Lbj Tropical Medical Center

Summary Statement of Deficiencies D0000 Federal Surveyors from the Centers for Medicare& Medicaid Services (CMS) Survey Branch conducted a recertification survey on 8/13/2025 to 8/15/2025 and 8/18/2025 The following standard level deficiencies were cited. 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: I. Based on review of manufacturer's instructions, interview with technical supervisor #3 and laboratory director, the laboratory failed to follow manufacturer's instructions for reconstituting the STA Coag plus controls with distilled water as indicated by the manufacturer as evidenced by: 1.In review of the manufacturer's instructions for the STA coag plus stated, "Reconstitute each vial of reagent 1 and 2 with exactly 2ml of distilled water." 2. In an interview with technical supervisor #3 on 8/15/2025 at 1023 she demonstrated that they use deionized (DI) water from the chemistry instrument water system. 3. In an interview with the laboratory director at on 8/15/2025 at 1026 she confirmed that they used DI water and that they were in process of ordering new water recommended from the manufacturer for their controls. 47107 II. Based on direct observation, review of manufacturer instructions, test volume records, and interview with the General Supervisor (GS)-10, according to the Centers for Medicare and Medicaid (CMS) Form 209, the laboratory failed to follow the manufacturer's instructions of using a high intensity incandescent lamp for 1 of 1 test methodology (Arlington Scientific RPR Card Test). Findings Included: 1. In direct observation on 8 /14/2025 at 11:18 AM in the laboratory, the Rapid Plasma Reagin (RPR) workbench was seen located in a dim corner of the room and did not have a high intensity Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- incandescent lamp for RPR card test readouts. 2. Review of the manufacturer's instruction from Arlington Scientific RPR Card Test for Syphilis stated the following requirements: "Assay Protocol - Qualitative 6. Immediately read results macroscopically in the "wet" state under a high intensity light source." 3. Review of the laboratory's test records provided revealed 11 RPR tests run from 06/01/2024 to 08 /14/2025, and a total annual test volume of 11,348 for Diagnostic Immunology. 4. In an interview on 8/14/2025 at 11:19 AM, GS-10 confirmed that an incandescent lamp was not utilized for RPR testing, in accordance with the manufacturer's instructions. 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: I. Based on direct observation, manufacturer's instructions, temperature records, and interview with the Laboratory Director (LD), according to the Centers for Medicare and Medicaid (CMS) Form 209, the laboratory failed to define, monitor and document the temperature in the Microbiology hallway, and phlebotomy room, where 30 of 30 boxes of Becton Dickinson (BD) Vacutainer tubes and 24 of 24 boxes of Biomerieux BACT/ALERT FN Plus bottles were stored. Findings Included: 1. In direct observation on 8/13/2025 at 9:53 AM, the following supplies with storage temperature requirements were seen in storage: Phlebotomy Room: a. 13 boxes of Gold BD Vacutainer SST Blood Collection Tubes, Lot #4353605, Manufacturer storage requirements 4 to 25 degrees Celsius b. 9 boxes of Purple BD Vacutainer K2E 5.4 mg Tubes, Lot #4344045, Manufacturer storage requirements 4 to 25 degrees Celsius c. 4 boxes of Red BD Vacutainer Serum Blood Collection Tubes, Lot #5098300, Manufacturer storage requirements 4 to 25 degrees Celsius. d. 4 boxes of Pink BD Vacutainer K2E 10.8 mg Tubes, Lot #5076222, Manufacturer storage requirements 4 to 25 degrees Celsius. Hallway outside of the Microbiology section: e. 8 boxes Biomerieux BACT/ALERT PF Plus blood culture tubes, Lot #0004103132, Manufacturer storage requirements 15 to 30 degrees Celsius. f. 8 boxes Biomerieux BACT/ALERT FN Plus blood culture tubes, Lot #0004063172, Manufacturer storage requirements 15 to 30 degrees Celsius. g. 8 boxes Biomerieux BACT/ALERT FA Plus blood culture tubes, Lot #0004103282, Manufacturer storage requirements 15 to 30 degrees Celsius. 