complete and authenticated for two of seventeen sampled patients (Patient 1, Patient 2). This failure resulted in patients’ medical records being modified by people not involved in patients’ care. (Refer to G1024). The cumulative effect of these systemic practices resulted in the failure of the HHA to ensure the provision of quality health care in a safe environment.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure one of seventeen sampled patients (Patient 1) clinical records included all the necessary forms. This failure resulted in an incomplete clinical record. A.During a record review of Patient 1’s Patient Profile sheet indicated a start of care date of 07/09/2025, with diagnoses including retention of urine (a condition Resulting in the inability to completely empty the bladder). During a concurrent interview and record review on 11/19/2025 at 11 am with LVN 3, Patient 1’s medical record communication log was reviewed. The communication log indicated, “7/22/2025 at 3:42 PM, LVN 3 indicated patients seen for Foley change, daughter called stating another nurse needs to come see patient again because Foley (urine collection device placed in the bladder) catheter was not placed right. Tried to advice patient to go to urgent care but is insisting on having another nurse come by today. LVN 3 indicated on the same day at 4:18 PM, her daughter took patient to urgent care.” LVN 3 stated, “I was the one who wrote this on 7/22/2025. RN 2 went to see Patient 1 on 7/22/2025 and changed the urinary catheter. I don't see a note from RN 2 for that date, but the FM 5 confirmed that RN 2 was there and changed a urinary catheter on 7/22/2025. I don't know what time RN 2 was there because there was no nursing note. I contacted the nurse, but we couldn’t get any nurses out because she wanted someone to go there within the next thirty minutes. I contacted the daughter about 40 minutes after her initial call, and FM 5 stated FM 5 had taken Patient 1 to urgent care and wasn’t willing to wait.” During a concurrent interview and record review on 11/19/2025 at 11:40 am with DPCS, DPCS stated, there is no evidence of a documented skilled nurse visit on 7/22/2025. RN 2 was the RN who visited Patient 1 on 7/22/2025, but I don't see a nursing visit note in the medical record for that date. We have a problem with RN 2 turning in her notes, our HR reaches out to them weekly, then I follow up to make sure the notes are turned in. This was missed. It is important for nurses to turn in their notes so we can know what was done during the visit. They have five days to turn in their notes.” During a record review of the agency’s policy and procedure titled, “Entries in the Clinical Record” undated, the policy and procedure indicated, “Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided...” The policy and procedure further indicated, “Clinical notes shall be signed and incorporated into the patient's health record within seven working days. The clinical note will include: A. Care that was provided B. Treatment and/or invasive procedures performed C. Patient response to treatment and/or procedures D. The date the service was provided (month, day, year) E. Signature of clinician and his/her credentials Signature authorization of clinical documentation will include the staff member's name and credentials (as specified on professional licenses and/or certification documents). Initials will be used on forms where authentication signature space is designated on the form. All entries into the clinical record will reflect the date care was provided, including the month, day, and year...”

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 interview and record review, the Home Health Agency (HHA) failed to send all necessary medical information to the primary care practitioner within 5 days of patient's discharge from home health services for two of seventeen sampled patients (Patient 15 and Patient 16). This deficient practice resulted in the primary care practitioner not receiving information regarding the services and care provided by the HHA. A. A record review of Patient 15’s record titled, Face Sheet, indicated a start of care date of 9/20/2025, with diagnosis including essential hypertension (high blood pressure). During a concurrent interview and record review, with the Director of Patient Care Services (DPCS), on 11/20/2025, at 10:52 a.m., the DPCS reviewed Patient 15’s record titled OASIS Discharge Physical Therapy, dated 11/13/2025. The DPCS stated the discharge summary had not been sent to the doctor. The DPCS stated the summary should have been sent within 2 days so the doctor would be aware the patient was discharged from the HHA. B. A record review of Patient 16’s document titled, Face Sheet indicated a start of care date of 7/26/2025, with diagnosis including essential hypertension (high blood pressure). During a concurrent interview and record review, with the DPC), on 11/20/2025, at 11:28 a.m., the DPCS reviewed Patient 16’s record titled OASIS Discharge Non-Visit, dated 8/6/2025. The DPCS stated the discharge summary was not sent to the doctor. The purpose of the discharge summary to be sent to the doctor, included adherence to the rules and regulations. Notifying what services were provided, if goals were met, provide the most recent medication list, were all reasons to provide the summary to the doctor. If the doctor did not receive this information, then the doctor does not know the status of the patient while in HHA services. A record review of the undated HHA’s document titled, Discharge Criteria and Process indicated, “A discharge summary will be completed for all discharged patients. A copy will be mailed to the primary physician.”

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 interview and record review, the Home Health Agency (HHA) failed to ensure patient care records were complete and authenticated for two of seventeen sampled patients (Patient 1, Patient 2). This failure resulted in patients’ medical records being modified by people not involved in patients’ care. A. During a record review of Patient 1’s Patient Profile sheet indicated a start of care date of 07/09/2025, with diagnosis including retention of urine (a condition Resulting in the inability to completely empty the bladder). During a concurrent interview and record review on 11/20/2025 at 11:45 am with DPCS Patient ’s medical record was reviewed and physicians order dated 7/18/2025 was not signed. The DPCS stated, “the MD has 30 days to sign the Plan of Care and Physician orders. It is important for the physician to see the plan of care and sign it because the physician needs to be aware and approve of the plan of care and orders.” B. During a record review of Patient 2’s Patient Profile sheet indicated a start of care date of 11/08/2024, with diagnosis including other artificial opening of urinary tract status (Refers to the presence of a surgically created opening in the urinary tract for draining urine). During a concurrent interview and record review on 11/20/2025 at 11:50 am., with DPCS Patient 2’s medical record was reviewed. The physicians order dated 9/3/2025, 9/17/2025, and 10/14/2025 were not signed. The DPCS stated, “the MD has 30 days to sign the Plan of Care and Physician orders. It is important for the physician to see the plan of care and sign it because the physician needs to be aware and approve of the plan of care and orders.” During a record review of the agency’s policy and procedure titled, “Entries in the Clinical Record” undated, the policy and procedure indicated, “Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided...” The policy and procedure further indicated, “Clinical notes shall be signed and incorporated into the patient's health record within seven working days. The clinical note will include: A. Care that was provided B. Treatment and/or invasive procedures performed C. Patient response to treatment and/or procedures D. The date the service was provided (month, day, year) E. Signature of clinician and his/her credentials Signature authorization of clinical documentation will include the staff member's name and credentials (as specified on professional licenses and/or certification documents). Initials will be used on forms where authentication signature space is designated on the form. All entries into the clinical record will reflect the date care was provided, including the month, day, and year...”

The following reflects the findings of the California Department of Public Health during a Full Survey from 9/15/23 to 9/19/23. Representing the California Department of Public Health: Surveyor #22303, Health Facilities Evaluator Nurse Surveyor #44186, Health Facilities Evaluator Nurse Sample Size - 17 Home Visits - 7 Active Patients- 675 Unduplicated Admissions: 7,265 On 9/18/2023, at 7:29 p.m., an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) was called in the presence of the agency’s Administrator Designee (ADMD) and Director of Patient Care Services Designee (DPCSD) related to the agency’s failure to follow the physician’s order for Patient 2's insulin medication RN 1 failed to check Patient 2’s blood sugar levels during home visits, failed to conduct medication reconciliation, and failed to provide teaching on the frequency of insulin medication. On 9/19/2023 at 1:28 p.m. the agency sent the IJ Removal Plan (the facility’s plan of action to correct the deficient practices) by email, and the survey team notified the DPCSD the IJ Removal Plan was not accepted at 1:45 p.m. On 9/19/2023, at 2:16 p.m., the agency sent a revised IJ Removal Plan by email, and the survey team notified the DPCSD the IJ Removal Plan was not accepted on 9/19/2023 at 3:47 p.m. On 9/19/23 at 4: 35 p.m., the survey team completed the survey tasks, and exited with the IJ not removed related to the failure to follow Patient 2’s POC. As a result, Patient 2 received the incorrect dosages of insulin (high-risk medication [medications that have a heightened risk of causing significant patient harm when they are used in error] that controls blood sugar levels) doses and placed Patient 2 at risk for hypoglycemia (low blood sugar levels) that could lead weakness, difficulty concentrating, confusion (lack of understanding), and unresponsiveness (loss of consciousness [the state of being aware]). The following Condition of Participation not met: 484.60 Care planning, coordination of services, and quality of care

