Ethical Home Health Care

“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: The agency failed to ensure that the Condition of Participation: G 700 484.75: Skilled professional services was in compliance when: Based on observation, interview, and record review, the agency failed to provide services ordered by the physician and indicated in the plan of care for two of seven sampled patients (Patients 1 and 2) when: 1a. For Patient 1: The Administrator/Director of Patient Care Services failed to provide ordered Physical Therapy (PT) services. (Refer to G 710) 1b. A Licensed Vocational Nurse (LVN 1) made two medication (montelukast superoxide dismutase [SOD]-a medication used to prevent wheezing, difficulty breathing, chest tightness, and coughing and hydralazine-a medication used to treat high blood pressure) administration errors. (Refer to G 710) 1c. LVN 1 failed to report Patient 1’s change of condition and changed a medication (acetaminophen-a medication used to control pain) order without calling the physician to report and obtain a new order. (Refer to G 710) 2. For Patient 2: a Licensed Vocational Nurse (LVN 1) failed to monitor a Blood Sugar (BS) Reading Log and report the BS readings to the Registered Nurse (RN) for report to the physician. (Refer to G 710) The cumulative effect of these systemic practices had the potential to cause Patient 1 to suffer continued physical weakness resulting in falls; poor control of wheezing, difficulty breathing, chest tightness, and coughing; low blood pressure and passing out and administration of a medication without physician oversight. Patient 2 had the potential to suffer continued uncontrolled high blood sugar levels leading to progressive internal organ and blood vessel damage.”

“Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This Condition is not met as evidenced by: The agency failed to ensure the Condition of Participation: G 940 484.105 Organization and administration of services was in compliance when: Based on observation, interview, and record review, the Governing Body (GB) failed to operate and manage the agency from January 1, 2023, to February 28, 2024, in a universe of 19 patients when: 1. A current California Department of Public Health (CDPH) Laboratory Registration was not provided. (Refer to G 942) 2. Policies and Procedures were not developed for a CDPH Laboratory Registration or a Clinical Laboratory Improvement Amendments of 1988 (CLIA- federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States) certification, for 14 months. (Refer to G 942) 3a. For Patient 1: The Administrator/Director of Patient Care Services failed to provide ordered Physical Therapy (PT) services. (Refer to G 942) 3b. A Licensed Vocational Nurse (LVN 1) made two medication (montelukast superoxide dismutase [SOD]-a medication used to prevent wheezing, difficulty breathing, chest tightness, and coughing and hydralazine-a medication used to treat high blood pressure) administration errors. (Refer to G 942) 3c. LVN 1 failed to report Patient 1’s change of condition and changed a medication (acetaminophen-a medication used to control pain) order without calling the physician to report and obtain a new order. (Refer to G 942) 4. For Patient 2: a Licensed Vocational Nurse (LVN 1) failed to monitor a Blood Sugar (BS) Reading Log and report the BS readings to the Registered Nurse (RN) for report to the physician. (Refer to G 942) The cumulative effect of these systemic practices resulted in the agency performing waived laboratory testing without CDPH oversight for 14 months, and deficient staff direction due to no waived laboratory testing policy and procedure establishment for 14 months. In addition, these failures had the potential to cause Patient 1 to suffer continued physical weakness resulting in falls; poor control of wheezing, difficulty breathing, chest tightness, and coughing; low blood pressure and passing out and administration of a medication without physician oversight. And Patient 2 had the potential to suffer continued uncontrolled high blood sugar levels leading to progressive internal organ and blood vessel damage.”

“EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, “Organizations” under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF’s emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This Standard is not met as evidenced by: Based on interview and record review, the agency failed to ensure all staff were knowledgeable on the agency’s Emergency Preparedness Program (EPP) and all contracted staff were trained on the EPP, for the 2022, 2023 and 2024 years reviewed, in a universe of 19 patients. This failure had the potential to place the agency’s patients at risk when agency staff and contracted staff were not aware of what to do during an emergency or disaster. During an interview with a Licensed Vocational Nurse (LVN 1) on February 27, 2024, at 11:31 AM, LVN 1 stated she would keep herself and her family safe during an emergency or disaster. LVN 1 stated she did not know what she would do if she could not contact the agency by phone. During an interview with a Licensed Vocational Nurse (LVN 2) on February 27, 2024, at 2:54 PM, LVN 2 stated if an emergency or disaster happened, she would start calling all the patients she routinely visited to see if they were alright. LVN 2 stated if a patient needed help, she would call the office and tell them. LVN 2 stated she did not know what she would do if she could not reach the office by phone. A review of the agency’s in-service binder from January 1, 2022, to February 29, 2024, was conducted. There was no documented evidence to show Occupational Therapy (OT), Speech Therapy (ST) or the Medical Social Worker (MSW) had received training on the agency’s Emergency Preparedness Program. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 29, 2024, at 12:58 PM, the Admin/DPCS stated she was responsible for the agency’s Emergency Preparedness Program. The Admin/DPCS stated LVN 1 and LVN 2 had received training on the agency’s EPP and should have known to call the office during an emergency or disaster to receive instruction on what to do. The Admin/DPCS stated LVN 1 and LVN 2 should have known about the alternative meeting site if the agency could not be reached by phone. The Admin/DPCS stated the agency had not provided training on their EPP to OT, ST or MSW. A review of the agency’s policy and procedure titled, “Emergency Management Plan,” dated February 3, 2020, indicated, “…17. All staff and new staff will be oriented and trained to the emergency operations plan. … Ongoing staff education and training will occur annually as part of an exercise or in response to an actual emergency. Job description/roles during emergency will be discussed so all staff understands their roles whenever emergency has been activated. …””

“Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA’s governing body. This Standard is not met as evidenced by: Based on interview, and record review, the agency failed to use quality indicator (a measurable element of the agency’s practice that can be used to assess the quality of care provided) data from OASIS (Outcome and Assessment Information Set) to monitor the quality of the agency’s services, from January 1, 2023, to February 29, 2024, in a universe of 19 patients. This failure had the potential for the agency to miss statistically significant data from OASIS reports and fail to identify patient population trends. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2023, to February 29, 2024. The QAPI binder indicated the following quality indicators: a. Patient Infections b. Adverse events c. Clinical chart audit to monitor for compliance with Conditions of Participation (CoPs) d. Patient satisfaction surveys The QAPI binder did not contain documented evidence to show a quality indicator had been chosen for the time period of: January 1, 2023, to February 29, 2024, from the following OASIS reports: a. Home Health Compare (a report on home health agency performance and patient satisfaction) b. Outcome-Bases Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing. (a report on incidence rates for 12 infrequently occurring untoward events. These potentially avoidable events reflect a serious health problem or decline in health status for an individual patient that potentially could have been avoided) c. Outcome-Based Quality Improvement (OBQI) Outcome Report (statistics from the agency’s OASIS reporting for use in the agency’s QAPI program) d. Patient/Agency Characteristics Report (presents a “snapshot” of agency patient characteristics) e. Submission Statistics by Agency Report (OASIS submissions made by or on behalf of an agency during a specified period of time) f. Error Summary Report by Home Health Agency (summarizes the errors an agency encountered in OASIS submissions during a specified period of time) During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 29, 2024, at 10:50 AM, the Admin/DPCS stated she had filled the role of QAPI Coordinator and was responsible for the QAPI Program. The Admin/DPCS stated the QAPI Committee had not chosen a quality indicator from the OASIS reports because she had not understood the requirement. The Admin/DPCS stated she had failed to follow the agency’s QAPI Program requirements. A review of the agency’s policy and procedure titled, “Organizational Quality Assessment and Performance Improvement (QAPI) Program,” dated February 3, 2020, indicated, “Goals: The primary goals of the organizational QAPI program shall be to continually and systematically plan, design, measure, assess and improve performance of organization wide key functions and processes relative to patient care, treatment, and services. To achieve this goal, the program strives to: … Collect data to monitor performance … Process design contains the following focus elements: … Utilizes reports generated from OASIS data, including the following OASIS reports: Outcome-Based Quality Monitoring (OBQM) Potentially Avoidable Events Report and Patient Listing, Outcome-Based Quality Improvement (OBQI) Outcome Report, Patient/Agency Characteristics Report, Submission Statistics by Agency Report, Error Summary Report by HHA [Home Health Agency] …””

“Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA’s services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This Standard is not met as evidenced by: Based on interview and record review, the agency failed to conduct and document performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the agency had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved, from January 1, 2023, to February 29, 2024, in a universe of 19 patients. This failure had the potential to cause problems in health outcomes, patient safety, and quality of care to go unaddressed and continue. A review of the agency’s “Quality Assessment and Performance Improvement (QAPI)” binder, undated, was conducted from January 1, 2023, to February 29, 2024. There was no documented evidence to show performance improvement projects had been initiated, were in process or had been completed for the 14 months (January 1, 2023, to February 29, 2024) reviewed. During a concurrent record review and interview, on February 29, 2024, at 11:34 AM, with the Administrator/Director of Patient Care Services (Admin/DPCS) the contents of the QAPI binder were reviewed. The Admin/DPCS stated she fulfilled the role of QAPI Coordinator and was responsible for the QAPI Program. The Admin/DPCS stated a PIP had not been initiated or conducted from January 1, 2023, to February 29, 2024, because she had not understood the requirement. The Admin/DPCS stated she had failed to follow the agency’s QAPI Program requirements. During a review of the agency’s policy and procedure titled, “Performance Improvement Projects,” dated February 3, 2020, indicated, “Policy: [Name of the agency] shall conduct performance improvement projects as part of its organization wide Quality Assessment and Performance Improvement (QAPI) program. Performance improvement project(s) shall be conducted at least annually. Performance improvement projects shall be documented and maintained. …””

“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 agency failed to ensure its staff followed the agency’s policy and procedure and professionally accepted infection control practices for two of seven sampled patients (Patients 1 and 2) when a Licensed Vocational Nurse (LVN 1) did not follow clean bag technique (a set of procedures to follow to prevent the healthcare worker’s bag from contaminating a patient’s home or becoming contaminated itself) when obtaining Patient 1 and 2’s vital sign readings (vital sign readings routinely monitored by medical professionals and health care providers included the following: temperature, heart rate, blood pressure, respiratory rate and pain level). This failure had the potential to cause spread of infection and disease amongst the agency’s patients. 1. A review of Patient 1’s care plan (contains information about a patient’s diagnosis, the goals of treatment, and specific nursing orders), undated, indicated a start of care date of May 3, 2023, with a recertification period of December 29, 2023 to February 26, 2024. Patient 1 had diagnoses that included diabetes mellitus (a disease that results in too much sugar in the blood). During a home visit and on February 27, 2024, at 10:32 AM with a Licensed Vocational Nurse (LVN 1). LVN 1 entered Patient 1’s home, greeted Patient 1 and placed her medical bag on Patient 1’s kitchen table without placing a barrier between the bag and the table. LVN 1 proceeded to take Patient 1’s vital signs. 2. A review of Patient 2’s care plan (contains information about a patient’s diagnosis, the goals of treatment, and specific nursing orders), undated, indicated a start of care date of March 21, 2022, with a recertification period of January 10, 2024 to March 9, 2024. Patient 2 had diagnoses that included diabetes mellitus (a disease that results in too much sugar in the blood). During a home visit and on February 27, 2024, at 12:23 PM with a Licensed Vocational Nurse (LVN 1). LVN 1 entered Patient 2’s home, greeted Patient 2 and placed her medical bag on Patient 2’s kitchen table without placing a barrier between the bag and the table. LVN 1 proceeded to take Patient 2’s vital signs. During an interview with LVN 1 on February 27, 2024, at 12:38 PM, LVN 1 stated she had been trained on clean bag technique. LVN 1 stated she should have put a barrier between her bag and Patient 1 and 2’s kitchen table but she forgot. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 28, 2024, from 10:45 AM to 11:07 AM, the Admin/DPCS stated LVN 1 had not placed a barrier between her bag and Patient 1 and Patient 2’s kitchen tables and should have. The Admin/DPCS stated she would also prefer LVN 1 had not placed her bag on Patient 1 and Patient 2’s kitchen tables where they eat but rather on the kitchen table’s chair. The Admin/DPCS stated LVN 1 had not followed “clean bag technique.” A review of the agency’s policy and procedure titled, “Staff Bag Policy,” dated December 8, 1998, indicated, “Policy Statement: It shall be the policy of this Agency that all staff members providing care to patients (field staff) utilize a staff bag. Purpose: … 2. To ensure all staff members are knowledgeable of infection control practices and of the supplies necessary to implement the practices. Procedure: … 9. Upon entry into a patient’s home, the staff bag and any new/clean patient supplies are to be placed on a clean work area. When necessary, staff may use a barrier (clean paper towels, wax paper) to establish a clean work area.” A review of the agency’s policy and procedure titled “Infection Control Practices Policy,” dated December 8, 1998, indicated, “… 14. All staff will observe infection control practices in a patient’s home which include but are limited to: a. establishing a ‘clean working area’ in the home to set the staff bag and/or supplies. Clean paper towels from the bag inventory can be used to establish the clean area; …””

“Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency’s overall management and operation, the provision of all home health services, fiscal operations, review of the agency’s budget and its operational plans, and its quality assessment and performance improvement program. This Standard is not met as evidenced by: Based on observation, interview, and record review, the Governing Body (GB) failed to operate and manage the agency from January 1, 2023, to February 28, 2024, in a universe of 19 patients when: 1. A current California Department of Public Health (CDPH) Laboratory Registration was not provided. 2. Policies and Procedures were not developed for a CDPH Laboratory Registration or a Clinical Laboratory Improvement Amendments of 1988 (CLIA- federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States) certification, for 14 months. 3a. For Patient 1: The Administrator/Director of Patient Care Services failed to provide ordered Physical Therapy (PT) services. 3b. A Licensed Vocational Nurse (LVN 1) made two medication (montelukast superoxide dismutase [SOD]-a medication used to prevent wheezing, difficulty breathing, chest tightness, and coughing and hydralazine-a medication used to treat high blood pressure) administration errors. 3c. LVN 1 failed to report Patient 1’s change of condition and changed a medication (acetaminophen-a medication used to control pain) order without calling the physician to report and obtain a new order. 4. For Patient 2: a Licensed Vocational Nurse (LVN 1) failed to monitor a Blood Sugar (BS) Reading Log and report the BS readings to the Registered Nurse (RN) for report to the physician. These failures caused the agency to perform waived laboratory testing without CDPH oversight for 14 months, and deficient staff direction due to no waived laboratory testing policy and procedure establishment for 14 months. In addition, these failures had the potential to cause Patient 1 to suffer continued physical weakness resulting in falls; poor control of wheezing, difficulty breathing, chest tightness, and coughing; low blood pressure and passing out and administration of a medication without physician oversight. And Patient 2 had the potential to suffer continued uncontrolled high blood sugar levels leading to progressive internal organ and blood vessel damage. 1. During an agency tour on February 26, 2024, at 11:06 AM, there was no posting of a California Department of Public Health (CDPH) Laboratory Registration, for the agency. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) and Owner on February 26, 2024, at 11:50 AM, the Owner stated he was the sole member of the agency’s Governing Body (GB) and it was his responsibility to ensure the agency had obtained a CDPH Laboratory Registration and had not. The Admin/DPCS stated she had been unaware of the CDPH Laboratory Registration requirement, and the agency did not have a policy and procedure for a CDPH Laboratory Registration. The Admin/DPCS and Owner stated the agency had been conducting waived laboratory testing without a CDPH Laboratory Registration for 14 months. 2. A review of the Agency’s Policy and Procedure Manual from January 1, 2023, to February 28, 2024, was conducted. There was no documented evidence to show policies and procedures had been developed for CDPH Laboratory Registration or CLIA certification. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) and Owner on February 26, 2024, at 11:50 AM, the Owner stated he was the sole member of the agency’s Governing Body (GB) and it was his responsibility to ensure policies and procedures were developed, approved and implemented in order to ensure staff direction and compliance with Federal, State and local laws. The Owner stated he had been unaware policies and procedures had not been developed for CDPH Laboratory Registration or CLIA certification. The Admin/DPCS stated she had not developed, submitted for GB approval, or implemented policies and procedures for CDPH Laboratory Registration or CLIA certification. The Admin/DPCS and Owner stated the agency had been conducting waived laboratory testing without policies and procedures for 14 months. A review of the agency’s policy and procedure titled, “Revision and Creation of Agency Policies,” dated December 8, 1998, indicated, “Policy Statement: It shall be the policy of this Agency to develop policies which reflect the organizational philosophies and objectives, and to ensure the policies are accessible to all staff persons. Purpose: 1. To establish a system for policy development, format, review, and approval. 2. To utilize patient rights as the basis for policy development. 3. To ensure compliance with Federal, State, and local laws, … Definitions: 1. An Agency Policy is a written plan providing direction on how the organization will achieve its objectives. 2. A Procedure may be a necessary part of a policy and is a series of related tasks that comprise the chronological sequence and established way of accomplishing the intent of the policy. … Procedure: … 6. The Administrator will submit all new and/or revised policies to the Board of Directors for final approval. … 8. The Administrator will provide the members of the Board of Directors with copies of new and/or revised policies. … 11. It is imperative that each staff member (including contractors), understand Agency policies. During the formal orientation program for each staff member, the appropriate policy manuals are reviewed thoroughly according to the job position. Each staff member is informed as to the location of the policy manuals. …” 3a. A review of Patient 1’s care plan (contains information about a patient’s diagnosis, the goals of treatment, and specific nursing orders), undated, indicated a start of care date of May 3, 2023, with a recertification period of December 29, 2023 to February 26, 2024. Patient 1 had diagnoses that included diabetes mellitus (a disease that results in too much sugar in the blood). A review of Patient 1’s physician’s “Assessment for Follow-Up Visit,” dated January 8, 2024, indicated, “…Treatment Plan: Fall Prevention, Physical Therapist … Therapy Orders: Physical Therapy. Provide gait training, strengthening and/or balance exercises to restore the patient’s ability to walk safely without pain. Teach the patient caregiver compensatory strategies for cognitive deficits. Teach patient caregiver compensatory environmental modification for safety. Provide maintenance therapy to prevent or slow a decline in condition.” During a home visit and interview with a Licensed Vocational Nurse (LVN 1) and Patient 1 on February 27, 2024, at 10:50 AM, Patient 1 stated he had not received Physical Therapy (PT) services and would like to have PT services. LVN 1 confirmed Patient 1 had stated he had not received PT services and would like to have PT services. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 28, 2024, at 10:45 AM, the Admin/DPCS verified Patient 1’s physician’s order for PT services. The Admin/DPCS stated it was her responsibility to arrange PT services for Patient 1 and she had not. The Admin/DPCS confirmed Patient 1 had been without PT services for 51 days. A review of the agency’s policy and procedure titled, “Services by Discipline Policy,” dated September 15, 2008, indicated, “8. Physical therapy services shall be provided in accordance with the physician’s orders.” 3b. During a home visit on February 27, 2024, with a Licensed Vocational Nurse (LVN 1) and in the presence of Patient 1, an observation of Patient 1’s actual medication bottles available in the home were compared with Patient 1’s most current Medication Profile (MP). During an observation on February 27, 2024, at 11:03 AM, with LVN 1 and Patient 1: a. A bottle indicated a fill date of January 10, 2024, for montelukast SOD, 10 mg (milligram-a unit of measurement) tablet, take one tablet by mouth twice a day. The MP indicated montelukast SOD, 10 mg tablet, take one tablet by mouth once a day. b. A bottle indicated a fill date of January 10, 2024, for hydralazine, 50 mg tablet, take one tablet by mouth once a day. The MP indicated hydralazine, 50 mg tablet, take one tablet by mouth three times a day. During an interview with LVN 1 and Patient 1 on February 27, 2024, at 11:23 AM, LVN 1 stated she visited Patient 1 once a week and filled his pill box with medication doses for a one-week period. Patient 1 stated he took whatever LVN 1 put into his pill box. LVN 1 stated she had been filling Patient 1’s pill box ever since Patient 1’s admission. LVN 1 stated she filled Patient 1’s pill box with montelukast SOD with a once per day dose, not a twice a day dose. LVN 1 stated she had not noticed the montelukast SOD dose frequency had changed. LVN 1 stated she made a medication administration error. LVN 1 stated she had not given enough montelukast SOD and Patient 1 could have suffered increased symptoms of wheezing, difficulty breathing, chest tightness, and coughing. LVN 1 stated she filled Patient 1’s pill box with hydralazine for a twice a day dose, not a once-a-day dose. LVN 1 stated she had not given Patient 1 a hydralazine dose three times a day as indicated on the MP because the pill box did not have enough spaces for three times a day. LVN 1 stated she had not noticed the hydralazine dose frequency had changed. LVN 1 stated she made a medication administration error. LVN 1 stated she had given too much hydralazine and Patient 1 could have suffered low blood pressure and passed out. A review of the agency’s policy and procedure titled, “Administration of Medications Policy,” dated November 11, 1997, indicated, “Policy Statement: It shall be the policy of this Agency to establish criteria for the administration of medications. Purpose: 1. To ensure patient safety. 2. To establish procedures for the safe administration of medications in the home environment. Procedure: … 2. All staff nurses are to review each medication a patient may be taking, prescribed or over the counter, to identify possible ineffective drug therapy … 6. Nurses administering medications will ensure the stability and safety of the medication being administered by performing the following activities: a. administering medications only from labeled containers; … d. verifying the patient’s name, date of filling, physician’s name, name and strength of medication, and directions for administering the medication; …” 3c. A review of Patient 1’s physician’s order dated December 29, 2023, indicated, “acetaminophen (Tylenol) [a pain medication] 325 mg [milligrams-a unit of measurement] 1 [one] – [to] 2 [two] tablets, PO [by mouth], Q [every] 4 [four] – [to] 6 [six] hours PRN [as needed].” During a home visit and interview with a Licensed Vocational Nurse (LVN 1) and Patient 1 on February 27, 2024, at 11:13 AM, LVN 1 stated she visited Patient 1 once a week and filled his pill box with medication doses for a one-week period. Patient 1 stated he took whatever LVN 1 put into his pill box. LVN 1 stated she had been filling Patient 1’s pill box ever since Patient 1’s admission. LVN 1 stated a week ago Patient 1 had told her his legs hurt all the time, so she decided to fill his pill box with acetaminophen for a twice a day dose, once in the morning and once at night. LVN 1 stated she had not called the physician or Registered Nurse (RN) to give report on Patient 1’s constant leg pain and had not obtained a new physician’s order to change acetaminophen from an “as needed” frequency to a twice a day frequency. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 28, 2024, at 10:45 AM, the Admin/DPCS stated LVN 1 should have called her about Patient 1’s constant leg pain so she could report to the physician and update Patient 1’s care plan with additional pain interventions. The Admin/DPCS stated LVN 1 should have called the physician for a verbal order before changing a medication’s dosing frequency. A review of the agency’s policy and procedure titled, “Communication with a Physician Policy,” dated December 8, 1998, indicated, “Policy Statement: It shall be the policy of this Agency to identify when staff are to communicate with a patient’s physician, and on what forms staff are to document the communications, both written and verbal. Purpose: 1. To ensure an ongoing communication, between staff, and the patient’s physician. 2. To ensure staff contact the physician whenever warranted by the patient’s condition. … Procedure: 1. Communication with a physician is required when: a. changes occur in the patient’s physical and psychosocial condition, and/or changes in the patient’s expected response to treatment and/or medications; … 2. Staff members communicating with a patient’s physician will document the communication via one or more of the following forms which are filed in the patient’s clinical record: … b. verbal order form, c. Nurses’ … visit notes …” 4. A review of Patient 2’s care plan (contains information about a patient’s diagnosis, the goals of treatment, and specific nursing orders), undated, indicated a start of care date of March 21, 2022, with a recertification period of January 10, 2024 to March 9, 2024. Patient 2 had diagnoses that included diabetes mellitus (a disease that results in too much sugar in the blood). A review of Patient 2’s physician’s “Communication Note,” dated February 12, 2024, indicated, “Reason/s: Chief Complaint: 4:25 PM Patient called regarding latest lab results which showed poor blood sugar control and is markedly elevated. Instructed to [follow] up with Endocrinologist [a specialist physician for people with diabetes mellitus] asap [as soon as possible] and strict ADA [American Diabetes Association] diet [a diet used by people with high blood sugar to minimize symptoms and dangerous complications of long-term elevations in blood sugar] compliance. Continue to monitor BS [blood sugar] regularly. Discussed elevated creatinine [a compound formed in protein metabolism and when elevated an indicator of kidney damage] also, will refer to Nephrologist [a medical doctor who specializes in kidney care and treating