Madison Home Health Services

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on record review, staff interview, patient interview, and policy review, the agency failed to ensure the physician’s plan of care contained the frequency and duration of visits to be made, diet orders, discharge plans, blood sugar parameters, complete list of diagnoses, services provided to reflect the primary diagnosis, and measurable goals. (G574). The agency failed to ensure there was a physician’s order for the services provided. This affected three (Patient #1, #2 and #3) of three patients with a home visit reviewed (G580). The agency failed to ensure therapy was referred as needed. This affected three (Patient #2, #5 and #7) out of seven patient records reviewed (G606). The agency failed to ensure written visit schedule, including frequency of visits by the agency personnel. This affected three (Patient #1, #2 and #3) out of three patient home visits reviewed (G614). The agency failed to ensure written patient medication instructions and the current medication profile were left in the home (G616). The cumulative effect of these systemic practices resulted in the agency’s inability to ensure the health and safety of the patients and staff.”

“Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA’s governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA’s performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This Condition is not met as evidenced by: Based on review of Quality Assurance Performance Improvement reports, staff interview, and review of policy, the agency failed to document what indicators or measures were used to collect the data, show how they were tracked and how often, and how the information used improved quality and safety. The agency failed to ensure the Governing Body approved the frequency and duration of the details of data collection (G644). The agency failed to ensure Performance Improvement Projects were done annually. (G658). The agency failed to ensure the Governing Body assumes overall responsibilities for ensuring the Quality Assessment and Performance Improvement (QAPI) efforts address priorities for improved quality of care and patient safety and that clear expectations for patient safety are established, implemented, and maintained (G660). The cumulative effect of these systemic practices resulted in the agency’s inability to ensure the health and safety of the patients and staff.”

“EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: Based on record review and staff interview the provider failed to conduct exercises to test the emergency plan per 42 CFR 484.102(d)(2). Record review of the emergency preparedness plan on 08/23/2024 at approximately 7:41 A.M. and again at 1:02 P.M. revealed there was no documentation the organization tested the plan on an annual basis. An interview via email requested documentation of the testing of the plan but no information was provided. The Administrator was again contacted by phone at approximately 12:05 P.M. and stated he would provide the information; however, an attachment was sent that stated that they were hazard vulnerability assessments.”

“Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This Standard is not met as evidenced by: Based on policy review and staff interview, the agency failed to ensure they were reporting and transmitting Outcome and Assessment Information Set (OASIS) information monthly. This had the potential to affect all patients. The census was 20. Review of the OASIS Submission binder revealed the last OASIS submission was 11/06/2018. Review of the agency policy titled “Reporting of OASIS Information,” revised 2021, revealed the Agency will report required data collected for the Outcome and Assessment Information Set (OASIS) items. The agency must encode and have the capability of transmitting OASIS data for each patient. The agency will electronically transmit completed, encoded and locked OASIS data for each completed OASIS assessment at least monthly to the System. Interview on 08/22/24 at 2:20 PM, the Administrator (Staff A) and the Director of Nursing (Staff B) confirmed the last transmission was 11/06/2018. Staff A stated they couldn’t get into iQIES because they didn’t accept his verification. Staff B stated they didn’t transmit the OASIS information and didn’t know how.”

“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 review of the Quality Assurance and Performance Improvement program, staff interview, and review of policy, the agency failed to document what indicators or measures were used to collect the data, show how they were tracked and how often, and how the information used improved quality and safety. The agency failed to ensure the Governing Body approved the frequency and duration of the details of data collection. This could potentially affect all patients. The census was 20. Review of the Quality Assurance and Performance Improvement (QAPI) binder did not reveal any data for the program, the quality indicator data, what measures were used to gather data, how data was being tracked, how this was being measured at intervals, or how the indicators and data were used for improvement. There was no documented evidence the Governing Body had approved the frequency and detail of data to be collected. There was no documented evidence of measurable improvement, or that quality indicator data derived from OASIS was used. Review of the agency policy titled “Quality Assurance and Performance Improvement (QAPI) Plan and Program,” revised 02/2022, revealed the Agency will establish an ongoing, agency-wide, data-driven program of quality assurance and performance improvement and maintain documentary evidence of its program. The Agency program will be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety and quality of care. The Agency must measure, analyze and track quality indicators, including adverse patient events. The program must utilize quality indicator data, including measures derived from OASIS. Interview on 08/22/24 at 3:56 PM the Director of Nursing and the Administrative Assistant confirmed this finding.”

