Every finding on record at Total Care Home Health Agency

The following reflects the findings of the California Department of Public Health during a standard recertification survey conducted on August 14, 2023, through August 17, 2023. The inspection included the Emergency Preparedness requirements under CFR §483.73(b)(6)-E0024. The facility was found to be in compliance with CFR 42 483.73 (b) (6), Requirements for Emergency Preparedness for Home Health Agency (HHA). Representing the California Department of Public Health: Surveyor 40988, Health Facilities Evaluator Nurse (HFEN); and Surveyor 32192, HFEN. Total unduplicated admission within the last year: 15 Patients. Active Patient Sample: Record Review Only (No Home Visit) - Two Patients. Active Patient Sample: Record Review With Home Visit - Three Patients. Discharged Patients: Closed Record Review - Two Patients. Total Survey Sample: Seven Patients. Agency's Current Active Census: Seven Patients.

The following reflects the findings of the California Department of Public Health during a recertification survey conducted from August 14, 2023, through August 17, 2023. Representing the California Department of Public Health: Surveyor 40988, Health Facilities Evaluator Nurse (HFEN); and Surveyor 32192, HFEN. Total unduplicated admission within the last year: 15 Patients. Active Patient Sample: Record Review Only (No Home Visit) - Two Patients. Active Patient Sample: Record Review With Home Visit - Three Patients. Discharged Patients: Closed Record Review - Two Patients. Total Survey Sample: Seven Patients. Agency's Current Active Census: Seven Patients.

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 facility failed to ensure the clinical records contained accurate comprehensive medication profiles for two of seven patients reviewed (Patients 2 and 5), when the medication profiles did not accurately reflect the medications Patients 2 and 5, were taking in the home. In addition, Patient 5's refill for the medication Cuvposa (medication used to reduce drooling) was not followed through. These agency failures increased the potential for the patients to not receive medications as ordered by the physician, placing the patients at risk for side effects, drug interaction, duplicate drug therapy, an increase in symptoms the medications were prescribed for, and possible non-compliance with physician’s orders and medication effectiveness. 2. On August 14, 2023, Patient 5’s record was reviewed. Patient 5 was admitted to the agency on May 22, 2023, with diagnoses which included Chronic Respiratory Failure. Patient 5’s Plan of Care (POC, for the certification period July 21, 2023 to September 18, 2023) and medication profile (dated August 14, 2023), included the following medications: - “Solu-cortef (steroid medication used to treat inflammation) 100 mg injection intramuscularly (into the muscle) Give 2 ML Q (every) 8HRS (hours)…; - Bacitracin (an antibiotic) 500 unt (sic) in gm (gram- unit of measurement) topical (applied to the skin) READ (sic) AREAS OF GT BID…; and - Cuvposa 2 mg oral (by mouth) solution via GT Give 5 ML Q 12HRS daily…” Patient 5’s “RECORD OF WEEKLY TREATMENT” indicated the following orders : - Treatment 1 for tracheostomy (incision in the windpipe) care daily and as needed; - Treatment 2 for GT care daily and as needed; and - Treatment 4 for changing the suction catheter daily as well as emptying the container every change of shift and as needed. On August 16, 2023, at 9:35 a.m., a home visit for Patient 5 was conducted with LVN 4. Also present in the home for a supervisory visit was the Registered Nurse (RN). During medication reconciliation, the following were observed: - The medication label for Solu-cortef indicated “Inject 2 mLs (100mg total) into the muscle nightly as needed…” - The “RECORD OF MEDICATION ADMINISTRATION” for the period dated August 13-19, 2023 indicated, “…Solu-cortef 100 mg injection INTRAMUSCULAR GIVE 2ML Q 8HRS…” LVN 4 was interviewed and she stated she performed medication reconciliation whenever she worked her shift, and would follow the instructions on the medication administration record, since these were the most updated and would have the latest orders from the doctor. LVN 4 further stated the Solu-cortef had not been given to Patient 5 because “she did not have symptoms,” and was to be given only when the patient needed it, “like a stress dose (when patient shows signs of respiratory distress).” SN 1 confirmed the order as