diseases of the kidneys] asap for further evaluation and management of possible CKD [chronic kidney disease] due to DM [diabetes mellitus] complications. … Physician’s orders: … Monitor BS regularly and log.” A review of Patient 2’s physician’s “Communication Note,” dated February 19, 2024, indicated, “Reason/s: Chief Complaint: 2:49 PM Update provided by Nurse [name of nurse] who is with the patient regarding elevated A1C [a blood test that measures average blood sugar levels over the past three months] which was 11 [an A1C above 9% [percent] increases the risk of long-term diabetes complications like blindness, nerve damage, and kidney failure]; will order med [medication] and repeat A1C in 3 [three] months. To continue monitoring BS closely and strict compliance with ADA diet emphasized. Plan of care for patient discussed with [name of nurse] and she verbalized understanding. Physician’s Orders: … Continue to monitor BS before breakfast and after meals and log. …” A review of Patient 2’s physician’s order dated February 19, 2024, indicated, “…Repeat A1C/CMP [comprehensive metabolic panel-a blood test that shows how well the kidneys are working] in 3 months continue to monitor BS before breakfast and after meals and log. Strict compliance with diet.” During a home visit and interview with a Licensed Vocational Nurse (LVN 1) and Patient 2 on February 27, 2024, at 12:23 PM, Patient 2 stated her granddaughter handled all her medications, but was away at an appointment. LVN 1 stated at her February 19, 2024, visit she left the paperwork for the granddaughter to log Patient 2’s BS readings in the morning and afternoon. Patient 2 stated she did not know anything about a log. LVN 1 stated she had not seen a log filled out and did not know where the log was. LVN 1 stated she did not review the log at her visits or provide the logs data to the Registered Nurse (RN) at the agency. LVN 1 stated she only checked Patient 2’s BS levels if Patient 2 told her she was not feeling “right.” During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 28, 2024, at 11:07 AM, the Admin/DPCS stated LVN 1 was supposed to review the BS log at each visit and send the results to the office. The Admin/DPCS stated she would then send the log’s data to the physician for review due to Patient 2’s continued noncompliance with the diabetic regime. The Admin/DPCS stated the physician wanted to keep an eye on Patient 2’s BS readings because she was at high risk. A review of the agency’s policy and procedure titled, “Communication with a Physician Policy,” dated December 8, 1998, indicated, “Policy Statement: It shall be the policy of this Agency to identify when staff are to communicate with a patient’s physician, and on what forms staff are to document the communications, both written and verbal. Purpose: 1. To ensure an ongoing communication, between staff, and the patient’s physician. 2. To ensure staff contact the physician whenever warranted by the patient’s condition. … Procedure: 1. Communication with a physician is required when: a. changes occur in the patient’s physical and psychosocial condition, and/or changes in the patient’s expected response to treatment and/or medications; … f. stipulated [specified] by the physician. Note: Examples of changes in the patient’s physical condition may include: 1. Abnormal vital signs; … 5. Complications of disease process are assessed. … 2. Staff members communicating with a patient’s physician will document the communication via one or more of the following forms which are filed in the patient’s clinical record: a. Physician’s Plan of Care form … b. verbal order form … c. nurses … visit notes …” During an interview with the Owner and in the presence of the Administrator/Director of Patient Care Services (Admin/DPCS) on February 28, 2024, at 12:09 PM, the Owner stated he was the sole member of the Governing Body (GB). The Owner stated he assumed full legal authority and responsibility for the operation of the agency, and for the quality of care and services provided. The Owner stated the GB had not identified: The Admin/DPCS’s failure to provide ordered Physical Therapy (PT) services to Patient 1, LVN 1’s two medication (montelukast superoxide dismutase [SOD]-a medication used to prevent wheezing, difficulty breathing, chest tightness, and coughing and hydralazine-a medication used to treat high blood pressure) administration errors, LVN 1’s failure to report Patient 1’s change of condition and change of a medication (acetaminophen-a medication used to control pain) order without calling the physician to report and obtain a new order, and LVN 1’s failure to monitor Patient 2’s Blood Sugar (BS) Reading Log and report the BS readings to the Registered Nurse (RN) for report to the physician. A review of the agency’s policy and procedure titled, “Board of Director’s Policy,” dated December 11, 1998, indicated, “Policy Statement: It shall be the policy of this Agency for the Governing Body, the Board of Directors, to assume full legal authority and responsibility for the operation of the Agency, and for the quality of care and services provided. Purpose: 1. To establish legal authority and administrative control for the management of the Agency and for the quality of care/services provided. 2. To define the role and responsibilities of the Governing Board. Procedure: … Responsibilities of the Board of Directors includes: 3. Selection, employment, and evaluation of a qualified Administrator to direct the overall administrative and operational functions of the Agency, … and to oversee the Agency’s quality management system. 4. Approve the selection, and employment of a qualified Director of Patient Care Services to direct the day-to-day clinical aspects of the Agency. … 7. Establish objectives and approve overall policies which provide guidance and direction for the delivery of home health care services. … 10. Provide for the Agency the strategic, operational, programmatic, and other plans and policies to achieve the agency’s mission, and to address the following eleven (11) important functions … Assessment, Care, Treatment, and Services, Education, Continuum of Care, Improving Organizational Performance, … Management of the Environment of Care …””

“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 interview and record review, the agency failed to ensure a review of all medications the patients were taking was conducted for three of seven sampled patients (Patients 1, 2, and 3) when: 1. For Patient 1: the Medication Profile (MP-a current list of all medications prescribed for a specific patient), indicated the wrong dosing frequency for two medications (montelukast superoxide dismutase [SOD]-a medication used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma and hydralazine-a medication used to treat high blood pressure). In addition, the MP indicated the wrong dose for one medication (hydrochlorothiazide-HCTZ-a medication used to treat high blood pressure and swelling). 2. For Patient 2: the MP indicated the wrong dosing frequency for one medication (gabapentin-a medication used to reduce nerve pain) and did not indicate four medications (metformin-a medication used to control high blood sugar, folic acid-a medication used to treat or prevent folate deficiency causing inadequate red blood cells, sertraline hydrochloride [HCL]-a medication used to treat depression, and methotrexate-a medication to treat cancer) Patient 2 was taking. 