Stevens Health Services

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on July 18, 2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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: A tour of the laboratory confirmed that there was not adequate protection against all potential hazards. THE FINDINGS INCLUDE: 1. A tour of the laboratory testing area revealed that a designated clean sink, to protect against potential cross contamination of specimens and testing personnel, was not available in the testing laboratory. 2. A tour of the laboratory facility revealed that 2 out of 2 of the fire extinguishers had no evidence of inspections, to assure functionality. 3. An interview with the laboratory staff confirmed that personnel were not informed of the location of all fire extinguishers in the testing laboratory facility. 4. An interview with the laboratory staff confirmed that personnel had not been trained on the proper usage of the fire extinguishers. 5. An exit interview, with the TC, on July 18, 2025, at 2:00 pm confirmed the lack of adequate protection against all potential hazards in the testing laboratory. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an 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 -- ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: A review of 2023 - 2025 Maintenance Records, 2023- 2025 Temperature Records, and 2023 - 2025 Quality Control Records confirmed that the laboratory failed to perform routine monitoring of laboratory operations to assure quality testing. THE FINDINGS INCLUDE: 1. A review of 2023 - 2025 Maintenance Records, 2023- 2025 Temperature Records, and 2023 - 2025 Quality Control Records confirmed that there was no documentation of quality assurance procedures 2. An exit interview, with the TC, on July 18, 2025 at 2:00 pm confirmed that the laboratory failed to perform routine monitoring of laboratory operations to assure quality testing. 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: A tour of the reagent storage refrigerator, the reagent storage freezer, and the 2023 - 2025 Temperature Records, confirmed that storage requirements, set by the manufacturer, was not met. THE FINDINGS INCLUDE: 1. A review of the reagents stored in the reagent storage freezer revealed the following manufacturers set storage requirements: a. TRIAGE 5 CONTROL 1: Storage requirement of ?-20C (?-4F); b. BRT LIQUID ASSAYED CHEMISTRY + LIPID CONTROL: Storage requirement of ?-15C (?5F); c. ACCESS FREE T4 CALIBRATORS: Storage requirement of ?-20 C (?-4F); d. ACCESS FREE T4 CALIBRATORS: Storage requirement of ?-20C (?-4 F); e. BIORAD LIQUICHEK IMMUNOLOGY PLUS CONTROLS Storage requirement of -70C - -20C (-94 F - -4F); f. QUIDEL TRIAGE TOX DRUG SCREEN TEST KIT Storage requirement of 2C - 8C (35.6F - 46.4 F) was stored in the freezer; and g. THAWED BECKMAN ACCESS CALIBRATOR: Storage requirement of ?-20C (UNTHAWED) and 8C (THAWED) (-4F - 46.4F); 2. A review of the thermometer used to monitor the temperature of the freezer revealed the current temperature of 14.56F (-9.69C). 3. A review of the 2024 - 2025 Temperature Records log sheet revealed an acceptable range of -22C - -8C (-8F - 18F) for the Reagent Storage Freezer. The Reagent Storage Freezer thermometer displayed a minimum setting of -5.15F (-20.5C) and a maximum setting of 43.98F (6.7 C). 4. A review of the 2024 - 2025 Temperature Records revealed there were no refrigerator temperatures recorded for the month of January 2024 and for April 22 - 30, 2024. There were also no freezer temperatures recorded for April 22 - 30, 2024. 5. A review of Temperature Records revealed that the required storage temperature of ?-20C (?-4 F) was met only on 13 of 547 days of storage usage. 6. A review of the 2024 - 2025 Temperature logs revealed that quality assurance overview and

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 12, 2024. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory 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 -- failed to successfully participate in proficiency testing (PT) in 2 of 3 events for Iron (FE) resulting in the initial unsuccessful participation for Iron. Refer to D2096 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 CMS CASPER 155 report and review of API PT reports, the laboratory failed to demonstrate satisfactory performance in 2 of 3 testing events for Iron (FE), resulting in the initial unsuccessful participation for FE. Findings: 1. A review of Casper Report 155 disclosed the laboratory failed FE on the following: 2022 Event 3 Score 40% 2023 Event 2 Score 60% 2. A review of the laboratory's API Reports confirmed the laboratory failed Iron with the aforementioned scores. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS CASPER 155 report and review of the API reports, the laboratory director failed to provide overall management and direction for successful participation in PT. The laboratory director failed to ensure PT samples were tested as required. 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 review of the CMS CASPER Report 155 and the API 2022 event 3 and 2023 event 2 PT evaluation reports, the laboratory director failed to ensure successful PT participation in 2 of 3 testing events. Refer to D 2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on August 22, 2023. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Successful participation [proficiency testing] D6000 - 493.1403 Laboratory Director, Moderate Complexity 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 Centers for Medicare and Medicaid (CMS) CASPER 155 Report and review of the American Proficiency Institute (API) 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 -- reports, the laboratory failed to successfully participate in 3 of 5 proficiency testing events resulting in the non- initial unsuccessful participation in Cholesterol (CHOL). Findings : Refer to D 2096 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 CMS CASPER 155 report and review of API PT reports, the laboratory failed to demonstrate satisfactory performance in three of five testing events for CHOL, resulting in the non- initial unsuccessful participation for CHOL Findings: 1. Desk review of CASPER 155 reports disclosed the laboratory failed CHOL with the following scores: 2022 event 2 = 0% 2022 event 3 = 40% 2023 event 2 = 40% 2. Desk review of the laboratory's proficiency testing reports from API confirmed the laboratory failed the aforementioned analyte. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS CASPER 155 report and review of API reports, the laboratory director failed to provide overall management and direction for successful participation in PT. The laboratory director failed to ensure PT samples were tested as required. Refer to D 6016 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 review of the CMS CASPER Report 155 and the API (2022 events 2 & 3 and 2023 event 2) PT evaluation reports, the laboratory director failed to ensure successful PT participation in three of five testing events. Refer to D 2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on May 17, 2023. The facility was found to be NOT in compliance with the CLIA conditions and standards for specialties /subspecialties for 42 CFR. D5200: (Condition) General Laboratory Systems 493.1230 D6000: (Condition) Moderate Complexity Laboratory Director 493.1403 NOTE: The CMS-2567 (Statement of Deficiencies) is an official , legal document,. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on September 14, 2022 At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events (1st event of 2022 and 2nd event of 2022), 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 -- resulting in the first unsuccessful occurrence for Endocrinology #525 including: Free Thyroxine (FT4) # 545. Findings include: Refer to D 2108 D2108 ENDOCRINOLOGY CFR(s): 493.843(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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecitive events (1st and 2nd events of 2022), resulting in the first unsuccessful performance for free thyroxine (FT4) analyte # 545. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 545 Free Thyroxine on event 1 of 2022 with a score of 20% and event 2 of 2022 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed Free thyroxine on Event 1 and 2 of 2022 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive events (1st and 2nd events of 2022), resulting in the first unsuccessful occurrence for Free Thyroxine, analyte # 545. Findings include: 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 proficiency testing desk review using the Centers for Medicare and -- 2 of 3 -- Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive events (1st and 2nd events of 2022), resulting in the first unsuccessful occurrence for Free Thyroxine (FT4) analyte # 545. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #545 , FT4 on event 1 of 2022 with a score of 20% and event 2 of 2022 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed FT4 on Events 1 and 2 of 2022, resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on July 28, 2021. Condition and Standard level Citations were found. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the 2020, American Proficiency Institute (API) Proficiency Testing (PT) documents and the 2020 Order Confirmation, the laboratory failed to register for PT. The order confirmation states that the PT was ordered on June 11, 2020. The laboratory missed the first event for Hematology and the first and second event for Chemistry, there was no evidence supporting attempts to order off schedule events to cover the missed events. REFERENCE: D2089, D2123, D2096 D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT), documents, the 2020 Order Confirmation, and Staff Interview, the laboratory failed to participate in the speciality of Chemistry for events 1 and 2 of 2020. Findings: 1. API PT document review and 2020 Order Confirmation confirmed the laboratory had not ordered the 2020 PT samples until June 11, 2020. The 1rst and 2nd events for the Chemistry speciality were missed. The laboratory did not participate in the 1rst or 2nd event for the Chemistry speciality and there was no documentation that the laboratory ordered off schedule samples for the missed events. 