written on the medication administration record did not indicate the Solu-cortef was to be given on an as needed basis. The record was also reviewed with the RN. The RN stated the Solu-cortef was a “PRN medication,” and that the instruction “PRN” should have been attached to it. The RN stated when there was a discrepancy with the medication orders, the physician should be notified to obtain the correct order for the medication. The RN stated the order should have been clarified with the physician, and the POC and medication administration record updated to reflect the correct instructions for the medication. The “RECORD OF WEEKLY TREATMENT” for the time period August 13-19, 2023, was reviewed with LVN 4. LVN 4 confirmed her initials and signature on the form, with her initials on the form for Treatments 1, 2 and 4 on the days she worked and cared for Patient 5, which indicated she performed the care because she affixed her initials on the form. On August 16, 2023, at 1:20 p.m. Patient 5’s record was further reviewed. The medication administration records for the time periods July 2-8, 2023; July 16-22, 2023; July 23-29, 2023; July 30 to August 5, 2023; and August 6-12, 2023 bearing LVN 4 and LVN 5's initials, indicated, “…Bacitracin 500 unt in gm topical ointment READ AREAS OF GT TID..” Another set of medication administration records for the same time periods bearing LVN 6 initials indicated, “Bacitracin 500 unt in gm topical ointment READ AREAS OF GT BID….” The medication administration record for the time period July 30 to August 5, 2023 was reviewed and indicated an SN note of “No refill” for the medication Cuvposa. There were no SN initials on the days the SN worked and cared for Patient 5, to signify the medication was administered to the patient. The medication administration record for the time period August 6-12, 2023 did not bear any SN initials to signify the medication Cuvposa was administered to Patient 5 on the days the SN worked and cared for the patient. The ”RECORD OF WEEKLY TREATMENT,” for the time periods May 21-27, 2023; May 28-June 3, 2023; June 18-24, 2023; July 30 to August 5, 2023; and August 6-12, 2023, bearing LVN 4 and 5's initials, indicated their initials for Treatment 1, but there were no SN initials for Treatments 2 and 4 on the days the SNs worked and cared for Patient 5. On August 17, 2023, at 11:17 a.m., a concurrent interview and review of Patient 5’s record was conducted with the Director of Patient Care Services (DPCS). The POC, medication profile, and medication administration record, indicating the discrepancy with Solu-cortef, was reviewed. The DCPS stated the order for Solu-cortef should have been clarified with the physician and the patient’s records updated to ensure the correct orders were followed by Patient 5’s nurses. The Bacitracin order on the POC and record of medication administration was reviewed. The DPCS stated there was a discrepancy with the Bacitracin order as written on the medication administration records compared to the POC. The DPCS stated the Bacitracin orders on the POC should match the order on the medication administration record. The DPCS stated if there was a discrepancy identified by the nurses regarding medication orders, the physician should be notified and the order clarified. The DPCS stated the Bacitracin order should have been clarified. The medication administration records for the periods July 30 to August 5, 2023 and August 6-12, 2023, regarding the medication Cuvposa was reviewed. The DPCS stated the SN should have facilitated the refill before the medication ran out so the patient would not miss a dose. The DPCS stated the physician should have been notified that the medication was not available. The treatment records were reviewed and the DPCS stated, the SNs should have initialed on the forms to indicate the treatments were done, since “if it’s not documented, it’s not done.” The agency's policy and procedure titled, ”MEDICATION PROFILE,” dated November 2020, was reviewed. The policy indicated, “…Patient receiving medications administered by the organization will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications…A drug regimen review will be performed at the time of admission, when updates to the comprehensive assessment are performed, when care is resumed after a patient has been placed on hold, and with the addition of a new medication. The review will be performed by qualified personnel and will identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, 