Summary:
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 staff interview, the laboratory failed to establish competency assessment policies and procedures to assess competency for the regulatory responsibilities for the clinical consultant (CC). Findings include: 1. Record review on 06/01/2026 of the staff training and competency files revealed lack of competency assessment policies and documented competency assessment records for the regulatory position of CC. 2. Staff interview on 06/01/2026 at 12:20 PM with the Laboratory Director confirmed the above finding. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to follow their established policies and procedures and document the open date and expiration date of quality control (QC) material in the specialty of hematology. 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 -- Findings include: 1. Surveyor observation on 06/01/2026 at 10:30 AM of the hematology laboratory refrigerator revealed the following liquid QC in use: a. 'EIGHTCHECK X-TRA-L: i. Lot number: 60760710 ii. Manufacturer expiration date: 2026-06-24 b. 'EIGHTCHECK X-TRA-N: i. Lot number: 60760711 ii. Manufacturer expiration date: 2026-06-24 c. 'EIGHTCHECK X-TRA-H: i. Lot number: 60760712 ii. Manufacturer expiration date: 2026-06-24 d. Lack of documentation of an open date and laboratory assigned expiration date from open date. 2. Record review on 06 /01/2026 of the laboratory's 'CBC/PLT with 3-Part Differential' standard operating procedure revealed the following: a. 'Unopened and properly stored, EIGHTCHECK X-TRA is table until the expiration date stated on the vial'. b. 'Open vial stability is 14 days when promptly refrigerated after each use'. c. 'Record the date on each vial upon opening'. 3. Staff interview on 06/01/2026 at 10:35 AM with the laboratory Testing Personnel #1 confirmed the above findings. 4. The laboratory performs 1500 tests annually in the specialty of hematology. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to perform and document annual room temperature thermometer function checks in the specialty of hematology. Findings include: 1. Surveyor observation on 06 /01/2026 at 9:45 AM of the hematology laboratory revealed a 'Traceable' brand thermometer on the wall with a serial number of 221156799 and an expiration date of 01/17/2024. 2. Record review on 06/01/2026 of the laboratory's 'Room Temperature Thermometer Calibration' log revealed lack of annual calibration documentation for the above room temperature thermometer listed in 1 above. 3. Revord review on 06/01 /2026 of the laboratory's 'Temperature Protocol' policies and procedures revealed 'All thermometers are certified annually by a NIST traceable thermometer'. 4. Staff interview on 06/01/2026 at 12:10 PM with the Laboratory Director confirmed the above findings. 5. The laboratory performs 1500 tests annually in the specialty of hematology. D5781