Arthritis Clinic Pllc

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 laboratory observation, review of the laboratory procedure manual, review of patient Complete Blood Count with automated White Blood Cell Differential (CBC w/Diff) records, and staff interviews, the laboratory failed to follow the established procedure for resolving potential errors with CBC w/Diff results for two of two flagged CBC results reviewed from July 2025. The findings include: 1. Laboratory observation on 07/16/25 at 8:15 a.m. revealed the Sysmex XN 330 used for patient testing for CBC w/Diff. During observation, the lead testing person was asked to describe how flagged CBC w/Diff results are handled by the laboratory. She stated the following: No action is taken. Because the results are interfaced, they are not printed, and the flags are not seen. She further stated that the flagged results do not cross to the Laboratory Information System (LIS) interface and are not part of the final patient test report. 2. A review of the laboratory procedure titled "SYSMEX DATA ERROR And FLAG REVIEW" revealed that samples with 'Suspicious' results were to be repeated and/or recollected with instructions to "**Always follow Sysmex guidelines for acceptable reporting of results." The document listed the sections of the Sysmex Instructions for Use to reference for resolving issues with CBC w/Diff testing. 3. A review of patient CBC w/Diff results revealed the following: Patient medical record number 3463, performed on 07/10/25: The instrument printout had asterisk flags on the White Blood Cell (WBC) Differential with a WBC IP Message of Blasts /Abnormal Lymphocytes, and Atypical Lymphocytes. The final patient test report from the LIS did not include any of the instrument flags. There was no documentation 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 -- that action had been taken to verify or resolve the potential problems with the WBC Differential. Patient medical record number 17702, performed on 07/16/25: The instrument printout had asterisk flags on the Basophil count with a WBC IP Message of WBC Abnormal Scattergram. The final patient test report from the LIS did not include any of the instrument flags. There was no documentation that actions had been taken to verify or resolve the potential problems with the WBC Differential. 4. Technical consultant number two confirmed the survey findings during interview on 07/16/25 at 4:30 p.m. Word Key: IP=Interpretative Program D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on laboratory observation, review of control package inserts, and staff interview, the laboratory failed to ensure 18 of 18 controls were labeled with either an open date and/or a corrected expiration date on the survey date (07/16/25). The findings include: 1. Laboratory observation on 07/16/25 at 8:15 a.m. revealed the following: Test systems used for patient testing included the Alcor Mini-Sed used for Erythrocyte Sedimentation Rate (ESR), the Sysmex XN 330 for CBC w/Diff, and the Ortho Vitros 5600 used for Chemistry, Endocrinology, and Immunology testing. The following controls were observed without either an open date and/or corrected expiration date as follows: Seditrol ESR (Lot C145 and C245) controls with no open or corrected expiration date. CBC w/Diff XN-L Check (Lot 51511401, 51511402, 51511403)-Open date of 7/7, but no corrected expiration date. Liquid Assayed Multiqual (Lot 46011, 46012, 46013) with an open date of 7/15, but no corrected expiration date. Immunoassay Plus Control (Lots 1003921, 1003922, and 1003923) with an open date of 7/08, but no corrected expiration date. Specialty Immunoassay Control (Lots 65001, 65002, and 65003) with an open date of 7/08, but no corrected expiration date. Viroltrol HaV-IgM, Viroclear, and Virotrol I and II controls all with an open date of 6/26, but no corrected expiration date. 2. A review of control package inserts revealed the following expiration dates for controls that had been opened: Seditrol ESR controls-60 days after opening. Sysmex XN-L CBC controls-15 days after opening. Multiqual Chemistry control-All analytes 14 days; Alkaline Phosphatase, AST/SGOT, Total Bilirubin, HDL Cholesterol, Creatine Kinase, Phosphorus, and Triglyceride: 7 days. Immunoassay Plus Control-All analytes 14 days. Specialty Immunoassay Control-All analytes-30 days, PTH (Intact) - 7 days. Virotrol HaV-IgM-60 days, Viroclear-60 days, Virotrol I and II-60 days. 3. Technical consultant two confirmed the survey findings during interview on 07/16/25 at 4:30 p. m. Word Key: AST/SGOT=Aspartate Aminotransferase HaV=Hepatitis A Virus HDL=High Density Lipoprotein IgM=Immunoglobulin M PTH=Parathyroid Hormone 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 -- 2 of 5 -- specified by the manufacturer. This STANDARD is not met as evidenced by: Based on laboratory observation, laboratory records, and staff interview, the laboratory failed to document the individual monthly maintenance tasks for the Ortho Vitros 5600 for three of three months reviewed from 2024 and 2025. 