Springs Pediatrics

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 laboratory 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 proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2023 records (1st and 2nd events), the laboratory failed to successfully participate 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 failed to successfully participate in the specialty of Hematology for the cell identification or white blood cell differential (Cell ID or WBC Diff) analyte. (Refer to D2130) 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 a proficiency testing desk review of the CASPER-0155 and API records (API) 2023 records (1st and 2nd events), the laboratory failed to achieve satisfactory performance (80% or greater) for two consecutive testing events in the specialty of Hematology for the cell identification or white blood cell differential (Cell ID or WBC Diff). 1. A review of the CASPER-0155 report revealed the following: Hematology 2023- 1st Event The Laboratory received an unsatisfactory score of 0% for the Cell ID or WBC Diff analyte. Hematology 2023- 2nd Event The Laboratory received an unsatisfactory score of 76% for the Cell ID or WBC Diff analyte. 2. A review of proficiency testing records from API 2023 confirmed the above findings. 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 proficiency testing desk review of the CASPER-0155 Individual Laboratory Report and API 2023 records (1st and 2nd events), 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: -- 2 of 3 -- Based on a proficiency testing desk review of the CASPER-0155 and API 2023 records (1st and 2nd events), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. (Refer to 2130) -- 3 of 3 --

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 laboratory 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 proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2020 (events 2 and 3), 2022 records (2nd event) and 2023 records (1st event), the laboratory failed to successfully participate 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 failed to successfully participate in the specialty of Hematology for the Red Blood Cell (RBC) analyte. (Refer to D2130) 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 a proficiency testing desk review of the CASPER-0155 and API records, the laboratory failed to achieve satisfactory performance (80% or greater) for two consecutive testing events in 2020 (events 2 and 3) and two of three testing events in 2022 (event 2) and 2023 (event 1) in the specialty of Hematology for the Red Blood Cell (RBC) analyte. 1. A review of the CASPER-0155 report revealed the following: Hematology 2020- 2nd event The laboratory received an unsatisfactory score of 0% for the RBC analyte. Hematology 2020- 3rd Event The laboratory received an unsatisfactory score of 20% for the RBC analyte. Hematology 2022- 2nd Event The laboratory received an unsatisfactory score of 60% for the RBC analyte. Hematology 2023- 1st Event The laboratory received an unsatisfactory score of 0% for the RBC analyte. 2. A review of proficiency testing records from API 2020, 2022 and 2023 confirmed the above findings. 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 proficiency testing desk review of the CASPER-0155 Individual Laboratory Report and API 2020 (events 2 and 3), 2022 (event 2) and 2023 (event 1) records, 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER-0155 and API 2020 (events 2 and 3), 2022 (event 2) and 2023 (event 1) records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. (Refer to 2130) -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 03/13/2023 and the laboratory was found not to be in substantial compliance with the laboratory requirements at 42 CFR Part 493, with deficiencies cited. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director, the laboratory failed to perform twice annual accuracy verification of urine colony counts for two of two years (2021-2022). The findings include: Review of laboratory testing records revealed the required twice annual accuracy assessment for the urine colony counts by Uricult was not being performed. Review of the undated "Uricult CLIA Compliance Reference Guide", revealed "No standard proficiency survey required but must participate in a bi-annual assessment program". During an interview on 03/13/2023 at 3:05 PM, the Laboratory Director stated the required accuracy assessment was not performed because she was told by a former consultant that the Uricult device test was a waived device. 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. 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 record review and interview, it was determined the laboratory failed to run a negative and positive control for urine colony counts for two (2) of two (2) years reviewed (2021 and 2022). The findings include: Review of the laboratory procedure manual revealed there was not a procedure for performing quality control for the urine colony counts by the Uricult device test. A review of the "CLIA Application for Certification", signed by the Laboratory Director (LD) and dated 03/07/2023, revealed urine colony counts, a waived test, by the Uricult device test was performed. Review of the undated "Uricult CLIA Compliance Reference Guide", revealed "Quality Control 1. a - Prepare Individualized Quality Control Plan (IQCP) Risk Assessment or b - Perform a positive and negative control with each shipment or Lot Number every six (6) months and 2. Visually inspect Uricult vials for damage, contamination and excess moisture before use. 3. Remove Certificate of Analysis from package insert and save". During an interview on 03/13/2023 at 3:05 PM, the LD stated the required quality controls were not performed because she was told by a former consultant that the Uricult device test was a waived device. -- 2 of 2 --

Summary Statement of Deficiencies 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 desk review of Bacteriology proficiency testing results from the American Proficiency Institute proficiency testing agency on 05/06/2019, the laboratory failed to successfully participate in the specialty of Bacteriology in two consecutive testing events. See D2020 and D2028 D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory 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 -- performance. This STANDARD is not met as evidenced by: Based on desk review of Bacteriology proficiency testing results from American Proficiency Institute on 05/06/2019, the laboratory failed to attain an overall testing score of 80 percent in two consecutive testing events. Findings include: The laboratory scored 0 percent in the third testing event of 2018, and scored 40 percent in the first testing event of 2019 for unsatisfactory performances. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of Bacteriology proficiency testing results from American Proficiency Testing agency on 05/06/2019, the laboratory failed to achieve satisfactory performance in two consecutive testing events in the specialty of Bacteriology. Findings include: The laboratory scored 0 percent in the third testing event of 2018 and scored 40 percent in the first testing event of 2019 for unsuccessful performances. -- 2 of 2 --

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on staff interview and record review, the Technical Consultant failed to perform and document annual competency using the six (6) mandated competency assessment requirements for testing personnel. Competency assessment was performed using zero (0) of six (6) methods of assessment for three (3) out of three (3) employees from July 12, 2016 through August 7, 2018. Findings include: Record review on 08/08/2018 revealed there was no documented competency assessments between July 12, 2016, and August 7, 2018, for three (3) employees that included the following: direct observation of routine patient test performance, direct observation of performance of instrument maintenance function checks and calibration, monitoring the recording and reporting of test results, review of worksheets, review of quality control records, review of proficiency test results, review of maintence records, assessment of testing external proficiency testing samples and problem solving skills. An interview with the staff on 08/08/2018 at 9:10 AM revealed the facility failed to have a system in place between July 12, 2016, and August 7, 2018, to ensure competency was performed using all six (6) mandated competency assessment requirements. 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 --