Surinder Vohra Md Pc

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 review of the laboratory's temperature records and interview with Testing Personnel #2 (TP), the laboratory failed to monitor and document room and refrigerator temperatures to ensure operating conditions were met for the proper storage of hematology reagents and ensure reliable test system operation of the Sysmex XP 300 from 01/20/2023 to 10/16/2024. Findings Include: 1. On the date of the survey, 10/16/2024 at 10:00 am, review of the laboratory's temperature control logs revealed the laboratory failed to monitor and document room temperatures (acceptable range: 15-30 degrees Celsius) and refrigerator temperatures (acceptable ranges 2-8 degrees Celsius) to ensure operating conditions for the Sysmex XP 300 were met for the following days from 01/20/2023 to 10/16/2024: - 23 of 30 days in September 2024 2. The hours of laboratory testing per the CMS 116 are Monday thru Wednesday 9:00 am to 05:00 pm. 3. TP#2 revealed during an interview, 10/17/2024 at 11:00 am, that temperatures were not monitored on weekends, holidays, and when personnel are not on site in the laboratory from 01/20/2023 to 10/16/2024. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on maintenance record review and interview with testing personnel #2 (TP), the laboratory failed to document maintenance performed on the Sysmex XP300 hematology analyzer from 2/14/2023 to 10/10/2024. Findings include: 1. On the day of the survey 10/16/2024 at 10:00 am, review of the laboratory's XP300 Maintenance Log revealed the laboratory failed to document the following maintenance performed on 1 of 1 Sysmex XP300 (B0622) from 02/14/2023 to 10/16/2024: - Daily Maintenance - Weekly Maintenance - Monthly Maintenance - Quarterly Maintenance 2. The laboratory performed 3486 complete blood cell examinations in 2024 (CMS 116 annual volume) 3. TP#2 confirmed the finding above on 10/16/2024 at 10:00 am 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 record review, lack of documentation, and interview with Testing Personnel #2 (TP), the laboratory failed to perform and document calibration procedures on the Sysmex XP300 hematology analyzer in 2024. Findings include: 1. The laboratory's Accreditation/Calibrations/Proficiency policy stated, calibrations "done by Sysmex service technicians twice a year, approximately every 6 months." 2. On the day of survey, 10/16/2024, the laboratory failed to provide documentation for the calibrations performed on the Sysmex XP300 hematology analyzer in 2024. 3. TP#2 confirmed the finding above on 10/16/2024 at 11:00 am. -- 2 of 2 --

Summary Statement of Deficiencies D8103 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(b)(c)(d) (b) General Requirements. As part of the inspection process, CMS or a CMS agent may require the laboratory to do the following: (b)(1) Test samples, including proficiency testing samples, or perform procedures. (b)(2) Permit interviews of all personnel concerning the laboratory's compliance with the applicable requirements of this part. (b)(3) Permit laboratory personnel to be observed performing all phases of the total testing process preanalytic, analytic, and postanalytic). (b)(4) Permit CMS or a CMS agent access to all areas encompassed under the certificate including, but not limited to, the following: (b)(4)(i) Specimen procurement and processing areas. (b)(4) (ii) Storage facilities for specimens, reagents, supplies, records, and reports. (b)(4)(iii) Testing and reporting areas. (b)(5) Provide CMS or a CMS agent with copies or exact duplicates of all records and data it requires. (c) Accessible records and data. A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. (d) Requirement to provide information and data. A laboratory must provide, upon request, all information and data needed by CMS or a CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel #1 (TP), the laboratory failed to have the required records accessible during the course of the laboratory survey performed on 01/19/2023. Findings Include: 1. On the day of the survey, 01/19/2023 at 10:36 am, the laboratory could not provide the following records upon request: - Annual competency assessments for 1 of 4 TP (CMS 209 TP# 4) that performed complete blood counts (CBC) from 05/11/2021 to 08/30/2022. - Credentials for 1 of 4 TP (CMS 209 TP # 4) that were employed at the facility from 05 /11/2021 to 08/30/2022. 2. TP #1 confirmed the findings above on 01/19/2023 around 11:30 am. 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 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 laboratory personnel interview and review of the policy & competency records, the Laboratory Director acting as Technical Consultant, failed to establish written policies and procedures to assess consultant competency for 4 of 4 Testing Personnel, from 05/09/2018 through the date of the survey. Findings: 1. The Technical Consultant failed to establish and follow written policies and procedures to assess competency for 4 of 4 Testing Personnel from 05/09/2018, through the date of the survey. 2. During the survey 10:00 09/23/2020, the Laboratory Supervisor confirmed, the above finding. 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: 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 -- Based on review of laboratory temperature records and interview with the Laboratory Supervisor, the laboratory failed to document room temperature for the laboratory, from 05/09/2018 through the date of the survey. . Findings include: 1. The manufacturer of Sysmex hematology controls, requires a room temperature range of (15 - 30 C) to equilibrate, prior to running hematology controls. 2. Sysmex hematology controls were run each day of patient testing from 05/09/2018 through through the date of the survey. 3. 3,596 Complete Blood Counts tests were performed using Sysmex hematology controls from 05/09/2018 through the date of the survey. 4. The laboratory could not provide documentation of room temperature from 05/09 /2018 through the date of the survey. 5. The Laboratory Supervisor confirmed the above findings during the survey on 09/23/2020 at 10:47 hours. -- 2 of 2 --