Drs Black & Benton, Psc

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's "Specimen Collection: Criteria for Rejection" policy, direct observation, and interview with the nursing supervisor, determined the laboratory failed to follow its policy for specimen labeling. The findings include: 1. Review of the laboratory's "Specimen Collection: Criteria for Rejection" policy stated, "Specimens must be labeled with patient's name." 2. Direct observation of one fingerstick specimen and one urine specimen on 12.15.2022 at approximately 8:40 a. m. revealed specimens were not labeled with patient's name. 3. Interview on 12.15.2022 at approximately 9:00 a.m. with the nursing supervisor confirmed the above findings. 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 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 -- electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of manufacturer's operator's manual, lack of documentation and interview with the nursing supervisor, the laboratory failed to monitor the humidity in the area where the complete blood count (CBC) instrument was located in 2020, 2021, and 2022. The findings include: 1. Observation of the laboratory on 12.15.2022 at 8:35 a.m. revealed the Cell-Dyn Emerald CBC instrument (serial #031016-006834) in use for patient testing. 2. Review of the manufacturer's specifications for operating revealed a maximum operating humidity range of 80% for temperatures up to 90 F (32 C). 3. There were no environmental records for monitoring of humidity for surveyor review. 4. Interview with the nursing supervisor on 12.15.2022 at approximately 9:00 a.m. confirmed the laboratory failed to monitor the humidity in the area where the CBC instrument was located in 2020, 2021 & 2022. -- 2 of 2 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: =================================== Based on a review of the Bilirubin Test Kit procedure, review of Bilirubin Standard results for patient tracers and upon interview with the Nurse Laboratory Manager, it was determined the daily bilirubin standards failed to be within the acceptable limits for 2018 and 2019. The findings include: 1. A review of the Bilirubin Test Kit procedure states to run the 5mg and 20mg standards each day of patient testing and the results should not drift more than (+/- 0.2mg/dl) daily. 2. A review of the Bilirubin Standard monthly results for patient tracers on dates: 4/12/18; 11/30/18; 1/25/19 and 8/12/19 were found not to be within the (+/- 0.2mg/dl) acceptable limits daily. 3. An interview at 12:15p.m. on November 25, 2019 with the Nurse Laboratory Manager confirmed the Bilirubin Standards were not within the acceptable limits upon review of patient tracers in 2018 and 2019. ==================================== 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 --