Ls Healthcare Services LLC

“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 record review and interview, the agency failed to conduct and document PIP(s) for each calendar year that reflected the scope, complexity and past performance of the agency’s services and operations. The agency did not have and document any quality improvement projects undertaken, the reason for conducting the projects, the measurable progress on achieving the projects, or any performance improvement projects either in development, ongoing or completed for three (2023, 2024, and 2025) of three calendar years reviewed. The failure placed the agency’s patients’ health and safety at risk if the agency did not identify and improve quality of care and service related to health and safety concerns. Findings included: During the entrance conference on 12/29/2025 at 10:10 a.m., the surveyor requested all agency QAPI documents/reports/manuals. Review of agency’s undated QAPI binder and undated business profile manual revealed the following: A Performance improvement project dated 10/13/2022. Continued review of the agency’s QAPI records did not reveal documentation that indicated the agency had: any quality improvement projects undertaken, the reason for conducting the projects, the measurable progress on achieving the projects, or any performance improvement projects either in development, ongoing or completed for each calendar years 2023, 2024, or 2025. During an interview on 01/02/2026 at 3:07 p.m. with the Admin/DON and Alt Admin, the surveyor reviewed the findings and asked who at the agency was responsible for the agency’s QAPI program. The Admin/DON replied, “Me.” The surveyor asked what the agency processes were for implementing the program. The Admin/DON stated that the Admin/DON and Alt Admin just talked about the agency’s QAPI. “We never document it.” The surveyor asked why the agency had not conducted PIP(s) for 2023, 2024, and 2025. The Admin/DON replied, “I am trying to work on performance improvement projects.” The surveyor asked what the agency could do differently to ensure that the regulation for performance improvement projects was followed. The Admin/DON stated that he now understood the importance of the QAPI program and that the agency should revolve around QAPI. Review of agency policies titled, “Quality Assessment Performance Improvement Program QAPI.5” last reviewed 09/15/24 revealed the following, “...Policy…III The Agency will maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS…Procedure…D. Performance improvement projects 1. 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. 2. The Agency will document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects…””

“Laboratory services/CLIA waivers CFR(s): 484.100(c)(1) Laboratory services. If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter. The HHA may not substitute its equipment for a patient’s equipment when assisting with self-administered tests. This Standard is not met as evidenced by: Based on record review and interview the agency failed to ensure the laboratory testing conducted by HHA employees was in compliance with all applicable requirements of chapter 42 of the Code of Federal Regulations part 493, in that: the agency’s CLIA Certification of (CLIA 1988) for providing waived laboratory services was expired for approximately 16 months (expired 09/22/2024). The agency provided testing to three (Patients # 3, 9, and 10) of three patients with a diagnosis of type 2 diabetes mellitus diabetes (long term elevated levels of sugar in the blood caused by the body’s inability to properly utilize insulin). The failure placed the agency’s patients at an increased risk of harm if the agency’s waived testing did not meet standards for accuracy, timely results, and reliability in monitoring blood sugar levels. Findings include: During the entrance conference at 10:10 a.m. on 12/29/2025, the surveyor asked to view the agency’s current CLIA certificate. The Alt Admin provided the agency’s undated business profile manual. Review of agency CLIA certificate of waiver revealed that it expired 09/22/2024. The Admin/DON stated that the agency had paid to renew the certificate. The surveyor requested records to show that the agency had renewed the CLIA certificate. 