Twin Rivers Medical Laboratory, Inc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on 3/21/2025. 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 surveyor proficiency testing (PT) desk review of the laboratory PT records, the American Proficiency Institute(API) Evaluation Reports, and CASPER Report 0155D from the Centers for Medicare and Medicaid Services (CMS) data system, and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- emails from the Technical Consultant (SP-2) on 03/21/205, the laboratory failed to achieve satisfactory performance in two out of three events (Event 2 of 2024 and Event 1 of 2025) resulting in unsuccessful participation in the subspecialty of Endocrinology for the analyte of thyroxine in 2024 and 2025. Refer to D2099. D2098 ENDOCRINOLOGY CFR(s): 493.843(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on surveyor proficiency testing (PT) desk review of the laboratory PT records, the American Proficiency Institute (API) Evaluation Reports, and CASPER Report 0155D from the Centers for Medicare and Medicaid Services (CMS) data system, and emails from the Technical Consultant (SP-1) on 3/21/2025, the laboratory failed to achieve satisfactory performance in two out of three events (event 2 in 2024 and event 1 in 2025) resulting in unsuccessful participation in the subspecialty of Endocrinology for the analyte of thyroxine in 2024 and 2025. Findings included: 1. Review of the "CASPER Report 0155D," run date 3/14/2025 indicated a score of 0% for event 2 2024, and 40% for event 1 2025 for thyroxine as reported by API. 2. Upon request for information on PT for 2024 and 2025 for thyroxine, via email on 3/21/2025 at 4:12 pm, SP-2 (Technical Consultant) provided a document "Performance Review and

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 observation, document review and interview, the laboratory failed to ensure the clean solution for the ISE (Ion Selective Electrode) used for the maintenance procedures for three of three analytes (sodium, potassium and chloride) tested on the Roche Cobas501/601 serial number 1619-02 had not exceeded its expiration date from 1-31-24 to 9-3-2024. Findings included: 1. During a lab tour on 9-3-2024 at 12: 00 pm, the following was observed: a) A Cobas Roche 501/601 serial # 1619-02 was in use for patient testing. b) A box of ISE (Ion Selective Electrode) cleaning solution used in the daily maintenance procedure for sodium, potassium and chloride was in the laboratory refrigerator with a date of 5-31-24. The bottle did not state if it was an open date or expiration date. c) Review of the original box listed an expiration date of 1-31-2024. The open bottle had an expiration date of 1-31-2024. 2. "ISE Cleaning /Elecsys SYS Clean" package insert, REF 11298500, removed from the open box of ISE Cleaning solution read, "The solution is stable to the stated expiration date when stored at 2-8 degrees Celsius". 3. During an interview on 9-3-2024 at 12:00 pm, SP-03 (testing Personnel) stated "the cleaning solution is used daily to clean the pipe". 4. Total annual test volume for Sodium, Potassium and chloride is 40,374 D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- 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 -- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the laboratory failed to follow their policy on performing quality control after calibration is completed to verify accuracy of the calibration for three of 32 analytes (analytes sodium, potassium and chloride) tested on the Cobas Roche 501/601analyzer and three of three patients (PT #1-PT#3) reviewed. Findings Include: 1. During a laboratory tour on 9-3-2024 at 12: 00 pm, a Cobas Roche 501/601 Chemistry analyzer serial number 1619-02 was in use for patient testing, including the analytes sodium, potassium and chloride. 2. In an interview on 9-3-2024 at 12:00 pm, SP-01 (testing personnel) stated that "the analytes sodium, potassium and chloride are calibrated daily." 3. Review of calibration reports for sodium, potassium and chloride indicated a calibration occurred on 8-27-2024 at 16:37 pm. 4. A review of patient (Pt) medical records indicated three patient (pt) samples were run on the Cobas Roche 501/601 serial # 169-02 on 8-28-2024 between 06:31 am and 06:38 am for the analytes of sodium (Na), potassium (K+) and chloride (cl). Pt Time Na K+ cl #1 06:31 am 140.0 4.2 101.7 #2 06:32 am 142.0 4.8 107.6 #3 06:38 am 141.0 3.9 99.8 3. Review of quality control records indicated quality control materials were run on 8-28-2024 at 08:46 am. 4. Policy dated on 8-16-2024 titled: Employee training sheet: Calibration Procedure for the Roche Cobas 6000 requires: "4.1 Running Quality Controls: After calibration run quality control samples to verify the accuracy of the calibration". 