Rheumatic Disease Center Physicians Sc

Summary Statement of Deficiencies D0000 Based on a desk review of proficiency testing records from the Certification and Survey Provider Enhanced Reporting (CASPER) database and verified with the proficiency testing provider the laboratory was found to be out of compliance with the following CONDITION level deficiencies: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency 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 -- Institute (API) Proficiency Testing (PT) records, the laboratory failed to successfully participate in a proficiency testing program for the hematology analyte Hematocrit for two consecutive PT events in 2025 (event 1 and event 2 of 2025) resulting in the initial unsuccessful PT performance (see D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to achieve satisfactory performance for the hematology analyte Hematocrit for two consecutive PT events in 2025 (event 1 and event 2 of 2025) resulting in the initial unsuccessful PT performance. Findings include: 1. Review of the CASPER Report 0155D, generated on 09-02-2025, the laboratory received the following unsatisfactory scores for the hematology analyte Hematocrit. Hematocrit (HCT) EVENT 1, 2025 - 60% Unsatisfactory EVENT 2, 2025 - 60% Unsatisfactory 2. Review of API PT evaluation reports (Hematology/Coagulation) confirmed the above unsatisfactory scores that resulted in the initial unsuccessful PT performance for the hematology analyte Hematocrit. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the hematology analyte Hematocrit resulting in the laboratory's initial unsuccessful PT performance (see D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) Proficiency Testing (PT) records the laboratory director -- 2 of 3 -- failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the hematology analyte Hematocrit (see D2130) resulting in the laboratory's initial unsuccessful PT performance. -- 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: A Based on review of the laboratory's policy and procedure manual, laboratory Quality Control (QC) records, and interview with technical consultant (TC); the laboratory failed to retain QC records for the Medonic M-series hematology analyzer (Serial number: 48527) for one of five dates reviewed. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the procedure, " Medonic M- series hematology analyzer procedure manual" which stated the following: "QC results obtained from every run must be documented and saved for a minimum of 2 years." 2. Review of laboratory QC records revealed the laboratory failed to maintain any QC records for one of five dates reviewed. Date with no QC records available 12- 27-23 3. During the survey on 07/29/2025 at 02:3 pm, the laboratory TC confirmed the laboratory failed to maintain QC results records for the Medonic M-series hematology analyzer for the date of 12-27-23. B Based on review of the laboratory's policy and procedure manual, laboratory Quality Control (QC) records, and interview with technical consultant (TC); the laboratory failed to retain package inserts for QC reagents for the Medonic M-series hematology analyzer (Serial number: 48527) as required for the last two years from the date of survey, 07/29/2025. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the procedure, " Medonic M-series hematology analyzer procedure manual" which stated the following: "The Quality control Package inserts must be saved for a minimum of 2 years." 2. Review of laboratory QC records revealed the laboratory failed to maintain any QC package inserts besides the currently in use package insert for QC reagents 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 -- used for the Medonic M-series hematology analyzer. 3. During the survey on 07/29 /2025 at 02:3 pm, the laboratory TC confirmed the laboratory failed to maintain package inserts for QC reagents for the Medonic M-series hematology analyzer. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the CMS-209 (Laboratory Personnel Form), laboratory policies and procedures, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to have a competency assessment policy and procedure in place to assess employee competency for one of one TC. Findings include: 1. Review of the CMS-209 (Laboratory Personnel Form) revealed one TC. 2. Review of the laboratory policies and procedures revealed the laboratory lacked a competency assessment policy and procedure to assess the competency of one of one TC. 3. Interview with TC on 7/29/2025, at 12:35 pm, confirmed the laboratory failed to have a competency policy and procedure in place to assess competency for one of one TC. 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 review of the laboratory's policy and procedure manual, laboratory maintenance documents, and interview with the Technical Consultant (TC); the laboratory failed to perform and retain maintenance records for the Medonic M-series hematology analyzer (Serial number: 48527) for five of five dates examined. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the procedure, "Medonic M-series hematology analyzer procedure manual" which stated the following: "Daily cleaning should be performed according to the Medonic M- series user's manual ... All maintenance should be documented (a maintenance log is recommended), and the documentation saved for a minimum of 2 years." 2. Review of laboratory maintenance documents revealed the laboratory failed to have maintenance records for the Medonic M-series Hematology analyzer (Serial number: 48527) for five of five dates reviewed. Dates missing maintenance records 1. 12/27/2023 2. 02/14 /2024 3. 04/19/2024 4. 11/15/2024 5. 03/17/2025 3. During the survey on 07/29/2025 at 02:33 pm, the laboratory TC confirmed the laboratory failed to perform or maintain maintenance records for the Medonic M-series hematology analyzer 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 -- 2 of 4 -- 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 surveyor review of laboratory policy and procedure manual, lack of documentation, laboratory calibration verification records, and interview with laboratory Technical consultant (TC) ; the laboratory failed to conduct calibration verification for 18 of 18 chemistry/general immunology analytes (albumin, alkaline phosphate, alanine transaminase (ALT), blood urea nitrogen (BUN), calcium, chloride, CO2, complement C3, complement C4, C- reactive protein, creatine kinase, creatinine, glucose, magnesium, potassium, sodium, total bilirubin, total protein, and uric acid) on the Ace Axcel (serial number: 22110573) every six months as required. Findings include: 1. Review of laboratory policy and procedure manual found the procedure titled, "Periodic Calibration, Calibration verifications (AMR) and Assay Correlations" which stated the following: "The AMR must be revalidated at least every six months. If the materials used for calibration or calibration verification include low, midpoint and high values that are near the stated AMR, and if the calibration verification data are within the laboratory's acceptance criteria, the AMR has been verified and no additional procedures are required." 2. No calibration verification documentation for the Ace Axcel was available to surveyors on the date of the survey 07/29/2025 for 18 of 18 chemistry/ general immunology analytes List of analytes with no calibration verification: albumin alkaline phosphate alanine transaminase (ALT) blood urea nitrogen (BUN) calcium, chloride CO2 complement C3 complement C4 C- reactive protein creatine kinase creatinine glucose magnesium potassium sodium total bilirubin total protein uric acid 3. During survey date 07-29- 2025 at 02:46 pm, the laboratory TC confirmed the laboratory had failed to perform calibration verification as required for the above mentioned analytes as required every six months. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) 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 review of laboratory personnel report CMS-209, laboratory competency records and interview with the laboratory Technical Consultant (TC); the technical consultant failed to evaluate and document the performance of one of three new TP at -- 3 of 4 -- least semiannually during the first year the individual tests patient specimens. Findings include: 1. Review of laboratory personnel report CMS-209 identified new testing personnel (TP) #2. 2. Review of testing personnel competency records revealed that TP #2 started on 7/8/2024 and had completed a one competency evaluation on 1/15/2025. 3. Interview with the laboratory TC on 07/29/2025 at 12:39 pm confirmed the laboratory failed to perform a second semi-annual competency assessment for TP #2 from 7/8/2024 to 7/8/2025. -- 4 of 4 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D Individual Laboratory Profile report and College of Pathologists (CAP) proficiency testing (PT) records, the laboratory failed to participate in CAP PT event 2 of 2023 (See D2077) and for the analyte rheumatoid factor (RF) and the subspecialty of general immunology failed to achieve a satisfactory PT performance for two of three events in 2023 through 2024 (event 2 of 2023 & event 1 of 2024) resulting in an initial unsuccessful PT performance (See D2084 & D2085). D2077 GENERAL IMMUNOLOGY 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 -- CFR(s): 493.837(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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D Individual Laboratory Profile report and College of Pathologists (CAP) proficiency testing (PT) records, the laboratory failed to participate in the diagnostic immunology CAP PT event 2 of 2023, resulting in a score of 0% for the testing event. Findings include: 1. Review of the CASPER 0155D report ran on 9-3- 2024 identified the 0% scores for the specialty of general immunology and the analyte rheumatoid factor for event 2 of 2023. 