North Houston Medicine, Tumor & Blood Clinic, Pa

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D6052 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on a review of the laboratory's annual competency assessments, patient test records, and staff interview, the technical consultant failed to assess problem solving skills for two of two annual competency assessments performed for Complete Blood Count (CBC) testing on the Abbott Emerald hematology analyzer in 2023. Findings include: 1. A review of the laboratory's annual competency assessments performed in 2023 revealed the technical consultant failed to assess problem solving skills for testing person #1 and testing person #2 for CBC testing on the Abbott Emerald hematology analyzer. 2. A review of the laboratory's patient test records revealed the laboratory estimated performing 3000 CBC tests on the Abbott Emerald hematology analyzer in 2023. 3. In an interview on 2/8/24 at 9:40 a.m. in the laboratory, after review of the records, the technical consultant (as indicated on the CMS 209 form) confirmed the above findings. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's submitted CMS 209 form, personnel records, the laboratory's patient test records, and staff interview, the laboratory failed to have documentation of training for one of two testing personnel prior to performing patient testing on the Abbott Emerald hematology analyzer in 2022. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed the laboratory identified two testing personnel performing moderate complexity testing on the Abbott Emerald hematology analyzer. 2. A review of the laboratory's personnel records revealed the laboratory failed to have documentation of training for the following testing personnel prior to performing patient testing: - Testing person #2 Hire date: 11/3/22 3. A review of the laboratory's patient test records revealed the laboratory estimated performing 3000 Complete Blood Count (CBC) tests on the Abbott Emerald hematology analyzer in 2022. 4. In an interview on 2/8/24 at 9:20 a.m. in the laboratory, after review of the records, the technical consultant (as indicated on the CMS 209 form) confirmed the above findings. -- 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 D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: No deficiency details available. 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: 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 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; 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. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, American Proficiency Institute (API) proficiency testing records, and confirmed in interviewed, the laboratory failed to test the proficiency testing material the same as patient samples for the CBC (complete blood count) testing on the Cell-Dyn Emerald hematology analyzer. Findings were: 1. Review of the laboratory policy Proficiency Testing - Guidelines revealed "all samples are to be tested in the same manner as routine clinical materials." 2. Review of the 2019 API 1st event proficiency testing records revealed the laboratory testing person analyzed the PT samples two times, then cleaned [performed maintenance] the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- analyzer, then reanalyzed the PT samples two more times. Records revealed 4 instrument printouts for each PT sample. 3. An interview with the primary testing person on 11/13/19 at 1050 hours in the laboratory confirmed that the laboratory does not perform patient samples twice, then perform maintenance, then reanalyze specimens. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of proficiency testing records and interview of facility personnel, the laboratory failed to successfully participate in a proficiency testing program for the specialty of routine hematology for Cell ID (White blood cell differential). Refer to D2130 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the 2019 American Proficiency Institute (API) proficiency testing (PT) records and confirmed in interview, the laboratory failed to obtain at least 80% for the hematology analyte: RBC (red blood cells) and Cell ID (white blood cell differential). Findings were: 1. Review of the API 2019 proficiency testing records revealed documentation the laboratory failed to obtain at least 80% for the following analytes: 2019 API 2nd event Cell ID - 27% Granulocytes - 0% Hem-06: 68.3 (acceptable range 57.7-63.7) Hem-07: 70.2 (acceptable range 60.6 - 64.9) Hem-08: 82.7 (acceptable range 73.7 - 78.4) Hem-09: 80.1 (acceptable range 68.0 - 74.0) Hem- 10: 45.0 (acceptable range 32.6 - 41.7) Lymphocytes - 20% Hem-06: 21.1 (acceptable range 25.2 - 34.8) Hem-07: 23.0 (acceptable range 24.8 - 31.4) Hem-08: 12.5 (acceptable range 12.9 - 18.1) Hem-10: 45.3 (acceptable range 47.4 - 60.3) Monocytes - 60 % Hem-08: 4.8 (acceptable range 6.8 - 10.0) Hem-09: 6.4 (acceptable range 11.1 -- 2 of 8 -- - 14.7) RBC - 40% Hem-06: 3.97 (acceptable range 3.98 - 4.50) Hem-07: 3.52 (acceptable range 3.57 - 4.04) Hem-10: 2.12 (acceptable range 2.18 - 2.46) 2019 API 1st event Cell ID - 13% Granulocytes - 0% Hem-01: 71.4 (acceptable range 59.3 - 64.7) Hem-02: 45.4 (acceptable range 32.9 - 42.2) Hem-03: 83.1 (acceptable range 72.0 - 78.1) Hem-04: 69.3 (acceptable range 57.2 - 64.0) Hem-05: 78.9 (acceptable range 61.4 - 71.1) Lymphocytes - 20% Hem-01: 23.5 (acceptable range 25.2 - 30.3) Hem-03: 12.7 (acceptable range 13.0 - 18.3) Hem-04: 25.9 (acceptable range 27.0 - 33.5) Hem-05: 14.0 (acceptable range 14.4 - 18.7) Monocytes - 20% Hem-01: 5.1 (acceptable range 8.6 - 11.9) Hem-03: 4.2 (acceptable range 7.7 - 10.6) Hem-04: 4.8 (acceptable range 7.0 - 11.3) Hem-05: 7.1 (acceptable range 13.8 - 20.4) 2. An interview with the primary testing person on 11/13/19 at 1105 in the laboratory confirmed the above findings. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of the laboratory American Proficiency Institute (API) proficiency testing records from 2019 and interview of facility personnel, the laboratory failed to attain an overall testing event score of at least 80 % for each event which constitutes unsatisfactory performance. Findings were: 1. A review of the 2019 API proficiency testing revealed a hematology event score of less than 80% (unsatisfactory performance) for the API 2nd event (77%). 2. An interview with the primary testing person on 11/13/19 at 1050 hours in the laboratory confirmed the above findings. 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 review of the laboratory policy, American Proficiency Institute (API) proficiency testing records, PT