Citilabs, Inc

Summary Statement of Deficiencies 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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with testing personnel (TP) #3; the laboratory failed to ensure patient testing records were documented and retained for five of five manual test methods including C-Reactive Protein (CRP) Latex, Anti-Streptolysin O (ASO) Latex, Heliobacter (H.) pylori Antibody (Ab) Latex, and Rheumatoid Factor (RF) Latex in the specialty of immunology and Erythrocyte Sedimentation Rate (ESR) in the specialty of hematology. Findings include: 1. Review of the patient log for the manual testing of CRP, ASO, H. pylori Ab, RF, and ESR revealed the log records began on 11/23/2024. 2. Review of patient records revealed manual testing was performed prior to 11/23 /2024: Patient: Tests Performed: Date of Testing: 24070 CRP, ESR, H. Pylori 09/21 /2023 3. Upon surveyor request on 09/11/2025, at 11:20 am, for patient logs of manual testing prior to 11/23/2024, it was confirmed by TP #3 the laboratory failed to ensure patient testing records were documented and retained for five of five manual test methods including CRP Latex, ASO Latex, H. pylori Ab Latex, and RF Latex in the specialty of immunology and ESR in the specialty of hematology prior to 11/23 /2024. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, American Proficiency Institute (API) and American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to ensure

Summary Statement of Deficiencies D0000 A Proficiency Testing (PT) desk review was performed on August 15, 2025. The laboratory was found to be out of compliance with the 42 CFR Part 493 CLIA requirements for the following CONDITION level deficiencies: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Proficiency 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 -- Institute (API) Proficiency Testing (PT) records, and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) PT records, the laboratory failed to successfully participate in and achieve satisfactory performance for the analyte, Chloride in the subspecialty of Routine Chemistry for two of three PT events in 2023 (event 1 of 2023 and event 3 of 2023) and two of three PT events in 2024 and 2025 (event 3 of 2024 and event 2 of 2025) resulting in the laboratory's subsequent unsuccessful PT performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Proficiency Institute (API) Proficiency Testing (PT) records, and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) PT records, the laboratory failed to achieve satisfactory performance for the analyte, Chloride in the subspecialty of Routine Chemistry for two of three PT events in 2023 (event 1 of 2023 and event 3 of 2023) and two of three events in 2024 and 2025 (event 3 of 2024 and event 2 of 2025) resulting in the laboratory's subsequent unsuccessful PT performance. Findings include: 1. Review of the CASPER Report 0155D, generated on 08-01-2025, the laboratory received the following unsatisfactory scores for the analyte, Chloride. Chloride Initial Unsuccessful PT Performance EVENT 1, 2023 - 60% Unsatisfactory EVENT 3, 2023 - 40% Unsatisfactory Subsequent Unsuccessful PT Performance EVENT 3, 2024 - 0% Unsatisfactory EVENT 2, 2025 - 20% Unsatisfactory 2. Review of API PT evaluation reports (Chemistry - Core) and AAB-MLE PT evaluation reports (Chemistry M1 & M3, 2023) confirmed the above unsatisfactory scores that resulted in the laboratory's subsequent unsuccessful PT performance for the analyte, Chloride. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Proficiency Institute (API) Proficiency Testing (PT) records, and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) PT records, the laboratory director failed to ensure successful participation in their PT program for the analyte, Chloride in the subspecialty of Routine Chemistry resulting in the laboratory's subsequent unsuccessful PT performance. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Proficiency Institute (API) Proficiency Testing (PT) records, and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) PT records, the laboratory director failed to ensure successful participation in their PT program for the analyte, Chloride in the subspecialty of Routine Chemistry resulting in the laboratory's subsequent unsuccessful PT performance. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records the laboratory failed to successfully participate in PT for the routine chemistry analyte chloride (Cl) for two of three events in 2023, resulting in the initial unsuccessful PT performance for chloride. See D2096. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records the laboratory failed to successfully participate in PT for the routine chemistry analyte chloride (Cl) for two of three events in 2023, resulting in the initial unsuccessful performance for Cl. Findings include: 1. Review of the CASPER Report 0155D ran on 12-1-2023, found the laboratory received the following unsatisfactory PT scores for the analyte Cl. Chloride (Cl) AAB EVENT-1, 2023 = 60% - Unsatisfactory AAB EVENT-3, 2023 = 40% - Unsatisfactory 2. Review of the AAB PT records confirmed the initial unsuccessful PT performance for Cl for two of three PT events in 2023. Chloride (Cl) AAB EVENT-1, 2023 = 60% - Unsatisfactory AAB EVENT-3, 2023 = 40% - Unsatisfactory 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the chemistry analyte chloride in 2023. See D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Association of Bioanalysts (AAB) Proficiency Testing (PT) records the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the chemistry analyte chloride (Cl). See D2096. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review, the Food and Drug Administration (FDA) CLIA Complexity website, and interview, the laboratory failed to enroll in an HHS approved proficiency testing (PT) program for Hepatitis B Surface Antigen (HBsAg) testing during the year of 2020 and 2021. Findings include: 1. The American Proficiency Institute (API)-PT documents for the years of 2019 to 2021, manufacturer's package insert, the FDA website, and procedures manual were reviewed. 2. The laboratory used an unapproved and uncleared FDA kit for testing HbsAg {SD Bioline HBsAg (ONE STEP)}. 3. Review of API-PT records found the laboratory compared the API-PT results of another laboratory (14D2075610) to its own test results in lieu of enrolling and participating in API's PT program. 4. Further review showed this comparison method was performed for events 1, 2 and 3 of 2020 and events 1 and 2 of 2021. 5. On a Recertification and Complaint survey conducted on 09/28/2021 at 2:00 PM, the LD confirmed the above findings. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 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 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 record review, the lack of documentation, and interview, the laboratory failed to retain the printouts of patient test results, quality control results (D3031) and proficiency testing (PT) sample results and PT program documents (D3037) for at least 2 years. 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 direct observation, record review, lack of documentation, and interview, the laboratory failed to retain quality control and patient test records from the Chemistry and Hematology testing performed for at least 2 years. Findings include: 1. The laboratory's procedures manual, the Clinical Laboratory Improvement Amendments (CLIA) application signed on 09/28/2021 by the laboratory director (LD), quality control records, and 19 randomly selected patients' Laboratory Information System (LIS) reports from 03/10/2020 to 08/24/2021 were reviewed. 2. On 09/28/2021 at 12: 00 PM during a tour of the laboratory, the surveyor observed the following analyzers: *Envoy 500 Blood Chemistry analyzer; *Abacus 5 Hematology analyzer for Complete Blood Counts (CBC); and *Access 2 analyzer for Endocrinology testing. 3. The CLIA application test menu listed the following analytes tested by the above analyzers: ENVOY 500 Albumin Alanine aminotransferase (ALT/SGPT) Alkaline phosphatase (ALP) Aspartate aminotransferase (AST/SGOT) Bilirubin, total Calcium, total Chloride Cholesterol Cholesterol, HDL Creatinine Creatine Kinase, Isoenzymes (CK) Glucose (Non-Waived) Iron (Fe) Magnesium Potassium Sodium Total Protein Triglycerides Urea Nitrogen (BUN) Uric Acid ACCESS 2 Ferritin Folate Prostate Specific Antigen (PSA) Free Thyroxine (T4) Total Thyroxine (T3) Vitamin B12 Vitamin D ABACUS 5 White Blood Cells (WBC) Red Blood Cells (RBC) Hemoglobin Hematocrit Platelets 4. The procedures manual stated the following: *#5. The results are now ready to be verified as per laboratory policy to detect any error or abnormal or panic values, and then it is transmitted to Laboratory information system (LIS) interface or printed and given to laboratory coordinator to enter in the LIS system. 5. Review of 19 selected patients LIS reports revealed the following: *19 out of 19 patients test results were immediately transmitted into LIS. *Patients results were not printed from the analyzer for review prior to transmission. *The laboratory failed to print 19 out of 19 patients' test results from the analyzers on the day of survey. 