3. For Patient 3: the MP indicated two medications which had been discontinued for three months (bydureon bcise-a medication used to control high blood sugar, and victoza-a medication used to control high blood sugar). This failure had the potential to cause ineffective drug therapy, significant side effects and noncompliance with drug therapy for Patients 1, 2, and 3. 1. A review of Patient 1’s care plan (contains information about a patient’s diagnosis, the goals of treatment, and specific nursing orders), undated, indicated a start of care date of May 3, 2023, with a recertification period of December 29, 2023 to February 26, 2024. Patient 1 had diagnoses that included diabetes mellitus (a disease that results in too much sugar in the blood). During a home visit on February 27, 2024, with a Licensed Vocational Nurse (LVN 1) and in the presence of Patient 1, an observation of Patient 1’s actual medication bottles available in the home were compared with Patient 1’s most current Medication Profile (MP). During an observation on February 27, 2024, at 11:03 AM, with LVN 1 and Patient 1: a. A bottle indicated a fill date of January 10, 2024, for montelukast SOD, 10 mg (milligram-a unit of measurement) tablet, take one tablet by mouth twice a day. The MP indicated montelukast SOD, 10 mg tablet, take one tablet by mouth once a day. b. A bottle indicated a fill date of March 6, 2023, for hydrochlorothiazide (HCTZ), 25 mg tablet, take one tablet by mouth once a day. The MP indicated hydrochlorothiazide (HCTZ), 50 mg tablet, take one tablet by mouth once a day. c. A bottle indicated a fill date of January 10, 2024, for hydralazine, 50 mg tablet, take one tablet by mouth once a day. The MP indicated hydralazine, 50 mg tablet, take one tablet by mouth three times a day. During an interview with LVN 1 and Patient 1 on February 27, 2024, at 11:23 AM, LVN 1 stated she visited Patient 1 once a week and filled his pill box with medication doses for a one-week period. Patient 1 stated he took whatever LVN 1 put into his pill box. LVN 1 stated she had been filling Patient 1’s pill box ever since Patient 1’s admission. LVN 1 stated she filled Patient 1’s pill box with montelukast SOD with a once per day dose, not a twice a day dose. LVN 1 stated she had not noticed the montelukast SOD dose frequency had changed. LVN 1 stated she made a medication administration error. LVN 1 stated she had not given enough montelukast SOD and Patient 1 could have suffered increased symptoms of wheezing, difficulty breathing, chest tightness, and coughing. LVN 1 stated she filled Patient 1’s pill box with a 25 mg tablet of hydrochlorothiazide (HCTZ) for a once-a-day dose. LVN 1 stated she had not noticed the dose had changed from 50 mg to 25 mg. LVN 1 stated she filled Patient 1’s pill box with hydralazine for a twice a day dose, not a once-a-day dose. LVN 1 stated she had not given Patient 1 a hydralazine dose three times a day as indicated on the MP because the pill box did not have enough spaces for three times a day. LVN 1 stated she had not noticed the hydralazine dose frequency had changed. LVN 1 stated she made a medication administration error. LVN 1 stated she had given too much hydralazine and Patient 1 could have suffered low blood pressure and passed out. 2. A review of Patient 2’s care plan (contains information about a patient’s diagnosis, the goals of treatment, and specific nursing orders), undated, indicated a start of care date of March 21, 2022, with a recertification period of January 10, 2024 to March 9, 2024. Patient 2 had diagnoses that included diabetes mellitus (a disease that results in too much sugar in the blood). During a home visit on February 27, 2024, with a Licensed Vocational Nurse (LVN 1) and in the presence of Patient 2, an observation of Patient 2’s actual medication bottles available in the home were compared with Patient 2’s most current Medication Profile (MP). During a concurrent observation and interview on February 27, 2024, at 12:51 PM, with LVN 1 and Patient 2, Patient 2 stated her granddaughter handled all her medications, but she was away at an appointment. Patient 2 provided four bottles of medications: metformin, folic acid, sertraline HCL, and methotrexate. LVN 1 confirmed the four medications were not listed on the MP. LVN 1 stated she did not know the medications were not on the MP. A fifth bottle indicated a fill date of February 12, 2024, for gabapentin, 300 mg tablet, take one tablet by mouth once a day. The MP indicated gabapentin, 300 mg tablet, take one tablet by mouth twice a day. LVN 1 stated she had visited Patient 2 on February 12, 2024, and February 19, 2024, but had not noticed the gabapentin dosing frequency had changed. 3. A review of Patient 3’s care plan (contains information about a patient’s diagnosis, the goals of treatment, and specific nursing orders), undated, indicated a start of care date of November 10, 2021, with a recertification period of December 30, 2023 to February 27, 2024. Patient 3 had diagnoses that included diabetes mellitus (a disease that results in too much sugar in the blood). During a home visit on February 27, 2024, with a Licensed Vocational Nurse (LVN 2) and in the presence of Patient 3, an observation of Patient 3’s actual medication bottles available in the home were compared with Patient 3’s most current Medication Profile (MP). During a concurrent record review and interview on February 27, 2024, at 3:31 PM, with LVN 2 and Patient 3, Patient 3 reviewed her MP. Patient 3 stated the bydureon bcise and victoza had been discontinued in December 2023. LVN 2 stated she did not know the bydureon bcise and victoza had been discontinued. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 28, 2024, from 10:45 AM to 11:20 AM, the Admin/DPCS stated during medication reconciliation all the bottles and boxes with pharmacy labels need to be compared against the medication profile and the family member and/or patient needed to be involved to see if anything had changed or if they were having any difficulties. The Admin/DPCS stated the Skilled Nurse (SN) should then call her (Admin/DPCS) with any changes or discrepancies and she would update the MP and report to the physician. The Admin/DPCS stated the MP should have been accurate and up to date for Patients 1, 2, and 3 and it was not. The Admin/DPCS stated LVN 1’s medication administration errors should not have happened. A review of the agency’s policy and procedure titled, “Administration of Medications Policy,” dated November 11, 1997, indicated, “Procedure … 3. A medication profile will be maintained in the clinical record for each patient and is available to all staff providing care. When a licensed professional from the agency monitors the use of medications as part of the care, the medication profile is used to evaluate the use of the drugs in the patient’s current regimen. The medication profile will include at the least: a. current medication therapy, including prescription and nonprescription drugs, and home remedies with the dose, frequency, and route; and b. ongoing medications updates, including initiation of, changes in, or discontinuation of medications. 4. When there is a discrepancy in the medications found in the home, and in the information provided to the Agency, a nurse will contact the physician as soon as possible to verify the correct medication regimen. The nurse/therapist will instruct the patient and family in the appropriate medication regimen. The nurse/therapist will document all telephone conversations and instructions given to the patient and/or family in the patient’s clinical record.””