12/30/2025 upon return to the agency the Admin/DON had not provided records that showed that the CLIA certificate had been renewed. Clinical Record # 3: Record review of the clinical record for Patient # 3 revealed a POC for certification period dated 12/12/2025 to 02/09/2026 with a SOC date of 12/12/2025. The POC was electronically signed by the Admin/DON on 12/12/2025 and included a primary diagnosis of Type 2 diabetes mellitus with hyperglycemia (long term elevated levels of sugar in the blood caused by the body’s inability to properly utilize insulin). The POC included an order for “SN to assess, monitor, and manage diabetes mellitus…perform finger stick for fasting and random blood sugar [monitoring] and evaluate trends for [physician] notification…” The POC included an order for SN visits one time per week for nine weeks and two as needed visits. Review of Patient # 3’s SN visit notes dated 12/19/2025 and 12/26/2025 revealed that agency employee, LVN A signed the visit notes. Review of SN note 12/19/2025 read in part: “…[Finger Stick Blood Sugar] performed by nurse [LVN A]…obtained from right 4th finger…Randon [blood sugar reading] 172…” Review of SN note 12/26/2025 read in part: “…“…[Finger Stick Blood Sugar] performed by nurse [LVN A] …obtained from right 2nd finger…Randon [blood sugar reading] 146…” Clinical Record # 9: Record review of the clinical record for Patient # 9 revealed a POC for certification period dated 04/08/2025 to 06/06/2025 with a SOC date of 12/09/2024. The POC was electronically signed by the Admin/DON on 04/07/2025. The POC included a primary diagnosis of Type 2 diabetes mellitus (long term elevated levels of sugar in the blood caused by the body’s inability to properly utilize insulin).The POC included an order for “SN to perform finger stick for fasting blood sugar or random blood sugar during visit if it has not been done…” The POC included an order for SN visits one time per week for eight weeks and two as needed visits. Review of Patient # 9’s SN visit notes dated 04/09, 16, 24, 30/2025 and 05/06, 14/2025 revealed that agency employee, LVN A signed the visit notes. Review of the SN notes read in part: “… [Finger Stick Blood Sugar] performed by nurse [LVN A] …” The notes indicated which finger the blood was obtained from and whether Patient # 9 was fasting or whether the finger stick was random. LVN A documented the blood sugar reading on the visit notes. Clinical Record # 10: Record review of the clinical record for Patient # 10 revealed a POC for certification period dated 07/14/2025 to 09/11/2025 with a SOC date of 01/15/2025. The POC was electronically signed by the Admin/DON on 07/09/2025. The POC included a with a primary diagnosis of fracture of ribs on the ride side and other diagnosis of Type 2 diabetes mellitus (long term elevated levels of sugar in the blood caused by the body’s inability to properly utilize insulin).The POC included an order for “SN to perform finger stick for fasting blood sugar or random blood sugar during visit if it has not been done…” The POC included an order for SN visits one time per week for nine weeks and two as needed visits. Review of Patient # 10’s SN visit notes dated 07/16, 23, 30/2025; 08/06, 13, 20, 27/2025; and 09/03/2025 revealed that agency employee, Admin/DON signed the visit notes. Review of the SN notes read in part: “… [Finger Stick Blood Sugar] performed by nurse [Admin/DON] …” The notes indicated which finger the blood was obtained from and whether Patient # 10 was fasting or whether the finger stick was random. The Admin/DON documented the blood sugar reading on the visit notes. During an interview on 01/02/2026 at 2:36 p.m. with the Admin/DON, the surveyor reviewed the findings and asked who at the agency was responsible to ensure that the CLIA certificate of waiver was renewed. He replied, “Both of us (Admin and Alt Admin) more me than [Alt Admin]. I would take the blame.” The surveyor asked why the CLIA certificate was not renewed timely. He stated that it was one of those things that was overlooked. “When I noticed (on 12/20/2025) I called and corrected it.” The surveyor requested records to show that the CLIA certificate was renewed. He sent an email on 01/02/2026 showing that he paid on 01/02/2026 to renew the CLIA certificate of waiver. The agency’s CLIA Certification for providing waived laboratory services expired on 09/22/2024, for approximately 16 months. The surveyor asked what the agency could have done differently to ensure agency’s policy and regulations were followed. He replied, “One of the things that we are planning to do is make a list and an alert to prompt us of tasks that need to be completed.” Review of agency policy titled; “Waived Testing Program” last reviewed 07/01/2025 read in part: “Purpose To establish a comprehensive