St Louis Medical Professionals

Summary Statement of Deficiencies D0000 A recertification survey was completed on August 22, 2024. It was determined that Immediate Jeopardy (IJ) existed for the following condition level deficiencies: 42 C.F. R. 493.1250 Condition: Analytic Systems 42 C.F.R. 493.1403 Condition: Laboratory Director D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the Siemens Clinitek Status manufacturer's instructions, observation of the Osom strep kit, review of the Abbott Afinion AS100 analyzer, lack of quality control (QC) documentation, and interview with the laboratory director, the laboratory failed to follow manufacturer's instructions for performing Clinitek Status urinalysis testing, Osom strep kit testing and hemoglobin A1c (HbA1c) testing. Findings: 1. Review of the Siemens Clinitek Status urinalysis analyzer manufacturer instructions states, "Test negative and positive controls whenever a new bottle of reagent strips is first opened." 2. Review of urinalysis strips revealed Siemens multistix 10SG lot # 303030 expiration date 9/30/24 in use. 3. Review of Siemens Clinitek Status urinalysis analyzer QC revealed the laboratory could not provide QC from July 28, 2022 to date August 20, 2024. 4. Observation of the waived tests kits revealed Osom strep kit lot # 221273 expiration 12/31/23 still in use. The laboratory was unable to provide the number of patient tests performed while the Osom strep kit was expired. 5. Review of Afinion HbA1c manufacturer's instructions states "Controls should be analyzed: with each new shipment of Afinion HbA1c test kits, with each new lot of Afinion HbA1c tests kits and at least every 30 days". 6. Review of Afinion HbA1c QC showed no QC performed in June 2024, July 2024 and August 2024. 7. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- Review of Afinion HbA1c manufacturer's instructions states "Opened control vials are stable for 60 days when stored refrigerated 2-8 degrees Celsius." 8. Observation of HbA1c QC showed lot # 902958609 opened 5/17/24, expired 7/17/24. One patient performed on August 19, 2024 with expired QC. 9. Interview with the laboratory director on August 20, 2024 at 11:00 AM confirmed the laboratory failed to follow manufacturer's instructions for performing Clinitek Status urinalysis testing, strep testing and hemoglobin A1c (HbA1c) testing. D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on interview with the laboratory director (LD), review of proficiency testing records for 2022, 2023, and to date August 20, 2024, and interview with the testing personnel (TP) #2, the laboratory failed to establish a means to verify the accuracy for urine microscopic testing twice a year in 2022, 2023 and to date August 20, 2024. Findings: 1. Interview with the laboratory director (LD) on August 20, 2024 at 10:30 AM, the LD states that "he performs urine microscopic testing occasionally or as needed." 2. Review of proficiency testing records for 2022, 2023, and to date August 20, 2024, showed the laboratory failed to prove accuracy on the non-regulated analyte urine microscopic testing. 3. Interview with the TP #2 on August 20, 2024 at 11:00 AM confirmed the laboratory failed to establish a means to verify the accuracy of urine microscopic testing twice a year. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation of two microscopes, observation of laboratory and laboratory refrigerators, laboratory procedures, temperature logs, review of the Cell-Dyn 22 Plus Control quality control (QC) package insert, observation of the Cell-Dyn 22 Plus hematology QC vials, observation of room temperature supplies, review of the Olympus AU400 chemistry analyzer maintenance logs, lack of documentation for function checks, review of the Abbott Cell-Dyn Emerald 22 AL hematology analyzer operator's guide, review of calibration records for the Abbott Cell-Dyn Emerald 22 AL hematology analyzer, patient results, review of calibration records for the Olympus AU400 chemistry analyzer, lack of Olympus AU400 chemistry analyzer patient logs, lack of Access 2 chemistry analyzer patient logs, Olympus AU400 chemistry analyzer QC, Access 2 chemistry analyzer QC, lack of Abbott Cell-Dyn Emerald 22 AL hematology patient logs, review of Abbott Cell-Dyn Emerald 22 AL -- 2 of 12 -- hematology analyzer QC, and interviews, the laboratory failed to meet the condition of analytic systems. The laboratory failed to document microscope maintenance (Refer to D5411); the laboratory failed to ensure room temperature, refrigerator temperature, freezer temperature and humidity was taken every day (Refer to D5413); the laboratory failed to document expiration date on hematology QC (Refer to D5415); the laboratory failed to ensure the laboratory's reagents, quality control and supplies were not used when they had exceeded their expiration date (Refer to D5417); the laboratory failed to perform and document maintenance for the Olympus AU400 chemistry analyzer, (Refer to D5429); the laboratory failed to define, perform and document function checks for laboratory centrifuges (Refer to D5435); the laboratory failed to follow manufacturer's recommended frequency for calibration verification of the hematology analyzer (Refer to D5437); the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range (Refer to D5439); the laboratory failed to include two controls materials of different concentrations each day of patient testing for chemistry and hematology testing (Refer to D5447). 