2. Review of the laboratory's temperature records revealed no temperature ranges defined, monitored or documented in the hallway outside of the microbiology section or phlebotomy room. 3. In an interview on 8/13/2025 at 9:55 AM, the LD confirmed that both areas where the temperature dependent supplies were stored, did not have defined temperature ranges and were not monitored or documented. II. Based on direct observation, manufacturer's instructions, temperature records, and interview with General Supervisor (GS)-10 of the Immunology/Serology section, according to the CMS Form 209, the laboratory failed to define, monitor and document humidity in the Immuno-Serology section of the laboratory where two of two temperature dependent analyzers were in use. Findings Included: 1. In direct -- 2 of 9 -- observation on 8/14/2025 at 10:40 AM, the following analyzers were seen in use: a. 1 Roche Cobas e411 (Serial Number #1072-24) b. 1 Beckman Coulter Access 2 Immunoassay System (Serial Number #510230) 2. Review of the manufacturer's instruction stated the following humidity requirements for the Roche Cobas e411 analyzer: "Cobas e411 analyzer specifications: Operating conditions - Ambient humidity: 20-80%" 3. Review of the Beckman Coulter manufacturer's instructions titled 'Quality Forward Convenience Forward Lab Forward Access 2 Immunoassay System' stated the following humidity requirements on page 4 of 4: "Power and Environmental Requirements: Ambient Operating Environment: Relative Humidity 20 to 80% relative, non-condensing" 4. Review of the laboratory's humidity records revealed no humidity ranges defined, monitored or documented in the immuno- serology room of the laboratory. 5. In an interview on 8/14/2025 at 10:41 AM in the immune-serology room, GS-10 confirmed the section did not define, monitor or document humidity. III. Based on direct observation, manufacturer's instructions, temperature records, and interview with Technical Supervisor (TS)-1 of the Chemistry section, the laboratory failed to define freezer temperature ranges consistent with the manufacturer's instructions, for nine of nine Quidel Triage Total 5 Control boxes. Findings Included: 1. In direct observation on 8/15/2025 at 1:41 PM in the Chemistry section, one freezer was observed in use for mixed-use reagent storage between the chemistry and immuno-serology section of the laboratory, set to a temperature of -18 degrees celsius and colder. The following chemistry control reagents were seen in storage, with corresponding manufacturer storage temperature requirements: a. 9 Quidel Triage 5 Control boxes, Lot #C4120AN, Manufacturer storage temperature requirements -20 degrees celsius or colder. 2. In an interview on 8/15/2025 at 1:42 PM, TS-1 of the chemistry section of the laboratory confirmed the freezer temperature range was not defined in accordance with manufacturer storage requirements of reagent controls stored within. IV. Based on direct observation, manufacturer's instructions, temperature records, and interview with General Supervisor (GS)-10 of the Chemistry section, the laboratory failed to define freezer temperature ranges consistent with the manufacturer's instructions, for 7 of 7 Bio-Rad Liquichek Tumor Marker Control reagents. Findings Included: 1. In direct observation on 8/14/2025 at 1:27 PM in the Chemistry section, one freezer was observed in use for mixed-use reagent storage between the chemistry and immuno-serology section of the laboratory, set to a temperature of -18 degrees Celsius and colder. The following immuno- serology control reagents were seen in storage, with corresponding manufacturer storage temperature requirements: a. 1 box Bio-Rad Liquichek Tumor Marker Control Level 1, Lot #94981, manufacturer storage temperature requirements -70 to -20 degrees celsius b. 4 boxes Bio-Rad Liquichek Tumor Marker Control Level 2, Lot #94982, manufacturer storage temperature requirements -70 to -20 degrees celsius c. 2 boxes Bio-Rad Liquichek Tumor Marker Control Level 3, Lot #94983, manufacturer storage temperature requirements -70 to -20 degrees celsius 2. In an interview on 8/14 /2025 at 1:28 PM, GS-10 of the immuno-serology section of the laboratory confirmed the freezer temperature range was not defined in accordance with manufacturer storage requirements of reagent controls stored within. 