Spectracell Laboratories Inc

Summary Statement of Deficiencies D0000 As part of the recertification process in combination with a complaint investigation, an unannounced survey of the laboratory was conducted 07/08/2025 through 07/11 /2025. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D6168 - 42 C.F.R. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel The complaint has been substantiated. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the College of American Pathologist (CAP) attestation forms, the laboratory's CAP proficiency testing records from 2025, and staff interview, the laboratory failed to have documentation of the laboratory director and/or testing personnel's signatures on three of six attestation statements in 2025. Findings include: 1. A review of the CAP attestation form revealed the following: "As stated in the February 28, 1992 United States Federal Register under Subpart H 493-801 (b)(1), "The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient work load using the laboratory's routine methods." The laboratory director or designee and the testing personnel must sign on the result form." 2. A review of the laboratory's CAP proficiency testing records from 2025 revealed the attestation form for the following events were missing the laboratory director and/or testing personnel's signatures: - FH2-B 2025 Hematology Auto Differentials, FH2 - missing laboratory director and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 17 -- testing personnel's signatures - MGL1-A 2025 Molecular Genetics Series- missing laboratory director and testing personnel's signatures - HMS-A 2025 Homocysteine- missing laboratory director's signature 3. In an interview on 7/9/25 at 12:00 p.m. in the laboratory, after review of the records, testing person #4 (as indicated on the CMS 209 form) confirmed the above findings. D3003 FACILITIES CFR(s): 493.1101(a)(2) (a)(2) Contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, contamination monitoring Wipe Test records and staff interview, the laboratory failed to follow its own protocols to perform Wipe Test at least monthly for four of eighteen months reviewed from January 2024 through June 2025. Findings included: 1. Review of laboratory's policy "Wipe Test (swab test)" (effective 04/18/2023) revealed: "Molecular Lab Technicians must ensure that routine Wipe Tests are conducted in their laboratories. Normally these wipe tests are conducted on a monthly basis at a minimum." 2. Review of the monthly Wipe Test records from 2024 and 2025 revealed there was no documentation of Wipe Tests for the following four of eighteen months reviewed: March 2024 October 2024 January 2025 May 2025 3. In an interview on 07/10/2025 at 1310 hours in the conference room Testing Person number 1 (as indicated on submitted Form CMS 209), after review of the policies and data, confirmed the findings. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor's observations, review of laboratory's safety guidelines, and staff interview, the laboratory failed to designate test plates containing radioactive material with appropriate radiation warning symbols for thirty-one of thirty-one Micronutrient test plates observed siting on the countertop ready for harvest. Findings included: 1. Surveyor's observations on 07/10/2025 at 1155 hours at the laboratory's harvesting bench revealed a stack of thirty-one plates marked with a green line or the letter "T". Surveyor asked TP7 (Testing Person number seven - as indicated on submitted Form CMS 209) as to the meaning of the green line/T designation and was informed that those designations indicated that the plates had added Tritiated Thymidine (a radioactive form of thymidine). There was no other indication on these plates that they contained radioactive material. 2. Review of laboratory's "Radiation Safety Precautions" guidelines (License No. L04617, Radiation Safety Manual, Updated 2022) revealed: "Every bottle, flask, tube, etc., which contains a radioactive material must be identified by a proper radiation warning symbol." 3. In an interview on 07/10 /2025 at 1155 hours at the laboratory's harvesting bench, the facility's TP7 confirmed the findings. -- 2 of 17 -- D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the laboratory's CMS 209 form, the laboratory's records, and staff interview, the laboratory failed to have documentation of a procedure to assess the competency for 2 of 2 technical supervisors and 10 of 10 testing personnel performing high complexity testing in 2024 and 2025. Findings include: 1. A review of the laboratory's CMS 209 form revealed the laboratory employed 2 technical supervisors and 10 testing personnel performing high complexity testing in 2024 and 2025. 