Advanced Biomedical, Inc

Summary Statement of Deficiencies D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) (b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records, CASPER report, and interview with the laboratory director (LD) and technical supervisor (TS); the laboratory failed to attain a score of at least 80 percent of acceptable responses for Sodium analyte in routine chemistry. The findings included: 1. Based on review of PT and CASPER reports, API reported 20% for Sodium analyte for the third event of 2025 (Q3-2025) which is an unacceptable result. 2. Based on the laboratory testing declaration submitted at the time of the survey on 01 /07/2025 the laboratory analyzed and reported approximately 1,970 routine chemistry tests which included Sodium analyte during the time the laboratory had unsatisfactory proficiency testing results. 3. The TS affirmed 01/07/2025 at approximately 11:45 a. m. that the laboratory received the above unsatisfactory proficiency testing score D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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; This STANDARD is not met as evidenced by: Based on the surveyor's review of the proficiency testing results documentation, 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 -- randomly selected patient test records, and interviews with the laboratory director and technical supervisor on January 1, 2025; the laboratory director is herein cited due to failure to ensure that aspects of the analytic phases of the laboratory testing were monitored. The findings include: D2088. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on touring the laboratory facility, review of the laboratory Protime (PT)/INR records, observe the digital thermometer (DT) device and review of temperature records, and interview with the laboratory testing personnel, it was determined that the laboratory failed to perform following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system. The findings included: A a. The laboratory performed Protime (PT) coagulation testing and report INR ratio, which was a calculated result by INR = (PT test/PT normal) ISI; where INR =International Normalized ratio PT test = tested prothrombin time PT normal = normal prothrombin time (mean) ISI = international sensitivity index b. The laboratory's policy and procedure for "PT -INR Adjustment Ratio" (page 3/3) item 4. "To determine the mean normal PT for the new thromboplastin, please perform the following: a. Run at least 6 normal patients in duplicates for PT studies and record the average "seconds" on the "PATIENT MEAN OF NORMAL" sheet. c. The laboratory failed to follow its written policy and procedure to run 'duplicates" in the new PT normal mean in 2/20/2020. B a. The laboratory failed to perform following the manufacturer's instructions of a DT device, and in a manner that provides test results within the laboratory's stated performance specifications. b. The laboratory used refrigerators and freezers to store the laboratory reagents, supplies, patient samples for the validity, stability, and quality of the laboratory testing systems. c. The laboratory used digital temperature (DT) thermometer to monitor the temperatures to maintain the storage conditions within the 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 -- laboratory established acceptable temperature ranges, 2 to 8 degrees Celsius for refrigeration. c. The DT features an Alarm on/off, Lo/Hi for acceptable (optimal) temperature range for storage of reagents etc. and Min/Max to indicate the temperature conditions while the laboratory was closed. d. On the date of survey (2/14 /2022 @ 11:45 am) an DT Alarm was off and when turned on, the alarm went off, which indicated at sometimes past, the storage temperature conditions was out of the acceptable temperature range. e. The laboratory failed to document any

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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory overall testing event score in two out of three consecutive testing events in the specialty of Bacteriology, constituting unsuccessful PT performance. (See D2028) 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 -- D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance in two out of three consecutive PT events for Bacteriology, resulting in an "initial" (first) unsuccessful performance. The findings include: a. The laboratory failed to maintain successful performance by failing to maintain a score of 80% of acceptable responses in two out of three consecutive PT events for Bacteriology, as follows: 2019 Q3 2020 Q1 Bacteriology 75% 75% Q1 = First Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance in two out of three consecutive PT resulted in an initial unsuccessful performance for Bacteriology. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing High Complexity Testing: Laboratory director was not met. The laboratory director, high complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6089) D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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 desk review of CMS PT records, it was determined the laboratory director, high complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For Bacteriology, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2028) -- 2 of 2 --

