Evergreen Medical Center

Summary Statement of Deficiencies D0000 The following deficiencies were cited as a result of a complaint survey conducted on 12/8/2025 after the occurrence of a possible Immediate Jeopardy incident. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the General Supervisor (GS), the Technical Consultant/Supervisor (TC/TS) failed to ensure Testing Personnel (TP) listed on the CMS-209 (Laboratory Personnel Report) had competency assessments which included the six minimal regulatory requirements. The surveyor noted five of the six requirements were missing from the annual and semi- annual assessments. The findings include: 1. A review of the 2024-2025 personnel records revealed the TP competency assessment for the Immunohematology-Blood Bank specialty had no documentation on five of the six minimal regulatory requirements. The surveyor noted the missing requirements were as follows: (1) Monitoring the recording and reporting of test results, (2) Review of intermediate test results of worksheets, quality control records, proficiency testing results, and preventive maintenance results. (3) Direct observation of performance of instrument maintenance and function checks. (4) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. (5) Assessment of problem-solving skills. 2. The GS confirmed the above findings during the exit conference on 12-08-2025 at 4:22 PM. D6103 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1445(e)(13) (e)(13) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on a review of the Testing Personnel (TP) competency assessment records and an interview with the General Supervisor (GS), the Laboratory Director (LD) and the General Supervisor (GS), the laboratory failed to perform competency assessments as per laboratory policy and procedures for 11 of the 11 Immunohematology-Blood Bank (BB) TP. The findings include: 1. A review of the TP competency assessment record revealed the TP completed their own annual competency assessment for BB testing. In addition, the completed form did not include the grade achieved during the evaluation and there were no established procedures for monitoring when remedial training was required. 2. During exit conference on 12-08-2025 at 4:22 PM, the GS confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of off-site proficiency testing (PT) desk review of scores in the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and verified with the laboratory's proficiency testing provider, AAB-Medical Laboratory Evaluation (AAB- MLE). The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: 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: 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 -- Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing in Triiodothyronine (T3) Uptake, an analytes in the Subspecialty of Endocrinology. The laboratory failed two consecutive PT events in 2025, resulting in initial unsuccessful proficiency testing performance. Refer to D2107. . D2107 ENDOCRINOLOGY CFR(s): 493.843(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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Triiodothyronine (T3) Uptake. The laboratory failed two consecutive 2025 PT events, resulting in initial unsuccessful proficiency testing performance. The findings include: 1. A review of the CASPER Reports revealed the laboratory received failing scores for T3 Uptake in two consecutive API PT events, as follows: A) 2025 Core Chemistry Event #1: T3 Uptake 0 % B) 2025 Core Chemistry Event #2: T3 Uptake 0 % 2. A review of the laboratory's proficiency testing evaluation reports from the API website confirmed these 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 off-site proficiency testing desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. 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: -- 2 of 3 -- Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program for Triiodothyronine (T3) Uptake for two consecutive 2025 PT events. Refer to D2107. -- 3 of 3 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on a review of maintenance records, temperature records, Diesse Erythrocyte Sedimentation Rate (ESR) Quality Control (QC) records, Medtox Diagnostics drugs of abuse (DOA) QC records, Quidel Triage QC records, serum Human Chorionic Gonadotropin (HCG) QC records, Beckman Coulter Access 2 immunology QC records, and an interview with the General Supervisor (GS) and Technical Consultant (TC), the laboratory failed to retain documentation for two years. This was noted for eight of twelve months in 2023 and two days of one month reviewed in 2024. The findings include: 1. A review of April through December 2023 documentation revealed no evidence of: a) Maintenance for the Beckman Coulter AU 700 Chemistry analyzer, Beckman Coulter Access 2 Immunology analyzer, ACL Elite Coagulation analyzer, and BactecFX40 Microbiology analyzer. b) Temperature records. c) Diesse ESR QC records. d) Medtox Diagnostics DOA QC records. e) Quidel Triage D-dimer and Cardiac QC records. f) Serum hCG QC records. 2. A review of the Beckman Coulter Access 2 Quality Control (QC) records for June 2024 revealed no QC documentation for 6/6/2024 and 6/12/2024. 3. During an interview on 4-23-2025 at 2: 57 PM, the GS and TC confirmed the 2023 documentation was stored by the previous Laboratory Manager and could not be located during the time of the survey; and the Access 2 can only go back to July 2024 QC records. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 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 -- 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 a review of the lack of 2023 documentation, Blood Bank Quality Control (QC) material, maintenance records, calibration records, QC records, and interviews with the General Supervisor (GS) and Technical Consultant (TC), the Laboratory failed to ensure: A) Retention of documentation for 2 years (refer to D 3031). B) QC material was not expired prior to patient testing (refer to D 5417). C) Weekly, bi- weekly, and monthly maintenance was documented (refer to D 5429). D) Calibration verification was performed and documented (refer to D 5439). E) A procedure was in place that monitors the accuracy and precision of test performance over time (refer to D 5441). F) Two control materials of different concentration were within the manufacturer's ranges for each day of patient testing (refer to D 5447). . D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of the Blood Bank Quality Control (QC) records, QC Blood Bank policy, and an interview with the General Supervisor (GS) and Technical Consultant (TC), the laboratory used expired QC material. The surveyor noted the laboratory utilized expired Screening Cells prior to patient testing for three days in 2024. The findings include: 1. A review of the Blood Bank QC records revealed Screening Cells lot # VSS562 expired 7/9/2024 and was utilized on 7/10/24-7/12/24; 6 patients were affected during this time. 2. A further review of the QC Blood Bank policy revealed, "No expired reagent will be used." 3. During an interview on 4-24-2025, at 12:44 PM, the GS was given permission by the Laboratory Director to utilize expired Screening Cells until new material was received. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Beckman Coulter (BC) AU 700 maintenance records, BC Access 2 maintenance records, ACL Elite maintenance records, BactecFX40 maintenance records, Blood Bank Refrigerator alarm checks, and an interview with the General Supervisor (GS) and Technical Consultant (TC), the Laboratory failed to -- 2 of 5 -- document the following maintenance during 2023, 2024 and/or 2025: 1) BC AU700 Monthly; 4 months in 2024, 2) BC Access 2 Weekly; 1 month in 2024 and 2 months in 2025, 3) ACL Elite Weekly, Bi-weekly, and Monthly; Weekly 2 months in 2024, Bi-weekly and Monthly 8 of 12 months in 2024, 4) BactecFX40 Monthly; 3 months in 2024, 5) Blood Bank Refrigerator alarm checks Monthly; no documentation from the previous survey (3-16-2023) to the current survey (4-24-2025). The findings include: 1. A review of the maintenance records revealed no evidence of documentation for the following: a) BC AU700 Monthly maintenance; April, July, August, and October 2024. b) BC Access 2 Weekly maintenance; December 2024, January and February 2025. c) ACL Elite: 1) Weekly maintenance; May and December 2024. 2) Bi-weekly maintenance; March, May, June, August, September, October, November, and December 2024. 3) Monthly maintenance; January, February, May, June, August, September, November, and December 2024. d) BactecFX40 Monthly maintenance; January, May, and July 2024. e) Blood Bank Refrigerator alarm checks Monthly; no documentation from the previous survey (3-16-2023) to the current survey (4-24- 2025). 2. During an interview on 4-23-2025, at 2:57 PM, the GS and TC confirmed the maintenance was performed but not documented. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Respiratory calibration verification (CV) records, Chemistry CV records, the Laboratory Quality Assurance Plan, and an interview with the GS (General Supervisor) and TC (Technical Consultant), the Laboratory failed to perform CV on the IL GEM Premier 3500 Arterial Blood Gas (ABG) respiratory analyzer and Beckman Coulter (BC) AU 700 chemistry analyzer every six months as per the laboratory policy. This was noted for one of two 2024 CV's missed for respiratory and chemistry since the previous survey (3-16-2023). The findings include: 1. A review of the IL GEM respiratory CV records revealed a CV performed on 10/31/2023 and then almost 12 months later on 10/2/2024. There was no documentation of CV the first half of 2022. 2. A review of the BC 700 AU CV records revealed no evidence of a CV performed and documented since the previous survey on 3-16-2023. 3. A further review of the Laboratory Quality Assurance Plan revealed, "5. Calibrations are done according to the manufacturer's recommendations and at least every six months." 2. -- 3 of 5 -- During an interview on 4-24-2025, at 11:01 AM, the GS and TC confirmed CV's are performed every 6 months and the CV due in April 2024 was not performed. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on a review of Beckman Coulter (BC) DxC 700 AU Chemistry analyzer, BC Access 2 Immunology analyzer, ACL Elite Coagulation analyzer, Sysmex XN 1000 and XN 550 Hematology Quality Control (QC) records and an interview with the General Supervisor (GS), the laboratory failed to have a procedure in place that monitors the accuracy and precision of test performance over time. This was noted since the previous survey (3-16-2023) to the current survey (4-23-2025). The findings include: 1. A review of BC DxC700 AU, BC Access 2, ACL Elite, Sysmex XN 1000 and 550 QC records revealed only raw data from the instrument. No evidence of Levy Jennings charts or peer group data was available for review at the time of survey. 2. During an interview on 4-24-2025 at 1:37 PM, the Surveyor inquired about the review of Levy Jennings charts for the Hematology, Chemistry, Coagulation, and Immunology analyzers. The GS confirmed that the laboratory was not monitoring Levy Jennings charts for shifts or trends for those testing systems. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on a review of the IL ACL Elite coagulation analyzer quality control (QC) records, patient test records, and an interview with the General Supervisor (GS) and Technical Consultant (TC), the laboratory failed to analyze two control materials of different concentration for each day of patient testing. This was noted for one out of thirty one days reviewed in July 2023. The findings include: 1. A review of the ACL coagulation QC records revealed on 7-27-2023 Partial Thromboplastin Time (PTT) level 1 was out of manufacturer's ranges; 2 patients were affected. 2. During an interview on 4-24-2025 at 1:37 PM, the GS confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the General Supervisor (GS) and Technical Consultant (TC), the previous TC failed to ensure all testing personnel had documentation of annual competency assessments. The surveyor noted no documentation of the 2023 annual competency assessment for two of nine testing personnel listed on the CMS-209 (Laboratory Personnel Report). The findings include: 1. A review of the personnel records revealed no evidence of 2023 annual competency documentation for Testing Personnel #4 and Testing Personnel #6. 2. During an interview on 4-23-2025, at 5:00 PM, the GS and TC confirmed the above findings. -- 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 a review of the CMS (Centers for Medicare and Medicaid Services) CASPER report, API (American Proficiency Institute) proficiency testing evaluations, and an interview, the laboratory failed to successfully participate in Toxicology testing for Theophylline, Tobramycin and Valproic Acid. The laboratory failed two of three consecutive testing events, Event #2, 2022 and Event #1, 2023 (Failure to Participate). These failures result in the laboratory's initial unsuccessful participation. The findings include: Refer to D2118. D2118 TOXICOLOGY 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 -- CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CMS (Centers for Medicare and Medicaid Services) CASPER report, API (American Proficiency Institute) proficiency testing evaluations, and an interview, the laboratory failed to perform satisfactorily in Toxicology testing for Theophylline, Tobramycin and Valproic Acid for two of three consecutive testing events, Event #2, 2022 and Event #1, 2023 (Failure to Participate). The findings include: 1. A review of the CASPER report revealed the laboratory scored the following: Event #2, 2022 Event #1, 2023 Theophylline = 60 % 0 % Tobramycin = 60% 0 % Valproic Acid = 60 % 0 % 2. The technical consultant confirmed in an interview on 3/15/2023 at 3:00 PM, the laboratory failed to submit their results timely for grading for Chemistry (Toxicology), Event #1, 2023. 3. A review of the API proficiency testing evaluations confirmed the above noted failures. -- 2 of 2 --