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…Based on review of the medication profile…changes to the plan of care may be required…” The agency's policy and procedure titled, ”VERIFICATION OF PHYSICIAN ORDERS,” revised November 2020, was reviewed. The policy indicated, “…PURPOSE To ensure that accurate physician…orders are obtained in accordance with applicable law and regulation…An order or prescription will be verified when there is a question or discrepancy in the order/prescription and when the order is communicated by someone other than the physician or his/her agent…” The agency's policy and procedure titled, ”ADMINISTRATION AND DOCUMENTATION OF MEDICATIONS,” revised November 2020, was reviewed. The policy indicated, “…PURPOSE To provide guidelines for safe administration of medications by licensed personnel…Licensed nursing personnel will administer and document only those medications which have been ordered as part of the plan of care and have been approved for safe administration and monitoring during a home visit…As part of the assessment process, a drug history will be taken, including prescribed and over-the-counter medications...A comparison will be made with the physician’s…orders and the current medications the patient is taking. Any discrepancies or contradictions should be reported to the physician for resolution…” Findings: 1. On August 14, 2023, the record for Patient 2 was reviewed. Patient 2 was admitted to the agency on July 25, 2022, with diagnoses which included spastic quadriplegic cerebral palsy (the loss of motor control in all four limbs and the entire body), chronic respiratory failure (when not enough oxygen travels from the lungs into the blood), and epilepsy (electrical activity in the brain that is not normal, causing seizures). The certification period reviewed was July 20, 2023, through September 17, 2023. On August 15, 2023, beginning at 12:33 p.m., a home visit for Patient 2 was conducted with Licensed Vocational Nurse (LVN) 1. The medication record provided by the agency was compared with Patient 2's medications in the home. The following medication was not listed on the agency's "Medication Profile (MP)," and was different than the medication prescribed and listed on the "Record for Medication Administration Record (RMAR)," in Patient 2's record in the home and was being administered since July 25, 2022: a. Omeprazole (acid reducer) 20 mg (milligrams – unit of measurement) daily but was prescribed as lansoprazole 30 mg delayed-release capsule GT (gastrostomy tube – medication delivered directly into the stomach) 1 cap (capsule) daily. The following medication was listed on the agency's "Medication Profile," and was not available in the home: a. Lactase (an enzyme that breaks down lactose, a sugar in milk and milk products) 9000 units caplet via GT give with each feeding. The following medications were listed on the agency's "Medication Profile," with a different dose and frequency of medication administration from the RMAR: a. Baclofen (muscle relaxant) 20 mg tablet GT 1.5 tabs (tablets) TID (three times a day) (MP); baclofen pump 2,000 mcg (microgram – unit of measurement)/ml (milliliters – unit of measurement) administered 679.5 mcg [(29.9 mcg/hr (hour)] for a total of 24 hours dose of 1,434.0 mcg/day; and b. Diazepam (to treat anxiety, muscle spasms, and seizures) 5 mg tablet GT 1 tab nightly prn (as needed) (MP); but the prescription bottle indicated diazepam 5 mg 1 tab BID (twice daily) prn. c. Diphenhydramine 2 mg/tab GT 2 tabs BID PRN (MP); but the bottle indicated diphenhydramine 25 mg/tab. During a concurrent interview with Patient 2’s family member (FM), she stated she had been giving the over-the-counter medication of omeprazole instead of the prescribed lansoprazole medication. On August 15, 2023, at 1:16 p.m., an interview was conducted with LVN 1 during the home visit. She stated she received a printout on July 25, 2023, with the change of Patient 2’s baclofen being administered by a pump. She stated she sent the printout to the agency. She stated the medication updates should have been documented on Patient 2’s medication profile. On August 17, 2023, at 10:07 a.m., the Director of Patient Care Services (DPCS) was interviewed. The DPCS stated the medications were to be checked at each skilled nursing visit and communicated to Patient 2’s physician, and the updated medications should have been documented in Patient 2’s medication profile.

