Floyd Valley Healthcare

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of Anti-Xa calibration records, review of coagulation records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 2:30 pm on 8/21/2024, the laboratory failed to retain the Anti-Xa calibration records for three out of four calibrations performed from 1/1/2023 - 8/21 /2024. The findings include: 1. The laboratory performed Anti-Xa calibrations on the following dates: 6/2/2023, 12/29/23, 1/17/2024 and 6/17/2024. 2. At the time of the survey, the laboratory did not retain the Anti-Xa calibration records for the calibrations performed on 6/2/2023, 12/29/2023, and 1/17/2024. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of proficiency testing records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 12:45 pm on 10/17/2022, the laboratory failed to successfully participate in a proficiency testing program for the analyte, partial pressure of oxygen (PO2), for two out of three consecutive testing events: 2022 testing events 1 and 3 (refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 12: 45 pm on 10/17/2022, the laboratory failed to achieve satisfactory performance for the analyte, partial pressure of oxygen (PO2), for two out of three consecutive PT events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 20% for 2022 testing event 1 and 40% for 2022 testing event 3. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of proficiency testing records, the Microbiology Procedure Manual and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 9:15 am on 1/27/2021, the laboratory failed to enroll in an approved proficiency testing program for the subspecialty, mycology (Candida albicans). The findings include: 1. The Microbiology Procedure manual included a policy for performing germ tube testing to identify Candida albicans. 2. Laboratory personnel identifier #1 confirmed the laboratory performed germ tube testing to identify Candida albicans. 3. At the time of the survey, the laboratory did not enroll in PT testing for the subspecialty, mycology (Candida albicans). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --