N T L Laboratory

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) (b)The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, and interview with the laboratory director (LD), the laboratory failed to test proficiency testing (PT) samples in the same manner as it tests patient samples when analyzing and reporting PT samples for five of five PT events reviewed in the specialty of general immunology in the years of 2023 and 2024. Findings include: 1. Review of laboratory policies and procedures revealed the policy manual titled, "General Policy", which stated: a) Under "III. [Quality Control] QC / [Quality Assurance] QA in the Laboratory": "C. Proficiency Testing 1. Enroll in CLIA-approved PT programs; do PT tests in conjunction with patient testing.", and "5. PT samples must be handled as patient samples ...." b) Under "V. Patient Identification and Preparation for Specimen Collection": "C. Ensuring accurate identification of patient specimen .... 5. Specimen should be registered in the [Laboratory Information System] LIS.", and "F. Reporting of Results": "7. Result will be accepted from the LIS ...." 2. Review of laboratory PT records revealed the test reports for the PT samples performed on the Bio-Rad Bioplex 2200 (Serial Number: 2200-0993) were generated from the Bio-Rad Bioplex 2200 instrument, not the laboratory's LIS (LIMSABC). PT Event: VM-A 2023 VM-C 2023 VM-A 2024 VM-B 2024 VM-C 2024 3. Interview with the LD on 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 -- 02/06/2025, at 2:10 pm, revealed that the laboratory had not been entering PT samples into the laboratory's LIS prior to running the PT specimens on the Bio-Rad BioPlex 2200 as done with patient specimens. 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: Based on review of laboratory policies and procedures, laboratory records, and interviews with the laboratory director, the laboratory director a) failed to ensure that the Bio-Rad Bioplex 2200 used for Human Immunodeficiency Virus (HIV) testing provided accurate results, affecting 93 patients (See D6082), and b) failed to ensure proficiency testing (PT) samples were tested in the same manner as patient samples when analyzing and reporting PT samples for six of six PT events in the specialty of diagnostic immunology in the years of 2023 and 2024 (See D6089). D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, and interviews with the laboratory director (LD), the laboratory director failed to ensure that the Bio-Rad Bioplex 2200 (Serial Number: 2200-0993) used for Human Immunodeficiency Virus (HIV) testing in the specialty of diagnostic immunology provided accurate results, affecting 93 patients from 09/08/2023 through the date of survey, 02/06/2025. Findings include: 1. Review of laboratory policies and procedures revealed the policy manual titled, "General Policy", which stated, in the section labelled "XI. Computer Policy Manual": a) Under "[Laboratory Information System] LIS Testing", "Programs shall be adequately tested for proper functioning when first installed and after any modifications, and that the laboratory director or designee has approved the use of all new programs and modifications." b) Under "Interface Result Integrity", "There is a procedure to verify that patient results are accurately transmitted from the point of data entry (interfaced instruments and manual input) to patient reports (whether paper or electronic) .... Interface validation should include examples of individual results, test packages or panels, abnormal flags, and results with comments/footnotes." 2. Review of laboratory records revealed 93 HIV reactive [positive] patients had been falsely reported as non-reactive [negative] from 09/28 /2023 to the date of survey, 02/06/2025. Accession #: Result Reported: Actual Result: 309110117 Non-reactive Reactive 309110115 Non-reactive Reactive 309110107 Non- reactive Reactive 309120566 Non-reactive Reactive 309120561 Non-reactive Reactive 309120556 Non-reactive Reactive 309120557 Non-reactive Reactive 309150345 Non-reactive Reactive 309300065 Non-reactive Reactive 310050147 Non- -- 2 of 4 -- reactive Reactive 310040294 Non-reactive Reactive 310050305 Non-reactive Reactive 310170253 Non-reactive Reactive 310260154 Non-reactive Reactive 311140416 Non-reactive Reactive 311300277 Non-reactive Reactive 312120162 Non- reactive Reactive 401160099 Non-reactive Reactive 401290161 Non-reactive Reactive 401310225 Non-reactive Reactive 402060128 Non-reactive Reactive 403010212 Non-reactive Reactive 403140217 Non-reactive Reactive 403160145 Non- reactive Reactive 403160080 Non-reactive Reactive 403180291 Non-reactive Reactive 403230072 Non-reactive Reactive 404100157 Non-reactive Reactive 404230202 Non-reactive Reactive 