Zoomcare Laboratory

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of preventive maintenance (PM) records and interview with the laboratory director (LD), the laboratory failed to perform PM of two instruments used in the laboratory. Findings include: 1. Review of PM records for the Select Medical Product PSS602 Serial Number (SN) 1202161 centrifuge revealed no PM records for the year 2023 and 2024. 2. Review of PM records for the Lumeon microscope SN G3AL20120909 revealed that last PM was done 04/2022. No PM records for the year 2023 and 2024. 3. Interview with the LD on 03/13/2024 at 15:52 confirmed that PM for these two instruments were not perform. 4. The laboratory reports 218,000 chemistry assays and 108,000 hematology assays annually. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of the approved normal values in the laboratory procedure manual, review of patient report, and interview with the laboratory director (LD), the laboratory failed to ensure the test report included pertinent normal ranges as 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 -- determined by the laboratory. One (1) out of fourteen (14) chemistry normal values listed on the laboratory information system (LIS) report differed from those in the approved procedure manual. Findings include: 1. Review of patient report 21-027- 00044 from the LIS system revealed the following. LIS Patient Report Procedure Manual Total 0.3 - 1.3 MG/DL 0.3 - 1.0 MG/DL Bilirubin 2.. Interview with the LD on 03/13/2024 at 15:30 confirmed the laboratory failed to ensure correct references ranges approved in the procedure manual were the same as in the LIS patient reports. 3. The laboratory reports 218,000 chemistry assays annually. -- 2 of 2 --

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 the Wisconsin State Health Laboratory (WSHL) proficiency testing (PT) and Casper Report 0155D, the laboratory had unsuccessful participation for the 1st and 2nd event of 2023 for the specialty Hematology. Refer to D2128 and D2130. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons 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 -- other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the Wisconsin State Health Laboratory (WSHL) proficiency testing (PT) and Casper Report 0155D, the laboratory had unsuccessful participation for the 1st and 2nd event of 2023 for the analyte WBC differential/Cell differential. Findings include: 1. WSHL 1st Event 2023 WBC differential/Cell differential = 8%. 2. WSHL 2nd Event 2023 WBC differential/Cell differential = 8%. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Wisconsin State Health Laboratory (WSHL) proficiency testing (PT) and Casper Report 0155D, the laboratory had unsuccessful participation for the 1st and 2nd event of 2023 for the analyte WBC differential/Cell differential. Findings include: 1. WSHL 1st Event 2023 WBC differential/Cell differential = 8%. 2. WSHL 2nd Event 2023 WBC differential/Cell differential = 8%. -- 2 of 2 --