2. Review of the CAP "S-B 2023 Diagnostic Immunology Original Evaluation" report (event 2 of 2023) dated 11/03/2024 stated, "[40] = Results for this kit were not received.". D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D Individual Laboratory Profile report and College of Pathologists (CAP) proficiency testing (PT) records, the laboratory failed to successfully participate in proficiency testing (PT) for the general immunology analyte rheumatoid factor (RF) during PT event 2 of 2023 and event 1 of 2024. Findings include: 1. Review of the CASPER 0155D report ran on 9-03-2024 identified the initial unsuccessful PT performance for the general immunology analyte RF. GENERAL IMMUNOLOGY RF - EVENT-2, 2023 = 0% - Unsatisfactory RF - EVENT-1, 2024 = 40% - Unsatisfactory 2. Review of the CAP PT evaluation reports confirmed the unsuccessful PT performance for RF during PT event 2 of 2023 and event one of 2024. D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D Individual Laboratory Profile report and College of Pathologists (CAP) proficiency testing (PT) records, the laboratory failed to successfully participate in proficiency testing (PT) for the subspecialty of general immunology during PT event 2 of 2023 and event 1 of 2024. Findings include: 1. Review of the CASPER 0155D report ran on 9-03-2024 identified the initial unsuccessful PT performance for the general immunology subspecialty. GENERAL IMMUNOLOGY General Immunology - EVENT-2, 2023 = 0% - Unsatisfactory General Immunology - EVENT-1, 2024 = 40% - Unsatisfactory 2. Review of the CAP PT evaluation reports confirmed the unsuccessful PT performance for general immunology during PT event 2 of 2023 and event 1 of 2024. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D Individual Laboratory Profile report and the College of Pathologists (CAP) proficiency testing (PT) records, the laboratory director failed to ensure successful participation in an Health and Human Services (HHS) approved PT program for the subspecialty of general immunology (see D6087) resulting in the laboratory's initial unsuccessful PT performance for the subspecialty of general immunology and the analyte rheumatoid factor for two of the three PT events (event 2 of 2023 and event 1 of 2024). D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D Individual Laboratory Profile report and ((CAP) Proficiency Testing (PT) records, the laboratory director failed to ensure the laboratory submitted PT results for diagnostic immunology event 2 of 2023 (See D2077); and failed to successfully participate in an Health and Human Services (HHS) approved PT program for the subspecialty of general immunology (See D2085) and the analyte rheumatoid factor (See D2084) resulting in the laboratory's initial unsuccessful PT performance for the subspecialty of general immunology and the analyte rheumatoid factor. -- 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 review of the CASPER Report 0155D and review of American Proficiency Institute (API) proficiency testing (PT) reports the laboratory failed to successfully participate in PT for the routine chemistry analyte potassium (K) during event two of 2022 and event one of 2023, resulting in unsuccessful PT performance for K. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER Report 0155D and review of American Proficiency Institute (API) proficiency testing (PT) reports the laboratory failed to successfully participate in PT for the routine chemistry analyte potassium (K) during event two of 2022 and event one of 2023, resulting in the unsuccessful PT performance for K. Findings include: 1. Review of the CASPER Report 0155D ran on 4-3-2023 identified the initial unsuccessful PT performance for the specialty of chemistry for potassium (K). ROUTINE CHEMISTRY K - EVENT-2, 2022 = 60% - Unsatisfactory K - EVENT-1, 2023 = 40% - Unsatisfactory 2. Review of API PT report documentation confirmed the unsuccessful PT performance for K during event two of 2022 and event one of 2023. 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 review of the CASPER Report 0155D and review of American Proficiency Institute (API) proficiency testing (PT) reports the laboratory director failed to meet the requirements of this condition. The laboratory director failed to ensure test methods were performed as required to provide accurate and reliable results for the specialty of chemistry analyte potassium in 2022 through 2023. See D6087. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0155D and review of American Proficiency Institute (API) proficiency testing (PT) reports the laboratory director failed to ensure test methods were performed as required to provide accurate and reliable results for the specialty of chemistry analyte potassium in 2022 through 2023. Findings Include: 1. The laboratory failed to ensure successful participation in proficiency testing for the chemistry analyte potassium during event two of 2022 and event one of 2023. See D2096. -- 2 of 2 --