1. Laboratory observation on 07/16/25 at 8:15 a.m. revealed the Ortho Vitros 5600 used for patient testing for Chemistry, Endocrinology, and Immunology testing. 2. A review of the Ortho Vitros 5600 maintenance records and form used for documenting monthly maintenance performance revealed that the laboratory failed to document the individual monthly maintenance tasks for three of the three months reviewed (September 2024, February 2025, and May 2025). 3. Technical consultant number two confirmed the survey findings during interview on 07/16/25 at 4:30 p.m. D5787 TEST RECORDS CFR(s): 493.1283(a) (a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on record review and staff interviews, the laboratory failed to have a system in place to identify who performed maintenance tasks, quality control activities, and patient testing for 2024 and 2025. 1. A review of laboratory records revealed the following: The "DAILY, WEEKLY, MONTHLY LOG" used for checking that laboratory tasks had been completed was initialed by the lead testing person on all dates of performance for the months of September 2024, February 2025, and May 2025. Testing person two had not initialed any of the documents. The tasks included Sysmex XN 330 QC, ESR QC, Vitros 5600 QC, Vitros 5600 and Sysmex XN 330 weekly maintenance tasks, as well as monthly Vitros 5600 maintenance tasks. The form used for recording ESR QC and patient results did not include the initials of the person who performed the testing. 2. The lead testing person stated the following during interview on 07/16/25 at 1:30 p.m: Testing person two performed maintenance tasks and quality control, but the laboratory did not have a process to identify who actually performed the task. The laboratory used one login for the laboratory information system for release of patient results that only included the identity of the lead testing person. Testing person two performed patient testing in all areas of the laboratory, but her initials were not captured for the tests she performed. 3. Technical consultant two confirmed the survey findings during interview on 07/16/25 at 4:30 p. m. 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. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, lack of documentation, review of quality assessment documentation, and staff interview, the laboratory failed to take

Summary Statement of Deficiencies D0000 During a recertification survey performed on 04/15/2024, the laboratory was found out compliance with the following conditions: 493.1208 Condition: General Immunology 493.1210 Condition: Routine Chemistry D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of manufacturer's instructions for use, quality assessment documents, quality control records, manufacturer's quality control package inserts, calibration records, lack of records, environmental records, laboratory procedures, patient test records, and staff interviews, the laboratory failed to ensure the laboratory maintained patient specimen storage and stability according to the manufacturer's requirements (Refer to D5401), failed to ensure procedures for use were approved by the laboratory director (Refer to D5407), failed to define temperature ranges for quality control storage (Refer to D5413), failed to ensure quality controls were not used past the manufacturer expiration date (Refer to D5417), failed to perform required calibrations for reagent lot changes (Refer to D5437), failed to follow the procedure to establish ranges for unassayed controls (Refer to D5441 Citation two), and failed to follow the laboratory procedure to monitor quality controls (Refer to D5791). D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, 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 8 -- laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of manufacturer's instructions for use, quality assessment documents, quality control records, manufacturer's quality control package inserts, calibration records, lack of records, environmental records, laboratory procedures, patient test records, and staff interviews, the laboratory failed to ensure the laboratory director had approved procedures for use (Refer to D5407), failed to define temperature ranges for quality control storage (Refer to D5413), failed to perform required calibrations for reagent lot changes (Refer to D5437), failed to ensure testing personnel performed quality control before patient testing (Refer to D5441 Citation one), failed to follow the laboratory procedure to print and review quality controls for the (Refer to D5791), and failed to have an effective quality assessment process to identify quality control standard deviations that exceeded the manufacturer standard deviations (Refer to D5793) for the Ortho Vitros 5600 instrument. 