Willard M West Md

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 155D (CMS 155D) and Medical Laboratory Evaluation (MLE) PT performance summary report, the laboratory failed to maintain satisfactory performance in the specialty of Hematolgoy for the Complete Blood Count (CBC) in the 1st event 2018, 1st and 2nd event 2019 and 1st event of 2020 resulting in the second unsuccessful PT performance occurrence. (Refer to D2031). 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 a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 155D (CMS 155D) and Medical Laboratory Evaluation (MLE) proficiency testing (PT) performance summary report, the laboratory failed to maintain satisfactory performance in the specialty of Hematology for CBC in 2018, 2019 and 2020 resulting in the second unsuccessful PT performance occurrence. The findings include: 1. Review of the CMS Casper 155D report revealed 1st event 2018 with a score of 0%, 1st and 2nd event 2019 with a score of 0% and 1st event of 2020 with a score of 62%. 2. Review of the MLE PT performance summary report revealed 1st event 2018 with a score of 0%, 1st and 2nd event 2019 with a score of 0% and 1st event of 2020 with a score of 62% resulting in the second unsuccessful PT performance occurrence. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assurance (QA) procedure and interview with the lead testing person, the laboratory failed to perform monthly QA monitors as indicated in the QA procedure for 2018 and 2019. The findings include: 1. Lack of monthly QA documents available for review for 2018 and 2019. 2. Interview with the lead testing person at 1:45 p.m. on December 16, 2019 confirmed the laboratory did not assess monthly QA as indicated in the QA procedure for 2018 and 2019. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the 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 -- 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 patient chart audit review and interview with the lead testing person the laboratory failed to perform calibration every 6 months per manufacturers instructions for the Beckman Coulter ACT-5 Complete Blood Count (CBC) analyzer in 2018. The findings include: 1. Review of patient chart audit to include calibration review determined there was only one calibration performed for the Beckman Coulter ACT-5 Complete Blood Count (CBC) analyzer in 2018. 2. Interview with the lead testing person at 1:45 p.m. on December 16, 2019 confirmed there was only one calibration performed for the Beckman Coulter ACT-5 Complete Blood Count (CBC) analyzer in 2018. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of patient Complete Blood Count (CBC) results, laboratory's CBC quality control (QC) procedure and interview with the lead testing person determined the laboratory failed to ensure CBC QC was performed prior to testing patient in 2018 and 2019. The findings include: 1. Review of 24 patients CBC results revealed QC was not performed on 5 out of 24 patients prior to resulting the CBC result on the following days 06/08/18, 05/07/19, 05/24/19, 06/26/19, 07/23/19. 2. Review of the laboratory's CBC QC procedure revealed 3 levels of QC must be run prior to patient testing. 3. Interview with the lead testing person on December 16, 2019 at 1:30 p.m. confirmed the laboratory failed to ensure CBC QC was performed prior to testing patient in 2018 and 2019 D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. -- 2 of 4 -- This CONDITION is not met as evidenced by: Based on review of the laboratory's Quality Control (QC) procedure, Quality Assessment (QA) procedure and interview with the lead testing person the Technical Consultant failed to ensure quality control are maintained throughout the entire testing process (D6042), evaluate competency of all testing personnel (D6046) and evaluate performance of testing persons semiannually for the Complete Blood Count (CBC) test (D6053) in 2018 and 2019. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) 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; This STANDARD is not met as evidenced by: Based on review of patient Complete Blood Count (CBC) results, laboratory's CBC quality control (QC) procedure and interview with the lead testing person determined the Technical Consultant failed to ensure CBC QC was performed prior to testing patient in 2018 and 2019. The findings include: 1. Review of patient CBC results found 5 of 24 did not have QC performed prior to reporting the CBC results on 06/08 /18, 05/07/19, 05/24/19, 06/26/19, 07/23/19. 2. Review of the laboratory's CBC QC procedure revealed 3 levels of QC must be run prior to patient testing. 3. Interview with the lead testing person on December 16, 2019 at 1:30 p.m. confirmed the Technical Consultant failed to ensure CBC QC were performed prior to testing patient on 06/08/18, 05/07/19, 05/24/19, 06/26/19, 07/23/19. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on testing personnel record review and interview with the lead testing person the Technical Consultant (TC) failed to evaluate competency assessment for the Complete Blood Count (CBC) for 2 of 2 testing persons in 2018 and 2019. The findings include: 1. Review of the testing personnel competency assessment record revealed 2 of 2 testing persons did not have documentation of the six required criteria of competency that include: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, assessment of problem solving skills in 2018 and 2019. 2. Interview with the lead testing person at 1:30 p.m. on December 16, 2019 confirmed the TC did -- 3 of 4 -- not evaluate competency assessment for the CBC test for 2 of 2 testing persons in 2018 and 2019. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the testing personnel records and interview with the lead testing person the Technical Consultant (TC) failed to evaluate 2 of 2 testing persons semiannually for the new Beckman Coulter ACT- 5 Complete Blood Count (CBC) analyzer in 2019. The findings include: 1. Testing person 1 and 2 did not have semiannual competency assessment by the TC for the new Beckman Coulter ACT- 5 CBC analyzer in 2019. 