Every finding on record at Carson Healthcare Services, LLC

The following reflects the findings of the Department of Public Health during a Complaint validation survey. Intake #: 61039 Representing the Department of Public Health: Surveyor # 22303, Health Facilities Evaluator Nurse Surveyor # 25046, Health Facilities Evaluator Nurse Surveyor # 09697, Health Facilities Evaluator Nurse Total Census: 40 Residents Sample Size:6 Home Visit: 3

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 failed to review all the medications and update the medication profile with currently used medications for two of six sampled patients (Patients 1 and 5). This deficient practice had the potential to put the patient at risk for medication errors and adverse drug reactions. 2. On 10/26/21, at 11 a.m., a home visit was conducted at Patient 1's residence with Licensed Vocation Nurse 2 (LVN 2). Patient 1 was observed sitting on his wheelchair in the living room. At 11:40 a.m., a review of Patient 1's actual medication bottles, indicated the following: a. Vitamin B 12 (a nutrient to keep the body healthy) 500 micrograms, one tablet daily and date of refill was 6/12/21. b. Vitamin D3 (a vitamin to keep bones and muscle strength) 400 international units, one tab daily and date of refill was 8/12/21. c. Mag Oxide 400 ( medicine that helps manage gastrointestinal problems, relieves depression, reduces blood pressure, reduces migraine and risk of stroke) milligram (mg) one tab at 8 a.m. daily and date of refill was 8/12/21. d. Melatonin (a medication that improves sleep, eye health, depression and gastrointestinal problems) 5 mg., 1 tab at p.m. daily and date of refill was 8/12/21. A review of Patient 1's medication profile did not indicate an update of the above lists of medications. The medication profile indicated Tamsulosin (medication to treat symptoms of enlarged prostate) 0.4 mg., however, the medication was not available. A review of Patient 1's admission record indicated Patient 1 was admitted to the facility on 8/13/2021, with diagnosis Type 2 Diabetes Mellitus (high blood sugar). A review of Patient 1's plan of care (POC) from dates 10/4/2021 to 12/2/2021, included an order for the SN (skilled nurse) to visit daily for 60 days, to perform complete physical assessment each visit with emphasis on wound and medication management and home safety. Instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). One of the prescribed medication included in the POC was Tamsulosin 0.4 mg (milligrams) 1/2 tab every evening by mouth. The POC did not indicate the orders for Vitamin B 12, Vitamin D3, Mag Oxide 400 and Melatonin. At 11:45 a.m., during an interview with LVN 2, when asked if she checks the patient's actual medications during her visits, LVN 2 stated she checked it once. LVN 2 also stated that the Director of Patient Care Services (DPCS) only instructed her to focus on patient's wound treatment. At 11:55 a.m., during an interview with Patient 1, he stated he was not aware he was supposed to take the Tamsulosin 0.4 mg medication for daily basis. On 10/27/2021, at 1 p.m., during an interview with the DPCS, he stated LVN 2 should be checking the patient's actual medication bottle and should have matched with the POC and medication profile medications orders on every visits. DPCS also stated, if there are any changes to any medications, LVN 2 should call the office for any medication updates or verifications. 1. On 10/26/2021, at 11:30 a.m., during a joint home visit with Licensed Vocational Nurse 1 (LVN 1) at Patient 5’s adult residential facility, Patient 5 was sitting in a chair near the kitchen, and Caregiver 1 was next to the patient. During a review of Patient 5's current medications and the medication profile provided by the agency, one bubble pack of Propranolol HCL (a blood pressure medicine) 10 milligrams (mg) dated 9/13/2021, and a bubble pack of Propranolol HCL 20 mg dated 9/13/2021 was observed. The medication profile indicated the patient was to take Propranolol HCL 20 mg daily. The direction in the bubble pack of Propranolol HCL 10 mg indicated one tablet by mouth daily for hypertension (high blood