Sun Clinical Laboratories

Summary Statement of Deficiencies 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 the surveyor's observation during the Cytology laboratory's tour and interviews with the testing personnel (TP), the laboratory failed to label staining reagents used in the laboratory to indicate the received date, opening, preparation, and expiration dates when such materials are used. The findings include: 1. Based on the surveyor's observation during the Cytology laboratory tour on July 9, 2025, at approximately 4:15 p.m. no received date, opening date, and preparation labels were used or documented Cytology staining reagents: alcohols, OG-6, EA-50, D- Limonene, Cytoseal, etc. 2. The laboratory's TP affirmed in an interview conducted on July 9, 2025, at approximately 4:20 p.m. that the Cytology reagents mentioned in statement #1 were not labeled properly with the received date, opening, preparation, and/or expiration date. 3. Based on the laboratory's annual testing declaration submitted at the time of the survey, the laboratory analyzed approximately 33,599 tests for Cytology using staining reagents not labeled properly. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, 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 -- and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on the surveyor's direct observation during the tour of the Cytology laboratory, it was determined that the laboratory director failed to provide effective preanalytical direction of the Cytology laboratory. See D5415. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed 1/9/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; Laboratory Director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and AAB-Medical Laboratory Evaluation records (2022-3, 2023- 1, and 2023-2), the laboratory failed to successfully participate in a proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the analyte Digoxin resulting in unsuccessful performances. See D2118. D2118 TOXICOLOGY CFR(s): 493.845(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation report, the laboratory failed to achieve satisfactory performance for three consecutive events (2022-3, 2023-1, and 2023-2) for Digoxin (specialty Toxicology): The finding include: 1. Digoxin 20% - 2022 third testing event; Digoxin 60% - 2023 first testing event; Digoxin 60% - 2023 second testing event. A review of the 2022 & 2023 scores from American Proficiency Institute (API) confirmed the above findings. 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 0155D report and AAB- Medical Laboratory Evualuation records for 2022-3, 2023-1, and 2023-2 events, 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) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and AAB- Medical Laboratory Evaluation records for 2022-3, 2023-1, and 2023-2 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2118. -- 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Toxicology constituting unsuccessful PT performance. (See D2118) 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 -- 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Digoxin, as follows: 2022 Q3 2023 Q1 Digoxin 20% 60% Q1 = First testing event Q3 = Third testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT resulted in an initial unsuccessful performance for the analyte, Digoxin.. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: For the analyte Digoxin, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance (see D2016 and D2118) -- 2 of 2 --

Summary Statement of Deficiencies D2109 TOXICOLOGY CFR(s): 493.845(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 review of second quarter event in 2022 (Q2-2022) and third quarter event 2022 (Q3-2022) of the American Association of Bioanalysts (AAB) proficiency testing (PT) records, random patient sampling test results, and interview with the laboratory director (LD) and technical supervisors (TS); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in the Therapeutic Drug Monitoring panels. The findings included: 1. The AAB reported for Q2-2022, an unsatisfactory PT score for Phenytoin analyte of 60% and an unsatisfactory PT score for Digoxin of 20%. 2. The LD and TS affirmed on May 30, 2023, at approximately 11:30 a.m. that the laboratory received the above unsatisfactory proficiency test scores. 3. Based on the test volume declaration signed by the laboratory director on 5/15/2023 the laboratory tested 2,671 Toxicology sample tests which included both analytes Digoxin and Phenytoin. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on observation on the lack of calibrated thermometers in the refrigerators, freezers, heating blocks, etc. to verify digital temperature readings, missing temperature checks during weekend days, and interview with the technical supervisors (TS) and technical consultant (TC) it was determined that the laboratory failed to monitor the digital temperature readings of equipment essential for proper storage of reagents and specimens that adversely affect patient test results. The findings included: 1. On the day of the survey, May 30, 2023, at approximately 2:30 p.m. based on the surveyors' observation and interview with the TS and TC; the laboratory failed to have calibrated thermometers on the refrigerators, freezers, etc., that verify accurate digital thermometers readings which affect reagents and patients' samples testing. 2. The TS and TC confirmed on 03/30/2023, at approximately 3:00 p.m. that the laboratory has no calibrated thermometers in the refrigerators, freezer, heating blocks, etc. to verify digital temperature readings. 3. Based on the laboratory's submitted testing declaration volume, the laboratory tested and reported approximately 8,710,830 samples annually. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of patient test results records, laboratory's policy and procedure manual, and interviews with the technical supervisors (TS) and technical consultant (TC); it was determined that the laboratory failed to establish written policies and procedures for turn-around-times of each test results as part of an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the post analytic systems. The findings included: 1. The laboratory did not have a written policy or procedure for turn-around-times for all the test performed in the laboratory. 2. Based on the laboratory's annual test declaration submitted and signed by the laboratory director on May 15, 2023; the laboratory analyzed and reported 8,710,830 test results for which there were no-turn-around times established policy to monitor timely test results reporting during the postanalytic phase of testing. 3. The TS affirmed on May 30, 2023, and May 31, 2023, at approximately 2:30 p.m. that the laboratory did not have a written policy or procedure for monitoring turn-around-times for each test performed in the laboratory. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on review of the laboratory's records for policies and procedures, patient review records, proficiency testing reports, direct observation by the surveyors during the lab tour, and interviews with the technical supervisors, technical consultant, and testing personnel on May 30 and May 31, 2023; it was determined that the laboratory director failed to ensure that several aspects of the preanalytic, analytic, and postanalytic phases of laboratory testing were monitored. See D2109, D5413, and D5891. -- 3 of 3 --

Summary Statement of Deficiencies D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews it was determined that the laboratory failed to establish written policies and procedures for the evaluation of four of six annual statistics (refer to D5629); failed to establish written policies and procedures for the establishment of individual workload limits (refer to D5633); failed to reassess workload limits at least every six months (refer to D5637); failed to follow written policies and procedures to ensure the laboratory maintained records of the total number of hours spent examining slides per 24-hour period (refer to D5645); and failed to establish written policies and procedures to ensure corrected test reports indicated the basis for the correction on the test report (refer to D5659). D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures for an annual statistical evaluation of four of six required cytology statistics. The laboratory failed to document four of six required annual statistics for 2020 and 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an annual statistical evaluation of four of six required cytology statistics. Statistics include: - The number of patient cases reported by diagnosis, including the number reported as unsatisfactory; - Gynecologic cases with a diagnosis of high grade squamous intraepithelial lesion (HSIL), adenocarcinoma or other malignant neoplasm for which histology results were available for comparison; - Gynecologic cases where cytology and histology are discrepant; - Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low grade intraepithelial lesion (LSIL), HSIL, adenocarcinoma or other malignant neoplasms. 2. The Survey Team requested and the laboratory failed to provide four of six required annual statistics for 2020 and 2021. Statistics include: - The number of patient cases reported by diagnosis, including the number reported as unsatisfactory; - Gynecologic cases with a diagnosis of HSIL, adenocarcinoma or other malignant neoplasm for which histology results were available for comparison; - Gynecologic cases where cytology and histology are discrepant; - Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as LSIL, HSIL, adenocarcinoma or other malignant neoplasms. 