5. Total annual test volume is 40,347 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was completed on 8/5/2024. It was determined that the following condition-level deficiencies existed: 42 C.F.R. 493.1250 Condition: Analytic systems 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 observation, lack of documentation, record review and interview, the laboratory failed to meet the following analytic system requirements: the laboratory failed to ensure the open and expiration dates were labeled for the three of three complete blood count (CBC) controls in use (refer to D5415); the laboratory failed to follow manufacturer's instructions for using calibration material with at least the frequency recommended by the manufacturer for five of 34 assays (triglycerides, alkaline phosphate, calcium, free thyroxine (FT4) and digoxin) tested in the specialty of chemistry using the Roche Cobas 601 serial # 1619-02 (refer toD5437); and the laboratory failed to include two levels of quality control (QC) material for each day of patient testing for one of one analyte (prothrombin time) tested on the Seimens Coagulations Analyzer CA 600 serial# 12253 (refer to D5447). D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, and interview, the laboratory failed to ensure the open and expiration dates were labeled for the three of three complete blood count (CBC) controls in use. Findings include: 1. During a tour of the laboratory on 7-23-2024 at 11:20 AM, the following was observed: a) An Abbott Cell Dyne Complete Blood Count analyzer was in use. b) A container in the laboratory refrigerator held three levels of Complete Blood Cell (CBC) quality control (QC) material. The QC material had a laboratory manufactured barcode label on top of each control vial. 2. In an interview on 7-23-2024 at 11:20 AM, SP-03 (testing personnel) verified no open or expiration dates were on the quality controls vials labeled Low, Normal, High. 3. During continuation of the laboratory tour on 7-23-2024 at 12:15 PM, SP-01 (testing personnel) and SP-03 (testing personnel) removed the laboratory manufactured barcode label off the quality control vials to reveal the Biotecneic quality control material lot number kk119 had an expiration date of 7-5-2024. 4. Total annual test volume for CBC is 11798. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on observation, lack of documentation, record review, and interview, the laboratory failed to follow manufacturer's instructions for using calibration materials with at least the frequency recommended by the manufacturer for five of 34 assays (triglycerides, alkaline phosphate, calcium, free thyroxine (FT4) and digoxin) tested in the specialty of chemistry using the Roche Cobas 601 serial # 1619-02. Findings include: 1. During laboratory tour on 7-23-2024 at 10:38 am, a Roche Cobas 601 serial #1619-02 was in use for patient testing in the specialty of chemistry including: triglycerides, alkaline phosphate, calcium, free thyroxine, and digoxin. 2. Upon request for manufacture package inserts for triglycerides, alkaline phosphatase, and calcium, on 7-23-2024 at 10:38 am, SP-02 (testing personnel) could not provide package inserts for the reagents or calibration materials. SP-02 further confirmed they did not have any calibration materials in the laboratory for triglycerides, alkaline phosphatase, or calcium. 3. The package inserts for the Cobas required the following: a. "Elecsys FT4 III" reference number 07976836190 required the analyte FT4 to be -- 2 of 3 -- calibrated at least every 30 days. b. "Elecsys Digoxn" reference number 11820796190 required the analyte digoxin to be calibrated at least every 30 days. 4. A calibration report printed from the Roche Cobas 601 dated 11-20-2023 for the analyte FT4 and dated 1-05-2024 for the analyte digoxin indicated these were the last calibration dates for each analyte. 5. In an interview on 7-23-23 at 2:53 pm, SP-01 (testing personnel) confirmed the last calibration dates for FT4 were 11-20-2023 and 1-05-2024 for digoxin. 6. Patient (PT)#1 had free thyroxine (FT4) tested on of 1-15-2024 at 7:46 am with a result of 1.7ng/dl without a calibration being performed every 30 days. 7. PT#2 had digoxin tested on 7-23-24 at 3:03 PM confirmed the laboratory performed patient testing on 2-21-2024 for the analyte digoxin without a calibration being performed every 30 days. 8. Total annual test volume for FT4 is 1,586 and digoxin is 130. 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 observation, record review, and interview, the laboratory failed to include two levels of quality control (QC) material for each day of patient testing for one of one analyte (prothrombin time) tested on the Seimens Coagulations Analyzer CA 600 serial# 12253. Findings Include: 1. On 7-23-2024 at 10:38 AM, a Seimens Coagulation analyzer CA 600 serial # 12253 was in use for the testing on patient samples for Prothrombin time (PT). 