Madison Core Laboratories

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) and College of American Pathologist (CAP) Proficiency Testing (PT) records and an interview with the Technical Supervisor (TS), the Laboratory Director failed to sign the PT attestation statements for the specialties in Immunology, Chemistry, and Microbiology. This was noted for 6 of 31 events reviewed in 2024 through 2025. The findings include: 1. A review of the API PT records revealed no signature by the Laboratory Director (or designee) on attestation statements for the following surveys: a) 2024 Chemistry 1st Event. b) 2024 Chemistry Miscellaneous 2nd Event. c) 2024 Immunology 2nd Event. d) 2024 Immunology 3rd Event. e) 2025 Immunology 1st Event. 2. A review of the CAP PT records revealed no signature by the Laboratory Director (or designee) on attestation statements for 2024 Microbiology MC3-C. 3. During an interview on 8/13/25, at 1:06 PM, the TS confirmed the above findings. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 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 -- 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 a review of the Cobas 6000 calibration verification (C-V) records and an interview with the Technical Supervisor, the laboratory failed to ensure C-V was performed and documented on the Cobas 6000 Chemistry / Immunoassay analyzer the first half of 2024 and Gabapentin and Urine Protein the second half of 2024. The findings include: 1. A review of the C-V records for the Cobas 6000 Chemistry / Immunoassay analyzer revealed no evidence of C-V documentation for the first half of 2024. Gabapentin and Urine Protein C-V documentation was also missing for the second half of 2024. 2. During an interview on 8/13/2025 at 2:00 PM, both Technical Supervisors stated the C-V could have been missed due to personnel turnover. -- 2 of 2 --

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 a review of the Cobas Chemistry analyzer calibration verification (C-V) records and an interview with the Laboratory Manager, the laboratory failed to ensure C-V was performed and documented on the Cobas 501C and 601E Chemistry analyzers the first half of 2023. The surveyor noted one of two C-V's was later than the semiannual frequency required by CLIA. The findings include: 1. A review of the Cobas 501C and 601E Chemistry analyzer C-V records revealed 49 of 56 assays were 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 -- calibrated with either one or two calibrators. Analytes calibrated with less than three calibrators must have a C-V every six months, as per CLIA regulatory requirements. 2. A review of the Cobas 501C and 601E records revealed documentation of C-V performed on 10/13/2022, however the next C-V was not performed until 7/31/2023, approximately nine and a half months later. 3. During an interview on August 24,2023, at 12:10 PM, the Laboratory Manager confirmed the C-V due the first half of 2023 was late because of a scheduling error. SURVEYOR ID#'s: 32558 and 46291 Licensure and Certification Surveyors -- 2 of 2 --

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 a review of the CASPER report #155, and the API (American Proficiency Institute) proficiency testing evaluations, the laboratory failed to successfully participate in Toxicology testing for Digoxin (therapeutic drug monitoring) for two of three consecutive testing events, Event #1 and Event #3, 2022. These failures resulted in an initial unsuccessful proficiency testing failure. The findings include: Refer to D2109. D2109 TOXICOLOGY CFR(s): 493.845(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 2 -- 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 a review of the CASPER report #155, and the API (American Proficiency Institute) proficiency testing evaluations, the laboratory failed to perform satisfactorily in Toxicology testing for Digoxin for two of three consecutive testing events, Event #1 and Event #3, 2022. The findings include: 1. A review of the CASPER report revealed the laboratory scored the following: a) Event #1, 2022 Digoxin 60 % b) Event #3, 2022 Digoxin 60 % 2. A review of the API proficiency testing evaluations confirmed the above mentioned scores. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of temperature records, the operator's manual, and an interview with the Technical Consultant and Quality Specialist, the laboratory failed to define acceptable criteria for humidity, consistent with the manufacturer's instructions for the operation of the Carolina Liquid Chemistries (CLC) 800. This was noted from January 2020 to current survey (03/10/2022). The findings include: 1. A review of temperature records revealed the following: a) 2020 room temperature/humidity log did not have a documented acceptable range. Nine out of twelve months reviewed had humidity below 40% for multiple days. b) 2021 room temperature/humidity log acceptable range was documented as 20 - 75%. Nine out of twelve months reviewed had humidity below 40% for multiple days. c) 2022 room temperature/humidity log acceptable range was documented as 15- 65%. Two out of two months reviewed had humidity below 40% for multiple days. 2. A review of the Operator's Manual for the CLC 800 revealed: "Relative humidity: 40% - 85". 