Lewis Family Care

Summary Statement of Deficiencies D0000 Based on desk review of proficiency testing (PT) from 2022 through 2023 the laboratory failed to meet the following conditions resulting in a noninitial unsuccessful PT performance: D2016 - SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) D6000 - MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 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 proficiency testing records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under 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 -- CLIA. The laboratory failed to successfully participate in the specialty of Routine Chemistry and the subspecialty of Endocrinology. (Refer to D2096, D2107, D2108) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 Individual Laboratory Report and American Proficiency Institute 2022 records (1st, 2nd and 3rd events), the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three events in the specialty of Routine Chemistry for the analyte Creatinine and two consecutive testing events for the analyte Total Bilirubin (Bili, Total). The findings include: 1. Review of the Casper -0155 report revealed the following: Routine Chemistry 2022- 1st Event Laboratory received an unsatisfactory score of 20% for Creatinine Routine Chemistry 2022- 3rd Event Laboratory received an unsatisfactory score of 0% for Creatinine. Routine Chemistry 2022- 2nd Event Laboratory received an unsatisfactory score of 40% for BILI, Total Routine Chemistry 2022- 3rd Event Laboratory received an unsatisfactory score of 0% for BILI, Total 2. A proficiency testing desk review from API 2022 proficiency testing records confirmed the above findings. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) testing records from 2022 and 2023, the laboratory failed to achieve a testing event score of satisfactory performance (80% or greater) for two consecutive testing events for the analyte Thyroid Stimulating Hormone (TSH) in the subspecialty in Endocrinology. The findings include: 1. Review of the Casper -0155 report revealed the following: Endocrinology 2022- 3rd Event Laboratory received an unsatisfactory score of 0% for TSH Endocrinology 2023- 1st Event Laboratory received an unsatisfactory score of 40% for TSH. 2. A proficiency testing desk review from API 2022 and 2023 proficiency testing records confirmed the above findings. D2108 ENDOCRINOLOGY CFR(s): 493.843(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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) report 155 Individual Laboratory Profile, American Proficiency Institute (API) testing records from 2022 and 2023, the laboratory failed to achieve an overall testing even score of satisfactory performance (80% or greater) for two consecutive testing events in the subspecialty Endocrinology resulting in unsuccessful performance. The findings include: 1. Review of the Casper -0155 report revealed the following: Endocrinology 2022- 3rd Event Laboratory received an overall unsatisfactory score of 0% FOR ENDOCRINOLOGY Endocrinology 2023- 1st Event Laboratory received an overall unsatisfactory score of 70% FOR ENDOCRINOLOGY 2. A proficiency testing desk review from API 2022 and 2023 proficiency testing records confirmed the above findings. 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 laboratory proficiency testing performance, it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. 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 a desk review of proficiency testing results, it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096, D2107, and D2108. -- 3 of 3 --

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 staff interview and record review on 06/03/2021, the Laboratory Director failed to perform and document annual competency using the 6 mandated competency assessment requirements for testing personel. Competency assessment was not performed using six (6) methods of assessment for testing personnel from 04/09/2019 though 06/02/2021. Findings include: 1. Record review on 06/03/2021 revealed there was no documented competency assessments for Hematology or Chemistry specialties from 04/09/2019 through 06/02/2021, for testing personnel. Competency assessments failed to include direct observation of routine patient test performance, direct observation of performance of instrument maintenance function checks and calibration, monitoring the recording and reporting of test results, review of worksheets, review of quality control records, review of proficiency test results, review of maintence records, assessment of testing external proficiency testing samples and problem solving skills. An interview with the staff on 06/03/2021 at 10: 00AM revealed the facility failed to have a system in place between 04/09/2019 through 06/02/2021 to ensure competency was performed using all six (6) mandated competency assessment requirements. 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 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 -- identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on staff interview and record review, it was determined the laboratory failed to perform quality assessment from 09/10/2019 through 06/02/2021. Findings include: 1. Record review revealed there was not documented evidence of quality assessment performed from 09/10/2019 through 06/02/2021. 3. An interview on staff on 06/03 /2021 at 1:00PM indicated that the facility has a quality assessment plan in place but was not followed from 09/10/2019 through 06/02/2021. 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 record review and staff interview on 06/03/2021, the laboratory failed to verify the performance specifications established by the manufacturer prior to reporting patient test results when the Beckman Coulter Access 2 and Alpha Wasserman ACE AXCEL analyzers were moved to a new location on 12/01/2019. Findings include: 1. Review of records revealed that the laboratory failed to assess the accuracy of test systems prior to reporting patient results after analyzer was moved 12 /01/2019. 2. Review of records revealed that the laboratory failed to assess day-to- day, run-to-run, and with-in run precision to ensure reproducibility prior to reporting patient results after analyzer was moved 12/01/2019. 3. Interview with staff at 1:00 PM on 06/03/2021 revealed the laboratory failed to have a system in place to ensure accuracy and precision performance specifications were verified after analyzers were moved. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on staff interview and record review on April 12, 2019, the laboratory failed to monitor and document the humidity in the laboratory where the testing was performed. Humidity was not recorded from April 5, 2017 through April 11, 2019. Findings include: The Manufacturer's Operations Manual for the Medonic Analyzer lists an operating range for humidity for the analyzer between zero percent (0%) and eighty percent (80%). The Manufacturer's Operations Manual for the Access 2 analyzer and the Alpha Wasserman lists an operating range for humidity for the analyzer between twenty percent (20%) and eighty percent (80%). Review of the Laboratory Temperature Log, revealed no documented evidence the humidity had been monitored and recorded from April 5, 2017 through April 11, 2019. Testing Personnel acknowledged in an interview on 04/12/19 at 9:10 AM, the Laboratory Director failed to have a system in place to ensure the humidity was monitored and documented daily. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of 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 -- 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 staff interview and record review on April 12, 2019, the Technical Consultant failed to perform and document Annual Competency using the six (6) mandated competency assessment requirements for testing personal. Competency Assessment was not performed using six (6) methods of assessment for one (1) out of one (1) employee reviewed from May 1, 2018 through April 11, 2019. Findings include: Record review on April 12, 2019 revealed there was no documented Competency Assessments between May 1, 2018 and April 11, 2019, for one (1) employee that included the following: direct observation of routine patient test performance; direct observation of performance of instrument maintenance function checks and calibration; monitoring the recording and reporting of test results; review of worksheets; review of quality control records; review of proficiency test results; review of maintenance records; assessment of testing external proficiency testing samples; and problem solving skills. Interview with staff on 04/12/19 at 8:55 AM, revealed the facility failed to have a system in place between May 1, 2018 and April 11, 2019 to ensure competency was performed using all six (6) mandated competency assessment requirements. -- 2 of 2 --