Bloomington Pediatrics, Ltd

Summary Statement of Deficiencies 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 laboratory records and interview with the laboratory director (LD); the laboratory failed to test proficiency testing (PT) samples with the same methodology used for patient specimens when analyzing and reporting PT results for total bilirubin and direct bilirubin testing in 2019 through 2021. Findings Include: 1. Review of the laboratory's American Academy of Family Physicians (AAFP) attestation statements indicated the following for the handling of total and direct bilirubin samples, "have as closely as practical, performed the analyses on these specimens in the same manner as regularly performed on patient samples". 2. Review of total and direct bilirubin calibration records found each date PT samples were ran the laboratory performed a calibration of the BR-2 Bilirubin Stat-Analyzer photometer for seven of seven PT dates reviewed form 2019 through 2021. 3. Interview on 08-20- 2021 with the LD at 12:35 pm confirmed the LD performed calibrations prior to running PT samples for direct and total bilirubin but this calibration is not performed each day of patient testing. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 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: A. Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to test proficiency testing (PT) samples by personnel who routinely perform testing in the laboratory for total and direct bilirubin in 2019 through 2021. Findings Include: 1. Review of the laboratory's policy and procedure manual identified testing personnel authorizations, which documented 3 of 19 testing personnel (TP) listed on the CMS-209 (Laboratory Personnel Report) who were authorized to perform total and direct bilirubin testing. 2. Review of the American Academy of Family Physicians (AAFP) PT attestation statements for total and direct bilirubin testing from 2019 through 2021 found TP#1 performed seven of seven PT events. 3. On survey date 08-20-2021, at 12:35 pm the LD confirmed two of three TP who were authorized to perform total and direct bilirubin testing failed to participate in PT for seven of seven PT events in 2019 through 2021. B. Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to test proficiency testing (PT) samples by personnel who routinely perform testing in the laboratory for throat and urine cultures in 2019 through 2021. Findings Include: 1. Review of the laboratory's policy and procedure manual identified testing personnel authorizations, which documented 4 of 19 testing personnel (TP) listed on the CMS-209 (Laboratory Personnel Report) who were authorized to perform and report test results for throat and urine cultures. 2. Review of the American Academy of Family Physicians (AAFP) PT attestation statements for throat and urine culture testing from 2019 through 2021 found TP#1 performed six of seven PT events and the other event was performed by TP#3. 3. On survey date 08-20-2021, at 12:35 pm the LD confirmed two of four TP, who were authorized to perform throat and urine testing failed to participate in PT for seven of seven PT events in 2019 through 2021. C. Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to test proficiency testing (PT) samples by personnel who routinely perform testing in the laboratory for bacteriology/virology tests performed on the Cepheid GeneXpert analyzer. Findings Include: 1. Review of the laboratory's policy and procedure manual identified testing personnel authorizations, which documented 19 of 19 testing personnel (TP) listed on the CMS-209 (Laboratory Personnel Report) who were authorized to perform and report test results for testing performed on the Cepheid GeneXpert. Test Menu Chlamydia Neisseria gonorrhoeae Influenza A Influenza B Respiratory Syncytial Virus (RSV) SARS-CoV-2 Group A Streptococcus (GAS) 2. Review of the American Academy of Family Physicians (AAFP) PT attestation statements for Cepheid GeneXpert testing from 2019 through 2021 found 5 of 19 TP performed seven of seven PT events for all seven analytes identified in finding number one. 3. On survey date 08-20-2021, at 12:35 pm the LD confirmed 5 of the 19 TP, who were authorized to perform testing for all seven analytes on the Cepheid GeneXpert had participated in PT for seven of seven PT events in 2019 through 2021. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. -- 2 of 9 -- The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to retain testing documentation for throat and urine cultures performed for seven of seven proficiency testing (PT) events in 2019 through 2021. Findings Include: 1. Review of the American Academy of Family Physicians (AAFP) records from 2019 through 2021 found the laboratory failed to retain any documentation related to the testing of urine and throat culture specimens for seven of seven proficiency testing events reviewed in 2019 through 2021. 