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. -- 3 of 9 -- This STANDARD is not met as evidenced by: Based on direct observation, review of manufacturer instructions, and confirmed in interview with the Technical Supervisor (TS) -1 of Chemistry according to the Form CMS-209, the laboratory failed to ensure the labeling of new preparation/open dates for four of four bottles of quality control (QC). Findings Included: 1. In direct observation on 8/13/2025 at 2:28 PM, in the Chemistry 2 to 8 degrees Celsius refrigerator, the following reagent bottles were observed with no preparation dates labeled: a. One bottle Microgenics Corporation MAS PAR TDM Level 1 control, Lot #TDA25081A, Expiry date 2025-08-31 b. One bottle Microgenics Corporation MAS PAR TDM Level 2 control, Lot #TDA250830, Expiry date 2025-08-31 c. One bottle Microgenics Corporation MAS Uricheck Level 1 control, Lot #UC25111A, Expiry date 2025-11-30 d. One bottle Microgenics Corporation MAS Uricheck Level 2 control, Lot #UC25112A, Expiry date 2025-11-30 2. Review of manufacturer's instructions for the Microgenics Corporation MAS controls stated the following storage and stability requirements: "Storage and Stability Store MAS PAR TDM at 2- 8 degrees Celsius. Unopened vials are stable until expiration date on the label. Once opened, vials of controls are stable for 30 days when stored tightly capped at 2-8 degrees Celsius. Do not freeze." 3. In an interview on 8/13/2025 at 2:30 PM, TS-1 could not confirm the date when bottles were opened, and the bottles expiration dates were not based on manufacturer instructions. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) (b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (b)(2)(i) Accuracy. (b)(2)(ii) Precision. (b)(2)(iii) Analytical sensitivity. (b) (2)(iv) Analytical specificity to include interfering substances. (b)(2)(v) Reportable range of test results for the test system. (b)(2)(vi) Reference intervals (normal values). (b)(2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on direct observation, manufacturer's instructions, and interview with Technical Supervisor (TS)-4, according to the Centers for Medicare and Medicaid Services (CMS) Form-209, the laboratory failed to establish performance specifications after modifying manufacturer storage temperatures for nine of nine KwikStix American Type Culture Collection (ATCC) organism control boxes. Findings Included: 1. In direct observation on 8/18/2025 at 9:17 AM, in the microbiology freezer, the following ATCC organism control boxes were seen in storage at -20 to -8 Celsius: a. One KwikStik ATCC P. aeruginosa box, Lot #353-558-62 b. One KwikStik ATCC K. quasipneumoniae box, Lot #784-86-24 c. One KwikStik ATCC S. maltophilia box, Lot #759-78-22 d. One KwikStik ATCC E. casseliflavus box, Lot #761-85-22 e. One KwikStik ATCC N. gonorrhoeae box, Lot #429-89-32 f. One KwikStik ATCC N. gonorrhoeae box, Lot #378-108-22 g. One KwikStik ATCC S. aureus box, Lot #365- 133-23 h. One KwikStik ATCC C. albicans box, Lot #443-1609-66 i. One KwikStik ATCC S. saprophyticus box, Lot #945-64-2 2. Review of the manufacturer's -- 4 of 9 -- instruction for the KwikStik ATCC organisms labeled "KwikStik Instructions for Use" revealed the following requirements for storage: "Storage and Expiration Store KWIK-STIK Plus microorganisms at 2 to 8 degrees Celsius in the original, sealed vial or pouch containing the desiccant, KWIK-STIK Plus microorganisms should not be used if: -Stored improperly -There is evidence of excessive exposure to heat or moisture -The expiration date has passed ..." 3. TS-4 was unable to provide stability studies to confirm the modification to storage requirements did not affect test sensitivity or specificity. 3. In an interview on 8/18/2025 at 9:20 AM, TS-4 stated the microbiology section stored the ATCC organisms in the freezer due to space and resource constraints, which never affected their QC results. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on direct observation, review of Quality Control (QC) records, test records, and interview with the Technical Supervisor (TS-1), according to the Centers for Medicare and Medicaid Services (CMS) Form-209, the laboratory failed to have control procedures that monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance process for 51 of 51 analytes tested in the Chemistry section. Findings Included: 1. In direct observation on 8/13/2025 at 2: 27 PM, the following 2 Beckman Coulter chemistry analyzers were seen in use: a. Beckman Coulter DXC 700 AU (Serial Number #2024054345) b. Beckman Coulter AU 680 (Serial Number #2014093435) 2. Review of the laboratory's QC records showed recalibrations performed after QC failures, but no record of QC standard deviations outliers in the instruments' Levy-Jennings (LJ) graph settings for all 51 analytes tested in the Chemistry section. The following example recalibrations were performed due to QC failure, with no record of the QC failures in the LJ chart: a. QC Failure, Recalibration, Test Name TBIL-C, 6/25/2025, 12:44 AM, Device No. 0093435 b. QC Failure, Recalibration, Test Name TBIL-C, 6/26/2025, 1:34 AM, Device No. 