Clearway Laboratory

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 laboratory procedure manual and temperature log review, and interview with the technical supervisor (TS), the laboratory did not ensure that the procedure for taking refrigerator and freezer temperatures accurately reflected the current practice in the laboratory. Findings: 1. The procedure, "LAB 105.0 Daily Temperature Checks" states that "Each thermometer in use is checked to monitor reagent storage temperatures daily. If any storage area exceeds its recommended temperature and cannot be immediately corrected, the contents must be transferred to another temperature-controlled environment. Any out-of-range documentation must include

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on temperature record review and interview with the technical specialist (TS), the laboratory did not did not define criteria for those conditions that are essential for proper storage of reagents for accurate and reliable test system operation, and test result reporting. Findings: 1. The laboratory put three new refrigerators in to use in March, 2018. The refrigerators and the freezers above them were labeled, "R2" and "F2," "R3" and "F3," and "R4" and "F4." 2. "R2" is used as storage for reagents, controls, and calibrators for an in-use chemistry analyzer, as well as urine specimens in tubes which are to be run for toxicology analysis; "R3" is used as storage for cups of urine from satellite offices which have not been processed; and "R4" is used as storage for cups of urine from satellite offices which have not been processed, as well as urine toxicology samples which are to be sent out to a reference laboratory or for stat analysis. Nothing is stored in "F2," "F3," or "F4." 3. Daily temperatures were recorded, but the temperature logs did not include the acceptable temperature range for the refrigerators or freezers in order to determine if daily temperatures were within range; and 4. During an interview on 7/12/18 at 1:15 PM, the TS stated that they "wanted to let it run for a while" before establishing the temperature range and confirmed that the laboratory did not define the acceptable temperature range for the new refrigerators and freezers. 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 -- D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require