Chitra Venkatraman Md Pa

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with the testing person (TP), the laboratory failed to document the eyewash checks. Findings: 1. The "General Maintenance" procedure stated that the "Eyewash should be checked weekly and cleaned and flushed at a minimum monthly" and to "Record on the eyewash log the date the maintenance was completed and the initials of performing tech." 2. During the survey on 02/21/2024 at 2:00 PM, the TP confirmed that there was no eyewash log to document performance of the eyewash checks. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the procedure manual and proficiency testing (PT) records and interview with the office manager (OM), the laboratory failed to document the review of PT results in three of five PT events reviewed. Findings: 1. The Proficiency Testing Policy stated that "Proficiency testing results will be reviewed within 30 days of receipt of results," "Initially, both the testing personnel and the Laboratory Supervisor should review the PT scores, and if all are satisfactory, the forms are signed and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- dated," and "The Laboratory Director also must sign the forms as reviewed, and reports are filed in the Proficiency Testing Manual." 2. The PT records for 2023 and 2024 were reviewed for a total of five PT events. 3. There was no documentation that PT results from the three 2024 PT events were reviewed by the testing personnel, laboratory supervisor, or laboratory director. 4. During the exit interview on 02/21 /2025 at 2:30 PM, the OM confirmed that there was no documentation that the PT results from 2024 were reviewed by laboratory personnel. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, review of the procedure, and interview with the testing personnel (TP), the laboratory failed to document the hematology quality control (QC) opened and expiration dates on the QC vial. Findings: 1. The "Sysmex XP-300 Automated Hematology Analyzer" procedure stated that the QC open vial stability was 14 days when promptly refrigerated after each use and instructed the TP to record the opened date on each vial upon opening. 2. The QC vials stored in the refrigerator were not labeled with the opened and expiration dates. 3. During the survey on 02/21 /2025 at 2:00 PM, the TP confirmed that the opened and expiration dates were not recorded on newly opened vials of QC material. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the procedure manual, review of quality control (QC) records, and interview with the testing person (TP) and office manager (OM), the laboratory had multiple procedures for parallel testing new QC lots for verification prior to use and no documentation that new lots of QC had been parallel tested for verification. Findings: 1. The "Sysmex XP-300 Automated Hematology Analyzer" procedure stated to "Parallel test new controls by analyzing the three levels of control a -- 2 of 4 -- minimum of twice a day for 5 days prior to expiration of the previous lot. After a minimum of 10 data points are accumulated and values are running within assay ranges, the lot may be placed into production." 2. The "Quality Control and Assessment" procedure (QC procedure) stated that "Assessment of a new lot of quality control material should be performed while the previous lot is still in use," "After 5 repetitions on 5 separate days with alternating operators, if the new control results are within the manufacturer's established range, the lot has been verified," "Attach the QC verification runs to the QC package insert," and "Lab director sign the verification worksheet and date as approval of verification." 3. The "Procedure for Change in Lot of Assayed Control Material" section of the QC procedure stated that "Each level of new control material must be evaluated 5 times, with alternating personnel and on multiple days when possible, to verify that control results fall within manufacturer stated 2SD ranges" and "Results may be compared against those found within the package insert and filed in the quality control binder, or documented on the chart template, to show acceptability of new lot control material." 4. On 02/21/2025 at 2:10 PM, the TP stated that new QC lots were tested with the old QC lots, but the results weren't printed and saved with the QC records. 5. During the exit interview on 02/21/2025 at 2:30 PM, the OM confirmed that there were multiple procedures with differing instructions for performing parallel testing on new QC lots and no documentation showing that new QC lots were parallel tested prior to use. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on observation and interview with the testing personnel (TP), the laboratory was not consistently documenting the identity of the TP who performed each hematology test. Findings: 1. The Sysmex XP-300 hematology analyzer included a field for the TP to enter their initials for each patient specimen that was tested. 2. During the survey on 02/21/2025 at 2:10 PM, the TP confirmed that the TP were not consistently entering their initials into the instrument to identify which TP performed testing for each patient specimen. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with the office manager -- 3 of 4 -- (OM), the hematology Levy-Jennings (L-J) graphs were unable to be printed and reviewed as stated in the procedure. Findings: 1. The "Quality Control and Assessment" procedure stated that "A pictorial representation of quality control results, such as Levy-Jennings graphs, is a valuable tool for assessing control results" and "Problems with the instrument, reagents, control materials, and operators can be assessed by examining these graphs at least weekly to look for unexpected patterns." 2. There were no L-J graphs printed for review from 2023 and 2024. 3. During the exit interview on 02/21/2025 at 2:30 PM, the OM stated that the L-J charts and summary QC data was currently unable to be printed from the analyzer and was therefore not reviewed. -- 4 of 4 --