pressure), in addition to the Propranolol HCL 20 mg. The direction of the bubble pack of Propranolol HCL 20 mg indicated one tablet by mouth daily for hypertension, in addition to Propranolol HCL 10 mg. A review of the medication list for Patient 5 in the document titled, "Home Health Certification and Plan of Care (POC)" for the certification period from 9/14/2021 to 11/12/2021, indicated Propanolol 20 mg once daily by mouth, hold for blood pressure less than 100/60 or pulse less than 60, and included an order for the skilled nurse (SN) to visit four times a day for 60 days to help with managing medications and noncompliance with medication regimen related to insulin and oral diabetic agents. SN was to instruct the patient/caregiver medication management. During an interview with Caregiver 1 on 10/26/2021, at 12 p.m., he stated the facility staff had been administering each 10 mg of Propranolol HCL and 20 mg of Propranolol HCL (total of 30 mg) every morning for a long time. He stated, the propranolol was dispensed on 9/13/2021. During a concurrent interview with LVN 1, she stated she had visited Patient 5 for insulin administration and diabetes management. LVN 1 stated she did not notice the discrepancy between the medication profile and the actual medications Patient 5 was taking because it was Caregiver’s job administering the oral medications, not her. She stated however, she should have clarified the dosage of Propranolol HCL with the physician and updated the medication profile. During an interview with the Patient Care Service (DPCS) on 10/27/2021, at 3:50 p.m., he stated the patient’s physician ordered the medication to the pharmacy and the facility got the medication from the pharmacy. He stated the agency staff had not checked with the patient’s oral medication because the facility (where patients reside) would not let the agency deal with oral medication and the agency got paid for only insulin injection by the regional center. However, he stated the agency staff should have checked Patient 5’s medication on hand by comparing with the medication profile. A review of the policy and procedure titled, "Medication profile", revised in December 2017, indicated the patient receiving medications administered by the organization will have a current, accurate medication profile in the clinical record. The Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications.

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 observation, interview and record review, the home health agency failed to perform wound assessments during each home visit, for one of six sampled patients, Patient 1, who had open wounds on the lower extremity. This failure had the potential for delay in wound healing and a decline in the condition of the wounds. Findings: On 10/26/21, at 11:20 a.m., during an interview with LVN 2, she stated Patient 1's wounds developed on the right sole of the foot and second toe of the left foot two weeks ago and she had been applying wound cleanser and bacitracin ointment (topical antibiotic) on the wounds. A review of Patient 1's admission record indicated Patient 1 was admitted to the facility on 8/13/19, with diagnosis Type 2 Diabetes Mellitus (high blood sugar). A review of Patient 1's plan of care (POC) dated from 10/4/2021 to 12/2/2021, included an order for the SN (skilled nurse) to visit daily for 60 days, to assess integumentary status, identify any signs and symptoms of impaired skin integrity and report any significant changes to the physician. A review of Patient 1's skilled nurse visits dated from 10/10/2021 to 10/25/2021, indicated there were no wound assessments done for Patient 1. During an interview on 10/2720/21 at 1:20 p.m., the Director of Patient Care Services (DPCS) stated the SN does not do weekly wound assessments. He also stated that the during home visits, the visiting nurse should be doing a wound assessment including measurements of the wound when providing wound care. A review of the agency's policy and procedure titled, "Wound Care Policy and Guidance" indicated the wound care, wound characteristics and wound measurements are documented at least once a week.

