Diagnostic Testing Solutions Inc

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: 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 A complaint survey was conducted on 06/15/2026. The laboratory was found to be out of compliance with the CLIA regulations (42 CFR Part 493) for the following condition-level deficiencies: D5200 - 42 C.F.R. 493.1230 Condition: General laboratory systems; D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6168 - 42 C.F.R. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, manufacturer's instructions for use, the CMS-209 (Laboratory Personnel Report) Form, laboratory records, lack of documentation, and interviews with the technical consultant (TC); the laboratory failed to establish and follow written policies and procedures to ensure optimum integrity of three of six patients' hematology specimens from the time of collection through completion of testing and reporting of results (see D5203), failed to follow written policies and procedures to assess technical consultant competency for one of one TC (see D5209), and failed to follow written policies and procedures for monitoring assessing, and correcting problems identified 2024 through the date of survey, 06/15/2026 (see D5291). 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 -- D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, manufacturer's instructions for use (IFU), laboratory records, and interview with the technical consultant (TC); the laboratory failed to establish and follow written policies and procedures to ensure optimum integrity of three of six patients' hematology specimens from the time of collection through completion of testing and reporting of results. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled "Processing and Testing Patients", which stated, under "Specimen Rejection Criteria", "Testing will be performed only when the minimum identification and safety criteria are met. Specimen will be rejected when: ...sample too old, and no longer appropriate for testing." 2. Review of the manufacturer's IFU for the Diatron Abacus 5 hematology analyzer (Serial Number: (21)510890) revealed, under "8 Sample Measurement ....8.1.4 Sample Collection and Handling", "Analyze blood samples within 7 hours of collection." 3. Review of patient test records revealed the laboratory failed to perform the hematologic analysis within the manufacturer's established timeframe for three of six patients reviewed. i) Patient: 3328 Specimen Collected: 08 /26/2024 at "09.30" Specimen Received: 08/26/2024 at "12.30" Specimen Analyzed: 08/27/2024 at 3:19 pm ii) Patient: 3740 Specimen Collected: 03/27/2025 at "03.16" Specimen Received: 03/27/2025 at "04.19" Specimen Analyzed: 03/27/2025 at 8:50 pm iii) Patient: 4093 Specimen Collected: 09/04/2025 at "03.12" Specimen Received: 09/04/2025 at "04.34" Specimen Analyzed: 09/04/2025 at 8:31 pm 4. Interview with the TC on 06/15/2026, at 2:58 pm, confirmed the laboratory failed to establish and follow written policies and procedures to ensure optimum integrity of three of six patients' hematology specimens from the time of collection through completion of testing and reporting of results. 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 review of the CMS-209 (Laboratory Personnel Report) Form, laboratory policies and procedures, laboratory records, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to follow written policies and procedures to assess technical consultant competency for one of one TC. Findings include: 1. Review of the CMS-209 (Laboratory Personnel Report) Form revealed one technical consultant. 2. Review of laboratory policies and procedures revealed the procedure titled "Personnel Competency", which stated, "Competency assessment is used to ensure that the laboratory personnel are fulfilling their duties as required by regulations." 3. Review of laboratory competency assessment records showed the -- 2 of 12 -- laboratory failed to assess competency for one of one TC. 4. Interview with the TC on 06/15/2026, at 12:35 pm, confirmed the laboratory failed to follow written policies and procedures to assess technical consultant competency for one of one TC. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to follow written policies and procedures for monitoring assessing, and correcting problems identified for 24 of 24 months from 2024 through the date of survey, 06/15 /2026. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled "Quality Assessment", which stated, "Parameters on each of the following systems in our laboratory will be valuated as scheduled to be sure that it meets our quality goals. "Monthly: Quality Control, Maintenance, Calibration Quarterly: Proficiency Testing Every Six months: Personnel Competency, Accuracy/ Cal. Ver. [Calibration Verification] Annually: Personnel Competency, Compliance & Safety, Procedures, Test request (LIS [Laboratory Information System]) Verification" 2. Review of laboratory records revealed a lack of documentation of quality assessment checks performed in the laboratory for the previous 24 months reviewed from June 2024 through June 2026. 3. Interview with the TC on 06/15/2026, at 5:08 pm, confirmed the laboratory failed to follow written policies and procedures for monitoring assessing, and correcting problems identified for 24 of 24 months from 2024 through the date of survey, 06/15/2026. 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 review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to follow written policies and procedures for monitoring assessing, and correcting problems identified for 24 of 24 months from 2024 through the date of survey, 06/15 /2026. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled "Quality Assessment", which stated, "Parameters on each of the following systems in our laboratory will be valuated as scheduled to be sure that it meets our quality goals. "Monthly: Quality Control, Maintenance, Calibration Quarterly: Proficiency Testing Every Six months: Personnel Competency, Accuracy/ -- 3 of 12 -- Cal. Ver. [Calibration Verification] Annually: Personnel Competency, Compliance & Safety, Procedures, Test request (LIS [Laboratory Information System]) Verification" 2. Review of laboratory records revealed a lack of documentation of quality assessment checks performed in the laboratory for the previous 24 months reviewed from June 2024 through June 2026. 