Summary Statement of Deficiencies 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 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 a review of Proficiency Testing (PT) records and an interview with the Technical Consultant, the laboratory failed to participate in Proficiency Testing for Routine Chemistry. This was noted for one out of four Chemistry events reviewed from November 2021 to the date of the current survey, 3/16/2023. The findings include: 1. A review of American Proficiency Institute PT records revealed the laboratory scored 0% on all analytes for 2023 Chemistry 1st due to failure to submit results within the time frame established by the PT provider. 2. During an interview on 3/15/2023 at 3:00 PM, the Technical Consultant confirmed the laboratory failed to submit their results under previous laboratory management. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of Calibration Verification (C/V) records, a review of Policies and Procedures, and an interview with the Technical Consultant, the laboratory failed to perform Calibration Verifications on the Beckman Coulter DxC 700 AU at least every six month as per CLIA regulations. The findings include: 1. A review of Calibration Verification records revealed the following: a) Uric Acid, Cholesterol, Blood Urea Nitrogen (BUN), Triglyceride, Phosphorus, Magnesium, Glucose, Creatinine, Calcium, Total Iron, Ammonia - C/V performed 5/22/22. No documentation of a C/V for the second half of 2022 was found for these analytes b) Total Iron, Ammonia, Sodium, Potassium, Chloride, Ethanol, Total Protein, Albumin, Direct Bilirubin, Total Bilirubin, Alkaline Phosphatase (ALP), Aspartate Transaminase (AST), Lipase, Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), Creatinine Kinase (CK), Amylase, Alanine Transaminase (ALT) - C/V performed 12/13/22. No documentation of a C/V for the first half of 2022 was found for these analytes. 2. A review of Policies and Procedures revealed under section "Calibration Verification", "...Calibration Verification is performed every six months.." 3. During an interview on 3/16/2023 at 9:45 AM, the Technical Consultant confirmed the above findings. 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-- (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 a review of Quality Control records, patient log records, and an interview with the Technical Consultant, the laboratory failed to ensure two levels of quality controls were run each day of patient testing. This was noted for seven total days in -- 2 of 4 -- April 2022 and August 2022. The findings include: 1. A review of Quality Controls records and patient log reports revealed the following: a) 4/5/22 - Level 1 out for Alkaline Phosphatase (ALP). 11 patients were run. b) 4/22/22 - Both levels out for Triglycerides. 6 patients were run. c) 4/23/22 - Level 2 out for Total Protein. 8 patients were run. d) 4/25/22 - Level 1 out for Alkaline Phosphatase. 8 patients were run. e) 4/26/22 - Level 1 out for Gentamycin. 6 patients were run. f) 8/13/22 - Level 2 out for Sodium, Calcium, Glucose, Blood Urea Nitrogen (BUN), Alkaline Phosphatase (ALP), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Total Protein, Total Cholesterol, Low-Density Lipoprotein (LDL), Iron, and Creatinine Kinase (CK). 34 patients were run. g) 8/26/22 i) Level 1 out for Sodium. 11 patients were run. ii) Level 2 out for Total Cholesterol, Triglyceride, Low-Density Lipoprotein (LDL), Amylase, and Lipase. 13 patients were run. iii) Both levels out for Glucose, Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Creatinine Kinase. 26 patients were run. 2. During an interview on 3/16/2023 at 10:15 AM, the Technical Consultant confirmed the above findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of Testing Personnel records and an interview with the Technical Consultant, the Technical Consultant failed to implement and document evaluations that included the six minimal regulatory requirements for assessment of competency for all non-waived testing in the Laboratory. This was noted for nine out of nine Testing Personnel listed on the Form CMS-209 (Laboratory Personnel Report). The findings include: 1. A review of Testing Personnel records revealed forms used for Competency Assessment entitled "Age Specific Competency Evaluation". The form failed to include the six minimal regulatory requirements for assessment of competency, as follows: a) Direct observation of routine patient testing b) Monitoring the recording and reporting of patient test results c) Review of quality control records, proficiency testing results, and preventive maintenance records d) Direct observations of performance of instrument maintenance and function checks e) Assessment of problem solving skills 2. During an interview on 3/16/2023 at 10:00 AM, the Technical Consultant confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with the Technical Consultant, the Technical Consultant failed to evaluate the performance of Testing Personnel annually. This was noted for two of nine Testing Personnel listed on the Laboratory Personnel Report (Form CMS-209). The findings include: 1. A -- 3 of 4 -- review of personnel evaluation records revealed the following: a) An annual competency dated 2/27/2023 for all non waived testing was reviewed for Testing Personnel #2. No evidence of an annual competency performed in 2022 was found for Testing Personnel #2 despite being previously qualified as of the date of the last survey (11/3/2021). b) An annual competency dated 3/6/2023 for the Instrumentation Laboratory GEM Premier 3500 Arterial Blood Gas Analyzer was reviewed for Testing Personnel #8. No evidence of an annual competency performed in 2022 was found for Testing Personnel #8 despite being previously qualified as of the date of the last survey (11/3/2021). 2. During an interview on 3/15/2023 at 2:00 PM, the Technical Consultant confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 11/2-11/3/2021 at Evergreen Medical Center. Based on a lack of validation documentation for the current lot number of HemosIL Prothrombin Time (PT) reagent, a review of instructions in the product insert and laboratory procedures, and interviews with the Laboratory Manager (also the Technical Consultant), the surveyor determined the laboratory failed to perform and document the validation for the current Lot # N0201886 of PT reagent, including establishing a normal patient mean, and manually checking the INR (International Normalized Ratio) calculation on the instrument. Due to the potential for serious injury or death when the INR is incorrectly calculated, the surveyor called an Immediate Jeopardy (IJ) situation on 11/3/2021 at 2:30 PM. [Refer to D5400, D5411, D6076 and D6086.] The surveyor provided the IJ template to the Technical Consultant, and received a voluntary statement, on 11/03/2021 at 2:58 PM, to suspend testing for PT/INR, until analytic processes are remediated. . D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Laboratory Manager (also the Technical Consultant), the Laboratory Director failed to sign the attestation statements for 36 of 36 PT surveys, and testing personnel failed to sign three of 36 attestation statements from the 2018 thru 2021 PT survey review period. The findings include: 1. A review of the 2018 - 2021 API PT records revealed the Laboratory Director (or a designee) had failed to sign attestation statements for 36 of 36 surveys. The testing analysts had also failed to sign three 2018 Event #2 surveys: Core Chemistry, Hematology 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 11 -- Immunohematology / Immunology. 