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: Observation of 2 microscopes and interview with the laboratory director (LD), the laboratory failed to document microscope maintenance for 2022 to date August 20, 2024. Findings: 1. Observation of 2 of 2 microscopes showed no documentation of maintenance for 2022 to date August 20, 2024. 2. Interview with the LD on August 20, 2024 at 11:00 AM confirmed the laboratory failed to document microscope maintenance. 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 observation of the laboratory, review of temperature logs, observation of refrigerator, Cell-Dyn Emerald hematology analyzer procedure, and interview with the laboratory director, the laboratory failed to monitor and document the temperature of room, refrigerator, freezer and humidity. Findings: 1. Observation of laboratory revealed a Cell-Dyn Emerald hematology analyzer. 2. Review of Cell-Dyn Emerald -- 3 of 12 -- hematology analyzer procedure states "To ensure the instrument and reagents function properly, it is important to maintain the temperature between 18 degrees Celsius to 32 degrees Celsius". 3. Review of room temperature log located in the laboratory showed no documentation of room temperature for 142 of 233 days in 2024. 4. Review of Cell- Dyn Emerald hematology analyzer procedure states "Maximum relative humidity 80% for temperatures up to 32 degrees Celsius". 5. Review of humidity log located in the laboratory showed no documentation of humidity for 142 of 233 days in 2024. 6. Observation of the urgent care room refrigerator revealed Cell-Dyn22 plus controls lot # MLH4183 expiration 9/13/24 temperature range 2 degrees Celsius to 8 degrees Celsius. 7. Review of refrigerator temperature log located in the urgent care room showed no documentation of refrigerator temperature for 153 of 233 days in 2024. 8. Review of freezer temperature log located in the urgent care room showed no documentation of freezer temperature for 158 of 233 days in 2024. 9. Interview with the laboratory director on August 20, 2024 at 11:00 AM confirmed the laboratory failed to ensure temperature logs were documented. 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 review of the Cell-Dyn 22 Plus Control quality control (QC) package insert, observation of the Cell-Dyn 22 Plus hematology QC vials and interview with the testing personnel (TP) #2, the laboratory failed to document open and expiration dates on hematology QC. Findings: 1. Review of the Cell-Dyn 22 Plus Control QC package insert states "8 Consecutive Day Open-Vial Stability." 2. Observation of opened Cell- Dyn 22 Plus hematology QC vials lot # L4183, N4183 and H4183 showed no open and expiration dates on QC vials. 3. Interview with the TP #2 on August 20, 2024 at 10:00 AM confirmed the laboratory failed to document open and expiration dates on hematology QC. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 of the laboratory's refrigerators, room temperature supplies and interview with the testing personnel (TP) #2, the laboratory failed to ensure the laboratory's reagents, quality control and supplies were not used when they had exceeded their expiration date. Findings: 1. Observation of the laboratory refrigerators showed reagents still in use: 1 box of Clean Chem Diagnostics Inc. Direct Bilirubin lot # 2238 expiration date 10/01/2023 1 box of Clean Chem Diagnostics Inc. Cholesterol, Total lot # 216501-120 expiration date 01/01/2024 1 box of Clean Chem -- 4 of 12 -- Diagnostics Inc. Carbon Dioxide (CO2) lot # 303901-025 expiration date 06/01/2024 1 box of Clean Chem Diagnostics Inc. Aspartate Aminotransferase (AST) lot # 218601-117 expiration date 02/01/2024 2. Observation of the laboratory's room temperature supplies showed reagents, quality control material and supplies still in use: 1 bottle of Beckman Coulter Contrad 70 lot # 803520 expiration date 05/04/2023 1 bottle of Beckman Coulter Citranox lot # C9E1 expiration date 05/31/2023 1 bottle of Beckman Coulter Access Wash Buffer II lot # 331861F expiration date 10/07/2023 1 box of Beckman Coulter ISE Low Serum Standard lot # 2694 expiration date 07/19 /2022 1 box of Beckman Coulter ISE High Serum Standard lot # 2697 expiration date 06/01/2022 9 Hologic Aptima Unisex Swab Collections kits lot # 286753HA expiration date 03/31/2022 5 UTM-RT w/o beads collection kits lot # B103746 expiration date 02/28/2023 10 BD Vacutainer, Urinalysis Transfer Straw kits lot # 2096183 expiration date 10/2023 1 box of Direct Enzymatic HbA1C Assay Control set lot # HBC001220-01-02 expiration date 11/29/2023 1 box of Direct Enzymatic HbA1C Assay Calibrator set lot # HBS003220-01-09 expiration date 06/08/2024 43 BD Vacutainer Serum tubes lot # 3059371 expiration date 06/30/2024 4 bottles of Thermo Scientific VersaTrek Redox 2 aerobic blood culture bottles 4 bottles of Thermo Scientific VersaTrek Redox 2 anaerobic blood culture bottles 3. Interview with the testing personnel (TP) #2 on August 20, 2024 at 11:00 AM confirmed the laboratory failed to ensure the laboratory's reagents, quality control material and supplies were not used when they had exceeded their expiration date. 