3. During an interview on March 2, 2022 at 11:45 AM, these findings were confirmed by the Laboratory Director/Technical Supervisor . D5633 CYTOLOGY CFR(s): 493.1274(d)(1) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1) The technical supervisor establishes a maximum workload limit for each individual who performs primary screening. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory documents and interview it was determined that the laboratory failed to establish written policies and procedures to ensure individual maximum workload limits were established. The laboratory failed to ensure workload limits were established for five of five cytotechnologists and one of one Laboratory Director/Technical Supervisors when performing primary screening for 2020, 2021 and to the date of the survey in 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure the Technical Supervisor established individual maximum workload limits for five of five cytotechnologists and one of one Laboratory Director/Technical Supervisors who performed primary screening. 2. The Survey Team requested and the laboratory failed to provide individual maximum workload limits for five of five cytotechnologists and one of one Laboratory Director /Technical Supervisors for 2020, 2021 and to the date of the survey in 2022. -- 2 of 5 -- Cytotechnologists include: -Cytotechnologist #1 -Cytotechnologist #2 - Cytotechnologist #3 -Cytotechnologist #4 -Cytotechnologist #5 Technical Supervisors include: -Laboratory Director/Technical Supervisor 3. During an interview on March 2, 2022 at 11:45 AM, these findings were confirmed by the Laboratory Director /Technical Supervisor. D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. This STANDARD is not met as evidenced by: A. Based on review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to reassess and adjust when necessary a maximum workload limit at least every six months for the Laboratory Director/Technical Supervisor. The laboratory failed to reassess workload limits for one of one Laboratory Director /Technical Supervisor who performed primary screening of nongynecologic cytology specimens in 2020 and 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail how the Laboratory Director/Technical Supervisor's workload limits would be reassessed at least every six months and adjusted when necessary. 2. The Survey Team requested and the laboratory failed to provide a reassessment of a workload limit for the Laboratory Director/Technical Supervisor in 2020 and 2021. 3. During an interview on March 2, 2022 at 11:45 AM, these findings were confirmed by the Laboratory Director/Technical Supervisor. B. Based on review of laboratory policies and procedures, laboratory records and interview it was determined that the laboratory failed to follow the procedure for reassessment of workload limits for four of five cytotechnologists every six months in 2020 and 2021. Findings include: 1. The laboratory failed to follow the written procedure CYTOTECHNOLOGIST SEMI- ANNUAL REVIEW, PERFORMANCE EVALUATION which stated: "These standards are based on CLIA 88 guidelines which require documentation of established workloads, results of all slides reviewed, proof of six-month reassessment and adjustment ..." 2. The cytotechnologist's semi-annual, performance evaluation forms from 2020 and 2021 did not include reassessed workload limits for four of five cytotechnologists. Cytotechnologists and dates without reassessed workload limits include: - General Supervisor/Cytotechnologist #1 August-December 2020 - Cytotechnologist #2 August-December 2020 August-December 2021 - Cytotechnologist #3 August-December 2020 January-July 2021 August-December 2021 - Cytotechnologist #4 August-December 2021 3. During an interview on March 2, 2022 at 11:45 AM, these findings were confirmed by the Laboratory Director /Technical Supervisor. D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of -- 3 of 5 -- the site or laboratory. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interview it was determined that the laboratory failed to follow written policies and procedures to ensure that the laboratory maintained records of the total number of hours one of one Laboratory Director/Technical Supervisors spent examining slides per 24-hour period for 2020, 2021 and to the date of the survey in 2022. Findings include: 1. The laboratory failed to follow the procedure GYN AND NON-GYN PRIMARY REVIEW WORKLOAD SURVEILLANCE PROCEDURE, which stated: "Cytotechnologists and pathologists doing primary screening are given Workload Surveillance charts on which they are to write the date, hours of review and number of primary review cases". 2. The Laboratory Director/Technical Supervisor's monthly Workload Surveillance charts from the years 2020, 2021 and to the date of the survey in 2022 failed to include the hours spent examining slides. 