Westwater Diagnostics Pllc

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 03/31/2026. The laboratory was found in substantial compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on surveyor's observations, review of laboratory's policies/procedures, temperature/humidity logs and staff interview, the laboratory failed to define and monitor temperature/humidity conditions to ensure slides were maintained under proper preservation conditions for one of one room where previous histology/cytology cases' specimen slides and blocks were stored. Findings included: 1. Surveyor's observations on 03/31/2026 at 1000 hours revealed slides and blocks from previous histology and cytology cases were stored in the office. There was no mechanism observed to monitor storage conditions in the room. 2. Review of laboratory's policies /procedures revealed there were no protocols in place defining monitoring storage conditions of previous case slides and blocks to ensure preservation. 3. Review of laboratory's temperature/humidity logs revealed there was no documentation of monitoring temperature or humidity in the slide/block storage area available for review. 4. In an interview on 03/31/2026 at 1030 hours in the office, Technical Supervisor number two (as indicated on submitted form CMS 209) confirmed the findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor's observations and staff interview, the laboratory failed to ensure reagents were not used beyond expiration date for seven of seven tissue marking dyes used in laboratory's histology procedures. Findings included: 1. Surveyor's observations on 03/31/2026 at 1000 hours in the laboratory revealed the following expired in-use Tissue Marking Dyes for laboratory's histology procedures sitting on the countertop in the specimen processing area: Vector Surgical REF (Reference): VIVSY Lot: VYS.1024 Expiration date: 2025-08-03 Vector Surgical REF: VIVSB Lot: VBS.1024 Expiration date: 2025-08-01 Vector Surgical REF: VIVSG Lot: VGS. 1024 Expiration date: 2025-08-07 Vector Surgical REF: VIVSU Lot: VUS.0924 Expiration date: 2025-07-26 Vector Surgical REF: VIVSV Lot: VVS.1024 Expiration date: 2025-08-02 Vector Surgical REF: VIVSR Lot: VRS.0924 Expiration date: 2025- 07-22 Vector Surgical REF: VIVSO Lot: VOS.0924 Expiration date: 2025-07-27 2. In an interview on 03/31/2026 at 1000 hours in the laboratory, Technical Supervisor number two (as indicated on submitted form CMS 209) confirmed the findings. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, surveyor's observations, patient test logs and staff interview, the laboratory failed to follow its own policy and document yearly equipment maintenance for four of four instruments used in laboratory's cytology/histology procedures. Findings included: 1. Review of laboratory's policy "LG-0008 - Quality Management" (Revision 2, effective 05/05 /2023) revealed: "QC - Equipment ... Equipment/instrumentation: the laboratory must maintain records of ... maintenance... ...equipment must be formally tested at least yearly ..." And, " ... Centrifuge calibration should be performed and documented yearly ..." And, "Microscopes must be thoroughly cleaned, inspected, and lubricated at least yearly." 2. Surveyor's observations on 03/31/2026 at 0940 hours in the laboratory revealed the following equipment was missing yearly maintenance as evidenced by service dates documented on the instruments' labels: Device: Tabletop Centrifuge Service Date: 04/30/2024 Next Service: 04/30/2025 Device: Microwave Service Date: 03/31/2024 Next Service: 03/31/2025 Device: Heating Devise Serial No (number) C&AR.120015 Service Date: 01/2022 Next Service: 01/2023 3. Surveyor's observations on 03/31/2026 at 1040 hours in the office revealed an Olympus microscope was also missing yearly maintenance as evidenced by service /maintenance dates documented on the instrument's label: Device: BX45 Microscope Service Date: 03/01/2025 Next Service: 03/01/2026 4. In interviews on 03/31/2026 at -- 2 of 3 -- 0940 hours in the laboratory and 1040 hours in the office, Technical Supervisor number two (as indicated on submitted form CMS 209) confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and staff interview, it was revealed that the laboratory failed to establish a written policy for an annual statistical evaluation of the number of non-gynecologic cytology cases reported as unsatisfactory. Findings include: 1. A review of the laboratory's policies revealed the laboratory failed to have a written policy for an annual statistical laboratory evaluation of the number of non- gynecologic cytology cases reported by diagnosis, to include unsatisfactory. 2. An interview with Technical Supervisor #2 on 9/23/22 at 10:30 a.m. in the laboratory, after review of the records, confirmed the above findings. 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 -- D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. This STANDARD is not met as evidenced by: Based on a review of laboratory's policies, the laboratory's records, and staff interview, it was revealed that the laboratory failed to establish written policies to ensure that the workload limit for two of two Technical Supervisors was reassessed at least every six months and adjusted when necessary in 2022. Findings include: 1. A review of the laboratory's policies revealed the laboratory failed to provide written policies to ensure that workload limits for two Technical Supervisors were reassessed at least every six months and adjusted when necessary in 2022. 2. A review of the laboratory's records revealed Technical Supervisor #1 and Technical Supervisor #2 started evaluating non-gynecologic cytology slides in January 2022. 3. Further review of the laboratory's record revealed there was no documentation of the reassessment of the workload limit for either Technical Supervisor by the time of the survey (elapsed time: 8 months). 4. An interview with Technical Supervisor #2 on 9/23/22 at 10:50 a. m. in the laboratory, after review of the records, confirmed the above findings. D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. This STANDARD is not met as evidenced by: Based on review of laboratory's policies and staff interview, it was revealed that the laboratory failed to establish written policies to ensure that the laboratory maintained records of the total number of hours each technical supervisor spent evaluating non- gynecologic cytology slides during each 24-hour period. Findings include: 1. A review of the laboratory's policies revealed the laboratory failed to provide written policies to ensure that the laboratory maintained records of the total number of hours each technical supervisor spent evaluating slides during each 24-hour period. 2. An interview with Technical Supervisor #2 on 9/23/22 at 10:35 a.m. in the laboratory, after review of the records, confirmed the above findings. -- 2 of 2 --