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 failed to meet the Condition of Participation for Care Planning, Coordination and Quality Care by failing to: Ensure that a care plan was developed for the wound management, for one of six sampled patients, Patient 1, who had a diagnosis of diabetes (high blood sugar), and had open wounds on the lower extremity. (Refer to G572)Administer the antihypertensive medication (medication to lower the blood pressure) as ordered by the physician for one of six sampled patients, Patient 1. (Refer to G576)Ensure that the physician orders for the treatment of the wounds were obtained for one of six sampled patients. (Patient 1). (Refer to G580)Ensure that the physician was notified promptly according to its plan of care for one of six sampled patients, (Patient 1), who had open wounds on his right sole of foot and the second toe of the left foot, and for two of six sampled patients (Patients 1 and 5), who had high blood sugar levels. (Refer to G590)The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality healthcare in a safe environment. Please refer to the following tags: 1. Refer to G572 2. Refer to G580 3. Refer to G576 4. Refer to G590

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 failed to ensure that a care plan was developed for the care of the wounds, for one of six sampled patients (Patient 1). For Patient 1 who had a diagnosis of diabetes (high blood sugar), and had open wounds on the lower extremity, there was no care plan developed with interventions that indicated treatment as ordered by physician. This failure had the potential for delay in wound healing and a decline in the condition of the wounds. Findings: On 10/26/2021, at 11 a.m., a home visit was conducted at Patient 1's residence with Licensed Vocational Nurse 2 (LVN 2). Patient 1 was observed sitting on his wheelchair in the living room. Patient 1 was observed with open wound on his right sole of the foot and the second toe of his left foot. On 10/26/2021, at 11:15 a.m., during an interview with Patient 1, he stated he is diabetic and the wound on his right sole of foot and the second toe on left foot had reopened few weeks ago when he accidentally bumped his foot to the side of his bed. On 10/26/2021, at 11:20 a.m., during an interview with LVN 2, she stated the patient's wounds developed on his right sole of foot and the second toe of the left foot two weeks ago, and she was applying wound cleanser and bacitracin ointment (topical antibiotic) on the wounds. LVN 2 also stated there was no physician orders for the cleanser and ointment. A review of Patient 1's admission record indicated Patient 1 was admitted to the facility on 8/13/2019, with diagnosis of Diabetes Mellitus. A review of Patient 1's Plan of Care (POC) dated from 10/4/2021 to 12/2/2021, included an order for the SN (skilled nurse) to visit daily for 60 days to assess integumentary status, identify any signs and symptoms of impaired skin integrity and report any significant changes to the physician. A review of Patient 1's clinical record indicated that an individualized care plan was not developed for the wound management on the right sole of foot and second toe of the left foot. There was no documentation that a treatment ordered by the physician was provided on the patient's wounds. During an interview on 10/27/2021, at 12 p.m., the Director of Patient Care Services stated LVN 2 should have developed an individualized care plan that included a treatment order from the physician when LVN 2 identified Patient 5's open wounds.

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 observation, interview and record review, the home health agency (HHA) failed to ensure the Plan of Care (POC) included the physician’s order of wound treatment and goals for one of 4 sampled patients (1). This deficient practice can prevent the nursing staff from following the physician’s order and providing care accordingly. On 12/12/2021, at 12:30 p.m., during a joint home visit with the Administrator and Licensed Vocational Nurse 2 (LVN 2), Patient 1 was observed sitting in a wheelchair. During an interview with Patient 1 and LVN 2, they stated the wound treatment on the scrotum and right plantar surface of the foot was done in the morning. A review of Patient 1's clinical record disclosed a start of care (SOC) dated 8/13/21, with diagnoses which included diabetes mellitus (DM - A chronic condition that affects the way the body processes blood sugar), hypertension (high blood pressure), and wound of scrotum. There was a physician’s order dated 8/5/2021, to perform wound care dressing daily with silverderm cream to the scrotum and may alternate with bacitracin ointment. A review of the physician’s order dated 11/26/2021, indicated to change right plantar wound dressing with Aquacel AG extra every 2 days and as needed for soiling. It also indicated to continue to alternate bacitracin ointment with siverderme cream daily and as needed to the scrotum wound until healed. A review of the LVN /LPN visit note dated 12/5/2021 indicated Aquacel AG extra wound dressing was applied to the scrotal wound. It indicated plantar wound was assessed, was cleansed with normal saline, pat dried and bacitracin cream was applied. A review of the LVN /LPN visit note dated 12/6/2021and 12/7/2021, indicated plantar wound was assessed, was cleansed with normal saline, pat dried and bacitracin cream was applied. The plan of care (POC) for the certification period from 12/3/20 through 1/31/22, included order for the Skilled Nurse (SN) visit of once daily for 60 days and two visits as necessary per week for 8 weeks to perform complete physical assessment each visit with emphasis on DM and wound care. However, the POC did not include the physician’s order for wound treatment for right plantar and scrotum wounds. The POC contained one goal which was “no acute hospitalization within this episode of care". There were no other goals for wound or pain in the POC. During an interview with the Administrator/Director of Patient Care services (DPCS), on 12/14/2021, at 11:40 a.m., he stated the physician’s order for wound treatment on the right plantar and scrotum, goals for wound and pain should have been included in the POC. A review of the agency’s policy of “Care Planning Process” revised on December 2017 indicated the clinical plan of care should include goals/outcomes to be achieved. It also indicated the POC should include the orders for specific home health services and disciplines, treatments and procedures including amount/frequency/duration.

