Jaro Company Llc

Summary Statement of Deficiencies 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 observation and interview with Testing Personnel (TP) #1, the laboratory failed to calibrate and/or replace the expired thermometer in the RCA refrigerator for 20 (April 2022 to December 2023) of 20 months in use. Findings include: 1. During a tour of the laboratory on 12/06/2023 at 9:39 am, the surveyor observed a Cardinal Health thermometer in the RCA refrigerator with an expiration date of 02/16/2007. 2. An interview on 12/06/2023 at 9:39 am, TP1 confirmed the thermometer in the RCA refrigerator had expired and was not calibrated and/or replaced. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 record review and interview with Testing Personnel #1 (TP1), the laboratory failed to monitor laboratory room temperature and humidity for 2 (March 2018 to March 2020) of 2 years reviewed. Findings include: 1. A record review of the laboratory's temperature monitoring documentation revealed a lack of room temperature and humidity documentation for the laboratory. 2. A review of the laboratory's "Temperature Checks and

Summary Statement of Deficiencies 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 record review and interview, the laboratory failed to ensure written competency policies were implemented for one (#5) of five testing personnel performing histology tissue specimen grossing in 2016 and 2017. Findings include: 1. On January 30, 2018 at 9:39 a.m., record review for the annual competency revealed there was no documentation to show competency was performed for one of five testing personnel performing the histology tissue specimen grossing in 2016 and 2017. 2. During the interview on January 30, 2018 at 9:39 a.m., the general supervisor as listed on the CMS-209 confirmed the annual competency was not completed as required. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --