Purohit Pediatric Clinic Moody

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 the tour of the laboratory and an interview with Testing Personnel (TP) #2, the laboratory utilized expired material prior to patient testing. This was noted for 45 days of 2 months reviewed for the Siemens Multistix Reagent Strips, 33 patient urinalysis were affected. The findings include: 1. The laboratory tour with TP#2 revealed the laboratory utilized expired Siemens Multistix Reagent Strips for patient Urinalysis testing. The manufacturer's label indicated Lot# 303016 had an expiration date of 08-31-2024. 2. A further review of the Siemens Clinitek analyzer's memory revealed 33 patients were tested after 08-31-2024 to the date of the survey (10-15- 2024). 3. During the exit interview on 10-15-2024 at 1:50 PM, TP#2 confirmed the above findings. 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 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 reviews of the 2018 - 2020 Medonic Hematology analyzer calibration records, the Medonic Operators Manual, and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to perform one out of six calibrations in the review period as frequently as required by the manufacturer. The findings include: 1. A review of the Medonic M Series Hematology Analyzer Operators Manual, Section 7: Calibration on page 59, revealed, "...Introduction...It is recommended to calibrate the instrument every six months. ...". 2. A review of the Medonic Hematology analyzer records revealed the last calibration of 2019 was performed on 11/25/2019; thereafter, the next calibration was eight and a half months later on 8/07 /2020. 3. During an interview on 12/21/2020 at 12:20 PM, Testing Personnel #1 reviewed the above noted findings, and confirmed Medonic calibrations should be performed every six months. SURVEYOR ID #32558Licensure and Certification Surveyor 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 --