Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of waived testing manufacturer's package insert instructions, lack of Quality Control (QC) documentation, as well as interview with the Laboratory Directory (LD), the laboratory failed to follow manufacturer's instructions for performing waived testing. FINDINGS: 1. There was no documentation of QC performance for the First Sign One-Step Urine Pregnancy Test Strip kits, lot: D5240525; expiration: April 30, 2028. 2. There was no documentation of ambient room temperature for the area where the First Sign One-Step Urine Pregnancy Test Strip kits were stored, patient specimens processed, and testing performed. 3. These are contrary to instructions included in the First Sign One-Step Urine Pregnancy Test Strip test kit manufacturer's instructions which specified storage temperature range of 4C to 30C (40F to 86F). 4. The LD confirmed the findings on January 28, 2026, at approximately 1:30 P.M. 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. In addition, retain the following: 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 -- This STANDARD is not met as evidenced by: Based on review of patient test result records, laboratory Standard Operating Procedure (SOP) policies and procedures manual, as well as interview with the LD, the laboratory failed to retain documented patient test records for at least two years. FINDINGS: 1. There was no documentation of Potassium Hydroxide (KOH) and scabies patient test results for calendar years 2024 and 2025. 2. This is contrary to record retention instructions indicated in the current, approved laboratory SOP policies and procedures manual. 3. The LD confirmed the KOH and scabies patient test results for calendar years 2024 and 2025 were unaccounted for and not available for review on January 28, 2026, at approximately 1:30 P.M. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)