405010306 Non-reactive Reactive 405080071 Non- reactive Reactive 405070336 Non-reactive Reactive 405070290 Non-reactive Reactive 405070150 Non-reactive Reactive 405070197 Non-reactive Reactive 405070351 Non-reactive Reactive 405160401 Non-reactive Reactive 405160414 Non- reactive Reactive 405170175 Non-reactive Reactive 405250128 Non-reactive Reactive 405300127 Non-reactive Reactive 406290116 Non-reactive Reactive 407050087 Non-reactive Reactive 407110224 Non-reactive Reactive 407120292 Non- reactive Reactive 407130128 Non-reactive Reactive 407200145 Non-reactive Reactive 407220238 Non-reactive Reactive 407270107 Non-reactive Reactive 408050229 Non-reactive Reactive 408200280 Non-reactive Reactive 408240137 Non- reactive Reactive 408290161 Non-reactive Reactive 409030255 Non-reactive Reactive 409030094 Non-reactive Reactive 409070193 Non-reactive Reactive 409070130 Non-reactive Reactive 409110358 Non-reactive Reactive 409110257 Non- reactive Reactive 409170324 Non-reactive Reactive 409250125 Non-reactive Reactive 409300304 Non-reactive Reactive 409300310 Non-reactive Reactive 409300308 Non-reactive Reactive 409300312 Non-reactive Reactive 409300192 Non- reactive Reactive 409300298 Non-reactive Reactive 409300274 Non-reactive Reactive 409300181 Non-reactive Reactive 409300210 Non-reactive Reactive 409300297 Non-reactive Reactive 410030234 Non-reactive Reactive 410260103 Non- reactive Reactive 410290153 Non-reactive Reactive 410290165 Non-reactive Reactive 410290244 Non-reactive Reactive 411060439 Non-reactive Reactive 411060392 Non-reactive Reactive 411090188 Non-reactive Reactive 411190134 Non- reactive Reactive 411230148 Non-reactive Reactive 411260401 Non-reactive Reactive 411260255 Non-reactive Reactive 412160252 Non-reactive Reactive 412160262 Non-reactive Reactive 412160245 Non-reactive Reactive 412190327 Non- reactive Reactive 412230274 Non-reactive Reactive 412260024 Non-reactive Reactive 501010012 Non-reactive Reactive 501010029 Non-reactive Reactive 501010023 Non-reactive Reactive 501040138 Non-reactive Reactive 3. Review of laboratory records revealed a letter to ordering providers regarding the false HIV reporting which stated, "[The] Laboratory has discovered a workflow issue in its serology reporting that has had an impact on, in particular, HIV screening results. "The nature of the issue is that the HIV Screen test, "HIV Combo [Antigen] Ag/ [Antibody] Ab", result is a calculated result based upon the direct instrument results for four analytes tested in our serology department. If any one or more of these analytes are resulted by the instrument as "Detected" or "Reactive" (Positive) then the calculated reportable result should also be "Reactive" (Positive). We have found that, since a LIMS system upgrade, this functionality has not been working as it should have been." 4. Interview with the LD on 02/06/2025, at 4:45 pm, confirmed the laboratory director failed to ensure that the Bio-Rad Bioplex 2200 used for Human Immunodeficiency Virus (HIV) testing in the specialty of diagnostic immunology provided accurate results, affecting 93 patients from 09/08/2023 through the date of survey, 02/06/2025. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) -- 3 of 4 -- (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 review of laboratory policies and procedures, laboratory records, and interview with the laboratory director (LD), the laboratory director failed to ensure proficiency testing (PT) samples were tested in the same manner as patient samples when analyzing and reporting PT samples for six of six PT events reviewed in the specialty of general immunology in the years of 2023 and 2024. See D2006. -- 4 of 4 --

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: A) Based on review of laboratory policy and procedure manual, the Federal Casper Report 0096D, College of American Pathologist (CAP) proficiency testing (PT) records, laboratory test records, lack of documentation, and interview with the laboratory director (LD); the laboratory a) failed to enroll in appropriate PT testing challenges for 21 of 21 regulated analytes for the subspecialty of routine chemistry and two of two regulated analytes for the specialty of hematology, regarding coagulation, for the year 2024, affecting 22,344 patients. Findings include: 1. Review of the laboratory's policy and procedure manual revealed, under "Enrollment in Proficiency Testing", "Proficiency testing shall be enrolled in .... using whichever of the proficiency test providers is suitable and acceptable per CLIA regulations." 