Arthritis Consultants, Inc

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 2022 and 2023 hematology proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the laboratory director, the laboratory failed to successfully participate in PT. See D-tag 2130; unsuccessful performance in two out of three consecutive red blood cell count PT events. D2130 HEMATOLOGY CFR(s): 493.851(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 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 review of hematology proficiency testing (PT) records for 2022/2023 and phone interview with the laboratory director, the laboratory failed to achieve satisfactory performance for red blood cell count in two out of three consecutive PT events. Findings: 1. Review of hematology PT results for the third event of 2022 showed the laboratory obtained an unacceptable score of 60 percent for red blood cell count. 2. Review of hematology PT results for the second event of 2023 showed the laboratory obtained an unacceptable score of 60 percent for red blood cell count. 3. Phone interview with the laboratory director on August 31, 2023 at 11:00 AM confirmed the laboratory failed to achieve satisfactory performance for red blood cell count in two out of three consecutive PT events. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the performance verification procedures for the DxH 560 hematology analyzer and interview with the technical consultant (TC), the laboratory failed to verify performance specifications prior to reporting patient test results. Findings: 1. Review of the performance specifications for the DxH560 hematology analyzer showed the laboratory failed to verify that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient population for the analytes: red blood cell (RBC), hemoglobin, hematocrit, platelet, and white blood cell (WBC) prior to the beginning of patient testing in November 2022. 2. Interview with the TC on April 18, 2023 at 9:00 AM confirmed the laboratory failed to verify performance specifications prior to reporting patient test results. 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 --

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 2022 hematology proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the technical consultant, the laboratory failed to successfully participate in PT. See D-tag 2130; unsuccessful performance in two out of three consecutive white blood cell and hemoglobin PT challenges. See D-tag 2131; unsuccessful performance in two out of three consecutive hematology specialty testing events. D2130 HEMATOLOGY CFR(s): 493.851(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 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 review of hematology proficiency testing (PT) records for 2022 and phone interview with the technical consultant, the laboratory failed to achieve satisfactory performance for white blood cell and hemoglobin analytes in two out of three consecutive PT events. Findings: 1. Review of hematology PT results for the first event of 2022 revealed the laboratory obtained an unacceptable score of 40 percent for white blood cell analyte and unacceptable score of 0 percent for the hemoglobin analyte. 2. Review of hematology PT results for the third event of 2022 revealed the laboratory obtained an unacceptable score of 60 percent for the white blood cell analyte and unacceptable score of 60 percent for the hemoglobin analyte 3. Phone interview with the technical consultant on December 15, 2022 at 1:30 PM confirmed the laboratory failed to achieve satisfactory performance for white blood cell and hemoglobin analytes in two out of three consecutive PT events. D2131 HEMATOLOGY CFR(s): 493.851(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 review of hematology proficiency testing (PT) records for 2022 and phone interview with the technical consultant, the laboratory failed to achieve an overall testing event score of satisfactory performance for the specialty of hematology in two out of three consecutive PT events. Findings: 1. Review of hematology PT results for the first event of 2022 revealed the laboratory obtained an unacceptable score of 56 percent for the specialty of hematology. 2. Review of hematology PT results for the third event of 2022 revealed the laboratory obtained an unacceptable score of 63 percent for the specialty of hematology. 3. Phone interview with the technical consultant on December 15, 2022 at 1:30 PM confirmed the laboratory failed to achieve satisfactory performance for specialty of hematology in two out of three consecutive PT events. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of procedure manuals for the Coulter AcT diff2 hematology analyzer, patient and background reports and interview with the technical consultant (TC), the laboratory failed to have a policy for hematology troubleshooting for analyzer flags and repeated failed background counts. Findings: 1. Review of the procedure manuals for Coulter AcT diff2 hematology analyzer and patient test reports showed the laboratory must refer to the troubleshooting manual for analyzer flags. The laboratory failed to define in a policy the acceptable criteria and resolution for patient samples when flags occurred on patient results. 2. Review of background counts for the startup of Coulter AcT diff2 hematology analyzer showed multiple attempts at failed background counts to achieve acceptability. The laboratory failed to define in a policy the acceptable criteria and resolution for failed background counts. 3. Interview with the TC on December 16, 2020 at 10:30 AM confirmed the laboratory failed to have a policy for troubleshooting patient result flags, and acceptable criteria and resolution for failed background counts. 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 --

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 2019, 2020 routine chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the tehnical consultant, the laboratory failed to successfully participate in PT. See D-tag 2096, unsatisfactory performance in two out of three consecutive PT challenges. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 review of chemistry proficiency testing (PT) results for 2019 and 2020 and phone interview with the technical consultant, the laboratory failed to achieve satisfactory performance for the analyte, albumin (ALB) in two out of three consecutive PT events. Findings: 1. Review of the chemistry PT results the second event of 2019 revealed the laboratory obtained an unsatisfactory score of 0 percent for ALB. 2. Review of the chemistry PT results for the first event of 2020 revealed the laboratory obtained an unsatisfactory score of 20 percent for ALB. 3. Phone interview with the technical consultant on April 9, 2020 at 2:30 PM confirmed the laboratory failed to achieve satisfactory performance for ALB testing in two out of three consecutive PT events for 2019 and 2020. -- 2 of 2 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of 2017, 2018 proficiency testing(PT) results for complete blood cell counts(CBC) performed on the ACT T diff 2 hematology analyzer, procedure manual and interview with the technical consultant, the laboratory failed to test the PT samples the same number of times as patient samples. Findings: 1. Review of 2017 first and second PT events for CBC results performed on the ACT T diff 2 analyzer showed the laboratory repeated the specimens three times. 2. Review of the 2018 second and third PT events for CBC results performed on the ACT T diff 2 analyzer showed the laboratory repeated the specimens three times. 3. Review of the procedure manual revealed "ensure PT is performed in the same manner as patient testing". 4. Interview with the technical consultant on December 12, 2018 at 10:30 AM confirmed the laboratory does not routinely repeat patient samples three times and failed to test PT samples the same number of times as patient samples. 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 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 -- 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 review of hematology calibration records for the Beckman Coulter ACT T diff 2 analyzer, review of the procedure manual and interview with the technical consultant, the laboratory failed to perform calibration verification procedures on the hematology analyzer for complete cell counts at least once every six months for 2017. Findings: 1. Review of calibration records for the ACT T diff 2 for 2017 revealed the laboratory failed to perform 1 of 2 calibrations for the required 6 month interval. 2. Review of the procedure manual revealed an approved policy to "verify calibrations are performed at frequency indicated by the manufacturer or at least every six months". 3. Interview with the technical consultant on December 12, 2018 at 10:30 AM confirmed the laboratory failed to perform calibration of the hematology analyzer every six months for 2017. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) 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 review of the procedure manual, personnel documentation and interview with the technical consultant, the laboratory director failed to ensure the technical consultant maintained competency for 2017 and to date December 4, 2018. Findings: 1. Review of 2017, 2018 employee competencies revealed "documentation of an evaluation every six months for the first year and annually thereafter". 2. Review of personnel documentation revealed the laboratory director failed to ensure the techncial consultant had an evaluation annually for 2017 and to date December 12, 2018. 3. Interview with the technical consultant on December 12, 2018 at 10:30AM confirmed the laboratory director failed to ensure competencies for 2017 and to date December 12, 2018 for the technical consultant were completed. -- 2 of 2 --