Eagan Valley Pediatrics

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 review of proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the laboratory failed to successfully participate in White Blood Cell Differential PT under the specialty of Hematology in 2023 and 2024. Finding are as follows: 1. The CMS CASPER Report 0155D and the API 2023 Hematology/Coagulation - 2nd Event Performance Summary and Comparative Evaluation and the 2024 API 2023 Hematology/Coagulation 1st Event Performance Summary and Comparative Evaluation were reviewed on May 1, 2024. The reports indicated the laboratory failed to achieve satisfactory performance for White Blood Cell Differential in two out of 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 -- three consecutive testing events from 2023 and 2024 resulting in unsuccessful performance. See 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 review of proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the laboratory failed to achieve successful PT performance for White Blood Cell Differential testing in two out of three consecutive PT events in 2023 and 2024. Findings include: 1. The CMS CASPER Report 0155D, reviewed on May 1, 2024, indicated the laboratory failed to obtain a White Blood Cell Differential PT successful score of at least 80 percent in two out of three consecutive testing events in 2023 and 2024. 2. The API 2024 Hematology/Coagulation - 1st Event Performance Summary confirmed the laboratory failed to obtain a White Blood Cell Differential PT score of at least 80 percent in two out of three consecutive testing events in 2023 and 2024. -2023 2nd event 60% -2024 1st event 67% . -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Eagan Valley Pediatrics laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on February 9, 2024. The following standard-level deficiencies were cited: 493.801 Testing of proficiency samples 493.1254 Maintenance and function checks 493.1289 Analytic Systems Quality Assessment . 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 document review and interview with laboratory personnel, the Laboratory Director (LD) failed to attest to the integration of proficiency testing samples into the routine patient workload on one of five occasions in 2022 and 2023. In addition, Testing Personnel (TP) failed to do the same on two of five occasions in the same time period. Findings are as follows: 1. The laboratory performed moderate complexity Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:00 a.m. on 02/09/24. 2. The Laboratory performed proficiency testing using the American Proficiency Institute (API) in 2022 and 2023. 3. The LD's signature and the TP's signature were required on the attestation statements for all PT events as indicated in the Proficiency Test Policy and Procedure found in the Policies and Procedures manual. 4. The Laboratory Director failed to sign the attestation statement for one of five PT events reviewed from 2022 and 2023. See below. APT event 2023 Hematology -3 5. The TP failed to sign the attestation 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 -- statement for two of five PT events reviewed from 2022 and 2023. See below. API event 2022 Hematology -3 2023 Hematology -3 5. In an interview at 11:00 a.m. on 02 /09/24, TP1 confirmed the above finding. . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform and document manufacturer required maintenance for the single Hematology analyzer in use in 2022 and 2023. Findings are as follows: 1. The laboratory performed moderate complexity Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:00 a.m. on 02/09/24. 2. A Sysmex KN-21N hematology analyzer was observed as present and available for use during the tour of the laboratory. 3. Manufacturer maintenance requirements for the Sysmex KN-21N analyzer were established in the manufacturer's KN-21N Operator's Manual. See below. Maintenance schedule Frequency Action Daily Shut down Weekly Clean sampling valve tray Monthly Clean waste chamber Clean transducer Quarterly Clean sample rotor valve 4. Documentation of the above required maintenance was not found for the time period reviewed, April 2022 - January 2024. The laboratory was unable to provide the missing documentation upon request. 5. The laboratory performed approximately 625 hematology tests annually as indicated on documentation provided by the laboratory on date of survey. 6. In an interview at 12:55 p.m. on 02/09/24, TP1 confirmed the above findings. TP1 indicated all maintenance activities, with the exception of the weekly maintenance, were tracked and prompted by the analyzer software. TP1 indicated maintenance was performed when prompted by the analyzer software but was not documented. . D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to establish a thermometer maintenance protocol and perform and document thermometer function check activities for one of one thermometers in 2023. Findings are as follows: 1. The laboratory performed moderate complexity Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:00 a.m. on 02/09/24. 