Exer Medical Corporation

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) (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 the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) records and interviews with the technical consultant (TC) and testing personnel (TP), the laboratory failed to attain at least 80 percent of the acceptable response from two out of five testing samples for the third event of the Hematology PT event in 2025 (Q3-2025). The findings include: 1. The laboratory is enrolled in the API - PT program and received an unsatisfactory score of 60% for the Hematocrit analyte for Q3-2025 as follows: Sample Reported Expected Performance HEM-11 42 39.1 - 42.5 Acceptable HEM-12 51.9 46.9 - 50.9 Unacceptable HEM-13 34.1 32.2 - 35.0 Acceptable HEM-14 48.6 43.9 - 47.7 Unacceptable HEM-15 16.9 15.6 - 17.0 Acceptable 2. The TC and TP affirmed by interviews on June 15, 2026, at approximately 12:15 p.m. that the laboratory obtained the PT unsatisfactory scores as mentioned in statement #1. 3. According to the laboratory testing declaration submitted on the day of the survey, the laboratory performed approximately 1,500 Hematology patient samples annually that included the Hematocrit analyte. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; 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: The laboratory director is herein cited for deficient practice in ensuring that systems for the preanalytic, analytic, and postanalytic phases of the laboratory were monitored and followed. Findings include: The laboratory received an unsatisfactory performance score for Hematology of 60%. See D2122 -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, patient test results, and interview with the laboratory technical consultant on January 6, 2023, at 1:40 pm, the laboratory testing person failed to follow the laboratory's policy & procedure in repeating the flagged test results. The findings include: 1. The laboratory used Micros ES60 automated CBC instrument from Horiba to measure platelet (plt). The instrument print out showed an asterisk, (*) following the plt results for the sample ID 230624 out of 5 patients' samples reviewed. The instrument manufacturer's instruction stated, "An asterisk following the parameter Plt indicates that for 3 counts analyzed, all 3 counts are outside of the instrument precision limit. Results should be verified by re-running the sample". However, the laboratory person reported the results without repeating the run. Therefore, the accuracy of the reported results can not be assured and might have harmed the patient. 2. The laboratory technical consultant on January 6, 2023, at 1:40 pm, affirmed that the laboratory testing person #1 did not follow the laboratory's procedure and repeat the test. 3. The laboratory's testing declaration form, signed by the laboratory director on 1/6/2023, stated that the laboratory performs approximately 2,000 plt tests, annually. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration 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 -- 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: Based on Surveyor review of laboratory's policy and procedure, patient test results and interview with the laboratory technical consultant on January 6, 2023, at 1:40 pm, it was determined that the laboratory director failed to direct the overall operation and administration of the laboratory. The findings include: See D5401 and D6070. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, patient test results and interview with the laboratory technical consultant and testing person on January 6, 2023, at 1:40 pm, it was determined that the laboratory testing person #1 failed to follow the laboratory's procedure for repeating the sample run. The findings include: See D5401. -- 2 of 2 --