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Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey completed on September 9, 2025. 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 review of laboratory policy, laboratory proficiency testing records, and confirmed in interview, the laboratory failed to ensure successful twice annual accuracy for Troponin performed on the Triage chemistry analyzer for records reviewed in 2023. The findings included: 1. Review of the laboratory policy titled "Laboratory Procedure Proficiency Testing", effective, November 1, 2020, stated the following: "The purpose of proficiency testing is to provide an external method of verifying the overall quality of the laboratory functions to include all regulated and unregulated analytes." Subsection "E.

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: I. Based on review of the manufacturer's instructions, quality control (QC) records, patient testing logs, and interview, the laboratory failed to document the results of the internal procedural controls for the Consult Diagnostics hCG (human chorionic gonadotropin) Urine Test Cassette for 21 of 21 patients tested from 03/04/2023 - 03/19 /2023. Findings follow. A. Review of the McKesson Consult Diagnostics hCG Urine Test Cassette, Rev 00 12/15, under Quality Control stated, "Internal procedural controls are included in the test. A red line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. A clear background is an internal negative background control. If the test is working properly, the background in the result area should be white to light pink and not interfere with the ability to read the test result..." B. Review of the Laboratory Master Specimen Log from 03/04/2023 - 03/19/2023 showed the documentation of the QC and patient testing logs: and showed 17 out of 21 patients missing the results of the positive procedural control, and 20 out of 21 patients missing the results for the negative procedural control: Date of Service Account # Missing Procedural Control 1. 03/19/2023 22684 Neg 2. 03/14/2023 22588 Neg 3. 03 /13/2023 22572 Neg 4. 03/13/2023 22556 Pos & Neg 5. 03/13/2023 22571 Neg 6. 03 /12/2023 22521 Pos & Neg 7. 03/11/2023 22504 Neg 8. 03/11/2023 22490 Neg 9. 03 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 -- /10/2023 22473 Neg 10. 03/09/2023 22450 Pos & Neg 11. 03/08/2023 22428 Neg 12. 03/08/2023 22434 Pos 13. 03/08/2023 22416 Neg 14. 03/07/2023 22397 Neg 15. 03 /07/2023 22392 Neg 16. 03/07/2023 22385 Neg 17. 03/07/2023 22387 Neg 18. 03/07 /2023 22383 Neg 19. 03/07/2023 22384 Neg 20. 03/06/2023 22356 Neg 21. 03/05 /2023 22333 Neg C. Interview with Technical Consultant #2, as listed on the CMS Form 209, on May 11, 2023 at 1835 hours in the laboratory acknowledged they should be documenting the internal controls. Interview with testing personnel #8 on May 11, 2023 at 1900 hours in the break room acknowledged he was not aware of a negative procedural control. II. Based on review of the manufacturer's instructions, quality control records, patient testing logs, and interview, the laboratory failed to document the results of the internal procedural controls for the Consult Diagnostics Strep A Tests Dipstick for 10 of 10 patients tested from 03/04/2023 - 03/19/2023. Findings follow. A. Review of the McKesson Consult Diagnostics Strep A Tests Dipstick, PVN C0218, under Internal Quality Control stated, "Internal procedural controls are included in the test. A red line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. A clear background is an internal negative background control. If the test is working properly, the background in the result area should be white to light pink and not interfere with the ability to read the test result." B. Review of the Laboratory Master Specimen Log from 03/04/2023 - 03/19/2023 showed the documentation of the QC and patient testing logs: and showed 4 out of 10 missing the results of the positive procedural control, and 6 out of 10 missing the results for the negative procedural control: Date of Service Account # Missing Procedural Control 1. 03/19/2023 22691 Neg 2. 03/13/2023 22551 Neg 3. 03/10/2023 22486 Neg 4. 03/08 /2023 22422 Neg 5. 03/07/2023 22406 Neg 6. 03/06/2023 22378 Pos 7. 03/07/2023 22381 Pos 8. 03/06/2023 22374 Neg 9. 03/05/2023 22348 Pos 10. 03/06/2023 22353 Pos C. Interview with Technical Consultant #2, as listed on the CMS Form 209, on May 11, 2023 at 1835 hours in the laboratory acknowledged they should be documenting the internal controls. Interview with testing personnel #8 on May 11, 2023 at 1900 hours in the break room acknowledged he was not aware of a negative procedural control. III. Based on review of the manufacturer's instructions, quality control records, patient testing logs, and interview, the laboratory failed to document the results of the internal procedural controls for the Consult Diagnostics Mononucleosis Tests Cassette for 1 of 1 patients tested from 03/04/2023 - 03/19/2023. Findings follow. A. Review of the McKesson Consult Diagnostics Mononucleosis Tests Cassette, Rev.00 12/15 P-52021-B, under Quality Control stated, "There are two internal control features in McKesson Consult Mononucleosis Cassette Test. A colored control band will always appear at the Control position (C) if the test has been performed correctly and if the device is working properly. This is considered an internal positive procedural control. A clear background in the result window is considered an internal negative procedural control. If the test has been performed correctly and McKesson Consult Mononucleosis Cassette Test is working properly, the background in the result window will be clear, providing a distinct result." B. Review of the Laboratory Master Specimen Log from 03/04/2023 - 03/19/2023 showed the documentation of the QC and patient testing logs: and showed 1 out of 1 missing the results of the negative procedural control: Date of Service Account # Missing Procedural Control 1. 03/19/2023 22691 Neg C. Interview with Technical Consultant #2, as listed on the CMS Form 209, on May 11, 2023 at 1835 hours in the laboratory acknowledged they should be documenting the internal controls. Interview with testing personnel #8 on May 11, 2023 at 1900 hours in the break room acknowledged he was not aware of a negative procedural control. D5441 CONTROL PROCEDURES -- 2 of 3 -- CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records, installation records, interview, and pre-survey paperwork, the laboratory failed to monitor over time the accuracy and precision of the Complete Blood Count (CBC) performed on the Sysmex XP-300 for 17 of 18 months reviewed. Findings follow. A. Review of QC records showed no monthly QC reports for the CBC which included calculations for mean and standard deviation (SD), along with QC target ranges prior to 03/30/2023. B. Review of the installation records showed the analyzer was installed on 11/04/2021. C. Interview with Technical Consultant #2, as listed on the CMS Form 209, on May 11, 2023 at 1535 hours in the laboratory confirmed the lab did not print QC reports showing daily QC performance, Levy Jennings, calculations for mean and SD, and the target ranges. D. Review of the CMS Form 116 showed an estimated 12,000 measured indices reported annually. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of the proficiency testing records, competency evaluation forms, and interview, the technical consultant failed to assess test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples for 5 out of 11 testing personnel competencies reviewed for the Complete Blood Counts (CBC) on the Sysmex XP-300, Troponin and D-Dimer using the Triage Alere, and Metlac 12 on the Piccolo Xpress. Findings follow. A. Review of the American Proficiency Institute (API) proficiency testing records attestation statements from the 1st event of 2023, and the 1st, 2nd, and 3rd events from 2022 showed testing personnel #1, 2, 5, 6, and 11, as listed on the CMS form 209, did not participate in proficiency testing. B. Review of the competency evaluations from 2022 stated, "Performs Proficiency Testing" with n/a or a line marked through for testing personnel # 2, 5, 6, and 11 for the CBC, Troponin, D-Dimer, and the Metlac 12. C. Interview with Technical Consultant #2, as listed on the CMS Form 209, on May 11, 2023 at 1450 hours in the break room confirmed test performance through previously analyzed specimens, internal blind testing samples, or external proficiency testing was not done for the PRNs. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on April 2, 2022, 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 Institute evaluation reports, the laboratory failed to achieve successful performance in 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 -- two of two consecutive testing events for the specialty Routine Chemistry for the analyte Sodium, resulting in unsuccessful performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 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 failed to attain a score of at least 80 percent for the analyte Sodium in two of two consecutive testing events in 2021 and 2022. 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 Sodium in the specialty of Routine Chemistry in two of two consecutive events: 2021 API 3rd event 60% 2022 API 1st event 60% 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 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 Sodium in Routine Chemistry. 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) Comparative Evaluations, the laboratory director failed to ensure -- 2 of 3 -- successful participation in a HHS approved proficiency testing program for analyte Sodium in the specialty of Routine Chemistry for two of two events in 2021 and 2022. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493. 1421 Condition: Laboratories Performing Moderate Complexity Testing; Testing Personnel D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Observations, review of manufacturer's instructions, patient final reports, personnel records and interview of facility personnel found the laboratory failed to follow the manufacturer's instructions when using the Sofia SARS Antigen FIA test kits and the BD Veritor System for SARS-CoV-2 test for testing patients as defined by the manufacturer under the Emergency Use Authorization (EUA). The findings included: 1. Observations made during the tour of the laboratory found the laboratory was using the following rapid test kits for detecting SARS-CoV-2 testing: a. Sofia SARS Antigen FIA lot 706424 expiration 2022-11-02 b. BD Veritor System for SARS-CoV- 2 lot 1011225402 expiration 2021-12-10 2. Review of the Sofia SARS Antigen FIA test kits manufacturer's instructions for use found under the heading CONDITIONS OF AUTHORIZATION FOR THE LABORATORY: "Authorized laboratories using your product must include with the test result reports, all authorized Fact Sheets." Review of the BD Veritor SystemSARS-CoV-2 instructions for use found on page 11 under the heading CONDITIONS OF AUTHORIZATION FOR THE LABORATORY (APPLICABLE IN THE US): "Authorized laboratories using your product will include witht he test result reports, all authorized Fact Sheets." 2. Review of patient test records found the laboratory tested 1441 patients for SARS- CoV-2 using the following test kits: a. Sofia SARS Antigen FIA - 1336 patients tested 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 -- between September 13, 2021 and October 21, 2021. b. BD Veritor System for SARS- CoV-2 - 105 patients were tested between September 5, 2020 and October 21, 2021. 3. Interview of the Technical Consultant conducted October 21, 2021 at 12:07 PM confirmed that the laboratory did not disseminate the Authorized Fact Sheets with SARS CoV-2 test results as required under the Emergency Use Authorization. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Review of proficiency testing records and interview of facility personnel found that the laboratory failed to perform and document

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 Institute proficiency testing records, the facility failed to achieve successful 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 -- performance in two of two consecutive testing events for the analyte Cell Identification or White Blood Cell Differential, 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 Cell Identification or White Blood Cell Differential count in two of two 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 Cell Identification or White Blood Cell Differential count in the specialty of Hematology in two of two consecutive events: 2020 API 3rd event 0% 2021 API 1st event 0% 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 to achieve satisfactory performance for the analyte Cell Identification or White Blood Cell Differential count in two of two 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 Cell Identification or White Blood Cell Differential count in the specialty of Hematology in two of two consecutive events: 2020 API 3rd event 0% 2021 API 1st event 0% 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. -- 2 of 3 -- This CONDITION 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 analytes Cell Identification or White Blood Cell Differential. 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 Cell Identification or White Blood Cell Differential in the specialty of Hematology. Refer to D2016. -- 3 of 3 --