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 observation of the laboratory, review of the manufacturer's instructions for use, quality assessment documents, and staff interviews, the laboratory failed to follow the procedure for specimen storage when testing was delayed for the antibody to hepatitis C virus (aHCV), hepatitis B surface antigen (HBsAg), and antibody to hepatitis B surface antigen (aHBS) analytes. The findings include: 1. Observation of the laboratory on 04/15/2024 at 8:45 am revealed an Ortho Vitros 5600 (Serial #J56004335) used for patient testing. During the observation, testing person one stated that patient samples for Hepatitis testing were processed and stored in the refrigerator and only tested on Thursdays. 2. A review of the manufacturer's instructions used as part of the laboratory's procedures revealed the following statement for the aHCV, HBsAg, and aHBs analytes: "If the test will not be completed within 48 hours or for shipment, freeze samples at or below -20 degrees Celsius (C)." 3. A review of the laboratory's quality assessment document dated 01/08/2024 revealed that the laboratory would only perform Hepatitis testing once a week on Thursdays. 4. An interview with the laboratory liaison on 04/15/2024 at 3:00 pm confirmed that the laboratory used the manufacturer's instructions as part of its procedure manual and failed to follow the established procedure for preserving and storing samples for Hepatitis testing in 2024. 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, -- 2 of 8 -- 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 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Casper report 155 (CMS 155) and the laboratory's American Proficiency Institute (API) proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory participation for two out of three proficiency testing events for the aspartate transaminase (AST /SGOT) analyte resulting in the first unsuccessful PT occurrence for the AST/SGOT analyte (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 a desk review of the CMS 155 and the laboratory's 2023 API PT evaluation reports, the laboratory failed to maintain satisfactory performance for two out of three test events for the AST/SGOT analyte. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory AST/SGOT scores: 2023 Event two 60% 2023 Event three 60% 2. Review of the API PT evaluation report for 2023 Event two revealed an overall score of 60% for the AST/SGOT analyte. 3. Review of the API PT evaluation report for the 2023 Event three revealed an overall score of 60% for the AST/SGOT analyte. -- 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: The laboratory failed to maintain satisfactory proficiency testing (PT) performance for the Complement C3 analyte and the specialty of immunology for 2020 event three and 2021 event one, resulting in the first unsuccessful PT performance for the Complement C3 analyte and the immunology specialty. (Refer to D2084 and D2085) D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155) and the laboratory's proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the Complement C3 analyte in two consecutive PT events, resulting in the first unsuccessful PT occurrence for the Complement C3 analyte. The finding include: 1. Review of the CMS 155 report revealed the following for the Complement C3 analyte: 2020 event three scored as 40% 2021 event one scored as 40% 2. Review of the laboratory's proficiency testing records for 2020 event three revealed sample numbers IMP-12, IMP-13, and IMP-14 scored as unacceptable for the Complement C3 analyte, resulting in an overall score of 40%. 3. Review of the laboratory's proficiency testing records for 2021 event one revealed sample numbers IMP-02, IMP-03, and IMP-05 scored as unacceptable for the Complement C3 analyte, resulting in an overall score of 40%, and the first unsuccessful PT occurrence for the Complement C3 analyte. 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. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155) and the laboratory's proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the immunology specialty in two consecutive PT events, resulting in the first unsuccessful PT occurrence for the immunology specialty. The findings include: 1. Review of the CMS 155 report revealed the following for the immunology specialty: 2020 event three scored as 70% 2021 event one scored as 70% 2. Review of the laboratory's proficiency testing records for 2020 event three revealed a score of 40% for the Complement C3 analyte, resulting in an overall event score of 70% for the immunology specialty. 