Tijerina Urology Clinic

Summary Statement of Deficiencies D0000 An onsite survey conducted 03/30/2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5401 PROCEDURE MANUAL 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 a review of reagent instructions for use, laboratory policy, quality control documents, the Centers for Medicare and Medicaid (CMS) form 116, and confirmed in an interview, the laboratory failed to have a policy for the establishment of new lot quality control means and ranges for PSA testing on the NanoEntek Frend system for one of one QC lot in use for eleven months from April 2022 to March 2023. The findings include: 1. Review of the "FREND PSA Plus" instructions for use, section "External quality control testing", had the following statement: "Individual laboratory policy will dictate exactly which control materials and lot number should be run, the frequency which controls are to be tested, criteria for acceptance of the results and required

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL 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 review of laboratory documentation for 2017, 2018 and 2019 confirmed by staff interview, laboratory personnel failed to follow written procedures for temperature monitoring, quality control performance and policy review. I. (a) The laboratory procedure manual states: "...the laboratory refrigerator will be between 36- 46 degrees F. If the temperatures/humidity are outside these ranges, corective action will be taken (i.e. adjusted temperature control knob and check testing supplies for deterioration) and documentation of the troubleshooting will be kept on Temperature /Troubleshooting Chart." (Laboratory Procedure Manual, Quality Assessment (QA) Program, I. QA Monitors, part A) (b) Review of laboratory refrigerator temperature monitoring documentation for 2018 and 2019 revealed the following temperatures outside acceptable range: Date Temperature Action noted 11-13-2018 30 F Adjusted Temperature 01-23-2019 31 F Adjusted Temperature 01-29-2019 31 F Adjusted Temperature 02-19-2019 32 F Adjusted Temperature 03-06-2019 30 F Adjusted Temperature (temperatures in degrees Fahrenheit) (c) The Troubleshooting section of the chart showed no indication that testing supplies were examined for deterioration when recorded temperatures were out of range. (d) In an interview at the site on 05-22- 2019, laboratory technical consultant 2 (CMS form 209) confirmed that the temperatures in question were out of acceptable range, and further stated that testing personnel had recorded the temperatures without documenting whether testing supplies had been affected. II. (a) The laboratory procedure manual states: "PSA (prostate specific antigen) control failures: Specimens are to be held for one week. If 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 -- there is a control failure, spot testing on the specimens will be done from the last successful quality control test to determine when the problem occurred." (Laboratory Procedure Manual, Quality Assessment (QA) Program, I. QA Monitors, part E) (b) The quality control (QC) log sheet for Level 2 QC, lot number 1706091A, expiration date 05-15-2019, performed 04-15-2019 shows a result on instrument B of 11.01 nanograms per mililiter (ng/mL). The acceptable range listed on the form is 11.02- 14.12. No