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 agency failed to ensure home health services were provided by the agency in accordance with the physician orders and the plan of care (POC), for three of seven sampled patients (Patients 1 and 4), when: 1. For Patient 1, a recertification visit was not conducted as ordered by the physician; 2. For Patient 4, skilled nurse (SN) visits were not provided as ordered by the physician, nor was the physician notified of Patient 4 being discharged from the agency; and 3. For Patient 5, the treatment record did not indicate the treatment was provided to the patient. These agency failures increased the potential for the patients to not receive the physician ordered services to improve their overall health condition. 3. On August 14, 2023, Patient 5’s record was reviewed. Patient 5 was admitted to the agency on May 22, 2023, with diagnoses which included chronic respiratory failure. Patient 5’s “RECORD OF WEEKLY TREATMENT” indicated the following treatment orders : - Treatment 1 for tracheostomy (incision in the windpipe) care daily and as needed; - Treatment 2 for GT care daily and as needed; and - Treatment 4 for changing the suction catheter daily as well as emptying the container every change of shift and as needed. On August 16, 2023, at 9:35 a.m., a home visit for Patient 5 was conducted with LVN 4. Also present in the home for a supervisory visit was the Registered Nurse (RN). The “RECORD OF WEEKLY TREATMENT” for the time period August 13-19, 2023, was reviewed with LVN 4. LVN 4 confirmed her initials and signature on the form, with her initials on the form for Treatments 1, 2 and 4 on the days she worked and cared for Patient 5, which indicated she performed the care because she affixed her initials on the form. On August 16, 2023, at 1:20 p.m. Patient 5’s record was further reviewed. The ”RECORD OF WEEKLY TREATMENT,” for the periods dated May 21 to 27, 2023; May 28 to June 3, 2023; June 18 to 24, 2023; July 30 to August 5, 2023; and August 6 to 12, 2023, bearing LVN 4 and 5's initials, indicated their initials for Treatment 1, but there were no SN initials for Treatments 2 and 4 on the days the SNs worked and cared for Patient 5. On August 17, 2023, at 11:17 a.m., a concurrent interview and review of Patient 5’s record was conducted with the Director of Patient Care Services (DPCS). The treatment records were reviewed and the DPCS stated, the SNs should have initialed on the forms to indicate the treatments were done, since “if it’s not documented, it’s not done.” The agency's policy and procedure titled, "Documentation Standards," dated January 26, 2023, indicated, "...Purpose...To establish documentation standards for maintaining the clinical record for every patient in accordance with professional standards, and federal, state, and local laws...To promote documentation that is an accurate record of the patient's status and the care provided...The written documentation of professional and paraprofessional staff in the clinical records reflects professional and clinical standards...Documentation reflects the process of care delivery...Documentation shows that care delivery conforms with the established plan of care...Documentation is timely...Staff documents all direct care delivery during the visit/shift or immediately after the visit/shift..." Findings: 1. On August 14, 2023, Patient 1’s record was reviewed. Patient 1 was admitted to the agency on August 25, 2021, with diagnoses including chronic respiratory failure (when not enough oxygen travels from the lungs into the blood), and cerebral palsy (the loss of motor control in all four limbs and the entire body). The Plan of Care for the certification period June 16, 2023, to August 14, 2023, indicated, "...SN 240 HRS (hours) Q (every) MONTH (112 HOURS Q 2 WEEKS)…RN (Registered Nurse) SUPERVISORY VISITS 2 HRS/VISIT (two hours per visit) 1 x/MONTH (one time per month)…” There was no documented evidence the RN Supervisory visit for recertification of Patient 1 was provided by the home health agency to Patient 2 on the following week (August 10, 2023, to August 14, 2023) as ordered by the physician. On August 17, 2023, at 9:17 a.m., a concurrent interview and review of Patient 1’s record was conducted with the Director of Patient Care Services (DPCS). The DPCS confirmed she did not conduct a recertification visit prior to the end of the last recertification period ending on August 14, 2023. Therefore, no recertification visit was completed for the recertification period beginning August 15, 2023, through October 13, 2023. She stated she should have completed her recertification visit by August 15, 2023, and she should have turned in her recertification documentation within 48 hours of the recertification visit. 