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 observation, interview and record review, the home health agency failed to administer the antihypertensive medication (medication to lower blood pressure) ordered for one of six sampled patients, Patient 1. This failure had the potential to not identify uncontrolled high blood pressure which can lead to complications including heart attack or stroke. a. On 10/26/21, at 11 a.m., a home visit was conducted at Patient 1's residence with Licensed Vocational Nurse 2 (LVN 2). Patient 1 was observed sitting on his wheelchair in the living room. At 11:40 a.m., during a review of Patient 1's actual medication bottles, a bottle of Metoprolol (medicine for high blood pressure) 50 milligrams (mg) twice daily by mouth, indicated a label to hold if systolic blood pressure (SBP, indicates the pressure of blood exerted against the artery walls when the heart beats) is less than 110, heart rate of less than 60. At 11:55 a.m., during an interview with Patient 1, he stated he takes Metoprolol medication in the morning and afternoon even though there is no one who could check his blood pressure to follow the instruction in the medication bottle label. At 12 p.m., during an interview, LVN 2 stated she was aware that Patient 1 was taking his Metoprolol in the afternoon and was aware that no one was taking his blood pressure. LVN 2 also stated that the regional center only authorized the agency to send a nurse in the morning and aware that Patient 1's caregiver could not check the blood pressure before Patient 1 takes Metoprolol in the afternoon. A review of Patient 1's admission record indicated that Patient 1 was admitted to the facility on 8/13/2019, with diagnoses that included Diabetes Mellitus (high blood sugar). A review of Patient 1's plan of care (POC) from the dates of 10/4/2021 to 12/2/2021, included an order for the SN (skilled nurse) to visit daily for 60 days to perform complete physical assessment each visit with emphasis on wound and medication management and home safety. SN to instruct on signs and symptoms of adverse reaction to report to medical doctor. A review of the POC indicated an order of Metoprolol 50 milligrams twice daily by mouth, to hold if SBP is less than 110, HR (heart rate) less than 60. During an interview on 10/27/2021, at 1 p.m., the Director of Patient Care Services stated, he was aware of the situation and he will coordinate with the physician to request a medication adjustment.

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 failed to ensure that the physician orders for wound treatment were obtained for one of six sampled patients (Patient 1). This failure had the potential for delay in wound healing and a decline in the condition of the wounds. On 10/26/21, at 11 a.m., a home visit was conducted at Patient 1's residence with Licensed Vocational Nurse 2 (LVN 2). Patient 1 was observed sitting on his wheelchair in the living room. Patient 1 was observed with an open wound on the right sole of his foot and the second toe of the left foot. On 10/26/21, at 11:15 a.m., during an interview with Patient 1, he stated he is diabetic and the wound on his right sole of the foot and the second toe of the left foot had opened up again few weeks ago when he accidentally bumped his feet to the side of his bed. On 10/26/21, at 11:20 a.m., during an interview with LVN 2, she stated the Patient 1's wounds developed on the right sole of the foot and second toed of the left foot two weeks ago and she had been applying wound cleanser and bacitracin ointment (topical antibiotic) on the wounds. LVN 2 also stated there was no physician order for treatment of the wounds. A review of Patient 1's admission record indicated Patient 1 was admitted to the facility on 8/13/2019, with diagnosis Type 2 Diabetes Mellitus (high blood sugar). A review of Patient 1's clinical record did not indicate a treatment order for Patient 1's wounds on the right sole of foot and the second toe of the left foot. A review of Patient 1's plan of care (POC) from the dates 10/4/2021 to 12/2/2021, included an order for the SN (skilled nurse) to visit daily for 60 days , to assess integumentary status, identify any signs and symptoms of impaired skin integrity and report any significant changes to the physician. During an interview on 10/27/2021, at 12:45 p.m., the Director of Patient Care Services stated that LVN 2 should have notified the physician to obtain wound treatment orders for the new open wounds of Patient 1.