3. Interview with the TC on 06/15/2026, at 5:08 pm, confirmed the laboratory failed to follow written policies and procedures for monitoring assessing, and correcting problems identified for 24 of 24 months from 2024 through the date of survey, 06/15/2026. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 direct observation, review of laboratory policies and procedures, and interview with the technical consultant (TC); the laboratory failed to follow policies and procedures regarding hematology, immunology, and chemistry patient specimen retention and disposal, affecting 43 patient specimens. Findings include: 1. Upon a tour of the laboratory on 06/15/2026, at 11:07 am, surveyors observed a rack of 43 patient specimens sitting out at room temperature dated as far back as 06/01/2026 through 06/11/2026. 2. Review of laboratory policies and procedures revealed the procedure titled "Processing and Testing Patients", which stated, under "Specimen Retention & Disposal", "All patient specimens are stored refrigerated for 7 days. Specimens older than 7 days are discarded in regulated waste." 3. Interview with the TC on 06/15/2026, at 1:17 pm, confirmed the laboratory failed to follow policies and procedures regarding hematology, immunology, and chemistry patient specimen retention and disposal, affecting 43 patient specimens. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on direct observation, review of manufacturer's instructions for use (IFU), and interview with the technical consultant (TC); the laboratory failed to follow the manufacturer's IFU for hematology testing by utilizing the incorrect ethylenediaminetetraacetic acid (EDTA) anticoagulant tube type for specimen collection and processing, affecting 1,600 patients. Findings include: 1. Upon a tour of the laboratory on 06/15/2026, at 11:07 am, surveyors observed BD Vacutainer K2- EDTA anticoagulant purple-top tubes (Reference Number: 367861) being utilized for hematology testing. 2. Review of the manufacturer's IFU for the Diatron Abacus 5 hematology analyzer (Serial Number: (21)510890) revealed, under "8 Sample Measurement ....8.1.4 Sample Collection and Handling", "Use only K3-EDTA -- 4 of 12 -- anticoagulated fresh whole blood as sample." 3. Interview with the TC on 06/15/2026, at 2:58 pm, confirmed the laboratory failed to follow the manufacturer's IFU for hematology testing by utilizing the incorrect EDTA anticoagulant tube type for specimen collection and processing, affecting 1,600 patients. 4. Review of the test volume worksheet revealed 1,600 hematology patients were performed in the past 12 months. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory policies and procedures, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to ensure three of three reagents/solutions were labeled to ensure accurate and reliable hematology, immunology, and chemistry testing. Findings include: 1. Upon a tour of the laboratory on 06/15/2026, at 11:07 am, surveyors observed clear liquids in 2 unlabeled urine collection cups and 1 unlabeled BD Vacutainer K2-EDTA anticoagulant purple-top tube. 2. Review of laboratory policies and procedures revealed the policy titled "Reagent, Solutions and Reference materials", which stated, under "Storage and Handling:", "Reagents, solutions, calibrators, and controls used for testing must be stored according to specifications and labeled to identify, -The material -Date received -Date opened and -Expiration date". 3. Interview with the TC on 06/15/2026, at 1:17 pm, confirmed the laboratory failed to ensure three of three reagents/solutions were labeled to ensure accurate and reliable hematology, immunology, and chemistry testing. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory policies and procedures, and interview with the technical consultant (TC); the laboratory failed to ensure reagents, kits, and supplies were not used when they had exceeded their expiration date for five of five routine chemistry Ion-Selective Electrode (ISE) calibrators and one of one hematology differential reagent. Findings include: 1. Upon a tour of the laboratory on 06/15/2026, at 11:07 am, direct observation of laboratory testing supplies found five of five routine chemistry ISE calibrators and one of one hematology differential reagent. Reagent/Supply: High ISE Calibrator Reference #: 55117 Lot #: 1454-DE Expiration Date: 2026-02 Reagent/Supply: High ISE Calibrator Reference #: 55117 Lot #: 1347 Expiration Date: 2024-05 Number of vials: 2 Reagent/Supply: Low ISE Calibrator Reference #: 55117 Lot #: 1347 Expiration Date: 2024-05 Number of vials: -- 5 of 12 -- 2 Reagent/Supply: Diatron-Diff-SP Reference #: D3021 Lot #: 3022440124 Expiration Date: 2026-01-31 2. Review of laboratory policies and procedures revealed the policy titled "Reagent, Solutions and Reference materials", which stated, under "Inventories:", "Monthly inventories are checked and ordered. Any expired, spoiled, and contaminated reagents/supply will be properly disposed and replaced." 3. Interview with the TC on 06/15/2026, at 1:17 pm, confirmed the laboratory failed to ensure reagents, kits, and supplies were not used when they had exceeded their expiration date for five of five routine chemistry ISE calibrators and one of one hematology differential reagent. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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 direct observation, review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to demonstrate that it could obtain performance specifications comparable to those established by the manufacturers for 18 of 18 analytes performed on the Envoy 500 chemistry analyzer, eight of eight analytes on the Beckman Coulter Access 2 immunoassay analyzer, six of six analytes on the Diatron Abacus 5 hematology analyzer, and four of four immunology kit tests. Findings include: 1. Upon a tour of the laboratory on 06/15/2026, at 11:07 am, surveyors observed the following tests being performed by the laboratory: Analyzer: Envoy 500 - Routine Chemistry Analytes performed: Albumin, Alkaline Phosphatase, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), Total Bilirubin, Calcium, Cholesterol, Carbon Dioxide, Creatinine Kinase, Creatinine, Glucose, Iron, HDL (High-Density Lipoproteins), Magnesium, Total Protein, Triglycerides, BUN (Blood Urea Nitrogen), and Uric Acid. Analyzer: Beckman Coulter Access 2 Analytes performed: FT4 (Free Thyroxine), TSH (thyroid-stimulating hormone), T3 (Triiodothyronine), Ferritin, Folate, PSA (Prostate-Specific Antigen), Vitamin B12, and 25-hydroxy vitamin D. Analyzer: Diatron Abacus 5 - Hematology Analytes performed: WBC (White Blood Cell Count), RBC (Red Blood Cell Count), Hemoglobin, Hematocrit, Platelets, and WBC Differential. Manufacturer: Arlington Scientific Kit Tests Analytes performed: Direct RF (Rheumatoid Factor), SLE (Systemic Lupus Erythematosus), and ASO (Anti-streptolysin O). Manufacturer: Germaine Laboratories Kit Test Analyte performed: C-Reactive Protein (CRP) 2. Review of laboratory policies and procedures revealed the policy titled "Method Validation", which stated, "Each new test/method performance specifications must be verified to substantiate the manufacturer's claim under the laboratory conditions and approved by the laboratory director for patient testing." 3. Review of laboratory records found no documentation to demonstrate that performance specifications were verified for any of the above-mentioned testing prior to patient testing. 4. Interview with the TC on 06/15/2026, at 1:47 pm, confirmed the laboratory failed to demonstrate that it could obtain performance specifications comparable to those -- 6 of 12 -- established by the manufacturers for 18 of 18 analytes performed on the Envoy 500 chemistry analyzer, eight of eight analytes on the Beckman Coulter Access 2 immunoassay analyzer, six of six analytes on the Diatron Abacus 5 hematology analyzer, and four of four immunology kit tests. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 direct observation, review of laboratory records, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to document preventative maintenance for three of three analyzers on 11 of 11 testing dates reviewed from 06/01/2026 through the date of survey, 06/15/2026. Findings include: 1. Upon a tour of the laboratory on 06/15/2026, at 11:07 am, surveyors observed routine chemistry testing performed on the Envoy 500+ analyzer (Serial Number: 43111056), immunoassay testing performed on the Beckman Coulter Access 2 analyzer (Serial Number: 507654), and hematology testing performed on the Diatron Abacus 5 analyzer (Serial Number: (21)510890). 2. Review of the preventative maintenance logs revealed the following required tasks: i. Envoy 500 - Daily: Check Zone Temperatures Check System Supplies Empty Liquid Waste Bottle Inspect Fluidic Module Clean Probe Exteriors Prime Substrate Run Daily Clean System Weekly: Clean Instrument Exterior Inspect Liquid Waste Bottle Check Waste Filter Bottle Inspect/Clean Primary Probe Replace/Clean Aspirate Probes Run System Check ii. Beckman Coulter Access 2 - Daily- AM: Check/Replace Rinse Sol[utio]n. Empty Waste Paper Supply Update Reagents Zero Photometer Clear Alert & Message Daily- PM: Archive 'Specimen Log' Backup Patient Archives Clear Alert & Message Check ISE* Reagents Vol[ume] Suspend Activity Wash Cuvette Wash ISE Module Weekly: Clean Sample Needles Extra Wash Cuvette Shutdown Re[p]lace Saline Diluent iii. Diatron Abacus 5 - Daily: Check Printer Paper Check Reagents Empty Waste Perform and Accept Blank Cycle Run Quality Control Clean Exterior Surfaces Perform Shut Down and Power Off 2. Review of laboratory preventative maintenance logs revealed a lack of documentation of any/all preventative maintenance performance for three of three analyzers on 11 of 11 testing dates reviewed in June 2026. Date of patient testing: Monday, 06/01/2026 Tuesday, 06/02/2026 Wednesday, 06/03/2026 Thursday, 06/04/2026 Friday, 06/05/2026 Monday, 06/08/2026 Tuesday, 06/09/2026 Wednesday, 06/10/2026 Thursday, 06/11/2026 Friday, 06/12/2026 Monday, 06/15/2026 3. Interview with the TC on 06/15/2026, at 3:43 pm, confirmed the laboratory failed to document preventative maintenance for three of three analyzers on 11 of 11 testing dates reviewed from 06/01/2026 through the date of survey, 06/15/2026. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: -- 7 of 12 -- Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the technical consultant; the laboratory failed to ensure two levels of quality control (QC) materials were ran each day of patient testing for one of eight patient testing dates reviewed prior to reporting complete blood count (CBC) testing on the Diatron Abacus 5 analyzer in the specialty of hematology and routine chemistry testing on the Envoy 500 analyzer. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled "Processing and Testing Patients", which stated, under "Testing:", "Daily QC must be performed for each analyzer and non-waived method prior [to] testing patients." 2. Review of laboratory records revealed the laboratory failed to perform/document QC for one of eight testing dates reviewed on the Diatron Abacus 5 hematology analyzer and the Envoy 500 routine chemistry analyzer prior to reporting patient results. Patient: 4771 Date of testing: 06/11/2026 3. Interview with the TC on 06/15/2026, at ___, confirmed the laboratory failed to ensure two levels of QC materials were ran each day of patient testing for one of eight patient testing dates reviewed prior to reporting complete blood count (CBC) testing on the Diatron Abacus 5 analyzer in the specialty of hematology and routine chemistry testing on the Envoy 500 analyzer. D5805 TEST REPORT CFR(s): 493.1291(c) (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. This STANDARD is not met as evidenced by: Based on review of patient test reports, lack of documentation, and interview with testing personnel (TP) #2; the laboratory failed to include the name and address of the laboratory that performed the complete blood count (CBC) in the specialty of hematology for one of six patient test reports reviewed. Findings include: 1. Review of one of six patient test reports reviewed for CBC testing in the specialty of hematology revealed the laboratory failed to indicate the name and address of the performing laboratory on the final patient test report. Patient: 4628 Collection Date: 05 /06/2026 Reported Date: 05/08/2026 2. Interview with TP #2 on 06/15/2026, at 3:20 pm, confirmed the laboratory failed to include the name and address of the laboratory that performed the CBC in the specialty of hematology for one of six patient test reports reviewed. 