2. A review of the laboratory's records revealed no procedure to assess the competency of the technical supervisors and testing personnel. 3. In an interview on 7 /10/25 at 1:30 p.m. in the conference room, after review of the records, the laboratory director confirmed the above findings. **NOTE** This is a repeat deficiency from the survey performed in November 2023. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's College of American Pathologists (CAP) proficiency testing records from 2025 and staff interview, the laboratory failed to have documentation of evaluating the proficiency testing results for two of six events in 2025. Findings include: 1. A review of the laboratory's CAP proficiency testing records from 2025 revealed the laboratory failed to have documentation of evaluating the proficiency testing results for the following events: - FH2-B 2025 Hematology Auto Differentials, FH2 - MGL1-A 2025 Molecular Genetics Series 2. In an interview on 7/9/25 at 12:00 p.m. in the laboratory, after review of the records, testing person #4 (as indicated on the CMS 209 form) confirmed the above findings. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the Participant Summary report, the laboratory's College of American Pathologists (CAP) proficiency testing records from 2025, and staff interview, the laboratory failed to have documentation of verifying the accuracy of analytes that were 'not graded' by the proficiency testing program for three of six proficiency testing events in 2025. Findings include: 1. A review of the Participant -- 3 of 17 -- Summary report revealed the following: "The CAP uses exception reason codes that signify the proficiency testing (PT) for an analyte has not been graded. Exception Reason Code Description: 20 - Response was not formally graded due to insufficient peer group data. Action Required: Applies to a response that is not formally evaluated when a peer group is not established due to fewer than 10 laboratories reporting. Document that the laboratory performed a self-evaluation using the data presented in the participant summary and compare its results to a similar method, all method, all participant statistics, or data tables for groups of 3-9 laboratories, if provided. Perform and document the

Summary Statement of Deficiencies D0000 An unannounced revisit survey was performed on 12/29/2023. The laboratory remains out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The condition not met was: D5400- 42 C.F.R. 493.1250 Condition: Analytic Systems ************************************* An announced survey of the laboratory was conducted from 11/01/2023 through 11/02/2023. In addition, a complaint investigation was conducted alongside the recertification survey starting on 11/02/2023. The complaint was substantiated. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: D5400- 42 C.F.R. 493.1250 Condition: Analytic Systems D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory's proficiency testing (PT) records, policies/procedures and staff interview the laboratory failed to document required attestation signatures for 1 of 24 PT records reviewed. Findings included: 1. Review of laboratory's PT records revealed the laboratory used College of American Pathologists (CAP) as its PT provider. CAP instructions included: "Attestation/Use of Other Form ... The laboratory director or designee and the testing personnel must sign on the result form. You must use the attestation form provided..." 2. Further review of the PT records for 2022 and 2023 revealed the laboratory director did not sign the attestation form for 1 of 24 reviewed PT events: Chemistry event C-C 2022 3. Review of laboratory's policies/procedures revealed the laboratory did not have protocols in place addressing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 23 -- PT attestation requirements. 4. In an interview on 11/01/2023 at 1500 hours in the office, the laboratory's Technical Supervisor (as indicated on submitted form CMS 209) confirmed the findings. Key: CMS - Centers for Medicare and Medicaid D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor's observations in the facility, review of policies/procedures and staff interview, the laboratory failed to ensure safety procedures were established and observed to ensure protection from physical and chemical hazards for three of three safety concerns observed, storage and disposal of chemicals, obsolete/discontinued equipment and/or patient related paperwork. Findings included: 1. Surveyors observations on 11/01/2023 at 0940 hours in the warehouse revealed 22 large 19-20L (Liter) canisters containing highly flammable materials (methanol [lot 23A1561008], acetone [lot unspecified], poured over into a methanol canister), hexanes [lot 165046]), stacked up to 4 high in an open area, propped up against a flammable cabinet, next to cardboard boxes and plastic bags strewn on the floor. Opened/empty canisters (some unstoppered) were intermixed with full ones. The canisters were not labeled full/empty. Upon investigation, the flammable cabinet behind the stacked canisters was found to be full of boxes containing various expired chemicals. Examples of found chemicals included ergocalciferol (no exp.