Summary Statement of Deficiencies D2066 SYPHILIS SEROLOGY CFR(s): 493.835(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing result reports, and interview with the laboratory consultant, and the laboratory personnel, it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent was unsatisfactory performance. The findings included: a. The laboratory performed RPR using ASI card test kit and enrolled its proficiency testing program with American Association of Biocatalysts (AAB). b. The laboratory attained an overall PT testing event score of 0% for RPR in the Q3 2019 AAB PT event which was unsatisfactory performance. c. The laboratory performed RPR in approximately 110 patient specimens monthly. d. The laboratory technical consultant affirmed (2/5/2020 @ 1:45 PM) that the laboratory attained an overall PT testing event score of 0% for RPR in the Q3 2019 AAB PT event which was unsatisfactory performance. D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(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 laboratory proficiency testing result reports, and interview with the technical consultant and the laboratory personnel, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses 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 -- Antinuclear antibody (ANA), Antistreptolysin ( ASO), Rheumatoid Factor (RF), and Rubella (RB) in each testing event was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory performed general immunology testing including ANA, ASO, RF, RB. b. The laboratory participated AAB proficiency testing programs to evaluate the proficiency testing performance of the above mentioned testing. c. The laboratory attained 0% for ANA, ASO, RF, and RB in the Q3 2019 AAB PT event, which was unsatisfactory analyte performance for the testing event. d. the laboratory performed in approximately 45 patient samples each for ANA, ASO, RF, and RB testing. e. The laboratory technical consultant affirmed (2/6/2020 @ 1:35 PM) that the laboratory attained scores of 0 % for ANA, ASO, RF, and RB in the Q3 2019 AAB PT event, which was unsatisfactory analyte performance for the testing event. 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 the laboratory proficiency testing result reports, and interview with the laboratory technical consultant and the laboratory personnel, it was determined that the laboratory failed to, at least twice annually, verify the accuracy of any test or procedure it performed those are not included in subpart I of 42 CFR part 493. The findings included: a. The laboratory performed Total Microalbumin (TM), Urine pH (pH), Urine Creatinine (UC), Growth Hormone (GH), Homocysteine (HC), Total Lipo A (LpA), Retic (Rc), which are not listed in the subpart I of 42 CFR part 493. b. The analyte mentioned above are not required to participate proficiency testing programs approved by CMS. However, it is required, at least twice annually, the laboratory must verify the accuracy of any test or procedure the laboratory performs. c. The laboratory, in order to verify the accuracy of the testing, elected to enroll with American Association of Bioanalysts (AAB) PT programs. d. The laboratory attained scores of 0 % for GH testing in the Q1, 2019 and TM testing in the Q3, 2019 AAB PT events which were unsatisfactory performance. e. The laboratory attained scores of 50 % and 0 % for HC testing in the Q1, 2019 and in the Q3, 2019, AAB PT events, respectively, which were unsatisfactory performance. f. The laboratory attained scores of 60 % and 0 % for LpA testing and RC, respectively in the Q3, 2019 AAB PT events, which were unsatisfactory performance. h. The laboratory performed GH and TM g. 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: -- 2 of 3 -- Based on review of the laboratory proficiency testing result reports, and interview with the technical consultant and the laboratory personnel, it was determined that the laboratory director failed to ensure that the proficiency testing results scoring at least 80% grade for ANA, ASO, RF, and RB in the Q3 2019 AAB PT event. The findings included: a. The laboratory director failed to ensure the the laboratory to attain at least 80 percent of acceptable responses for each analyte in each testing PT event was unsatisfactory analyte performance. b. The laboratory attained 0% scores for ANA, ASO, RF, RB & RPR in the Q3 2019 AAB PT, which were unsatisfactory performances (see D-2066 and D-2075) D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(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 review of the laboratory proficiency testing result reports, and interview with the laboratory technical consultant, and the laboratory personnel, it was determined that the laboratory director failed to ensure the establishment and maintenance of acceptable levels of analytical performance for TM, pH, UC, GH, HC, LpA, and RC testing systems. The findings included: a. The laboratory failed to verify the accuracy of analyte, including, but are not limited to the followings: TM, GH, HC ..(see D-5217). -- 3 of 3 --

Summary Statement of Deficiencies 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 review of the laboratory a records, and interview with the laboratory staff, it was determined that the laboratory failed to perform and document calibration verification (CV) procedures at least twice a year, 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. The findings included: a. The laboratory used Beckman Coulter AU 680 to perform 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 -- routine chemistry and reported electrolytes including sodium, potassium, chloride and CO2. b. The testing procedures for electrolyte tests requires to perform and document CV at least twice annually to verify the reportable range of test. results for the system. c. The laboratory failed to perform and document the CV, at least twice, for electrolytes in the year of 2016-2017. d. The laboratory affirmed (1/12/2018 @13:25) that the laboratory failed to perform CV as required by the CLIA rules and regulations. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory quality control records, and interview with the laboratory staff, it was. Determined that the laboratory failed to perform control procedures for antimicrobial susceptibility test each day are performed including its zone sizes or minimum inhibitory concentration for control organisms within established limits before reporting patient results. The findings included: a. Interview with the laboratory staff for the antimicrobial susceptibility test, the laboratory performed quality control for antimicrobial susceptibility weekly. b. The laboratory affirmed (1/12/2018 @ 12:25) that the laboratory used IQCP quality control procedures. c. No laboratory documents to support the laboratory had followed IQCP protocol to establish the IQCP quality control procedures. d. The laboratory affirmed (1/12/2017 @ 12:30) that the failed to perform IQCP protocol to establish antimicrobial susceptibility test procedures. D6020 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 the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's records, quality control procedures, and interview with the laboratory staff, it was determined that the laboratory director failed to be responsible for the overall operation including, but is not limited to the following; to ensure that the quality control programs were established and maintained to assure the quality of laboratory services provided. The findings included: See D-5439, and D- 5507 -- 2 of 2 --