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 review of the Olympus AU400 chemistry analyzer manufacturer maintenance logs and interview with the lab director (LD), the laboratory failed to perform and document maintenance for the Olympus AU400 chemistry for 2023 to date chemistry testing was discontinued in February 2024. Findings: 1. Review of the Olympus AU400 chemistry analyzer manufacturer maintenance logs showed no documentation of maintenance for "monthly analyzer" maintenance for April 2023, May 2023, August 2023, September 2023, October 2023, November 2023 and January 2024. 2. Review of the Olympus AU400 chemistry analyzer manufacturer maintenance logs showed no documentation of maintenance for "every three months analyzer and every three months ISE" maintenance for 2023 to date testing was discontinued in February 2024. 3. Interview with the LD on August 20, 2024 at 11:00 AM confirmed, the laboratory failed to perform and document maintenance for the Olympus AU400 chemistry analyzer. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result -- 5 of 12 -- reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on lack of documentation for function checks and interview with the testing personnel (TP) #2, the laboratory failed to define, perform and document function checks for 2 of 2 laboratory centrifuges in 2022, 2023 and to date August 20, 2024. Findings: 1. Lack of function check documentation showed the laboratory failed to define, perform and document function checks for the Unico Powerspin FX centrifuge and the Fisher Healthcare Horizon model 642E centrifuge in 2022, 2023 and to date August 20, 2024. 2. Interview with the testing personnel (TP) #2 on August 20, 2024 at 10:30 AM confirmed that the laboratory failed to define, perform and document function checks for the laboratory's centrifuges. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the Abbott Cell-Dyn Emerald 22 AL hematology analyzer operator's guide, 2022/2023/2024 calibration records for the Abbott Cell-Dyn Emerald 22 AL hematology analyzer, patient results and interview with the testing personnel (TP) #2, the laboratory failed to follow manufacturer's recommended frequency for calibration verification of the hematology analyzer in 2022 and to date August 20, 2024. Findings: 1. Review of the Abbott Cell-Dyn Emerald 22 AL hematology analyzer operator's guide states "When to Calibrate, Calibration verification criteria include: At least every six months." 2. Review of 2022, 2023, and 2024 calibration records for the Abbott Cell-Dyn Emerald 22 AL hematology analyzer showed the laboratory failed to perform a calibration verification following manufacturer's recommended frequency of every six months in 2022, 2023 and to date August 20, 2024 for the analytes: white blood cell, red blood cell, hemoglobin, hematocrit and platelet. 3. The laboratory was unable to provide the number of hematology tests that they perform per year. 4. Interview with the TP #2 on August 20, 2024 at 10:00 AM confirmed the laboratory failed to follow manufacturer's recommended frequency of every six months for calibration of the Abbott Cell-Dyn Emerald 22 AL hematology analyzer. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) -- 6 of 12 -- 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 2022, 2023, and to date August 20, 2024 calibration records for the Olympus AU400 chemistry analyzer and interview with the laboratory director (LD), the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range for 22 of 22 analytes. Findings: 1. Review of Olympus AU400 chemistry calibration records for 2022, 2023, and to date August 20, 2024 showed no calibration every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range for the analytes: albumin, alkaline phosphatase, aspartate aminotransferase, alanine transaminase, direct bilirubin, total bilirubin, blood urea nitrogen, calcium, chloride, cholesterol, CO2, creatine kinase, creatinine, glucose, high-density lipoprotein, low-density lipoprotein, magnesium, phosphorus, potassium, sodium, total protein and triglycerides. 