Texas Children's Pediatrics University Association

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on May 19, 2021, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency 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 -- Institute proficiency testing records, the facility failed to achieve successful performance in two of three consecutive testing events for the analyte Platelet count, resulting in unsuccessful performance. Refer to D2121 and 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the facility failed to attain a score of at least 80 percent for the analyte Platelet count in two of three consecutive testing events in 2020 and 2021. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the analyte Platelet count in the specialty of Hematology in two of three consecutive events: 2020 API 2nd event 60% 2021 API 1st event 60% 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. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the facility failed achieve satisfactory performance for the analyte Platelet count in two of three consecutive testing events in 2020 and 2021. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsuccessful performance for the analyte Platelet count in the specialty of Hematology in two of three consecutive events: 2020 API 2nd event 60% 2021 API 1st event 60% Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. 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: -- 2 of 3 -- Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for analyte Platelet count in the speciality of Hematology. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for analyte Platelet count in the specialty of Hematology. Refer to D2016. -- 3 of 3 --

Summary Statement of Deficiencies 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 review of laboratory policies, review of the laboratory's American Proficiency Testing (API) proficiency testing (PT) records, and confirmed in interview of facility personnel, the laboratory failed to provide documentation of 3 of 6 attestation statements being signed by those who were required to sign them. The findings were: 1. Review of the laboratory's policy titled, "Proficiency Testing" (not approved by the current laboratory director) stated, "8. Sign the attestation statements." 2. Review of API's attestation statement form 2019 Hematology /Coagulation (events 1, 2, and 3) and 2020 Hematology (Coagulation (events 1, 2, 3) stated, "Testing personnel and the laboratory director must physically sign an attestation statement for all PT results, and retain the signed statement (or a copy) for a minimum of 2 years. Either the attestation statement below or a printed copy of the form provided online can be used for this purpose." 3. Review of the laboratory's API proficiency testing records from 2019 Hematology/Coagulation (events 1, 2, and 3) and 2020 Hematology/Coagulation (events 1, 2, and 3) found the following attestation statements were not signed: 2020 (event 1) not signed by laboratory director 2020 (event 2) not signed by laboratory director not signed by testing person 2020 (event 3) not signed by laboratory director 4. An interview with testing personnel #1 (as listed on Form CMS-209) on March 24, 2021 at 10:45 hours in the break room confirmed the findings D2121 HEMATOLOGY 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 -- 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 laboratory's American Proficiency Institute (API) proficiency testing (PT) records and confirmed in interview, the laboratory failed to attain a score of at least 80% for each analyte in a testing event. The findings were: 1. Review of the laboratory's PT records for hematology from 2018 (event 3), 2019 (events 1, 2, and 3) and 2020 (events 1, 2, and 3) found the laboratory received the following scores: 2018 Hematology (event 3) RBC (Red Blood Cell) Score: 20% 2020 Hematology (event 2) PLT (Platelet) Score: 60% 2. Failure to achieve a score of at least 80% is unsatisfactory performance for each analyte. 3. The findings were confirmed in interview with testing personnel #1 (as listed on Form CMS-209) on March 24, 2021 at 09:30 hours in the break room. Key: CMS - Centers for Medicare and Medicaid Services D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records and interview, the laboratory failed to retain the QC package inserts used on the CELL-DYN Emerald hematology analyzer for 2020. Findings follow. 1. Review of the QC records from 2020 showed the Cell-Dyn 18 Plus quality control package inserts containing Lot number, Expiration date, target means, and ranges were not retained for 2020. 2. Interview with testing personnel #1, on the CMS Form 209, on March 24, 2021 at 1325 hours in the breakroom confirmed QC package inserts for 2020 were not retained. 