Sterling Urgent Care

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and an interview with the laboratory supervisor on 3/10/2025, the Laboratory Director failed to approve, sign and date the laboratory policies and procedures. The findings include: 1. A record review of laboratory policies and procedures identified that the Laboratory Director failed to approve, sign and date laboratory policies and procedures since becoming the Laboratory Director on 6/21/2024. 2. An interview with the laboratory supervisor on 3 /10/2025 at 2:11 pm, confirmed that the Laboratory Director has not approved, signed or dated the laboratory policies and procedures. 3. The laboratory reports performing 510 tests annually. 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 D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions for use (IFU), a direct observation and an interview with he laboratory supervisor on 11/13/2023, the laboratory failed to follow the IFU for specimen processing for testing on the NanoEntek frend. The findings include: 1. A review of NanoEntek frend IFUs for testosterone, prostate specific antigen (PSA), thyroid stimulating hormone (TSH) and free thyroxine (FT4) identified that samples are to be centrifuged for 10 minutes at 3,000 RPM. 2. A direct observation of the centrifuge preventive maintenance (PM) label from 2/8/2023 identified that the fixed time and speed centrifuge ran at 3292 RPM for 15 minutes. 3. A review of the testing IFUs and the direct observation of centrifuge PM documents identified that the laboratory failed to follow the manufacturer's specimen centrifuge time for PSA, TSH, FT4 and testosterone testing. 4. An interview with the laboratory supervisor on 11/13/2023 at 3:05 pm confirmed that they were not centrifuging samples for the correct length of time. 5. The laboratory reports performing 300 tests annually on the NanoEntek frend. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other 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 -- 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 a direct observation and an interview with the laboratory supervisor on 11/13 /2023, the laboratory failed to discontinue the use of expired collection and transport devices. The findings include: 1. During the laboratory tour on 11/13/2023 a direct observation identified that the laboratory failed to discontinue the use of three expired BD Affirm ambient temperature transport system kits lot BO1E257M expiration 10/31 /2023 and three expired Aptima unisex swab specimen collection kits lot 330850 expiration 6/3/2023. 2. An interview with the laboratory supervisor on 11/13/2023 at 2:55 pm confirmed the above findings. -- 2 of 2 --