6. The laboratory failed to generate QC printouts from the analyzers for the 11 -- 2 of 8 -- test dates the 19 selected patients were tested. 7. Review of the laboratory records found the laboratory lacked any documented proof patients' tests and QC results were verified prior to LIS transmission. 8. The laboratory failed to establish a written policy and procedure that instructs the retention of controls and patient test printouts for at least 2 years. 9. On a Recertification and Complaint Investigation survey conducted on 09/28/2021 at 2:00 PM, the laboratory director (LD) confirmed the above findings. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview, the laboratory failed to retain all proficiency testing records for at least 2 years. Findings include: 1. The laboratory's procedures manual and the American Proficiency Institute (API)-PT documents for the years of 2019 to 2021 were reviewed. 2. The laboratory was enrolled in API-PT program for Chemistry and Hematology testing. 3. The API-PT records revealed the following: *PT sample results for five out of five events were Laboratory Information System (LIS) generated final reports instead of analyzer generated test printouts. *API-PT program documents were not retained for three out of five events reviewed. 4. The laboratory failed to follow written procedures to retain the PT program documents and PT specimen test data for at least 2 years. 5. On a Recertification and Complaint Investigation survey conducted on 09/28/2021 at 2:00 PM, the laboratory director (LD) confirmed the above findings. 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 record review, Food and Drug Administration website, and interviews, the laboratory failed to verify the accuracy of the Hepatitis C Antibody (Anti-HCV) testing performed, during the years of 2020 and 2021. Findings Include: 1. The quality control (QC) records, manufacturer's package insert, selected patient test records from 03/2020 to 11/2020, and procedures manual were reviewed. 2. The laboratory used an unapproved and uncleared FDA kit for testing Hepatitis C Antibody (SD Bioline HCV). 3. Review of laboratory records found the laboratory failed to establish a method to verify the accuracy of the HCV test system. 4. Six out of six selected patients were tested using the Anti-HCV kits during the time period reviewed. 5. On a Recertification and Complaint Investigation survey conducted on 09/28/2021 at 2:00 PM, the laboratory director (LD) confirmed the above findings. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test -- 3 of 8 -- system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review, Food and Drug Administration website, lack of documentation, and interviews, the laboratory failed to establish the performance specifications for their Hepatitis B Surface Antigen (HbsAg) and Hepatitis C Antibody (Anti-HCV) laboratory developed tests (LDTs), affecting six out of 19 patients. Findings Include: 1. The quality control (QC) records, manufacturer's package inserts, selected patient test records from 03/2020 to 11/2020, and procedures manual were reviewed. 2. The laboratory used the following unapproved and uncleared FDA kits for testing HbsAg and Anti-HCV: *SD Bioline HCV and SD Bioline HBsAg (ONE STEP). 3. Review of QC records and manual revealed the laboratory lacked any documentation that the manufacturer's performance specifications were verified prior to testing patients. 4. The laboratory failed to establish and perform methods to provide evidence of each test system's: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. accuracy, precision, analytical sensitivity, and analytical specificity of the procedure is adequate to meet the patients' needs as determined by the laboratory director and clinical consultant. 5. Six out of 19 patients selected for review were tested using the HbsAg and Anti-HCV kits. 6. On a Recertification and Complaint Investigation survey conducted on 09/28/2021 at 2:00 PM, the laboratory director (LD) confirmed the above findings. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on direct observation, record review, the Clinical Laboratory Improvement Amendments application (CMS 116), and interviews, the laboratory failed to ensure the information interfaced into the Laboratory Information System (LIS)was transmitted accurately, affecting quality control, proficiency testing, and patients' test results. Findings: 1. The procedures manual, the CLIA application signed on 09/28 /2021 by the laboratory director (LD), quality control records, and 19 randomly selected patients' LIS reports from 03/10/2020 to 08/24/2021 were reviewed. 