2. Interview with the LD on August 20, 2024 at 11:00 AM confirmed the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, lack of Olympus AU400 chemistry analyzer patient logs, lack of Access 2 chemistry analyzer patient logs, Olympus -- 7 of 12 -- AU400 chemistry analyzer quality control (QC), Access 2 chemistry analyzer QC, patient results and interview with the laboratory director (LD), the laboratory failed to include two controls materials of different concentrations each day of patient testing. Findings: 1. Review of "The Olympus AU400" procedure states "During operation of the AU400/AU400e, at least two levels of control material should be tested a minimum of once a day". 2. Lack of Olympus AU400 chemistry analyzer patient logs revealed the laboratory could not provide dates of patient testing from June 2022 to February 2024 when patient testing ceased. 3. Review of Olympus AU400 QC showed the laboratory could not provide documentation for QC performed each day of patient testing for the analytes: albumin, alkaline phosphatase, aspartate aminotransferase, alanine transaminase, direct bilirubin, total bilirubin, blood urea nitrogen, calcium, chloride, cholesterol, CO2, creatine kinase, creatinine, glucose, high-density lipoprotein, low-density lipoprotein, magnesium, phosphorus, potassium, sodium, total protein and triglycerides. 4. Review of the "Quality Control Materials" procedure states "Instruments that require 3 quality control, 2 out of 3 controls must pass before performing patient tests". 5. Review of Access 2 chemistry analyzer patient logs revealed the laboratory could not provide dates of patient testing from June 2022 to October 2023 when patient testing ceased. 6. Lack of Access 2 QC showed the laboratory could not provide documentation for QC performed each day of patient testing for the analytes: prostate specific antigen, thyroid stimulating hormone, and Free T4. 7. The laboratory was unable to provide the volume of patient tests performed on the Olympus AU400 chemistry analyzer and Access 2 chemistry analyzer while QC was not performed. 8. Interview with the LD on August 20, 2024 at 11:00 AM confirmed the laboratory failed to include two controls materials of different concentrations each day of patient testing on the Olympus AU400 chemistry analyzer and Access 2 chemistry analyzer. 44735 Based on review of laboratory procedures, lack of Abbott Cell-Dyn Emerald 22 AL hematology patient logs, review of Abbott Cell-Dyn Emerald 22 AL hematology analyzer quality control (QC), and interview with the testing personnel (TP) #2, the laboratory failed to include two controls materials of different concentrations on the Abbott Cell-Dyn Emerald 22 AL hematology analyzer each day of patient testing. Findings: 1. Review of laboratory procedure "Quality Control Materials" states "Quality control materials must be performed each day of use." 2. Lack of Abbott Cell-Dyn Emerald 22 AL hematology patient logs showed the laboratory could not provide dates of patient testing from January 2023 to date August 20, 2024. 3. Review of Abbott Cell-Dyn Emerald 22 AL hematology analyzer quality control (QC) showed the laboratory could not provide documentation for QC performed each day of patient testing on the Abbott Cell-Dyn Emerald 22 AL hematology analyzer. 4. Interview with the TP #2 on August 20, 2024 at 10:00 AM confirmed the laboratory failed to document two control materials each day of patient testing. 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 observation of the laboratory, review of laboratory procedures, review of form CMS 209 provided by the laboratory, review of proficiency testing (PT) records, review of the Abbott Cell-Dyn Emerald 22 AL hematology analyzer quality control -- 8 of 12 -- (QC), patient reports, review of chemistry QC and interviews, the laboratory director (LD) failed to provide overall management and direction to the laboratory. The laboratory director (LD) failed to provide overall operation of the laboratory (Refer to D6004); the LD failed to ensure PT samples are tested by all of the individuals who perform patient testing (Refer to D6016); the LD failed to ensure all proficiency testing reports received were reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the performance verification procedures for the Cell-dyn Emerald hematology analyzer and Beckman Coulter Access 2 chemistry analyzer, review of patient results and interview with the laboratory director (LD), the laboratory failed to verify performance specifications prior to reporting patient test results. Findings: 1. Review of the performance specifications for the Cell-dyn Emerald hematology analyzer showed the laboratory failed to verify that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient population for the analytes: red blood cell (RBC), hemoglobin, hematocrit, platelet, white blood cell (WBC) and differential prior to the beginning of patient testing in July 2021. 2. Review of patient results from July 2021 to date August 23, 2022 showed approximately 1784 complete blood count (CBC) patient results were reported. 