Exer Medical Corporation

Summary Statement of Deficiencies D0000 D2016 Based on Surveyor review of laboratory's proficiency testing (PT) results from API, and interview with the laboratory technical consultant on April 14, 2024, at 12: 45 p.m., the laboratory failed to successfully participate in the proficiency testing program for the hematocrit test. The findings include: 1. The laboratory participated in the API PT testing program for hematocrit in the specialty of hematology in the year 2025. However, it received an unsatisfactory score of 40% at the 1st and 3rd events for the hematocrit test which resulted in unsuccessful PT participation (see D2130). Therefore, the accuracy of the patients' hematocrit test results rendered by the laboratory in 2025 cannot be assured. 2. The laboratory technical consultant on April 14, 2026, at 12:45 p.m., affirmed that the laboratory did not receive a satisfactory score for the hematocrit test at the 1st and 3rd events in 2025. 3. The laboratory's testing declaration form, signed by the laboratory director on 4/6/2026, stated that the laboratory performed approximately 720 hematocrit tests, annually. Lab: "All the outliers noted above are clinically insignificant outliers, indicating random error - on repeat analysis: Hem-04 HCT 41.7, Hem-05 34.0 & Hem-05 RBC 4.14, all of which are within acceptalbe peer range... D6000 The laboratory director failed to ensure the maintenance of an acceptable levels of analytical performance for the hematocrit test. (See D6023) 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 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 -- 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: D2130 HEMATOLOGY CFR(s): 493.851(f) (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 Surveyor review of laboratory's proficiency testing (PT) results from API, and interview with the laboratory technical consultant on April 14, 2026, at 12:45 p. m., the laboratory failed to achieve satisfactory performance for the hematocrit test in two out of three consecutive events which resulted in an unsuccessful performance for the test. The findings include: 1. The laboratory participated in the API PT testing program for hematocrit test in the specialty of hematology in 2025. However, it received an unsatisfactory score of 40% at the 1st and 3rd events for the hematocrit test that resulted in an unsatisfactory analyte performance. Laboratory's failure to achieve satisfactory performance for the same analyte in two out of three consecutive events resulted in an unsuccessful PT performance. Therefore, the accuracy of the patients' test results rendered by the laboratory during that time cannot be assured. 2. The laboratory technical consultant on April 14, 2026, at 12:45 p.m., affirmed that the laboratory received an unsatisfactory score of 40% at the1st and 3rd events in 2025 for the hematocrit test. 3. The laboratory's testing declaration form, signed by the laboratory director on 4/6/2026, stated that the laboratory performs approximately 720 hematocrit tests, annually. 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 0155D report and American Proficiency Institute (API) records for 2025-1 and 2025-3 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) -- 2 of 3 -- (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and API records for 2025-1 and 2025-3 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2130 . D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) results from API, and interview with the laboratory technical consultant on April 14, 2026, at 12:45 p. m., the laboratory failed to achieve satisfactory performance for hematocrit test in two out of three consecutive PT events. The findings include: See D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 THIS LABORATORY IS IN COMPLIANCE WITH THE REQUIREMENTS OF 42 CFR PART 493. REQUIREMENTS FOR CLINICAL LABORATORIES. 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 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: Based on observation, review of patient sampling test result and interview with the testing personnel and technical consultant (9/6/2018, 1600) it was determined that the laboratory failed to follow manufacturers' instructions for performing the test for Prothrombin Time (PT) using the Roche CoaguChek XS system. The findings included: 1a. The laboratory uses Roche CoaguChek XS system for analyzing PT/INR testing. CoaguChek XS PT testing manufacturer's guidelines under section: Expected results/Unusual results: "If the meter displays an error message, refer to the Error Message section of the CoaguChek XS Pro System User Manual. If the meter displays an unusual test result (other than an error message), check the following: - Certain drugs may affect results by interfering with warfarin pharmacology. The potential effect of a drug interaction with warfarin or the effect of underlying diseases (e.g., liver disease, congestive heart failure) must be considered when interpreting a result. - Changes in the patient's diet can cause unusually low or high results. - Any unusual results should always be followed up with inquiries to define the cause of the unusual result. If the result does not match the clinical symptoms, repeat the patient test to rule out procedural error." 1b. The laboratory uses Roche CoaguChek XS system for analyzing PT/INR testing. CoaguChek XS PT testing manufacturer's guidelines under section: Expected results/Measuring range states that "Each system has a reportable range of 0.8 to 8.0 INR." b. For one (1) out of five (5) random patient sampling test results reviewed for PT/INR, covering period from 1/1/2018 to 6/15/2018. Patient #1 (PT/INR ordered 1/1/2018, 5:01P.M.), PT result was 0.0, INR was 2.0. c. The laboratory's policies and procedures manual under section "Critical Values" for 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 -- Hematology states an INR >=5 was considered to be a critical value. The final patient test report (EMR) flag indicated in bold letters as, "CRITICAL LOW." There were no other actions taken by the testing personnel. d. The testing personnel and the technical consultant affirmed (9/6/2018, 1600) that the laboratory analyzed and reported the PT /INR without any further actions taken. e. The laboratory's form CMS-116 submitted on 09/06/2018 estimated the waived test perform (which includes PT/INR) as 1000 tests annually, the validity of the test results reported could not be assured. 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 second quarter (Q2-2018) of the American Proficiency Institute (API) proficiency testing records, laboratory's proficiency testing performance summary reports, and interview with the technical consultant, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Red Blood Cell (RBC) count. The findings included: a. Q2- 2018, API reported an unsatisfactory score of 40% for RBC count. b. For eleven (11) out of sixteen (16) random patient sampling test results reviewed covering period from 10/26/2017 to 7/7/2018, eleven (11) Complete Blood Count (CBC) which included RBC count were analyzed and reported during the time the laboratory received the unsatisfactory proficiency testing score for RBC. c. The technical consultant affirmed (9/6/2018, 1600) that the laboratory received the above unsatisfactory proficiency testing score for RBC count. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: 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, based on the observation and review of random patient test results on 9/6/2018 (survey date) the laboratory director failed to ensure that the overall operation of the laboratory. See D 1001. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, -- 2 of 3 -- respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. D8100 INSPECTION REQUIREMENTS CFR(s): 493.1771 Each laboratory issued a CLIA certificate must meet the requirements in 493.1773 and the specific requirements for its certificate type, as specified in 493.1775 through 493.1780. All CLIA-exempt laboratories must comply with the inspection requirements in 493.1773 and 493.1780, when applicable. This CONDITION is not met as evidenced by: Based on interviews with the technical consultant, a testing person (9/6/2018, 1600), review and observation of random patient test results covering period from 10/26 /2018 to 7/7/2018, one patient had an order of PT/INR on 1/1/2018, the Prothrombin time (PT) result was 0.0 and INR result was 2.0. There was no documentation of