2. On 09 -- 4 of 8 -- /28/2021 at 12:00 PM during a tour of the laboratory, the surveyor observed the following analyzers: *Envoy 500 Blood Chemistry analyzer; *Abacus 5 Hematology analyzer, and *Access 2 analyzer. 3. The CLIA application test menu listed the following analytes tested by the above analyzers: ENVOY 500 Albumin Alanine aminotransferase (ALT/SGPT) Alkaline phosphatase (ALP) Aspartate aminotransferase (AST/SGOT) Bilirubin, total Calcium, total Chloride Cholesterol Cholesterol, HDL Creatinine Creatine Kinase, Isoenzymes (CK) Glucose (Non- Waived) Iron (Fe) Magnesium Potassium Sodium Total Protein Triglycerides Urea Nitrogen (BUN) Uric Acid ACCESS 2 Ferritin Folate Prostate Specific Antigen (PSA) Free Thyroxine (T4) Total Thyroxine (T3) Vitamin B12 Vitamin D ABACUS 5 White Blood Cells (WBC) Red Blood Cells (RBC) Hemoglobin Hematocrit Platelets 3. The laboratory failed to retain the analyzers' quality controls (QC) tests, proficiency testing (PT) sample tests, and patients test to verify the LIS transmission accuracy. See D3000, D3031, and D3037. 4. The laboratory failed to establish policies and procedures to perform periodic electronic transmission checks and failed to provide any documentation verifying the accuracy of its LIS interface. 5. On a Recertification and Complaint Investigation survey conducted on 09/28/2021 at 2:00 PM, the laboratory director (LD) confirmed the above findings. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure reference ranges or normal values are included in the final test report, affecting 10 out of 19 patients. Findings: 1. The Laboratory Information System (LIS) final reports of 19 randomly selected patients were reviewed. 2. Ten (10) of the 19 selected patients were tested for the following analytes: *Hepatitis B Surface Antigen (HBsAg) *Hepatits C antibody (Anti-HCV) *Rheumatoid Factor (RF) *Antistreptolysin O (ASO) *Antinuclear antibody (ANA) *C-reactive protein (CRP) *Helicobacter Pylori (H.Pylori) 3. The laboratory failed to indicate the "reference intervals" or "normal" values for the above analytes on the 10 LIS generated patient reports. 4. On a Recertification and Complaint Investigation survey conducted on 09/28/2021 at 2:00 PM, the laboratory director (LD) confirmed the above findings. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on direct observation, record review, lack of documentation, and interviews, -- 5 of 8 -- the laboratory failed to notify the authorized person ordering patients' test of reporting errors and failed to maintain duplicates of the original report for 5 out of 19 patients. Findings include: 1. The Laboratory Information System (LIS) final reports of 19 randomly selected patients,

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and an interview with the technical consultant (TC); the laboratory failed to follow quality control procedures for the General Immunology tests performed for the years of 2018 and 2019. Findings include: 1. The laboratory quality control (QC) logs for Rheumatoid Factor (RF), C-reactive protein (CRP), and Systemic Lupus Erythematosus (SLE) test kits and laboratory manuals were reviewed. 2. The QC logs from October, November, and December of 2018 and January, June and July of 2019 revealed the following: *The laboratory failed to record the controls' lot numbers and expiration dates of each kit used for testing, as required; *The laboratory failed to perform and document the parallel testing for each new kit lot received, prior to testing patients' samples. 3. The laboratory failed to complete QC procedures for the RF, CRP and SLE tests performed in the laboratory. 4. On a Recertification survey conducted on 10/09/2019 at 2:15 PM, the TC confirmed the above findings. D5419 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(e) Components of reagent kits of different lot numbers must not be interchanged unless otherwise specified by the manufacturer. 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 -- This STANDARD is not met as evidenced by: Based on direct observation, record review, and an interview with the technical consultant (TC); the laboratory failed to ensure components of reagent kits of different lot numbers are not interchanged, during the years of 2018 and 2019. Findings: 1. On 10/09/2019 at 12:15 PM during a tour of the laboratory; the surveyor observed the following Arlington Scientific Inc (ASI) Systemic Lupus erythematosus (SLE) slide test kits: *One kit A1, Lot #8B28S3 expiration date 12/31/2019; Marked - opened 06 /27/2018 *One kit A2, Lot #9A08S3 expiration date 12/31/2019; Marked - opened 04 /11/2019 *One kit A3, Lot #8L31S3 expiration date 08/31/2020; Not opened; and *One kit A4, Lot #8J24S3 expiration date 08/31/2020; Not opened. The controls of both kits A1 and A2 were opened; however, kit A1 did not contain SLE slide test cards. 