2. During an interview with the Laboratory Manager on 11/2/2021 at 2:45 PM, the surveyor reviewed the instructions on the attestation statement requiring the Laboratory Director (or designee) and testing personnel to sign the document. The Manager confirmed the laboratory personnel has failed to follow these instructions. . D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Laboratory Manager (also the Technical Consultant), the surveyor determined the laboratory failed to implement mechanisms to monitor, assess and correct problems identified when the laboratory received scores less than 100% (percent) on the PT surveys. This was noted to occur on 36 of 36 surveys reviewed during the 2018 - 2021 PT survey period. The findings include: 1. A review of the 2018-2021 API Proficiency Testing records revealed no quality assessment procedure or mechanism to investigate and correct problems when the laboratory received scores less than 100%. The laboratory had failed to implement a strategy to prevent: A) Clerical errors: a) 2018 Event #3 Hematology--Wet Prep with a failing score of 0%, b) 2018 Event #3 Bacteriology--Clostridium difficile with a score of 80%, c) 2019 Event #3 Chemistry--Theophylline with a score of 80%, d) 2020 Event #1 Chemistry--BNP (Beta-type Natriuretic Peptide) with a score of 80% e) 2021 Event #3 Chemistry--Arterial Blood Gas pH with a score of 80% B) Flagged result errors: 2020 Event #1 Chemistry--Erroneous flagged results for Gentamycin were reported resulting in a failing score of 60% C) "Failure to participate" errors: 2018 Event #2 Immunohematology-DAT (Direct Antiglobulin Testing) and all tests on 2020 Event #3 Chemistry 2. A further review of the API evaluations revealed significant negative biases in the SDI (Standard Deviation Index) results for the electrolytes in the 2020 Event #1 Chemistry survey; Sodium had a failing score of 20%, however the laboratory failed to note the significance of the biases and implement reviews to ensure patient testing was not impacted. 3. The surveyor noted results less than 100% were generally repeated with no documentation of further Quality Assurance investigation of the calibration dates, presence of quality control shifts and trends, reagent age or other factors that can affect results, to determine when the problem originated and whether patient testing was affected. The surveyor also noted the proficiency testing records were not reviewed for completeness; the Laboratory Director (or Designee) had failed to sign 36 of 36 attestation statement, and the testing analysts had failed to sign 3 of 36 statements. (Refer to D2009.) Survey review to ensure records were retained together was also a noted problem. 4. During an interview on 11/2/2021 at 2:45 PM, the surveyor reviewed and confirmed the above noted concerns with the Laboratory Manager. The surveyor explained the laboratory needed a mechanism (such as a procedure or worksheet) to document their investigations and determine the cause of any results less than 100%, especially when a failure has occurred. The Manager confirmed the laboratory did not have this. . D5400 ANALYTIC SYSTEMS -- 2 of 11 -- 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 a review of laboratory records and interviews with the Laboratory Manager / Technical Consultant, the laboratory failed to: 1) Ensure new lot numbers of Prothrombin Time reagent were not utilized until a validation was performed and documented (including establishing a normal patient mean and the manual check of the INR). [Refer to D5411 and D6086.] 2. Ensure Hematology calibrations were performed every six months, and Hematology QC was performed before patient testing resumed. [Refer to D5437.] 3. Ensure Calibration Verification was performed and documented every six months. [Refer to D5439.] 4. Ensure a method to monitor and document shifts and trends over time for the Chemistry/Toxicology/C-Reactive Protein and Coagulation QC was performed. [Refer to D5441.] 5. Ensure the inspection of the audible alarm system for the Blood Bank refrigerator, and Fresh Frozen Plasma freezer was performed and documented; and ensure Immunohematology QC was performed each day of patient testing. [Refer to D5551 and D5555.] 6. Ensure procedures verifying the manufacturer's performance specifications on the Beckman Coulter DxC 700AU were reviewed and approved by the Laboratory Director before patient testing began. [Refer to D6086.] . D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a lack of validation documentation for the current lot number of HemosIL Prothrombin Time (PT) reagent, a review of instructions in the product insert and laboratory procedures, and interviews with the Laboratory Manager (also the Technical Consultant), the surveyor determined the laboratory failed to perform and document the validation for the current Lot # N0201886 of PT reagent, including establishing a normal patient mean, and manually checking the INR (International Normalized Ratio) calculation on the instrument. This was noted on one of one lot numbers of PT reagent in use. The findings include: 1. During the entrance tour on 11 /2/2021 at approximately 10:15 AM, the Laboratory Manager stated coagulation testing (PT [Prothrombin Time] and PTT [Partial Thromboplastin Time]) was performed on the IL (Instrumentation Laboratory) ACL Elite. The surveyor requested a review of the current lot number of PT reagent with the ISI (International Sensitivity Index) programmed in the analyzer. At 11:35 AM the Laboratory Manager provided the "LIQUID SETUP REPORT" printed from the ACL Elite, which documented the PT Reagent Lot number as "N0201886", and the ISI as "1.610". The surveyor noted -- 3 of 11 -- this matched the information on the HemosIL product insert taken from the PT reagent box in the refrigerator. 2. A review of the manufacturer's instructions on the HemosIL reagent insert under "Instrument / test procedures" revealed, "Enter the ISI value from the insert and establish the mean of the Normal Range with each new lot number". 3. A review of the Beckman Coulter "INR CALCULATION - ACL ELITE PRO" procedure revealed, "This procedure is performed ... With a change of the thromboplastin lot number." The "Principles of the Procedure" section specified the INR equals the ratio of the patient's PT to the normal patient mean raised to the ISI (International Sensitivity Index) of the thromboplastin used, including the following: ... "Note that each lot number of reagent will have a unique ISI value and mean of normal reference interval...". 4. A review of the undated laboratory procedure, "Normal Mean Population" revealed, "Normal population range (reference range) consists of data generated from a group of individuals to be free of any abnormalities. The establishment of a normal population mean must be accurate because it plays an important part in establishing the equivalency of different laboratories INR [International Normalized Ratio] values. ... Procedure: Draw 20 patients with normal PT". 5. During the routine review of records at approximately 8:45 AM on 11/3/2021, the surveyor requested the validation documentation for the latest lot number of PT reagent, including the data used to calculate the normal patient mean, new quality control (QC) ranges, and the manual check of the instrument's INR calculation. 