[expiration], marked as poison), concanavalin A (exp.2009), magnesium sulfate (exp. 2015), L-methionine (exp. 2014), iron (II) sulfate heptahydrate (exp. 2014), thymidine (exp. 2017), bovine serum albumin (exp. 2016). Along with the boxes of expired chemicals gallon containers of vacuum pump oil and descaler were observed. In a separate area of the warehouse another two 19L canisters of methanol were found sitting on the floor in front of another flammable cabinet. A 1L bottle of denatured ethanol (lot FC 08053EC) was sitting on top of the cabinet. The cabinet was half empty. 2. Surveyor's observations on 11/01/2023 at 1010 hours in the Lipoprotein Particle Profile (LPP) centrifuge room revealed two tables next to the ultracentrifuges piled up with open cardboard boxes with patient requisitions from 2020 and 2021, closed cardboard boxes containing more paperwork, plastic crates filled with dusty unused paper holders and centrifuge parts, along open and closed dusty Styrofoam containers and old/unused reagent containers. A chemical spill kit was also found on top of the table. It was unclear if the kit was current or expired. Next to all this were found two new boxes of Eppendorf pipette tips currently used in LPP testing. Under the table an old, decommissioned Siemens analyzer was sitting on the floor. Disintegrating reagent boxes, still containing reagent contents, were attached to the instrument via tubing. Next to the instrument, spare parts, paper and reagent cardboard boxes were on the floor. The boxes had stains and tears on the bottom due to unknown cause. 3. Review of laboratory's policies and procedures revealed there were no safety protocols in place for storage and disposal of large quantities of flammable materials, expired chemicals/reagents, or decommissioned equipment. Laboratory's policies did not address separation of old versus in-use reagents or equipment to prevent cross contamination. Laboratory's policies did not address maintaining a clean environment, free of tripping, slipping or falling objects' hazards. Laboratory's policies did not address requirements for storage of patient related paperwork. 4. In an interview on 11 -- 2 of 23 -- /01/2023 at 1050 hours in the office, the laboratory's General supervisor and Technical Supervisor (as indicated on submitted form CMS 209), after touring the laboratory and warehouse, confirmed the findings. Key: CMS - Centers for Medicare and Medicaid D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the laboratory's quality control records for CBC (Complete Blood Count) testing on the Coulter ACT diff 2 hematology analyzers and staff interview, the laboratory failed to retain the following records: a) analyzer results for the daily quality control material analyzed from January 1, 2022 to April 27, 2022 for the two Coulter ACT diff 2 hematology analyzers b) Levy Jennings charts, evaluating quality control values over time, for the daily quality control material analyzed from January 1, 2023 to March 29, 2023 for the two Coulter ACT diff 2 hematology analyzers. Findings include: 1. A review of the laboratory's quality control records for CBC testing on the Coulter ACT diff 2 analyzers (serial numbers AU20394 and AW21329) revealed the laboratory failed to retain the following records: a) analyzer results for the daily quality control material analyzed from January 1, 2022 to April 27, 2022 for the two Coulter ACT diff 2 hematology analyzers b) Levy Jennings charts, evaluating quality control values over time, for the daily quality control material analyzed from January 1, 2023 to March 29, 2023 for the two Coulter ACT diff 2 hematology analyzers. 2. An interview with the general supervisor on 11/1/23 at 1355 hours in the conference room, after review of the records, confirmed the above findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: An unannounced revisit was performed on 12/29/2023. D5209 - remains uncorrected. Based on review of the laboratory plans of correction with a completion date of 12/29 /2023, laboratory's personnel records, and staff interview the laboratory failed to follow its own