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 observation, interview and record review, the home health agency failed to ensure that the physician was notified promptly according to its plan of care for three of six sampled patients when: a. Patients 1 and 5 had developed high blood sugar levels; b. Patient 1 had developed open wound on his right sole of foot and the second toe of the left foot. This failure had the potential for delay in interventions which can delay wound healing and a decline in the condition of Patient 1's wounds. This failure also increases the risk of heart disease and vision problems for Patients 1 and 5. b. On 10/26/2021, at 11 a.m., a home visit was conducted at Patient 1's residence with Licensed Vocational Nurse 2 (LVN 2). Patient 1 was observed sitting on his wheelchair in the living room. Patient 1 was observed with open wounds on his right sole of foot and second toe of left foot. During an interview on 10/26/2021, at 11:15 a.m., Patient 1 stated he is diabetic and the wound on his right sole of foot and the second toe of the left foot second toe had reopened few weeks ago when he accidentally bumped his feet to the side of his bed. During an interview on 10/26/2021, at 11:20 a.m., LVN 2 stated that Patient 1's wounds on the right sole of foot and the second toe of his left foot started two weeks ago and she was applying wound cleanser and Bacitracin ointment (topical antibiotic) on the wounds. When LVN 2 was asked if she notified Patient 1's physician and the agency, LVN 2 stated she did not remember if she notified the physician about it. A review of Patient 1's admission record indicated he admitted to the facility on 8/13/2019, with diagnoses that included type 2 Diabetes Mellitus (high blood sugar). A review of Patient 1's plan of care (POC) dated between 10/4/2021 to 12/2/2021, indicated an order for the SN (skilled nurse) to visit daily for 60 days to assess integumentary status, identify any signs and symptoms of impaired skin integrity and report any significant changes to the physician. One of the SN interventions was to monitor the blood sugar levels, to assess efficacy of medication, and to coordinate care with the physician for need to change plan of care. The POC also indicated to notify the physician when the fasting blood sugar or the random blood sugar was greater than 170 milligram (mg) /deciliter (dl) or less than 70 mg/dl (normal range for blood sugar is less than 140, and not below 70 mg/dl). A review of Patient 1's clinical record did not indicate treatment orders for the wounds on the right sole of foot and the second toe of left foot. The nurses notes did not indicate any documentations that LVN 2 had notified the physician, and no communication notes that the wounds were coordinated with the interdisciplinary team. A review of Patient 1's vital signs records and the diabetic flow sheet indicated that blood sugar level readings on 8/30/2021, 221 mg/dl, on 8/31/2021, 205 mg/dl, on 9/14/2021, 272 mg/dl, on 9/25/2021, 226 mg/dl, on 9/28/2021, 210 mg/dl, on 10/11/2021, 242 mg/dl, on 10/12/2021, 210 mg/dl, on 10/18/2021, 248 mg/dl, on 10/19/2021, 226 mg/dl, on 10/21/2021, 205 mg/dl, on 10/23/2021, 250 mg/dl. The record did not indicate that Patient 1's physician was notified of the blood sugar levels as per POC. During an interview on 10/27/2021 at 12:30 p.m., the Director of Patient Care Services (DCPS) stated he was not made aware of Patient 1's blood sugar levels and the open wounds on the right sole of foot and second toe of the left foot. DPCS also stated that LVN 2 should have reported Patient 1's blood sugar levels and the wounds to the physician. a. During a joint home visit with LVN 1 on 10/26/2021 at 11:30 a.m., Patient 5 was observed sitting on a chair near the kitchen with Caregiver 1. LVN 1 was observed checking Patient 5’s blood sugar with a result of 91 mg/dl, and stated she will not administer the regular insulin because Patient 5 did not need it at that time. A review of Patient 5's clinical record indicated a start of care dated 1/14/2021, with diagnoses that included diabetes mellitus and hypertension (high blood pressure). A review of Patient 1's POC for the certification period from 3/14/2021 to 5/12/2021, 5/14/2021 to 7/12/2021 and 9/14/2021 to 11/12/2021 included an order for the skilled nurse (SN) to visit four times a day for 60 days to help with managing medications and noncompliance with medication regimen related to insulin and oral diabetic agents. The SN was to monitor BS levels to assess efficacy of medication and dietary therapy and to coordinate care with the physician for need to change plan of care. The physician order for Patient 5 indicated Lantus (diabetes medicine) 100 unit/milliliter (ml) subcutaneous (tissue injection) in the morning and at dinner time, and regular insulin four times a day per sliding scale (insulin dose depending on the result of blood sugar). The POC also indicated to notify the physician when the fasting blood sugar (BS) or the random blood sugar was greater than 170 milligram (mg) /deciliter (dl) or less than 70 mg/dl. A review of the skilled nurse visit notes for Patient 5 indicated the following blood sugar (BS) levels: 1. On 3/17/2021 at 11 a.m. - BS was 64 mg/dl. The nurse's notes did not indicate that the physician was notified. 