Gigi Wood Davis, Do Family Practice

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of maintenance records, patient data logs, and staff interviews, the laboratory failed to retain the Background function check (one of three dates reviewed) for the Sysmex instrument used to perform complete blood count with automated differential (CBC w/Diff) patient testing in 2025. The findings include: 1. Observation of the laboratory on 05/07/2025 at 10:15 am revealed the Sysmex XP-300 (Serial B6106) instrument used for CBC w/Diff patient testing. 2. A review of the laboratory's Medicus laboratory information system (LIS) report titled "Blank Check Results" for 04/01/2025 through 04/30/2025 revealed that the laboratory did not record a background function check for 04/08/2025. Documentation of the background function check from 04/08/2025 was not available on the survey date (05/07/2025). 3. A review of the laboratory's patient data records, titled "Accession Log," revealed that five CBC w/Diff patient samples were reported on 04/08/2025. 4. An interview with the laboratory director on 05/07/2025 at 1:00 pm confirmed the survey findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for 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 -- specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

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 observation of the laboratory, review of the manufacturer's instructions for use, the laboratory's environmental records, recorded humidity readings, and staff interview, the laboratory failed to ensure it monitored humidity according to the manufacturer's requirements for 12 of 18 months reviewed for 2022, 2023, and 2024. The findings include: 1. Observation of the laboratory on 03/25/24 at 8:20 am revealed the Sysmex XP 300 instrument used for performing patient testing for Complete Blood Count with White Blood Cell Differential (CBC w/Diff). 2. The manufacturer's stated operating humidity range was 30 to 85%. 3. Review of the laboratory's environmental records revealed a humidity range of 10-80% for the months of 11/2022, 12/2022, 01/2023, 03/2023, 04/2023, 09/2023, 10/2023, 11/2023, 11/2023, 12/2023, 01/2024, 02/2024 and 03/2024. 4. The laboratory director stated during interview on 03/25/24 at 2 pm that the laboratory had somehow used the wrong form for monitoring humidity for several months since November 2022. This confirmed the survey findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the laboratory and staff interview, the laboratory failed to ensure capillary tubes used for collecting patient fingerstick samples for CBC w/Diff had not expired on the date of the survey (03/25/24.) 1. Observation of the laboratory on 03/25/24 at 8:20 am revealed capillary tubes used for collection of CBC samples that were expired. The observed expiration dates ranged from 9/30/2020 to 12/31 /2023. 2. The lead testing person confirmed during interview on 03/25/24 at 8:50 am that the capillary tubes used for collecting fingerstick samples for CBC were expired. D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(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-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, staff interview during observation, and subsequent interview with the laboratory director, the laboratory failed to perform QC on the Sysmex XP 300 CBC instrument after changing reagents. 1. Observation of the laboratory on 03/25/24 at 8:20 am revealed the Sysmex XP 300 instrument used for performing patient testing for CBC w/Diff. The lead testing person was asked to describe when quality control was performed. She stated each morning before patient testing. When asked if QC was performed after changing reagents she stated they did not perform QC after reagent changes. 2. The laboratory director confirmed the survey findings during interview on 03/25/24 at 2 pm. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer's QC package insert, the laboratory's QC ranges in the Medicus Laboratory Information System (LIS), Sysmex Insight QC records, and staff interview, the laboratory failed to ensure it verified the manufacturer's stated QC ranges for the hematocrit analyte before use on 03/04/24 for lot number 40510710 (one of fifteen lots reviewed). The findings include: 1. Observation of the laboratory on 03/25/24 at 8:20 am revealed the Sysmex XP 300 instrument used for performing patient testing for Complete Blood Count with White Blood Cell Differential (CBC w/Diff). The current QC lot observed was 4051 (levels low-40510710, normal-40510711, and high-40510712). 2. The manufacturer QC range for hematocrit for lot 40510710 was 16.3 +/- 1.5. 3. The QC range entered in the Medicus LIS system for hematocrit for lot 40510710 was 16.6 +/- 1.5. 4. Sysmex Insight QC records revealed the laboratory put lot 40510710 in use on 03/04 /24. 4. The laboratory director confirmed the survey findings during an interview on 03 /25/24 at 2 pm. 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. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's QC data, lack of documentation, and staff interview, the laboratory failed to follow the laboratory policy for review of quality control data for the period from 01/03/23 to 01/06/23 for QC lot 2277 (low, normal and high levels). The findings include: 1. Review of the laboratory's Sysmex Insight QC report for lot 2277 (levels low, normal and high) revealed the lots were used in January 2023 from 01/03/23 to 01/06/23. 2. There was no documented review of the QC data for lot 2277 for the period in January 2023 when the lot number was in use. 3. The laboratory director confirmed during interview on 08/25/24 at 2 pm that the laboratory failed to print and review the QC data for lot 2277 in January 2023 after changing lot numbers on 01/09/23. -- 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 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 automated white blood cell (WBC) differential (DIFF) resulting in the first unsuccessful PT occurrence for the WBC DIFF analyte. (See D2130) 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 desk review of the CMS 155 and the laboratory's 2022 and 2023 API PT evaluation reports, the laboratory failed to maintain satisfactory performance for two out of three test events for the automated WBC DIFF analyte. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory WBC DIFF scores: 2022 Event two 33% 2023 Event one 73% 2. Review of the API PT evaluation report for 2022 Event two revealed an overall score of 33% for the WBC DIFF analyte. 3. Review of the API PT evaluation report for 2023 Event one revealed an overall score of 73% for the WBC DIFF analyte. -- 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 observation of the laboratory, review of the Sysmex XP300 manufacturer instructions for use, document request, and interview with the lab director, the laboratory did not monitor the room temperature or humidity for operation of the Sysmex XP300 complete blood count (CBC) instrument in 2020, 2021, or 2022. The findings include: 1. Observation of the laboratory on 08/24/2022 at 8:20 am revealed the Sysmex XP300 (serial # B6106) in use for patient testing for complete blood count (CBC). 2. Review of the Sysmex XP300 manufacturer instructions for use revealed the instrument has an operating temperature of 15-30 degrees Celsius and a humidity range of 30-85%. 3. Request on 08/24/2022 at 9:30 am to the lab director for temperature and humidity monitoring records revealed no records were available. 4. Interview on 08/24/2022 at 3:30 pm with the lab director confirmed the lab did not monitor the room temperature or humidity in the area where the Sysmex XP300 CBC instrument was being used in 2020, 2021 and 2022. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system 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 -- 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 verification of performance specifications (VoPS) studies for the Sysmex XP300, review of patient test records, interview with the lab director, and review of an email communication, the laboratory failed to verify the manufacturer normal ranges for the Sysmex XP 300 complete blood count (CBC) instrument in 2020, 2021 and 2022, with approximately 5,147 patient CBCs performed since testing began. The findings include: 1. Review of the VoPS studies performed for the Sysmex XP300 CBC instrument revealed a normal range (reference range) study was not performed. 2. Review of patient test records revealed the first patient was reported on 06/23/2020 (specimen id 2736). 3. During an interview with the lab director on 08/24 /2022 at 3:30 pm the lab director stated the laboratory uses the manufacturer's normal range and confirmed that a normal range study was not performed to verify the manufacturer ranges were appropriate for the laboratory's patient population. The laboratory began testing patients on 06/23/2020 until date of survey on 08/24/2022. 4. Review of an email communication received on 08/31/2022 at 10:01 am revealed the laboratory performed approximately 5,147 patient CBCs since testing began on 06/23 /2020. 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. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of refrigerator temperature records, the laboratory procedure manual, quality assessment records and interview with the laboratory director, the laboratory failed to follow the written quality assurance procedure in May 2021, resulting in storage of complete blood count (CBC) controls that were outside the acceptable range for eight of nineteen days in May 2021. The findings include: 1. Observation of the laboratory on 08/24/2022 at 8:20 am revealed a refrigerator used for storing CBC controls. 2. Review of the refrigerator temperature log/record for May 2021 revealed an acceptable storage range of 2-8 degrees Celsius. Eight of nineteen days had temperatures recorded that were outside the acceptable temperature range. No

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing (PT) records and interview with the lead testing personnel, the laboratory failed to ensure the laboratory director signed the attestation statements for proficiency testing events 2017 event two miscellaneous chemistry, 2017 event three hematology, 2018 event one miscellaneous chemistry, and 2018 event two hematology (4 of 10 PT events). The findings include: 1) Review of the laboratory 2017, 2018, and 2019 proficiency testing records revealed attestation statements were not signed by the laboratory director for the following proficiency testing events: 2017 event two for miscellaneous chemistry, 2017 event three for hematology 2018 event one for miscellaneous chemistry, 2018 event two for hematology 2) Interview with the lead testing personnel on May 15, 2019 at 10:30 am confirmed the laboratory failed to ensure the laboratory director signed attestation statements for 4 of 10 proficiency testing events in 2017 and 2018. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- Based on review of the laboratory quality control (QC) records and interview with the lead testing personnel, the laboratory failed to retain the complete blood count (CBC) and urine microalbumin and creatinine QC manufacturer assay sheets in 2018 and 2019. The findings include: 1) Review of the laboratory quality control records for CBC revealed the following lot numbers in use from September 9, 2018 through April 1, 2019: 8183, 8267, 8351. No manufacturer QC assay sheets were present. 2) Review of the laboratory quality control records for urine microalbumin and urine creatinine revealed lot numbers 10196679 and 10196680 in use during 2018 and 2019. No manufacturer assay sheets were present. 3) Interview with the lead testing personnel on May 15, 2019 at 3:30 pm confirmed the laboratory failed to retain the manufacturer assay sheets for CBC control lots 8183, 8267, and 8351; and urine microalbumin and urine creatinine QC lot numbers 10196679 and 10196680 in 2018 and 2019. 