3. During an interview on 03/10 /2022 at 2:00 PM, the Technical Consultant and Quality Specialist confirmed the acceptable range for the relative humidity in the CLC Room (accessioning room) should have been 40 - 85%. Also, they confirmed that on multiple days, the staff documented relative humidity below 40% for the room that houses the CLC 800. 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 -- D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of adulterants (specific gravity (SG), pH, and creatinine) quality control, package inserts, quality control procedure, and an interview with the Technical Consultant, the laboratory failed to perform quality control at the frequency specified by the manufacturer for creatinine and provide an Individualized Quality Control Plan (IQCP) for SG and pH. This was noted from previous survey (05/22 /2019) to current survey (03/10/2022). The findings include: 1. A review of adulterants quality control revealed the following: a) Specific gravity had one level of control run each day of patient testing from July 2019 to June 2020. Starting in July 2020, each week, one lower and one upper level control was performed on specific gravity. The remaining days of the week that patient testing was performed, only one level of control was performed. b) pH had one level of control run each day of patient testing from July 2019 to June 2020. Starting in July 2020, each week, one lower and on upper level control was performed on pH. The remaining days of the week that patient testing was performed only one level of control was performed. c) Creatinine had one level of control run each day of patient testing from July 2019 to June 2020. Starting in July 2020, each week, one lower and on upper level control was performed on creatinine. The remaining days of the week that patient testing was performed only one level of control was performed. 2. A review of adulterants reagents package inserts revealed the following: a) DRI Gravity-Detect Test (specific gravity) - "All quality control requirements should be performed in conformance with local, state and /or federal regulations or accreditation requirements." b) DRI pH-Detect Test (pH) - "Good laboratory practice suggests the use of control specimens to validate the calibration and the ensure proper assay performance." c) Creatinine Liquid Reagent Assay - "These controls should be run at least with every working shift in which Creatinine assays are performed." 3. A review of the laboratory's Quality Control Plan revealed under Quality Control Frequency "...Each week one lower and one upper- level control are used to determine acceptability. For daily control purposes, ... only the lower level is used for adulterants..." 4. During an interview on 03/10/2022 at 12: 00 PM , the Technical Consultant stated the IQCP for SG and pH could not be located and confirmed the package insert for Creatinine would not allow an IQCP. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a lack of 2018-2019 proficiency testing, and an interview with the Technical Supervisor (TS) #1, the surveyor determined the laboratory failed to enroll in proficiency testing (PT) with a CMS-approved PT provider for regulated tests in the Microbiology specialties since patient testing began in December 2017. The findings include: 1. During the entrance tour of the laboratory on 5/22/2019 at approximately 9: 00 AM, TS #1 explained the laboratory had implemented major changes in the scope of testing due to a change in ownership after the initial survey on 7/5/2017. The laboratory name had also changed since the previous survey. TS #1 listed the following on the new laboratory test menu: Urine Toxicology Screening on the CLC (Carolina Liquid Chemistries Corporation)-800 (Nine drugs plus urine Creatinine) Confirmatory Drug Testing on the Agilent Technologies 6420 Triple Quad LC/MS (Liquid Chromatography/Mass Spectrometry) Molecular (PCR or Polymerase Chain Reaction) Testing for infectious organisms on two QuantStudio 12K Flex Systems and the Autogenomics Infinity HTS system 2. In an interview with TS #1 on 5/22 /2019 at 11:00 AM, the surveyor asked whether testing of patients was interrupted due to the change in the laboratory ownership. TS #1 explained no testing was performed August to November 2017. In December 2017 the laboratory began performing PCR 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 -- Testing for Respiratory Pathogens on the Autogenomics Infinity HTS. After the new ownership change in May 2018, the laboratory resumed toxicology testing; additional PCR testing for Bacterial Vaginosis and Candidal Vaginitis using the Autogenomics Infinity HTS began in August 2018. In May and August 2018 the laboratory also validated two QuantStudio 12K Flex Systems which were used for PCR detection of pathogens in Wound, Urine and STD (Sexually Transmitted Diseases) patient specimens. 