6. At 9:40 AM on 11/3/2021, the surveyor noted the Laboratory Manager had not located the validation studies for PT reagent lot number N0201886. The surveyor then asked for a review of the current reference value in the ACL Elite analyzer. At 9:45 AM the surveyor noted it was 12.5 seconds, and asked how this value was established; the Laboratory Manager stated she believed the testing personnel ran the Normal QC multiple times, and calculated the mean. After review of the above procedures, the Manager confirmed the testing personnel failed to follow the "Normal Mean Population" procedure. The surveyor stated they needed to review the validation data to confirm that. 7. At 10:25 AM on 11/3/2021, the surveyor asked if the laboratory included a manual check of the instrument's INR calculation whenever a new lot number of reagent was validated; the Manager was not aware this was a requirement, and did not know how to manually check the INR calculation. 8. At approximately 2: 25 PM on 11/3/2021 the Laboratory Manager was still unable to locate validation records for PT reagent lot number N0201886. The Manager had not determined who had performed the validation studies, or when the lot number was first used for patient testing. At 2:30 PM on 11/3/2021, the surveyor declared an Immediate Jeopardy due to the laboratory's failure to perform and document the validation for the current Lot # N0201886 of PT reagent, including establishing a normal patient mean as per laboratory procedure, and manually checking the INR calculation on the instrument. The surveyor provided the IJ template to the Technical Consultant, and received a voluntary statement, on 11/03/2021 at 2:58 PM, to suspend testing for PT/INR, until analytic processes are remediated. . 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) -- 4 of 11 -- 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 reviews of the Beckman Coulter DxH 600 Hematology analyzer calibration, linearity, and quality control records, and an interview with the Laboratory Manager (also the Technical Consultant), the surveyor determined the laboratory failed to follow the manufacturer's instructions: 1) to perform calibrations every six months; the laboratory failed to perform one of two calibrations due in 2019 and one of two due in 2020; and 2) to verify calibrations by running quality controls (QC) before patient testing resumed on 2/21/2020 and on 10/27/2021. The findings include: 1. A review of calibration and calibration linearity records for the Beckman Coulter DxH 600 Hematology analyzer revealed the following: A) A calibration linearity was performed on 1/4/2019; there was no record of a calibration or calibration linearity the second half of 2019. B) A calibration linearity was performed on 2/21/2020; there was no record of a calibration or calibration linearity the second half of 2020. C) A calibration were also performed on 2/21/2020 at 2:00 PM; there was no record of QC after the calibration until 2/22/2020 at 1:23 AM. D) A calibration was performed on 10 /27/2021 at 3:31 PM; there was no record of QC after the calibration until 10/28/2021 at 2:22 AM. 2. During an interview and review of the records on 11/3/2021 at 10:45 AM, the Laboratory Manager reviewed and confirmed the above noted findings. When asked about the required calibration frequency, the Laboratory Manager confirmed calibration (or calibration linearity) should be performed every six months, and QC should be performed before patient testing resumed. The surveyor then asked if any patient CBC's (Complete Blood Counts) were performed; the Manager stated four patient CBC's were performed after the 2/21/2020 calibration, and nine patient CBCs were performed after the 10/27/2021 calibration. . D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. -- 5 of 11 -- This STANDARD is not met as evidenced by: Based on a review of the calibration verification (C/V) records for the Beckman Coulter DxC 700AU Chemistry analyzer and an interview with the Laboratory Manager (also the Technical Consultant), the laboratory failed to perform C/V's every six months as required by CLIA regulations. The laboratory failed to perform two of two C/V's due in 2020. The findings include: 1. A review of Beckman Coulter DxC 700AU Chemistry analyzer records revealed calibration verification for all analytes was performed during the installation on 4/30/2019 thru 5/8/2019. The next record of C/V on analytes calibrated with less than three calibrators was 22 months later in March 2021. There was no documentation of the two C/V's due in 2020. 2. During an interview on 11/3/2021 at 8:40 PM, the Laboratory Manager confirmed she had been unable to perform C/V's in 2020. . D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a lack of quality control records and an interview with the Laboratory Manager (also the Technical Consultant), the laboratory failed to document a method to monitor shifts and trends over time for the Chemistry/Toxicology/C-Reactive Protein for the September 2021 quality control (QC), and for six months of Normal coagulation QC in 2020. The findings include: 1. A review of the September 2021 QC records for the Beckman Coulter DxC 700AU analyzer revealed only a summation of the monthly QC data for the individual analytes on a "Quality Control" chart. The laboratory had no records documenting the monitoring of QC shifts and trends over time. (Examples include printing Levey-Jennings [L-J] charts periodically, or submitting data to a QC company's Interlaboratory Quality Assurance Program [IQAP] with documentation of review). 2. A review of the Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) QC performed on the IL (Instrumentation Laboratory) ACL Elite revealed only the daily QC values for the Normal level QC performed 7/1-11/29/2020 and 12/2-12/30/2020. The laboratory had no records documenting the monitoring of Normal QC shifts and trends over time. 3. During an interview on 11/3/2021 at 3:30 PM, the surveyor asked how the laboratory monitored the Chemistry QC for shifts and trends. The Laboratory Manager stated each month she compared the actual QC values to the expected "base values", and reviewed the Biorad Unity reports electronically. The surveyor explained the laboratory needed documentation of review of QC for shifts and trends, especially when proficiency testing failures occurred. (Refer to D5291.) The surveyor then requested the L-J charts for the July-December 2020 Normal PT and PTT QC; the Manager confirmed the L-J charts were not in the binder, and did not provide the records during the survey. . -- 6 of 11 -- D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of four months of Immunohematology (Blood Bank) logs and an interview with the Laboratory Manager (also the Technical Consultant), the laboratory failed to document quality control (QC) results for ABO, Rh, and unexpected Antibody Detection on two days in January and August 2021. The findings include: 1. A review of the Immunohematology (Blood Bank) logs revealed no documentation of ABO, Rh, and unexpected Antibody Detection QC on 1/19/2021 (one patient tested for ABO, Rh, and unexpected Antibody Detection) and 8/11/2021 (two patients tested). 2. During an interview on 11/3/2021 at 2:08 PM, Laboratory Manager/ Technical Consultant confirmed the testing personnel had failed to document the Immunohematology QC for the above dates. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of Immunohematology (Blood Bank) records and an interview with the Laboratory Manager (also the Technical Consultant), the laboratory failed to document inspection of the audible alarm system for the Blood Bank refrigerator the first quarter of 2021, and failed to implement a procedure documenting inspection of the audible alarm system for the Fresh Frozen Plasma (FFP) freezer since the previous survey on 7/26/2018. The findings include: 1. A review of the quarterly "Alarm Checks" on the refrigerator where red blood cell units were stored revealed documentation of the high and low temperature alarm checks on 12/20/2020; the next alarm check was on 7/2/2021. There was no documentation of an alarm check the first quarter of 2021. 2. A review of the 2018-2021 Immunohematology records revealed no documentation of audible alarm checks on the FFP freezer. 3. During an interview on 11/3/2021 at 2:08 PM, Laboratory Manager/ Technical Consultant confirmed the laboratory had missed the alarm check on the refrigerator, and had not performed alarm checks on the FFP freezer. . -- 7 of 11 -- D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of laboratory records, quality assurance documentation and interviews with the Laboratory Manager (also the Technical Consultant), the surveyor determined the laboratory failed to implement effective quality assessment reviews to identify and correct problems identified in the analytical systems. The findings include: 1. A review of quality assurance documentation revealed the laboratory routinely performed monthly quality assurance activities, however the reviews were inadequate to discover and correct problems in the following areas: A. Prothrombin Time Reagent Validation--Failure to implement a mechanism to ensure new lot numbers of Prothrombin Time reagent were not utilized until a validation was performed (including establishing a normal patient mean and the manual check of the INR), documented and approved. [Refer to D5400, D5411, D6076 and D6086.] B. Hematology Calibrations--Failure to implement a mechanism to ensure calibrations were performed every six months and QC was performed before patient testing resumed. [Refer to D5437.] C. Calibration Verification (C/V)--Failure to implement a mechanism ensuring analytes calibrated with less than three calibrators had C/V performed and documented every six months. [Refer to D5439.] D. Quality Control (QC)--Failure to document a method to monitor shifts and trends over time for the Chemistry/Toxicology/C-Reactive Protein QC and Normal Coagulation QC [Refer to D5441.] E. Immunohematology Audible Alarm Checks and QC--Failure to document inspection of the audible alarm system for the Blood Bank refrigerator, and Fresh Frozen Plasma freezer; and failure to perform Immunohematology QC each day of patient testing [Refer to D5551 and D5555.] F. New Instrumentation Validation Approval--Failure to document the Laboratory Director's review and approval of procedures verifying the manufacturer's performance specifications before patient testing began on the Beckman Coulter DxC 700AU [Refer to D6013.] 2. In the exit summation on 11/3/2021 at approximately 4:55 PM, the surveyor reviewed and confirmed the above quality assurance concerns with the Laboratory Manager. . D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of laboratory records and interviews with the Laboratory Manager (also the Technical Consultant), the Technical Consultant failed to ensure: 1) New lot numbers of Prothrombin Time reagent were not utilized until a validation was performed and documented (including establishing a normal patient mean and the manual check of the INR). 2). Hematology calibrations were performed every six months, and Hematology QC was performed before patient testing resumed. 3). -- 8 of 11 -- Calibration Verification was performed and documented every six months. 4). A method to monitor and document shifts and trends over time for the Chemistry /Toxicology/C-Reactive Protein and Coagulation QC was performed. The findings include: 1. Refer to D6036. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on a review of laboratory records and interviews with the Laboratory Manager (also the Technical Consultant), the Technical Consultant failed to provide technical oversight to ensure: 1) New lot numbers of Prothrombin Time reagent were not utilized until a validation was performed and documented (including establishing a normal patient mean and the manual check of the INR). 2). Hematology calibrations were performed every six months, and Hematology QC was performed before patient testing resumed. 3). Calibration Verification was performed and documented every six months. 4). A method to monitor and document shifts and trends over time for the Chemistry/Toxicology/C-Reactive Protein and Coagulation QC was performed. The findings include: 1. Refer to D5411. 2. Refer to D5437. 3. Refer to D5439. 4. Refer to D5441. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on reviews of personnel files and interviews with the Laboratory Manager (also the Technical Consultant), the Technical Consultant failed to perform and document the semi-annual competency evaluation for two of six new Testing Personnel (TP) hired since the previous survey on 7/26/2018. The findings include: 1. A review of the Form CMS-209 (Laboratory Personnel Report) revealed six new Testing Personnel (TP #2, #3, #4, #5, #6, and #10) hired since the previous survey on 7/26/2018. 2. A review of personnel files revealed no semiannual competency assessments for the following: A) TP #2 with documentation of training on 11/17/2018; there was no documentation of competency until 12/30/2019. B) TP #4 was hired 8/16/2018; an "August 2019" evaluation was signed by the Technical Consultant, with no date. A "2020" evaluation was signed by the TP; there was no signature of the person who had performed the evaluation. An August 2020 was signed by the TP; there was no signature of the person who had performed the evaluation. A "2021" evaluation was signed by the TP; there was no signature of the person who had performed the evaluation. 3. During an interview on 11/2/2021 at 12:30 PM, the surveyor reviewed the competency evaluations with the Laboratory Manager / Technical Consultant, who confirmed the above noted findings. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES -- 9 of 11 -- CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on reviews of personnel files and interviews with the Laboratory Manager (also the Technical Consultant), the Technical Consultant failed to perform and document the annual competency evaluation for three of ten Testing Personnel (TP) listed on the Form CMS-209 (Laboratory Personnel Report). The findings include: 1. A review of personnel files for TP listed on the Form CMS-209 revealed no annual competency assessments for the following: A) TP #1: No 2020 documentation of competency B) TP #3: No 2020 documentation of competency C) TP #4: Competencies were incomplete and did not specify when and by whom the evaluation was performed, as follows: TP #4 was hired 8/16/2018; the "2020", "August 2020", and "2021" evaluations were signed and dated by TP#4, however there was no signature of the person who had performed the evaluations. 2. During an interview on 11/2/2021 at 12: 30 PM, the surveyor reviewed the competency evaluations with the Laboratory Manager / Technical Consultant, who confirmed the above noted findings. . 