Pediatrics Of Greater Houston

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 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; 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 a desk review of proficiency testing records obtained from the CMS national 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 -- database and verified with the proficiency testing company the College of American Pathologists (CAP) found the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Hematology and for one of seven regulated analytes in two of three proficiency testing events in 2022 and 2023. Platelets CAP FH2-C 2022 CAP FH2-A 2023 Key: CMS=Center for Medicare and Medicaid Services 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 a desk review of proficiency testing records obtained from the CMS national database and verified with the proficiency testing company the College of American Pathologists (CAP) found the laboratory failed to attain a score of at least 80% of acceptable responses for one of seven regulated analytes in 2022 and seven of seven regulated analytes in 2023 resulted in unsatisfactory performances. The findings were: 1. Review of CAP FH2-C 2022 for the third event in 2022 revealed the laboratory received unsatisfactory scores for the following: Platelets 60% 2. Review of CAP FH2-A 2023 for the first event in 2023 revealed the laboratory received unsatisfactory scores for the following: Hematology 0% Cell I.D. or WBC Diff 0% RBC 0% HCT (Non-waived) 0% HGB (Non-waived) 0% WBC 0% Platelets 0% Key: CMS=Center for Medicare and Medicaid Services RBC=Red Blood Cell HCT=Hematocrits HGB=Hemoglobin WBC=White Blood Cell 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 desk review of proficiency testing records obtained from the CMS national database and verified with the proficiency testing company the College of American Pathologists (CAP) found the laboratory failed to attain an overall testing event score of at least 80% of acceptance responses for one of one CAP proficiency testing events in 2023. The finding was: 1. Review of CAP FH2-A 2023 for the first event in 2023 revealed the laboratory received an overall unsatisfactory score for hematology specialty of 0%. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS national database and verified with the proficiency testing company the College of American Pathologists (CAP) found the laboratory failed to achieve satisfactory performance (80% or greater) for the same analytes in two consecutive testing events in the specialty of Hematology for one of seven regulated analytes for one of two CAP proficiency testing events in 2022 and one of one CAP proficiency testing events in 2023. Analyte: Platelets D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS national database and verified with the proficiency testing company the College of American Pathologists (CAP) found the laboratory director failed to provide overall management and direction of the laboratory services. (Refer to D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS national database and verified with the proficiency testing company the College of American Pathologists (CAP) found the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful testing performances in a HHS approved proficiency testing program. (Refer to D2130). -- 3 of 3 --

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. . 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. . D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on the review of the laboratory's policy, annual competency records in 2020 and 2021, and confirmed in an interview found the technical consultant failed to include 1 of 6 required competency assessment component (assessment of test performance through testing previously analyzed specimens or internal blind testing samples or external proficiency testing) for 3 of 8 TP in 2021 and 1 of 8 TP in 2020 for 1 of 1 Medonic M-series CBC instrument (SN# 27451). The findings were: 1. Review of the laboratory's policy titled Quality Control Program, under Competency Assessment Program, ".... 4. Evaluation: Competency evaluation may consist of the following:... Assessment of test performance through previously analyzed specimens, proficiency testing results, or internal blind specimens...." 2. Review of the annual competency records revealed 3 of 8 TP in 2021 and 1 of 8 TP in 2020 had no documentation of the component of Assessment of test performance (PT/blind samples) records. TP#2 Hired date 1/6/2009 for 2021 TP#4 Hired date 3/2007 for 2021 TP#5 Hired date 3/4/2019 for 2020 and 2021 3. Confirmed in an interview with 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 -- the technical consultant and clinic supervisor on 3/8/22 at 10:38 am in the office confirmed the above findings. Key: TP=Testing Personnel -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. 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. 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 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. 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 2016, 2017 and 2018 American Proficiency Institute (API) proficiency testing (PT) records and confirmed in interview, the laboratory failed to obtain at least 80% for the hematology analyte Red Cell Count (RBC) for 2017 1st event and lymphocytes for the 2016 3rd event. Findings were: 1. Review of PT records for 2017 for red blood cells revealed the laboratory received the following scores for the 2017 Hematology 1st event: API 1st event 2017 = 60% sample lab result (x10E12/L) Hem-01 4.41 acceptable result 3.86 - 4.36 Hem-03 5.54 acceptable result 4.89 - 5.52 2. Review of PT records for 2016 for lymphocytes revealed the laboratory received the following scores for the 2016 Hematology 3rd event: API 3rd event 2016 = 60% sample lab result (%) acceptable result Hem-11 18.7 9.2 - 17.3 Hem-13 14.7 11.9 - 14.6 3. An interivew with the technical consultant on 7/27/18 at 1040 hours in the office confirmed the above findings. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) 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 -- 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: Based on review of the manufacturer's instructions, laboratory policy, patient records, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions to ensure system flags were verified prior to reporting patient results from the Medonic M-series hematology analyzer. Findings were: 1. Review of the Medonic M-series user manual revealed the following