2. On August 16, 2023, Patient 4’s record was reviewed. Patient 4 was admitted to the agency on November 6, 2022, with diagnoses including chronic respiratory failure, and epilepsy (electrical activity in the brain that is not normal, causing seizures). The Plan of Care for the certification period November 6, 2022, to January 4, 2023, indicated, "...SN 480 HRS Q MONTH (224 HOURS Q 2 WEEKS)…RN SUPERVISORY VISITS 2 HRS/VISIT 1 x/MONTH…” There was no documented evidence the SN visits ordered by the physician to be conducted daily was provided by the home health agency to Patient 4 on November 7 to 17, 2022 (11 days). The Plan of Care for the second certification period January 5, 2023, to March 5, 2023, indicated, "...SN 480 HRS Q MONTH (224 HOURS Q 2 WEEKS)…RN SUPERVISORY VISITS 2 HRS/VISIT 1 x/MONTH…” There was no documented evidence the physician was notified Patient 4 was discharge from the services provided by the home health agency. There was no documented evidence a discharge summary was completed when Patient 4 was discharged from the agency on February 11, 2023. On August 17, 2023, at 10:40 a.m., a concurrent interview and review of Patient 4’s record was conducted with the DPCS. The DPCS confirmed the missed SN visits were due to Patient 4’s family member (FM) not informing the office that Licensed Vocational Nurse (LVN) 2 did not show up from November 7 to November 17, 2022. The DPCS stated she did not follow up with Patient 4’s FM after completing the start of care on November 6, 2022, to ensure Patient 4 was being seen by LVN 2. Additionally, the DPCS stated she did not notify Patient 4’s primary care physician of the missed visits, nor of completing the discharge summary and notifying the primary care physician of Patient 4’s discharge from the agency on February 11, 2023. The DPCS stated the agency should have notified the physician of the missed skilled visits and Patient 4's discharge from home health services. The agency’s policy and procedure titled, “REASSESSMENTS/RECERTIFICATION,” revised November 2020, was reviewed. The policy indicated, “…The comprehensive assessment must be updated and revised every 60 days beginning with the start of care…The total plan of care must be renewed at least every 60 days, or more often as warranted by the condition of the patient. Any assessment findings that suggest a need to alter the plan of care will be reported to the patient’s physician…The recertification statement must indicate the patient’s continuing need for home health services…For each new episode of care, a comprehensive assessment will be completed no earlier than five (5) days before and no later than one (1) day before the calendar day on which the new episode of care will begin…” The agency’s policy and procedure titled, “MISSED VISITS,” revised November 2020, was reviewed. The policy indicated, “…Missed visits will be communicated to the clinical supervisor and the patient’s physician. A missed visit will be rescheduled the same week if possible…The clinical supervisor will track the number and reasons for the missed visits to assess patterns and to assure the plans of care contain the correct number of planned visits…” The agency’s policy and procedure titled, “ATTENDANCE AND ABSENTEEISM,” revised November 2020, was reviewed. The policy indicated, “…Personnel will be expected to notify their supervisor of changes in their schedule, which include, but are not limited to, cancellation or absenteeism…Absenteeism without notification (no call/no show) will be considered as voluntary resignation…Absenteeism will be monitored by supervisors as follows:…Not calling in on the day of absence…” The agency’s policy and procedure titled, “COMMUNICATION WITH OFFICE,” revised November 2020, was reviewed. The policy indicated, “…Clinicians will contact the office daily to:…Confirm their schedule for the day…Receive any necessary reports on patient to be visited…Confirm caseload with Clinical Supervisor or designee…Clinicians will communicate with the office to verify that all planned visits for the day were made, report availability for visit the next day, and receive reports on admission or changes for the next day’s schedule…Clinicians cannot alter the schedule for assignment of cases without the prior approval of Clinical Supervisor or designee. The clinician must alert the Clinical Supervisor of any requests…It is essential that all organization personnel contact the office as soon as the workday begins if advance notice could not be given…”

12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure the Certified Home Health Aide (CHHA) received the required 12-hour in-service training annually, for one of one CHHA personnel file reviewed (CHHA 1). This agency failure increased the potential for the agency staff to not be properly trained, screened, or qualified, to safely conduct patient care in the field. Findings: 1. On August 17, 2023, the personnel file for CHHA 1 was reviewed. CHHA 1 was hired on December 28, 2021. There was no documentation CHHA 1 completed a 12 hour in-service training for the past 12 months. On August 17, 2023, at 12:17 p.m., the Office Manager (OM) was interviewed. The OM stated CHHA 1 did not have a 12-hour in-service training for the past 12 months. She stated the agency did not conduct any in-service training for their personnel. The agency’s policy and procedure titled, “SCOPE OF THE PROGRAM/PROCESS METHODOLOGY,” revised November 2020, was reviewed. The policy indicated, “…Organization personnel will demonstrate knowledge and proficiency of skills appropriate to their assigned responsibilities, including an ability to perform specified duties determined by the organization. Skills will be maintained and improved through continuing education programs, based on the analysis of trends and outcomes identified through the Clinical Competency Program, on-site supervision and established reviews…Skill proficiency can be determined by verbal or written examination; skill demonstration in a lab setting or patient’s home….The organization establishes and annually re-evaluates its job specific “Competency Based Orientation Checklist” which reflects duties commonly required in the performance of clinical positions…If necessary, additional training, or inservice education will be provided to the staff member. Organization personnel will not provide the care or service independently until satisfactory completion of required skills competency…After the completion of orientation, competency will be monitored annually thereafter as part of the annual performance evaluation process…”