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: -- 8 of 12 -- Based on direct observation, review of the CMS-209 (Laboratory Personnel Report) Form, laboratory policies and procedures, laboratory records, lack of documentation, and interviews with the technical consultant and laboratory director (LD); the LD failed to ensure tests performed could obtain performance specifications comparable to those established by the manufacturers (see D6013), failed to ensure two levels of quality control materials were ran each day of patient testing (see D6020), failed to ensure one of two testing personnel were qualified for high complexity testing (see D6029), and failed to ensure competency assessments were completed annually for two of two testing personnel (see D6030). D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the technical consultant (TC); the laboratory director failed to ensure tests performed could obtain performance specifications comparable to those established by the manufacturers for 18 of 18 analytes performed on the Envoy 500 chemistry analyzer, eight of eight analytes on the Beckman Coulter Access 2 immunoassay analyzer, six of six analytes on the Diatron Abacus 5 hematology analyzer, and four of four immunology kit tests (see D5421). D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the technical consultant; the laboratory director failed to ensure two levels of quality control (QC) materials were ran each day of patient testing for one of eight patient testing dates reviewed prior to reporting complete blood count (CBC) testing on the Diatron Abacus 5 analyzer in the specialty of hematology and routine chemistry testing on the Envoy 500 analyzer (see D5447) and failed to ensure written policies and procedures for monitoring assessing, and correcting problems identified were followed for 24 of 24 months from 2024 through the date of survey, 06/15/2026 (see D5291). D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; -- 9 of 12 -- This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory personnel records, and interview with the laboratory director (LD); the laboratory director failed to ensure one of two testing personnel were qualified for high complexity C-Reactive Protein (CRP) Latex testing in the specialty of diagnostic immunology (see D6168). D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of the CMS-209 (Laboratory Personnel Report) Form, laboratory policies and procedures, laboratory records, lack of documentation, and interview with the technical consultant (TC); the laboratory director failed to ensure competency assessments were completed annually for two of two moderate complexity testing personnel (TP) performing hematology, chemistry, endocrinology, and immunology testing from 2024 through the date of survey, 06/15/2026 (see D6046). D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on review of the CMS-209 (Laboratory Personnel Report) Form, laboratory policies and procedures, laboratory records, lack of documentation, and interview with the technical consultant (TC); the TC failed to ensure competency assessments were completed annually for two of two moderate complexity testing personnel (TP) performing hematology, chemistry, endocrinology, and immunology testing from 2024 through the date of survey, 06/15/2026. Findings include: 1. Review of the CMS- 209 (Laboratory Personnel Report) Form revealed two TP performed moderate complexity testing in the (sub)specialties of hematology, endocrinology, chemistry, and immunology. 2. Review of laboratory policies and procedures revealed the procedure titled "Personnel Competency", which stated, "Director or Designee will perform and document Competency Assessment of staff semiannually from hire and annually thereafter." 3. Review of laboratory personnel records revealed no competency assessments for two of two TP listed on the CMS-209 (Laboratory Personnel Report) Form from 2024 through the date of survey, 06/15/2026. 4. Interview with the TC on 06/15/2026, at 12:36 pm, confirmed the TC failed to ensure competency assessments were completed annually for two of two moderate -- 10 of 12 -- complexity TP performing hematology, chemistry, endocrinology, and immunology testing from 2024 through the date of survey, 06/15/2026. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on direct observation, review of laboratory personnel records, and interview with the laboratory director (LD); the laboratory failed to ensure one of two testing personnel were qualified for high complexity C-Reactive Protein (CRP) Latex testing in the specialty of diagnostic immunology (see D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; or (b)(2)(i) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(2)(ii) Be qualified under the requirements of 493.1443(b)(3) or 493.1449(c)(4) or (5); or (b)(3)(i) Have earned an associate degree in a laboratory science or medical laboratory technology from an accredited institution or (b)(3)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes (b)(3)(ii) (A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either (b)(3)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(3)(ii)(A)(2) 24 semester hours of science courses that include (b)(3)(ii)(A)(2)(i) 6 semester hours of chemistry; (b)(3)(ii)(A)(2)(ii) 6 semester hours of biology; and (b)(3)(ii)(A)(2)(iii) 12 semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(3)(ii)(B) Have laboratory training that includes: (b)(3)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES or the CAAHEP (this training may be included in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this section); or (b)(3)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing; or (b)(4) Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(5) Notwithstanding any other provision of this section, an individual is considered qualified as a high complexity testing personnel under this section if they were qualified and serving as a high complexity testing personnel in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. (b)(6) For blood gas analysis (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b) (6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution. (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (f) to perform tissue examinations. -- 11 of 12 -- This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory personnel records, and interview with the laboratory director (LD); the laboratory failed to ensure one of two testing personnel (TP) were qualified for high complexity C-Reactive Protein (CRP) Latex testing in the specialty of diagnostic immunology. Findings include: 1. Upon a tour of the laboratory on 06/15/2026, at 11:07 am, surveyors observed CRP Latex testing being performed utilizing Germaine Laboratories Aim CRP Test Kit. 2. Review of personnel records revealed one of two TP (TP #2) failed to have qualifying educational documentation for high complexity CRP Latex testing in the specialty of diagnostic immunology. 3. Interview with the LD on 06/15/2026, at 12:35 pm, confirmed the laboratory failed to ensure one of two TP were qualified for high complexity CRP Latex testing in the specialty of diagnostic immunology. -- 12 of 12 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the laboratory director (LD), the laboratory failed to enroll in an approved Centers for Medicare and Medicaid Services (CMS) proficiency testing (PT) program for three of three regulated immunology analytes before reporting Antistreptolysin-O (ASO), AntiNuclear antibodies (ANA), and Rheumatoid Factor (RF) patient test results for immunology in 2023. Findings Include: 1. Review of laboratory records revealed the laboratory performed regulated immunology analyte testing of Antistreptolysin-O (ASO), AntiNuclear antibodies (ANA), and Rheumatoid Factor (RF), utilizing the ASI Slide Test latex agglutination assay from the month of January 2023 to the date of survey 11/17/2023. 2. Review of laboratory records revealed no documented evidence of PT enrollment in an approved CMS program for the following three analytes: a) Antistreptolysin-O (ASO) b) AntiNuclear antibodies (ANA) c) Rheumatoid Factor (RF) 3. On 11/17/2023, at 1:30 p.m., the LD confirmed the above findings. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the laboratory director (LD), the laboratory failed to monitor and evaluate the overall quality for C-Reactive Protein (CRP) testing at least twice a year in 2023. (Refer to D5217). 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 laboratory records, lack of documentation, and interview with the laboratory director (LD), the laboratory failed to evaluate the biannual method accuracy for C-Reactive Protein (CRP) testing at least twice a year in 2023. Findings Include: 1. Review of laboratory records revealed the laboratory performed moderate complexity immunology testing of C-Reactive Protein (CRP), utilizing the ASI Slide Test latex agglutination assay from the month of January 2023 to the date of survey, 11/17/2023. 2. Review of laboratory records and lack of documentation revealed that the laboratory failed to evaluate and document the biannual method accuracy for C- Reactive Protein (CRP) testing in 2023. 3. On 11/17/2023, at 1:30 p.m., the LD confirmed the above finding. 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 review of laboratory records, patient test reports, lack of documentation, and interview with the laboratory director (LD) the laboratory: a) failed to demonstrate performance specifications comparable to the manufacturer's characteristics for accuracy, precision, reportable range of test results, and verification of the manufacturer's reference intervals for one of one moderate complexity latex agglutination assay (ASI Slide Test) before reporting four of four moderate complexity immunology (Antistreptolysin-O (ASO), AntiNuclear antibodies (ANA), -- 2 of 10 -- C-Reactive Protein (CRP), and Rheumatoid Factor (RF) analytes in 2023. Affecting 200 patient tests performed (refer to D5421); b) failed to record two control materials of different concentrations performed on the Vital Envoy 500 analyzer (SN: 43111056) for reporting 19 of 19 (Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, Blood Urea Nitrogen, Creatinine, Calcium, Iron (total iron-binding capacity), Total Protein, Albumin, Aspartate Aminotransferase / Serum Glutamic Oxaloacetic Transaminase (AST / SGOT), Alanine Aminotransferase / Serum Glutamic-Pyruvic Transaminase (ALT / SGPT), Alkaline Phosphatase, Total Bilirubin, Total Cholesterol, Triglycerides, High-density lipoprotein (HDL) - Cholesterol, Low-density lipoprotein (LDL) - Cholesterol) moderate complexity chemistry analytes on three of three (01/27/2023, 05/01/2023 and 11/15/2023) patient testing dates (refer to D5447); c) failed to perform positive and negative control procedures on the ASI Slide Test latex agglutination assay for reporting four of four (Antistreptolysin-O (ASO), AntiNuclear antibodies (ANA), C-Reactive Protein (CRP), and Rheumatoid Factor (RF)) moderate complexity immunology analytes on four of four (01/27/2023, 05/01/2023, 08/04/2023 and 11/11/2023) patient testing dates(refer to D5449); d) failed to maintain the instrument run records for 19 of 19 (Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, Blood Urea Nitrogen, Creatinine, Calcium, Iron (total iron-binding capacity), Total Protein, Albumin, Aspartate Aminotransferase / Serum Glutamic Oxaloacetic Transaminase (AST / SGOT), Alanine Aminotransferase / Serum Glutamic-Pyruvic Transaminase (ALT / SGPT), Alkaline Phosphatase, Total Bilirubin, Total Cholesterol, Triglycerides, High- density lipoprotein (HDL) - Cholesterol, Low-density lipoprotein (LDL) - Cholesterol) moderate complexity chemistry analytes utilizing the Vital Envoy 500 analyzer (SN: 43111056) for three of three dates in 2023; the laboratory also failed to maintain the testing records for four of four (Antistreptolysin-O (ASO), AntiNuclear antibodies (ANA), C-Reactive Protein (CRP) moderate complexity immunology analytes utilizing the ASI Slide Test latex agglutination assay for four of four dates in 2023 (refer to D5789). 