3. During an interview on March 2, 2022 at 11:45 AM, these findings were confirmed by the Laboratory Director /Technical Supervisor. D5659 CYTOLOGY CFR(s): 493.1274(e)(6) (e) The laboratory must establish and follow written policies and procedures that ensure the following: (e)(6) Corrected reports issued by the laboratory indicate the basis for correction. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interview it was determined that the laboratory failed to establish a written policy or procedure to indicate the basis for the correction on the test reports and failed to follow the laboratory procedure for corrected test reports. The laboratory failed to indicate the basis for the correction on two of two corrected test reports from January and February, 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide a written policy or procedure for indicating the basis for the correction on a corrected test report. 2. The laboratory failed to follow the written procedure AMENDED PAP SMEAR REPORT PROCEDURE which stated: "The new report will contain the words "THIS IS AN AMENDED REPORT". Under this phrase there will be the words "PREVIOUSLY REPORTED AS...". 3. Two of two reports were identified as not having a statement as to why they were corrected and as not following the laboratory procedure policy to correct the reports. Reports include: - 220045270 - 220048360 4. During an interview on March 2, 2022 at 11:45 AM, these findings were confirmed by the Laboratory Director/Technical Supervisor. D6130 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(c)(2)(3) (c) In cytology, the technical supervisor or the individual qualified under 493.1449(k) (2)-- (c)(2) Must establish the workload limit for each individual examining slides and (c)(3) Must reassess the workload limit for each individual examining slides at least every 6 months and adjust as necessary. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on review of written policies and procedures, laboratory records and interview it was determined that the Technical Supervisor failed to establish individual workload limits and to reassess the workload limits in 2020 and 2021 for four of five cytotechnologists and one of one Technical Supervisors in 2020, 2021 and to the date of the survey in 2022. Cross refer to D5633 and D5637 Finding include: 1. The Technical Supervisor failed to establish individual workload limits for five of five cytotechnologists and one of one Technical Supervisors in 2020, 2021 and to the date of the survey in 2022. 2. The Technical Supervisor failed to reassess workload limits for four of five cytotechnologists and one of one Laboratory Director/Technical Supervisors in 2020 and 2021. 3. During an interview on March 2, 2022 at 11:45 AM, these findings were confirmed by the Laboratory Director/Technical Supervisor. D6133 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(c)(6) In cytology, the technical supervisor or the individual qualified under 439.1449(k)(2), if responsible for screening cytology slide preparations, must document the number of cytology slides screened in 24 hours and the number of hours devoted during each 24- hour period to screening cytology slides. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interview it was determined that one of one Technical Supervisors failed to document the number of hours devoted to performing primary screening of nongynecologic cytology slides during each 24-hour period in 2020, 2021 and to the date of survey in 2022. Cross refer to D5645 Findings include: 1. The Laboratory Director/Technical Supervisor failed to provide records of the total number of hours spent screening nongynecologic cytology slides during each 24-hour period in 2020, 2021 and to the date of the survey in 2022. 2. During an interview on March 2, 2022 at 11:45 AM, these findings were confirmed by the Laboratory Director/Technical Supervisor. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 5 of 5 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of General Immunology constituting unsuccessful PT performance. (See D2084) 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 -- D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, IGE, resulting in an "initial" (first) unsuccessful performance. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, IGE, as follows: 2021 Q1 2021 Q2 IGE 0% 20% Q1 = First Testing Event Q2 = Second Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, IGE. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, IGE, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (see D2016 and D2084) -- 2 of 2 --