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: Based on interview and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation (refer to the requirements that healthcare organizations must meet to participate in federal healthcare programs) for Care Planning, Coordination of Services, and Quality of Care as follows: 1. Based on interview and record review, the HHA failed to follow a written plan of care (POC, documents the process of identifying a patient's needs and facilitating complete care and ensures collaboration among nurses, patients, and other healthcare providers) for one of 17 sampled patients (Patient 2). For Patient 2, the Registered Nurse 1 (RN 1) did not check Patient 2’s blood sugar (BS) levels during home visits, did not conduct a medication reconciliation (the process of identifying the most accurate list of all medications the patient is taking), and did not provide instructions to Patient 2’s Primary Caregiver (PCG) on the frequency of BS checks. This deficient practice resulted for Patient 2 to receive the incorrect dosages of insulin (helps your body turn food into energy and controls your blood sugar levels) doses and placed Patient 2 at risk for hypoglycemia (low blood sugar levels) that could lead weakness, difficulty concentrating, confusion (lack of understanding), and unresponsiveness (loss of consciousness [the state of being aware]). (Refer to G572). 2. Based on interview and record review, the home health agency (HHA) failed to ensure the medications and treatments were administered as ordered by the physician for one of 17 sampled patients (Patient 2). For Patient 2, Registered Nurse 1 (RN 1) failed to know the correct prescribed insulin (helps your body turn food into energy and controls your blood sugar levels) medications Patient 2 took. Patient 2 did not follow the correct Humalog (fast-acting insulins used to control high blood sugar) and Humulin NPH (short-acting insulin) insulin dosages as ordered. This deficient practice placed Patient 2 at risk for hypoglycemia (low blood sugar levels). (Refer to G-580). 3. Based on interview and record review, the Home Health Agency failed to notify the physician of the patient's blood sugar readings for one of 17 sampled patients (Patient 2). The Registered Nurse (RN 1) did not notify the physician when Patient 2's blood sugar reading ranging from 273 milligrams per deciliter (mg/dL, a unit of measurement for blood sugar level) to 388 mm/dL. This deficient practice placed Patient 2 at risk to have a hyperglycemia (high blood sugar). (Refer to G590). 4. Based on interview and record review, the Home Health Agency (HHA) failed to ensure Registered Nurse 1 (RN 1) provided instructions to the patient’s Primary Care Giver (PCG) on how to administer insulin (helps your body turn food into energy and controls your blood sugar levels) and health teaching on how to check the blood sugars for one of 17 sampled patients (Patient 2). This deficient practice had the potential for Patient 2 and PCG not to be able to perform and monitor Patient 2's blood sugar level timely and consistent, and could impact Patient 2's health status and wellbeing. (Refer to G-610). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated (State law) compliance with Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure highest quality health care is provided to patients assessed to receive home health services.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to follow a written plan of care (POC) for one of 17 sampled patients (Patient 2). For Patient 2, the Registered Nurse 1 (RN 1) did not check Patient 2’s blood sugar (BS) levels during home visits, did not conduct a medication reconciliation (the process of identifying the most accurate list of all medications that the patient is taking), and did not provide instructions to Patient 2’s Primary Caregiver (PCG) on the frequency of BS level checks. As a result, Patient 2 received the incorrect dosages of insulin (high-risk medication [medications that have a heightened risk of causing significant patient harm when they are used in error] that controls blood sugar levels) doses and placed Patient 2 at risk for hypoglycemia (low blood sugar levels) that could lead weakness, difficulty concentrating, confusion (lack of understanding), and unresponsiveness (loss of consciousness [the state of being aware]). On 9/18/2023, at 7:29 p.m., an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) was called in the presence of the agency’s Administrator Designee (ADMD) and Director of Patient Care Services Designee (DPCSD) related to the agency’s failure to follow the physician’s order for Patient 2's insulin medication RN 1 failed to check Patient 2’s blood sugar levels during home visits, failed to conduct medication reconciliation, and failed to provide teaching on the frequency of insulin medication. On 9/19/2023 at 1:28 p.m. the agency sent the IJ Removal Plan (the facility’s plan of action to correct the deficient practices) by email, and the survey team notified the DPCSD the IJ Removal Plan was not accepted at 1:45 p.m. On 9/19/2023, at 2:16 p.m., the agency sent a revised IJ Removal Plan by email, and the survey team notified the DPCSD the IJ Removal Plan was not accepted on 9/19/2023 at 3:47 p.m. On 9/19/23 at 4: 35 p.m., the survey team completed the survey tasks, and exited with the IJ not removed related to the failure to follow Patient 2’s POC. Findings: A review of Patient 2's Start of Care (SOC) record indicated the HHA admitted Patient to on 7/19/2023, with a diagnosis of Diabetes Type 2 (a medical condition characterized by the body's inability to regulate blood sugar levels). A review of Patient 2's Plan of Care (POC) for the certification period of 7/19/2023 to 9/19/2023, indicated that a skilled nurse (SN, a licensed nurse in general) was to assess and instruct Patient 2 and Patient 2’s caregiver (PCG) the importance of medication compliance and high-risk medication use, side effects, contraindications, and possible drug to drug interactions (occur when two or more drugs react with each other). The POC indicated one of the SN interventions was to assess Patient 2 and PCG’s knowledge of diabetic condition and instruct on knowledge deficits and BS monitoring four times a day on every visit. A physician's order dated 7/19/2023, included in the POC had the following prescribed medications: 1. Lispro (fast acting insulin) (U-100) 100 unit/ml (milliliters, a unit of measurement) subcutaneous (means the injection is given in the fatty tissue, just under the skin) to administer ten (10) units twice a day. 2. Humulin N NPH (is an intermediate [middle] acting insulin that is slower to act and lasts longer) U-100 insulin 100 unit/ml (3 ml) subcutaneous to administer ten (10) units at a.m., and ten (10) units at p.m., as needed for increased blood glucose level. A review of Patient 2’s Physician's Supplemental Order dated 7/24/2023, had the following new prescribed medications: 1. Lispro (U-100) 100 unit/ml subcutaneous to administer ten (10) units at a.m., and 10 units at p.m., as needed for increased blood glucose level. 2. Humulin N NPH U-100 insulin 100 unit/ml (3 ml) subcutaneous to administer ten (10) units at a.m., and p.m., as needed for increased blood glucose level to administer both insulin if BS reading greater than 150. On 9/16/2023, at 1 p.m., a home visit was attempted at Patient 2's residence and Patient 2 declined to be visited. During a telephone interview on 9/18/2023, at 11 a.m., with Patient 2 and PCG, Patient 2 stated PCG administered two different insulin medications (not specified) twice a day, one time in the morning and in one time in the evening. During a telephone interview on 9/18/2023, at 2 p.m., with RN 1, RN 1 stated he was the assigned nurse for Patient 2. RN 1 stated Patient 2 was taking NPH 70/30 insulin ten (10) units and Humalog insulin 10 units twice daily. RN 1 stated PCG administered both insulin medications (NPH 70/30 insulin ten [10] units and Humalog insulin 10 units) twice a day. RN 1 stated he (RN 1) did not check Patient 2’s BS readings on his home visits. RN 1 stated he would just document Patient 2’s BS readings taken by PCG every morning on his nursing notes. During a telephone interview on 9/18/2023, at 6:30 p.m., with the DPCS (director of patient care services), DPCS stated she was at Patient 2's residence (during the time of the interview) checking Patient 2's medications. DPCS stated PCG administered Lispro ten units and Humulin insulin 10 (ten) units twice a day to Patient 2 instead of as needed as indicated in Patient 2’s Physician's Supplemental Order dated 7/24/2023 to administered Lispro ten (10) units at a.m., and 10 units at p.m., as needed for increased blood glucose level and Humulin N NPH U-100 ten (10) units at a.m., and 10 units at p.m., as needed for increased blood glucose level. The DPCS stated PCG administered the incorrect insulin dosages to Patient 2 and Patient 2 was at risk for hypoglycemia. During an interview on 9/19/2023, at 2 p.m., with the DPCS, the DPCS stated every medication that a patient (in general) took should be on the patient’s medication profile. DPCS stated RN 1 needed to conduct a medication reconciliation on every home visit and verify the insulin dosages with Patient 2’s PCG to ensure PCG administered the correct insulin dosages to Patient 2. DPCS stated RN 1 needed to perform Patient 2’s BS readings and needed to provide patient teaching on how to obtain Patient 2’s BS readings and to teach how to self-administer his prescribed insulin during visits as written in Patient 2’s plan of care. A review of the agency's undated policy and procedure titled "Care Planning Process", indicated the purpose of the policy is to provide clinical direction to clinicians providing direct patient care. A written individualized plan of care will be initiated within five days of start of care and updated at least every 60 days, or as patient’s condition warrants. The patient-specific clinical plan of care includes all pertinent diagnoses, mental status, types of services/equipment, frequency of visits, goals and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, treatments, safety measures, instructions, discharge plan. The plan of care will be based upon the physician’s (or other authorized licensed independent practitioner’s) orders and will encompass the equipment, supplies, and the services required to meet the patient’s needs.

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 home health agency staff failed to ensure the plan of care contained specific goals and interventions for pain management for two of 17 sampled patients (Patients 11 and 12). This deficient practice placed Patients 11 and 12 at risk for ineffective pain management. Findings: a. A review of Patient 11's Patient Profile indicated a start of care date of 8/7/2023, with diagnoses including atherosclerotic heart disease (a build-up of cholesterol plaque in the walls of arteries causing obstruction of blood flow) of native coronary artery without angina pectoris (a type of chest pain caused by reduced blood flow to the heart), type 2 diabetes mellitus (a medical condition characterized by the body's inability to regulate blood sugar levels), and presence of aortocoronary bypass graft (a surgical procedure to treat coronary artery disease, the buildup of plaques in the arteries of the heart). A review of Patient 11's Plan of Care (POC) from 8/7/2023 through 10/5/2023, included an order for the skilled nurse to visit once a week for six weeks, twice a week for two weeks, and then once a week for one week to assess the vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), medication compliance, monitoring of blood sugar level, and perform wound care on right leg incision. There was no documented evidence the POC included pain management, assessing the patient's pain, location, duration, severity (rating scale), alleviating factors, current treatment, and response to treatment. A review of Patient 11’s Medication Profile indicated an order dated 8/7/2023 for Norco (combination medication used to relieve moderate to severe pain) 5 milligram(mg, a unit of measurement)-325 mg one tablet every six hours as needed for pain. b. A review of Patient 12's Patient Profile indicated a start of care date of 8/29/2023, with diagnosis of abscess (a confined pocket of pus that collects in tissues, organs, or spaces inside the body) of the breast and nipple. A review of Patient 12's POC from 8/29/2023 through 10/27/2023, included an order for the skilled nurse to visit four times a week for one week, then six times a week for one week, then four times a week for one week, then two times a week for one week, and six times a week for two weeks to assess vital signs, medication compliance, and perform wound care on patient’s left and right breast wound. There was no documented evidence that the POC included pain management, assessing the patient's pain, location, duration, severity (rating scale), alleviating factors, current treatment, and response to treatment. A review of Patient 12’s Medication Profile indicated an order dated 8/29/2023 for Percocet (indicated for the relief of moderate to moderately severe pain) 10mg-325 mg one tablet every six hours as needed for pain. During a concurrent interview and record review with the Director of Patient Care Services (DPCS) on 9/18/2023 at 10:45 a.m., when informed of the findings the DPCS stated there was no documentation which included pain management on Patients 11 and 12’s care plan. DPCS stated Patients 11 and 12 were status post-surgery (after surgery) and had wound care treatment on surgical wounds and were on opioid pain medication (are powerful pain-reducing medications) on admission, and the patients' care plan should have documentation regarding pain management. A review of the agency’s undated policy and procedure titled “Pain Assessment,” indicated the organization will develop a plan based on the patient’s clinical condition, past medical history, and pain management goal. The pain treatment plan will include patient goals and objectives for treating pain, and education on pain management, treatment options and safe use of opioid and non-opioid medications when prescribed. A review of the agency’s undated policy and procedure titled “Care Planning Process,” indicated the patient plan of care will be developed or revised within five working days of initiation of each service or of the reassessment of the patient. Based on the assessment and conclusions, the plan of care will include, but not be limited to patient specific interventions and education, identified patient problems and needs, and reasonable, measurable, and individualized goals and outcomes identified by the organization and the patient anticipated to occur as a result of implementing and coordinating the plan of care.