3. Review of the performance specifications for the Beckman Coulter Access 2 chemistry analyzer showed the laboratory failed to verify that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient population for the analytes: thyroid-stimulating hormone (TSH), total prostate- specific antigen (Total PSA), free thyroxine (free T4), testosterone, vitamin D, sex hormone binding globulin (SHBG) prior to the beginning of patient testing in August 2021. 4. Review of patient results from August 2021 to date August 23, 2022 showed 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 -- 150 TSH, 61 total PSA, 82 free T4, 15 testosterone, 53 vitamin D, and 10 SHBG patient results were reported. 5. Interview with the LD on August 23, 2022 at 10:00 AM confirmed the laboratory failed to verify performance specifications prior to reporting patient test results. -- 2 of 2 --

Summary Statement of Deficiencies D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor-- (b)(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must-- (c)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (c)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- accredited institution; and (c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and (c)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-- (d)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (e)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (e) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (e)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(3)(ii) Have at least 1 year of laboratory training or experience, or both in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical -- 2 of 7 -- laboratory science or medical technology from an accredited institution; and (e)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-- (f)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (f)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (f)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (g)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (g) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (g)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical -- 3 of 7 -- laboratory science or medical technology from an accredited institution; and (g)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must- (h)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (h)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (h)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (i)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (i)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-- -- 4 of 7 -- (j)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (j)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (j)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (j) (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must-- (k)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must-- (l)(1) Meet one of the following requirements: (l)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (l)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(2)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may -- 5 of 7 -- delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(3)(i) (A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (m) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (m)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (m)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (m)(2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (n)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-- (o)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric -- 6 of 7 -- medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must-- (q)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (q)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (q)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (q)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Note: The technical supervisor requirements for "laboratory training or experience, or both'' in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology. This STANDARD is not met as evidenced by: No deficiency details available. -- 7 of 7 --

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 review of proficiency testing (PT) records for 2020 and interview with the technical supervisor, the laboratory failed to enroll in an approved PT program for regulated analytes listed in subpart I performed on the Sight Diagnostics Olo hematology analyzer. Findings: 1. Review of PT records for 2020 revealed the laboratory did not enroll in an approved PT program for the following regulated analytes performed on the Sight Diagnostics Olo hematology analyzer: Leukocyte count Erythrocyte count Hemoglobin Hematocrit Platelet count Cell identification /White blood cell differential 2. Interview with the technical supervisor on November 10, 2020 at 11:30 AM confirmed the laboratory failed to enroll in an approved PT program for the regulated analytes listed above in finding #1. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State 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 -- Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation and interview, the laboratory failed to maintain a uni-directional workflow process to prevent contamination of COVID-19 PCR testing (Refer to D3005). D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on observation of the COVID-19 testing room, review of the Lyra Direct SARS-CoV-2 assay procedure, observation of the Healgen COVID-19 IgG/IgM rapid test, and interview with the technical supervisor (TS), the laboratory director (LD), and testing personnel (TP) #3, the laboratory failed to have a uni-directional workflow that includes separate areas for specimen preparation, amplification, and product detection for COVID-19 using the Lyra Direct SARS-CoV-2 assay. Uni-directional workflow refers to the manner in which testing personnel and patient specimens move through the molecular testing process to prevent cross-contamination of patient specimens, and consists of separate areas for reagent preparation, pre-amplification, and post-amplification. Findings: 1. Observation of the COVID-19 testing room showed one hood located in the corner for processing and setting up the patient extraction 96 well plate. One desk area is located in the middle of the room for putting buffer into tubes, heating patient tubes in heat block, mixing patient tubes, preparing master mix, pipetting master mix into PCR plate, vortexing specimens in PCR plate, and performing the Healgen COVID-19 IgG/IgM rapid test. One Applied Biosystems 7500 Fast Real Time PCR analyzer is located on the wall by the hood for performing COVID-19 testing. One refrigerator and two freezers on the wall are located on the opposite side to the desk area and down the wall 2 more refrigerators and tables are located for patient specimens. The COVID-19 pre-amplification and molecular amplification area did not include a uni-directional workflow process to prevent contamination during reagent preparation, specimen preparation, amplification, and detection. 2. Interview with TP #3 on November 20, 2020 at 08:45 AM confirmed the laboratory could not provide a diagram, floorplan, mechanism or describe an acceptable workflow pattern to demonstrate uni-directional workflow for molecular amplification procedures to prevent cross-contamination. TP #3 explained the workflow process which included pre-amplification and amplification procedures performed at same desk area as well as testing personnel walking back and forth several times on a single run to obtain specimens, set up, obtain reagents, quality control, and supplies. 3. Review of the Lyra Direct SARS-CoV-2 Assay procedure states "Proper workflow planning is essential to minimize contamination risk. Always plan laboratory workflow in a uni-directional manner, beginning with pre- -- 2 of 3 -- amplification and moving through amplification and detection. Use dedicated supplies and equipment in pre-amplification and amplification areas. Do not allow cross movement of personnel or equipment between areas. Keep amplification supplies separate from pre-amplification supplies at all times." 4. Observation of the Healgen COVID-19 IgG/IgM rapid test showed the Healgen rapid test is performed on same desk as the pre-amplification and amplification procedures are performed for the Lyra Direct SARS-CoV-2 Assay. 5. Interview on November 10, 2020 at 11:30 AM with the TS and LD confirmed the laboratory failed to have a uni-directional workflow to include separate areas to prevent contamination of patient specimens, equipment, instruments, reagents, materials, and supplies. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Sight Diagnostics Olo hematology analyzer quality control (QC), and interview with the technical supervisor (TS), laboratory director (LD), and testing personnel #3, the laboratory failed to establish or verify the criteria for acceptability of hematology QC material from September 4, 2020 to date November 10, 2020. Findings: 1. Review of Olo hematology QC showed no acceptable ranges and no criteria for acceptability of QC. 2. Interview with the TS and LD on November 10, 2020 at 12:20 PM confirmed the laboratory failed to establish or verify the criteria for acceptability of hematology QC material. -- 3 of 3 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records for 2019 and 2020 and interview with the technical supervisor (TS) the laboratory director (LD) failed to sign 5 of 9 attestation statements. Finding: 1. Review of 2019 and 2020 PT records showed the LD did not sign three attestation statements for second and third events 2019 and two attestation statements for first and second events 2020. 2. Interview with the TS on September 30, 2020 at 10:30 A.M. confirmed the LD failed to sign the attestation statements documenting PT samples were tested in the same manner as patient specimens. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: 43990 This CONDITION is not met as evidenced by: Based on record review, observation and interview the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problems.The laboratory failed to monitor temperature and humidity conditions (Refer to D5411); failed to verify performance specifications (Refer to D5421); failed to establish a maintenance protocols (Refer to D5433); and failed to evaluate and define relationship between test systems at least twice a year (Refer to D5795). 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 review of manufacturer's package inserts and interview with the technical supervisor, the laboratory failed to follow manufacturer's instructions for temperature and humidity conditions in the COVID-19 testing section and hematology testing section. Finding: 1. Review of the manufacturer'sassay procedure stated controlled room temperature of "20 to 25 degrees Celsius" required for COVID-19 testing. 2. Review of COVID-19 testing section showed laboratory did not monitor room temperature. 3. Review of the manufacturer's product insert for performance specifications for hematology analyzer revealed an acceptable range of relative humidity of "10 to 80% percent." 4. Review of the room temperature documentation logs showed the laboratory failed to document humidity for the hematology testing section. 5. Interview with the TS on September 29, 2020 at 10:00 AM confirmed the laboratory failed to follow the manufacturer's instructions for temperature and humidity conditions. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the performance verification procedures for the Healgen Covid-19 IgG/IgM rapid test, patient records and interview with the laboratory director (LD), -- 2 of 10 -- the laboratory failed to verify performance specifications. Findings: 1. Review of the verification procedures for the Healgen Covid-19 IgG/IgM rapid test which the laboratory started patient testing on August 8, 2020 showed no accuracy, precision, reportable range and no verification that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. 2. Review of patients test results showed 32 patients have been tested since August 8, 2020 3. Interview with the LD on September 29, 2020 at 10:30 AM confirmed the laboratory failed to verify performance specifications prior to performing patient testing. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation of the steriguard 111 advance safety cabinet hood and interview with the laboratory director (LD), the laboratory failed to establish a maintenance protocol that ensures equipment performance. Findings: 1 Observation of the steriguard 111 advance safety cabinet hood showed no maintenance was documented for 2017, 2018, 2019 and to date September 28, 2020. 2. Interview with the LD on September 28, 2020 at 12:15 PM confirmed the laboratory failed to establish a maintenance protocol for the steriguard 111 advance safety cabinet hood. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of chemistry and coagulation instrument comparisons and interview with the laboratory director (LD), the laboratory failed to evaluate and define relationship between test results using different methodologies or instruments twice a year for 2018, 2019 and to date September 29, 2020. Findings: 1. Review of Olympus AU400 chemistry analyzer and Piccolo analyzer for the analytes: alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total carbon dioxide, total bilirubin, total protein, creatinine, albumin, calcium, chloride, glucose, potassium, sodium and urea nitrogen showed no documentation and evaluation between test results using different methodologies twice a year for 2018, 2019 and to date September 29, 2020. 2. Review of the Stago sta satellite analyzer and Coag-Sense analyzer for prothrombin time showed no documentation and evaluation between test results using different methodologies twice a year for 2018, 2019 and to date -- 3 of 10 -- September 29, 2020. 3. Interview with the LD on September 29, 2020 at 11:30 AM confirmed the laboratory failed to evaluate and define relationship between test results using different methodologies or instruments twice a year. 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: 43990 This CONDITION is not met as evidenced by: Based on observation, record review and interviews the laboratory director (LD) failed to provide overall management and direction to the laboratory. The LD failed to provide a safe environment in which employees are protected from chemical and biological hazards (Refer to D6084); failed to ensure the verification procedures were adequate to determine the accuracy, precision and other pertinent performance characteristics of the method (Refer to D6086); failed to ensure appropriate staff evaluated the laboratory's performance and identify any problems that required