2. The following thermometer was observed in the laboratory as present and in use during the tour: Type - Control Solutions VFC -- 2 of 3 -- 400 Vaccine Temperature Data Logger Location - Refrigerator Serial number - 7862975685 Calibration expiration - 11/08/23 The refrigerator held Hematology testing supplies and patient specimens. 3. A thermometer function check protocol was not found during review the laboratory's Policies and Procedures manual. 4. Thermometer function check documentation was not found during review of laboratory records. 5. The laboratory was unable to provide a thermometer maintenance protocol or documentation of thermometer function checks for the above equipment upon request. 6. The laboratory performed approximately 625 hematology tests annually as indicated on documentation provided by the laboratory on date of survey. 7. In an interview at 12:20 p.m. on 02/09/24, TP1 confirmed the above findings. . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to follow an established quality assurance procedure in seven of twenty two months reviewed from April 2022 through January 2024. Findings are as follows: 1. The laboratory performed moderate complexity Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:00 a.m. on 02/09/24. 2. A Sysmex KN-21N hematology analyzer was observed as present and available for use during the tour of the laboratory. 3. Ten chart audits were required monthly as established in the Policy and Procedure Monthly Clerical Error Chart Audit procedure found in the Monthly Clerical Error Chart Audit manual. 4. Chart audit documentation from July 2023 through January 2024 was either incomplete or not found during review of laboratory records. See below. 2023 Month Charts audited July 3 August 0 September 5 October 0 November 0 December 0 2024 Month Charts audited January 0 The laboratory was unable to provide the missing documentation upon request. 5. The laboratory performed approximately 625 hematology tests on patient specimens annually as indicated on documentation provided by the laboratory on date of survey. 6. In an interview at 12:25 p.m. on 02/09/24, TP1 confirmed the above finding. . -- 3 of 3 --

Summary Statement of Deficiencies 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 document review and interview with laboratory personnel, the Laboratory Director failed to provide overall management and direction to ensure testing personnel competency was assessed annually in accordance with 493.1407 of this subpart. Findings are as follows: 1. The Laboratory Director failed to ensure 1 of 2 testing personnel in 2020 and 1 of 3 testing personnel in 2021 were evaluated annually for test procedure competency. See D6030 2. D6030 was previously cited during the 09/02/20 survey. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; 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 document review and interview with laboratory personnel, the Laboratory Director failed to ensure 1 of 2 testing personnel in 2020 and 1 of 3 testing personnel in 2021 were evaluated annually for test procedure competency. Findings are as follows: 1. The laboratory was cited for non-performance of annual competency evaluations during the two previous surveys conducted on 04/19/18 and 09/02/20. 2. Annual competency evaluations were not found on date of current survey, 04/08/22, for 1 of 2 testing personnel in 2020 records and 1 of 3 testing personnel in 2021 records. See D6054. 3. In an interview at 2:15 p.m. on 04/08/22, Testing Personnel 1 confirmed the above finding. *This is a repeat citation. This deficiency was previously cited during the 09/02/20 survey.* . 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: . Based on document review and interview with laboratory personnel, the Technical Consultant failed to evaluate the competency of 1 of 2 testing personnel in 2020 and 1 of 3 testing personnel in 2021. Findings are as follows: 1. The laboratory performed Microbiology and Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 1:05 p.m. on 04/08/22. 2. The Quality Assurance procedure located in the Policies and Procedures manual indicated personnel were evaluated semi-annually during the first year of employment and annually thereafter. 3. A 2020 Hematology annual competency assessment for TP2 was not found during review of the laboratory's records. The laboratory was unable to provide the document upon request. 4. 2021 Hematology and Microbiology annual competency assessments for TP2 were not found during review of the laboratory's records. The laboratory was unable to provide the documents upon request. 5. In an interview at 2:15 p.m. on 04/08 /22, TP1 confirmed the above finding. *This is a repeat citation. This deficiency was previously cited during the 04/19/18 and 09/02/20 surveys.* -- 2 of 2 --