2. Interview with the lead testing person at 1:35 p.m. on December 16, 2019 confirmed the TC failed to asses testing persons 1 and 2 semiannual competency assessment for the new Beckman Coulter ACT- 5 CBC analyzer in 2019. -- 4 of 4 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 153 & 155 (CMS 153 &155) and the Medical Laboratory Evaluations (MLE) evaluation reports, the laboratory failed to enroll in the specialty Hematology Complete Blood Count (CBC) for all analytes: red blood cells (RBC), white blood cells (WBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet (Plt), and automated WBC differential (WBC diff) for the year 2017. 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 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 -- 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 proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 153 & 155 (CMS 153 &155) and the Medical Laboratory Evaluations (MLE) evaluation reports, the laboratory failed to maintain satisfactory performance in the specialty Hematology Complete Blood Count (CBC) for all analytes: red blood cells (RBC), white blood cells (WBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet (Plt), and automated WBC differential (WBC diff) for the 1st and 2nd events of 2018 and 2019 (4 of 5 events unsuccessful) resulting in the second unsuccessful performance occurrence. (Refer to D2131). 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 a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 153 & 155 (CMS 153 &155) and the Medical Laboratory Evaluations (MLE) evaluation reports, the laboratory failed to maintain satisfactory performance in the specialty Hematology Complete Blood Count (CBC) for all analytes: red blood cells (RBC), white blood cells (WBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet (Plt), and automated WBC differential (WBC diff) resulting in the second unsuccessful occurrence. The findings include: 1. Review of the CMS CASPER report 153 & 155 revealed a score of 0% in the specialty Hematology Complete Blood Count (CBC) for all analytes: red blood cells (RBC), white blood cells (WBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet (Plt), and automated WBC differential (WBC diff) for the 1st and 2nd events of 2018 and 2019 (4 of 5 events unsuccessful). 2. Review of MLE evaluation reports revealed a score of 0% in the specialty Hematology Complete Blood Count (CBC) for all analytes: red blood cells (RBC), white blood cells (WBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet (Plt), and automated WBC differential (WBC diff) for the 1st and 2nd events of 2018 and 2019 (4 of 5 events unsuccessful). 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on a review of the laboratory's unsatisfactory performance of proficiency testing (PT) second unsuccessful performance, the laboratory failed to maintain satisfactory performance in the specialty Hematology Complete Blood Count (CBC) for all analytes: red blood cells (RBC), white blood cells (WBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet (Plt), and automated WBC differential (WBC diff) for the 1st and 2nd events of 2018 and 2019 (4 of 5 events unsuccessful) resulting in the second unsuccessful performance occurrence. (See 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 review of the laboratory's unsatisfactory performance of proficiency testing (PT) second unsuccessful performance, the laboratory failed to maintain satisfactory performance in the specialty Hematology Complete Blood Count (CBC) for all analytes: red blood cells (RBC), white blood cells (WBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet (Plt), and automated WBC differential (WBC diff) for the 1st and 2nd events of 2018 and 2019 (4 of 5 events unsuccessful) resulting in the second unsuccessful performance occurrence. Findings include: 1. Review of the CMS CASPER report 153 & 155 revealed a score of 0% in the specialty Hematology Complete Blood Count (CBC) for all analytes: red blood cells (RBC), white blood cells (WBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet (Plt), and automated WBC differential (WBC diff) for the 1st and 2nd events of 2018 and 2019 (4 of 5 events unsuccessful). 2. During a review of an email correspondence from the PT agency (MLE) official on August 8, 2019, at 1:44:50pm, revealed the laboratory failed a score of 0% in the specialty Hematology Complete Blood Count (CBC) for all analytes: red blood cells (RBC), white blood cells (WBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet (Plt), and automated WBC differential (WBC diff) for the 1st and 2nd events of 2018 and 2019 (4 of 5 events unsuccessful). -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 153 & 155 (CMS 153 &155) and the Medical Laboratory Evaluations (MLE) evaluation reports, the laboratory failed to maintain satisfactory performance in the specialty Hematology Complete Blood Count (CBC) for all analytes: red blood cells (RBC), white blood cells (WBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet (Plt), and automated WBC differential (WBC diff) for the 1st and 2nd events of 2018 resulting in the first unsuccessful occurrence. (Refer to D2131). 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 -- 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 a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 153 & 155 (CMS 153 &155) and the Medical Laboratory Evaluations (MLE) evaluation reports, the laboratory failed to maintain satisfactory performance in the specialty Hematology Complete Blood Count (CBC) for all analytes: red blood cells (RBC), white blood cells (WBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet (Plt), and automated WBC differential (WBC diff) resulting in the first unsuccessful occurrence. The findings include: 1. Review of the CMS CASPER report 153 & 155 revealed a score of 0% in the specialty Hematology Complete Blood Count (CBC) for all analytes: red blood cells (RBC), white blood cells (WBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet (Plt), and automated WBC differential (WBC diff) for the 1st and 2nd events of 2018. 2. Review of MLE evaluation reports revealed a score of 0% in the specialty Hematology Complete Blood Count (CBC) for all analytes: red blood cells (RBC), white blood cells (WBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet (Plt), and automated WBC differential (WBC diff) for the 1st and 2nd events of 2018. -- 2 of 2 --