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 interview and record review, the home health agency (HHA) failed to ensure the medications and treatments were administered as ordered by the physician for one of 17 sampled patients (Patient 2). For Patient 2, Registered Nurse 1 (RN 1) failed to know the correct prescribed insulin (helps your body turn food into energy and controls your blood sugar levels) medications Patient 2 took. Patient 2 did not follow the correct Humalog (fast-acting insulins used to control high blood sugar) and Humulin NPH (short-acting insulin) insulin dosages as ordered. This deficient practice placed Patient 2 at risk for hypoglycemia (low blood sugar levels). (Refer to G-580). Findings: A review of Patient 2's Start of Care (SOC) record indicated the HHA admitted Patient 2 on 7/19/2023, with a diagnosis of Diabetes Type 2 (a medical condition characterized by the body's inability to regulate blood sugar levels). A review of Patient 2's Plan of Care (POC, documents the process of identifying a patient's needs and facilitating complete care and ensures collaboration among nurses, patients, and other healthcare providers) for the certification period of 7/19/2023 to 9/19/2023, indicated a skilled nurse (SN, a licensed nurse in general) was scheduled to visit Patient 2 once a week for one week starting 7/19/2023, two times a week for one week starting 7/23/2023, twice a week for three weeks starting 7/30/2023, once a week for one week starting 8/16/2023, once a week for five weeks starting 8/22/2023, once a week for one week starting 9/16/2023, and once a week for four weeks starting 9/17/2023. The POC indicated for the SN to assess and instruct Patient 2 and Patient 2’s caregiver (PCG) the importance of medication compliance and high-risk medication (medications that have a high risk of causing significant patient harm or death when used in error). The POC indicated one of the SN interventions was to assess Patient 2 and PCG’s knowledge of diabetic condition and instruct on blood sugar (BS) monitoring four times a day on every visit. A review of Patient 2’s Physician Order dated 7/19/2023, included in the POC had the following prescribed medications: 1. Lispro (fast acting insulin) (U-100) 100 unit/ml (milliliters, a unit of measurement) subcutaneous (means the injection is given in the fatty tissue, just under the skin) to administer ten (10) units twice a day. 2. Humulin N NPH (Neutral Protamine Hagedorn, is an intermediate [middle] acting insulin that is slower to act and lasts longer) U-100 insulin 100 unit/ml (3 ml) subcutaneous (under the skin) to administer ten (10) units at a.m., and ten (10) units at p.m., as needed for increased blood glucose level. A review of Patient 2’s Physician's Supplemental Order dated 7/24/2023, had the following new prescribed medications: 1. Lispro (U-100) 100 unit/ml subcutaneous to administer ten (10) units at a.m., and 10 units at p.m., as needed for increased blood glucose level. 2. Humulin N NPH U-100 insulin 100 unit/ml (3 ml) subcutaneous to administer ten (10) units at a.m., and p.m., as needed for increased blood glucose level to administer both insulin if BS reading greater than 150. A review of Patient 2's undated Skilled Nurse Visit Note, indicated no documented evidence that the visiting nurse provided a patient teaching with a return demonstration by the patient/PCG on how to use the glucometer (a device for measuring the BS) to check Patient 2’s BS and for PCG to administer insulin the correct way. A review of Patient 2's Skilled Nurse Visit Note indicated the following dates and BS readings: a. 8/3/23- BS reading of 131 milligrams per deciliter (mg/dL, a unit of measurement 80–130 mg/dl [normal ranges for someone with diabetes]). b. 8/7/23- BS reading of 93 mg/dL. c. 8/8/23- BS reading of 141 mg/dL. d. 8/14/23- BS reading of 138 mg/dL. e. 8/16/23- BS reading of 148 mg/dL. f. 9/6/23- BS reading of 142 mg/dL. On 9/16/2023, at 1 p.m., a home visit was conducted at Patient 2's residence and Patient 2 declined the visit. During a telephone interview on 9/18/2023, at 11 a.m., with Patient 2 and PCG, Patient 2 stated PCG administered two different insulin medications (not specified) twice a day, one time in the morning and in one time in the evening. During a telephone interview on 9/18/2023, at 2 p.m., with RN 1, RN 1 stated he was the assigned nurse for Patient 2. RN 1 stated Patient 2 was taking NPH 70/30 insulin ten (10) units and Humalog insulin 10 units twice daily. RN 1 stated PCG administered both insulin medications (NPH 70/30 insulin ten [10] units and Humalog insulin 10 units) twice a day. RN 1 stated he (RN 1) did not check Patient 2’s BS readings on his home visits. RN 1 stated he would just document Patient 2’s BS readings taken by PCG every morning on his nursing notes. During a telephone interview on 9/18/2023, at 6:30 p.m., with the DPCS (director of patient care services), DPCS stated she was at Patient 2's residence (during the time of the interview) checking Patient 2's medications. DPCS stated PCG administered Lispro ten units and Humulin insulin 10 (ten) units twice a day to Patient 2 instead of as needed for increased blood glucose level as indicated in Patient 2’s Physician's Supplemental Order dated 7/24/2023. The DPCS stated PCG administered the incorrect insulin dosages to Patient 2 and stated Patient 2 was at risk for hypoglycemia. On 9/19/23, at 2 p.m., during an interview with the DPCS, she stated that medication reconciliation should be done on every nurse visit by verifying PCG 1's administering of correct insulin dosage coverage as ordered. During an interview on 9/19/2023, at 2 p.m., with the DPCS, the DPCS stated every medication a patient (in general) took should be on the patient’s medication profile. DPCS stated RN 1 needed to conduct a medication reconciliation (a process of comparing medications by creating an accurate list of both prescription and over the counter medications that includes the drug name, dosage, frequency, route, and indication for use for the purpose of preventing unintended changes). on every home visit and verify the insulin dosages with Patient 2’s PCG to ensure PCG administered the correct insulin dosages to Patient 2. DPCS stated RN 1 needed to perform Patient 2’s BS readings and needed to provide patient teaching on how to obtain Patient 2’s BS readings and to teach how to self-administer his prescribed insulin during visits as written in Patient 2’s plan of care. A review of the agency’s undated policy and procedure titled, “Monitoring Patient’s Response/Reporting to Physician”, indicated clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient. The patient’s physician (or other authorized licensed independent practitioner) will be contacted when any of the following occur: changes in patient’s condition, changes in the patient’s expected response to treatment or medications, and when a visit is missed for any reason.

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 interview and record review, the Home Health Agency (HHA, is an agency or organization primarily engaged in providing skilled nursing services and other therapeutic services to a patient's personal residence) failed to notify the physician of the patient's blood sugar readings for one of 17 sampled patients (Patient 2). The Registered Nurse (RN 1) did not notify the physician when Patient 2's blood sugar reading ranging from 273 milligrams per deciliter (mg/dl, a unit of measurement for blood sugar level) to 388 mm/dl. This deficient practice placed the patient at risk to have a hyperglycemia (high blood sugar). A record review of Patient 2's "Patient Information" indicated a start of care date (SOC) of 7/19/2023, with diagnosis that included hyperkalemia (a high level of electrolyte potassium in the blood). A review of Patient 2's Plan of Care (POC) for the certification period of 07/19/2023 to 09/19/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient once a week for one week starting 7/19/2023, two times a week for one week starting 7/23/2023, twice a week for three weeks starting 7/30/2023, once a week for one week starting 8/16/2023, once a week for five weeks starting 8/22/2023, once a week for one week starting 9/16/2023, once a week for four weeks starting 9/17/2023, to assess and instruct the patient and caregiver the importance of medication compliance and high risk medication use, side effects, contraindications, possible drug to drug interactions and special consideration. One of the skilled nurse (SN) intervention was to assess patient/caregiver knowledge of diabetic condition and instruct on knowledge deficits and blood sugar (BS) monitoring four times a day on every visit. A physician's order dated 7/19/2023, included in the POC had the following prescribed medications: 1. Lispro (a fast-acting insulins [is one of many hormones that helps the body turn the food we eat into energy] used to control high blood sugar) (U-100) 100 unit/milliliters (ml, unit of measurement) subcutaneous (injection of medication given in the fatty tissue, just under the skin) to administer 10 units twice a day. 2. Humulin N (an intermediate acting insulin that is slower to act and lasts longer) NPH U-100 insulin 100 unit/ml (3 ml) subcutaneous to administer 10 units at a.m. and p.m. as needed for increased blood glucose (blood sugar) level. Patient 2's POC did not indicate a parameter for increase glucose level. A review of the agency's Physician's Supplemental Order dated 7/24/2023, had the following new prescribed medications: a. Lispro (U-100) 100 unit/ml( milliliters) subcutaneous to administer 10 units at a.m. and 10 units at p.m. as needed for increased blood glucose level. b. Humulin N NPH U-100 insulin 100 unit/ml (3 ml) subcutaneous to administer 10 units at a.m. and p.m. as needed for increased blood glucose level. c. to administer both insulin if BS reading greater than 150. On 9/16/2023, at 1 p.m., a home visit was conducted at Patient 2's residence. However, a last minute text call was made by the DPCS stating Patient 2 refused to be visited On 9/18/2023, at 11 a.m., during a phone interview with Patient 2 and the PCG 1, when Patient 2 was asked if he takes his prescribed insulins, he stated that PCG 1 was administering to him two different insulin medications twice a day, one time in the morning and in the evening. A review of Patient 2's Blood Glucose Log Sheet dated 8/2023 and 9/2023 have the following dates and BS readings: a. 8/14/2023 after dinner- BS reading of 273 mg/dl. b. 8/15/2023- BS reading after dinner of 366 mg/dl. c. 8/18/2023- BS reading after dinner of 388 mg/dl. d. 8/19/2023- BS reading after dinner of 288 mg/dl. e. 8/24/2023- BS reading after dinner of 320 mg/dl. f. 8/25/2023- BS reading after dinner of 330 mg/dl. g. 9/2/2023- BS reading after dinner of 330 mg/dl. h. 9/5/2023- BS reading after dinner of 288 mg/dl. i. 9/6/2023- BS reading after dinner of 293 mg/dl. j. 9/7/2023- BS reading after dinner of 294 mg/dl. k. 9/12/2023- BS reading after dinner of 319 mg/dl. l. 9/16/2023- BS reading after dinner of 349 mg/dl. During an interview on 9/19/2023 at 1:30 p.m., the Director of Patient Care Services (DPCS) stated, RN 1 should have been checking Patient 2's Blood Glucose Log Sheet during his visits to notify the physician regarding the patient's high BS readings for possible insulin dose adjustments. A review of the agency’s undated policy and procedure titled, “Monitoring Patient’s Response/Reporting to Physician”, indicated clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient. The patient’s physician (or other authorized licensed independent practitioner) will be contacted when any of the following occur: changes in patient’s condition, changes in the patient’s expected response to treatment or medications, and when a visit is missed for any reason.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, is an agency or organization primarily engaged in providing skilled nursing services and other therapeutic services to a patient's personal residence) failed to ensure the Skilled Nurse (SN) provided instructions or health teaching on how to check blood sugar reading and for patient caregiver (PCG 1) to administer insulin (is any pharmaceutical preparation of the protein hormone insulin that is used to treat high blood glucose) for one of 17 patients (Patient 2). This deficient practice had the potential for Patient 2 and PCG not to be able to perform and monitor Patient 2's blood sugar level timely and consistent and could impact Patient 2's health status and wellbeing. (Refer to G-610). A record review of Patient 2's "Patient Information" indicated a start of care date (SOC) of 7/19/2023, with diagnosis that included hyperkalemia (a high level of electrolyte potassium in the blood). A review of Patient 2's Plan of Care (POC) for the certification period of 07/19/2023 to 09/19/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient once a week for one week starting 7/19/2023, two times a week for one week starting 7/23/2023, twice a week for three weeks starting 7/30/2023, once a week for one week starting 8/16/2023, once a week for five weeks starting 8/22/2023, once a week for one week starting 9/16/2023, once a week for four weeks starting 9/17/2023, to assess and instruct the patient and caregiver the importance of medication compliance and high risk medication use, side effects, contraindications, possible drug to drug interactions and special consideration. One of the SN (skilled nurse) intervention was to assess patient/caregiver knowledge of diabetic condition and instruct on knowledge deficits and blood sugar (BS) monitoring four times a day on every visit. A physician's order dated 7/19/2023, included in the POC had the following prescribed medications: 1. Lispro (fast-acting insulins used to control high blood sugar) (U-100) 100 unit/milliliters (ml, unit of measurement) subcutaneous (the injection is given in the fatty tissue, just under the skin) to administer 10 units twice a day. 2. Humulin N (an intermediate acting insulin that is slower to act and lasts longer) NPH U-100 insulin 100 unit/ml (3 ml) subcutaneous to administer 10 units at a.m. and p.m. as needed for increased blood glucose level. A review of the agency's Physician's Supplemental Order dated 7/24/23, had the following new prescribed medications: 1. Lispro (U-100) 100 unit/ml( milliliters) subcutaneous to administer 10 units at a.m. and 10 units at p.m. as needed for increased blood glucose level. 2. Humulin N NPH U-100 insulin 100 unit/ml (3 ml) subcutaneous to administer 10 units at a.m. and p.m. as needed for increased blood glucose level. to administer both insulin if BS reading greater than 150. On 9/16/2023, at 1 p.m., a home visit was conducted at Patient 2's residence. However, a last minute text call was made by the Director of Patient Care Services (DPCS) stated Patient 2 refused to be visited. During a telephone interview on 9/18/2023, at 11 a.m., with Patient 2 and the PCG 1, when Patient 2 was asked if he takes his prescribed insulins, he stated that PCG 1 was administering him two different insulin medications twice a day, one time in the morning and in the evening. During a telephone interview on 9/18/2023, at 2 p.m., RN 1, stated he was the assigned nurse for Patient 2. When RN 1 was asked if he checks the patient's medication during his visits and if Patient 2 had prescribed diabetic pill (medication for diabetes) or insulin medications, he stated yes, that he checks the patient's medications. RN 1 stated, Patient 2 takes NPH 70/30 insulin 10 units and Humalog insulin 10 units twice daily. RN 1 stated, PCG 1 administered both insulin medications twice daily to Patient 2. When RN 1 was asked if he checks the patient's BS reading on his visits, he stated no, and he just documented the BS reading taken by PCG1 every morning in his nursing notes. During a telephone interview on 9/18/2023, at 6:30 p.m., the DPCS stated that she was at Patient 2's residence at this time checking the patient's medications. DPCS stated, she confirmed by interviewing Patient 2 and PCG 1 that the patient was taking Lispro and Humulin insulin 10 units twice a day being given by PCG1. A review of Patient 2's Skilled Nurse Visit Notes from dates 7/19/2023 to 9/16/2023, indicated no documented evidence the visiting nurse provided patient teaching on glucometer usage nor proper technique to administer insulin with a return demonstration by the PCG 1 to validate teaching. During an interview on 9/19/2023, at 2 p.m., the DPCS stated the visiting nurse should be teaching regarding glucometer usage and proper insulin administering technique and PCG 1 should do a return demonstration to the visiting nurse to show proper way and to validate the teaching. A review of the agency's policy "Patient Education" indicated the agency should educate patients about their disease process, care plan and treatments while on service.

