Purohit Pediatric Clinic Grandview

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Reichert Bilirubinometer Bilirubin Quality Control (QC) logs, QC procedures for Bilirubin, and an interview with the Testing Personnel (TP) #1, the laboratory failed to ensure two levels of QC were documented prior to Proficiency Testing (PT). The surveyor noted no QC was documented for six out of six PT events from 2023 and 2024. The findings include: 1. A review of the Reichert Bilirubinometer Bilirubin QC records revealed no evidence of doumented QC testing prior to performing the following PT events: a) 2023 Chemistry First Event b) 2023 Chemistry Second Event c) 2023 Chemistry Third Event d) 2024 Chemistry First Event e) 2024 Chemistry Second Event f) 2024 Chemistry Third Event 2. A further review of the Quality Control Procedures for Bilirubin revealed "The lab personnel is required to document control dates, ranges, and results..." The Clinical Laboratory Improvement Amendments require "treat proficiency testing samples in the same manner as it treats materials derived from the human body referred to it for laboratory examinations." The laboratory documents QC for patients and should also document QC for PT samples. 3. TP #1 confirmed these finding during the exit conference on 11-07-2024 at 2:20 PM. 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 D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of the Hematology quality control records and function checks for the Medonic, a review of the online Operators' Manual, and an interview with the laboratory manager, the surveyor determined the laboratory staff failed to ensure acceptable background counts were achieved, prior to running patient specimens. This affected four days in 2019 of random quality control/function checks review for eleven months in 2019 and 2020. The findings include: 1. A review of the quality control and function check records for 2019 and 2020 revealed the following: a) On 3 /29/19, 4/05/19 and 4/12/19: all parameters (White Blood Cell Count, Red Blood Cell Count, Hemoglobin and Platelet Count) coded DP, diluent system problem - run prime cycle. No repeat performance of the function checks were documented. b) On 7 /18/19, the platelet count of the background check read 18 High (acceptable range is 0 -10). No repeat performance of the function check was documented. 2. In an interview on 11/24/2020 at 11:34 AM, the surveyor asked the Laboratory Manager (LM) what staff were trained to do, when background counts are outside of acceptable ranges. The LM stated the background count should be repeated. When asked what should be done if a diluent flag was obtained, the LM stated the system should be primed and the background count should be rerun. The surveyor discussed with the laboratory 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 -- manager the validity of results if the background count fails. 3. A review of the online Operators' Manual for the Medonic, page 38, section 5.2 Startup Sequence, revealed the following: "...When complete the background count results are displayed. If the results are acceptable (see table for accepted background values according to section 5.3)... Note If the background count results have a H (high) indicator press [RERUN] and follow the screen instructions to analyze the background count again..." -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policy and procedure manual, a review of an IQCP (Individualized Quality Control Plan), quality control and installation records, patient logs, and an interview with Testing Personnel (TP) #1(also the Clinic Manager), the surveyor determined the laboratory failed to ensure an IQCP was established and implemented for this laboratory to include risk factors and mitigation of risks associated with this laboratory. The laboratory utilized its sister laboratory's IQCP, which was developed prior to the opening of this laboratory and prior to the establishment of any historical data related to factors, which may affect this laboratory. The findings include: 1. The initial certification survey was conducted on 10/24/2018. 2. A review of the installation records revealed the Reichert Unistat Bilirubinometer (Routine Chemistry testing) was installed in June of 2018. The laboratory's first patient specimen was tested in mid-July. 3. A review of the policy and procedure manual revealed quality control testing for the Bilirubinometer (Bilirubin) included two manufacturer cuvettes for high and low levels were tested daily. Two external liquid controls were tested at least once per month, based on an IQCP plan (see paragraph 4). 4. A review of the IQCP for Bilirubins revealed a page which referenced the use of the plan at two sister facilities. Further review revealed 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 Laboratory Director signed the plan, dated 10/01/2017, one year prior to this laboratory's opening. 5. At 11:06 AM on 10/24/2018, the surveyor asked TP #1 if the same exact plan was utilized at the other two facilities. TP #1 answered yes the plan was the same one. When asked, TP #1 stated no historical data had been established for this laboratory at the time of opening to develop an IQCP. Thus, the elements of risk (Testing Personnel, Environment, Reagents, Test System and Specimen) were considered in general terms, and not unique to this laboratory. The surveyor discussed with the testing personnel the possibility of these elements being affected differently by factors which may be unique to this site, or at least different (such as ability of testing personnel to perform, environmental factors, the test system, etc. 6. A review of the quality control records revealed the external controls, two levels, were being tested once per month. 7. The patient logs revealed 9-10 patients had been tested from July - October 24, 2018. Patricia Watson, BS, MT (ASCP) Licensure and Certification Supervisor -- 2 of 2 --