0093435 3. Review of the laboratory's test records revealed the following volumes for testing performed on the following analytes (sample of 9 analytes out of 51 total): a. January 1 - December 31, 2024 (713,385) - Albumin (37,542) ALP (36,011) Amphetamine (875) Amylase (5,083) Bilirubin, T (33,323) BUN (38,004) Calcium, T (40,465) Carbamazepine (44) CO2 (40,860), etc. b. January 1 - July 31, 2025 (490,108) - Albumin (23,691) ALP (23,503) Amphetamine (322) Amylase (3,316) Bilirubin, T (21,879) BUN (24,460) Calcium, T (58,250) Carbamazepine (5) CO2 (26,734), etc. 4. In an interview on 8/13/2025 at 3:01 PM, TS-1 confirmed she permanently deleted QC LJ standard deviation outliers once a QC re-run and/or re- calibration came in within range again and could not accurately monitor the accuracy and precision of the test system over time. -- 5 of 9 -- D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(g) (d)(3)(iii) Test procedures producing graded or titered results, include a negative control material and a control material with graded or titered reactivity, respectively; This STANDARD is not met as evidenced by: Based on review of the laboratory Quality Control (QC) records, test records and interview with the General Supervisor (GS)-10, according to the Centers for Medicare and Medicaid (CMS) Form 209, the laboratory failed to perform controls of known titered reactivity for 1 of 11 Rapid Plasma Reagin (RPR) tests run from 6/01/2024 to 8 /14/2025 (Random review). Findings Included: 1. Review of the laboratory QC records showed RPR QC being performed to signify a 'Weak Reactive' titer as 1:2, and a 'Reactive Titer' as 1:8. 2. Review of the laboratory's test records from 6/01/2024 to 8/14/2025, revealed a total of 11 RPR tests run, and 1 RPR test performed on 7/09 /2025, with the following controls and results reported as higher titers than the 1:8 reactive titer control run: a. 6/28/2024; Patient ID 10021945, TPPA-Reactive, RPR - Reactive 1:16 Controls 'Weak Reactive' 1:2; Reactive 1:8. 3. In an interview on 8/14 /2025 at 2:06 PM, GS-10 confirmed the laboratory did not run reactive controls beyond 1:8, but at times reported out results to patients at 1:16 and above. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (1) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Control QC records, patient testing records, and interview with testing person # 25, the laboratory failed to perform QC on Bact/Alert FA Plus and Bact/Alert PF Plus blood culture bottles two of two shipments received in 2025 as evidenced by: 1. In review of the QC records or BACT /Alert FA plus #410852 100 per box, and Bact/Alert PF #410853 100 per box, the blood culture bottles were received on 4/2/2025.The laboratory did not perform QC on the plastic blood culture media. The laboratory did not have an Individual Quality Control Plan (IQCP) for blood culture media. 2. In review of the QC records for BACT/Alert FA plus lot #0004103282 100 per box, and Bact/Alert PF lot# 0041803132 100 per box , blood culture bottles were received on 6/5/2025. The laboratory did not perform QC on the plastic blood culture media. The laboratory did not have an Individual Quality Control Plan (IQCP) for blood culture media. 3.The following random sampling of patients were tested without quality control performed on bottle culture: a.Test date 7/29/2025 Hospital number 203193 accession # 12687 b. Test date 7/31/2025 Hospital number #250012659 accession #12659 c.Test date 7/31 /2025 Hospital number # 92329 d.Test date 7/31/2025 accession #12656 4. In an interview with testing person #25 confirmed on 8/18/2025 at 1050 that they did not do QC on the blood culture bottles. -- 6 of 9 -- D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood shall be stored in a clean and orderly environment in a manner to prevent mix-ups. Expired blood must not be in the routine inventory. Unacceptable units must be segregated from routine inventory. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, blood bank temperature records, and confirmed in interview with technical supervisor #2, the laboratory failed to perform temperature probe audio alarm check and establish a frequency on when to perform the audio alarm check for the Helmer refrigerator containing blood products for 7 of 7 months (2025) reviewed as evidenced by: 1.In review of the laboratory policy, "Equipment Maintenance: Alarm Quality Control Check on Helmer Fridge (Blood Units), the laboratory did not have a step by step process on how to perform the alarm checks using ice and warm (on the probe) to check the alarm's audible parameters set at 5.5 degrees C and 1.5 degrees. The laboratory did not establish a frequency on how often they perform the temperature probe audio alarm check. 2.In review of the laboratory's blood bank temperature records from January 2025 to the date of the survey, there were no temperature spikes recorded on the blood bank continuous temperature monitoring charts. 3.In interview with technical supervisor # 2 at 8/13 /2025 at 1315 confirmed that the audio alarm check was not reflected on the continuous temperate monitoring chart from the Helmer refrigerator in 7 of 7 months reviewed in 2025. D5783