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 interview and record review, the home health agency (HHA is an agency or organization primarily engaged in providing skilled nursing services and other therapeutic services to a patient's personal residence) failed to ensure that the plan of care (POC) included parameters for oxygen (is an important gas in the air we breathe) levels and significant oxygen results to be reported to the physician for one of 17 sampled patients (Patient 13). This deficient practice has the potential to place the patient at risk for respiratory distress (symptoms related to breathing problems) that could lead to hospitalization. Findings: A review of Patient 13's Patient Profile indicated a start of care (SOC) date of 1/13/23, with diagnoses which included cerebral palsy (weakness or problems with using the muscles), epilepsy (a brain disorder that causes recurring, unprovoked seizures), and seizures (a sudden, uncontrolled burst of electrical activity in the brain that can cause changes in behavior, movements, feelings and levels of consciousness). A review of Patient 13's POC for the certification period from 7/12/23 to 9/9/23, included an order for the registered nurse (RN) to visit once a month for licensed vocational nurse (LVN) supervision, and for LVN to visit 32-40 hours per week to provide skilled care which includes, but not limited to observation and monitoring of patient condition including vital signs (measurements of the body's most basic functions including the heartbeat, breathing rate, temperature, and blood pressure) and changes in condition and provide intervention as the need arises. The POC further indicated an order for oxygen inhalation (treatment that provides you with supplemental, or extra, oxygen [is an important gas in the air we breathe] 0.75 liters per minute (LPM) continuous, and for the skilled nurse (SN) to provide comfort and implement aspiration precautions. On 9/18/23 at 10:45 a.m., during a concurrent interview and record review, the Director of Patient Care Services (DPCS) stated, the POC for Patient 13 did not include parameters for normal oxygen saturation (the amount of oxygen that's circulating in your blood) level and the significant oxygen results that was needed to be reported to the physician. The DPCS stated that it should have been included in the patient’s POC. A review of the agency’s undated policy and procedure titled “Care Planning Process,” indicated that the purpose of the POC is to provide clinical direction to the clinicians providing direct patient care. Based on the assessment and conclusions, the plan of care will include, but will not be limited to: A. Identified patient problems and needs, including functional limitations B. Reasonable, measurable, and individualized goals and outcomes identified by the organization and the patient anticipated to occur as a result of implementing and coordinating the plan of care C. Specific services and treatments to be provided

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey from 6/13/2023 to 6/16/2023. Complaint #: CA00098912 Representing the California Department of Public Health: Surveyor #22303, Health Facilities Evaluator Nurse Surveyor #44186, Health Facilities Evaluator Nurse Sample Size - 8 Home Visit - 4 Active Patients- 1173

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on interview, and record review, the home health agency (HHA) failed to ensure the emergency preparedness training for all staffs was conducted at least annually. This failure had the potential to result in the HHA staffs' lack of knowledge to readily and effectively respond during an emergency crises situation. Findings: During a review of the agency's emergency preparedness program indicated no documented evidence the emergency preparedness training was conducted to all HHA staffs. On 6/16/23, at 11 a.m., during an interview with the administrator designee, stated he did not conduct emergency preparedness training for all staffs. The HHA's undated policy and procedure titled, "Emergency Preparedness Plan" indicated the plan uses the term "all hazard" to address all types of incidents. The incidents which may require action by home care and emergency service personnel to prevent or minimize loss of life or damage to property and environment.

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey from 6/13/2023 to 6/16/2023. Intake No.: 98912 Representing the California Department of Public Health: Surveyor #22303, Health Facilities Evaluator Nurse Surveyor #44186, Health Facilities Evaluator Nurse Sample Size - 8 Home Visit - 4 Active Patients- 1173 On 6/15/2023, at 2:02 p.m., an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) was called in the presence of the agency’s Administrator (ADM), Administrator Designee (ADMD), Director of Patient Care Services Designee (DPCSD), Registered Nurse Supervisor (RN Supervisor), and Office Manager (OM) related to the agency’s failure to follow the physician’s order for Patient 2's insulin medication. The nursing failed to check patient’s blood sugar level during visits, failed to conduct medication reconciliation, and failed to provide teaching on how to self-administer insulin and to check blood sugar levels. On 6/16/2023, at 1:24 p.m., the RN Supervisor submitted an acceptable IJ removal plan that included the following: 1. Immediately sent an RN to patient’s home to perform a thorough medication reconciliation, coordinated with MD on blood sugar readings and abnormal vital signs findings, and verified medication orders over the phone. Teaching on blood sugar monitoring, glucometer calibration correct medication dosage and frequency was done, and patient verbalize understanding and performed return demonstration. 2. A new glucometer was provided to the patient. 3. SN established a blood sugar log with written parameters, case manager coordinated with MD on establishing a blood sugar parameter and additional regular insulin with sliding scale. 4. Order for Metformin confirmed with MD: Metformin (Glucophage XR) 500 mg 2 tablets every morning with breakfast and 2 tablets every evening with dinner. 5. One-on-one counseling done with SN involved regarding compliance with blood sugar check and vital signs monitoring. 6. Daily QA check to patients through Care Connection Program for newly admitted and existing patient if blood sugars are being taken and monitored based on MD order. Twice a week supervisory visit and phone call by RN Supervisor. 7. Robust communication system between patient, clinicians, and doctor will be implemented to report any changes in condition. This will be achieved through weekly case conferences. 8. Emergency in-service was conducted to All Care home health clinicians via Teams Meeting. Subject were medication reconciliation, adherence to MD orders, vital signs taking specifically blood sugar readings, and reportable incidents which includes abnormal vital signs and change in condition. 9. A weekly monitoring of clinician compliance on medication verification, vital signs monitoring, and diabetic management which includes blood sugar monitoring and glucometer calibration will be implemented to be supervised by the DPCS and care coordinators to all new and existing patients. 10. Monthly in-service will be conducted on medication reconciliation, MD order adherence, vital signs taking, diabetic management, patient teaching/education, and strict compliance on reporting to MD about abnormal findings and change in condition. 11. A quarterly PAQM (Professional Advisory Quality Management) meeting to evaluate the rate of compliance and changes to company protocol. On 6/16/2023, at 2:30 p.m., the survey team removed the IJ in the presence of the DPCSD and RN Supervisor, after verifying and confirming onsite that the agency implemented the IJ removal plan. The following three Conditions of Participation (COP) were not met: 484.55- Comprehensive Assessment of Patients 484.60-Care planning, Coordination, Quality of care 484.75- Skilled Professional Services

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 observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Comprehensive Assessment of Patients as follows: 1. The HHA failed to review and document all the medication changes and update the “Medication Profile” (the information about the medicine a person is using and has used) for three of eight sampled patients (Patient 2, Patient 3, and Patient 6). (Refer to G536) 2. The HHA failed to ensure a completed pressure ulcer (injury to the skin due to prolong pressure on the skin) wound assessment was conducted for one of eight sampled patients (Patient 1). (Refer to G544) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with the Federal Regulations for Comprehensive Assessment of Patients to ensure the provision of quality health care services in a safe manner. .