2. On survey date 8- 20-2021, at 12:35 pm, the LD confirmed the laboratory failed to retain any documentation related to PT for throat and urine cultures for the seven of seven PT events reviewed in 2019 through 2021. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to document review for four of seven proficiency testing (PT) events for all analytes in 2019 through 2021. Findings Include: 1. Review of American Academy of Family Physicians (AAFP) PT records from event B of 2019 through event B of 2021 revealed the laboratory failed to document review of PT results for all analytes for the following events: Events B & C of 2019 Events A & B of 2021 2. On survey date 8-20-2021, at 12:35 pm, the LD confirmed the laboratory failed to document review of PT results for events identified above. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 records and interview with the technical consultant (TC); the laboratory failed to ensure all testing personnel (TP), who performed proficiency testing (PT), signed the attestation statement for 5 of 6 PT events in 2017 through 2018. Findings Include: 1. Review of American Academy of Family Physicians (AAFP) PT records found for 5 of 6 events in 2017 through 2018 that the attestation statements were not signed by the personnel performing the testing. a. 2018 Event C found the attestation statement was not signed by the TP who performed the readings of urine cultures, bilirubin, and lead testing. b. 2018 Event A found the attestation statement was not signed by TP#10 who performed some of the bilirubin testing. c. 2017 Event C found the attestation statement was not signed by TP#10 who performed bilirubin testing. d. 2017 Event B found the attestation statement was not signed by TP#5 who performed the reading of urine cultures. e. 2017 Event A found the attestation statement was not signed by TP#1 who performed the bilirubin and lead testing. 2. Interview with the TC on survey date 4-17-2019, at 3:35 pm, confirmed all TP failed to sign the AAFP attestation statements for 5 of 6 PT events in 2017 through 2018. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the technical consultant (TC); the laboratory failed to establish policies and procedures to assess competency of all personnel listed on the CMS-209 (Laboratory Personnel Report). Findings Include: 1. Review of the laboratory's policy and procedure manual identified the policy, "Laboratory Personnel Competency Evaluation", which failed to address competency for the technical consultant. 2. On survey date 04-17-2019 at 03:35 pm, the TC confirmed the above findings. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the technical consultant (TC); the laboratory failed to evaluate ungraded neonatal bilirubin (Direct) proficiency testing (PT) scores for 6 of 6 PT events reviewed in 2017 through 2018. Findings Include: 1. Review of American Academy of Family Physicians (AAFP) PT records found for 6 of 6 PT event in 2017 through 2018 AAFP did not grade PT results for neonatal bilirubin (Direct). 2. Review of PT documentation found no assessment of ungraded neonatal bilirubin (Direct) PT scores. 3. Review of test volume records indicate between January 5, 2018 and January 5, 2019, 208 patient test results were documented for neonatal bilirubin (Direct). 4. On survey date 4-17- 2019, at 3:35 pm, the TC confirmed ungraded neonatal bilirubin (Direct) were not reviewed for 6 of 6 PT events in 2017 through 2018. 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: A. Based on review of laboratory records and interview with the technical consultant (TC); the laboratory failed to demonstrate it can obtain performance specifications for influenza A & B testing on the Cepheid GeneXpert prior to patient testing. Findings Include: 1. During tour of the laboratory facility on 4-16-2019, at 10:28 am, the TC confirmed the laboratory began influenza A & B testing using the Cepheid GeneXpert analyzer in October of 2018. 2. Review of the laboratory policy and procedure manual identified the policy, "New Tests", which states the following: "The lab will verify the -- 2 of 5 -- manufacture's performance specifications provided in the package insert - for accuracy, precision, reportable range, and reference ranges for each new, moderate complexity test." 3. Review of verification documentation found no data showing the accuracy, precision, and reportable range had been verified for influenza testing on the Cepheid GeneXpert analyzer for influenza A&B testing. 