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 proficiency testing (PT) record review and interview with the technical consultant (TC), the laboratory did not ensure that all the testing personnel who tested patient samples perform the PT. Findings: 1. The laboratory currently has 2 testing personnel listed on the "Laboratory Personnel Report (CMS-209)." During an interview at 10:15 AM on the day of the survey the office manager stated that they also perform patient testing when the other TP are not able to. 2. A review of hematology/coagulation PT attestation worksheets from 2020 and 2021 showed that PT was not performed by the office manager for 5 of 5 events. 3. During an interview on 11/12/2021 at 1:30 PM, the TC confirmed that PT samples are not tested each year by all the staff who perform patient testing to ensure accurate and reliable patient test results. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the technical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- consultant (TC), the laboratory failed to ensure that the laboratory director (LD) and testing personnel (TP) sign the PT attestation statements, attesting to the routine integration of the samples into the patient workload using the laboratory's routine methods. Findings: 1. A review of hematology PT records from 2020 to 2021 showed that for 1 of 5 events the office manager filled in the names of the LD and TP. The LD and TP did not sign the attestation statement, attesting that PT specimens were run in the same way as patient samples. 2. This was confirmed by the TC during an interview on 11/12/2021 at 1:30 PM. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on laboratory procedure manual and record review and interview with the testing personnel (TP) and technical consultant (TC), the laboratory did not ensure that written procedures for performing laboratory testing are followed by the laboratory TP. Findings: 1. The procedure, "Manual Review" states that "All testing personnel must possess adequate knowledge to process specimens, perform testing, adhere to CLIA, OSHA safety rules and regulations, and report test results" and "Laboratory Personnel must document review of this manual by signing below." 2. Review of the signatures of TP on the document showed that 1 of 3 TP performing testing as of the day of the survey did not sign the "Manual Review" sheet to show that they had reviewed the laboratory's procedure manual. 3. The procedure, "Material Management" states to "Document on the Reagent Inventory Log for each section the following: a. Date item was received, b. Name of item, c. Quantity received, d. Lot number, e. Expiration date, f. Date opened (Once item is opened), and g. Date expired once opened if different from shelf life expiration date (expiration date may be adjusted once opened/ refer to package insert for stability once opened)." 4. Record review showed that there were no "Reagent Inventory Logs" present at the time of the survey. TP #1 stated that the laboratory did not document reagents and controls on the "Reagent Inventory Log." 5. The procedure "Specimen Collection, Handling and Transport; Patient Test Management" states under "General Handling of Anticoagulated Specimens", "EDTA Specimens" that "Samples are mixed on the hematology rocker while awaiting analysis in the laboratory." The "Sysmex" procedure states, "Do not place samples on a mechanical rocker. Constant rocking may alter white cell membranes, which may result in inappropriate flagging." 6. During an interview at 10:15 AM on the day of the survey TP #1 stated that patient specimens drawn into EDTA tubes are placed on the mechanical rocker if the Medical Assistant is not immediately available to run them on the hematology analyzer. 7. During an interview on 11/12/2021 at 1:30 PM the TC confirmed that the laboratory did not ensure that written procedures for performing laboratory testing were followed by the laboratory TP. II. Based on laboratory procedure manual and record review and interview with the testing personnel (TP) and technical consultant (TC), the laboratory did not ensure that written procedures for performing parallel testing of new hematology controls accurately reflect the current practice in the laboratory. Findings: 1. The procedure "Quality Control and Assessment", "Procedure for Change in Lot of Control Material (Sysmex XP-300)" states "Run each level of new control material 5 -- 2 of 5 -- times over 5 days using more than one operator." The "Sysmex" procedure, subheading "Starting a New Lot of Controls" states "Parallel test new controls by analyzing the three levels of controls a minimum of twice a day for 5 days prior to expiration of the previous lot. After a minimum of 10 data points are accumulated and values are running within assay ranges, the lot may be placed into production." 2. During an interview at 10:15 AM the TP stated that they perform parallel testing of new and old lot numbers of hematology controls "2-3 days before" starting the new lot number. 3. Quality assurance record review showed that on the "Quality Assessment Plan" "Monthly Checklist" for June 2021 the TC documented that the hematology controls "Lots 11380710, 711, 712 Exp. 8.25.21 in use 6/2-30/21" were "Not Parallel Tested." 4. A review of quality control records from 03/01/2021 to 10/31/2021 showed that the "new" lot of hematology controls (lot # 10540710, 10540711, 10540712) was tested in parallel with the "old" lot of controls a total of 4 times from 03/05/2021 to 03/10/2021. 5. During an interview on 11/12/2021 at 1:30 PM the TC confirmed that the laboratory's procedures for performing parallel testing of hematology controls are not consistent and do not reflect the current practice in the laboratory. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: The laboratory did not follow the manufacturer's instructions for performing parallel testing of new hematology controls. Cross-refer to D5401, part II. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, procedure manual and manufacturer instructions review, and interview with the technical consultant (TC), the laboratory did not ensure that hematology controls and reagents are labeled with their opened and expiration dates. Findings: 1. The laboratory runs "Eightcheck-3WP/X-Tra" controls on their Sysmex XP-300 hematology analyzer. A review of manufacturer instructions showed that the hematology controls expire 14 days after opening. 