Bootin And Savrick Pediatric Associates

Summary Statement of Deficiencies D0000 A PTDR (Proficiency testing desk review) was performed on 11/11/25. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual 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 -- Laboratory Profile and verified with American Associates of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to attain successful performance for 4 of 4 consecutive testing events in specialty of Hematology for a regulated analyte of Hematocrit for 4 of 4 proficiency testing events for 2024 3rd event, 2025 1st event, , 2025 2nd event, and 2025 3rd event, resulting in non-initial PT failure. Refer to D2130. Key: PT=Proficiency testing D2130 HEMATOLOGY CFR(s): 493.851(f) (f) 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 proficiency testing records obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with the proficiency testing company AAB-MLE, the laboratory failed to achieve successful performance for 4 of 4 consecutive testing events in specialty of Hematology for the regulated analyte of Hematocrit for 4 of 4 proficiency testing events for 2024 3rd event, 2025 1st event, 2025 2nd event, and 2025 3rd event, resulting in non-initial PT failure. The findings were: 1. Review of the CASPER Report 155 Individual Laboratory Profile revealed the laboratory received unsatisfactory scores in 2024 3rd event, 2025 1st event, 2025 2nd event, and 2025 3rd event. HCT (Non-waived) 2024 3rd event: 20% 2025 1st event: 60% 2025 2nd event: 60% 2025 3rd event: 0% 2. Review of the AAB-MLE Proficiency Testing records confirmed the laboratory received the above results for the hematocrit analyte in 4 of 4 proficiency testing events in 2024 and 2025. Key: AAB-MLE=American Associates of Bioanalysts-Medical Laboratory Evaluation CMS=Center for Medicare and Medicaid Services 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 proficiency testing records obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with the proficiency testing company American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) for 2024 3rd event, 2025 1st event, 2025 2nd event, and 2025 3rd event, 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) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with the proficiency testing company American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to achieve successful performance for 4 of 4 consecutive testing events in specialty of Hematology for a regulated analyte of Hematocrit for 4 of 4 proficiency testing events for 2024 3rd event, 2025 1st event, 2025 2nd event, and 2025 3rd event, resulting in non-initial unsuccessful PT performance. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertified onsite survey was completed on 06/20/2025. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 the review of the laboratory's policy, proficiency testing events for 2024 and 2025, and confirmed in an interview, the laboratory failed to have documentation of signed attestation statement for 3 of 7 proficiency testing events. The findings were: 1. Review of the laboratory's policy titled Proficiency Testing Guidelines under Procedure revealed "8. Attestation statements are signed by each individual performing the testing and by the laboratory Director or designee." 2. Review of the laboratory proficiency testing events from AAB-MLE for 2024 and 2025 revealed no documentation of signed attestation statement for 3 of 7 proficiency testing events. Chemistry M1 2024- Testing personnel did not sign Chemistry M2 2024- Both testing personnel and Laboratory Director or designee did not sign AAB-MLE M1 2025- Testing personnel did not sign 3. An interview on 06/20/25 at 12:13 pm in the lab, the technical consultant (as indicated on the CMS 209 form) confirmed the above findings. Key: AAB-MLE=American Association of Bioanalysts Medical Laboratory Evaluation CMS=Center for Medicare and Medicaid Services D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(g) 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 -- (d)(6) 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. This STANDARD is not met as evidenced by: Based on the surveyor's direct observation, the laboratory's reagent replacement logs from 02/05/2025 to 05/10/2025, QC logs, patient records, and confirmed in an interview, the laboratory failed to document a quality control run after a change in a reagent for 3 of 3 days reviewed on one of one Sysmex XN-330 hematology instrument. The findings were: 1. The surveyor's direct observation on 06/20/2025 at 10:15 am revealed the laboratory used the following 4 reagents for Sysmex XN-330 hematology instrument (SN: 16317). Cellpack DCL Lysercell WDF Fluorocell DCL Sulfolyser 2. Random review of the reagent replacement logs from 02/05/2025 to 05 /10/2025 revealed 3 of 3 days reviewed had no documentation of a quality control run after the following reagent change on the Sysmex XN-330 hematology analyzer. 02/05 /2025 Changed Cellpack DCL at 11:34 am Changed Fluorocell WDF at 12:19 pm 04 /17/2025 Changed Fluorocell WDF at 10:32 am 05/10/2025 Changed Sulfolyser at 10: 33 am 3. Review of the laboratory's QC logs for the above dates revealed the QC was performed for the day and failed to perform a level of QC run after reagent changes until QC was performed the next day. 02/05/2025 Changed Cellpack DCL at 11:34 am Changed Fluorocell WDF at 12:19 pm QC Level 1 was run at 9:30 am QC Level 2 was run at 9:32 am QC Level 3 was run at 9:34 am 04/17/2025 Changed Fluorocell WDF at 10:32 am QC Level 1 was run at 9:55 am QC Level 2 was run at 9:57 am QC Level 3 was run at 9:59 am 05/10/2025 Changed Sulfolyser at 10:33 am QC Level 1 was run at 9:27 am QC Level 2 was run at 9:31 am QC Level 3 was run at 9:33 am 4. Review of the patient records for the above dates revealed the laboratory performed 6 patient CBC testing after the reagent change with no documentation of a quality control run after reagent change. 