4. Review of the test volume worksheet indicate 2,183 patient tests were performed between January 5, 2018 to January 5, 2019 for influenza A & B. 5. On survey date 04-17-2019, at 3:35 pm, the TC confirmed no analysis had been documented to show the accuracy, precision and verification of the reportable range. B. Based on review of laboratory records and interview with the technical consultant (TC); the laboratory failed to demonstrate it can obtain performance specifications for streptococcus A testing on the Cepheid GeneXpert prior to patient testing. Findings Include: 1. During tour of the laboratory facility on 4-16-2019, at 10:28 am, the TC confirmed the laboratory began streptococcus A testing using the Cepheid GeneXpert analyzer in October of 2018. 2. Review of the laboratory policy and procedure manual identified the policy, "New Tests", which states the following: "The lab will verify the manufacture's performance specifications provided in the package insert - for accuracy, precision, reportable range, and reference ranges for each new, moderate complexity test." 3. Review of verification documentation found no data showing the accuracy, precision, and reportable range had been verified for streptococcus A testing on the Cepheid GeneXpert analyzer. 4. Review of the test volume worksheet indicate 5,190 patient tests were performed between January 5, 2018 to January 5, 2019 for streptococcus A. 5. On survey date 04-17-2019, at 3:35 pm, the TC confirmed no analysis had been documented to show the accuracy, precision and verification of the reportable range. 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 review of laboratory records and interview with technical consultant (TC); the laboratory failed to develop a complete Individual Quality Control Plan (IQCP) for influenza A & B and streptococcus A testing on the Cepheid GeneXpert analyzer. Findings include: 1. Interview with the TC on 4-16-2019, at 10:28 am, confirmed the laboratory had developed an IQCP for testing on the Cepheid GeneXpert analyzer. 2. Review of the IQCP documentation for influenza A & B and streptococcus A testing on the Cepheid GeneXpert analyzer found the IQCP failed to address the following required components of an IQCP: a. Risk Assessment - Failed to address the specimens, test system, reagents, and environment and cover the entire test process from pre-analytical, analytical, and post analytical processes as well as supporting documentation. b. Quality Control Plan - No plan identified. c. Quality Assessment - No plan identified. 3. Review of the laboratory test volume worksheet indicated 7,373 patient tests were performed on the Cepheid GeneXpert for Influenza A&B and streptococcus A from January 5, 2018 through January 5, 2019. 4. On survey date 04- -- 3 of 5 -- 17-2019, at 3:35 pm, the TC confirmed the laboratory failed to have a complete IQCP for testing on the Cepheid GeneXpert analyzer. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the technical consultant (TC); the laboratory failed to include all the required components of a laboratory test report for 8 of 8 streptococcus A test reports reviewed for testing on the Cepheid GeneXpert. Findings Include: 1. Review of 8 of 8 patient test reports for streptococcus A testing on the Cepheid GeneXpert found the laboratory failed to clearly indicate the test result: a. Patient #: C2, Test Date: 02-14-2019 b. Patient #: C3, Test Date: 02-16- 2019 c. Patient #: C5, Test Date: 11-09-2018 d. Patient #: C7, Test Date: 12-20-2018 e. Patient #: C11, Test Date: 11-10-2018 f. Patient #: C12, Test Date: 11-09-2018 g. Patient #: C14, Test Date: 12-20-2018 h. Patient #: C15, Test Date: 01-23-2019 2. On survey date 4-17-2019, at 3:35 pm, the TC confirmed the patient test reports seem to indicate the result from the Preliminary Quidel Rapid Strep A test and not the result from the Cepheid GeneXpert test system. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: A. Based on review of laboratory records and interview with the technical consultant (TC); the TC failed to ensure annual competency assessments were completed for 5 of 5 testing personnel (TP) performing urine cultures in 2017 and 2018. Findings Include: 1. Review of the laboratory policy and procedure manual identified the policy, "Laboratory Personnel Competency Evaluation", which includes a competency evaluation form. 2. Review of competency assessment records for 5 of 5 TP (#1, 2, 3, 4, 5), who perform urine culture testing, failed to have competency assessment forms completed in 2017. 3. Review of competency records for 2018 found assessment of test performance documentation was documented, however 2 of 5 testing personnel miss read urine culture results and no