Summary Statement of Deficiencies 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)

Summary Statement of Deficiencies D2076 GENERAL IMMUNOLOGY CFR(s): 493.837(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) proficiency testing (PT) records and an interview with the technical consultant (TC), the laboratory failed to attain an overall testing event score of at least 80 percent for testing in the subspecialty of General Immunology, during the year of 2019. Findings: 1. The API Immunology results for 2018 and 2019 were reviewed. 2. The laboratory failed to receive a satisfactory performance score for General Immunology testing. The API- PT records revealed the following: *For event #1 of 2019, the laboratory receive an overall score of 73% in General Immunology. *The analyte Immunoprotein Complement C3 (C3) received a score of 20%; and *Rheumatoid Factor (RF) PT results received a "not graded" result due to less than 10 participants. 3. On a recertification survey conducted 09/04/2019 at 3:15 PM, the TC confirmed the above findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review, the Laboratory Personnel Report (CMS 209), and 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 6 -- interview with the technical consultant (TC1); the laboratory failed to establish written procedures to assess employees performing TC and technical supervisor (TS) responsibilities, affecting 1 out of 1 employee. Findings: 1. The CMS 209, personnel records, and the laboratory's Performance/Competency Testing policies were reviewed. 2. The competency policy failed to establish a written competency procedure that assesses the TC's performance of the following responsibilities: *Providing technical and scientific oversight of the laboratory; *Availability *Selection of test methodology appropriate for the clinical use of the test results; *Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics; *Enrollment and participation in an HHS approved proficiency testing (PT) program commensurate with the services offered; *Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; *Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications; *Ensuring that patient test results are not reported until all

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the surveyor's review of the Laboratory Personnel Report (CMS 209), the policies, procedures, employee records, and an interview with the technical supervisor (TS); the laboratory failed to establish written policies and procedures that meet the personnel requirements in subpart M to assess employees performing moderately and highly complex testing, affecting 4 out of 4 testing personnel (TP). Findings: 1. The CMS 209 lists 4 TP performing Blood Chemistry, Hematology and General Immunology (both highly and moderately complex) testing in the laboratory. 2. The personnel files presented revealed that 4 out of 4 TP competencies did not indicate whether the TP were competent to perform the various tests conducted in the laboratory. 3. The competency procedure in-use is a check list of observations. There is no written indication on the 11 out of 11 competencies reviewed that the TP assessed had performed with "Satisfactory" or "Unsatisfactory" performances; or whether supervision or non-supervision is required for the assessed employee. 4. The laboratory's competency policy and step-by-step procedure does not include: b). Monitoring the recording and reporting of test results through document review (procedure only indicates observation of the TP recording and reporting); c). The review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records (not just the observing of the TP performing these functions); e). The assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency 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 -- testing samples; and f). The assessment of problem solving skills, 5. On a Recertification survey conducted on February 20, 2018 at 2:00PM, the TS confirmed the above findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) reports, laboratory records, manual, reports, and an interview with the technical supervisor (TS); the laboratory failed to verify the accuracy of the Synovial fluid and General Immunology testing it performs at least twice annually. Findings: 1. The laboratory's manual states that the laboratory will participate in the CAP-PT program for Special Immunology to fulfill the twice annual verification requirements for some of it's General Immunology tests. 