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 a lack of validation documentation for the current lot number of HemosIL Prothrombin Time (PT) reagent, a review of instructions in the product insert and laboratory procedures, a review of Beckman Coulter DxC 700 AU installation procedures, and interviews with the Laboratory Manager (also the Technical Consultant), the surveyor determined the Laboratory Director failed to: 1) ensure the laboratory performed and documented the validation for the current Lot # N0201886 of PT reagent, including establishing a normal patient mean, and manually checking the INR (International Normalized Ratio) calculation on the instrument. This was noted on one of one lot numbers of PT reagent in use; and 2) document review and approval of the Beckman Coulter DxC 700 AU installation procedures as verification of the manufacturer's performance specifications before patient testing began. This affected one of one new instruments performing moderate-complexity tests. The findings include: 1. Refer to D5411 and D6086. . D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. -- 10 of 11 -- This STANDARD is not met as evidenced by: Based on a lack of validation documentation for the current lot number of HemosIL Prothrombin Time (PT) reagent, a review of instructions in the product insert and laboratory procedures, a review of Beckman Coulter DxC 700 AU installation procedures, and interviews with the Laboratory Manager (also the Technical Consultant), the surveyor determined the Laboratory Director failed to: 1) ensure the laboratory performed and documented the validation for the current Lot # N0201886 of PT reagent, including establishing a normal patient mean, and manually checking the INR (International Normalized Ratio) calculation on the instrument. This was noted on one of one lot numbers of PT reagent in use; and 2) document review and approval of the Beckman Coulter DxC 700 AU installation procedures as verification of the manufacturer's performance specifications before patient testing began. This affected one of one new instruments performing moderate-complexity tests. The findings include: 1. Refer to D5411 concerning a lack of validation documentation for the current lot number of HemosIL Prothrombin Time (PT) reagent. 2. Beckman Coulter DxC 700 AU installation procedures: A). A review of the 4/30-5/8/2019 validation records for the Beckman Coulter DxC 700AU Chemistry analyzer, revealed no documentation (signature and date) of the Laboratory Director's review and approval of the procedures verifying the manufacturer's performance specifications. Patient testing began in May 2019. B). During a review of the records, and an interview on 11/3/2021 at 8:30 AM, the Laboratory Manager reviewed and confirmed the above noted findings. SURVEYOR ID#32558 Licensure and Certification Surveyor -- 11 of 11 --

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 a review of CMS (Centers for Medicare and Medicaid) CASPER reports and API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed to successfully participate in proficiency testing for Albumin and Total Cholesterol for two of three consecutive testing events, Event #3, 2020 and Event #2, 2021. The failure to submit the results timely to API for Event #3, 2020 contributed to the laboratory's unsuccessful participation for these analytes. This is an initial unsuccessful for Albumin and Total Cholesterol. The findings include: 1. A review of the CASPER reports (#153/#155) revealed the laboratory scored zero percent (0 %) for Albumin and Total Cholesterol for Event #3, 2020, due to 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 2 -- laboratory's failure to submit the results timely to API for grading. 2. The laboratory scored 60 % for Albumin and Total Cholesterol for Event #2, 2021, resulting in failures for two of three consecutive testing events, an unsuccessful proficiency testing participation. 3. A review of the API proficiency evaluations for these events confirmed the above noted failures. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of CMS (Centers for Medicare and Medicaid) CASPER reports and API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed Albumin and Total Cholesterol for two of three consecutive testing events, Event #3, 2020 and Event #2, 2021. The failure to submit the results timely to API for Event #3, 2020 contributed to the laboratory's unsuccessful performance and unsuccessful participation for these analytes. This is an initial unsuccessful for Albumin and Total Cholesterol. Refer to D2016. -- 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 a review of CMS CASPER reports and a review of the American Proficiency Institute (API) proficiency testing evaluations, the surveyor determined the laboratory failed to successfully participate in proficiency testing for Chemistry testing [Glucose (Non-waived) and Alcohol (Blood)] as follows: A) The laboratory scored 0 % for Glucose (Non-waived) for Event #3 2020 and 60% for Event #1 2021, two of three consecutive testing events. B) The laboratory scored 0 % for Alcohol (Blood) for Event #3 2020 and 60% for Event #1 2021, two of three consecutive testing events. These failures resulted in an initial unsuccessful proficiency testing participation for the laboratory. The findings include: A review of the CASPER 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 -- reports and API proficiency testing evaluations revealed the laboratory scored the above mentioned scores for Event #3 2020 and Event #1 2021, resulting in unsuccessful participation for Glucose (Non-waived) and Alcohol (Blood). D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of CMS CASPER reports and a review of the American Proficiency Institute (API) proficiency testing evaluations, the surveyor determined the laboratory failed to submit the results for Event #3 2020 to ensure grading. The failure to submit the results timely to API contributed to the laboratory's unsuccessful participation in proficiency testing for Chemistry as follows: A) The laboratory scored 0 % for Glucose (Non-waived) for Event #3 2020 and 60% for Event #1 2021, two of three consecutive testing events. The laboratory scored 0 % for Event #3, 2020, due to a failure to submit the results for grading. B) The laboratory scored 0 % for Alcohol (Blood) for Event #3 2020 and 60% for Event #1 2021, two of three consecutive testing events. The laboratory scored 0 % for Event #3, 2020, due to a failure to submit the results for grading. These failures resulted in initial unsuccessful proficiency testing participation for the laboratory. The findings include: See D2016. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of CMS CASPER reports and review of the American Proficiency Institute (API) proficiency testing evaluations, the surveyor determined the laboratory failed to satisfactorily perform in proficiency testing for Glucose (Non-waived) and Alcohol (Blood). The failure to submit the results timely to API for Event #3, 2020 contributed to the laboratory's unsatisfactory performance and unsuccessful participation for Chemistry as follows: A) The laboratory scored 0 % for Glucose (Non-waived) for Event #3 2020 and 60% for Event #1 2021, two of three consecutive testing events. The laboratory scored 0 % for Event #3, 2020, due to a failure to submit the results for grading. B) The laboratory scored 0 % for Alcohol (Blood) for Event #3 2020 and 60% for Event #1 2021, two of three consecutive testing events. The laboratory scored 0 % for Event #3, 2020, due to a failure to submit the results for grading. The findings include: See D2016. D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(ii) The laboratory director must ensure the results are returned within the timeframes established by the proficiency testing program. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of CMS CASPER reports and a review of the American Proficiency Institute (API) proficiency testing evaluations, the surveyor determined the Laboratory Director failed to ensure results for Event #3, 2020 were submitted to the provider to ensure grading. API scored the laboratory zero percent (0 %) for Event #3, 2020, due to the laboratory's failure to submit the results. The failure to submit the results timely to API contributed to the laboratory's unsuccessful participation in proficiency testing for several analytes in Chemistry. The findings include: See D2016. -- 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 a review of CMS CASPER reports, a review of the American Proficiency Institute (API) proficiency testing evaluations, and a telephone interview with the Laboratory Manager, the surveyor determined the laboratory failed to successfully participate in proficiency testing for Chemistry testing [Total Cholesterol, Sodium (Na) and Gentamicin] as follows: A) The laboratory scored 0 % (zero percent) for Total Cholesterol for Events #2 and #3 of 2020, two consecutive testing events. The laboratory scored 0 % for Event #3, 2020, due to a failure to submit the results for grading. B) The laboratory scored 20 % for Na for Event #1, 2020 and 0 % for Event #3, 2020, two of three consecutive testing events. C) The laboratory scored 60 % for 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 -- Gentamicin for Event #1, 2020 and 0 % for Event #3, 2020, two of three consecutive testing events. These failures resulted in initial unsuccessful proficiency testing participation for the laboratory. The findings include: A review of the CASPER reports and API proficiency testing evaluations revealed the laboratory scored the above mentioned scores for Events #1, #2 and #3, 2020, resulting in unsuccessful participation for Gentamicin, Na and Total Cholesterol. During an interview on 11/17 /2020 at 10:50 AM, the Laboratory Manager confirmed the above noted findings. The Laboratory Manager stated just as she was submitting the results for Event #3, 2020, the electricity and internet failed, due to a storm/hurricane. The manager further confirmed she waited until the last day to attempt to submit the proficiency testing results to API. . D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of CMS CASPER reports, a review of the American Proficiency Institute (API) proficiency testing evaluations, and a telephone interview with the Laboratory Manager, the surveyor determined the laboratory failed to submit the results for Event #3, 2020 to ensure grading. The failure to submit the results timely to API contributed to the laboratory's unsuccessful participation in proficiency testing for Chemistry as follows: A) The laboratory scored 0 % (zero percent) for Total Cholesterol for Events #2 and #3 of 2020, two consecutive testing events. The laboratory scored 0 % for Event #3, 2020, due to a failure to submit the results for grading. B) The laboratory scored 20 % for Na for Event #1, 2020 and 0 % for Event #3, 2020, two of three consecutive testing events. The laboratory scored 0 % for Event #3, 2020, due to a failure to submit the results for grading. C) The laboratory scored 60 % for Gentamicin for Event #1, 2020 and 0 % for Event #3, 2020, two of three consecutive testing events. The laboratory scored 0 % for Event #3, 2020, due to a failure to submit the results for grading. These failures resulted in initial unsuccessful proficiency testing participation for the laboratory. The findings include: See Also D2016. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of CMS CASPER reports, a review of the American Proficiency Institute (API) proficiency testing evaluations, and a telephone interview with the Laboratory Manager, the surveyor determined the laboratory failed to satisfactorily perform in proficiency testing for Sodium (Na), Gentamicin and Total Cholesterol. The failure to submit the results timely to API for Event #3, 2020 contributed to the laboratory's unsatisfactory performance and unsuccessful participation for Chemistry -- 2 of 3 -- as follows: A) The laboratory scored 0 % (zero percent) for Total Cholesterol for Events #2 and #3 of 2020, two consecutive testing events. The laboratory scored 0 % for Event #3, 2020, due to a failure to submit the results for grading. B) The laboratory scored 20 % for Na for Event #1, 2020 and 0 % for Event #3, 2020, two of three consecutive testing events. The laboratory scored 0 % for Event #3, 2020, due to a failure to submit the results for grading. C) The laboratory scored 60 % for Gentamicin for Event #1, 2020 and 0 % for Event #3, 2020, two of three consecutive testing events. The laboratory scored 0 % for Event #3, 2020, due to a failure to submit the results for grading. The findings include: See Also D2016. D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(ii) The laboratory director must ensure the results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of CMS CASPER reports, a review of the American Proficiency Institute (API) proficiency testing evaluations, and a telephone interview with the Laboratory Manager, the surveyor determined the Laboratory Director failed to ensure results for Event #3, 2020 were submitted to the provider to ensure grading. API scored the laboratory zero percent (0 %) for Event #3, 2020, due to the laboratory's failure to submit the results. The failure to submit the results timely to API contributed to the laboratory's unsuccessful participation in proficiency testing for several analytes in Chemistry. The findings include: See Also D2016. -- 3 of 3 --

Summary Statement of Deficiencies 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 a review of 2016-2018 American Proficiency Institute (API) proficiency testing records and an interview with the laboratory manager (also the Technical Consultant), the laboratory failed to evaluate proficiency testing events assigned an artificial score of 100% (percent) for two of five surveys. The findings include: 1. A review of the proficiency testing records revealed the 3rd event in 2016 for Endocrinology and 1st event in 2017 for Hematology and free Thyroxine (FT4) were given scores of 100%. In the 3rd event in 2016 sample CH-13 revealed ungraded results due to no consensus for Free T4 and Thyroid Stimulating Hormone (TSH). In the 1st event in 2017 all Hematology analytes were given an ungraded result due to wrong instrument method entered and sample CH-01 for Free T4 was ungraded due to no consensus for the 1st event in 2017. 2. The laboratory did not perform a self- evaluation for ungraded proficiency testing results that were given an artificial score of 100%. 3. In a interview on 7/25/2018 at 2:18 PM, the laboratory manager reviewed the proficiency testing records with the surveyor and confirmed the above noted findings. Jeremy Westry, BS, MT (ASCP) Licensure and Certification Surveyor 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 --