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 of the laboratory's policy and procedure and interview, the laboratory failed to perform calibrations every 6 months for the CELL-DYN Emerald hematology analyzer used to test Complete Blood Counts. Findings follow. 1. Review of the laboratory's policy and procedure titled CBC CELL DYN Emerald, effective 10 /01/2015 (see D5407), under CALIBRATION stated, "Calibration of the Cell-Dyn Emerald should occur at least once every 6 months or any time quality control values indicate that the instrument is 'out' of calibration." 2. Review of the maintenance log -- 2 of 5 -- report printed from the instrument showed calibrations had been performed: a. 03/21 /2019, and b. 09/24/2019 (19 months had elapsed). 3. Interview with testing personnel #1, on the CMS Form 209, on March 24, 2021 at 1015 in the breakroom acknowledged they probably did not do calibrations in 2020, and confirmed they were due for another calibration. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedures, interview, and CMS Form 116, the current laboratory director failed to approve, sign and date the laboratory procedures prior to use. Findings follow. 1. Review of the laboratory's policy and procedure titled General Laboratory Policies, effective 03/07/2001, under Procedure Manual Review stated, "the procedure manual will be reviewed at least annually by the laboratory director." 2. Review of the Policy and Procedure Manual Documentation of Review stated, "all procedures in this manual are approved by the Director at the time of adoption and/or revision. Additionally, the Laboratory Director reviews the manual on an annual basis to ensure that all policies and procedures reflect the current testing and operating practices of the laboratory..." showed the last review by the previous Laboratory Director was on 10/25/2017. 3. Review of the laboratory's policy and procedure titled CBC CELL-DYN Emerald, showed the Technical Consultant signed the procedure on 10/01/2015, and the previous Laboratory Director had signed the procedure. 4. Interview with testing personnel #1 on March 24, 2021 at 1500 confirmed the current laboratory director had not signed the laboratory's policies and procedures. 5. Review of CMS Form 116 submitted by the laboratory for a change in Laboratory Director was signed by the current Laboratory Director on 03/06/2020. 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: Based on review of the manufacturer's instructions, laboratory policy and procedures, test reports, and interview, the laboratory failed to follow the manufacturer's instructions for verifying the Complete Blood Count (CBC) indicies with flags tested on the CELL-DYN Emerald on 1 of 1 test reports reviewed with flags. Findings follow. 1. Review of the CELL-DYN Emerald Operator's Manual, 9140846F April 2012, under Section 3 Instrument alarms, Operational Alerts, and Measured Data Flags section WBC Measurand Flags starting on page 3-13 stated, "An Asterisk (*) for count invalidation of (s) suspect measurand flags are displayed with the corresponding results. These flags are generated after the instrument evaluates the measured data for a particular measurand or group of measurands. The result may be -- 3 of 5 -- suspect due to interfering substances or the inability of the instrument to measure a measurand due to a sample abnormality. The name of each flag, how it is displayed, the cause of the flag, and the action to be taken are given in the following explanations." Multiple error flags were listed, including WBC (White Blood Cell) and Differential for the "*" which stated under "Action": "Check the specimen for clots or agglutination. Follow your laboratory's review criteria or review a stained smear to confirm the differential results and verify the WBC count. Redraw and retest the specimen as required." 2. Review of the laboratory's policy and procedure titled CBC CELL-DYN Emerald, effective 10/01/2015 (see D5407), on page 2 under Patient Testing stated, "5. When the cycle is complete, check results for alerts or flags, abnormal results and critical values. 6. Scan the CBC report in the Electronic Medical Record according to the laboratory's EMR reporting policy." 3. Review of instrument printouts from the patient's chart showed a. ID # 00001, at sequence 00009, tested on 10/02/2020 reported the White Blood Cell Differential results including Lymphocytes %, Mids %, Granulocytes %, absolute Lymphocytes, absolute Mids, and absolute Granulocytes, with the * flag. No other test reports were available to verify the counts. 4. Interview with testing personnel #1 on March 24, 2021 at 1340 hours in the breakroom confirmed the testing person should have rerun the sample and redraws if necessary. KEY EMR= Electronic Medical Record D5781

Summary Statement of Deficiencies No Tags 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 --