2. On 3/18/2021 at 7 a.m. - BS was 62 mg/dl. The nurse's notes did not indicate that the physician was notified. 3. On 3/25/2021 at 7 a.m. – BS was 56 mg/dl. The nurse's notes did not indicate that the physician was notified. 4. On 3/30/2021 at 4 p.m. – BS was 62 mg/dl and orange juice was given. The nurse's notes did not indicate that the physician was notified. 5. On 3/31/2021 at 4 p.m. - BS was 40 mg/dl. Patient 5 was sweating and was clammy and was given orange juice and glucose gel. The nurse's notes did not indicate that the physician was notified. 6. On 4/15/2021 at 7 a.m.) – BS was 40 mg/dl. Patient 5 was given orange juice and the nurse's notes did not indicate that the physician was notified. During an interview on 10/27/2021 at 3:50 p.m., the DPCS stated the SN should have notified the physician when the BS levels were less than 70 mg/dl as indicated in the POC. A review of the agency’s policy and procedure titled “Communication to Practitioners about Change in Patient’s Condition", dated 2/23/2019, indicated all observable changes in patient’s condition must be reported to the physician within 24 hours and the nursing supervisor must be immediately notified.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on observation, interview and record review, the home health agency failed to ensure the Conditions of Participation for Infection Prevention and Control were met by failing to: 1. Implement its policy for COVID-19 (Coronavirus disease, a severe respiratory illness caused by virus and spread from person to person) prevention program to control employees' exposure to the COVID-19 virus that may occur in the workplace. (Refer to G 682) 2. Develop guidelines for the agency when to use an N-95 mask (is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles). (Refer G 682) 3. Ensure that all 29 employees were fit tested (test the seals between N-95 mask or respirator's facepiece and the face) when required to use an N95 mask. (Refer G 682) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment Please refer to the following tags: 1. Refer to G 682 2. Refer to G 682 3. Refer to G 682

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 interview and record review, the home health agency failed to: 1. Implement its policy and procedure for COVID-19 (Coronavirus disease, a severe respiratory illness caused by virus and spread from person to person) prevention program to control employees' exposure to the COVID-19 virus that may occur in the workplace. 2. Develop procedures for the agency when to use an N-95 mask (is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles). 3. Ensure that all 29 employees were fit tested (test the seals between N-95 mask or respirator's facepiece and the face) for N-95 as indicated in the agency's COVID-19 prevention program. This failure had the potential to spread COVID-19 virus and infection among staff and other patients under the agency's care. Findings: A review of the agency's employee list dated 10/25/21 indicated the agency had a total of 29 employees. During an observation at the agency on 10/25/2021 at 11:10 a.m., boxes of N-95 (a respiratory protective device designed to achieve a very close facial fit to form a seal around the nose and mouth to efficiently filter airborne particles) masks were observed on the floor. During an interview on 10/25/2021 at 11:40 a.m., the Administrator stated the agency provided the personal protective equipment ([PPE] protective clothing, garments or equipment designed to protect the wearer from infections) to the staff including N-95. During a joint home visit with the Licensed Vocational Nurse 1 (LVN 1) on 10/26/2021 at 11:30 a.m., at Patient 5’s residence, LVN 1 was observed wearing a disposable face mask. During a concurrent interview, LVN 1 stated she would wear N-95 masks, only when she would visit a patient with COVID-19 positive. LVN 1 stated she was not fit tested for the use of N-95 mask. During an interview on 10/27/2021 at 10:45 a.m., the Administrator stated the staff would purchase their own PPE, then the agency would reimburse the employee. The Administrator stated all the employees were not fit tested for N-95. The Administrator stated the employees used and bought their own N-95 but did not had a fit test. The Administrator stated he would start to have N-95 fit test for all the employee. A review of the agency's document titled, "COVID-19 prevention program for Carson Healthcare Services LLC", dated 11/24/2020, indicated to review applicable