Mountain View Clinic 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 the 2021 CMS Casper Reports 0155D, 0153 D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte Total Bilirubin. Survey Findings follow: 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 as cited at 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 2021 CMS Casper Reports 0155D and 0153 D and American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte Total Bilirubin (TB) and the analyte Carbon Dioxide (CO2). Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a sore of 0% for the analyte CO2 and 0% for the analyte TBILI in the first proficiency testing event of 2021. B. A review of the proficiency testing results revealed the laboratory received a score of 40% for the analyte of CO2 in the second proficiency testing event of 2021 and a score of 60% for the analyte TBILI in the third proficiency testing event of 2021. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: . Based on review of 2021 proficiency testing results, it was determined the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: . Based on review of 2021 proficiency testing event, it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Analyte Total Bilirubin. Refer to D2096 -- 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: . Through a review of the laboratory policy and procedure manual, manufacturer's instruction for Sysmex XP-300 Hematology Analyzer, patient results, lack of documentation and interview with laboratory personnel, it was determined the laboratory failed to follow its own policy for resolving flags prior to their release to the healthcare provider. As evidenced by: A. A review of the laboratory policy for Histogram Flags revealed "When the Histogram Flags are displayed, perform the analysis again. If after the repeat analysis the flags are still displayed, the sample is considered to correspond to the "Probable Sample Cause" listed on page 8-21 and 8- 22 of the Sysmex XP-300 Operators Manual. B. A review of manufacturer's instruction for the Sysmex XP-300 Hematology analyzer page 8-21 and 8-22 under the section "Flagging Summary" revealed the manufacturer identified the following flags and possible actions for: Differentials: Flag [WL]: Probable cause: Incomplete lysing of red cells, presence of nucleated red blood cells, increase of large platelets, platelet aggregation or agglutination, precipitation or fibrin. Correction: [1] Centrifuge the sample and replace the plasma with equal volume of saline or CELLPACK and repeat analysis, [2] Check smear. Flag [T1]: Probable cause: Presence of Chronic Myelogenous Leukemia (CML) or other immature Granulocytes, incomplete lysing of red blood cells. Correction: [1] Check smear [2] Centrifuge sample and replace the plasma with equal volume of saline or CELLPACK and repeat analysis, warm sample at 37 degrees Celsius for 30 minutes and repeat analysis. Flag [T2]: Probable Cause: Presence of CML or other immature Granulocytes, incomplete lysing of red blood 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 -- cells, aged sample. Correction: [1] Check smear, [2] Centrifuge sample and replace the plasma with equal volume of saline or CELLPACK and repeat analysis, warm sample at 37 degrees Celsius for 30 minutes and repeat analysis. Platelet Flags: Flag [AG]: Probable cause: Presence of nucleated red blood cells, effects of fragmented red blood cells, increase of large platelets, platelet aggregation or agglutination, precipitation of fibrin, etc. Correction: Check smear. C. In an interview on 9/25/2019 at 1430, the technical consultant confirmed the laboratory does not perform manual differentials or slide review. If after repeat analysis the histogram flags are present, the sample should be verified by the reference laboratory. D. A review of patient Complete Blood Count (CBC) results revealed ten of twenty-five patients result had flags that were not resolved prior to their release to the healthcare provider. Patient #10109453 Flag: AG and T2 No repeat analysis performed specimen was not sent to reference laboratory for verification. Patient #10109463 Flag: AG No repeat analysis performed specimen was not sent to reference laboratory for verification. Patient #1019467 Flag: AG No repeat analysis performed specimen was not sent to reference laboratory for verification. Patient #10109517 Flag: AG No repeat analysis performed specimen was not sent to reference laboratory for verification. Patient #1019542 Flag: AG No repeat analysis performed specimen was not sent to reference laboratory for verification. Patient #10109545 Flag: WL and AG No repeat analysis performed specimen was not sent to reference laboratory for verification. Patient #10109547 Flag: AG No repeat analysis performed specimen was not sent to reference laboratory for verification. Patient #10109430 Flag: AG No repeat analysis performed specimen was not sent to reference laboratory for verification. Patient #10109439 Flag: AG No repeat analysis performed specimen was not sent to reference laboratory for verification. Patient 1019363 Flag: AG No repeat analysis performed specimen was not sent to reference laboratory for verification. E. The Surveyor asked for documentation of resolving the flags prior to their release to healthcare provider. No documentation was provided. F. In an interview on 9/25/2019 at 1500, technical consultant confirmed the findings and that the specimens were not sent to the reference laboratory for verification. 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: . Through a review of the new instrument Verification Studies, which was performed on 08/20/2019 for the Ortho Clinical Diagnostics Vitros 350, lack of documentation, as well as interviews with staff, it was determined the laboratory failed to verify the reportable range established by the manufacturer for three of nineteen Chemistry Analytes verified on the Ortho Clinical Diagnostics Vitros Chemistry Analyzer. As evidenced by: A. A review of the Ortho Clinical Diagnostics analytical measurement range study for three of nineteen analytes revealed the reportable ranges for Total Bilirubin (TBILI) as 0.1 to 27, Triglycerides (TRIG) 10 to 525 and Alkaline Phosphatase (ALKP) 20 to 1500. B. A review of the Ortho Clinical Diagnostics -- 2 of 3 -- analytical measurement range study dated 8/21/2019 include the following ranges verified by testing standard solutions: TBILI 1.1 to 17.14, TRIG 26.4 to 474.3 and ALKP 20 to 1250.5. The laboratory did not verify the full analytic range established by the manufacturer. C. In an interview on 9/25/2019 at 14:00 on the technical consultant confirmed the laboratory did not verify the full reportable range established by the manufacturer for the Ortho Clinical Diagnostic Vitros 350 Chemistry Analyzer. -- 3 of 3 --