laboratory testing program that meets all requirements in order to perform waived tests according to CLIA the Clinical Laboratory Improvement Amendments of 1988… IV. Certificate of Waiver (CLIA Waiver) is a required certificate provided to any facility that performs any laboratory testing on patient/clients in which the testing material is derived from the human body for the purpose of providing information for diagnosis, prevention or treatment of any disease or impairment or for the assessment of the health of patient/clients. If a facility performs these tests, it is considered a laboratory and must obtain a certificate from the appropriate state agency… Policy… The Agency will perform only laboratory tests considered as “waived tests” according to CLIA using approved devices such as… blood glucose, coagulation, hemoglobin A1C meters (measures average blood sugar for previous three months) ... The results will be used for diagnostic and/or treatment purposes. Procedure … The Agency will obtain a CLIA waiver for any device approved to be used for patient/client testing. The Agency will be compliant with any state specific requirements… A. The Agency will maintain and post certificates for all operational locations/branches… B. The Agency will ensure compliance with renewal of the certificate…” Review of the Food and Drug Administration website at https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments, on 01/07/2026 revealed the following: “…Clinical laboratory testing helps health care providers screen for or monitor specific diseases or conditions. It also helps assess patient health to make clinical decisions for patient care. The Clinical Laboratory Improvement Amendments (CLIA) of 1988 (42 USC 263a) and the associated regulations (42 CFR 493) provide the authority for certification and oversight of clinical laboratories and laboratory testing. Under the CLIA program, clinical laboratories are required to have the appropriate certificate before they can accept human samples for testing… Three federal agencies are responsible for administering the CLIA program: the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC)...””

“Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure proper written notice was provided, in advance of terminating on-going care in four (Patients # 7, 8, 9, and 10) of four inactive patient records reviewed. The agency failed to provide Patients # 7 through # 10 with the Centers for Medicare and Medicaid form titled “Notice of Medicare Non-Coverage (NOMNC)”. The failure placed the patient’s health and safety at risk and could result in harm due to lack of consistency and continuing care in the patient’s post discharge needs. The failure caused the clients to not have written advance notice to appeal the discharge decision if desired. Findings include: Inactive Patient # 7: Review of the agency’s patient discharge roster revealed a discharge date for Patient # 7 as 04/09/2025. Record review of the clinical record for Patient # 7 revealed a POC for the certification period of 02/18/2025 to 04/18/2025. Review of the POC revealed a start of care date of 12/20/2024 with a primary diagnosis of intellectual disabilities and a secondary diagnosis of hyperlipidemia (increased levels of fat in the blood). The POC was dated 02/17/2025 and electronically signed by the Admin/DON. The POC contained an order for skilled nursing visits one time per week for nine weeks and two as needed visits. Continued review of the records revealed a discharge summary signed by the Admin/DON and dated 04/09/2025. Review of the discharge summary revealed that Patient # 7 “Status at discharge” was with goals met. Further review of Patient # 7’s records did not reveal that the patient or patient representative received a proper written notice of intent to discharge no later than two days in advance of terminating on-going care on 04/09/2025. The record did not include a written NOMNC. Inactive Patient # 8: Review of the agency’s patient discharge roster revealed a discharge date for Patient # 8 as 05/08/2025. Record review of the clinical record for Patient # 8 revealed a POC for the certification period of 03/10/2025 to 05/08/2025. Review of the POC revealed a start of care date of 03/10/2025 with a primary diagnosis of cerebral palsy (a disorder that disrupts the brain’s ability to control muscles) and a secondary diagnosis of hyperlipidemia (increased levels of fat in the blood). The POC was dated 03/10/2025 and electronically signed by the Admin/DON. The POC