2. Interview with the TC, on July 28, 2021, at approximately 2:16 pm in the upstairs conference room confirmed the aforementioned statement 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 American Proficiency Institute (API), Proficiency Testing (PT) documents, and staff interview, the laboratory failed to score acceptable results in two consecutive events for the speciality Chemistry in 2020. The laboratory failed to order the API, PT documents in time to complete events 1 and 2. There was no documentation that the laboratory ordered off schedule samples for the missed events. Findings: 1. Review of the APT PT documents confirmed the laboratory failed to score acceptable results in two consecutive events (events 1 and 2 ) in 2020, the for specialty Chemistry. The following subspecialty test did not receive acceptable scores: 0255-ALT/SGPT 0265-ALBUMIN 0275-ALK PHOS 0295-AST/SGOT 0305- BILI,TOTAL unsuccessful in three out of five events -2020, events one and two and 2021 event 2 score of 40% 0345-CALCIUM, TOTAL 0355-CHLORIDE 0365- CHOLESTEROL, TOTAL unsuccessful in 4 events-2020, events one, two, and three, and 2020 events 1 and 2 0375-CHOLESTEROL,HDL unsuccessful in 4 events-2020, events one, two, and three, and 2020 events 1 and 2 0385- CK, TOTAL 0395-CK, ISO 0405-CREATININE 0415-GLUCOSE(NON-WAIVED) unsuccessful in three out of five events-2020, events one and two, and 2021 event 2 score of 40% 0425- IRON, TOTAL 0455-MAGNESIUM 0465-POTASSIUM 0475-SODIUM 0485- TOTAL PROTEIN 0495-TRIGLYCERIDE 0505-BLOOD UREA NITROGEN 0545- FREE THYROXIN 0585-THYROID STIMULATING HORMONE 2. Staff interview with the TC, on July 28, 2021, at approximately 2:10 pm, confirmed the above aforementioned statement. \ D2123 HEMATOLOGY -- 2 of 6 -- CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT), documents, the 2020 Order Confirmation, and Staff Interview, the laboratory failed to participate in the speciality Hematology event 1 of 2020. Findings: 1. API PT document review and 2020 Order Confirmation, showed that the laboratory had not ordered the 2020 PT samples until June 11, 2020. The first event for the speciality Hematology were missed. The laboratory did not participate in the 1rst event for the specialty Hematology and there was no documentation that the laboratory ordered off schedule samples for the missed events. 2. Interview with the TC, on July 28, 2021, at approximately 2:15 pm, in the upstairs conference room, confirmed the aforementioned statement. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the Calibration and Quality Control documents for the Hematology Analyzer, (Sysmex) XP-300 for 2019 and 2020, and review of the Calibration / Verification and Quality Control documents for the Medica (EASYRA) for 2019 and 2020, the Laboratory failed to monitor and evaluate the overall quality of the general laboratory systems for each speciality and subspecialty of testing performed. REFERENCE: D5439, D5447, D5211, D5211 D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API), Proficiency Testing -- 3 of 6 -- (PT), documents and staff interview, the laboratory failed to document that the all PT evaluation reports were signed as reviewed by the Laboratory Director (LD) or the Technical Consultant (TC) for 2019, 2020, and 2021. Findings: 1. Review of the API, PT documents for 2019, 2020, and 2021, the laboratory failed to document review of the following events: 2019, Chemistry Core, event 3 2020, Hematology, event 3 2020, Chemistry Core, event 3 2021, Chemistry Core, event 2 2. Staff interview with the TC, on July 28, 2021, at approximately 2:15 pm, in the upstairs conference room, confirmed the above aforementioned statement. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) documents for 2019, 2020, and 2021, and staff interview, the laboratory failed to document

Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on August 8, 2019. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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: Tour of the laboratory and staff interview, showed that the laboratory did not have sterile solutions in the eyewash bottles, hanging on the wall. Findings: 1. During a tour of the laboratory, it was observed that the eyewash station bottles were empty and did not have sterile solution in either of the two bottles. It was also observed that the eyewash station bottle set was not attached to the wall properly and would fall off the wall if they were touched. 2. Interview with the Laboratory Director and Technical Consultant, on August 8, 2019, at approximately 12:50 pm in the conference room confirmed that the eyewash station bottle set was empty. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 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 -- This STANDARD is not met as evidenced by: Based on review of the Laboratory operating manuals, and staff interview, the laboratory did not have written Quality Assurance policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems requirements. Findings: 1. Review of the operating manuals showed that there was not a Quality Assurance policy and procedure for an ongoing mechanism to monitor, assess, and correct problems in the general laboratory system. 2. Staff interview with the Laboratory Director and Technical Consultant, on August 8, 2019, at approximately 12:53pm in the conference room, confirmed that the laboratory did not have a Quality Assurance Policy and Procedure. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)