“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 review of the Quality Assurance Performance Improvement binder, staff interview, and policy review, the agency failed to ensure Performance Improvement Projects were done annually. This could potentially affect all patients. The census was 20. Review of the Quality Improvement binder did not reveal any Performance Improvement Activities for 2023 or 2024. Review of agency policy titled “Objectives of Quality Assessment and Performance Improvement Program,” with no effective date, revealed projects identify problems, establish a plan and take action to resolve, reprioritize if necessary and reevaluate results. Review of the agency policy titled “Performance Improvement Projects,” revised 03/2018, revealed the number and scope of distinct improvement projects conducted annually will reflect the scope, complexity and past performance of the Agency’s services and operations. The Agency should have one performance improvement project either in development, ongoing or completed each calendar year. Per interview on 08/22/24 at 9:55 AM the Administrator confirmed this.”

“Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA’s governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This Standard is not met as evidenced by: Based on review of the Governing Body minutes, staff interview, and review of policy, the agency failed to ensure the Governing Body assumes overall responsibilities for ensuring the Quality Assessment and Performance Improvement (QAPI) efforts address priorities for improved quality of care and patient safety and that clear expectations for patient safety are established, implemented, and maintained. This could potentially affect all patients. The census was 20. Review of the Governing Body (GB) meeting minutes from 01/28/21 to 07/18/24 did not reveal documentation the GB assumes overall responsibility for ensuring the QAPI program reflects a patient safety program that is defined, implemented and maintained. Review of the agency policy titled “Quality Assurance and Performance Improvement (QAPI) Plan and Program,” revised 02/2022, revealed the Agency will establish an ongoing, agency-wide, data-driven program of quality assurance and performance improvement and maintain documentary evidence of its program. The Governing Body is ultimately responsible for an ongoing QAPI and patient safety program that is defined, implemented and maintained. Interview on 08/22/24 at 4:02 PM the Administrator and Administrative Assistant confirmed this finding.”

“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 observations, staff interview, and review of policy, the agency failed to ensure proper hand hygiene was used during treatment and care of the resident, failed to ensure the supply bag was placed on a water-resistant barrier, and failed to ensure all equipment was disinfected before returning to the supply bag. This affected two (Patient #1 and #3) out of two patients reviewed with contact from staff. The census was 20. 1. A home visit was made to Patient #1 on 08/20/24 at 8:00 AM with the Director of Nursing (DON) present. Observations at 8:17 AM revealed the DON put on gloves without using hand sanitizer first. At 8:30 AM the DON was observed to replace the thermometer and pulse-oximetry back into the nursing bag without disinfecting them first. 2. A home visit was made to Patient #3 on 08/20/24 at 10:00 AM with the licensed practical nurse, Staff D, present. Observations at 10:08 AM revealed Staff D to place the nursing bag directly on used pads on the patient’s chair. Patient #3 was identified as incontinent of bowel and bladder with a strong odor of urine in the room. At 10:09 AM Staff D was observed to put on gloves without using hand sanitizer first. At 10:10 AM Staff D was observed to take Patient #3’s blood pressure and returned the blood pressure cuff to the nursing bag without disinfecting it first. At 10:12 AM Staff D was observed assessing and touching Patient #3, then with dirty gloves Staff D reached into the nursing bag for a clean mask, leaving the bag open. At 10:14 AM Staff D was observed to put on a clean mask with dirty gloves and no hand hygiene. At 10:18 AM Staff D was observed to use the same dirty gloves to get Patient #3’s blood sugar meter. Staff D reached into the clean box of needles without changing gloves or using hand hygiene. At 10:22 AM Staff D was observed to use the same dirty gloves and used the blood sugar needle to prick Patient #3’s finger twice with the same needle. At 10: 24 AM Staff D was observed to use the same dirty gloves to get clean supplies out of the nursing bag. Review of the agency policy titled “Hand Hygiene Policy and Compliance Program,” revised 07/2021, revealed indications for staff performing hand hygiene are before and after direct patient care, before and after each procedure and before re-entering nursing bag or patient’s clean supplies. Bacteriostatic foam/gel/liquid is the preferable hand hygiene method. Use of gloves are not a substitute for hand hygiene. Change or remove gloves if moving from contaminated to clean patient site or environment. Review of the agency policy titled “Nursing Bag Technique,” with no effective date, revealed when inside patient’s home the nursing bag is to be placed on a water-resistant barrier. Remove all necessary items for the visit from the bag and place items on a clean water-resistant barrier. If needed, perform hand hygiene per agency policy and apply personal protective equipment, as needed. Close bag compartments and bag opening after removing equipment. Staff must perform hand hygiene prior to retrieving items additional equipment/supplies needed from the nursing bag. After providing care and before returning items to supply bag, clean all equipment with agency approved low-level disinfectant. (alcohol wipes). Interview on 08/20/24 at 3:49 PM the DON confirmed the DON and Staff D did not follow agency policy for hand hygiene and infection control of the nursing bag.”

“Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This Standard is not met as evidenced by: Based on observation and staff interview, the skilled nurse failed to do a complete patient assessment. This effected one (Patient #3) out of two patient assessments observed.The census was 20. Observations during a home visit for Patient #3 on 08/20/24 at 10:00 AM revealed upon entering the patient’s room there was a very strong urine odor. The licensed practical nurse, Staff D, was observed to do an assessment on Patient #3 who was bed bound and incontinent of urine and stool. Staff D did not check Patient #3’s back or heels for skin breakdown or redness. Staff D did not question the strong odor of urine or check the patient for incontinence until the surveyor questioned it at the end of the assessment. Interview on 08/20/24 at 10:28 AM with the registered nurse, Staff E, confirmed this finding.”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on record review, staff interview and review of policy, the agency failed to ensure the signature of the registered nurse contained the date and title. This affected five (Patient #1, #2, #3, #4, #5) out of five patient records reviewed. The census was 20. 1. Review of the medical record for Patient #1 and physician’s plan of care dated 06/24/24 did not have a date with the signature in box #23 “Nurse’s Signature and Date of Verbal Start of Care.” 2. Review of the medical record for Patient #2 and physician’s plan of care dated 06/23/24 did not have a date with the signature in box #23 “Nurse’s Signature and Date of Verbal Start of Care” 3. Review of the medical record for Patient #3 and physician’s plan of care dated 08/15/24 did not have a date with the signature in box #23 “Nurse’s Signature and Date of Verbal Start of Care.” 4. Review of the medical record for Patient #4 and physician’s plan of care dated 07/17/24 did not have a date with the signature in box #23 “Nurse’s Signature and Date of Verbal Start of Care.” 5. Review of the medical record for Patient #5 and physician’s plan of care dated 07/17/24 did not have a date with the signature in box #23 “Nurse’s Signature and Date of Verbal Start of Care.” Review of the agency policy titled “Plan of Care – CMS #485 and Physician’/Practitioners Orders,” with no effective date, revealed verbal orders are put in writing, signed, timed and dated with the date of receipt by the registered nurse. Review of the agency policy titled “Medical Record Entries and Authentication,” revised 03/2018, revealed all entries in the medical records will be authenticated by staff signature and title. Interview on 08/20/24 at 2:13 PM the Director of Nursing confirmed these findings.”

“Administrator CFR(s): 484.115(a) Standard: Administrator, home health agency. (1) For individuals that began employment with the HHA prior to January 13, 2018, a person who: (i) Is a licensed physician; (ii) Is a registered nurse; or (iii) Has training and experience in health service administration and at least 1 year of supervisory administrative experience in home health care or a related health care program. (2) For individuals that begin employment with an HHA on or after January 13, 2018, a person who: (i) Is a licensed physician, a registered nurse, or holds an undergraduate degree; and (ii) Has experience in health service administration, with at least 1 year of supervisory or administrative experience in home health care or a related health care program. This Standard is not met as evidenced by: Based on personnel file review, review of Governing Body minutes, and staff interview, the agency failed to ensure the administrator met the qualifications for employment. This could potentially affect all patients and staff. The census was 20. Review of the personnel file for the Administrator revealed a hire date of 05/05/23. There was no documented evidence of a resume. The only work experience was in Human Resources. Interview on 08/21/24 at 4:00 PM the Administrator stated they had graduated from high school and confirmed they had no prior experience in health service administration with one year of supervisory or administrative experience in home health care. Per interview on 08/22/24 at 11:00 AM Staff H, a governing body member, confirmed they knew in 05/2023 the Administrator was not qualified. Review of Governing Body meeting minutes dated 05/01/23 revealed the Administrator had been assigned and approved by the governing body to be a temporary administrator. The company will be looking for an affordable and qualified administrator in future. No further documentation was found related to finding a qualified administrator.”