Summary Statement of Deficiencies D6118 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(5) The technical supervisor is responsible for resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications. This STANDARD is not met as evidenced by: No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the following CONDITION LEVEL DEFICIENCIES: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems. Noted deficiencies and plans of correction were discussed with the laboratory representative (s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the following CONDITION LEVEL DEFICIENCIES: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems. Noted deficiencies and plans of correction were discussed with the laboratory representative (s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory College of American Pathologists (CAP) proficiency testing records, lab records, and confirmed in interview, the laboratory failed to verify twice annually the accuracy of 4 of 22 analytes on the Siemens XPi 2000 chemistry analyzer for the year 2018 and 2019. (thyroglobulin, thyroxine- binding globulin, Anti-thyroid peroxidase (TPO) antibodies, anti-thyroglobulin antibody) Findings were: 1. Review of the 2018 and 2019 CAP proficiency testing records revealed no documentation of testing for 4 of 22 analytes performed on the XPi 2000 chemistry analyzer. thyroglobulin thyroxine-binding globulin Anti-thyroid peroxidase (TPO) antibodies anti-thyroglobulin antibody 2. Review of the laboratory records revealed no documentation of verifying twice annually the accuracy of the above analytes for the year 2018 and 2019. 3. Further review of the laboratory records revealed the laboratory performed 44544 endocrinology testing annually. 4. An interview with the laboratory QA/QC Director on 1/10/2020 at 1335 hours in the conference room confirmed the above findings. He was unaware the above analytes were not included in their CAP surveys. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 laboratory verification records and confirmed in interview, the laboratory failed to document complete verification studies for the Siemens XPi 2000 chemistry analyzer. (precision) Findings were: 1. Review of the new Siemens XPi 2000 analyzer (SNJ4122) installed in 06/10/2019 revealed no documentation of the precision studies. 2. An interview with the QA/QC director on 1/13/2020 at 1055 hours confirmed the above findings. He acknowledged that precision should have been assessed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the laboratory's maintenance records for the Beckman Coulter AU680 chemistry analyzer from March 2018 - December 2019, and staff interview it was revealed the laboratory failed to have documentation of performing all required monthly, quarterly, and every 6 month maintenance. Findings include: 1. A review of the laboratory's maintenance records for the Beckman Coulter AU680 chemistry analyzer from March 2018- December 2019 revealed the following maintenance was required to be performed: a) Monthly Maintenance: - Clean the sample probe, reagent probe, and HbA1c wash wells - Clean the mix bar wash wells - Clean the wash nozzle unit and check the tube mounting joints - Clean the DI water tank, DI filter, and sample probe - Sonicate the sample probe b) Quarterly Maintenance: - Clean Air Filters - Inspect and if needed, replace the DI water filter and sample probe filter - Replace the wash solution roller pump tubing c) Every 6 months Maintenance: - Replace the photometer lamp - Clean the cuvettes and the cuvette wheel 2. Further review of the laboratory's maintenance records for the Beckman Coulter AU680 chemistry analyzer from March 2018- December 2019 revealed the laboratory failed to have documentation of performing the following maintenances: a) Monthly Maintenance was not performed for the following months: - June 2018 - August 2018 - August 2019 - October 2019 b) Quarterly Maintenance was not performed for the following quarters: - 2nd Quarter of 2018 (April- June 2018) - 3rd Quarter of 2018 (July- September 2018) was missing - Clean air filters - Inspect and if needed, replace the DI waster filter and sample probe filter - 1st Quarter of 2019 (January- March 2019) - 2nd Quarter of 2019 (April- June 2019) - 3rd Quarter of 2019 (July- September 2019) - 4th Quarter of 2019 (October- December 2019) c) Every 6 month -- 2 of 4 -- Maintenance was not performed for the following time frames: - Replace Photometer Lamp was done March 4, 2018 and March 28, 2019 - missing the Every 6 month maintenance due September 2018 and September 2019 - Clean the Cuvettes and the Cuvette wheel was done March 26, 2018 -missing the Every 6 month maintenance due September 2018, March 2019, September 2019 3. The laboratory was asked to provide documentation of performing the required maintenance. No documentation was provided. 