3. On 5/22/2019 at 1:10 PM the surveyor requested proficiency testing records for the above test menu. TS #1 explained they had discontinued enrollment in PT after the termination of the moderate-complexity testing in August 2017, and they had not enrolled in 2018 or 2019 after implementation of the new test menu. Instead, TS #1 provided the Testing Personnel with "spiked samples" for Toxicology and Molecular (PCR) Diagnostic testing in April 2019. TS #1 stated the Testing Personnel also performed the blind testing in October 2018, however the laboratory had no documentation of the results due to "power surge damage to a computer during a tornado" in early May 2019. The TS assessed accuracy of the CLC-800 by comparing the patient results with the results obtained on the Agilent LC/MS system, and tabulating the statistical accuracy. 4. As the interview continued at 1:15 PM, the surveyor explained CLIA required PT enrollment for the regulated Microbiology specialties, if PT was available. The surveyor then reviewed the CMS approved PT providers, and which one had proficiency testing available for the laboratory's Molecular (PCR) Diagnostic testing. . 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 a lack of 2018 accuracy verification documentation, no accuracy verification procedures, and an interview with the Technical Supervisor (TS) #1, the surveyor determined the laboratory failed to either enroll in proficiency testing (PT) with a CMS-approved PT provider or perform any accuracy verification comparing the laboratory's results with an outside laboratory at least twice a year since patient testing began in December 2017. The findings include: 1. During the entrance tour of the laboratory on 5/22/2019 at approximately 9:00 AM, TS #1 explained the laboratory had implemented major changes in the scope of testing due to a change in ownership after the initial survey on 7/5/2017. The laboratory name had also changed since the previous survey. TS #1 listed the following on the new laboratory test menu: Urine Toxicology Screening on the CLC (Carolina Liquid Chemistries Corporation)-800 (Nine drugs plus urine Creatinine) Confirmatory Drug Testing on the Agilent Technologies 6420 Triple Quad LC/MS (Liquid Chromatography/Mass Spectrometry) Molecular (PCR or Polymerase Chain Reaction) Testing for infectious organisms on two QuantStudio 12K Flex Systems and the Autogenomics Infinity HTS system 2. In an interview with TS #1 on 5/22/2019 at 11:00 AM, the surveyor asked whether testing of patients was interrupted due to a change in the laboratory ownership. TS #1 explained no testing was performed August to November 2017. In December 2017 the laboratory began performing PCR Testing for Respiratory Pathogens on the Autogenomics Infinity HTS. After the new ownership change in May 2018, the laboratory resumed Urine Toxicology testing; additional PCR testing for Bacterial Vaginosis and Candidal Vaginitis using the Autogenomics Infinity HTS began in August 2018. In May and August 2018 two QuantStudio 12K Flex Systems were -- 2 of 4 -- validated, and in use for patient testing for PCR detection of pathogens in Wound, Urine and STD (Sexually Transmitted Diseases) patient specimens. 3. On 5/22/2019 at 1:10 PM the surveyor requested proficiency testing records for the above test menu. TS #1 explained they had discontinued enrollment in PT after the termination of the moderate-complexity testing in August 2017, and they had not enrolled in 2018 or 2019 after implementation of the new test menu. Instead, TS #1 provided the Testing Personnel with "spiked samples" for Toxicology and Molecular (PCR) Diagnostic testing in April 2019. The TS stated the Testing Personnel also performed the blind testing in October 2018, however the laboratory had no documentation of the results due to "power surge damage to a computer during a tornado" in early May 2019. The TS assessed accuracy of the CLC-800 by comparing the patient results with the results obtained on the Agilent LC/MS system, and tabulating the statistical accuracy. 