3. Review of the laboratory's proficiency testing records for 2021 event one revealed a score of 40% for the Complement C3 analyte, resulting in an overall event score of 70%, and the first unsuccessful PT occurrence for the immunology specialty. -- 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: The laboratory failed to maintain satisfactory proficiency testing (PT) performance for the automated white blood cell (WBC) differential analyte in 2019 event two, 2020 event one, and 2020 event two, resulting in the second unsuccessful PT occurrence for the automated WBC differential analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- 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 Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2019 and 2020 proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance in three out of four PT events for the white blood cell (WBC) differential, resulting in the second unsuccessful occurrence for the WBC differential. The findings include: 1) Review of the CMS 155 revealed the following unsatisfactory WBC differential scores: 2019 event two = 73% 2020 event one = 0% 2020 event two = 73% 2) Review of the laboratory's 2019 event two PT evaluation report revealed unacceptable scores for WBC differential as follows: Granulocytes %-sample number HEM-06, Lymphocytes %-sample number HEM-07, Monocytes/Mids %-sample numbers HEM- 06 and HEM-07, resulting in an overall score of 73% for the WBC differential. 3) Review of the laboratory's 2020 event one PT evaluation report revealed a score of 0% for the WBC differential for 'Failure to Participate.' 4) Review of the laboratory's 2020 event two PT evaluation report revealed unacceptable scores for WBC differential as follows: Granulocytes %-sample number HEM-06, Monocytes/Mids %- sample numbers HEM-06, HEM-08 and HEM-09, resulting in an overall score of 73% for the WBC differential, and the second unsuccessful PT occurrence. 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: The laboratory director failed to maintain compliance with successful white blood cell (WBC) differential analyte proficiency testing performance and failed to follow the approved allegation of compliance (AOC) for the WBC differential analyte, resulting in the second unsuccessful PT occurrence for the WBC differential analyte. (Refer to D6004) D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Services Casper -- 2 of 3 -- report 155 (CMS 155), the laboratory's 2019 and 2020 proficiency testing (PT) evaluation reports and the laboratory's Allegation of compliance (AOC), the laboratory director failed to follow the approved May 12, 2020 AOC for the WBC differential analyte, resulting in the second unsuccessful PT occurrence for the WBC differential analyte. The findings include: 1) Review of the CMS 155 report and the laboratory's PT evaluation report for 2019 event two, 2020 event one and two revealed the WBC differential scores as follows: 2019 event two = 73%, 2020 event one = 0%, 2020 event two = 73%. 2) Review of the laboratory's AOC dated May 12, 2020, in reference to a previous failure to maintain compliance with successful PT, signed by the laboratory director on May 14, 2020 revealed the following statement: "To prevent this from reoccurring the TP were trained on sample handling, mixing and correct procedure for submitting results online." "The technical consultant will review this clinic quarterly to be sure this does not reoccur." -- 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: The laboratory failed to maintain satisfactory participation in two out of three proficiency testing (PT) events for the automated white blood cell (WBC) differential, resulting in the first unsuccessful PT occurrence for the automated WBC differential. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- 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 Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2019 and 2020 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the automated white blood cell (WBC) differential in two out of three PT events, resulting in the first unsuccessful PT occurrence for the automated WBC differential. The findings include: 1) Review of the CMS 155 revealed the following unsatisfactory PT scores for the automated WBC differential: 2019 event two: 73% 2020 event one: 0% 2) Review of the laboratory's proficiency testing records revealed the following: 2019 event two: Unacceptable scores for Lymphocyte % for sample number HEM-07, Monocytes/Mids % sample numbers HEM-06 and HEM-07, and Granulocyte % sample number HEM-06, resulting in an overall score of 73% for the automated WBC differential. 2020 event one: WBC Differential scored as 0% for "Failure to Participate," resulting in the first unsuccessful PT occurrence for the automated WBC differential. -- 2 of 2 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the 2018 and 2019 proficiency testing (PT) records and interview with the technical consultant, the laboratory failed to perform PT samples in the same manner as patient samples. The findings include: 1) Review of the 2018 and 2019 PT records revealed the following: repeatedly testing the PT samples for the complete blood count (CBC), the erythrocyte sedimentation rate (ESR), the chemistry analytes, the immunology analytes and not documenting the PT results on the laboratory logsheets. 2) Interview on April 15, 2019 at 10:00 a.m. with the technical consultant confirmed the PT samples are not performed in the same manner as patient samples, when repeatedly testing and not documentation correctly on the laboratory logsheets. 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 --