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the home health agency staff receive the appropriate orientation, training, and competency evaluation, for six of six personnel files reviewed. In addition, the CardioPulmonary Resuscitation (CPR - emergency lifesaving procedure when the heart stops beating) card of Licensed Vocational Nurse (LVN) 1 did not indicate the date until when the CPR certificate was valid. This agency failure had the potential for patients to receive care and services from unqualified and/or underqualified agency staff. 2. On August 17, 2023, beginning at 12:20 p.m, the personnel files for the CEO, LVN 4, and the Director of Patient Care Services (DPCS) were reviewed and indicated the following: - The CEO was hired by the agency on February 20, 2020, and the CEO’s personnel files did not include documentation to indicate a background check was conducted for the CEO; - LVN 4 was hired by the agency on May 18, 2023, and LVN 4’s file did not include documentation to indicate a background check was conducted for LVN 4; and - The DPCS was hired by the agency on July 1, 2021, and the DPCS’s file did not include documentation to indicate a background check was conducted for the DPCS. There was no documented evidence annual performance evaluations were conducted for the DPCS. There was no documented evidence skills and competency checks were conducted for the DPCS. On August 17, 2023, at 3:30 p.m., the OM was interviewed. The OM stated the CEO, LVN 4, and the DPCS did not have any documentation in their personnel files to indicate a background check was conducted for them. The OM further stated, for the DPCS, the DPCS should have had a 90-day evaluation and skills & competency checks. The OM stated the DPCS should have had annual performance evaluations, and skills and competency checks, for the years 2022 and 2023. The OM stated there was no documentation in the DPCS' personnel file to indicate the annual performance evaluation, as well as the skills and competency checks were completed. On August 17, 2023, at 3:35 p.m., the CEO was interviewed. The CEO stated a Live Scan (an ink-less electronic fingerprinting that scans fingerprints directly into the computer so that a background check can be done) was usually conducted on employees when they obtain their professional licenses and since the agency staff had licenses which were verified by the agency as active, this indicated the personnel did not have any outstanding issues prior to being hired. The CEO stated there were no copies of the Live Scan results in the agency personnel files reviewed. The CEO further stated he was unsure who should conduct the annual evaluations and skills and competency checks for the DPCS. The agency's policy and procedure titled, “PERFORMANCE EVALUATION,” revised November 2020, was reviewed. The policy indicated, “…PURPOSE…To provide consistent and regular performance evaluations to promote improvement…All organization personnel will be evaluated at periodic intervals by their supervisors based on the appropriate job description to determine the strengths and areas requiring performance improvement…Performance evaluations will be documented on the applicable form, signed by the person completing the evaluation of the employee…At least annually, clinical personnel must demonstrate proficiencies in the appropriate core competency…Components of the annual evaluation will include:…Assessment …with established criteria as defined in the appropriate job description…competency testing for clinical personnel…” The agency's policy and procedure titled, “COMPETENCY ASSESSMENT,” revised November 2020, was reviewed. The policy indicated, “…The competence of all organizational clinical personnel (employed, contract or volunteer) will be assessed during orientation, during the probationary period, periodically throughout the course of the year and during the annual performance evaluation…Competency of the supervisors and/or management staff will be assessed by the individual’s immediate supervisor and may include peer review as a component of the process…” Findings: 1. On August 17, 2023, the personnel files for Licensed Vocational Nurse (LVN) 1 and LVN 3 were reviewed. - LVN 1 was observed to not have completed documentation indicating her orientation, skills and competency, in-service training, background check was not completed, and an illegible cardiopulmonary resuscitation (CPR) card was also observed in her personnel chart. LVN 1 was hired on November 18, 2022, and there was no indication her personnel file was complete; and - LVN 3 was observed to not have completed documentation indicating her in-service training and background check were completed. LVN 3 was hired on August 25, 2021, and there was no indication her personnel file was complete. On