2. Review of the Federal Casper Report 0096D revealed no scores were reported to the Center for Medicare and Medicaid Services (CMS) for the following analytes in the year of 2024: a) Sodium b) Chloride c) Potassium d) Serum Creatinine e) Calcium f) Blood Urea Nitrogen (BUN) g) Glucose h) Alanine Aminotransferase (ALT) i) Aspartate Aminotransferase (AST) j) Total Bilirubin (T-Bili) k) Total Protein l) Alkaline Phosphatase (ALP) m) Albumin n) Cholesterol o) Triglycerides p) High Density Lipoprotein (HDL) q) Total Iron r) Uric Acid s) Magnesium t) Amylase u) 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 -- Lactic Acid Dehydrogenase (LDH) 3. Review of CAP PT records revealed that the laboratory failed to enroll in testing for 21 of 21 above-mentioned regulated routine chemistry analytes in 2024. 4. Review of the laboratory's CAP PT records revealed the laboratory failed to enroll for the correct five challenges, three times per year for two of two regulated coagulation analytes for specialty of hematology for the year 2024. a) Protime b) Partial Thromboplastin Time (PTT) 5. Review of the laboratory's CAP PT records revealed the laboratory had enrolled in "Coagulation, Limited Quality Cross Check", which only provides three challenges, twice per year and states, under "Program Notes", "Quality Cross Check is not proficiency testing. These results will not be sent to any [United States] US [Clinical Laboratory Improvement Amendments] CLIA regulatory agency." 6. Review of patient test records found the laboratory reported out results for 21,525 chemistry patients and 819 coagulation patients from 01/01/2024 through the date of survey, 09/25/2024. 7. Interview with the LD at 4:05 pm, on 09/24/2024, confirmed that the laboratory failed to enroll in appropriate PT testing challenges for 21 of 21 regulated analytes of routine chemistry and two of two regulated coagulation analytes for specialty of hematology for the year 2024. B) Based on review of laboratory policies and procedure manual, proficiency testing (PT) records, laboratory test volume worksheet, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to maintain method accuracy testing procedures for 17 of 17 non-regulated analytes for the subspecialty of routine chemistry and nine of nine non-regulated analytes for the subspecialty of toxicology for the year of 2024, affecting 21,525 patients. (See D2003). 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 review of laboratory policies and procedure manual, proficiency testing (PT) records, laboratory test volume worksheet, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to maintain method accuracy testing procedures for 17 of 17 non-regulated analytes for the subspecialty of routine chemistry and nine of nine non-regulated analytes for the subspecialty of toxicology for the year of 2024, affecting 21,525 patients. Findings include: 1. Review of the laboratory's policy and procedure manual revealed, under "Enrollment in Proficiency Testing", "Proficiency testing shall be enrolled in .... using whichever of the proficiency test providers is suitable and acceptable per CLIA regulations." 2. Review of CAP PT records revealed the laboratory failed to enroll in PT, and therefore failed to maintain method accuracy, for 17 of 17 non-regulated routine chemistry analytes in 2024: a) Carbon Dioxide b) Globulin c) Very Low Density Lipoprotein (VLDL) d) Urine Bilirubin e) Folic Acid (Folate) f) Urine Microalbumin g) Transferrin h) C- Reactive Protein, High Sensitivity (CRP-HS) i) Total Iron Binding Capacity (TIBC) j) Lipase k) Creatinine Urine l) Gamma-Glutamyl Transferase (GGT) m) Phosphorus n) Creatine Phosphokinase (CPK) Total o) Direct Bilirubin (D-Bili) p) C-Reactive Protein q) Urine Total Protein 3. Review of CAP PT records revealed the laboratory failed to enroll in PT, and therefore failed to maintain method accuracy, for nine of nine non-regulated toxicology analytes in 2024: a) Amphetamine b) Cocaine c) Opiate d) Barbiturates e) Benzodiazepines f) Methadone g) Phencyclidine (PCP) h) Buprenorphine i) Oxycodone 4. Review of patient test records found the laboratory -- 2 of 12 -- reported out results for 21,525 chemistry patients, including toxicology patients, from 01/01/2024 through the date of survey, 09/25/2024. 5. Interview with the LD at 4:05 pm, on 09/24/2024, confirmed that the laboratory failed to maintain method accuracy testing procedures for the subspecialties of routine chemistry and toxicology for the year of 2024. 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 direct observations, review of laboratory records, policies and procedures, test volume worksheet, lack of documentation, and interviews with the laboratory director (LD) and testing personnel (TP); the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283. Findings include: 1. The laboratory failed to have a procedure manual in place for two of twelve molecular assays performed. See D5401. 