Brazosport Hematology/Oncology

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . 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 the review of MLE proficiency records from August 2021 to September 2022, the laboratory personnel CMS 209 report, CMS 116 application, and confirmed in an interview found the laboratory failed to test the proficiency samples by personnel who routinely perform the testing in the laboratory for four of four hematology testing events. The findings were: 1. Review of MLE proficiency records from August 2021 to September 2022 revealed for four of four hematology testing events were all performed by TP#1. 2021 MLE-M3 Hematology 3rd event 2022 MLE- M1 Hematology 1st event 2022 MLE-M2 Hematology 2nd event 2022 MLE-M3 Hematology 3rd event 3. Review of the laboratory Personnel CMS 209 Report signed by the LD on 12/07/2022 revealed the laboratory has 6 TP. 4. Review of the laboratory's CMS 116 application signed by the LD on 12/07/2022 revealed the annual volume was 3000. 5. An interview with the director of laboratory service, a POCT medical technologist, and a lead registered nurse on 12/07/2022 at 9:50 am in the conference room/breakroom confirmed the above findings. Key: MLE=Medical Laboratory Evaluation CMS=Center of Medicare and Medicaid Services LD=Laboratory Director TP=Testing personnel POCT=Point-of-care 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 -- D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 the review of the laboratory's policy, the laboratory daily logs from 12/1 /2021 to 11/30/2022, CMS 116 application, and confirmed in interview revealed the laboratory failed to document daily maintenance for 50 of 50 days reviewed following the laboratory's policy on one of one Boule Medonic M-Series hematology instrument. The findings were: 1. Review of the laboratory's policy titled COMPLETE BLOOD COUNT using CDS MEDONIC M-Series Hematology ANALYZER under page 9 Daily Maintenance revealed " 1. Wipe OT sample probe and Pre-dilute probe with alcohol wipe. 2. Remove possible trace of salt crystals or blood at the top of the Open Tube probe, Pre-dilute probe, probe rinse cup, and around the top of the Cap Pierce. 3. Clean outside of instrument with soft cloth or DI water if needed." 2. Further review of the laboratory's policy titled COMPLETE BLOOD COUNT using CDS MEDONIC M-Series Hematology ANALYZER under page 7 Maintenance revealed "Daily cleaning should be performed according to the Medonic M-Series User's Manual....All maintenance should be documented (a maintenance log is recommended)...." 3. Random review of the laboratory's daily logs from 12/1/2021 to 11/30/22 revealed no documentation of daily maintenance for 50 of 50 days reviewed for one of one Boule Medonic M-Series hematology instrument (SN: 18551). 4. Review of the laboratory's CMS 116 application signed by the LD on 12/07 /2022 revealed the annual volume was 3000. 5. An interview with the director of laboratory service, a POCT medical technologist, and a lead registered nurse on 12/07 /2022 at 11:40 am in the conference room/breakroom confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services LD=Laboratory Director POCT=Point-of-care -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: An unannounced revisit was performed on 11/26/19. Based on laboratory policy, surveryor observations, laboratory records, and confirmed in interview, the laboratory failed to follow the laboratory policy for specimen acceptability for CBC (complete blood count) patient testing on the QBC Star hematology analyzer. Findings were: 1. Review of the laboratory policy Complete Blood Counts using CDS Medonic M- series Hematology Analyzer under specimen rejection criteria revealed "tubes less than 1/2 full will not be acceptable draws." 2. Observations on 11/26/19 at 1050 hours in the laboratory revealed the testing person analyzed 2 of 2 specimen EDTA tubes that were less than 1/2 full. 3. Review of the laboratory records revealed the laboratory reported the 2 observed specimens analyzed. Specimen ID 5914 5915 4. An interview with the office manager on 11/26/19 at 1130 hours in the laboratory confirmed the above findings. She acknowledged that the specimen tubes were "short." She was unaware the EDTA tube had a minimum volume. 