2. During a tour of the laboratory at 10:15 AM, it was observed that the opened and in use hematology controls in the laboratory refrigerator were not labeled with the date that they were put in to use. The controls were in a cup labeled with the manufacturer's expiration date for unopened controls. The cup was not labeled with the opened date or new opened expiration date for the controls. 3. The "Sysmex" procedure manual under "III. Supplies and -- 3 of 5 -- Reagents" states that the "CELLPACK Stability" is "Opened, CELLPACK is stable for 60 days" and the "STROMATOLYSER-WH Stability" is "Opened, STROMATOLYSER-WH is stable for 90 days." These reagents are used on the Sysmex XP-300 hematology analyzer. 4. It was observed at 10:15 AM that the in-use "CELLPACK" reagent (lot # Y1071/expiration date: 01/18/2023) and the in-use "STROMATOLYSER-WH" reagent (lot # Y1002/expiration date 04/29/2022) were labeled with an opened date of 11/08/2021. The reagents were not labeled with their new opened expiration dates. 5. During an interview on 11/12/2021 at 1:30 PM, the TC confirmed that the in-use hematology controls and reagents were not labeled with their opened and expiration dates. 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 laboratory record and procedure manual review and interview with the technical consultant (TC), the laboratory failed to ensure that the lot numbers and expiration dates of reagents used for hematology testing are documented. Findings: 1. The laboratory performs hematology testing on a Sysmex XP-300 hematology analyzer. The laboratory did not document the new opened expiration date of the hematology reagents used on the analyzer. Cross-refer to D5415. 2. The "Sysmex" procedure manual under "III. Supplies and Reagents" states that the "CELLPACK Stability" is "Opened, CELLPACK is stable for 60 days." A review of "CELLPACK" reagent records on the hematology analyzer from June through November, 2021 showed that the hematology analyzer records the lot number and manufacturer's expiration date of the unopened reagent once it is loaded onto the analyzer, but it does not update the expiration date to reflect the new opened expiration date. 3. Record review showed that the laboratory did not utilize the "Reagent Log" provided in the laboratory's procedure manual. Cross-refer to D5401. 4. During an interview on 11/12 /2021 at 1:30 PM, the TC confirmed that the documentation of lot numbers and expiration dates of reagents used for hematology testing was incomplete. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on record review and interview with the testing personnel (TP) and technical consultant (TC), the TC failed to ensure that each individual performing tests receives training and education appropriate for the type and complexity of the laboratory services performed. Findings: 1. The laboratory currently has 2 TP listed on the "Laboratory Personnel Report (CMS-209)." During an interview at 10:15 AM on the day of the survey the office manager stated that they also perform patient testing when -- 4 of 5 -- the other TP are not able to. 2. A review of training records showed that there was no documentation that the office manager was trained to perform hematology testing on the Sysmex XP-300 hematology analyzer. 3. During an interview on 11/12/2021 at 1: 30 PM the TC confirmed that the appropriate training was not performed on all staff who perform patient testing. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and interview with the testing personnel (TP) and technical consultant (TC), the TC failed to perform and document the competency reviews on all TP. Findings: 1. The laboratory currently has 2 TP listed on the "Laboratory Personnel Report (CMS-209)." During an interview at 10:15 AM on the day of the survey the office manager stated that they also perform patient testing when the other TP are not able to. 2. A review of competency assessment records from 2020 and 2021 showed that there was no documentation of competency assessments performed on the office manager. 3. During an interview on 11/12/2021 at 1:30 PM the TC confirmed that competency reviews were not performed on all staff who perform patient testing. -- 5 of 5 --

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 record review and interview, the lab did not maintain refrigerator temperature records and room temperature records for six of twenty-four months reviewed for 2017 and 2018. Findings: 1. The laboratory stores reagent for the automated hematology analyzer in the refrigerator and has written procedures to observe and record the refrigerator temperature, the laboratory also observes and records the temperature of the room that automated hematology testing is performed to ensure it meets the hematology analyzer manufacturer requirements; 2. The lab has a written record to document the refrigerator and room temperatures each day of testing; 3. The laboratory did not have refrigerator and room temperature records for the months of December 2017, November 2017, October 2017, September 2017, July 2017 and April 2017; and 4. It was confirmed during interview with the technical consultant (TC) at noon on the day of survey, the laboratory was unable to provide the records. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures 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 -- that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the lab did not maintain the individual quality control test results obtained from testing hematology quality control reagents. Findings: 1. The laboratory quality control records did not include the individual quality control test results for the high, normal and low control levels for April 1, 2017 to April 23, 2017, March 23, 2017 to March 30, 2017 and January 1, 2017 to January 16, 2017; 2. The laboratory quality control records did not include the individual quality control test results for the high control level for August 24, 2017 to August 31, 2017; and 3. It was confirmed during interview with the technical consultant (TC) at noon on the day of survey, the laboratory was unable to provide the records. D5779