August 17, 2023, at 12:17 p.m., the Office Manager (OM) was interviewed. She stated the agency did not conduct any in-services or background checks for their personnel. She stated and confirmed LVN 1 did not have a completed orientation, skills and competency check, and an illegible CPR card was in her personnel chart. On August 17, 2023, at 12:21 p.m., the Chief Executive Officer (CEO) was interviewed. The CEO stated he conducted a live scan on the personnel prior to being hired, but there was not a copy of the live scan results in the personnel files reviewed. The agency’s policy and procedure titled, “ORIENTATION,” revised November 2020, was reviewed. The policy indicated, “…All personnel will be required to attend an orientation program upon employment and at the time of reassignment…All personnel will demonstrate knowledge and proficiency in skills appropriate to their assigned responsibilities during the orientation period…All clinical personnel prior to being assigned to care must present documentation of current CPR certification. CPR certification must be renewed per American Heart Association Guidelines…” The agency’s policy and procedure titled, “COMPETENCY BASED ORIENTATION,” revised November 2020, was reviewed. The policy indicated, “…The organization ensures that the competency of all personnel is assessed on hire, prior to providing care to organization patients…Orientation is intended to prepare the employee to perform the duties of a new role with a competent level of skill…When the Competency Orientation Skills Checklist is completed, it is reviewed by the preceptor and the Clinical Supervisor. Additional training and education is performed as indicated until competence is demonstrated…” The agency’s policy and procedure titled, “SCOPE OF THE PROGRAM/PROCESS METHODOLOGY,” revised November 2020, was reviewed. The policy indicated, “…Organization personnel will demonstrate knowledge and proficiency of skills appropriate to their assigned responsibilities, including an ability to perform specified duties determined by the organization. Skills will be maintained and improved through continuing education programs, based on the analysis of trends and outcomes identified through the Clinical Competency Program, on-site supervision and established reviews…Skill proficiency can be determined by verbal or written examination; skill demonstration in a lab setting or patient’s home….The organization establishes and annually re-evaluates its job specific “Competency Based Orientation Checklist” which reflects duties commonly required in the performance of clinical positions…If necessary, additional training, or inservice education will be provided to the staff member. Organization personnel will not provide the care or service independently until satisfactory completion of required skills competency…After the completion of orientation, competency will be monitored annually thereafter as part of the annual performance evaluation process…”

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure expired medical supplies were not readily available for use. This agency failure increased the potential for patients to receive expired medical supplies to be used for patients. Findings: On August 14, 2023, at 9:48 a.m., a tour of the medical supply room cabinet was conducted with the Office Manager (OM). The OM stated the Medical Supply Clerk (MSC) comes into the office on Tuesdays and Wednesdays to check the medical supplies. She stated she was not sure when the medical supplies were last checked. The following medical supplies were observed expired and stored in the medical supply cabinet: - One “One Touch Ultra 2” blood glucose monitor (a machine used to check blood sugar levels) with an expiration date of December 2016; - One box of “Microlet” lancets (a pointed piece of surgical steel encased in plastic, used to puncture the skin on one's finger (or other body part) to get a blood sample) containing 100 pieces with an expiration date of March 2022; - One container of “Clorox” bleach germicidal wipes with an expiration date of February 8, 2018; - One “Breeze 2” blood glucose monitor with an expiration date of September 2011; - One packet of “Motrin IB” (pain medication) 200 mg (milligrams – unit of measurement) with an expiration date of September 2010; - Six 4” (inch) x 4” gauze sponges with an expiration date of March 2011; - Two “Bard” piston irrigation trays (used to flush catheters) with a use by date of September 2021; - Two boxes of “Easy Comfort” sterile insulin syringes ½ cc (cubic centimeters – unit of measurement) 5/16” needle of 100 each (total of 200 syringes) with an expiration date of April 5, 2021; - One box of “Global Easy Glide” sterile insulin syringes ½ cc 5/16” needle containing 100 syringes with an expiration date of April 24, 2022; - One “Invacare” abdominal pad dressing with an expiration date of November 2015; and - One “Kendall monoject prefill advance” 0.9% (percent) sodium chloride 10 ml (milliliters – unit of measurement) syringe with an expiration date of January 2011. On August 16, 2023, at 9:08 a.m., the MSC was interviewed. She stated she had not checked the medical supply cabinet since October 2022. She stated the expired items should not have been in the medical supply cabinet. She stated the agency did not have a policy and procedure regarding monitoring of expired medical supplies.