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review the Home Health Agency (HHA) failed to review and document all the medication changes for three of 8 sampled patients (Patients 2, 3, and 6). This deficient practice had the potential to result in placing the patients at risk for drug interactions, adverse actions, and medication errors that could affect the patients' already compromised health status. Findings: b. A review of Patient 6's clinical record indicated a start of care date (SOC) of 05/22/2023, with diagnosis that included essential hypertension (high blood pressure), acquired absence of other left toe, and type two diabetes mellitus (disease in which there is a high level of sugar in the blood). A review of Patient 6's Plan of Care (POC) for the certification period of 05/22/2023 to 07/20/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient once a week for one week, then two times a week for three weeks and once a week for one week to, among others, assess and instruct the patient and caregiver the importance of medication compliance and high risk medication use, side effects, contraindications, possible drug to drug interactions and special consideration. On 06/14/2023, at 10:15 a.m., a joint home visit with the Licensed Vocational Nurse (LVN 3) was conducted at Patient 6’s residence. A review of Patient 6’s current medication list provided by the agency, indicated that the patient was using Santyl collagenase topical ointment (a topical medication used for removing damaged or burned skin to allow for wound healing and growth of healthy skin) 250 units/gram for his wound. During an interview with Patient 6 on 06/14/2023 at 11:10 a.m., he stated that he never used Santyl ointment for his wound because it was never delivered to his house on time, and the physician ordered a different wound care treatment for his wound. During an interview with the Director of Patient Care Services Designee (DPCSD) on 06/16/2023 at 11:40 a.m., he stated that every medication that a patient is taking should be on the medication profile. DPCSD further stated that medication reconciliation should be done on every nurse visit. A review of the agency’s policy and procedure titled “Medication Profile,” indicated that patients receiving medications will have a current, accurate medication profile in the clinical record. The policy and procedure further indicated that medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications. a. A review of Patient 2's Patient Information indicated, an SOC date of 5/20/23, with diagnosis that included encounter for change or removal of surgical wound dressing. A review of Patient 2's Plan of Care (POC) for the certification period of 05/20/2023 to 07/18/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient seven times a week for one week, twice a week for one week, once a week for one week, four times a week for one week, twice a week for one week, five times a week for one week, seven times a week for one week, once a week for one week, to assess and instruct the patient and caregiver the importance of medication compliance and high risk medication use, side effects, contraindications, possible drug to drug interactions and special consideration. A physician's order included in the POC had the following prescribed medications: 1. Humulin N NPH U-100 insulin Kwikpen 100 unit /ml( milliliters) (3 ml) subcutaneous to administer 7 units every evening before dinner . 2. Humulin N NPH U-100 insulin Kwikpen 100 unit/ml (3 ml) subcutaneous to administer 20 units every morning before breakfast. On 6/14/23 at 1 p.m., a home visit was conducted at Patient 2's residence with RN 1 (Registered Nurse). Patient 2 was observed sitting in a chair in the bed room. During a review of Patient 2's medications indicated, there were one opened and one new insulin Kwikpens with a label that stated Humulin N NPH U-100 unit/ml ( 3 ml) stored in their refrigerator and one medication bottle labeled Metformin ER 500 mg (milligrams) (filled date 4/5/23) one tab to take two tablets in the morning and two tablets in the evening every evening. On 6/14/23 at 1:30 p.m., during an interview with Patient 2, he stated he takes Humulin 18 units in the morning before breakfast and 20 units every evening before dinner. He also stated that his physician told him to take the Humulin insulin dosages before he was admitted to the agency. He also stated that he was taking Metformin 500 mg two tabs in the morning and two tabs in the evening since two months ago. When patient was asked if the visiting nurse checks his medications during their visits, he stated only once during the initial visit. A further review of Patient 2's clinical record indicated no physician's order for Metformin 500 mg medication for Patient 2. On 06/16/2023 at 11:40 a.m., during an interview with the DPCSD (director of patient care services designee), she stated that every medication that a patient is taking should be on the medication profile. DPCSD further stated that medication reconciliation should be done on every nurse visit. b. A review of Patient 3's Patient Information indicated, an SOC date of 4/17/23, with diagnosis that included encounter diabetes mellitus ( a group of diseases that results in too much sugar in the blood). A review of Patient 2's Plan of Care (POC) for the certification period of 4/17/23 to 6/15/23, indicated that a skilled nurse (SN) was scheduled to visit the patient two times a week for one week, three a week for one week, seven a week for one week, seven times a week for one week, seven times a week for one week, seven times a week for one week, four times a week for one week, twice a week for one week, to assess and instruct the patient and caregiver the importance of medication compliance and high risk medication use, side effects, contraindications, possible drug to drug interactions and special consideration. On 6/14/23 at 11:30 a.m., a home visit was conducted at Patient 3's residence with LVN 1 (license vocational nurse). Patient 3 was observed sitting in a chair in the living room with a dressing on his left big toe. During a review of Patient 3's medications indicated one medication bottle labeled Ciproflexin 500 mg (milligrams) (filled date 6/6/23) one tablet twice daily. On 6/14/23 at 11:50 a.m., during an interview with Patient 3, he stated he was taking the Ciproflexin medication since a week ago> He also stated the visiting nurse does not check his medications when they visit him. A further review of Patient 3's clinical record indicated no physician's order for Ciproflexin 500 mg medication for Patient 3. On 06/16/2023 at 11:40 a.m., during an interview with the DPCSD (director of patient care services designee), she stated that every medication that a patient is taking should be on the medication profile. DPCSD further stated that medication reconciliation should be done on every nurse visit.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure a completed pressure ulcer (injuries to the skin due to prolong pressure on the skin) wound assessments were conducted that included the size of the ulcer including length and width in centimeters, tunneling (a wound that progressed to form passageways underneath the surface of the skin), undermining (the region underneath the overlying loose skin around a pressure ulcer), necrotic (dead tissue, usually dark in color) tissue, and slough (dead tissue, usually cream or yellow in color) for one of eight sampled patients (Patient 1). This deficient practice had the potential to result in the delay of treatment that could lead to delayed wound healing and wound infection. Findings: A review of Patient 1's clinical record indicated a start of care date (SOC) of 09/21/2022, with diagnosis that included fracture of the lumbar vertebra (or lumbar spine, the largest of your spine), and Alzheimer’s disease (a brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks). A review of Patient 1's Plan of Care for the certification period of 9/21/22 to 11/19/22, indicated a skilled nurse (SN) was scheduled to visit for skilled observation and assessment of vital signs (measure the basic functions of your body that includes your body temperature, blood pressure (BP), pulse and respiratory [breathing] rate), response/compliance with medications/treatment, and home safety. A review of Patient 1’s Home Health Physician Order dated 10/5/22, indicated a skilled nurse was scheduled to visit two times a week starting 10/5/22 and then three times a week thereafter, to perform wound care to patient’s pressure ulcer on the sacral area.( area bottom of the spine and above the tail bone). A review of Patient 1’s SN Visit Note dated 11/01/22 and 11/03/22, indicated patient had UTD (Unstageable, a full thickness tissue loss in which actual depth of the ulcer is completely obscured by slough [yellow, tan, gray, green, or brown] and/or eschar (drack, dry scab) [tan, brown, or black] in the wound bed) pressure ulcer on the sacrum(triangular bone wedged into the rear section of the pelvis) and that wound care treatment was provided as follows: cleansed wound with NS(normal saline), pat dry, apply Medi honey (medical-grade honey-based product for the management of wounds and burns) to wound bed, then cover with island dressing. The SN note did not indicate an assessment of the size and tunneling/undermining of the wound. There was also no assessment as to the percentage of necrotic tissue or slough that covers the wound bed. During a concurrent record review and interview with the Director of Patient Care Services Designee (DPCSD) on 6/16/23 at 11:40 a.m., DPCSD stated the nursing staff should have assessed the pressure ulcer completely. The DPCSD acknowledged SN pressure ulcer assessment on 11/01/22 and 11/03/22 for Patient 1 was incomplete. A review of the agency’s policy and procedure titled, “Wound Care Policy”, dated November 2016, indicated a qualified Registered Nurse or Registered Physical Therapist will assess wounds as part of the comprehensive initial assessment and will document all clinical findings as per agency policy. The admitting clinician will document each wound status including, location and etiology, measurement of length, width, and depth, undermining and tunneling if present, description of the wound bed, drainage, signs and symptoms of infection, healing and peri wound skin condition. At each visit the patient’s skin will be assessed. At each dressing change the wound will be assessed and documentation will include a description of the wound bed, drainage, signs and symptoms of infection, healing and peri wound skin condition.