“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 provide services ordered by the physician and indicated in the plan of care for two of seven sampled patients (Patients 1 and 2) when: 1a. For Patient 1: The Administrator/Director of Patient Care Services failed to provide ordered Physical Therapy (PT) services. 1b. A Licensed Vocational Nurse (LVN 1) made two medication (montelukast superoxide dismutase [SOD]-a medication used to prevent wheezing, difficulty breathing, chest tightness, and coughing and hydralazine-a medication used to treat high blood pressure) administration errors. 1c. LVN 1 failed to report Patient 1’s change of condition and changed a medication (acetaminophen-a medication used to control pain) order without calling the physician to report and obtain a new order. 2. For Patient 2: a Licensed Vocational Nurse (LVN 1) failed to monitor a Blood Sugar (BS) Reading Log and report the BS readings to the Registered Nurse (RN) for report to the physician. These failures had the potential to cause Patient 1 to suffer continued physical weakness resulting in falls; poor control of wheezing, difficulty breathing, chest tightness, and coughing; low blood pressure and passing out and administration of a medication without physician oversight. Patient 2 had the potential to suffer continued uncontrolled high blood sugar levels leading to progressive internal organ and blood vessel damage. 1a. A review of Patient 1’s care plan (contains information about a patient’s diagnosis, the goals of treatment, and specific nursing orders), undated, indicated a start of care date of May 3, 2023, with a recertification period of December 29, 2023 to February 26, 2024. Patient 1 had diagnoses that included diabetes mellitus (a disease that results in too much sugar in the blood). A review of Patient 1’s physician’s “Assessment for Follow-Up Visit,” dated January 8, 2024, indicated, “…Treatment Plan: Fall Prevention, Physical Therapist … Therapy Orders: Physical Therapy. Provide gait training, strengthening and/or balance exercises to restore the patient’s ability to walk safely without pain. Teach the patient caregiver compensatory strategies for cognitive deficits. Teach patient caregiver compensatory environmental modification for safety. Provide maintenance therapy to prevent or slow a decline in condition.” During a home visit and interview with a Licensed Vocational Nurse (LVN 1) and Patient 1 on February 27, 2024, at 10:50 AM, Patient 1 stated he had not received Physical Therapy (PT) services and would like to have PT services. LVN 1 confirmed Patient 1 had stated he had not received PT services and would like to have PT services. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 28, 2024, at 10:45 AM, the Admin/DPCS verified Patient 1’s physician’s order for PT services. The Admin/DPCS stated it was her responsibility to arrange PT services for Patient 1 and she had not. The Admin/DPCS confirmed Patient 1 had been without PT services for 51 days. A review of the agency’s policy and procedure titled, “Services by Discipline Policy,” dated September 15, 2008, indicated, “8. Physical therapy services shall be provided in accordance with the physician’s orders.” 1b. During a home visit on February 27, 2024, with a Licensed Vocational Nurse (LVN 1) and in the presence of Patient 1, an observation of Patient 1’s actual medication bottles available in the home were compared with Patient 1’s most current Medication Profile (MP). During an observation on February 27, 2024, at 11:03 AM, with LVN 1 and Patient 1: a. A bottle indicated a fill date of January 10, 2024, for montelukast SOD, 10 mg (milligram-a unit of measurement) tablet, take one tablet by mouth twice a day. The MP indicated montelukast SOD, 10 mg tablet, take one tablet by mouth once a day. b. A bottle indicated a fill date of January 10, 2024, for hydralazine, 50 mg tablet, take one tablet by mouth once a day. The MP indicated hydralazine, 50 mg tablet, take one tablet by mouth three times a day. During an interview with LVN 1 and Patient 1 on February 27, 2024, at 11:23 AM, LVN 1 stated she visited Patient 1 once a week and filled his pill box with medication doses for a one-week period. Patient 1 stated he took whatever LVN 1 put into his pill box. LVN 1 stated she had been filling Patient 1’s pill box ever since Patient 1’s admission. LVN 1 stated she filled Patient 1’s pill box with montelukast SOD with a once per day dose, not a twice a day dose. LVN 1 stated she had not noticed the montelukast SOD dose frequency had changed. LVN 1 stated she made a medication administration error. LVN 1 stated she had not given enough montelukast SOD and Patient 1 could have suffered increased symptoms of wheezing, difficulty breathing, chest tightness, and coughing. LVN 1 stated she filled Patient 1’s pill box with hydralazine for a twice a day dose, not a once-a-day dose. LVN 1 stated she had not given Patient 1 a hydralazine dose three times a day as indicated on the MP because the pill box did not have enough spaces for three times a day. LVN 1 stated she had not noticed the hydralazine dose frequency had changed. LVN 1 stated she made a medication administration error. LVN 1 stated she had given too much hydralazine and Patient 1 could have suffered low blood pressure and passed out. A review of the agency’s policy and procedure titled, “Administration of Medications Policy,” dated November 11, 1997, indicated, “Policy Statement: It shall be the policy of this Agency to establish criteria for the administration of medications. Purpose: 1. To ensure patient safety. 2. To establish procedures for the safe administration of medications in the home environment. Procedure: … 2. All staff nurses are to review each medication a patient may be taking, prescribed or over the counter, to identify possible ineffective drug therapy … 6. Nurses administering medications will ensure the stability and safety of the medication being administered by performing the following activities: a. administering medications only from labeled containers; … d. verifying the patient’s name, date of filling, physician’s name, name and strength of medication, and directions for administering the medication; …” 1c. A review of Patient 1’s physician’s order dated December 29, 2023, indicated, “acetaminophen (Tylenol) [a pain medication] 325 mg [milligrams-a unit of measurement] 1 [one] – [to] 2 [two] tablets, PO [by mouth], Q [every] 4 [four] – [to] 6 [six] hours PRN [as needed].” During a home visit and interview with a Licensed Vocational Nurse (LVN 1) and Patient 1 on February 27, 2024, at 11:13 AM, LVN 1 stated she visited Patient 1 once a week and filled his pill box with medication doses for a one-week period. Patient 1 stated he took whatever LVN 1 put into his pill box. LVN 1 stated she had been filling Patient 1’s pill box ever since Patient 1’s admission. LVN 1 stated a week ago Patient 1 had told her his legs hurt all the time, so she decided to fill his pill box with acetaminophen for a twice a day dose, once in the morning and once at night. LVN 1 stated she had not called the physician or Registered Nurse (RN) to give report on Patient 1’s constant leg pain and had not obtained a new physician’s order to change acetaminophen from an “as needed” frequency to a twice a day frequency. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 28, 2024, at 10:45 AM, the Admin/DPCS stated LVN 1 should have called her about Patient 1’s constant leg pain so she could report to the physician and update Patient 1’s care plan with additional pain interventions. The Admin/DPCS stated LVN 1 should have called the physician for a verbal order before changing a medication’s dosing frequency. A review of the agency’s policy and procedure titled, “Communication with a Physician Policy,” dated December 8, 1998, indicated, “Policy Statement: It shall be the policy of this Agency to identify when staff are to communicate with a patient’s physician, and on what forms staff are to document the communications, both written and verbal. Purpose: 1. To ensure an ongoing communication, between staff, and the patient’s physician. 2. To ensure staff contact the physician whenever warranted by the patient’s condition. … Procedure: 1. Communication with a physician is required when: a. changes occur in the patient’s physical and psychosocial condition, and/or changes in the patient’s expected response to treatment and/or medications; … 2. Staff members communicating with a patient’s physician will document the communication via one or more of the following forms which are filed in the patient’s clinical record: … b. verbal order form, c. Nurses’ … visit notes …” 2. A review of Patient 2’s care plan (contains information about a patient’s diagnosis, the goals of treatment, and specific nursing orders), undated, indicated a start of care date of March 21, 2022, with a recertification period of January 10, 2024 to March 9, 2024. Patient 2 had diagnoses that included diabetes mellitus (a disease that results in too much sugar in the blood). A review of Patient 2’s physician’s “Communication Note,” dated February 12, 2024, indicated, “Reason/s: Chief Complaint: 4:25 PM Patient called regarding latest lab results which showed poor blood sugar control and is markedly elevated. Instructed to [follow] up with Endocrinologist [a specialist physician for people with diabetes mellitus] asap [as soon as possible] and strict ADA [American Diabetes Association] diet [a diet used by people with high blood sugar to minimize symptoms and dangerous complications of long-term elevations in blood sugar] compliance. Continue to monitor BS [blood sugar] regularly. Discussed elevated creatinine [a compound formed in protein metabolism and when elevated an indicator of kidney damage] also, will refer to Nephrologist [a medical doctor who specializes in kidney care and treating diseases of the kidneys] asap for further evaluation and management of possible CKD [chronic kidney disease] due to DM [diabetes mellitus] complications. … Physician’s orders: … Monitor BS regularly and log.” A review of Patient 2’s physician’s “Communication Note,” dated February 19, 2024, indicated, “Reason/s: Chief Complaint: 2:49 PM Update provided by Nurse [name of nurse] who is with the patient regarding elevated A1C [a blood test that measures average blood sugar levels over the past three months] which was 11 [an A1C above 9% [percent] increases the risk of long-term diabetes complications like blindness, nerve damage, and kidney failure]; will order med [medication] and repeat A1C in 3 [three] months. To continue monitoring BS closely and strict compliance with ADA diet emphasized. Plan of care for patient discussed with [name of nurse] and she verbalized understanding. Physician’s Orders: … Continue to monitor BS before breakfast and after meals and log. …” A review of Patient 2’s physician’s order dated February 19, 2024, indicated, “…Repeat A1C/CMP [comprehensive metabolic panel-a blood test that shows how well the kidneys are working] in 3 months continue to monitor BS before breakfast and after meals and log. Strict compliance with diet.” During a home visit and interview with a Licensed Vocational Nurse (LVN 1) and Patient 2 on February 27, 2024, at 12:23 PM, Patient 2 stated her granddaughter handled all her medications, but was away at an appointment. LVN 1 stated at her February 19, 2024, visit she left the paperwork for the granddaughter to log Patient 2’s BS readings in the morning and afternoon. Patient 2 stated she did not know anything about a log. LVN 1 stated she had not seen a log filled out and did not know where the log was. LVN 1 stated she did not review the log at her visits or provide the logs data to the Registered Nurse (RN) at the agency. LVN 1 stated she only checked Patient 2’s BS levels if Patient 2 told her she was not feeling “right.” During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on February 28, 2024, at 11:07 AM, the Admin/DPCS stated LVN 1 was supposed to review the BS log at each visit and send the results to the office. The Admin/DPCS stated she would then send the log’s data to the physician for review due to Patient 2’s continued noncompliance with the diabetic regime. The Admin/DPCS stated the physician wanted to keep an eye on Patient 2’s BS readings because she was at high risk. A review of the agency’s policy and procedure titled, “Communication with a Physician Policy,” dated December 8, 1998, indicated, “Policy Statement: It shall be the policy of this Agency to identify when staff are to communicate with a patient’s physician, and on what forms staff are to document the communications, both written and verbal. Purpose: 1. To ensure an ongoing communication, between staff, and the patient’s physician. 2. To ensure staff contact the physician whenever warranted by the patient’s condition. … Procedure: 1. Communication with a physician is required when: a. changes occur in the patient’s physical and psychosocial condition, and/or changes in the patient’s expected response to treatment and/or medications; … f. stipulated [specified] by the physician. Note: Examples of changes in the patient’s physical condition may include: 1. Abnormal vital signs; … 5. Complications of disease process are assessed. … 2. Staff members communicating with a patient’s physician will document the communication via one or more of the following forms which are filed in the patient’s clinical record: a. Physician’s Plan of Care form … b. verbal order form … c. nurses … visit notes …””