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 D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory Medical Laboratory Evaluation (MLE) proficiency test records from 2018 and 2019, laboratory records, and confirmed in interview, the laboratory failed to verify the accuracy of their hematology testing after receiving a score of 0% for failure to participate in 1 of 4 PT events. Findings were: 1. Review of the MLE testing events from 2018 and 2019 revealed 1 of 4 events (MLE event 2) when the laboratory received a grade of 0% for failure to participate. The laboratory missed the cutoff to submit test results. 2. Review of the laboratory MLE event 2 proficiency test records revealed no documentation of the self-evaluation for 5 of 5 specimens analyzed. MLE event 2 HD 06 HD 07 HD 08 HD 09 HD 10 2. An interview with the testing person #2 on 9/24/19 at 1435 hours in the conference room confirmed the above findings. She was unaware the laboratory was required to perform a self-evaluation of the MLE results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory policies, review of quality control records, review of patient final reports, and confirmed in interview, the laboratory failed to monitor and evaluate the overall quality of its analytic systems. Refer to D5401, D5421, 5783 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: Based on review manufacturer's instructions, laboratory policy, patient results, and confirmed in interview, the laboratory failed to follow the laboratory policy to resolve CBC flags prior to their release to the healthcare provider on the Medonic M-series hematology analyzer. The findings were: 1. Review of the manufacturer's instructions for the Medonic M-series hematology analyzer under section 9: Parameter and System Information Messages, under "Introduction" stated, "The Medonic M-Series has several parameter and system information messages related to the measured parameters and the instrument. These messages alert the operator of possible pathologic samples and parameter value and instrument errors." 2. Further review of the operator's manual under, "System Information Messages" stated: "HF Message: HGB Measuring Problem - run prime cycle Action: Run a "Prime cycle," before re- analyzing the sample." "OM Message: WBC DIFF: Only one WBC population found; slide review advised. Action: Blood sample too old or pathological sample. Follow laboratory's protocol for verification of results." "BD Message: WBC DIFF: High interference between populations. Action: Blood sample too old or pathological sample. Follow laboratory's protocol for verification of results." "TM Message: WBC DIFF: Too many WBC population found; slide review advised. Action: Blood sample too old or pathological sample. Follow laboratory's protocol for verification of results." 3. Review of the laboratory's policy for Complete Blood Counts Using CDS Medonic M-Series Hematology Analyzer revealed "results with these flags: BD, NM, OM, TM indicate that the blood sample is too old or there is a pathological issue. These specimens should be sent to CHI St. Luke's lab to be verified." 4. Random review of patient test records from February, July, August 2019 and December 2018 revealed 11 of 20 patient test records with the following flags and no documentation of the verification of the results per the laboratory policy. Date Patient ID Flag 08/01 /19 3835 OM 08/05/19 3862 OM 08/07/19 3925 BD 08/20/19 4131 BD 08/28/19 4263 OM 07/02/19 3352 OM 07/11/19 3498 OM 02/04/19 7928 TM 02/25/19 8234 -- 2 of 6 -- OM 12/03/18 7027 BD 12/17/18 7244 OM 5. An interview with testing person #2 on 9 /24/19 at 1440 hours in the conference room confirmed the above findings. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory records, and confirmed in interview, the laboratory failed to document the verification studies for the new Medonic M-series hematology analyzer: Findings were: 1. Review of the manufacturer's instructions (P/N 203050D R 03.17.09) revealed "CLIA regulations require that all new analyzers have testing performed to validate: the analytical measurement range (AMR or linearity) of the instrument; the accuracy and precision of the instrument." 2. Review of the laboratory records revealed the laboratory received a new Medonic M-series hematology analyzer in 05/2019 (SN18551). 3. Review of the laboratory records revealed no documentation of the linearity, accuracy and precision studies of the new instrument. 4. An interview with the laboratory director on 9/24/19 at 1530 hours in the conference room confirmed the above findings. She stated that the laboratory performed controls but no linearity, accuracy and precision prior to patient testing. She was unaware the laboratory was required to perform verification studies on the new instrument. D5783