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity. testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and College of American Pathologists (CAP) records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of Routine Chemistry for the Aspartate transaminase (AST) analyte, in the overall subspecialty of Toxicology and for the individual toxicology analytes carbamazepine, lithium, phenobarbital, and theophylline. Refer to D2096, D2118, and D2119 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and College of American Pathologists (CAP) 2024 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of two consecutive testing events (2024 Events 1 and 2) in the subspecialty of Routine Chemistry for the Aspartate Transaminase (AST) analyte. Findings included: 1. Review of the CASPER 0155 report revealed the following results: CAP Chemistry 2024 - 1st Event The laboratory received an unsatisfactory score of 40% for the AST. CAP Chemistry 2024 - 2nd Event The laboratory received an unsatisfactory score of 20% for the AST. 2. A review of CAP 2024 proficiency testing records confirmed the laboratory received the above results. D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and College of American Pathologists (CAP) 2024 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of two consecutive testing events (2024 Events 1 and 2) in the subspecialty of Toxicology for the individual toxicology analytes carbamazepine, lithium, phenobarbital, and theophylline. 1. Review of the CASPER 0155 report revealed the following results: CAP Chemistry 2024 - 1st Event The laboratory received an unsatisfactory score of 0% for the Carbamazepine. The laboratory received an unsatisfactory score of 0% for the Lithium. The laboratory received an unsatisfactory score of 0% for the Phenobarbital. The laboratory received an unsatisfactory score of 0% for the Theophylline. CAP Chemistry 2024 - 2nd Event The laboratory received an unsatisfactory score of 0% for the Carbamazepine. The laboratory received an unsatisfactory score of 0% for the Lithium. The laboratory received an unsatisfactory -- 2 of 3 -- score of 0% for the Phenobarbital. The laboratory received an unsatisfactory score of 0% for the Theophylline 2. A review of CAP 2024 proficiency testing records confirmed the laboratory received the above results. D2119 TOXICOLOGY CFR(s): 493.845(g) 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 a proficiency testing desk review of the College of American Pathologists (CAP) 2024 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the overall subspecialty of Toxicology in two of two consecutive testing events (2024 Events 1 and 2). A review of CAP 2024 proficiency testing records revealed the following results: 1. CAP Chemistry 2024 - 1st Event The laboratory received an overall unsatisfactory score of 43% for Toxicology. 2. CAP Chemistry 2024 - 2nd Event The laboratory received an overall unsatisfactory score of 43% for Toxicology. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and College of American Pathologists (CAP) 2024 proficiency testing records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and College of American Pathologists (CAP) 2024 proficiency testing records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096, D2118, and D2119. -- 3 of 3 --