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 review of the laboratory procedure manual, and interview with the laboratory director, the laboratory failed to have a procedure that met the personnel requirements in subpart M to include all six criteria for assessing personnel competency. The procedure did not include semiannual competency during the first year of patient testing by testing personnel. The findings include: 1) Review of the laboratory procedure titled Quality Assurance Plan, under the section titled PERSONNEL ASSESSMENT, revealed the following six criteria were not included in the procedure: 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. The procedure did not include requirements for semiannual competency assessment during the first year of patient testing. 2) Interview on May 15, 2019 at 5:00 p.m. with the laboratory director confirmed the testing personnel competency procedure did not include all six criteria for testing personnel competency assessment required by the Centers for Medicare and Medicaid Services (CMS) and did not include a procedure for assessing competency at least semiannually during the first year of patient testing. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory proficiency testing -- 2 of 7 -- records and interview with the laboratory director, the laboratory failed to verify the accuracy of urine microalbumin and urine creatinine twice a year in 2018. The findings include: 1) Observation of the laboratory on May 15, 2019 at 8:30 am revealed the Alere Afinion AS100 moderately complex instrument in use for patient testing for urine microalbumin and urine creatinine testing. 2) Review of the laboratory proficiency testing records revealed enrollment in proficiency testing for two events per year. For 2018 event one the laboratory scored a 67% for urine microalbumin and 67% for urine creatinine. No documentation was present for verification of accuracy of the urine microalbumin and urine creatinine assay. 3) Interview with the laboratory director on May 15, 2019 at 5:00 pm confirmed the laboratory failed to verify the accuracy of the urine microalbumin and urine creatinine assay twice a year in 2018. 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 review of the laboratory procedure manual, quality control records, and interview with the laboratory director, the laboratory failed to follow quality control procedure for complete blood count (CBC) in 2018 and 2019. The findings include: 1) Review of the laboratory procedure manual revealed that quantitative quality control values will be plotted on Levey Jennings graphs. 2) Review of the complete blood count quality control revealed that quality control data for lot numbers 8183, 8267, and 8351 (in use 9.6.18 through 4.1.19) was not plotted on Levy Jennings graphs. 3) Interview with the laboratory director on May 15, 2019 at 5:00 pm confirmed the laboratory failed to follow laboratory quality control policy for CBC in 2018 and 2019. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer package insert, and interview with the lead testing personnel, the laboratory failed to label complete blood count (CBC) controls with open date and corrected expiration date in 2019. The findings include: 1) Observation of the laboratory on May 15, 2019 at 8:30 am revealed CBC controls in use for patient testing that were not labeled with open dates or corrected expiration dates. 2) Review of the CBC control manufacturer package insert revealed the following statement: "8 Consecutive-Day Open-Tube Stability" 3) Interview with the lead testing personnel on May 15, 2019 at 11:30 am confirmed the -- 3 of 7 -- laboratory failed to label CBC controls with open dates and corrected expiration date in 2019. D5783

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 2017 event two, 2017 event three, and 2018 event one, resulting in the second unsuccessful PT occurrence for the 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 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 Casper Report 155 (CMS 155) and the laboratory's 2017 and 2018 proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for three consecutive proficiency testing events for the automated white blood cell (WBC) differential resulting in the second unsuccessful PT occurrence for the WBC differential. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory automated WBC differential scores: 2017 event two 0%, 2017 event three 0%, 2018 event one 0%. 2. Review of the 2017 PT event two evaluation report revealed unacceptable scores for WBC differential for 'Failure to Participate.' 3. Review of the 2017 PT event three evaluation report revealed unacceptable scores for Granulocyte % for sample numbers HEM-11, HEM-12, HEM- 13, HEM-14, HEM-15, Lymphocyte % for sample numbers HEM-11, HEM-12, HEM- 13, HEM-14, HEM-15 and Mono/Mid % for sample numbers" HEM-11, HEM-12, HEM-13, HEM-14, HEM-15. 4. Review of the 2018 PT event one evaluation report revealed unacceptable scores for Granulocyte % for sample number HEM-01, HEM- 02, HEM-03, HEM-04, HEM-05; Lymphocyte % for sample number HEM-01, HEM- 02, HEM-03, HEM-04, HEM-05; Mono/Mid % for sample number HEM-01, HEM- 02, HEM-03, HEM-04, HEM-05; resulting in the second unsuccessful PT occurrence for the WBC differential. 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 proficiency testing (PT) for three events in a row and failed to follow the approved allegation of compliance (AOC) for the WBC differential, resulting in the second unsuccessful PT occurrence for the WBC differential. (Refer to D6019) D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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 for two consecutive proficiency testing events for white blood cell differential (WBC diff) resulting in the first unsuccessful proficiency testing (PT) occurrence for the WBC diff 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 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 Oscar Report 155 (CMS 155) and the laboratory's 2017 proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive proficiency testing events for the white blood cell (WBC) differential. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory WBC differential scores: 2017 event two 0%, 2017 event three 0%. 2. Review of the 2017 PT event two evaluation report revealed unacceptable scores for WBC differential for 'failure to participate.' 3. Review of the 2017 PT event three evaluation report revealed unacceptable scores for WBC differential for the following sample numbers: HEM- 11, HEM-12, HEM-13, HEM-15. -- 2 of 2 --