Every finding on record at Jamestown Hospital Home Health Agency

For the standard and partial extended Medicare/Medicaid recertification survey, started on 10/04/21 and completed 10/05/21, the sample included 4 records reviewed with no home visits and 3 records reviewed with home visits.

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 review of a Clinical Laboratory Improvement Amendments (CLIA) document, policy review, a State Agency interview, and staff interview, the home health agency's board of governors failed to ensure the agency, which is part of the medical center, complied with all applicable requirements of the CLIA federal regulations for 1 of 1 CLIA Certificate reviewed. Failure to obtain a required CLIA certificate of waiver or be included in the medical center's CLIA Certificate of Accreditation does not meet the requirements to allow agency staff to perform point of care laboratory testing on patients. Findings include: Review of the medical center policy titled "Point-Of-Care Testing" occurred on 10/05/21. This undated policy stated, ". . . Point of Care Testing (POCT): A term used to describe laboratory testing performed at or near the patient site usually by non-laboratory employees (e.g. [such as] nurses . . .) . . . Examples include kits and instruments that are hand-carried or otherwise transported to the vicinity of the patient for immediate testing at that site. . . . Waived Test: Tests approved by the FDA [Federal Drug Administration] for home use and employing methods that are strightforward and accurate such that the likelihood of erroneous results and patient injury are negligible. . . . LICENSED REQUIREMENTS: Waived Tests [required a] CLIA Certificate of Waiver . . ." An attachment to this policy listed one Point of Care Testing at the medical center's laboratory for Home Health staff as "Coaguchek" (hand-held device used to measure the International Normalized Ratio [INR] in patients taking the anticoagulant medication Coumadin). Items requested on entrance on 10/04/21 included the agency's CLIA certificate of waiver. An administrative staff member (#1) provided a CLIA document identified as a "Certificate of Accreditation" for the medical center associated with the agency. The certificate listed an effective date of 01/03/21 and an expiration date of 01/02/23. During an interview on 10/05/21 at 9:46 a.m., the CLIA State Agency confirmed the laboratory testing conducted by the home health agency was not covered under the CLIA Certificate of Accreditation for the medical center associated with the agency. During an interview on 10/05/21 at 4:05 p.m., an administrative staff member (#1) stated the home health nurses performed point of care testing to monitor INRs of patients in the home setting and thought the medical center's CLIA certificate covered the home health agency.