4. As the interview continued at 1:15 PM, the surveyor asked if the laboratory had procedures for performance of accuracy verification with criteria for acceptability, and TS #1 answered, "Not really". The surveyor then explained the laboratory must have a method of verifying the accuracy of non-regulated Urine Toxicology testing at least every six months (or twice a year), however the laboratory provided no 2018 documentation. Of further concern was the fact that the laboratory had no mechanism of verifying the accuracy of their results via an outside laboratory or thru enrollment with an approved PT provider. Only results for two internally-prepared spiked samples run in April 2019 were available for review. The laboratory failed to provide any 2018 accuracy verification records. 5. The surveyor further explained CLIA required PT enrollment for regulated Microbiology specialties, if PT was available. (Refer to D2000.) D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the maintenance procedures in the electronic Operator's Manual for the two QuantStudio 12K Flex Systems (which use PCR [Polymerase Chain Reaction] to identify pathogenic organisms), a lack of laboratory maintenance records, and interviews with the Technical Supervisor (TS) #1 and the Manager of Quality and Training, the surveyor determined the laboratory failed to perform and document the weekly, monthly and annual maintenance with the frequency required by the manufacturer since January 2018. The findings include: 1. A review of the maintenance records for the two QuantStudio 12K Flex Systems revealed only documentation of annual calibrations performed on 5/3/2019 for Quant #406; the calibration for the newer Quant #448 was dated 4/29/2019. The Quant #406 was in use for infectious disease testing since May 2018 when the laboratory ownership changed, per the TS #1 in an interview on 5/22/2019 at 11:00 AM. Quant #448 was validated and in use in August 2018. 2. A review of an electronic copy of the QuantStudio 12K Flex Operator's Manual in section 2, page 36, "Recommended calibration and maintenance", revealed the following: "...Weekly ...Power off the computer that controls the QuantStudio 12K Flex System, then after 30 seconds power on the computer. Clean the surface ... with a lint-free cloth. Perform ... Instrument self-test" "Monthly Perform a background calibration. Run disk cleanup and disk defragmentation." "Annually Perform a regions of interest (ROI),...a -- 3 of 4 -- background, ...a uniformity, ...a dye, [and] ...a normalization calibration. Perform an instrument verification run." [There was no documentation the annual calibrations were performed in 2018 for Quant #406.] 3. During a review of the above electronic information and an interview on 5/22/2019 at approximately 4:15 PM, TS #1 and the Manager of Quality and Training confirmed the laboratory had not documented performance of the above maintenance procedures. . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of quality assurance documentation and interviews with the Technical Supervisor (TS) #1, the surveyor determined the laboratory failed to implement effective quality assessment reviews to identify and correct problems identified in the analytical systems. The findings include: 1. A review of quality assurance documentation revealed the laboratory implemented documentation of monthly quality assurance activities in January 2019, however the reviews in 2018 and 2019 were inadequate to discover and correct problems in the following areas: A.) 2018-2019 Enrollment in proficiency testing (PT) with a CMS-approved PT provider for regulated tests in the Specialty of Microbiology; PT enrollment or implementation of a mechanism comparing the laboratory's results with an outside laboratory at least twice a year to ensure verification of the accuracy of test results for non-regulated moderate and high-complexity Urine Toxicology testing (Refer to D2000 and D5217.) B.) Perform and document the QuantStudio 12K Flex System weekly, monthly and annual maintenance with the frequency required by the manufacturer (2018 and 2019) (Refer to D5429.) C.) Review of environmental logs to ensure acceptable room temperature ranges were specified as determined by review of the manufacturer's operating requirements for the equipment in use (2018 and 2019) D.) Review of 2018 validation records to ensure the Laboratory Director and Technical Supervisor dated their review/approval of three new procedures, thus ensuring there was documentation the approval was made before the new systems were utilized for patient testing. 2. During the exit summation on 5/22/2019 at 5:00 PM, these concerns were reviewed and discussed with TS #1. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 4 of 4 --