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 manufacturer's package insert instructions as well as interview with the Laboratory Director (LD), the laboratory failed to follow waived test manufacturer's instructions. FINDINGS: 1. There was no documentation of Quality Control (QC) performance for the Consult Diagnostics Human Chorionic Gonadotropin (hCG) urine tests dipstick kits. 2. There was no documentation of date received or in-use date for the Consult Diagnostics hCG urine tests dipstick kit lot numbers. 3. This is contrary to instructions included in the manufacturer's package insert. 4. The LD confirmed the findings on November 18, 2025, at approximately 3: 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: This STANDARD is not met as evidenced by: Based on review of analytic system records, Standard Operating Procedures (SOPs), as well as interview with the LD, the laboratory failed to retain QC and records Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- documenting all analytic systems activities. FINDINGS: 1. There was no documentation of Avantik QS12 cryostat, Avantik G30 fume hood, Thermo Scientific Linistat automated stainer, and Olympus BX46 microscope service and annual preventive maintenance for 2024 and 2025. 2. The current, approved SOPs did not include instructions for retention of service and maintenance records for all laboratory equipment located in the Mohs processing laboratory. 3.The LD confirmed the findings on November 18, 2025, at approximately 3:30 P.M. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of personnel training and competency assessment records, SOPs, as well as interview with the LD, the laboratory failed to establish and approve written policies and procedures to assess employee training and competency. FINDINGS: 1. There was no documentation of Mohs laboratory Testing Personnel (TP) initial training and six-month competency assessment. 2. It was noted that annual competency assessments were performed, documented for 2025. 3. The current, approved SOPs did not include instructions for performing and documenting such activity. 4. The LD confirmed the findings on November 18, 2025, at approximately 3: 30 P.M. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of SOPs, lack of Proficiency Testing (PT) records, as well as interview with the LD, the laboratory failed to at least twice annually verify the accuracy of Provider Performed Microscopy (PPM) Procedures. FINDINGS: 1. There was no documentation of minimum twice annual Potassium Hydroxide (KOH) prep verification performance for 2024 and 2025. 2. The current, approved SOPs did not include instructions for performing and documenting such activity. 3. Seven patient KOH preps were performed in 2024 and five in 2025. 4. The LD confirmed the findings on November 28, 2025, at approximately 3:30 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- -- 2 of 4 -- 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)