4. An interview with technical supervisor #1 (as indicated on the CMS 209 form, signed by the laboratory director on 1/5/20) on 1/10/20 at 2:35 p.m. in the office, after review of the records, confirmed the above findings. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: A. Based on review of the laboratory records and confirmed in interview, the laboratory failed to document calibration verfication for 8 of 24 analytes on the Simenes Immulite 2000 XPi chemistry analyzer. Findings were: 1. Review of the laboratory records revealed the laboratory has 2 Siemens Immulite 2000 XPi chemistry analyzers (System ID F1645, J4122) that both perform the following 24 analytes: C-Peptide Total Testosterone Free Testosterone DHEA-S FSH LH Estradiol Estriol Progesterone SHBG Prolactin Androstenedione IGF Total PSA Free T3 Free T4 Total T4 TSH Anti-thyroglobulin Antibody Anti-TPO Antibody Thyroxine Binding Globulin Thyroglobulin Cortisol Insulin 2. Review of the laboratory calibration records revealed the following 8 of 24 analytes used 2 or less calibrators. Insulin Estriol anti-thyroid peroxidase (anti-TPO) Anti-TG Ab (Anti-Thyroglobulin Ab) IGF SHBG thyroxine-binding globulin (TBG) Thyroglobulin 2. Review of the laboratory quality control records revealed the above analytes are tested with 2 levels of controls twice daily. 3. Review of the laboratory records revealed the laboratory performed 1 calibration verfication for the above analytes once in 2018 for the Siemens analyzer F1645. No documentation of the second calibration verification for 2018 were available for review. 4. Review of the laboratory records revealed the laboratory performed 1 calibration verfication for the above analytes once in 2019 for -- 3 of 4 -- the Siemens analyzer F1645 and one for the Siemens analyzer J4122. No documentation of the second calibration verification for 2019 for either instrument were available for review. 5. An interview with the QA/QC director on 1/13/2020 at 1130 hours in the conference room confirmed the above findings. 41687 B. Based on a review of the laboratory's calibration verification records from 2019 and staff interview, it was revealed the laboratory failed to have documentation of evaluating the calibration verification records for analytes run on the Beckman Coulter AU680 chemistry instrument. Findings include: 1. A review of the laboratory's calibration verification records from 10/3/2019 revealed the following analytes were tested on the Beckman Coulter AU680 chemistry analyzer: - ALB (Albumin) - HDL (High-density Lipoprotein) - LDL (Low-density Lipoprotein) 2. Further review of the records revealed the laboratory failed to have documentation of evaluating the results to determine if the assay was linear for each of the analytes tested. 3. The laboratory was asked to provide documentation of evaluating the results to determine the linearity of the assays. No documentation was provided. 4. An interview with technical supervisor #1 (as indicated on the CMS 209 form, signed by the laboratory director on 1/5/20) on 1/10/20 at 1:40 p.m. in the office, after review of the records, confirmed the above findings. 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 the laboratory records and confirmed in interview, the laboratory failed to document twice annually the comparison of 23 of 23 it tests on 2 of 2 Siemens Immulite 2000 XPi chemistry analyzer; and 1 of 1 test it tests on the 2 Siemens Immulite 2000 XPi and AU 640 chemistry analyzers. Findings were: 1. Review of the laboratory records revealed the laboratory has 2 Siemens Immulite 2000 XPi chemistry analyzers (System ID F1645, J4122) that both perform the following 23 analytes: C-Peptide Total Testosterone Free Testosterone DHEA-S FSH LH Estradiol Estriol Progesterone SHBG Prolactin Androstenedione IGF Total PSA Free T3 Free T4 Total T4 TSH Anti-thyroglobulin Antibody Anti-TPO Antibody Thyroxine Binding Globulin Thyroglobulin Cortisol 2. . Review of the laboratory records revealed the laboratory has 2 Siemens Immulite 2000 XPi chemistry analyzers (System ID F1645, J4122) and 1 Beckman AU 680 chemistry analyzers that perform the Insulin on all three analyzers. 3. Review of the laboratory records from 2018 - 2019 revealed no comparison of tests among the above instruments of the tests listed above. 4. An interview with the QA/QC director on 1/13/20 at 1100 hours in the conference room confirmed the above findings. -- 4 of 4 --