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 laboratory records, lack of documentation, and interview with the laboratory director (LD), the laboratory failed to demonstrate performance specifications comparable to the manufacturer's characteristics for accuracy, precision, reportable range of test results, and verification of the manufacturer's reference intervals for one of one moderate complexity latex agglutination assay (ASI Slide Test) before reporting four of four moderate complexity immunology (Antistreptolysin-O (ASO), AntiNuclear antibodies (ANA), C-Reactive Protein (CRP), and Rheumatoid Factor (RF) analytes in 2023. Affecting 200 patient tests performed. Findings Including: 1. Review of the "Diagnostic Testing Solutions DTS Method Validation 09" revealed the following: "Unmodified, EUA, FDA - cleared or -- 3 of 10 -- approved methods: Each new test / method performance specifications must be verified to substantiate the manufacturer's claim under the laboratory conditions and approved by the laboratory director for patient testing. Patient testing should NOT occur prior training and authorization." 2. Review of laboratory records, and lack of documentation revealed the laboratory failed to demonstrate performance specifications comparable to the manufacturer's characteristics for accuracy, precision, reportable range of test results, and verification of the manufacturer's reference intervals for one of one moderate complexity latex agglutination assay (ASI Slide Test) before reporting four of four moderate complexity immunology analytes in 2023 (affecting 200 patient tests performed): a) Antistreptolysin-O (ASO) b) AntiNuclear antibodies (ANA) c) C-Reactive Protein (CRP) d) Rheumatoid Factor (RF) 3. On 11 /17/2023, at 12:14 p.m., the LD confirmed the above findings. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the laboratory director (LD), the laboratory failed to perform two control materials of different concentrations for 19 of 19 moderate complexity chemistry analytes for three of three patient testing dates utilizing the Vital Envoy 500 analyzer (SN: 43111056) in 2023. Findings Include: 1. Review of laboratory records and patient test reports identified the laboratory performed testing for 19 (Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, BUN, Creatinine, Calcium, Iron (TIBC),Total Protein, Albumin, AST / SGOT, ALT / SGPT, Alkaline Phosphatase, Total Bilirubin, Total Cholesterol, Triglycerides, HDL - Cholesterol, LDL - Cholesterol) moderate complexity chemistry analytes utilizing the Vital Envoy 500 analyzer (SN: 43111056) in 2023. 2. Review of laboratory records revealed two control materials of different concentrations were not performed on the Vital Envoy 500 analyzer (SN: 43111056) prior to reporting the 19 analytes identified in Finding 1 for three of three dates when patient results were reported. a. REPORT DATE: 01/27/2023 LAB #: 1753 ANALYTE REPORTED: Iron (TIBC) b. REPORT DATE: 05/01/2023 LAB #: 2166 ANALYTE REPORTED: Iron (TIBC) c. REPORT DATE: 11/15/2023 LAB #: 2664 ANALYTES REPORTED: Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, BUN, Creatinine, Calcium, Total Protein, Albumin, AST / SGOT, ALT / SGPT, Alkaline phosphatase, Total Bilirubin, Total Cholesterol, Triglycerides, HDL - Cholesterol, LDL - Cholesterol 3. On 11/17/2023, at 12:14 p.m., the LD confirmed the above findings. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) -- 4 of 10 -- The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records, patient test reports, lack of documentation, and interview with the laboratory director (LD), the laboratory failed to perform positive and negative control materials for four moderate complexity immunology analytes utilizing the ASI Slide Test latex agglutination assay in 2023. Findings Include: 1. Review of laboratory records and patient test reports identified the laboratory performs testing for four (Antistreptolysin-O (ASO), AntiNuclear antibodies (ANA), C-Reactive Protein (CRP), and Rheumatoid Factor (RF)) moderate complexity immunology analytes utilizing the ASI Slide Test latex agglutination assay in 2023. 2. Review of laboratory records revealed no positive and negative control procedures were performed for the ASI Slide Test latex agglutination assay for four moderate complexity immunology analytes (Antistreptolysin-O (ASO), AntiNuclear antibodies (ANA), C-Reactive Protein (CRP), and Rheumatoid Factor (RF)) corresponding to four of four patient test reports for the following dates: a. REPORT DATE: 01/27 /2023 LAB #: 1753 ANALYTES REPORTED: Antistreptolysin-O (ASO), AntiNuclear antibodies (ANA), C-Reactive Protein (CRP), Rheumatoid Factor (RF) b. REPORT DATE: 05/01/2023 LAB #: 2166 ANALYTES REPORTED: Antistreptolysin-O (ASO), AntiNuclear antibodies (ANA), C-Reactive Protein (CRP), Rheumatoid Factor (RF) c. REPORT DATE: 08/04/2023 LAB #: 2433 ANALYTES REPORTED: Antistreptolysin-O (ASO), AntiNuclear antibodies (ANA), C-Reactive Protein (CRP), Rheumatoid Factor (RF) d. REPORT DATE: 11/11/2023 LAB #: 2662 ANALYTES REPORTED: Antistreptolysin-O (ASO), AntiNuclear antibodies (ANA), C-Reactive Protein (CRP), Rheumatoid Factor (RF) 3. On 11/17/2023, at 12: 14 p.m., the LD confirmed the above findings. D5789 TEST RECORDS CFR(s): 493.1283(b) Records of patient testing including, if applicable, instrument printouts, must be retained. This STANDARD is not met as evidenced by: Based on review of laboratory