2. The laboratory failed to outline all components of test procedures for ten of ten molecular assay procedures. See D5403. 3. The laboratory failed to ensure that the normal patient prothrombin mean study was performed after a new lot of Neoplastine reagent was implemented and prior to reporting patient results for the specialty of hematology, regarding to coagulation. See D5411. 4. The laboratory failed to ensure one of six agar media types, chocolate agar, used for bacteriology testing, had not exceeded its expiration date. See D5417. 5. The laboratory failed to establish the performance specifications for 12 of 12 molecular assays on three of four molecular platforms. See D5423. 6. The laboratory failed to include at least one control material that is capable of detecting errors through the extraction process for twelve of twelve molecular assays performed. See D5453. 7. The laboratory failed to check gram stains for positive and negative reactivity using control organisms at least each week of use. See D5503. 8. The laboratory failed to have a system in place that twice a year evaluates and defines the comparison of test results between four of four thermal cycler platforms used for molecular testing. See D5775. 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 review of laboratory policy and procedure manuals, test volume worksheet, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to have a procedure manual in place for 2 of 12 molecular assays performed. -- 3 of 12 -- Findings include: 1. Review of the laboratory's test volume worksheet revealed the following twelve molecular assays performed: a) Chlamydia trachomatis, Neisseria gonorrhea, Trichomonas vaginalis Assay Set b) Claro Series Bacterial Vaginosis c) Claro Series Candida Vaginitis d) Claro Series Covid Direct Method e) Claro Series Respiratory Multiplex f) Sigmoida Gastroenteritis Panel g) Sigmoida Respiratory Pathogen Panel (RPP) h) Sigmoida Sexually Transmitted Infection (STI) Panel i) Sigmoida Antibiotic Resistance (ABR) Panel j) Sigmoida Urinary Tract Infections (UTI) Panel k) Sigmoida Series Wound Infection Panel l) Sigmoida Series Nail Panel 2. Review of the laboratory's policy and procedure manual found the laboratory lacked procedures for 2 of 12 molecular assays performed. i) Sigmoida Respiratory Pathogen Panel (RPP) ii) Sigmoida Series Nail Panel 3. Interview with the LD on 09 /25/2024, at 12:29 pm, revealed the laboratory failed to have procedures for 2 of 12 molecular assays performed. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, and email correspondence with the AAB-MLE PT program representative confirmed the laboratory's subsequent unsuccessful PT performance for the subspecialty of bacteriology (See D2028) for three consecutive PT events in 2023 (events one, two, and three). D2028 BACTERIOLOGY 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 -- CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, and email correspondence with the AAB-MLE PT program representative the laboratory failed to achieve satisfactory performance for the subspecialty of bacteriology for three consecutive PT events in 2023 (events one, two, and three) resulting in the subsequent unsuccessful PT performance for the subspecialty of bacteriology. Findings include: 1. Review of the CASPER Report 0155D, generated on 01-19-2024, and AAB-MLE PT records, the laboratory received the following unsatisfactory scores for the subspecialty of bacteriology. BACTERIOLOGY EVENT 1, 2023 14% - Unsatisfactory EVENT 2, 2023 59% - Unsatisfactory EVENT 3, 2023 71% - Unsatisfactory 2. An email with the AAB-MLE PT representative on 01-08-2024 at 8:20 AM, confirmed the subsequent unsuccessful performance for the subspecialty of bacteriology. 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: Based on an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, and email correspondence with an AAB-MLE PT program representative the laboratory director failed to ensure successful participation in an Health and Human Services (HHS) approved PT program for the subspecialty of bacteriology (see D6087) resulting in the laboratory's subsequent unsuccessful PT performance for the subspecialty of bacteriology for three consecutive PT events (events one, two, and three) in 2023. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) Proficiency -- 2 of 3 -- Testing (PT) records, and email correspondence with an AAB-MLE PT program representative the laboratory director failed to ensure successful participation in an Health and Human Services (HHS) approved PT program for the subspecialty of bacteriology (see D2028) resulting in the laboratory's subsequent unsuccessful PT performance for the subspecialty of bacteriology for three consecutive PT events (events one, two, and three) in 2023. -- 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 an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, and interview with the AAB-MLE PT program representative confirmed the laboratory's initial unsuccessful PT performance for the hematology analyte cell identification/white blood cell differential (See D2130) for two of three PT events in 2023 (events one & three). D2130 HEMATOLOGY 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 -- CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, and interview with the AAB-MLE PT program representative found the laboratory failed to achieve satisfactory performance for the hematology analyte cell identification/white blood cell differential for two of three PT events in 2023 (events one & three). Findings Include: 1. Review of the CASPER Report 0155D, generated on 12-05-2023, and the AAB-MLE PT records found the laboratory received the following unsatisfactory analyte scores: Cell Identification/White Blood Cell Differential EVENT 1, 2023 0% Unsatisfactory EVENT 3, 2023 40% Unsatisfactory 2. A phone interview with the AAB-MLE PT representative on 12-05- 2023 at 2:26 PM, confirmed the laboratory failed to submit results for event one of 2023 and scored a 40% for event three of 2023. The AAB- MLE representative indicated the laboratory reported absolute numbers for event three of 2023 and not percentages for white blood cell differential. 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: Based on an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, and interview with the AAB-MLE PT program representative found the laboratory director failed to meet the requirements of this condition. The laboratory director failed to ensure test methods were performed as required to provide accurate and reliable results for the hematology analyte cell identification /white blood cell differential in 2023. See D6087. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, and interview with the AAB-MLE PT program representative -- 2 of 3 -- found the laboratory director failed to ensure laboratory personnel were performing test methods ss required to provide accurate and reliable results for the hematology analyte cell identification/white blood cell differential in 2023. See D2130. -- 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 review of the CASPER Report 0155D and interview with a American Association of Bioanalysts (AAB) representative the laboratory failed to successfully participate in proficiency testing (PT) for the endocrinology analyte total thyroxine (TT4) during events three of 2022 and one of 2023. See D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 CASPER Report 0155D and interview with a American Association of Bioanalysts (AAB) representative; the laboratory failed to successfully participate in proficiency testing (PT) for the endocrinology analyte total thyroxine (TT4) during events three of 2022 and one of 2023. Findings include: 1. Review of the CASPER Report 0155D ran on 5-1-2023 identified the initial unsuccessful PT performance for the endocrinology analyte TT4. ENDOCRINOLOGY TT4 - EVENT- 3, 2022 = 60% - Unsatisfactory TT4 - EVENT-1, 2023 = 0% - Unsatisfactory 2. A phone interview with the AAB PT representative on 05/01/2023, at 12:48 pm, confirmed the unsuccessful PT performance for TT4 during events three of 2022 and one of 2023. 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: Based on review of the CASPER Report 0155D and interview with a American Association of Bioanalysts (AAB) representative the laboratory director failed to meet the requirements of this condition. The laboratory director failed to ensure test methods were performed as required to provide accurate and reliable results for the endocrinology analyte total thyroxine (TT4) in 2022 through 2023. See D6087. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0155D and interview with a American Association of Bioanalysts (AAB) representative the laboratory director failed to ensure test methods were performed as required to provide accurate and reliable results for the endocrinology analyte total thyroxine (TT4) in 2022 through 2023. Findings Include: 1. The laboratory failed to ensure successful participation in proficiency testing for the endocrinology analyte TT4 during event three of 2022 and event one of 2023. See D2107. -- 2 of 2 --

