Summary:
Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation of the laboratory reagents and interview with the Officwe Manager (OM), the laboratory failed to ensure protection from chemical and physical hazards at the time of survey. The findings include: 1. Observation of the flammable cabinet and undersink cabinet revealed that all flammable and inhalation risk reagents were not kept in the flammable cabinet. 2. Five containers of 100% Reagent Alcohol were stored in the laboratory undersink cabinet. 3. The OM confirmed on 10/20/22 at 1:35 pm that the laboratory did not ensure protection from chemical and physical hazards. 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 the lack of Competency Assessment (CA) records and interview with the Office Manager (OM), the laboratory failed to perform a CA on two out of two testing 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 -- personnel for the calendar years 2020, 2021 and 2022. The OM confirmed on 10/20 /22 at 1:30 pm that the CA was not performed as stated above. Note: This was previously cited: 1/22/20 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 surveyor review of the Procedure Manual (PM), and interview with the Office Manager (OM), the laboratory failed to have a procedure written for the preparation of Toluidin Blue reagent from 1/22/20 to the date of the survey. The OM confirmed on 10/20/22 at 1:30 pm that the laboratory did not have the aforementioned written procedure. 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 surveyor review of the Temperature Log (TL) and interview with the Office Manager (OM), the laboratory failed to define an acceptable Room temperature and humidity range where Histopathology tests are performed from 1/22/19 to the date of the survey. The finding include: 1. The TL did not have an acceptable range for Temperature or Humidity. 2. The OM confirmed on 10/20/22 at 1:35 pm that an acceptable range was not defined. 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: a) Based on surveyor observation of the laboratory Cabinet and interview with the Office Manager (OM), the laboratory failed to appropriately label Toluidine Blue -- 2 of 4 -- reagent used for Histopathology testing from 1/22/20 to the date of the survey. The finding includes: 1. There were no preparation and expiration dates on the container containing Toluidine Blue. 2. The OM confirmed on 10/20/22 at 1:35 pm that all reagents were not labeled correctly. b) Based on surveyor observation of the Staining Station and interview with the OM, the laboratory failed to label the identity of all staining jars used for Histopathology testing from 1/22/20 to the date of the survey. The OM confirmed on 10/20/22 at 1:35 pm that all staining jars were not labeled. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of the Flammable Cabinet and interview with the Office Manager (OM), the laboratory used expired Eosin Y Alcoholic Working Solution reagent for Histopatholgy testing on 11/15/21. The findings include: 1. Eosin Y Alcoholic Working Solution Lot # 063019 expired 10/8/21. 2. Approximately 5 patients were tested with the expired reagent. 3. The OM confirmed on 10/20/22 at 1: 30 pm that the laboratory used expired reagent. D5781