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: Based on observation, interview and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Care Planning, Coordination of Services, and Quality of Care as follows: 1. The HHA failed to follow the patient's written plan of care (POC), for two of 8 sampled patients (Patients 1 and Patient 2). For Patient 1, the HHA failed to ensure for the skilled nurse (SN) to visit the patient, 3 times per week as per physician order. This deficient practice had a potential for Patient 1 not to receive care and services to meet the patient care goals. For Patient 2, the SN did not check the patient’s blood sugar level during visits, did not conduct medication reconciliation, and did not provide the patient’s education on how to self-administer insulin medication and check blood sugar. This deficient practice resulted in Patient 2 did not have a record of blood sugar check, HHA transcribed the incorrect order of insulin dose to the POC and the patient was self administering incorrect dose of insulin medication. On 5/20/23 skilled nurse check the patient blood sugar, result was 577 deciliter per milligram (mg/dl, unit of measurement) (Refer to G572). 2. The HHA failed to ensure an order for insulin (a hormone produced in the pancreas that lowers the level of glucose (a type of sugar) in the blood) was indicated in the patient's admission order of insulin, in the plan of care for one out of 8 sampled patients (Patient 2). This deficient practice had a potential for the patient not to receive medications timely that could place the patient at risk for complication. (Refer to G576) 3. The HHA failed to ensure the medications and treatments were administered as ordered by the physician for three of 8 sampled patients (Patient 1, Patient 2, and Patient 3). For Patient 1 , the skilled nurse (SN) failed to obtain further wound order/treatment from the physician. This deficient practice had the potential for performing a treatment on the patients' wound without a physician’s order which could result in ineffective wound treatment and delay in wound healing. For Patient 2, the SN failed to obtain order for Metformin medication (used in patients with diabetes) from the physician and the patient failed to follow correct Humulin NPH insulin (an intermediate-acting insulin given to help control blood sugar levels in people with diabetes) dosage as ordered. This deficient practice placed the patient at risk to have hypo/hyperglycemia crisis (are both life-threatening medical emergencies wherein your blood glucose level is either very low or very high). For Patient 3, the SN failed to obtain order for Ciproflexin medication (used to treat a variety of bacterial infections) from the physician. This deficient practice placed the patient's wound at risk for infection. (Refer to G580). 4. The HHA failed to notify the physician promptly of the patient's change of the pressure ulcer wound (damage to an area of the skin caused by constant pressure on the area for a long time) for one of 8 sampled patients (Patient 1). This deficient practice had a potential for delay wound healing and risk for infection. (Refer to G590). 5. The HHA failed to ensure the Skilled Nurse (SN) provided instructions or health teaching to the patient on how to check blood sugar reading and to self-administer insulin for one of 8 patients (Patient 2). This deficient practice had a potential for the patient lack of knowledge to perform and monitor the patient's blood sugar accurately and timely that could affect the patient's health status and wellbeing. (Refer to G 610). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure highest quality health care is provided to patients assessed to receive home health services.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to follow the patient's written plan of care (POC) for two of eight sampled patients (Patient 1 and Patient 2). For Patient 1, HHA failed to ensure for the skilled nurse (SN) to visit the patient 3 times per week. This deficient practice had a potential for Patient 1 not to receive care and services to meet the patient care goals. For Patient 2,the SN did not check the patient’s blood sugar level during visits, did not conduct medication reconciliation, and did not provide the patient’s education on how to self-administer insulin medication and check blood sugar. This deficient practice resulted in Patient 2's blood sugar level was not check as indicated on the POC, HHA transcribed the incorrect order of insulin dose to the POC and the patient was self administering incorrect dose of insulin medication. On 5/20/23 skilled nurse check the patient blood sugar, result was 577 deciliter per milligram (mg/dl, unit of measurement). On 6/15/2023 at 2:02 p.m., an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) was called in the presence of the agency’s Administrator (ADM), Administrator Designee (ADMD), Director of Patient Care Services Designee (DPCSD), Registered Nurse Supervisor (RN Supervisor), and Office Manager (OM) because of the seriousness related to the agency’s failure to follow the physician’s order for Patient 2 insulin medication. The agency’s nursing staffs did not check patient’s blood sugar level during visits, did not conduct medication reconciliation, and failed to provide Patient 2 teaching on how to self-administer insulin and to check blood sugar reading. On 6/16/2023 at 1:24 p.m., the RN Supervisor submitted an acceptable IJ removal plan that included the following: 1. Immediately sent an RN to patient’s home to perform a thorough medication reconciliation, coordinated with MD on blood sugar readings and abnormal vital signs findings, and verified medication orders over the phone. Teaching on blood sugar monitoring, glucometer calibration correct medication dosage and frequency was done, and patient verbalize understanding and performed return demonstration. 2. A new glucometer was provided to the patient. 3. SN established a blood sugar log with written parameters, case manager coordinated with MD on establishing a blood sugar parameter and additional regular insulin with sliding scale. 4. Order for Metformin confirmed with MD: Metformin (Glucophage XR) 500 mg 2 tablets every morning with breakfast and 2 tablets every evening with dinner. 5. One-on-one counseling done with SN involved regarding compliance with blood sugar check and vital signs monitoring. 6. Daily QA check to patients through Care Connection Program for newly admitted and existing patient if blood sugars are being taken and monitored based on MD order. Twice a week supervisory visit and phone call by RN Supervisor. 7. Robust communication system between patient, clinicians and doctor will be implemented to report any changes in condition. This will be achieved through weekly case conferences. 8. Emergency in-service was conducted to all All Care home health clinicians via Teams Meeting. Subject were medication reconciliation, adherence to MD orders, vital signs taking specifically blood sugar readings, and reportable incidents which includes abnormal vital signs and change in condition. 9. A weekly monitoring of clinician compliance on medication verification, vital signs monitoring, and diabetic management which includes blood sugar monitoring and glucometer calibration will be implemented to be supervised by the DPCS and care coordinators to all new and existing patients. 10. Monthly in-service will be conducted on medication reconciliation, MD order adherence, vital signs taking, diabetic management, patient teaching/education, and strict compliance on reporting to MD about abnormal findings and change in condition. 11. A quarterly PAQM (Professional Advisory Quality Management) meeting to evaluate the rate of compliance and changes to company protocol. On 6/16/2023, at 2:30 p.m., the survey team removed the IJ in the presence of the DPCSD and RN Supervisor, after verifying and confirming onsite that the agency implemented the IJ removal plan. A review of Patient 2's Patient Information indicated, an SOC date of 5/20/23, with diagnosis that included encounter for change or removal of surgical wound dressing. A review of Patient 2's Plan of Care (POC) for the certification period of 05/20/2023 to 07/18/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient seven times a week for one week, twice a week for one week, once a week for one week, four times a week for one week, twice a week for one week, five times a week for one week, seven times a week for one week, once a week for one week, to assess and instruct the patient and caregiver the importance of medication compliance and high risk medication use, side effects, contraindications, possible drug to drug interactions and special consideration. One of the SN (skilled nurse) intervention was to assess patient/caregiver knowledge of diabetic condition and instruct on knowledge deficits and BS (blood sugar) monitoring every visit. A physician's order included in the POC had the following prescribed medications: 1. Humulin N NPH U-100 insulin Kwikpen 100 unit /ml( milliliters) (3 ml) subcutaneous to administer 7 units every evening before dinner . 2. Humulin N NPH U-100 insulin Kwikpen 100 unit/ml (3 ml) subcutaneous to administer 20 units every morning before breakfast. On 6/14/23 at 1 p.m., a home visit was conducted at Patient 2's residence with RN 1 (Registered Nurse). Patient 2 was observed sitting in a chair in the bed room. During a review of Patient 2's medications indicated, there were one opened and one new insulin Kwikpens with a label that stated Humulin N NPH U-100 unit/ml ( 3 ml) stored in their refrigerator and one medication bottle labeled Metformin ER 500 mg (milligrams) (filled date 4/5/23) one tab to take two tablets in the morning and two tablets in the evening every evening. On 6/14/23 at 1:30 p.m., during an interview with Patient 2, he stated he takes Humulin 18 units in the morning before breakfast and 20 units every evening before dinner. He also stated that his physician told him to take the Humulin insulin dosages before he was admitted to the agency. He also stated that he was taking Metformin 500 mg two tabs in the morning and two tabs in the evening since two months ago. When patient was asked if the visiting nurse checks his medications during their visits, he stated the visiting nurse checked his meds only once during the initial visit. When patient was asked if visiting nurse was checking his BS readings, he stated no but he checks his BS by himself using his own glucometer three times a day. He further stated that he was not aware if his glucometer needed to be calibrated or not upon usage. A further review of Patient 2's clinical record indicated no physician's order for Metformin 500 mg medication for Patient 2. A review of Patient 2's Skilled Nurse Visit Note from dates 5/20/23 to 6/12/23, indicated no documented evidence that the visiting nurse performed a BS reading on every visits and provided a patient teaching with a return demonstration by the patient on how to calibrate the glucometer and to do his own finger stick using his glucometer to obtain BS readings daily. On 06/16/2023 at 11:40 a.m., during an interview with the DPCSD (director of patient care services designee), she stated that every medication that a patient is taking should be on the medication profile. DPCSD also stated that medication reconciliation should be done on every nurse visit. She further stated the visiting nurse should perform BS readings and provide patient teaching on how to use his glucometer the correct way to obtain accurate BS readings during visits as written in their plan of care. Findings: a. A review of Patient 1's clinical record indicated a start of care date (SOC) of 09/21/2022, with diagnosis that included fracture of the lumbar vertebra (or lumbar spine, the largest of your spine), and Alzheimer’s disease (a brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks). A review of Patient 1's Plan of Care for the certification period of 09/21/2022 to 11/19/2022, indicated that a skilled nurse (SN) was scheduled to visit for skilled observation and assessment of vital signs (measure the basic functions of your body that includes your body temperature, blood pressure (BP), pulse and respiratory [breathing] rate), response/compliance with medications/treatment, and home safety. A review of Patient 1’s Home Health Physician Order dated 10/05/2022, indicated that a skilled nurse was scheduled to visit two times a week starting 10/05/2022 and then three times a week thereafter. A review of Patient 1’s clinical records during the week starting from 10/30/2022 to 11/05/2022, indicated Patient 1 was only visited two times. During a concurrent record review and interview with the Director of Patient Care Services Designee (DPCSD) on 06/16/2023 at 11:40 a.m., DPCSD was unable to provide documented evidence that Patient 1 was visited according to the plan of care for the week starting from 10/30/2022 to 11/05/2022.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the HHA failed to ensure that an insulin (a hormone produced in the pancreas that lowers the level of glucose (a type of sugar) in the blood) was indicated in the patient's admission order for insulin in the plan of care for one out of 8 sampled patients (Patient 2). This deficient practice had a potential for the patient not to receive medications timely that could place the patient at risk for complication. Findings: A review of Patient 2's Patient Information indicated, an SOC date of 5/20/23, with diagnosis that included encounter for change or removal of surgical wound dressing. A review of Patient 2's referral/admission orders from the acute hospital dated 4/12/23, indicated an insulin order of Humulin N NPH U-100 insulin Kwik Pen 100 unit /ml(milliliters) (3 ml) subcutaneous to administer 17 units every evening before dinner and 20 units every morning before breakfast. A review of Patient 2's Plan of Care (POC) for the certification period of 5/20/23 to 7/18/23, indicated a skilled nurse (SN) was scheduled to visit the patient seven times a week for one week, twice a week for one week, once a week for one week, four times a week for one week, twice a week for one week, five times a week for one week, seven times a week for one week, once a week for one week, to assess and instruct the patient and caregiver the importance of medication compliance and high risk medication use, side effects, contraindications, possible drug to drug interactions and special consideration. A physician's order in the POC had the following prescribed medications: 1. Humulin N NPH U-100 insulin Kwikpen 100 unit /ml(milliliters) (3 ml) subcutaneous to administer 7 units every evening before dinner and 20 units every morning before breakfast. On 6/13/23, at 2 p.m., during an interview with the DPCSD (director of patient care services designee), when asked what the correct Humulin NPH insulin unit was dosage order to administer every evening for Patient 2, she stated the correct insulin order was from the admission order that stated to administer Humulin NPH 17 units every evening. She also stated that the HHA staff who received the admission order incorrectly transcribed Humulin NPH 7 units every evening in the POC and in the medication profile sheet which was a typo error. A review of the agency’s policy and procedure titled “Care Planning Process,” undated, indicated that the purpose of the policy and procedure is to provide clinical direction to the clinicians providing direct patient care. The patient-specific clinical plan of care includes all pertinent diagnoses, mental status, types of services/equipment, frequency of visits, goals, and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, treatments, safety measures, instructions, discharge plan.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to ensure that the medications and treatments were administered as ordered by the physician for three of 8 sampled patients (Patient 1, Patient 2, and Patient 3). For Patient 1 , the skilled nurse (SN) failed to obtain further wound order/treatment from the physician. This deficient practice had the potential for performing a treatment on the patients' wound without a physician’s order which could result in ineffective wound treatment and delay in wound healing. For Patient 2, the SN failed to obtain order for Metformin medication (used in patients with diabetes) from the physician and the patient failed to follow correct Humulin NPH insulin (an intermediate-acting insulin given to help control blood sugar levels in people with diabetes) dosage as ordered. This deficient practice placed the patient at risk to have hypo/hyperglycemia crisis (are both life-threatening medical emergencies wherein your blood glucose level is either very low or very high). For Patient 3, the SN failed to obtain order for Ciproflexin medication (used to treat a variety of bacterial infections) from the physician. This deficient practice placed the patient's wound at risk for infection. Findings: A review of Patient 1's clinical record indicated a start of care date (SOC) of 09/21/2022, with diagnosis that included fracture of the lumbar vertebra (or lumbar spine, the largest of your spine), and Alzheimer’s disease (a brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks). A review of Patient 1's Plan of Care for the certification period of 09/21/2022 to 11/19/2022, indicated that a skilled nurse (SN) was scheduled to visit for skilled observation and assessment of vital signs (measure the basic functions of your body that includes your body temperature, blood pressure (BP), pulse and respiratory [breathing] rate), response/compliance with medications/treatment, and home safety. A review of Patient 1’s Home Health Physician Order dated 10/05/2022, indicated that a skilled nurse was scheduled to visit two times a week starting 10/05/2022 and then three times a week thereafter. A review of Patient 1's SN Visit Note dated 10/05/2022, indicated the patient had developed stage 2 (partial thickness loss of dermis presenting as a shallow open ulcer with a red or pink wound bed, without slough or bruising) pressure ulcer 3 centimeter (cm) x 3 cm on the sacrum (sometimes called the sacral vertebra or sacral spine, is a large, flat, triangular-shaped bone nested between the hip bones and positioned below the last lumbar vertebra/spine), yellowish in appearance with small amount of drainage. The visit note indicated that wound care treatment was provided following the physician order: cleansed wound with normal saline (NS), pat dry, apply medihoney (medical-grade honey-based product for the management of wounds and burns) to wound bed, then cover with island dressing. A review of Patient 1’s SN Visit Note dated 10/27/2022, indicated the sacral pressure ulcer increased in size to 5 cm x 3 cm, has eschar (dead tissue that eventually sloughs off healthy skin after an injury), and was assessed by the visiting SN (LVN 1) from stage 2 pressure ulcer to unstageable (or UTD, a full thickness tissue loss in which actual depth of the ulcer is completely obscured by slough [yellow, tan, gray, green, or brown] and/or eschar [tan, brown, or black] in the wound bed) pressure ulcer. The note indicated that wound care treatment was provided following the same physician order on 10/05/2022: cleansed wound with NS, pat dry, apply medihoney to wound bed, then cover with island dressing. A review of Patient 1’s SN Visit Note dated 11/01/2022 and 11/03/2022, indicated patient had UTD pressure ulcer on the sacrum and that wound care treatment was provided as follows: cleansed wound with NS, pat dry, apply medihoney to wound bed, then cover with island dressing. A review of Patient 1’s clinical record indicated there was no documented evidence the agency’s staff had notified/communicated with the physician regarding Patient 1’s pressure ulcer wound that has increased in size, nor clarified current wound care treatment and obtain further wound orders from the physician for a change of wound condition from stage 2 pressure ulcer to an unstageable pressure ulcer on the sacral region. During a concurrent record review and interview with the Director of Patient Care Services Designee (DPCSD) on 06/16/2023 at 11:40 a.m., DPCSD was unable to provided documented evidence physician was notified and/or wound care treatment order was clarified regarding a change of pressure ulcer wound condition. DPCSD stated if there was a change in patient’s wound status, agency’s nurse should clarify current wound orders with the physician. A review of the agency’s undated policy and procedure titled, “Monitoring Patient’s Response/Reporting to Physician”, indicated clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient. The patient’s physician (or other authorized licensed independent practitioner) will be contacted when any of the following occur: changes in patient’s condition, changes in the patient’s expected response to treatment or medications, and when a visit is missed for any reason. b. A review of Patient 2's Patient Information indicated, an SOC date of 5/20/23, with diagnosis that included encounter for change or removal of surgical wound dressing. A review of Patient 2's admission orders from the acute hospital dated 5/20/23, indicated an insulin order of Humulin N NPH U-100 insulin Kwikpen 100 unit /ml( milliliters) (3 ml) subcutaneous to administer 17 units every evening before dinner and 20 units every morning before breakfast. . A review of Patient 2's Plan of Care (POC) for the certification period of 05/20/2023 to 07/18/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient seven times a week for one week, twice a week for one week, once a week for one week, four times a week for one week, twice a week for one week, five times a week for one week, seven times a week for one week, once a week for one week, to assess and instruct the patient and caregiver the importance of medication compliance and high risk medication use, side effects, contraindications, possible drug to drug interactions and special consideration. One of the SN (skilled nurse) intervention was to assess patient/caregiver knowledge of diabetic condition and instruct on knowledge deficits and BS (blood sugar) monitoring every visit. A physician's order included in the POC had the following prescribed medications: 1. Humulin N NPH U-100 insulin Kwikpen 100 unit /ml( milliliters) (3 ml) subcutaneous to administer 7 units every evening before dinner . 2. Humulin N NPH U-100 insulin Kwikpen 100 unit/ml (3 ml) subcutaneous to administer 20 units every morning before breakfast. On 6/13/23, at 2 p.m., during an interview with the DPCSD (director of patient care services designee), when asked what was the correct Humulin NPH insulin unit dosage order to administer every evening for Patient 2, she stated the correct insulin order was from the admission order that stated to administer Humulin NPH 17 units every evening. She also stated that the HHA staff who received the admission order incorrectly transcribed Humulin NPH 7 units every evening in the POC and medication profile sheet which was a typo error. On 6/14/23 at 1 p.m., a home visit was conducted at Patient 2's residence with RN 1 (Registered Nurse). Patient 2 was observed sitting in a chair in the bed room. During a review of Patient 2's medications indicated, there were one opened and one new insulin Kwikpens with a label that stated Humulin N NPH U-100 unit/ml ( 3 ml) stored in their refrigerator and one medication bottle labeled Metformin ER 500 mg (milligrams) (filled date 4/5/23) one tab to take two tablets in the morning and two tablets in the evening every evening. On 6/14/23 at 1:30 p.m., during an interview with Patient 2, he stated he takes Humulin 18 units in the morning before breakfast and 20 units every evening before dinner. He also stated that his physician told him to take the Humulin insulin dosages before he was admitted to the agency. He also stated that he was taking Metformin 500 mg two tabs in the morning and two tabs in the evening since two months ago. A further review of Patient 2's clinical record indicated no physician's order for Metformin 500 mg medication for Patient 2. On 06/16/2023 at 11:40 a.m., during an interview with the DPCSD (director of patient care services designee), she stated the visiting nurse should have obtained a physician's order for the Metformin medication and should have done a medication reconciliation on every nurse visit by verifying patient's self administration of correct insulin dosage coverage as ordered. c. A review of Patient 3's Patient Information indicated, an SOC date of 4/17/23, with diagnosis that included encounter diabetes mellitus ( a group of diseases that results in too much sugar in the blood). A review of Patient 3's Plan of Care (POC) for the certification period of 4/17/23 to 6/15/23, indicated that a skilled nurse (SN) was scheduled to visit the patient two times a week for one week, three a week for one week, seven a week for one week, seven times a week for one week, seven times a week for one week, seven times a week for one week, four times a week for one week, twice a week for one week, to assess and instruct the patient and caregiver the importance of medication compliance and high risk medication use, side effects, contraindications, possible drug to drug interactions and special consideration. On 6/14/23 at 11:30 a.m., a home visit was conducted at Patient 3's residence with LVN 1 (license vocational nurse). Patient 3 was observed sitting in a chair in the living room with a dressing on his left big toe. During a review of Patient 3's medications indicated one medication bottle labeled Ciproflexin 500 mg (milligrams) (filled date 6/6/23) one tablet twice daily. On 6/14/23 at 11:50 a.m., during an interview with Patient 3, he stated he was taking the Ciproflexin medication since a week ago> He also stated the visiting nurse does not check his medications when they visit him. A further review of Patient 3's clinical record indicated no physician's order for Ciproflexin 500 mg medication for Patient 3. On 06/16/2023 at 11:40 a.m., during an interview with the DPCSD (director of patient care services designee), she stated the visiting nurse should have obtained a physician's order for Ciproflexin medication for Patient 3.