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 2019 and 2020 routine chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the technical consultant, the laboratory failed to successfully participate in PT. See D-tag 2096 failure to successfully participate in three of four consecutive PT challenges. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 routine chemistry proficiency testing (PT) results for 2019 and 2020 and phone interview with the technical consultant, the laboratory failed to achieve satisfactory performance for the analyte, triglycerides (TRIG), in three of four PT events. Findings: 1. Review of the chemistry PT results for the first event of 2019 revealed the laboratory obtained an unsatisfactory score of 60 percent for the analyte, TRIG. 2. Review of the chemistry PT results for the third event of 2019 revealed the laboratory obtained an unsatisfactory score of 20 percent for the analyte, TRIG 3. Review of the chemistry PT results for the first event of 2020 revealed the laboratory obtained an unsatisfactory score of 40 percent for the analyte, TRIG. 4. Phone interview with the technical consultant on April 7, 2020 at 1:30 PM confirmed the laboratory failed to achieve satisfactory performance for TRIG testing in three of four events for 2019 and 2020. -- 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 review of 2019 chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with testing personnel, the laboratory failed to successfully participate in PT. See D-tag 2096, unsatisfactory performance in two out of three consecutive total cholesterol, high density lipoprotein, triglyceride, and glucose PT challenges. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 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 chemistry proficiency testing (PT) results for 2019 and phone interview with testing personnel, the laboratory failed to achieve satisfactory performance for the analytes: total cholesterol (CHOL), high density lipoprotein (HDL), glucose (GLU), and triglycerides (TRIG) in two out of three consecutive PT events. Findings: 1. Review of the chemistry PT results for the first event of 2019 revealed the laboratory obtained unsatisfactory scores of 20 percent for CHOL, 40 percent for HDL, 20 percent for glucose, and 60 percent for TRIG. 2. Review of the chemistry PT results for the third event of 2019 revealed the laboratory obtained unsatisfactory scores of 0 percent for CHOL, 20 percent for HDL, 40 percent for GLU and 20 percent for TRIG. 3. Phone interview with testing personnel on October 23, 2019 at 10:30 AM confirmed the laboratory failed to achieve satisfactory performance for CHOL, HDL, GLU, and TRIG for two out of three consecutive testing events for 2019. -- 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 review of 2018, 2019 routine chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the general supervisor, the laboratory failed to successfully participate in PT. See D-tag 2096, unsatisfactory performance in two consecutive sodium (Na) PT challenges. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 chemistry proficiency testing (PT) results for 2018, 2019 and phone interview with the general supervisor, the laboratory failed to achieve satisfactory performance for the analyte, sodium, in two consecutive PT events. Findings: 1. Review of the chemistry PT results for the third event of 2018 revealed the laboratory obtained an unsatisfactory score of 40 percent for the analyte, sodium. 2. Review of the chemistry PT results for the first event of 2019 revealed the laboratory obtained an unsatisfactory score of 60 percent for sodium. 3. Phone interview with the general supervisor on May 6, 2019 at 10:30 AM confirmed the laboratory failed to achieve satisfactory performance for sodium testing in two consecutive events for 2018, 2019. -- 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 review of 2017, 2018 chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the general supervisor, the laboratory failed to successfully participate in PT. See D-tag 2096, unsatisfactory PT performance for the total bilirubin analyte for two consecutive testing events. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 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 chemistry proficiency testing (PT) results for 2017, 2018 and phone interview with the general supervisor, the laboratory failed to achieve satisfactory performance for the total bilirubin analyte testing in two consecutive PT events. Findings: 1. Review of the chemistry PT results for the third event of 2017 revealed the laboratory obtained an unsatisfactory score of 60 percent for the analyte, total bilirubin. 2. Review of the chemistry PT results for the first event of 2018 revealed the laboratory obtained an unsatisfactory score of 0 percent for total bilirubin. 3. Phone interview with the general supervisor on September 12, 2018 at 10: 30 AM confirmed the laboratory failed to achieve satisfactory performance for total bilirubin testing in two consecutive events for 2017, 2018. -- 2 of 2 --