Mainstreet Clinic

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and procedures and interview with Testing Personnel (Staff A), the laboratory did not perform i-STAT thermal probe checks every six months in two of the last two years. Findings include: 1. Review of laboratory records showed no evidence staff had performed thermal probe checks on the i-STAT analyzer. 2. Review of the 'i-STAT Procedure' showed the procedure required performance of the thermal probe checks every six months. 3. Interview with Staff A on August 13, 2024, at 2:30 PM confirmed thermal probe checks had not been performed on the i-STAT analyzer. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: 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 -- Based on surveyor review of laboratory procedures and records and interview with Testing Personnel (Staff A), the Laboratory Director did not ensure one of one Individualized Quality Control Plan (IQCP) was reviewed annually since August 9, 2022. Findings include: 1. Review of the laboratory's quality management plan showed the laboratory required annual review of the IQCP with the other procedures. 2. Review of the IQCP showed the Laboratory Director reviewed the plan on August 9, 2022. 3. Interview with Staff A on August 13, 2024, at 2:40 PM confirmed the Laboratory Director had not reviewed the IQCP since August 9, 2022, and confirmed the director had not established and maintained a quality assessment program for review of the IQCP to assure quality of laboratory services. 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 surveyor review of competence evaluation records and interview with Testing Personnel (Staff A), the technical consultant did not evaluate and document the annual evaluation of Staff A one of the last two years. Findings include: 1. Review of competence evaluation records showed no evidence of evaluation of Staff A in 2023. 2. Interview with Staff A on August 13, 2024, at 1:30 PM confirmed the technical consultant did not complete a competence evaluation for Staff A in 2023 for the testing performed in the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on surveyor observation of testing personnel and patient blood samples in the laboratory, review of procedures, and interview with testing personnel, the laboratory did not follow their written policies concerning labeling of patient samples to ensure positive identification for one patient drawn on September 22, 2020. Findings include: 1. Observation of testing personnel on September 22, 2020 at 9:30 AM revealed staff B brought three blood tubes into the laboratory and requested printed patient labels for the tubes. The labels were then applied to the tubes. 2. Observation of the blood sample tubes on September 22, 2020 at 11:00 AM revealed the printed labels on the tubes were for patient 2. Further observation revealed the tubes were not labeled behind the stickers that had been applied in the laboratory. 3. Review of the laboratory's "Specimen Collection and Handling Procedure", showed the following statement in the "Specimen Labeling" section, "Blood tubes must be labeled before leaving the patient". 4. Interview with testing personnel, staff A, on September 22, 2020 at 11:15 AM confirmed testing personnel B did not label the blood tubes before leaving the patient and brought unlabeled tubes to the laboratory. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of hematology proficiency testing (PT) records from event 1 in 2020 and interview with testing personnel, the laboratory did not verify the accuracy of the platelet test when sample AT-3 was not scored by the PT provider. Findings include: 1. Review of PT records from event one in 2020 showed the following results for the platelet test: Sample / reported result / acceptable range AT-1 / 249 / 209 - 349 AT-2 / 56 / 56 - 93 AT-3 / 54 / 57 - 95 Not scored - non-consensus AT-4 / 519 / 405 - 675 AT-5 / 248 / 206 - 344 The records show no evidence of review of the not scored result for sample AT-3. 2. Interview with testing personnel, staff A, on September 22, 2020 at 10:45 AM confirmed the results were not reviewed to verify the accuracy of the platelet results. This is a repeat deficiency previously cited on June 10, 2008 and June 13, 2012. 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with testing personnel, PT samples were not tested by two of three testing personnel who routinely perform patient testing. Findings include: 1. Review of PT records show staff A has performed each of the hematology PT events since 2017. 2. Review of the CMS (Centers for Medicare and Medicaid Services) Form 209, Laboratory Personnel Report (CLIA), signed by the laboratory director on July 20, 2018, showed three testing personnel perform moderate complexity testing in the laboratory. 3. Interview with staff A on July 26, 2018 at 2:00 PM confirmed moderate complexity hematology testing is performed by all three testing personnel and also confirmed PT sample testing has not been rotated through all testing personnel who perform patient testing. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the procedure for competency evaluation of testing personnel and interview with testing personnel, the procedure does not specify how 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 -- individuals who conduct non-waived testing will be evaluated, and does not include the six required elements or the requirement for semiannual evaluation during the first year of testing. Findings include: 1. Review of the laboratory procedure for competency evaluation showed the procedure did not identify the six required elements or the timing requirements for the evaluation of staff competency. 2. Interview with staff A on July 26, 2014 at 2:00 PM confirmed the procedure does not provide specific instructions for evaluating competency of testing personnel. This is a repeat deficiency previously cited on June 25, 2014. 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: Based on surveyor review of competency records and interview with testing personnel, competency was not evaluated semiannually during the first year new staff tested patient specimens. Findings include: 1. Review of competency records showed no semiannual evaluation for staff A after the initial evaluation in May 2017. 2. Interview with testing personnel, staff A, confirmed competency evaluation was not documented at least semiannually during the first year of patient specimen testing. -- 2 of 2 --