Summary Statement of Deficiencies 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 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 observation, document review and interview with laboratory personnel, the laboratory failed to establish a function check procedure and maintain function check records for all laboratory equipment. Findings are as follows: The laboratory performed Chemistry, Hematology, and Microbiology testing as confirmed by Testing Personnel 1 (TP-1) during a tour of the laboratory on 04/19/18 at 9:05 a.m. A. Refrigerators 1. Two Danby single-door refrigerators were observed as present and available for use during a tour of the laboratory. 2. A Fisher Scientific digital electronic temperature monitor was observed as attached to each of the refrigerators to display internal temperatures. Monitor Unit Manufacturer Calibration Serial Number Expiration Date 3154 3 / 2018 3155 3 / 2018 3. The laboratory was unable to provide a function check procedure or calibration records for the above equipment upon request. 4. In an interview on 04/19/18, at 11:30 a.m., TP-1 confirmed that the thermometer units were outside of the manufacturer calibration period, and that a function check procedure for the above equipment had not been established, and function check records for the thermometers were not available. B. Incubator 1. A Boekol Inc. Incubator was observed as present and available for use during a tour of the laboratory. 2. The incubator was equipped with an internal digital temperature 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 -- display, but no other temperature monitoring device. 3. The laboratory was unable to provide a function check procedure or calibration records for the above equipment upon request. 4. In an interview on 04/19/18, at 11:30 a.m., TP-1 confirmed that a function check procedure for the above equipment had not been established, and function check records for the thermometers were not available. . D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to perform calibration verification on a hematology analyzer at least once every 6 months. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Testing Personnel 1 (TP-1) during a tour of the laboratory on 04/19/18 at 9:05 a.m. 2. A Sysmex KN-21 hematology analyzer was observed as present and available for use during a tour of the laboratory. 3. The laboratory exceeded the 6 month calibration verification interval for the Sysmex KN-21 hematology analyzer on one occasion in the time period reviewed; March 2016 through date of survey. See below: Previous cal. Subsequent cal. Time elapsed 01/27/17 10/25/17 9 months 4. The laboratory was unable to provide additional calibration verification records between 01 /27/17 and 10/25/17. 5. In an interview on 04/19/18 at 2:45 p.m., the TP-1 confirmed the above findings. . D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: -- 2 of 3 -- . Based on document review and interview with laboratory personnel, the Technical Consultant (TC) failed to assess the competency of 2 of 4 new Testing Personnel at least twice annually during the first year of testing. Findings are as follows: 1. The laboratory performed Chemistry, Hematology, and Microbiology testing as confirmed by Testing Personnel 1 (TP-1) during a tour of the laboratory on 04/19/18 at 9:05 a.m. 2. Semi-annual competency assessments for 2 of 4 Testing Personnel (TP) were not found during review of laboratory records as follows: Testing Personnel Testing Area TP-4 Throat Culture Hematology TP-5 Throat Culture Hematology 3. The laboratory was unable to provide the required documentation upon request. 4. In an interview on 04/19/18 at 10:30 a.m., the TP-1 confirmed the above findings. . 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: . Based on observation, document review and interview with laboratory personnel, the Technical Consultant failed to ensure comprehensive competency assessments for 3 of 4 Testing Personnel were performed annually. Findings are as follows: 1. The laboratory performed Chemistry, Hematology, and Microbiology testing as confirmed by Testing Personnel 1 (TP-1) during a tour of the laboratory on 04/19/18 at 9:05 a.m. 2. Annual competency assessments for 3 of 4 Testing Personnel (TP) were not found during review of laboratory records as follows: Testing Personnel Testing Area Year TP-2 Throat Culture 2017 Hematology 2017 TP-3 Throat Culture 2016 Throat Culture 2017 Hematology 2017 TP-4 Throat Culture 2017 Hematology 2017 3. The laboratory was unable to provide the missing competency assessments upon request. 4. In an interview on 04/19/18 at 10:30 a.m., the TP-1 confirmed the above findings. . -- 3 of 3 --