Vaseem Moulana Md Psc

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on staff interview and record review of proficiency testing (PT) results from American Proficiency Institute (API) on 12/13/2021, the laboratory director failed to ensure proficiency test results were reviewed for two (2) out of two (2) events for 2021. Findings include: 1. The laboratory scored an eighty percent (80%) for the analyte White Blood Cell (WBC) count for the API PT 1st event of 2021 and a ninety- three percent (93%) for the analyte Cell Identification or White Blood Cell Differential for API PT 2nd Event of 2021. Record review revealed that the laboratory failed to document a

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 staff interview and record review on 12/17/2019, the laboratory failed to ensure humidity readings were consistent with manufacturer's specifications in the operation of the SYSMEX XP-300 hematology analyzer twenty-three (23) of thirty- one (31) days of patient testing from 11/01/2019 through 12/17/2019. Findings include: 1. The Manufacturer's operations manual for the SYSMEX XP-300 analyzer lists an operating range for humidity thirty percent (30%) to eighty-five percent (85 %). 2. Review of temperature logs for humidity revealed readings less that 30% on 11 /04, 11/08, 11/11, 11/12/, 11/13, 11/14, 11/15, 11/18, 11/19, 11/20, 11/21, 11/25, 11 /26, 12/02, 12/03, 12/04, 12/05, 12/06, 12/11, 12/12, 12/13, 12/16, and 12/17/2019. 3. Testing personnel acknowledged in an interview at 11:30 AM on 12/17/2019, the laboratory failed to have a system in place to ensure humidity was monitored and readings were consistent with manufacturer's specifications. 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 --