2. The laboratory provided evidence of PT participation in the Special Immunology category for the following events: S2-C 2015; S2-A 2016; S2-B 2016; and S2-C 2016 for the following analytes: Anti-SSA/Ro autoantibodies (Anti-Sjgren ' s-syndrome-related antigen A); Anti-SSB/La autoantibodies (Anti-Sjgren ' s-syndrome-related antigen B); Anti-dsDNA (Anti-double stranded DNA) antibodies; Anti-nRNA (Anti-nuclear Ribonucleoprotein); Anti-Sm (Anti-Smith ); and Anti-Centromere No documentation was provided as evidence that the laboratory verified the accuracy of it's Special Immunology testing during the year of 2017 to present. 3. No documented evidence was provided to show that the laboratory chose another method to verify the accuracy of its testing during 2017 when it did not participate in the CAP-PT program. 4. The laboratory also tests for the following special Immunology analytes which are not included in the CAP-PT program: Anti-Scl-70 (anti-topoisomerase I); Anti-Jo-1 antibodies; Anti-Histone; and Anti-Centromere B. The laboratory's method to verify the accuracy of these analytes are to take positive patient samples, freeze the samples, and retest them a week later 2 times, then analyze the results for accuracy and precision. The summary results provided from this method does not confirm the test systems accuracy. 5. The laboratory also test synovial fluid. The laboratory's manual does not define the method and procedure the laboratory will use to verify the accuracy of this test. No documentation was provided to show that the Uric Acid Crystal test had been verified for accuracy during the years of 2015, 2016 and 2017. 6. On a Recertification survey conducted on 02/20/2018 at 2:30 PM, the TS confirmed the above findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's manual, the Laboratory Personnel -- 2 of 5 -- Report (CMS 209), and an interview with the technical supervisor (TS); the laboratory failed to establish and follow written procedures for all tests, assays, and examinations performed by the laboratory, affecting 90 patients. Findings: 1. The laboratory's procedures manual does not include a procedure for testing synovial fluid for Uric Acid crystals. 2. The CMS 209 lists 1 testing personnel performing Uric Acid Testing. 3. On a Recertification survey conducted on 02/20/2018 at 2:00 PM, the TS confirmed the above findings and stated that he thought Uric Acid testing was considered a Provider Performed Microscopy (PPM) test. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the surveyor's review of the laboratory personnel records and an interview with the technical supervisor (TS); the laboratory failed to have a director who meets the qualification requirements of 493.1405 and providing overall management and direction in accordance with 493.1407. Findings: 1. The laboratory failed to have a director who possesses a current State of Illinois Medical license. See D6003 D6078 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1443 The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b) (1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2) Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and (b)(2)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and-- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be -- 3 of 5 -- qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: Based on the surveyor's review of the Laboratory Personnel Report (CMS 209), the laboratory personnel records and an interview with the technical supervisor (TS); the laboratory failed to have a laboratory director (LD) who possesses a current license issued by the State of Illinois. Findings: 1. The CMS 209 lists the employee on line 1 as the LD of the laboratory which performs moderately and highly complex testing. 2. The personnel file of the LD revealed that their State of Illinois Medical license to practice had expired 07/31/2017. 3 On a Recertification survey conducted on 02/20 /2018 at 2:15PM, the TS confirmed the above findings. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on the surveyor's review of the laboratory's records, manual, and an interview with the technical supervisor (TS); the TS failed to provide technical supervision in accordance with 493.1451 of this subpart in the specialty of Immunology, affecting 9776 tests. Findings: 1. The TS failed to resolve technical problems and ensure that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications. See D6118. D6118 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(5) The technical supervisor is responsible for resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records, manual, the Clinical Laboratory Improvement Amendment (CLIA) application (CMS 116), and an interview with the technical supervisor (TS); the TS failed to resolve technical problems and ensure that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications in the specialty of Immunology, affecting 9776 tests. Findings: 1. The TS failed to evaluate the non- scored results received from the proficiency testing (PT) program to determine the test system's performances during PT Events from 2015 through 2016, and, if applicable, establish