Summary Statement of Deficiencies 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 a random review of patient test records and an interview with testing personnel (TP) #11 on August 23, 2023, the laboratory failed to ensure test results were accurately and reliably sent from the point of data entry (interfaced or manual entry) to final report destination in a timely manner. The laboratory reported performing approximately 10,000 general immunology tests annually. Findings: 1. Upon review of randomly selected patient test results, one of nine patient results selected was not reported from the initial instrument run to the patient's electronic medical record. 2. The patient test result selected for Hepatitis B core antibody (HBcAb) was initially tested on the Roche Cobas e 411 analyzer on February 8, 2023, and the result was positive. The laboratory protocol requires positive results for HBcAb to be retested before reporting. The sample was never retested, and a final test result was never transcribed into the patient's electronic medical record as of August 23, 2023, at 12:15 PM. 3. An interview with TP #11 on August 23, 2023, at approximately 12:15 PM confirmed that the laboratory failed to report one of nine patient test results in an accurate and timely manner. 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 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 proficiency testing (PT) records review of the CMS-155 report, the laboratory's 2021 College of American Pathology (CAP) proficiency testing (PT) records and email received from the Laboratory Director on March 31, 2022 , it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analyte PO2 blood gas in two (2) out of three (3) Chemistry testing events resulting in unsuccessful PT performance. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site proficiency testing (PT) records review of the CMS-155 report, the laboratory's 2021 College of American Pathology (CAP) proficiency testing (PT) records and email received from the Laboratory Director on March 31, 2022, it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analyte PO2 blood gas in two (2) out of three (3) Chemistry testing events resulting in unsuccessful PT performance. Findings include: 1. Desk review of the CMS-155 report and the laboratory's 2021 CAP PT records revealed PO2 blood gas scores of less than eighty percent for the following Chemistry events: 2021 CAP Event 2 -score of 60% 2021 CAP Event 3- score of 60% 2. ln an email received from the Laboratory Director on March 31, 2022 at 7:45 pm, it was confirmed that the laboratory was unsuccessful in the PT events listed above. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's College of America Pathologist (CAP) proficiency testing (PT) records, review of the CMS CASPER 155D reports for PT second quarter (Q2-2016), first quarter (Q1-2017), first quarter (Q1-2018), second quarter (Q2-2018) for parasitology and third quarter (Q3-2017), first quarter (Q1- 2018) for AST(SGOT), and interview with the laboratory director and the laboratory technical supervisors on November 12, 2019, the laboratory failed to participate successfully for the subspecialty parasitology, and the analyte AST(SGOT). The findings included: a. The laboratory failed to achieve successfull participation in the subspeciatly parasitology PT which resulted in subsequent unsuccessful PT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- participation. See D2053 b. The laboratory failed to successfully participate and provide documentation of evaluation and remedial actions for unsatisfactory PT performance for two of three PT testing events in the subspecialty of routine chemistry for the analyte AST(SGOT), (unsuccessful PT performance). See D2094, D2096 D2053 PARASITOLOGY CFR(s): 492.829(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of analyte performance from the CMS CASPER 155D report for the years 2016 (Q2) , 2017 (Q1), 2018 (Q1, Q2), the laboratory's College of American Pathologists (CAP) proficiency records for second quarter (Q2-2016), first quarter (Q1-2017), first quarter (Q1-2018), second quarter (Q2-2018) and interview with the laboratory director and the department technical supervisor on November 12, 2019, the laboratory failed to achieve satisfactory scores in parasitology PT performance. The findings included: a. The laboratory is enrolled with College of American Pathology (CAP) for Microbiology (parasitology) PT testing since 2016. b. For the subspecialty of parasitology, the laboratory had unsuccessful PT performance for two of of three events in 2016, 2017 and 2018: CAP reported event for parasitology: Event Score % Q2 2016 60 Q1 2017 50 Q1 2018 66 Q2 2018 66 e. Patient test results review covering periods from January 22, 2018 through November 12, 2018. the laboratory had performed approximately 320 parasitology specimens. d. The laboratory director confirmed by interview on November 12, 2019 at approximately 10:30 a.m., that the laboratory had received the above unsatisfactory proficiency testing scores. f. The laboratory reports performing approximately 577 parasitology patient specimens annually. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's College of American Pathologist (CAP) Proficiency Testing (PT) records, CMS 0155D CASPER report and interview with the laboratory director and the laboratory chemistry department technical supervisor on November 12, 2019, the laboratory failed to (1) to undertake appropriate training and -- 2 of 7 -- employ the technical assistance necessary to correct problems associated with proficiency testing failure and (2) The laboratory failed to take remedial action and document the action taken, and maintain documentation of the actions taken by the laboratory for two years from the date of participation in the failed proficiency testing event. The findings included: a. The laboratory is enrolled with CAP for chemistry proficiency testing since quarter 1 of 2016. b. In quarter two (Q2-2017) the laboratory failed PT testing for CK ISO), in quarter one (Q3-2017) the laboratory failed AST (SOGT) testing, in quarter one (Q1-2018) the laboratory failed AST (SGOT) testing, in quarter quarter three (Q3-2018) the laboratory failed CK, Total and LDH Total, in quarter one (Q1-2019) the laboratory failed glucose and BUN PT performance testing. Test Event Score CK ISO Q2 2017 0 AST(SOGT) Q3 2017 0 AST(SGOT) Q1 2018 0 CK Total Q3 2018 60 LDH Total Q3 2018 20 Glucose (NW) Q1 2019 60 BUN Q1 2019 40 c. For AST (SGOT)- Coding change error with CAP, event (Q3-2017) was documented as the issue for the initial unsatisfactory result. For (Q1-2018) AST (SGOT) failure, the laboratory documented the same response (clerical issue) as the reason for the second PT failure. d. The laboratory had no documentation of remedial actions taken for initial analyte unacceptable testing event scores, for the first or second unacceptable analyte testing event scores. e. A random patient review of (11) patient chemistry records and review of quality control logs and interview with the laboratory director and technical supervisor confirmed the testing of patient samples during the time of failed proficiency testing scores for the above analytes and during the period of unsuccessful analyte performance for AST(SGOT) (Q3 2017-Q1 2018). f. The laboratory reports performing a 478,556 routine chemistry tests annually which include (CK ISO, CK Total, AST (SGOT), LDH total, Glucose, BUN). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the laboratory College of American Pathologist (CAP) Proficiency Testing (PT) report, the CMS CASPER 0155D report, and interview with the laboratory director and chemistry technical supervisor on November 12, 2019, the laboratory failed to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events resulting in unsuccessful PT performance. The findings included: a. The laboratory is enrolled in CAP for the subspecialty of routine chemistry. Quarter three of 2017 (event 3) the laboratory recieved unaccaptable scores for the PT chemistry analyt AST(SGOT) and in quarter one (Q1-2018) 2018 the laboratory recieved unacceptable PT scores again for the chemistry analyte AST(SGOT). Event Score Q3 2017 0% Q1 2018 0% b. Based on interview, and a random sampling of patients from January 2018 through August of 2019, the laboratory director confirmed on November 12, 2019 at approximately 12:30 p.m. that the laboratory had continued testing patients for AST. c. The laboratory reports performing approximately 478,556 routine chemistry patient specimens annually which include AST(SGOT). D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) -- 3 of 7 -- Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the laboratory's Chemistry verification data for the new chemistry analyzer (Beckman AU) installed on April 1st, 2019, and interview with the department technical supervisor on November 13, 2019, the laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics, (accuracy, precision, reportable range for test result for the test system) and failed to verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. The findings included: a. The laboratory previously ran their chemistry patient specimens on a Siemens dimension analyzer. In 2019 the laboratory purchased a Beckman AU chemistry analyzer. b. The manufacturer performed comparison sampling for the laboratory on the two instruments during the implementation phase of the installation. The patient sampling results were entered into a program by the Beckman representative showing the linearity and bias of the Beckman analyzer. c. The laboratory did not have