records, patient test reports, lack of documentation, and interview with the laboratory director (LD), the laboratory failed to maintain records of the laboratory information system (LIS) instrument print outs for 19 moderate complexity chemistry analytes utilizing the Vital Envoy 500 analyzer for three of three dates in 2023; and testing records for four moderate complexity immunology analytes utilizing the ASI Slide Test latex agglutination assay for four of four testing dates in 2023. Findings Include: 1. Review of the "Diagnostic Testing Solutions DTS (17) Laboratory Information System (LIS)" manual revealed: "Conclusion: All data from verification must be identical. File all the reports, prints, worklists, and requisitions used as LIS Verification. If any data comparison is unacceptable, contact the LIS support to troubleshoot the problem. Any discrepancy must be resolved before utilizing the LIS to generate patient report." 2. Review of laboratory records revealed the laboratory failed to maintain the instrument run records for 19 moderate complexity chemistry analytes utilizing the Vital Envoy 500 analyzer for three of three testing dates in 2023 (Refer to D5447); the laboratory also failed to maintain the -- 5 of 10 -- testing records for four moderate complexity immunology analytes utilizing the ASI Slide Test latex agglutination assay for four of four testing dates in 2023 (Refer to D5449). D5800 POSTANALYTIC SYSTEMS CFR(s): 493.1290 Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in 493.1291 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 postanalytic systems and correct identified problems as specified in 493. 1299 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory records, patient test reports, lack of documentation, and interview with the laboratory director (LD) the laboratory: a) failed to ensure the accuracy of test results entered for 17 moderate complexity chemistry analytes on two of five final patient test reports in 2023 (refer to D5801) b) failed to document the name and location of the referral testing laboratory (NTL Laboratory CLIA #14D2075610) on two of five patient test reports for 29 moderate complexity chemistry analytes; one moderate complexity hematology analyte; and two moderate complexity immunology analytes in 2023 (refer to D5805). 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 review of laboratory records, and interview with the laboratory director (LD), the laboratory failed to ensure the accuracy of test results entered for 17 moderate complexity chemistry analytes on two of five (5/1/2023 and 8/4/2023) final patient test reports in 2023. Findings Include: 1. Surveyor's review of the "Diagnostic Testing Solutions DTS Processing and Testing Patients 16" manual revealed the following: "Result Reporting: Laboratory test results must be entered correctly to provide optimal patient care. Results that are reported incorrectly may cause unnecessary treatment or loss of life. The data entry must compare LIS report with the instrument prints, tapes, worksheets, and any discrepancy must be resolved or corrected before releasing patient report." 2. Review of laboratory patient reports and "NTL Laboratory" (referral lab CLIA #: 14D2075610) test reports revealed the laboratory failed to ensure the accuracy of test results entered for 17 (Sodium, Potassium, Chloride, Carbon Dioxide, Creatinine, Calcium, Blood Urea Nitrogen, Albumin, Aspartate Aminotransferase, Alkaline Phosphatase, Cholesterol, Total -- 6 of 10 -- Protein, Triglycerides, High-density lipoprotein (HDL) - Cholesterol, Low-density lipoprotein (LDL) - Cholesterol, and Ferritin) moderate complexity chemistry analytes on two of five "Diagnostic Testing Solutions" final patient test reports in 2023. REPORT A: "NTL LABORATORY CLIA #: 14D2075610 - Client Details Name: Diagnostic Testing Solutions Received: 04/29/2023 01:36 Reported: (Not indicated) Name: XXX Requisition # 2304345227 - CHEMISTRY COMPREHENSIVE METABOLIC PANEL" REPORT B: "DIAGNOSTIC TESTING SOLUTIONS - Received Date: 4/27/2023 01.16 Reported Date: 5/1/2023 16:57 Name: XXX Lab # 2166 - CHEMISTRY COMPREHENSIVE METABOLIC PANEL" ANALYTE* REPORT A REPORT B NA 142.9 mmol/L 145 mEq/L K 4.69 mmol/L 4.6 mEq/L CO2 20.7 Low mEq/L 21 mEq/L BUN 62.9 High mg/dL 62 H mEq/L Alb 3.59 g/Dl 3.6 g/dL AST 10.8 Low U/L 11 L U/L ALP 119.9 High U/L 119 H U/L Chol 106.5 mg/dL 106 mg/dL TG 117.5 mg/dL 117 mg/dL HDL 37.33 mg/dL 37 mg/dL LDL 45.7 mg/dL 45 mg/dL Fe 1003.9 High ng/mL 1003 H ng/mL REPORT C: "NTL LABORATORY - Client Details Name: Diagnostic Testing Solutions Received: 08/03 /2023 02:03 Reported: 08/04/2023 12:52 Name: XXX Requisition # 308030028 - CHEMISTRY COMPREHENSIVE METABOLIC PANEL" REPORT D: "DIAGNOSTIC TESTING SOLUTIONS - Received Date: 8/2/2023 12.46 Reported Date: 8/4/2023 16:57 Name: XXX Lab # 2433 - CHEMISTRY COMPREHENSIVE METABOLIC PANEL" ANALYTE* REPORT C REPORT D NA 146.7 High mmol /L 145 mEq/L Cl 107 mEq/L 106 mEq/L Creat 3.88 High mg/dL 2.3 H mg/dL Ca 8.2 Low mg/dL 8.9 mg/Dl TP 5 Low g/dL 5.1 L g/dL 3. On 11/17/2023, at 1:12 p.m., the LD confirmed the above finding. * ANALYTE KEY: NA =Sodium K = Potassium Ca = Calcium CO2 = Carbon Dioxide Cl = Chloride Creat = Creatinine Serum BUN = Blood Urea Nitrogen Alb = Albumin AST = Aspartate Aminotransferase ALP = Alkaline Phosphatase Chol = Cholesterol TP = Total Protein TG = Triglycerides HDL = HDL Cholesterol LDL = LDL Cholesterol Fe = Ferritin 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. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation and interview with the laboratory director (LD), the laboratory failed to indicate the name and location of the referral testing laboratory on two of five (05/01/2023 and 08/04/2023) patient test reports in 2023. Findings Include: 1. Review of laboratory patient reports and lack of documentation revealed the laboratory failed to document the name and location of the referral testing laboratory (NTL LABORATORY CLIA #: 14D2075610 - 8833 Gross Point Rd, Ste 308, Skokie, IL 60077) on two of five patient test reports for 29 (Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, Blood Urea Nitrogen, Creatinine, Calcium, Iron (total iron-binding capacity), Total Protein, Albumin, Aspartate Aminotransferase / Serum Glutamic Oxaloacetic Transaminase (AST / SGOT), Alanine Aminotransferase / Serum Glutamic-Pyruvic Transaminase (ALT / -- 7 of 10 -- SGPT), Alkaline Phosphatase, Total Bilirubin, Total Cholesterol, Triglycerides, High- density lipoprotein (HDL) - Cholesterol, Low-density lipoprotein (LDL) - Cholesterol, Glomerular Filtration Rate (GFR), Hemoglobin A1C, Ferritin, Cortisol, Triiodothyronine (T3), Thyroid-stimulating hormone (TSH), and Free thyroxine (FT4)) chemistry analytes; one (Reticulocyte Count) hematology analyte and two (Hepatitis B Surface Antigen and Hepatitis C Antigen) immunology analytes in 2023. A. Date: 05/01/2023 Patient name: XXX LAB #: 2166 REFERRAL LABORATORY RESULTS: CHEMISTRY: Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, Blood Urea Nitrogen, Creatinine, Calcium, Iron (total iron-binding capacity), Total Protein, Albumin, Aspartate Aminotransferase / Serum Glutamic Oxaloacetic Transaminase (AST / SGOT), Alanine Aminotransferase / Serum Glutamic-Pyruvic Transaminase (ALT / SGPT), Alkaline Phosphatase, Total Bilirubin, Total Cholesterol, Triglycerides, High-density lipoprotein (HDL) - Cholesterol, Low- density lipoprotein (LDL) - Cholesterol, Glomerular Filtration Rate (GFR), Hemoglobin A1C, Ferritin, Cortisol, Triiodothyronine (T3), Thyroid-stimulating hormone (TSH), and Free thyroxine (FT4) HEMATOLOGY: Reticulocyte Count IMMUNOLOGY: Hepatitis B Surface Antigen B. Date: 08/04/2023 Patient name: XXX LAB #: 2433 REFERRAL LABORATORY RESULTS: CHEMISTRY: Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, Blood Urea Nitrogen, Creatinine, Calcium, Iron (total iron-binding capacity), Total Protein, Albumin, Aspartate Aminotransferase / Serum Glutamic Oxaloacetic Transaminase (AST / SGOT), Alanine Aminotransferase / Serum Glutamic-Pyruvic Transaminase (ALT / SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid, Creatine Kinase (CK), Total Cholesterol, Triglycerides, High-density lipoprotein (HDL) - Cholesterol, Low-density lipoprotein (LDL) - Cholesterol IMMUNOLOGY: Hepatitis B Surface Antigen and Hepatitis C Antigen 2. On 11/17/2023, at 1:12 p.m., the LD confirmed the above finding. 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 review of laboratory records, lack of documentation, and interview with the laboratory director (LD), the LD: a) failed to ensure the verification of specifications comparable to the manufacturer's characteristics for accuracy, precision, reportable range of test results, and verification of the manufacturer's reference intervals for the latex agglutination assay (ASI Slide Test) before reporting four of four immunology analytes in 2023 (refer to D6013); b) failed to ensure accurate and reliable testing for 19 of 19 chemistry analytes utilizing the Vital Envoy 500 analyzer (SN: 43111056); and four of four immunology analytes utilizing the ASI Slide Test latex agglutination assay in 2023 (refer to D6014); c) failed to ensure the enrollment in an approved Centers for Medicare and Medicaid Services (CMS) proficiency testing (PT) program for three of three regulated assays in 2023 (refer to D6015); d) failed to record and report accurate patient test results for 29 chemistry analytes; one hematology analyte; and two immunology analytes on two of five final patient test reports in 2023 (refer to D6026). D6013 LABORATORY DIRECTOR RESPONSIBILITIES -- 8 of 10 -- CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the laboratory director (LD), the LD failed to ensure the verification of specifications comparable to the manufacturer's characteristics for accuracy, precision, reportable range of test results, and verification of the manufacturer's reference intervals for latex agglutination assay (ASI Slide Test) before reporting four of four immunology analytes in 2023. Affecting 200 patient tests performed. (Refer to D5421). D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) 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 laboratory records, lack of documentation, and interview with the laboratory director (LD), the LD failed to ensure accurate and reliable testing for 19 of 19 chemistry analytes utilizing the Vital Envoy 500 analyzer (SN: 43111056); and four of four immunology analytes utilizing the ASI Slide Test latex agglutination assay in 2023. Findings Include: 1. The laboratory failed to perform two control materials of different concentrations for 19 of 19 chemistry analytes utilizing the Vital Envoy 500 analyzer (SN: 43111056) in 2023. Refer to (D5447). 2. The laboratory failed to perform positive and negative control materials for four of four immunology analytes utilizing the ASI Slide Test latex agglutination assay in 2023. (Refer to D5449). D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. -- 9 of 10 -- This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the laboratory director (LD), the LD failed to ensure the enrollment in an approved Centers for Medicare and Medicaid Services (CMS) proficiency testing (PT) program for three of three immunology analytes in 2023. 200 samples were tested without meeting this mandatory requirement for compliance. (Refer to D2000). 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 review of laboratory records, lack of documentation, and interview with the LD, the LD failed to ensure that test results included pertinent information required for the interpretation of 29 chemistry analytes; one hematology analyte; and two immunology analytes on two of five final patient test reports in 2023. Findings Include: 1. The laboratory failed to ensure the accuracy of test results required for interpretation of 19 chemistry analytes on two of five final patient test reports in 2023. (Refer to D5801). 2. The laboratory failed to identify testing performed by reference laboratory "NTL LABORATORY CLIA #: 14D2075610" for 29 chemistry analytes; one hematology analyte; and two immunology analytes on two of five final patient test reports in 2023. (Refer to D5805). -- 10 of 10 --