Summary Statement of Deficiencies D2025 BACTERIOLOGY CFR(s): 493.823(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review the the laboratory's records, proficiency testing (PT) reports, and an interview with the technical supervisor (TS), the laboratory failed to return proficiency testing results to the proficiency testing program within the time frame specified by the program and received unsatisfactory performance scores of '0' for the testing event in the subspecialty of Bacteriology. Findings: 1. The CASPER Individual Laboratory Profile (Report 0155) showed that the laboratory received an unsatisfactory performance score of '0' in Bacteriology for Event #1 of 2017. 2. The laboratory's PT reports confirmed the laboratory's score of '0' for Bacteriology in Event #1 of 2017 due to late submission: 3. On a Recertification survey conducted on 10/11/2018 at 3:00 PM, the TS confirmed the above findings. D2071 SYPHILIS SEROLOGY CFR(s): 493.835(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review the the laboratory's records, proficiency testing (PT) reports, and an interview with the technical supervisor (TS), the laboratory failed to 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 -- return proficiency testing results to the proficiency testing program within the time frame specified by the program and received unsatisfactory performance scores of '0' for the testing event in the subspecialty of Syphilis Serology. Findings: 1. The CASPER Individual Laboratory Profile (Report 0155) showed that the laboratory received an unsatisfactory performance score of '0' in Syphilis Serology for Event #1 of 2017. 2. The laboratory's PT reports confirmed the laboratory's score of '0' for Syphilis testing for Event #1 of 2017 due to late submission: 3. On a Recertification survey conducted on 10/11/2018 at 3:00 PM, the TS confirmed the above findings. D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review the CASPER Individual Laboratory Profile (Report 0155), the laboratory's proficiency testing (PT) reports, and an interview with the technical supervisor (TS), the laboratory failed to attain satisfactory performance for each analyte in each testing event in the subspecialty of General Immunology. Findings: 1. The Report 0155 showed that the laboratory received an unsatisfactory analyte performance score for Anti-HIV (Anti- Human immunodeficiency virus) analysis during Event #2 of 2018. 2. The laboratory's PT reports confirmed that the laboratory missed 2 out of 5 PT samples, thus receiving the score of 60% for anti-HIV analysis during Event #2 of 2018. 3. On a Recertification survey conducted on 10/11 /2018 at 3:00 PM, the TS confirmed the above findings. D2081 GENERAL IMMUNOLOGY CFR(s): 493.837(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review the the laboratory's records, proficiency testing (PT) reports, and an interview with the technical supervisor (TS), the laboratory failed to return proficiency testing results to the proficiency testing program within the time frame specified by the program and received unsatisfactory performance scores of '0' for the testing event in the subspecialty of General Immunology. Findings: 1. The CASPER Individual Laboratory Profile (Report 0155) showed that the laboratory received an unsatisfactory overall performance score of '0' in General Immunology for Event #1 of 2017. 2. The laboratory's PT reports confirmed that the laboratory scored '0' for the following analytes due to late submission: a). ANA - Antinuclear Antibody b). ASO - Antistreptolysin O c). Anti-HIV - Anti- Human immunodeficiency virus (HIV) d). Hbs Ag - Hepatitis B Antigen e). Anti-HBC - Anti-Hepatitis B Core Total Antibodies; and f). RA/RF - Rheumatoid Arthritis/ Rheumatoid Factor 3. On a Recertification survey conducted on 10/11/2018 at 3:00 PM, the TS confirmed the above findings. D2127 HEMATOLOGY -- 2 of 3 -- CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review the the laboratory's records, proficiency testing (PT) reports, and an interview with the technical supervisor (TS), the laboratory failed to return proficiency testing results to the proficiency testing program within the time frame specified by the program and received unsatisfactory performance scores of '0' for the testing event in the specialty of Hematology. Findings: 1. The CASPER Individual Laboratory Profile (Report 0155) showed that the laboratory received an unsatisfactory analyte performance score of '0' in Hematology for Event #1 of 2017. 2. The laboratory's PT reports confirmed that the laboratory scored '0' for the following analytes due to late submission: a). Cell ID or WBC Diff - Cell Identification or White Blood Cell Differential Count b). RBC - Red Blood Cell Count c). Hct - Hematocrit d). Hgb - Hemoglobin e). WBC- White Blood Cell Count; f). Platelets; g). PTT - Partial Thromboplastin Time; and h). PT - Prothrombin Time 3. On a Recertification survey conducted on 10/11/2018 at 3:00 PM, the TS confirmed the above findings. -- 3 of 3 --