documentation of the Siemens chemistry analyzer"known" samples. The "known" samples results were no longer available in the Siemens analyzer memory and the print outs had been accidentally shredded. d. The laboratory did not have documentation summarizing the acceptability of the the validation report and its acceptability for implementing the new test methodology platform prior to testing and reporting patient results. e. The laboratory technical supervisor and laboratory director confirmed by interview on November 13, 2019 at approximately 1:15 p.m. that lack of proper validation of the new chemistry analyzer prior to testing patient specimens. f. The laboratory reports performing approximately 478,556 routine chemistry tests annually. D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of patient testing report logs and interview with testing personnel and the general supervisor on November 13, 2019, the laboratory failed to establish and perform quality control procedures in accordance with 493.1269(a) for manual cell counts performed using a hemocytometer--the laboratory failed to perform (a)(1) One control material tested each 8 hours of operation; and (d) The laboratory failed to document all control procedures performed. The findings included: a. The laboratory performs diluted and undiluted body fluid cell counts on a hemocytometer. b. The laboratory has no documentation of quality control materials being performed each -- 4 of 7 -- eight hours of patient testing. c. The laboratory has no documentation of an individualized quality control plan (IQCP) in place for establishing alternative quality control procedures. d. The hematology general supervisor confirmed by interview on November 13, 2019 at approximately 09:00 a.m. that the laboratory did not have a quality control plan for hemocytometer body fluid cell counts and do not perform quality control or document quality control procedures for body fluid cell counts. e. The laboratory reports performing approximately 370 body fluid patient specimens annually. D5809 TEST REPORT CFR(s): 493.1291(e) The laboratory must, upon request, make available to clients a list of test methods employed by the laboratory and, as applicable, the performance specifications established or verified as specified in 493.1253. In addition, information that may affect the interpretation of test results, for example test interferences, must be provided upon request. Pertinent updates on testing information must be provided to clients whenever changes occur that affect the test results or interpretation of test results. This STANDARD is not met as evidenced by: Based on review of patient test reports, the Cobas Elecsys Total PSA product insert and interview with department technical supervisor and testing personnel on November 13, 2019, the laboratory failed to make available to clients information that may affect the interpretation of test results for Total Prostate-Specific Antigen testing. The findings included: a. The laboratory performs Total PSA on the Cobas immunoassay analyzer using the Elecsys total PSA reagent. b. The product insert states "the laboratory finding must therefore always contain a statement on the tPSA assay method used. tPSA values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations". c. A random sampling of (11) patients from January 2018 to August 2019 indicated that the patient test reports did not contain this statement. The laboratory had changed laboratory information systems and that comment had been dropped from the patient tPSA reports. d. The laboratory director and technical supervisor confirmed by interview on November 13, 2019 at approximately 16:15 p.m. that the patient tests reports for tPSA did not contain the required interpretive statement. e. The laboratory reports performing approximately 726 tPSA patients in 2018, and approximately 968 tPSA patients in 2019. 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 the severity of the deficiecies cited herin, the Condition: Laboratoriories performing High Complexity testin: Laboratory director failed to meet the requirements of 493.1445 of this subpart in providing overall management and direction for high complexity testing. The findings included: a. Failure to ensure -- 5 of 7 -- satisfactory Proficiency Testing, See D2016, D2096, D6089 b. Failure to ensure verification of Performance procedures and characteristics for new methodologies are performed prior to testing and releasing of patient results, See D5421, D6092 c. Failure to ensure