Summary:
Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of the Quality Assessment (QA) policy, the laboratory failed to establish a written policy for monitoring pre-analytic, analytic, and post-analytic systems in the laboratory. Finding: 1. Annual QA review was not performed from 2020 through the survey date. 2. Confirmed above finding on an interview with TP#2 and TP#3 on 2/7/2023 at approximately 12:30 P.M. 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 the review of the histopathology laboratory humidity log from 2020 through the survey date, the laboratory failed to document humidity as required. Findings: 1. 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 -- Histopathology laboratory humidity log was not available for review from 2020 through the survey date. 2. Confirmed above finding on an interview with TP#3 on 2/7 /2023 at approximately 12:00 P.M. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observation of aliquot bottles in the Mohs laboratory, the laboratory failed to properly identify the reagent, concentration, lot number, expiration date, and storage requirement for the following: Findings: 1. 10% Formalin Fixative vial containing black dye. 2. 10% Neutral Buffer vial containing green dye. 3. 10% Formalin Fixative vial containing red dye. 4. Frozen embedding media vial containing 100% reagent grade alcohol. 5. Sodium hypochlorite vial containing water. 6. Para Gard vial does not identify concentration, lot number, and expiration date. 7. Confirmed above findings on an interview with testing person (TP)#2 on 2/7/2023 at approximately 11 A.M. D5781