Summary:
Summary Statement of Deficiencies D0000 A Certification Survey was performed on April 8, 2019 at I. Ricardo Martinez, MD, PhD, LLC, CLIA ID # 19D0692192. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to verify the accuracy of the performance of Histopathology testing at least twice annually. Findings: 1. Review of the laboratory's Task 1 and 3 form revealed the laboratory reads Hematoxylin ad Eosin (H&E) stained Histopathology slides. 2. Review of the laboratory's policies and procedures revealed the laboratory did not have a written policy for verification of the accuracy of performance of Histopathology testing. 3. In interview on April 8 , 2019, Personnel 1 stated he performs diagnosis comparisons on some Histopathology cases. 4. Review of the laboratory's documents revealed the laboratory did not have documentation of the verification of the accuracy of Histopathology testing at least twice annually for the following two (2) years: 2017: laboratory did not have documentation of performance after April 2017 2018 5. In interview on April 8, 2019 at 1:48 pm, Personnel 1 stated he performed diagnosis comparisons in 2018. Personnel 1 further stated all cases performed in 2018 would have to be reviewed to find documentation. Personnel 1 confirmed he did not have documentation of verification of the accuracy of Histopathology testing at least twice annually for the identified years at the time of the survey. D5401 PROCEDURE MANUAL 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 -- CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policies and procedures revealed it did not include the following: a) Twice a year verification of the accuracy of histopathology test performance to include frequency, acceptability criteria, and