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 interview and record review, the home health agency (HHA) failed to notify the physician promptly of the patient's change of the pressure ulcer wound (damage to an area of the skin caused by constant pressure on the area for a long time) for one of 8 sampled patients (Patient 1). This deficient practice had a potential for delay wound healing and risk for infection. (Refer to G590). Findings: A review of Patient 1's clinical record indicated a start of care date (SOC) of 9/21/2022, with diagnosis that included fracture of the lumbar vertebra (or lumbar spine, the largest of your spine), and Alzheimer’s disease (a brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks). A review of Patient 1's Plan of Care for the certification period of 9/21/2022 to 11/19/2022, indicated that a skilled nurse (SN) was scheduled to visit for skilled observation and assessment of vital signs (measure the basic functions of your body that includes your body temperature, blood pressure (BP), pulse and respiratory [breathing] rate), response/compliance with medications/treatment, and home safety. A review of Patient 1’s Home Health Physician Order dated 10/05/2022, indicated that a skilled nurse was scheduled to visit two times a week starting 10/05/2022 and then three times a week thereafter, to perform wound care to patient’s pressure ulcer wound on the sacral area. A review of Patient 1's SN Visit Note dated 10/05/2022, indicated the patient had stage 2 pressure ulcers 3 centimeter (cm) x 3 cm on the sacrum (sometimes called the sacral vertebra or sacral spine, is a large, flat, triangular-shaped bone nested between the hip bones and positioned below the last lumbar vertebra/spine), yellowish in appearance with small amount of drainage. SN Visit Note dated 10/27/2022, indicated the sacrum pressure ulcer increased in size to 5 cm x 3 cm and has eschar (dead tissue that eventually sloughs off healthy skin after an injury). A review of Patient 1’s clinical record indicated there was no documented evidence the agency’s staff had promptly alerted the physician regarding the significant changes of Patient 1’s pressure ulcers. On 4/04/2023, at 10:32 a.m., during the complaint investigation, a phone interview was conducted with FM 1. FM 1 stated the agency nursing staff did not provide instruction on how to prevent the spread of the pressure ulcer, suggest the necessary equipment to do so, and did not provide education regarding wound care. During the complaint validation survey on 6/16/2023, at 8:45 a.m., Patient 1’s family member (FM 1) was contacted by telephone and was unsuccessful. During a concurrent record review and interview with the Director of Patient Care Services Designee (DPCSD) on 6/16/2023, at 11:40 a.m., DPCSD stated for any change in patient’s status, patient’s physician should be notified promptly on the same day, and all verbal orders should be signed on the same day, or the next day physician’s verbal orders was received. A review of the agency’s undated policy and procedure titled, “Monitoring Patient’s Response/Reporting to Physician”, indicated clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient. The patient’s physician (or other authorized licensed independent practitioner) will be contacted when any of the following occur: changes in patient’s condition, changes in the patient’s expected response to treatment or medications, and when a visit is missed for any reason.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the Home Health Agency (HHA) failed to ensure the Skilled Nurse (SN) provided instructions or health teaching on how to check blood sugar reading and to self-administer insulin for one of 8 patients (Patient 2). This deficient practice has the potential for the patient lack of knowledge to perform and monitor the patient's blood sugar accurately and consistently that could impact the patient's health status and wellbeing. Findings: A review of Patient 2's Patient Information indicated, an SOC date of 5/20/23, with diagnosis that included encounter for change or removal of surgical wound dressing. A review of Patient 2's Plan of Care (POC) for the certification period of 5/20/2023 to 7/18/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient seven times a week for one week, twice a week for one week, once a week for one week, four times a week for one week, twice a week for one week, five times a week for one week, seven times a week for one week, once a week for one week, to assess and instruct the patient and caregiver the importance of medication compliance and high risk medication use, side effects, contraindications, possible drug to drug interactions and special consideration. One of the SN (skilled nurse) interventions was to assess patient/caregiver knowledge of diabetic condition and instruct on knowledge deficits and BS (blood sugar) monitoring every visit. On 6/14/23, at 1 p.m., a home visit was conducted at Patient 2's residence with RN 1 (Registered Nurse). Patient 2 was observed sitting in a chair in the bedroom with a dressing on his right foot. On 6/14/23, at 1:30 p.m., during an interview, Patient 2 was asked if the visiting nurse checks his BS readings during their visits, and Patient 2 stated, "No" and does checks his BS himself using his personal glucometer. Patient 2 further stated that he was not aware if his glucometer needed to be calibrated or not. Patient 2 also stated that the visiting nurse did not provide patient teaching on how to self-administer his prescribed insulin. A review of Patient 2's Skilled Nurse Visit Notes from dates 5/20/23 to 6/12/23, indicated no documented evidence the visiting nurse provided patient teaching on glucometer usage with a return demonstration by the patient/caregiver to validate teaching. On 6/16/23, at 12 p.m., during an interview with the DPCSD (director of patient care services designee), she stated the visiting nurse should be teaching regarding glucometer usage and self-administering of insulin and patient/caregiver should do a return demonstration to the visiting nurse to show proper way and to validate the teaching. A review of the agency's policy "Patient Education" indicated the agency should educate patients about their disease process, care plan and treatments while on service.

