St Thomas Clinical Reference Laboratory

Summary Statement of Deficiencies D0000 A recertification survey was conducted July 1, 2026. The laboratory was found to be in compliance with condition level deficiencies. The following standard-level deficiencies were cited. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory policies, and interview with the Technical Supervisor (TS) according to the Form Centers for Medicare and Medicaid (CMS) 209, the laboratory failed to establish and follow written policies and procedures for conditions of specimen transportation for 2 of 2 years (2024 and 2025). Findings Included: 1) Review of the laboratory policy titled 'St. Thomas Clinical Reference Lab QA Lab Systems Manual' failed to define conditions of specimen preservation and transportation (i.e. temperatures), and stated the following on page 8: "Sample Collected by The Patient or Outside the Lab ...Once the sample arrives at the laboratory, the sample will be verified if the specimen complies with the shipment and sample transport requirements (detailed in manual sampling and in the reference laboratories) and the following procedures ..." 2) The laboratory failed to provide the the reference laboratories' shipment and sample transport requirements. 3) The laboratory's QA procedures did not state shipment and sample transportation requirements as the policy stated above. 4) In an interview on 7/1/2026 at 10:59 AM, 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 -- the TS confirmed the laboratory failed to provide specimen preservation and transportation criteria within their policies. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (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 direct observation, review of manufacturer's instructions, laboratory policy and procedures, test records, verification studies, lot verification studies, and interview with the Technical Supervisor (TS) according to the Form Centers for Medicare and Medicaid (CMS) 209, the laboratory failed to follow the manufacturer's instructions in establishing a new patient normal mean for 1 of 1 new lot of Dade Innovin reagents used for the Sysmex CA-600 analyzer. Findings Included: 1. Based on direct observation on July 1, 2026 at 11:50 AM, one Sysmex CA-600 analyzer (Serial Number 13545) was in use. 2. Review of the manufacturer's instructions 'Siemens Healthineers Dade Innovin 11528733_en Rev. 13' stated the following instructions on page 4 of 9: "The mean normal Prothrombin Time (MNPT) is defined as the mean value of the normal range. It must be determined specifically for each thromboplastin lot using the method used to analyze the patient samples and, where appropriate, using the coagulation analyzer used for the analysis. Follow appropriate laboratory guidelines for establishing an MNPT, if applicable. Use of CLSI guideline is recommended." 3. Review of the laboratory's policy titled 'St. Thomas Clinical Reference Laboratory Manual for Coagulation Equipment Sysmex CA-600' stated (translated from Spanish to English): "1. Establish a New Normal Patient Mean (Geometric Mean PT Value in Healthy Subjects) 2. Perform a comparison between old and new PT reagent lots (parallel testing) 3. Program the ISI and the Normal Patient Mean in the analyzers ... INR Calculation = Patient PT divided by Mean PT to the power of the ISI. The ISI is assigned to each reagent lot and listed on the thromboplastin reagent package insert .... With every new PT reagent lot (innovin) or every 6 months (whichever comes first), verify the following: 1. Verify the reference INR value using 20 normal patients. Apply 2 standard deviations to establish the reference value. 2. Use these same normal patient results, calculate the Geometric Mean, which becomes the Population Mean for the new PT reagent lot and is used to recalculate the INR. 3. The new INR calculation must be entered into the analyzer. 4. As part of the hematology performance program, patient results are used to verify the analyzer's INR calculation formula ..." 3. Review of the laboratory's 2026 Validation study on the Sysmex CA-600 and review of patient test reports revealed the laboratory's established PT reference interval for normal patients as 9.95 to 11.00. 4. Review of the laboratory's New Lot Study (Dade Innovin Lot Number 564703A), conducted March 2026 after the instrument was installed, titled 'Population mean and reference value of the new PT reagent lot St. Thomas Clinical Reference Lab', revealed the usage of patients with PT values of 9.9 for 5 out of the 20 normal health patients chosen for the Geometric mean calculation purposes. The normal established reference interval, as per the laboratory's validation study and reported on patient test reports was 9.95 on the low end. 5. In an interview on July 1, 2026, at 11:56 AM, the TS confirmed some of the patients used for the new lot Dade Innovin study were lower than the laboratory's established normal reference range. -- 2 of 3 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 direct observation, manufacturer's instructions, review of the laboratory's temperature records, and interview with the Technical Supervisor (TS) according to the Form Centers for Medicare and Medicaid (CMS) 209, the laboratory failed to define freezer temperature ranges in accordance with manufacturer's instructions for 4 of 4 reagents. Findings Included: 1) During a laboratory tour on July 1, 2026, at 1:33 PM, one Kenmore Freezer (Serial Number BA34739592) was directly observed in use storing the following reagents and test kits: a. 3 Bio-Rad Inteliq Immunoassay Controls, Lot Number 10551T, Manufacturer storage temperature requirements -70 to -20 degrees Celsius. b. 1 Siemens Healthineers Atellica CH ENZ 3 Calibrator, Lot Number 00636, Manufacturer storage temperature requirements -25 to -15 degrees Celsius. 2) Review of the laboratory's temperature log sheet revealed an acceptable freezer temperature range of -20 to -10 degrees Celsius. 3) In an interview on July 1, 2026 at 1:45 PM, the TS confirmed the laboratory's acceptable temperature ranges of the freezer were not defined in accordance with manufacturer's instructions. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 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: 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 -- Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) 2025 records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of Parasitology and in the specialty of Hematology for the Hematocrit (HCT) analyte. Refer to D2055 and D2130. D2055 PARASITOLOGY CFR(s): 493.829(e) (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 a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for two of two consecutive testing events (2025 Events 1 and 2) in the subspecialty of Parasitology. Findings included: 1. A review of the CASPER 0155 report revealed the following results: AAB-MLE 2025 - 1st Event The laboratory received an unsatisfactory score of 70% for Parasitology. AAB-MLE 2025 - 2nd Event The laboratory received an unsatisfactory score of 60 % for Parasitology. 2. A review of AAB-MLE 2025 proficiency testing records confirmed the laboratory received the above results. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of two consecutive testing events (2025 Events 1 and 2) for the specialty of Hematology for the Hematocrit (HCT) analyte. Findings included: 1. A review of the CASPER 0155 report revealed the following results: AAB-MLE 2025 - 1st Event The laboratory received an unsatisfactory score of 20% for the HCT analyte. AAB-MLE 2025 - 2nd Event The laboratory received an unsatisfactory score of 40% for the HCT analyte. 2. A review of AAB-MLE 2025 proficiency testing records confirmed the laboratory received the above results. 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, 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) (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 a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2055 and D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 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: 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 -- Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) 2024 records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of Routine Chemistry for the Total Bilirubin analyte. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2024 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of two consecutive testing events (2024 Events 1 and 2) in the subspecialty of Routine Chemistry for the Total Bilirubin analyte. Findings included: 1. Review of the CASPER 0155 report revealed the following results: AAB-MLE Chemistry 2024 - 1st Event The laboratory received an unsatisfactory score of 40% for Total Bilirubin. AAB-MLE Chemistry 2024 - 2nd Event The laboratory received an unsatisfactory score of 40 % for Total Bilirubin. 2. A review of AAB-MLE 2024 proficiency testing records confirmed the laboratory received the above results. 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 0155 report and AAB- MLE 2024 proficiency testing records, 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: -- 2 of 3 -- Based on a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2024 proficiency testing records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at St. Thomas Clinical reference laboratory on September 20 -21, 2020 by the CMS New York CLIA Branch Location federal surveyor. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the technical supervisor the laboratory failed to label reagents with preparation and expiration dates in the chemistry sections of the laboratory. Findings include: On 09/20/21 at approximately 11:00am a tour of the chemistry section of the laboratory revealed the reagents were not labeled with an open date/ expiration dates. The surveyor requested reagent logs for reagents loaded to the Centaur XP, the laboratory testing personnel stated "We dont have a reagent log and we don't label expiration dates on the reagents, we just put them on the machine, we change the reagents based on the reservoir level". During an exit interview on 09 /21/2021 at approximately 2:30 PM with the technical supervisor confirmed the laboratory did not label reagents with open/ expiration dates. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with the technical supervisor the laboratory failed to discard reagents that exceeded their expiration date. Findings include: On 09/20/21 at approximately 11:00am during a tour of the chemistry section of the laboratory the surveyor observed two of the following reagents in use on the Centaur XP chemistry instrument: Acid Reagent expiration date 06-30-2021 Base Reagent expiration date 06-30-2021 During an exit interview on 09/21/2021 at approximately 2:30 PM ,the technical supervisor confirmed the laboratory used expired reagents on the Centaur XP chemistry instrument. 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 observation and interview with the technical supervisor the laboratory failed perform preventative maintenance on the Centaur XP as defined by the manufacturer . Findings include: On 09/20/21 at approximately 11:00am, a tour of the chemistry section of the laboratory revealed the lack of daily maintenance procedures performed on Centaur XP included the following: Daily cleaning procedure was not performed for three months from the date of the survey last performed 06/16/2021. Cleaning Solution replacement was not performed for three months from the date of the survey last performed 06/22/2021 During an exit interview on 09/21/2021 at approximately 2: 30 PM with the technical supervisor confirmed the laboratory did not perform the preventative maintenance as defined by the Centaur XP manufacturer. -- 2 of 2 --

Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of records, observation, and interview with the laboratory owner, technical supervisor, and laboratory clerk, the laboratory failed to ensure that the date of collection and, if appropriate, the specimen collection was on the requisition and in SAIL, the Laboratory Information Systems (LIS). The findings include: 1. The test requisition did not include a data field for collection date and time. 2. On observation, SAIL LIS did not have a data field for collection date and time. 3. There was no documentation of collection date and time for Specimen 003137299 that had a request for stool occult blood. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on review of records, observation of SAIL (LIS) , and interview with the laboratory owner, technical supervisor, the laboratory failed to document the receipt date and time of specimens. The findings include: a. The registration print out of the LIS indicated order date and time. The laboratory owner stated the order date and time was the same as the receipt date and time of specimens that were collected and or drawn in the laboratory and specimens collected by patients themselves. b. There was no policy stating the the order date and time was equivalent to receipt date and time. b. SAIL, the LIS did not have a data field for receipt date and time. SAIL had data field for order date and time and report date and time. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of records and interview with and confirmation by the laboratory owner and technical supervisor, the laboratory failed to enroll in Proficiency testing Program for second event 2017. The owner stated the laboratory started to perform testing on February 2, 2017. -- 2 of 2 --