2. The laboratory failed to discard the controls from kit A1 prior to opening kit A2. 3. The laboratory manual failed to include an established method to ensure that all components of a test that are packaged together in a kit are not interchanged. 4. On a Recertification survey conducted on 10/09/2019 at 2:15 PM, the TC confirmed the above findings. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on direct observation, record review, and an interview with the technical consultant (TC); the laboratory failed to ensure results of control materials meet the manufacturer's test system criteria for acceptability before reporting patient test results for 2 out of 4 days of patient testing for Cell Blood Count (CBC) analysis. Findings Include: 1. On 10/09/2019 at 11:55 AM during a tour of the laboratory, the surveyor observed the following Hematology controls in-use: *Low - Lot #KK091L; *Normal - Lot #KK091N; and *High - Lot #KK091H. 2. The manufacturer's "Assay Values and Expected Ranges"; the hematology quality controls (QC) data sheets from 09/09 /2019; 09/23/2019; 09/27/2019; and 10/08/2019, patient records, and procedures manual were reviewed. 3. The CBC controls failed to meet the acceptable criteria of the manufacturer on 09/09/2019 and 10/08/2019. 4. Review of patient records revealed 11 CBC results were reported on the above dates. 5. The laboratory failed to ensure hematology QCs were within expected ranges prior to reporting the patients' results. 6. On a Recertification survey conducted on 10/09/2019 at 2:15 PM, the TC and testing personnel confirmed the above findings. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record review and an interview with the technical consultant (TC); the laboratory failed to ensure test reports indicate *the name and address of the laboratory where the tests were performed; and *the test report date from the referred laboratory. Findings include: 1. The patients' requisitions and final reports, and the laboratory's test menu were reviewed. 2. The 3 patients' (patients D1, D2, and D3) requisitions reviewed were from the following dates: 03/16/2018; 10/29/2018; and 05 /23/2019. 3. Review of the final reports for patients D1, D2, and D3 and the laboratory's test menu revealed the following: *The test results for Hepatitis-B surface antigen (HBSag); Hepatitis-C antibody (HCV-AB); and Prostate Specific Antigen (PSA) were included in the final reports. *The laboratory does not perform the above tests. *The final reports failed to indicate the date tested and the name and location of the laboratory that performed the above tests. 4. On a Recertification survey conducted on 10/09/2019 at 2:15 PM, the laboratory director and the TC confirmed the above findings. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on record review, manufacturer's instructions, and an interview with the technical consultant (TC); the laboratory director (LD) failed to ensure that reports of test results include pertinent information required for interpretation of tests performed in the subspecialty of General Immunology testing, affecting 3 out of 3 patients. Findings: 1. The procedures manual, the Arlington Scientific package inserts for the Rheumatoid Factor (RF), the C-reactive protein (CRP), Systemic Lupus Erythematosus (SLE) slide tests, and patients' test results from 03/16/2018; 10/29 /2018; and 05/23/2019 were reviewed. 2. The manufacturer's instructions revealed the following reporting requirements: *RF - Agglutination indicates an RF concentration of greater than or equal to 8 IU/ml in the serum sample; shown as > or = 8 IU/ml. *CRP -Agglutination indicates a CRP concentration of greater than or equal to 6 mg/L in the serum sample; shown as > or = 6 mg/L; and *SLE - Agglutination indicates a "reactive" SLE sample. 3. The patients' X1, X2, and X3 final reports showed the above analytes reported as follows: *RF result was reported without the cut-off statement of " > or = 8 UI/ml " *CRP result was reported without the cut-off statement of " > or = 6 mg/L"; *Systemic Lupus Erythematosus (SLE) results were reported as Antinuclear Antibody (ANA) test results. 4. The LD failed to ensure the manufacturer's cut-off statements were reported with the patients' results to the authorizing providers from 03/16/2018 to the date of survey (10/09/2019). 5. On a recertification survey conducted 10/09/2019 at 1:30PM, the TC and testing personnel (TP) confirmed the above findings. -- 3 of 3 --