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 observation, interview, and record review, the Home Health Agency (HHA) failed to ensure the agency skilled nurse (SN) performed standard precautions to prevent the transmission of infections and communicable diseases for two of eight sampled patients (Patient 3 and Patient 5). For Patient 3, LVN 1 failed to maintain aseptic technique (free from contamination, to prevent spread of infection) by not washing hands after cleaning an open wound during wound care. This deficient practice placed the patient at a potential risk for wound infection. For Patient 5, LVN 2 failed to sanitize the patient's blood pressure equipment after its use. This deficient practice had the potential to place patients at risk for transmission of infectious agents. Findings: b. A review of Patient 5's clinical record indicated a Start of Care date (SOC) of 04/01/2023, with a diagnosis that includes stage 4 pressure ulcer (this happens when the sore digs deeper below the surface of your skin) of sacral region (the portion of your spine between your lower back and tailbone), and paraplegia (paralysis of the legs and lower body). A review of Patient 5's Plan of Care (POC) for the certification period of 05/31/2023 to 07/29/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient once a week for one week, then two times a week for seven weeks for skilled observation and assessment of vital signs (measure the basic functions of your body that includes your body temperature, blood pressure (BP), pulse and respiratory [breathing] rate), response/compliance with medications/treatment, home safety, and wound care. On 06/13/2023, at 3:18 p.m., a joint home visit with the Licensed Vocational Nurse (LVN 2) was conducted at Patient 5’s residence. Patient 5 was observed alert and oriented x 3 (to person, place, and time), sitting in her wheelchair. During the home visit, LVN 2 was observed taking Patient 5’s blood pressure and heart rate using the equipment he took out of his bag. Once he completed taking the patient’s blood pressure, he proceeded to place his equipment backed into his bag. LVN 2 did not clean his equipment after taking Patient 5’s blood pressure. During an interview with LVN 2 on 6/13/2023, at 4:10 p.m., he stated he forgot to clean his BP equipment after checking Patient 5’s blood pressure. LVN 2 stated all equipment that he used for the patient should be cleaned and sanitized before and after each patient used. During an interview with the Director of Patient Care Services Designee (DPCSD) on 06/16/2023 at 11:40 a.m., he stated the equipment should be cleaned and sanitized before and after patient care. A review of the agency’s policy and procedure titled “Bag Technique,” dated April 2015, indicated the purpose of the policy and procedure is to describe the procedure for maintaining a clean patient care supply bag/computer bag and preventing cross-contamination. As part of the infection/exposure control plan, All Care Home Health personnel will consistently implement principles to maximize efficient use of the patient care supply bag when used in caring for patients. When the visit is completed, reusable equipment will be cleaned using alcohol and/or soap and water as appropriate, hands will be washed, and equipment and supplied will be returned to the bag. A review of Patient 3's Patient Information indicated, an SOC date of 4/17/23, with diagnosis that included encounter diabetes mellitus ( a group of diseases that results in too much sugar in the blood). A review of Patient 3's Plan of Care (POC) for the certification period of 4/17/23 to 6/15/23, indicated that a skilled nurse (SN) was scheduled to visit the patient two times a week for one week, three a week for one week, seven a week for one week, seven times a week for one week, seven times a week for one week, seven times a week for one week, four times a week for one week, twice a week for one week, to perform a comprehensive skilled assessment on integumentary status (skin), to assess and instruct patient and caregiver measures to prevent skin breakdown. One of the Sn (skilled nursing) intervention was to provide wound care at left hallux as follows: cleanse with Vashe cleanser, apply Santyl ointment, cover with woven gauze and Kerlix wrap and secure with tape. On 6/14/23 at 11:30 a.m., a home visit was conducted at Patient 3's residence with LVN 1 (license vocational nurse). During a wound care observation, Patient 3 was observed sitting on a chair while his left foot was elevated on a a chair. Patient 3 had an open wound at left hallux. LVN 1 was observed initially washing her hands, then putting on a new pair of gloves, removed the soiled dressing at left hallux with minimal yellow drainage, placed it in his plastic bag. LVN 1 then picked up a clean pair of gauze, wet the gauze with Vashe cleanser and wiped the open wound with it. LVN 1 applied Santyl ointment on the wound, covered with gauze and Kerlix wrap and secured it with tape. All throughout the procedure, LVN 1 did not changed her soiled gloves and wash her hands. On 6/14/23, at 12 p.m., during an interview with LVN 1, she stated she forgot to wash her hands because she was so nervous. On 6/16/23, at 12 p.m., during an interview with the DPCSD (director of patient care services designee), she stated LVN 1 should have washed her hands in between dressing changes for Patient 3. A review of the agency's policy titled "Hand Hygiene and Compliance Program (undated)", indicated that staff should perform hand hygiene (wash hands) before and after direct patient care, when hands are soiled and after any contact with contaminated materials.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to ensure that the Condition of Participation for Skilled Professional Services was met as follows: 1. The HHA failed to follow the plan of care (POC) for two of eight sampled patients (Patient 2 and Patient 6). The agency’s skilled nurse (SN) failed to check Patient 2's blood sugar level. The agency’s skilled nurse (SN) failed to check Patient 6's temperature and blood sugar level. (Refer to G710) 2. The HHA failed to ensure designated attending physician was notified and notifications were documented when ordered home visits services were missed for one of eight sampled patients (Patient 1). (Refer to G718) The cumulative effect of these systemic practices resulted in the failure of the home health agency's inability to deliver statutorily mandated compliance with Federal regulations for Skilled Professional Services to ensure the provision of highest quality health care services in a safe environment. .

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 observation, interview, and record review, the home health agency (HHA) failed to follow the plan of care (POC) for two of eight sampled patients (Patient 2 and Patient 6). The agency’s skilled nurse (SN) failed to check Patient 2's blood sugar level. The SN failed to check Patient 6’s temperature and blood sugar level. These deficient practices resulted in the patients not receiving the quality of care and services identified in the POC. Findings: b. A review of Patient 6's clinical record indicated a start of care date (SOC) of 05/22/2023, with diagnosis that included essential hypertension (high blood pressure), acquired absence of other left toe, and type two diabetes mellitus (disease in which there is a high level of sugar in the blood). A review of Patient 6's Plan of Care (POC) for the certification period of 05/22/2023 to 07/20/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient once a week for one week, then two times a week for three weeks and once a week for one week for skilled observation and assessment of vital signs (measure the basic functions of your body that includes your body temperature, blood pressure (BP), pulse and respiratory [breathing] rate), response/compliance with medications/treatment, home safety, and blood sugar monitoring by patient/caregiver and/or SN on every visit. The POC also indicated for the SN to notify physician (MD) if temperature is greater than 101 degrees Fahrenheit (F, a unit of measure) or higher, and to notify MD if blood sugar is above 300 mg/dl (milligrams per deciliter, which is a unit of measure) or below 60 mg/dl. On 06/14/2023, at 10:15 a.m., a joint home visit with the Licensed Vocational Nurse (LVN 3) was conducted at Patient 6’s residence. LVN 3 was observed checking the patient’s blood pressure, pulse and respiratory rate but did not check the patient’s temperature. During an interview with LVN 3 on 06/14/2023 at 11:25 a.m., he stated that he forgot to assess the patient’s temperature. LVN 3 stated vital signs including temperature checks should be done on every SN visit. A review of Patient 6’s Skilled Nurse Visit Notes, dated 05/25/2023, 05/29/2023, 06/01/2023, 06/06/2023, and 06/09/2023 indicated that there was no documentation that the blood sugar was checked during these visits. During a concurrent record review and interview with the Director of Patient Care Services Designee (DPCSD) on 06/16/2023 at 11:40 a.m., he stated that since the POC indicated that blood sugar should be checked and monitored, the nurse should have checked and documented on the clinical notes. DPCSD also stated vital signs including temperature checked should be done on every nurse visit. A review of the agency’s policy and procedure titled “Care Planning Process,” undated, indicated that the purpose of the policy and procedure is to provide clinical direction to the clinicians providing direct patient care. The patient-specific clinical plan of care includes all pertinent diagnoses, mental status, types of services/equipment, frequency of visits, goals, and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, treatments, safety measures, instructions, discharge plan. A review of Patient 2's Patient Information indicated, an SOC date of 5/20/23, with diagnosis that included encounter for change or removal of surgical wound dressing. A review of Patient 2's Plan of Care (POC) for the certification period of 05/20/2023 to 07/18/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient seven times a week for one week, twice a week for one week, once a week for one week, four times a week for one week, twice a week for one week, five times a week for one week, seven times a week for one week, once a week for one week, to assess and instruct the patient and caregiver the importance of medication compliance and high risk medication use, side effects, contraindications, possible drug to drug interactions and special consideration. One of the SN (skilled nurse) intervention was to assess patient/caregiver knowledge of diabetic condition and instruct on knowledge deficits and BS (blood sugar) monitoring every visit. On 6/14/23 at 1 p.m., a home visit was conducted at Patient 2's residence with RN 1 (Registered Nurse). Patient 2 was observed sitting in a chair in the bed room with a dressing on his right foot. On 6/14/23 at 1:30 p.m., during an interview with Patient 2, when patient was asked if the visiting nurse checks his BS readings during their visits, he stated no but he checks his BS by himself using his personal glucometer. He further stated that he was not aware if his glucometer needed to be calibrated or not upon usage. A review of Patient 2's Skilled Nurse Visit Notes from dates 5/20/23 to 6/12/23, indicated no documented evidence the visiting nurse performed BS readings to the patient during visits. On 6/16/23, at 12 p.m., during an interview with the DPCSD (director of patient care services designee), she stated the visiting nurse should be checking/monitoring the patient's blood sugar readings during their visits as stated in the plan of care.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure designated attending physician was notified and notifications were documented when ordered home visit services were missed for one of eight sampled patients (Patient 1). This failure had the potential for the patient’s condition to deteriorate with no immediate interventions due to the lack of physician notification by the HHA. Findings: A review of Patient 1's clinical record indicated a start of care date (SOC) of 09/21/2022, with diagnosis that included fracture of the lumbar vertebra (or lumbar spine, the largest of your spine), and Alzheimer’s disease (a brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks). A review of Patient 1's Plan of Care for the certification period of 09/21/2022 to 11/19/2022, indicated that a skilled nurse (SN) was scheduled to visit for skilled observation and assessment of vital signs (measure the basic functions of the body that includes body temperature, blood pressure (BP), pulse and respiratory [breathing] rate), response/compliance with medications/treatment, and home safety. A review of Patient 1’s Home Health Physician Order dated 10/05/2022, indicated that a skilled nurse was scheduled to visit two times a week starting 10/05/2022 and then three times a week thereafter. A review of Patient 1’s clinical records during the week starting from 10/30/2022 to 11/05/2022, indicated Patient 1 was only visited two times. The clinical records indicated there was a missed visit note dated 10/10/2022, 10/22/2022, and 10/29/2022. There was no documented evidence that the agency’s staff had notified or communicated with the physician about the missed visit according to the agency’s policy and procedure. During a concurrent record review and interview with the Director of Patient Care Services Designee (DPCSD) on 06/16/2023 at 11:40 a.m., the DPCSD stated for any missed visits or change in patient’s status, patient’s physician should be notified promptly, and all verbal orders should be signed on the same day, or the next day physician’s verbal orders were received per the agency’s policy and procedure. A review of the agency’s undated policy and procedure titled, “Monitoring Patient’s Response/Reporting to Physician”, indicated clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient. The patient’s physician (or other authorized licensed independent practitioner) will be contacted when any of the following occur: changes in patient’s condition, changes in the patient’s expected response to treatment or medications, and when a visit is missed for any reason. A review of the agency’s undated policy and procedure titled, “Verification of Physician Orders”, indicated verbal orders will be documented on a form provided by All Care Home Health. The order will then be read back to the ordering physician and seek confirmation. A copy of the order will be kept in the patient’s clinical record. Signed orders will be placed in the clinical record within 30 days of initiation of the order, unless otherwise specified by applicable state law and regulation.