2. In an interview on 7-23-2024 at 2:32 PM, SP- 03 (testing personnel) stated "we only run one level of quality control daily". 3. Review of the quality control for the date of 7-08-2024 revealed only one level of quality control material was run. 4. Review of policy titled "Quality Control Activities", with no review date by the current laboratory director, reads..."B. Procedure for Daily Quality Control Decisions using Two Level Program..." The policy does not define the "Two Level Program". 5. Review of the "Daily Control Report" "Name: "COAG GC-02" run on 7/8/2024 confirmed only 1 level of Quality Control was performed. 6. Total annual test volume for prothrombin is 1,939. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Proficiency Testing Review survey was completed on 7/23/2024. It was determined that the following condition-level deficiencies existed: 42 Code of Federal Regulation (CFR) 493.803(a)(b)(c) Successful Participation 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 record review and interview, the laboratory failed to achieve satisfactory performance of 80% or greater for two consecutive proficiency testing (PT) events in 2024 (event 1 in 2024 and event 2 in 2024) for one of four regulated analytes tested in the subspecialty of endocrinology (triiodothyronine (T3)) and for two of four analytes tested in the subspecialty of toxicology (digoxin and phenytoin). T3 results were 60% 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 -- for event 1 and 20% for event 2 of 2024 (refer to D2099). Digoxin results were 40% for event 1 and 0% for event 2 2024. Phyenytoin results were 60% for event 1 and 60% event 2 of 2024 (Refer to D2118). D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to achieve satisfactory performance of 80% or greater for two consecutive proficiency testing (PT) events in 2024 (event 1 in 2024 and event 2 in 2024) for one of four analytes tested in the subspecialty of endocrinology (triiodothyronine (T3)). T3 results were 60% for event 1 and 20% for event 2 of 2024. Findings Include: 1. Review of the Casper Report 0155D (Individual laboratory Profile) indicated the following scores for triiodothyronine: Event 1 of 2024 = 60% and Event 2 of 2024 =20%. 2. Review of the American Proficiency Institute (API) Performance Summary 2024 Core- 2nd event confirmed the scores for triiodothyronine for event 1 of 2024 = 60% and event 2 of 2024 =20%. 3. In an interview on 7-23-24 at 12:52 PM, SP-01 (testing personnel) and SP-02 (testing personnel) confirmed the results. 4. Total annual test volume for Triiodothyronine is 39 patients. 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 record review and interview, the laboratory failed to achieve satisfactory performance of 80% or greater for two consecutive PT events in 2024 for two of four analytes in the specialty of Chemistry, subspecialty toxicology (digoxin and phenytoin). Digoxin results were 40% for event 1 and 0% for event 2 2024. Phyenytoin results were 60% for event 1 and 60% event 2 of 2024 (Refer to D2118). Findings Include: 1. Review of the Casper Report 0155D (Individual Laboratory Profile) indicated the following unsatisfactory scores: a) digoxin event 1 of 2024=40%, event 2 of 2024 = 0%, and b) phenytoin event 1 2024= 60%, event 2 of 2024=60%. 2. Review of the American Proficiency Institute (API) Performance Summary 2024 Core- 2nd event confirmed the digoxin results were 40% for event 1 and 0% for event 2 2024, and Phyenytoin results were 60% for event 1 and 60% event 2 of 2024 3. Interview on 7-23-2024 at 12:52 PM with SP-01 (testing personnel) and SP-02 (testing personnel) confirmed the scores were accurate for digoxin and phenytoin. 4. Total annual test volumes: Digoxin = 130 patients per year Phenytoin = 32 patients per year. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on 8/30/2023. It was determined that the following condition-level deficiencies existed: 42 Code of Federal Regulation (CFR) 493.803(a)(b)(c) Successful Participation 42 CFR 493.1411 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: Repeat deficiency. Based on record review and staff interview, the laboratory failed to successfully participate in American Association of Bioanalysts (AAB), proficiency testing (PT) for three out of five consecutive events (1 and 3 in 2022 and 2 in 2023) in the subspecialty Bacteriology, for the analyte, Urine Culture (Refer to D2028). 