“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, record review staff and patient interviews, and review of agency policy, the agency failed to ensure all medications taken by the patient were listed on the medication profile. This affected one (Patient #2) of one patient with home medications reviewed. The census was 20. Observations during a home visit to Patient #2 on 08/20/24 at 8:45 AM with home health aide (HHA), Staff F, present revealed a tube of an anti-itch cream was observed to be nearly empty and a tube of hydrocortisone Cream 1 % was observed to be used. A bottle of Clotrimazole 1 % drops (antifungal topical solution) was observed with Patient #2’s medications. A review of the medication profile dated 06/20/24 of the medications Patient #2 took at home did not list these medications. Interview on 08/20/24 at 9:16 AM with Staff F confirmed Patient #2 did use both the anti-itch cream and hydrocortisone creams on his/her eczema. Interview on 08/20/24 at 9:19 AM, Patient #2 stated they have used the Clotrimazole 1 % drops on his/her toenails for about a year. Review of the agency policy titled “Medication Reconciliation” with no effective date, revealed the Agency will reconcile patient’s medications at time of admission and on an ongoing basis 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. Medications ordered while the patient is receiving care will be compared to the medication list/profile. The medication list/profile will be updated with each new or changed medication. Interview on 08/20/24 at 2:30 PM, the Director of Nursing (Staff B) confirmed Patient #2 does use these medications and they were not listed on the medication profile.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on record review, staff interview, and review of policy, the agency failed to ensure the physician’s plan of care contained the frequency and duration of visits to be made, diet orders, discharge plans, blood sugar parameters, complete list of diagnoses, services provided to reflect the primary diagnosis, and measurable goals. This affected seven (Patient #1, #2, #3, #4, #5, #6 and #7) out of seven patients reviewed. The census was 20. 1.Review of the medical record for Patient #1 revealed a physician’s plan of care dated 06/24/24 revealed a primary diagnosis of hypothyroidism. The plan of care did not have documented evidence of measurable goals. The plan of care revealed the registered nurse (RN) was to go twice a week to monitor vital signs, identify situations that exacerbate and relieve pain, educate in infection control and proper medication management and use/teach skin care and hygiene, teach management of respiratory exacerbations, assess Patient #1 in home safety measures, to prevent falls. RN to teach Patient #1 stress management, and coping strategies. The plan of care revealed the home health aide (HHA) was to go 43 hours per week to supervise Patient #1 when ambulating and offer hands on assistance when needed. The HHA was to remind client when medications are to be taken and assist by providing food/drink with medications. Assist with upper and lower body dressing and assist client with homemaking tasks: vacuum, sweep, wet mop, dusting, dishes, refrigerator, laundry, change bed linens, toilet, tub and sink care, trash remova. The HHA was to assist client with sanitation of durable medical equipent and supplies, assist with client hygiene and grooming, sanitation of the kitchen before and after preparing meals, and to assist and supervise bathing of Patient #1 either by tub, bed or chair to assist with prevention of infection. The interventions listed on the plan of care were not related to Patient #1‘s primary diagnosis. Review of the agency policy titled “Plan of Care – CMS 485 and Physician’s/Practitioners Orders,” with no effective date, revealed the individualized plan of care must include all pertinent diagnoses, the frequency and duration of visits to be made, nutritional requirements, all medications, discharge planning and patient-specific interventions and education and measurable outcomes and goals identified by the agency and the patient. Interview on 08/20/24 at 1:38 PM Staff B the Director of Nursing (DON) confirmed the interventions listed on the plan of care were not related to Patient #1’s primary diagnosis. Interview on 08/20/24 at 1:50 PM the DON confirmed there was no frequency or duration of visits for the HHA and no measurable goals on the plan of care for Patient #1. 2. Review of the medical record for Patient #2 1 revealed a physician’s plan of care dated 06/23/24 which identified the HHA was to provide care 18 hours per week. The plan of care did not have documented evidence of measurable goals. The plan of care did not reveal a diet order. Review of the 60 summary on the physician’s plan of care, dated 06/23/24, revealed the skilled nurse assessed Patient #2 for edema, weight gains, and for signs and symptoms of congestive heart failure (CHF), which was not a listed diagnosis. Interview on 08/20/24 at 9:21AM, HHA, Staff F, stated they weigh Patient #2 daily and notify the nurse if there is two or more pounds of weight gain. Interview on 08/20/24 at 12:04 PM the DON confirmed the staff weight the patient daily and the nurse monitors for edema, weight gain, and symptoms of CHF. The DON stated they forgot to add the diet and CHF as a diagnosis on the plan of care. Interview on 08/20/24 at 1:50 PM the DON confirmed there was no frequency or duration of visits for the HHA and no measurable goals on the plan of care for Patient #2. 3. Review of the medical record for Patient #3 revealed a physician’s plan of care dated 08/15/24 which identified the HHA was to provide care 52 hours per week The plan of care did not have documented evidence of measurable goals. Interview on 08/20/24 at 1:50 PM the DON confirmed there was no frequency or duration of visits for the HHA and no measurable goals on the plan of care for Patient #3. 4. Review of the medical record for Patient #4 and the physician’s plan of care dated 07/17/24 did not reveal a diet order, parameters to notify the physician for the patient’s blood sugars, and did not have documented evidence of measurable goals. Congestive heart failure and diabetes were not included in the diagnoses. Interview on 08/20/24 at 1:50 PM the DON confirmed there were no measurable goals on the plan of care for Patient #4. Interview on 08/21/24 at 2:17 PM the DON confirmed the plan of care did not contain a diet order, parameters to notify the physician for the patient’s blood sugars, and did not have CHF and diabetes included in the diagnoses. 5. Review of the medical record for Patient #5 and physician’s plan of care dated 07/17/24 did not reveal a diet order and did not have documented evidence of measurable goals. Bipolar was not included in the diagnoses. Interview on 08/20/24 at 1:50 PM the DON confirmed there were no measurable goals on the plan of care for Patient #5. Interview on 08/21/24 at 2:17 PM the DON confirmed bipolar was not included in the diagnoses on the plan of care. 6. Review of the medical record for Patient #6 and physician’s plan of care dated 05/30/24 did not reveal discharge plans and did not have documented evidence of measurable goals. Interview on 08/20/24 at 1:50 PM the DON confirmed there were no measurable goals on the plan of care for Patient #6. 7. Review of the medical record for Patient #7 revealed the plan of care identified the HHA was to provide care 49 hours per week. The plan of care did not have documented evidence of measurable goals. The plan of care did not reveal a diet order, medications, and discharge plans. Interview on 08/20/24 at 1:50 PM the DON confirmed there was no frequency or duration of visits for the HHA and no measurable goals on the plan of care for Patient #7.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on record review, observation, staff interview, and review of policy, the agency failed to ensure there was a physician’s order for the services provided. This affected three (Patient #1, #2 and #3) of three patients with a home visit reviewed. The census was 20. 1.Review of the medical record for Patient #1 revealed the physician’s plan of care, dated 06/24/24, contained a diagnosis of diabetes. There were no blood sugar parameters ordered identifying when to notify the physician. Review of the 60-day Clinical Summary revealed Patient #1 had unstable sugars with readings beteween 150-250. Diabetic teaching was done. Observations during a home visit for Patient #1 on 08/20/24 at 8:00 AM with the Director of Nursing (DON) present revealed the DON monitored Patient #1’s blood sugar. The result was 197. 2. A home visit was made to Patient #2 on 08/20/24 at 8:45 AM with the Home Health Aide, Staff F, present. Per interview on 08/20/24 at 9:33 AM Staff F stated they weigh Patient #2 daily and report to the skilled nurse if there is a two-pound gain. Review of the Aide Plan of Care, signed by the registered nurse 06/18/24, did not have documentation the home health aide (HHA) was to weigh Patient #2 and monitor the weight daily. Review of the medical record for Patient #2 and the physician’s plan of care dated 06/23/24 did not reveal orders to weigh Patient #2 daily. 3. A home visit was made to Patient #3 on 08/20/24 at 10:00 AM with the DON present. Per interview on 08/20/24 at 10:25 AM during the visit, the licensed practical nurse, Staff D, stated they feed Patient #3 and then administer the morning medications by mouth. Staff D stated the HHA/ caregiver is not available in the morning to administer the medications. Review of the medical record for Patient #3 and the physician’s plan of care dated 08/15/24 did not reveal an order for the skilled nurse (SN) to feed Patient #3 and administer medications. Additionally, the 60-day summary for Patient #3 revealed the registered nurse did diabetic teaching and there was no order for it. Review of the agency’s policy titled “Plan of Care – CMS #485 and Physician/Practitioners Orders,” with no effective date, revealed care and services provided will be provided according to physician’s/practitioner orders. Interview on 08/20/24 at 3:48 PM the DON confirmed the above findings.”

“Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This Element is not met as evidenced by: Based on record review, patient interview, staff interview, and review of policy, the agency failed to ensure therapy was referred as needed. This affected three (Patient #2, #5 and #7) out of seven patient records reviewed. The census was 20. 1. Review of the medical record for Patient #2 revealed the start of care was 04/24/24 with diagnoses of cerebral iInfarction and chronic obstructive pulmonary disease. The physician’s plan of care wa dated 06/23/24. The 60-day clinical summary stated Patient #2 required assistance with activities of daily living and personal care due to weakness. There was no documented evidence that physical therapy or occupational therapy referrals were made. Interview on 08/20/24 at 9:13 AM Patient #2 stated they had left sided weakness due to a stroke. 2. Review of the medical record for Patient #5 revealed the start of care was 07/17/24 with diagnoses of Parkinson’s disease, primary osteoarthritis and fusion of the spine. The physician’s plan of care dated was 07/17/24. Review of the Clinical Summary stated Patient #5 uses a rollator and walker for transfer and ambulation. Patient #5 required hands on assistance with most activities of daily living due to weakness and short of breath with minimal exertion. There was no documented evidence that physical therapy or occupational therapy referrals were made. 3. Review of the medical record for Patient #7 revealed the start of care was 04/08/23. Diagnoses included anxiety disorder and low back pain. The physician’s plan of care was dated 02/02/24. The record revealed Patient #7 had functional limitations with ambulation. There was no documented evidence that physical therapy or occupational therapy referrals were made. Interview on 08/19/24 at 1:47 PM the Director of Nursing (DON) stated Patient #7 had difficulty walking and was unsteady on their feet. The DON stated physical therapy (PT), occupational therapy (OT) and speech therapy were contracted if needed. Review of agency policy titled “Coordination of Patient Care,” with no effective date, revealed the agency must coordinate care delivery to meet the patient’s needs. The agency must integrate services to assure the patient needs and factors that could affect patient safety. Interview on 08/21/24 at 11:56 AM the DON confirmed the lack of therapy referrals for Patient #2, #5, and #7.”

“Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This Element is not met as evidenced by: Based on record review, patient interview, staff interview, and policy review, the agency failed to ensure written visit schedule, including frequency of visits by the agency personnel. This affected three (Patient #1, #2 and #3) out of three patient home visits reviewed. The census was 20. 1. A home visit was made to Patient #1 on 08/20/24 at 8:00 AM with the Director of Nursing (DON) present. Review of the patient’s folder from the agency did not reveal a written visit schedule. Interview on 08/20/24 at 8:33 AM the DON confirmed there was no written visit schedule for the patient. 2. A home visit was made to Patient #2 on 08/20/24 at 8:45 AM with the home health aide, Staff F, present. Review of the patient’s folder from the agency did not reveal a written visit schedule. Interview on 08/20/24 at 9:17 AM Patient #2 stated they didn’t know when the home health aide (HHA) or the skilled nurse were to come. They just come. 3. A home visit was made to Patient #3 on 08/20/24 at 10:00 AM with the licensed practical nurse, Staff D, present. eview of the patient’s agency folder did not reveal a written visit schedule for the HHA or skilled nurse. Interview on 08/20/24 at 10:27 AM Staff D stated they do not leave a written visit schedule. Review of the agency policy titled “Coordination of Patient Care,” with no effective date, revealed the agency will coordinate care with the patient by providing a copy of written instructions outlining a visit schedule, including frequency of visits by agency personnel. The written visit schedule provided to the patient is consistent with the patient’s most current plan of care.”

“Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This Element is not met as evidenced by: Based on record review, resident interviews, staff interviews and policy review, the agency failed to ensure written patient medication instructions and the current medication profile were left in the home. This affected three (Patient #1, #2 and #3) out of three patient folders in the home reviewed. The census was 20. 1. A home visit was made to Patient #1on 08/20/24 at 8:00 AM with the Director of Nursing (DON) present. Review of the folder in Patient #1’s home from the agency did not reveal a copy of the medication profile. Interview on 08/20/24 at 8:33 AM a family member confirmed there was no medication list or instructions left for the patient. Review of the agency policy titled “Medication Reconciliation,” with no effective date, revealed the Agency provides the patient and/or caregiver with written patient medication schedule/instructions, including medication name, dose, strength, route and frequency. The patient’s medication list in the home will also be updated. 2. A home visit was made to Patient #2 on 08/20/24 at 8:45 AM with the home health aide (HHA), Staff F, present. Review of the folder in Patient #2’s home from the agency did not reveal a copy of the medication profile. Interview on 08/20/24 at 9:10 AM Staff F and Patient #2 both confirmed there was no medication profile or instructions left in the home for the patient. 3. A home visit was made to Patient #3 on 08/20/24 at 10:00 AM with licensed practical nurse, Staff D, present. Review of the folder in Patient #3’s home from the agency did not reveal a copy of the medication profile. Interview on 08/20/24 at 10:28 AM Staff D confirmed this finding.”

“Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This Element is not met as evidenced by: Based on review of personnel files and staff interview, the agency failed to ensure the licensed practical nurse (LPN) was supervised by a registered nurse (RN). This could potentially affect all patients. The census was 20. Review of Staff D’s personnel file did not reveal documented evidence that the licensed practical nurse (LPN) was supervised by a registered nurse (RN). Interview on 08/22/24 at 1:59 PM the Administrator and the Acting Administrator confirmed the agency LPN was not supervised by the RN.”

“Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This Element is not met as evidenced by: Based on record review, review of time sheets, staff interview, and policy review, the agency failed to ensure the home health aide (HHA) followed the Aide Care Plan established by the registered nurse. This affected three (Patient #2, #3 and #7) out of three patient aide care plans reviewed. The census was 20. 1. Review of the medical record for Patient #2 and the aide plan of care by the registered nurse, dated 06/18/24, revealed the HHA was to provide hair care, shampoo, skin care, mouth/denture care, dressing, personal care, and shower at every visit. Review of the HHA time sheets from 06/23/24 to 08/10/24 revealed the HHA provided services seven days per week. There was no documented evidence the HHA provided assistance with hair care, shampoo, skin care, mouth/denture care, dressing, personal care, and shower at every visit. 2. Review of the medical record for Patient #3 and the aide plan of care dated 06/15/24, revealed personal care, bathing, hair care, shampoo, skin care, dressing and mouth/denture care were to be done at every visit. Review of the HHA time sheets from 07/07/24 to 08/10/24 did not reveal these services were provided at each visit. Interview on 08/21/24 at 1:49 PM the Acting Administrator confirmed these findings. 3. Review of the aide plan of care for Patient #7, dated 01/29/24, revealed the HHA was to provide skin care, mouth/denture care and assist with toileting/hygiene each visit. Review of the HHA time sheets from 01/28/24 to 03/02/24 revealed the HHA provided service seven days per week for seven hours per day. There was no documentation skin care, mouth/denture care or assistance with toileting and hygiene were provided. Review of the agency policy titled “Care Planning Process,” revised 02/2021, revealed the patient care plan for the HHA will be the HHA assignment sheet, developed by a registered nurse (RN) prior to the HHA rendering care. Reviewed at least every 14 days during supervisory visits. The assignment sheet/plan of care will be communicated to the HHA by the RN. Interview on 08/21/24 t 12:56 PM the Director of Nursing confirmed these findings.”

“Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This Element is not met as evidenced by: Based on review of the Governing Body minutes and staff interview, the Governing Body failed to appoint a qualified acting administrator. This could potentially affect all patients and staff. The census was 20. Review of the Governing Body meeting minutes did not reveal documented evidence the Governing Body had appointed an acting administrator when the administrator was not available. Interview on 08/21/24 at 4:34 PM the Administrative Assistant confirmed there was no Acting Administrator when the Administrator was unavailable.”