orders and general and industry-specific guidance from the State of California, Cal/OSHA, and the local health department related to COVID-19 hazards and prevention. The document indicated that the fact the particles containing the virus can travel more than six feet, especially indoors, so physical distancing, face coverings, increased ventilation indoors and respiratory protection decrease the spread of COVID-19 and are most effective when used in combination. It also indicated that, …employees voluntarily using respirators will be trained according to section 5144 (c)(2) requirements... since COVID-19 is an airborne disease, N-95s and more protective respirators protect the users from airborne disease. A review of the agency's an undated document titled, "Additional Consideration #1" indicated that the agency immediately performs a review of potentially relevant COVID-19 policies, procedures, and controls and implement changes as needed to prevent further spread of COVID-19... implementing changes to reduce the transmission of COVID-19 based on the investigation and review, the agency consider requiring respiratory protection in compliance with section 5144... A review of the California Code of Regulations, Title 8, Section 5144 (c), indicated that employers are required to develop and implement a written respiratory protection program with worksite-specific procedures and elements for required respirator use... the employer shall provide respirators, training, and medical evaluations at no cost to the employee... before an employee may be required to use any respirator, the employee must be fit tested with the same make, model, style, and size of respirator that will be used... the employer shall ensure that an employee using a tight-fitting facepiece respirator is fit tested prior to initial use of the respirator and at least annually... A review of the California Department of Public Health All Facilities Letter (AFL) 20-15.1, dated 4/9/2020, indicated if your facility suspects COVID-19 infection, to refer to the CDPH recommendations for suspect COVID-19 patients...employers of healthcare workers should follow Cal/OSHA regulations for employee protection when providing direct patient care that includes the use of N95. It also indicated that on 4/3/2020, certain models of KN95 respirators that were recently approved for use in healthcare settings... as with N95s, KN95s should be fit tested if worn to comply with a Cal/OSHA respiratory protection standard that requires fit-testing. A review of the Cal/OSHA guidance on COVID-19 for Health Care Facilities, dated 8/6/2020, indicated an initial respirator fit testing is required before an employee uses a respirator and an annual respirator fit testing is also required.

Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA's policies and procedures. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the home health agency failed to label an opened insulin pen [a reusable or disposable pen like device with a disposable needle attached that contain insulin (a diabetes medicine), used for injecting a desired dose to regulate blood sugar levels] and an insulin vial (a small bottle containing insulin used for multiple patients), for one of six patients, (Patient 5). This failure had the potential for an ineffective treatment when an expired insulin were administered to Patient 5 and other patients under the agency's care, and, had the potential to cause more complications, including death to the affected patients. On 10/26/2021, at 11:30 a.m., during a joint home visit with Licensed Vocational Nurse 1 (LVN 1) at Patient 5’s adult residential facility, Patient 5’s medications were reviewed. A lantus insulin pen (100 unit/milliliter) and a vial of Novolin R (100 unit/ml) insulin was observed opened without a date when it was opened. During an interview with LVN 1 on 10/26/2021, at 12 p.m., she stated the insulin pen and the vial should have been labeled with the opened date. A review of Patient 5's clinical record indicated the start of care was dated 1/14/2021, with diagnoses which included Diabetes Mellitus (high blood sugar) and hypertension (high blood pressure). A review of Patient 1's plan of care for the certification period from 9/14/21 to 11/12/21, included an order for the skilled nurse (SN) to visit four times a day for 60 days to help with managing medications and noncompliance with medication regimen related to insulin and oral diabetic agents. The SN was to instruct the patient/Caregiver medication management. The physician order indicated lantus 100 unit/milliliter, 30 units in the morning subcutaneous (injection at the tissue) and regular insulin per sliding scale (number of units insulin to be given depending on the blood sugar test result). A review of the agency’s policy and procedure titled “Dating Insulin”, dated 2/23/2019, indicated insulin must be dated once opened by the nurse.