Drs Chhabra & Sait, Md Pa

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and patient testing logs and interview with the laboratory supervisor (LS), the laboratory failed to document urine and throat culture PT sample results in the same manner as routine patient specimen results in four of six testing events reviewed. Findings: 1. Urine culture and throat culture PT records for three events in 2020 and three events in 2021 were reviewed. 2. The laboratory recorded results of routine patient specimen urine and throat culture testing on separate logs. 3. Review of the urine culture and throat culture patient testing logs showed that PT sample results were logged with the patient specimen results on the 2020 1st and 2nd events but not the 2020 3rd event and all three 2021 events. 4. During the survey on 06/09/2022 at 2:00 PM, the LS confirmed that urine and throat culture PT sample results were not documented on routine patient specimen results logs for the 2020 3rd event and all three 2021 events. 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 review of the analyzer operator's manual and laboratory records and interview with the laboratory supervisor (LS), the laboratory failed to record humidity in the laboratory where hematology testing was performed. Findings: 1. The laboratory performed hematology testing using a CELL-DYN Emerald analyzer. 2. The analyzer operator's manual stated that relative humidity for instrument operation is less than 80%. 3. Laboratory records did not include documentation of humidity. 4. During the survey on 06/09/2022 at 2:00 PM, the LS confirmed that the laboratory was not recording humidity in the laboratory where hematology testing was performed. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

Summary Statement of Deficiencies D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with the testing personnel and technical consultant, the laboratory did not check each batch of selective strep throat culture agar and urine culture agar for sterility, the ability to support growth and inhibit growth of specific organisms prior to using for patient testing. Findings: 1. Review of the laboratory worksheets for 2018 through August 2019 showed that the laboratory did not perform a risk assessment for the media purchased from an outside vendor. The laboratory did not check the throat agar and urine culture agar for sterility, the ability to support growth and inhibit growth of specific organisms prior to using for patient testing. 2. During the survey on 08/09/19 at 12:30 PM the testing personnel and technical consultant confirmed that the throat culture agar and urine culture were not checked for sterility, the ability to support growth and inhibit growth of specific organisms prior to using for patient testing. The laboratory had not completed an Individual Quality Control Plan (IQCP) and risk assessment to eliminate the need for the end user quality control requirements. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) 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 -- (b) The postanalytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --