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Summary Statement of Deficiencies D2076 GENERAL IMMUNOLOGY CFR(s): 493.837(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 the surveyor's review of the laboratory's policy and procedure, American Proficiency Institute (API) proficiency testing (PT) records, and an interview with the laboratory supervisor (LS); it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in General Immunology for the Rheumatoid Factor (RF) analyte. The findings include: 1. The surveyor reviewed the PT records wherein API reported an unsatisfactory score of 60% for the RF analyte in the third event of 2024. 2. The LS affirmed by an interview on September 18, 2025, at approximately 10:30 a.m. that the laboratory obtained the unsatisfactory PT scores mentioned in statement #1. 3. According to the laboratory's testing declaration form (Lab-144) submitted on the day of the survey, the laboratory performed approximately 8,700 patient test samples annually for General Immunology, including the RF analyte during the period when the unsatisfactory score was obtained. Thus, the accuracy and reliability of patient test reported cannot be determined D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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: 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 the surveyor's review of the laboratory's policy and procedure, American Proficiency Institute (API) proficiency testing (PT) records, and an interview with the laboratory supervisor (LS); it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for the Alkaline Phosphatase (ALP), and Gamma-Glutamyl Transferase (GGT) analytes. The findings include: 1. The surveyor reviewed the PT records wherein API reported unsatisfactory scores for ALP and GGT analytes. The results were as follows: a. ALP PT analyte in second event of 2024 (Q2-2024), Overall score: 60% Specimen Reported Expected CH-06 184 183 - 341 CH-07 *98 100 - 187 CH-08 22 22 - 42 CH-09 *79 80 - 150 CH-10 42 40 - 76 b. GGT PT analyte in the first event of 2025 (Q1-2025), Overall score: 20% Specimen Reported Expected CH-01 *66 71 - 97 CH-02 *24 25 - 36 CH- 03 *147 158 - 215 CH-04 22 22 - 33 CH-05 *45 48 - 65 Legend: * = unsatisfactory score reported 2. The LS affirmed by an interview on September 18, 2025, at approximately 10:10 a.m. that the laboratory obtained the unsatisfactory PT scores mentioned in statement #1. 3. The accuracy and reliability of patient test reported cannot be determined. 4. According to the laboratory's testing declaration form (Lab- 144) submitted on the day of the survey, the laboratory performed approximately 17,000 patient test samples annually for Routine Chemistry, which included the ALP and GGT analytes, including the time the laboratory received unsatisfactory proficiency testing scores. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (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 surveyor's review of patient records, American Proficiency Institute proficiency testing (PT) records, and an interview with the laboratory supervisor on September 18, 2025; it was determined that the laboratory director failed to ensure that PT was performed for the years 2024 and 2025 as required under subpart H of this part. The findings include: 1. PT unsatisfactory score for Genral Immunology. See D2076 2. PT unsatisfactory score for Routine Chemsitry. See D2087 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on April 10, 2024, the laboratory was found not in compliance with the with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 Privider Enhanced Reporting (CASPER)-0155D and American Proficiency Institute (API) records (2023-2, 2023-3) and (2024-1), the laboratory failed to successfully participate in a proficiency 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 -- program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the subspecialty of Endocrinology for the analyte Triiodothyronine (T3) resulting in subsequent unsuccessful performance. Refer to D2098. D2098 ENDOCRINOLOGY CFR(s): 493.843(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 desk review of Certification and Survey Privider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API evaluation reports, the laboratory failed to achieve satisfactory performance for three of three events proficiency events in 2023 and 2024 for analyte Triiodothyronine (T3). The finding include: 1. The laboratory recieved the following scores: 60% on the 2023 T3 second event 0% on the 2023 T3 third event 60% on the 2024 T3 first event 2. A review of the 2023 and 2024 proficiency testing scores from American Proficiency Institute confirmed the above findings. 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 155 report API records for 2023-2, 203-3 and 2024-1 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) 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 a proficiency testing desk review of CASPER 155 report API records for 2023-2, 2023-3 and 2024-1 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2098. -- 2 of 2 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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's API (American Proficiency Institute) proficiency testing (PT) test result reports, and interview with the laboratory personnel, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory attained a score of 20% for Sodium (Na) in Q3 2021 API PT event which was unsatisfactory analyte performance for the PT testing event. b. The laboratory performed Na in approximately 955 patient samples per month. c. The laboratory personnel affirmed (4 /18/2023 @ 11:45 am) that the laboratory attained a score of 20% for Na in Q3 2021 API PT event which was unsatisfactory analyte performance for the testing event. D2098 ENDOCRINOLOGY CFR(s): 493.843(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's API (American Proficiency Institute) proficiency testing (PT) test result reports, and interview with the laboratory personnel, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event was unsatisfactory analyte 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 for the testing event. The findings included: a. The laboratory attained a score of 40% for TSH in Q2 2022 PT event which was unsatisfactory analyte performance for the API PT testing event. b. The laboratory performed TSH in approximately 200 patient samples per month. c. The laboratory personnel affirmed (4 /18/2023 @ 11:45 am) that the laboratory attained a score of 40% for TSH in Q2 2022 PT event which was unsatisfactory analyte performance for the API PT 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's API (American Proficiency Institute) proficiency testing (PT) result reports, and interview with the laboratory personnel, it was determined that the laboratory failed to ensure and to verify, at least twice annually, 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 routine chemistry, general immunology and endocrinology tests including, but are not limited to Phos, CRP (hs), Free T3 (FT3) and Estradiol (E2), which are NOT listed in the subpart I of 42 CFR part 493. b. The laboratory elected to enroll the API PT programs and failed to ensure and to verify, at least twice annually, the accuracy of Phos, CRP (hs), FT3 and E2 as follows. Score in %; Vol = estimated monthly test volume PT event Analyte Score Vol Q3 2021 Phos 40 955 Q3 2021 CRP (hs) 0% 78 Q1 2022 FT3 60 % 72 Q3 2022 E2 50% 56 c. The laboratory personnel affirmed (4/18/2023 @ 11. 50 AM) that the laboratory failed to ensure and to verify, at least twice annually, the accuracy of Phos, CRP (hs), FT3, and E2 API PT events. 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 review of the laboratory's API (American Proficiency Institute) proficiency testing (PT) result reports, and interview with the laboratory personnel, it was determined that the laboratory director failed to be responsible for the overall operation and failed to ensure that the proficiency testing samples were tested as required. The findings included: a. The laboratory director failed to be responsible for the overall operation and failed to ensure and to verify that the accuracy of the API PT testing samples was tested as required. b. The laboratory performed routine chemistry, endocrinology tests including but not limited to Sodium (Na) and TSH which are listed in the subpart I of 42 CFR part 493 and attained scores of 20% and 40% for Na and TSH in Q3 2021 and Q2 2022 PT, respectively, were unsatisfactory performance, see D-2087 and D-2098. c. The laboratory performed routine chemistry, general -- 2 of 3 -- immunology and endocrinology tests including, but not limited to Phos, CRP (hs), E2, and FT3 which are NOT listed in the subpart I of 42 CFR part 493 and failed to attain, at least twice annually, scores of at least 80% in PT events, see D-5217 -- 3 of 3 --

Summary Statement of Deficiencies 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's records, the laboratory API (American Proficiency Institute) proficiency testing (PT) results reports, and interview with the laboratory testing personnel (TP), it was determined that the laboratory failed to, at least twice annually, verify the accuracy of the tests the laboratory performed which are not listed in the subpart I of 42 CFR part 493. The findings included: a. The laboratory performed routine chemistry, endocrinology, and virology and reported the test results included but are not limited to the followings: Inorganic Phosphorus (Phs), Free T3 (FT3), UIBC, Vitamin B-12 (Vit 12), and SARS-CoV-2 (COV). b. The laboratory elected to enroll with API to verify the accuracy of the tests not listed in the subpart I of 42 CFR part 493 for evaluation of proficiency testing performance listed above (a). c the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each PT testing event was unsatisfactory analyte performance for the PT testing event as follows: Event = PT event; Test = analyte; Re (%) = Result in %; TV = estimated test volume monthly. Event Test Re (%) TV 2019 Q1 FT3 40 103 2019 Q1 Phs 20 193 2019 Q3 Phs 40 193 2019 Q3 UIBC 0 163 2020 Q3 UIBC 60 163 2021 Q1 FT3 60 103 2021 Q2 Vit B 60 144 2021 Q2 COV 0 4,066 c. The laboratory TP affirmed (9/7/2021 @ 1:30 PM) that the laboratory failed to attain a score of at least 80% of acceptable responses for each analyte in each testing event was unsatisfactory analyte performance for the PT testing. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) 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 -- 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, observed digital thermometers (DT) for monitoring the storage equipment's, and interview with the laboratory personnel (TP), it was determined that the laboratory failed to follow 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. The laboratory failed to follow the manufactuer's instruction how to use the DT device. b. The laboratory used DT device for monitoring the temperature of the storage equipment to assure and maintain the quality of the laboratory supplies, quality control or standard materials, and the patient samples in the storage equipment. c. See D-5413 D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on touring the laboratory facility, observed digital thermometers (DT) for monitoring the storage equipment, and interview with the laboratory testing personnel (TP), it was determined that the laboratory failed to be consistent with the manufacturer's instructions for the DT device used. The DT must be monitored and documented. The findings included: a. The laboratory used DT device for monitoring the temperature of the storage equipment to assure and maintain the quality of the laboratory's supplies, quality control or standard materials, and the patient samples in the storage equipment. b. The DT features a "Mode" to indicate Min/Max for the temperature when reached in the past, and Low/High for the setting of the acceptable temperature range to trigger an Alarm system (On/Off), if out of the acceptable temperature setting, so the laboratory could take remedial actions immediately, to assure and to maintain the good quality of the materials stored inside of the storage equipment. c. The laboratory defined an acceptable temperatures range for the refrigerator is between 2 to 8 oC. d. A DT for a refrigerator was found to have set the Low/High acceptable range between 10 and 30 oC and the Alarm was set to "Off". e. When one switched the Alarm to "On" position, this DT's ring alarmed to indicated that temperature was out of the acceptable range sometime in the past. f. Interview of the TP at the time of survey (9/7/21 @ 11:35 am) that the laboratory was not aware the DT setting for that refrigerator and did not notice the acceptable temperature setting was not for a refrigerator (2 to 8 oC). D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) -- 2 of 6 -- (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 touring the laboratory facility, observed the Levy Jennings (LJ) chart from the instrument monitor, review the laboratory records, and interview with the laboratory testing personnel (TP), it was determined that the laboratory failed to monitor over time the accuracy and precision of test performance including review of the LJ charts for trend and shift that may be influenced by changes in test system performance, environmental conditions, and variance in operator performance. The laboratory failed to document remedial actions taken, if identified. The findings included: a. The laboratory used Horiba hematology analyzer to perform Complete Blood Cell Count (CBC) and reported WBC, with cell differentials, RBC, Hemoglobin (Hgb), Hematocrit (Hct) and Platelet count (Plt). b. Observed the CBC LJ chart on 5/4/21 thru 7/2/21 from the instrument monitor, there were numbers of the daily QCs, High, Norm and Low, noted and indentified that they were out of +/- 3SD including WBC, RBC, Hct, Plt. c. The laboratory failed to document the

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 review of the laboratory's proficiency testing (PT) result reports and records, and interview with the laboratory personnel, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events was unsuccessful performance. The findings included: See D-2107 D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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's proficiency testing (PT) result reports, and interview with the laboratory personnel, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory performed endocrinology testing including but are not limited to Free T3, TSH , b. The laboratory attained a score of 0% for TSH in the 3rd 2017 PT event. c. The laboratory performed TSH in approximately 20 patient samples monthly. d. The laboratory personnel affirmed (04/15/2019 @2:15 PM) that the laboratory failed to attained at least 80 % of responses for TSH was unsatisfactory analyte performance for the testing event. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 laboratory's proficiency testing (PT) result reports and records, and interview with the laboratory personnel, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events was unsuccessful performance. The findings included: a. The laboratory performed endocrinology testing including but are not limited to Free T3. b. The laboratory elected to enroll its evaluation of PT performance with API (American Proficiency Institute) to compline with CLIA regulations. c. The laboratory attained scores of 60 % and 40% for analyte Free T3 in the 3rd 2018 and the 1st 2019 PT, respectively events. d. The laboratory failed to achieve satisfactory performance for Free T3 in two consecutive testing events was unsuccessful performance. e. The laboratory performed Free T3 in approximately 20 patient samples monthly f. The laboratory personnel affirmed (04/15/2019 @ 2:20 PM) that the laboratory failed to achieve satisfactory performance for Free T3 in two consecutive testing events was unsuccessful performance. 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's proficiency testing (PT) result reports and records, and interview with the laboratory personnel, it was determined that the laboratory failed to verify, at least twice annually, the accuracy of any test or procedure it performs that is not included in subpart I of 42 CFR Part 493. The findings included: -- 2 of 4 -- a. The laboratory performed serum phosphors (iP), 25-OH Vitamin D, Estradiol (E2), urine Microalbumin (uAbu) (semi-quant), Urine Creatinine (uCr) (semi-quant), and E2 which are not listed in the subpart I of 42 CFR Part 493. b. In order to compline with CLIA regulations to ensure the laboratory verify, at least twice annually, the accuracy of the testing systems which are not listed in the subpart I of 42 CFR Part 493. The laboratory elected to enroll the analyte mentioned (a) above with API (American Proficiency Institute PT programs. c. The laboratory attained scores of 0%, 20% and 20% for analyte iP, respectively in the 2nd 2018, the 3rd 2018 and the 1st 2019 PT events. d. The laboratory attained scores of 67% for analyte of uAbu and uCr, respectively in the 2nd 2017 PT event. e. The laboratory attained scores of 67% for analyte of E2 in the 2nd 2018 PT event. f. The laboratory attained scores of 67% for analyte of 25-OH Vit D (Vit D) in the 1st 2017 PT event. g. The laboratory performed iP, uCr, uAbu, E2, and Vit D for approximately 6, 1,846, 10, 54, and 66 patient samples, respectively in a monthly. h. The laboratory personnel affirmed (10 /15/2019 @ 2:15 PM) that the laboratory failed to attained, for the listed analyte above (c - f), at least 80 % of acceptable responses for each analyte in each testing event was unsatisfactory analyte performance for the testing event. i. The laboratory failed to verify, at least twice annually, the accuracy of any test or procedure it performs that is not included in subpart I of 42 CFR Part 493. D5467 CONTROL PROCEDURES CFR(s): 493.1256(d)(9)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- When using calibration material as a control material, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's documents and records, and interview with the laboratory personnel, it was determined that the laboratory failed to use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. The findings included: a. The laboratory used Shimadzu LC /MS/MS to perform urine drugs confirmation testing and provided urine concentration for the drug confirmed. b. The laboratory purchased its drug analyte from one source manufacture with same lot number to prepare for working calibrator and quality control materials. c. The laboratory must use different lot number to prepare for calibrators and quality control materials and documented all procedures performed. 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 review of the laboratory's proficiency testing (PT) result reports and records, -- 3 of 4 -- and interview with the laboratory personnel, it was determined that the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. The findings included: See D-6016 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 review of the laboratory's proficiency testing (PT) result reports, and interview with the laboratory personnel, it was determined that the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of 42 CFR Part 493. The findings included: See D-2098, D-2107, D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must 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's records, and interview with the laboratory personnel, it was determined that the laboratory director failed to ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. The findings included: See D-5467 -- 4 of 4 --

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 performance for the same analyte or test in two out of three consecutive testing events in the specialty of Endocrinology constituting unsuccessful PT performance. (See D2107) 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 -- D2107 ENDOCRINOLOGY CFR(s): 493.843(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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Triiodothyronine (T3), resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, T3, as follows: 2018 Q2 2018 Q3 T3 60% 40% Q2 = Second Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, T3. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, T3, 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 D2107) -- 2 of 2 --