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 -- D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Repeat deficiency. Based on record review and staff interview, the laboratory failed to successfully participate in proficiency testing (PT) by achieving a score of 80% or higher for three out of five consecutive events (1 and 3 in 2022 and 2 in 2023) in the subspecialty Bacteriology, for the analyte, Urine Culture. Findings include: 1) Review of Oscar Report 155D (Individual Laboratory Profile) indicated the following unsatisfactory scores for Bacteriology and the analyte Urine Culture: Event 1 (2022) = 0%, Event 3 (2022 ) = 67%, and Event 2 (2023) = 20%. 2) Review of proficiency testing scores from American Association of Bioanalysts (AAB) Medical Laboratory Evaluation "CMS Cumulative Scores- Regulated Analytes" dated 10/18/2022 and "Nch22Q3 Score NCH23M1 Score Nch23M2 Score" no date, confirmed the above Bacteriology scores for Urine Culture: Event 1 (2022) = 0%, Event 3 (2022) = 67%, and Event 2 (2023) = 20% 3) On 12/21/2022 at 1:13 pm, SP#1 (Technical Supervisor), confirmed the scores for Event 1/2022 (0%) and Event 3/2022 (67%) for Bacteriology and the analyte, Urine Culture. 4) On 8/21/2023 at 4:23 pm, SP#1 (Technical Supervisor), confirmed the scores for Event 2/2023 (20%) for Bacteriology and the analyte, Urine Culture. 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 document review and interview, the laboratory director failed to ensure the laboratory successfully participated in the American Association of Bioanalysts (AAB) proficiency testing (PT) program in the subspecialty of Bacteriology. The laboratory had unsatisfactory overall PT event testing scores (less than 80%) for three out of five consecutive events (1 and 3 in 2022 and 2 in 2023) in the subspecialty Bacteriology, for the analyte, Urine Culture (Refer to D6089). D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on document review and interview, the laboratory director failed to ensure the laboratory successfully participated in the American Association of Bioanalysts (AAB) proficiency testing (PT) program in the subspecialty of Bacteriology. The -- 2 of 3 -- laboratory had unsatisfactory overall PT event testing scores (less than 80%) for three out of five consecutive events (1 and 3 in 2022 and 2 in 2023) in the subspecialty Bacteriology, for the analyte, Urine Culture Findings included: 1) Review of Oscar Report 155D (Individual Laboratory Profile) indicated the following unsatisfactory scores for Bacteriology and the analyte Urine Culture: Event 1 (2022) = 0%, Event 3 (2022 ) = 67%, and Event 2 (2023) = 20%. 2) Review of proficiency testing scores from American Association of Bioanalysts (AAB), confirmed the above Bacteriology scores for Urine Culture: Event 1 (2022) = 0%, Event 3 (2022) = 67%, and Event 2 (2023) = 20% 3) On 12/21/2022 at 1:13 pm, SP#1 (Technical Supervisor), confirmed the scores for Event 1/2022 (0%) and Event 3/2022 (67%) for Bacteriology and the analyte, Urine Culture. 4) On 8/21/2023 at 4:23 pm, SP#1 (Technical Supervisor), confirmed the scores for Event 2/2023 (20%) for Bacteriology and the analyte, Urine Culture. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to successfully participate in proficiency testing (PT) for two out of three consecutive events (1 and 3 in 2022) in the subspecialty Bacteriology, for the analyte, Urine Culture (Refer to D2028). D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to successfully participate in proficiency testing (PT) for two out of three consecutive events (1 and 3 in 2022) in the subspecialty Bacteriology, for the analyte, Urine Culture. Findings include: 1) Review of Oscar Report 155D (Individual Laboratory Profile) indicated the following unsatisfactory scores for Bacteriology: Event 1 (2022) = 0% and Event 3 (2022 ) = 67%. 2) Review of proficiency testing scores from American Association of Bioanalysts (AAB), confirmed the above Bacteriology scores for Urine Culture: Event 1 (2022) = 0% and Event 3 (2022) = 67%. 3) On 12/21/2022 at 1:13 pm, SP#1 (Technical Supervisor), conformed the scores for Event 1/2022 (0%) and Event 3 /2022 (67%) for the sub-specialty Bacteriology and the analyte, Urine Culture. -- 2 of 2 --

Summary Statement of Deficiencies 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 lack of documentation and interview, the laboratory failed to establish a written policy and procedure to assess employee competency for six of six testing personnel (SP1-SP6). Findings include: 1. Review of policies and procedures provided for the survey indicated that a policy on employee competency had not been established. 2. Review of the form CMS 209 "Laboratory Personnel Report (CLIA)", signed by the laboratory director on 7/26/2022, indicated there are six employees who perform laboratory testing (SP1-SP6). 2. On 08/08/22 at 12:50 pm, upon request for a copy of the laboratory's written competency policy, SP-1 (laboratory Owner/ General Supervisor) acknowledged the laboratory did not have a written policy. 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 --