contained an order for skilled nursing visits two times per week for nine weeks and two as needed visits. Continued review of the records revealed a discharge summary signed by the Admin/DON and dated 05/08/2025. Review of the discharge summary revealed that Patient # 8 “Status at discharge” was goals met. Further review of Patient # 8’s records did not reveal that the patient or patient representative received a proper written notice of intent to discharge no later than two days in advance of terminating on-going care on 05/08/2025. The record did not include a written NOMNC. Inactive Patient # 9: Review of the agency’s patient discharge roster revealed a discharge date for Patient # 9 as 05/16/2025. Record review of the clinical record for Patient # 9 revealed a POC for the certification period of 04/08/2025 to 06/06/2025. Review of the POC revealed a start of care date of 12/09/2024 with a primary diagnosis of type 2 diabetes mellitus (a condition where the body cannot properly utilize insulin and the blood has increased levels of sugar). The POC was dated 04/07/2025 and electronically signed by the Admin/DON. The POC contained an order for skilled nursing visits one time per week for nine weeks and two as needed visits. Continued review of the records revealed a discharge summary signed by the Admin/DON and dated 05/16/2025. Review of the discharge summary revealed that Patient # 9 “Status at discharge… patient with slight improvement. [Patient] was discharge due to the insurance change].” Further review of Patient # 9’s records did not reveal that the patient or patient representative received a proper written notice of intent to discharge no later than two days in advance of terminating on-going care on 05/16/2025. The record did not include a written NOMNC. Inactive Patient # 10: Review of the agency’s patient discharge roster revealed a discharge date for Patient # 10 as 09/11/2025. Record review of the clinical record for Patient # 10 revealed a POC for the certification period of 07/14/2025 to 09/11/2025. Review of the POC revealed a start of care date of 01/15/2025 with a primary diagnosis of fracture of ribs on the ride side. The POC was dated 07/09/2025 and electronically signed by the Admin/DON. The POC contained an order for skilled nursing visits one time per week for nine weeks and two as needed visits. Continued review of the records revealed a discharge summary signed by the Admin/DON and dated 09/11/2025. Review of the discharge summary revealed that Patient # 10 “Status at discharge” was progressing well and discharged due to insurance. Further review of Patient # 10’s records did not reveal that the patient or patient representative received a proper written notice of intent to discharge no later than two days in advance of terminating on-going care on 09/11/2025. The record did not include a written NOMNC. During an interview on 01/02/2026 at 3:04 p.m. with the Admin/DON, the surveyor reviewed the findings and asked who at the agency was responsible for providing the discharge notice. The Admin/DON stated he was responsible. The surveyor asked what the agency processes were for discharging patients. The Admin/DON stated when the agency discharged patients they provided the five day-notice (state requirement that did not include the Quality Improvement Organization’s name and contact number). The surveyor asked why the agency had not provided proper written notice of the intent to discharge with the NOMNC form no later than two days in advance of terminating on-going care for Patients # 7 through # 10. The Admin/DON stated that he did not know about the requirement. “All I knew was the five days (discharge notice).” Review of agency policy titled, “Patient/Client Transfer and Discharge Notices” last reviewed 02/01/2025 read in part: “ ... III. The Agency will deliver the Notice of Medicare Non-Coverage (an Office of Management and Budget-approved Medicare form) to the patient/client, or representative, at least two (2) calendar days before Medicare covered services end, or the second to last day of service if care is not provided daily... A. Agency staff will deliver a completed and valid NOMNC to the patient/client, or representative…even if the patient/client agrees with the discharge. At least two (2) calendar days before Medicare covered services end or the second to last day of service if care is not provided daily. B. If the Agency fails to give valid notice, patient/client coverage continues for at least two (2) days after the notice is received...””

“Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This Element is not met as evidenced by: Based on record review, observation and interviews, the agency failed to ensure the patients’ right to be advised of the name, address, and telephone number of a federally funded entity that serviced the area where the patient resided, in one (Patient # 2) of two patients who received home visits. The agency failed to advise the patient of the Quality Improvement Organization (QIO’s) name, address, and telephone number that serviced the area where the patient resided. The failure placed the patient’s health and safety at risk if they were unable to access the QIO to appeal a premature discharge. The failure could place the patients at risk of not having time to access needed resources (medical equipment or outpatient services) that were available for them in their service area. Findings included: Review of agency’s record titled, “Contact Information…Federal and State Public Agencies” dated 01/13/18 revealed the name, address, and telephone number of a (Former QIO) Quality Improvement Organization (federally funded entity). Further review of the record revealed that the name, address, and telephone number of the Quality Improvement Organization was not correct. Patient # 2 Review of the clinical record for Patient # 2 revealed a POC for the certification period of 11/14/2025 to 01/12/2026. Review of the POC revealed a start of care date of 11/14/2025 and a primary diagnosis of Paroxysmal Atrial Fibrillation (irregular heartbeats that start and stop on their own with an increased the risk of stroke). The Admin/DON signed and dated the POC on 11/14/2025. The POC contained the following orders for SN visits one time per week for nine weeks and two as needed visits; PT to evaluate and treat. Continued review of the record revealed a PT evaluation signed by PT A and dated 11/21/2025. Review of the PT evaluation revealed an order for PT visits one time per week for two weeks and two times per week for six weeks. Further review of the record revealed a PT re-evaluation signed by PT A and dated 12/18/2025. Review of the re-evaluation revealed an order for PT visits two weeks per week for three weeks. During a home visit, record review, observation, and interview on 12/30/2025 at approximately 3:00 p.m., the surveyor observed PT B provide physical therapy services for Patient # 2. The surveyor reviewed the agency folder, which included patient rights records, which was provided to the patient at admission. Review of the records revealed that it included the following: the agency’s record titled, “Contact Information…Federal and State Public Agencies” dated 01/13/18 with the name, address, and telephone number of a (Former QIO) Quality Improvement Organization (federally funded entity). Further review of the record revealed that the name, address, and telephone number of the Quality Improvement Organization was not correct. Through a family member interpreter, the surveyor asked Patient # 2 if the agency staff had advised [Patient # 2] of the name and contact information for how to appeal a discharge if Patient # 2 did not agree with the discharge decision. Patient # 2 stated that the agency did not advise [Patient # 2] the name and contact information for the current QIO. During an interview on 01/02/2025 at 2:49 p.m. with the Admin/DON the surveyor reviewed the findings and asked if the Admin/DON knew the name of the current QIO. The Admin/DON replied, “No.” The surveyor asked who was responsible for ensuring that the agency’s patient rights information for federally funded entities (Quality Improvement Organization name and contact information) was correct. The Admin/DON replied, “It would be me.” The surveyor asked why the patient was not advised of current the correct name, address, and telephone number of the (Current QIO) Quality Improvement Organization that served the area where the patients resided. The Admin/DON replied, “We did not know (about the requirement).” The surveyor asked what the agency could have done differently to ensure that the agency was aware of regulatory requirements. Admin/DON stated that the agency could review the patient rights information every six months and print out (update) the information and add to the booklet provided to the patients upon admission to the agency. Review of agency policy titled “Patient/Client Rights and Responsibilities” last reviewed 09/15/24 read in part: “Purpose [:] To ensure all patients/clients their representatives (if any) and agency staff acknowledge, observe, and implement the patient’s/client’s rights and responsibilities…Procedure [:] I. Agency staff will be responsible for knowing, observing, and implementing the patient’s/client’s rights, patient/client conduct, and patient/client responsibilities on an ongoing basis…VI. The patient/client has the right to…K. Be advised of the names, addresses, and telephone numbers of the following Federally funded and state-funded entities that service the area where the patient/client resides: 1. Agency on Aging 2. Center for Independent Living 3. Protection and Advocacy Agency, 4. Aging and Disability Resource Center; and 5. Quality Improvement Organization...” Review of Center for Medicare Advocacy website on 12/09/2025 at, https://medicareadvocacy.org/medicare-quality-improvement-organization-changes-name/, revealed the following: Beneficiary and Family-Centered Care Quality Improvement Organizations (BFCC-QIOs) help Medicare beneficiaries with their concerns about quality of care, and in filing an appeal if coverage is ending too soon. As of July 1, 2024, the BFCC-QIO formerly known as [Former QIO] is officially [Current QIO]. In December of 2022, CNSI, “a leading provider of innovative healthcare technology solutions,” and [Former QIO], “a leading provider of technology-enabled care management, quality oversight and clinical assessment services” merged. The [Current QIO] brand was born in 2023, and notices with the new brand’s logo have been received by Medicare beneficiaries. [Current QIO] assures beneficiaries there have been no changes to the services it provides. [Current QIO]’s service areas include the following CMS Regions…Region 6…[Texas]…””