Summary Statement of Deficiencies D2047 PARASITOLOGY CFR(s): 493.829(a) 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 review of the second quarter (Q2-2018) of the American Associations of Bioanalysts (AAB) proficiency testing records and interview with the Technical supervisors, it was determined; that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Parasitology (Identification, ID). The findings included: a. AAB reported an unsatisfactory score of 50% for Parasitlogy (ID). b. Based on the laboratory's annual testing declaration submitted for 2018-2019, the laboratory analyzed and reported 1,625 for Parasitlogy tests that results cannot be assured. c. The Technical supervisors confirmed (7/24/2019, 1600) that the laboratory received the above unsatisfactory proficiency testing score. D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the first quarter (Q1-2019) of the American Associations of Bioanalysts (AAB) proficiency testing records and interview with the Technical supervisors, it was determined; that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Rubella IgM analyte. The findings included: a. AAB reported an unsatisfactory score of 67% for Rubella IgM. b. Based on the 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 -- laboratory's annual testing declaration submitted for 2018-2019, the laboratory analyzed and reported 7,334 for Rubella tests that results cannot be assured. c. The Technical supervisors confirmed (7/24/2019, 1600) that the laboratory received the above unsatisfactory proficiency testing score. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and interview with the testing personnel and Technical supervisors, it was determined; that the laboratory lacks a flammable cabinet for storage chemicals and toxic reagents. The laboratory failed to observe Safety procedures to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. The findings included: a. The laboratory lacked storage of; Laboratory-grade flammable alcohols, Xylene, and staining reagents (Parasitology, Cytology, Hematology and Chemistry), including but not limited to hematoxylin and eosin. b. Patients pathology reports revealed that biopsy specimens were received in Formalin, a highly toxic liquid mixture of formaldehyde, methyl alcohol, and other soluble chemicals. c. Based on the laboratory's annual testing volume declaration submitted for 2018-2019, the laboratory analyzed and reported; Cytology and Histopathology 54,974, Parasitology 130, and Hematology 1,257,266 which uses flammable chemical s that are not stored properly. d. The technical supervisors confirmed (7/24/2019, 1600) that the laboratory did not have a flammable cabinet for chemical and biochemical storage. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing records and interview with the Technical supervisors it was determined that; the laboratory failed to verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance. The findings included: a. Q1-2019, AAB reported an artificial 100% proficiency score for the following analytes. Homocysteine Spec.: Reported Grading Mean: Value: Range: 1# 3.9 4.2-9.2 6.68 Note: True score for Homocysteine should have been 50%. Protein, Total-Urine Chemistry Spec.: Reported Grading Mean Value: Range: 1? 8 8.1-13.5 10.79 Note: True score for Protein, Total-Urine Chemistry should have been 50%. Uric Acid-Urine Chemistry Spec.: Reported Grading Mean Value: Range: 1? 3.7 4.1-5.8 4.96 2? 5.2 5.3-7.5 6.42 Note: True score for Uric Acid- Urine Chemistry should have been 0%. Chloride-Urine Chemistry Spec.: Reported Grading Mean -- 2 of 7 -- Value: Range: 1? 74 76-84 80.1 2* 160 163-180 171.5 Note: True score for Chloride- Urine Chemistry should have been 0%. Sodium-Urine Chemistry Spec.: Reported Grading Mean Value: Range: 1* 92 83-91 86.9 b. Q2-2019, AAB reported an artificial 100% proficiency score for the following analytes. Uric Acid-Urine Chemistry Spec.: Reported Grading Mean Value: Range: 2# 6.4 6.5-9.1 7.79 Note: True score for Uric Acid- Urine Chemistry should have been 50%. Bilirubin, Direct- Chemistry Spec.: Reported Grading Mean Value: Range: 3# 0.8 1.0-1.8 1.38 4# 0.8 1.0-1.8 1.41 Note: True score for Bilirubin, Direct Chemistry should have been 60%. c. Q3-2018, AAB reported an artificial 100% proficiency score for the following analytes: CMV- Virology Spec.: Reported Intended Value: Result: 3? Negative Positive Note: True score for CMV 70%. Abbreviation: Cytomegalovirus (CMV) d. The AAB has the following footnotes: ?= This score may not truly evaluate performance for these specimens which were not graded because of a lack of participants consensus. #= this method was not grade due to an insufficient number of peer respondents. No appropriate default grouping was available. The listed ranges should provide a reasonable guide to your performance, however exercise caution in evaluating your results. *= Out of grading range or incorrect respone. e. The testing personnel confirmed (7/24/2019, 1600) that the laboratory received the above artificial 100% scores and that the laboratory did not have a