02/05/2025 at 2:41 pm Sample ID: MARJA056 02/05 /2025 at 2:59 pm Sample ID: MAREN003 04/17/2025 at 2:31 pm Sample ID: SCHWA004 04/17/2025 at 2:49 pm Sample ID: SMIT0001 04/17/2025 at 5:02 pm Sample ID: APOER000 05/10/2025 at 10:40 am Sample ID: BROWA 5. An interview on 06/20/25 at 1:08 pm in the lab, the technical consultant (as indicated on the CMS 209 form) confirmed the above findings. Key: QC=Quality Control CBC=Complete Blood Count CMS=Center for Medicare and Medicaid Services D6055 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on the review of the laboratory's SN-330 hematology instrument validation records, testing personnel's training records, and confirmed in an interview, the technical consultant failed to have training documentation for 9 of 10 testing personnel prior to performing CBC testing on XN-330 hematology instrument. The findings were: 1. Review of the laboratory's XN-330 (SN: 16317) hematology instrument validation records revealed the laboratory director signed the validation -- 2 of 3 -- data in December, 2024. An interview on 06/20/25 at 12:50 pm in the lab, the technical consultant (as indicated on the CMS 209 form) confirmed the laboratory started using XN-330 hematology instrument in December, 2024. The technical consultant also confirmed the laboratory was using Sysmex XP-300 and K-series prior to XN-330. 2. Review of the laboratory's testing personnel training records revealed no documentation of training records for 9 of 10 testing personnel prior to use XN- 330 hematology instrument. Testing personnel #2 Hired Date: 12/24/2014 Testing personnel #3 Hired Date: 11/18/2022 Testing personnel #4 Hired Date: 09/15/2021 Testing personnel #5 Hired Date: 08/05/2024 Testing personnel #6 Hired Date: 05/13 /2024 Testing personnel #7 Hired Date: 01/02/2024 Testing personnel #8 Hired Date: 08/26/2024 Testing personnel #9 Hired Date: 12/16/2024 Testing personnel #10 Hired Date: 05/23/2016 3. An interview on 06/20/25 at 12:55 pm in the lab, the technical consultant (as indicated on the CMS 209 form) confirmed the above findings. Key: CMS=Center for Medicare and Medicaid Services -- 3 of 3 --

Summary Statement of Deficiencies D0000 The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; 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 obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with American Associates of Bioanalysts-Medical 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 -- Laboratory Evaluation (AAB-MLE), the laboratory failed to attain successful performance for two of three consecutive testing events in specialty of Hematology for a regulated analyte of Hematocrit for 2 of 3 proficiency testing events for 2024 3rd event and 2025 1st event, resulting in unsuccessful performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) 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 proficiency testing records obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with the proficiency testing company AAB-MLE, the laboratory failed to attain successful performance for 2 of 3 consecutive testing events in specialty of Hematology for a regulated analyte of Hematocrit for 2 of 3 proficiency testing events for 2024 3rd event and 2025 1st event, resulting in unsuccessful performance. The findings were: 1. Review of the CASPER Report 155 Individual Laboratory Profile revealed the laboratory received unsatisfactory scores in 2024 3rd event and 2025 1st event. HCT (Non-waived) 2024 3rd event: 20% 2025 1st event: 60% 2. Review of AAB-MLE records in 2024 revealed the laboratory received unsatisfactory score of 20% for Hematocrit in 2024 3rd event. Nonchemistry M3 2024 Hematocrit, %-Hematology W/ 5 or 6-Part Dif -Sysmex Spec #11 Reported Value: 37.8 Grading Range: 38.4-43.3 Spec #12 Reported Value: 17.3 Grading Range: 17.5- 19.7 Spec #13 Reported Value: 37.9 Grading Range: 38.4-43.3 Spec #15 Reported Value: 17.2 Grading Range: 17.5-19.7 3. Review of AAB-MLE records in 2025 revealed the laboratory received unsatisfactory score of 60% for Hematocrit in 2025 1st event. AAB-MLE M1 2025 Hematocrit, %-Hematology W/ 5 or 6-Part Dif - Sysmex Spec #12 Reported Value: 50.2 Grading Range: 50.8-55.1 Spec #15 Reported Value: 17.1 Grading Range: 17.2-18.6 Key: AAB-MLE=American Associates of Bioanalysts-Medical Laboratory Evaluation CMS=Center for Medicare and Medicaid Services HCT=Hematocrit 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 proficiency testing records obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with the proficiency testing company American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), 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) -- 2 of 3 -- (e)(4)(i) 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 records obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with the proficiency testing company American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to attain successful performance for two of three consecutive testing events in specialty of Hematology for a regulated analyte of Hematocrit for 2 of 3 proficiency testing events for 2024 3rd event and 2025 1st event, resulting in unsuccessful performance. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; 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 obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with the proficiency testing company American 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 -- Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to achieve an overall satisfactory performance (80% or greater) for two consecutive testing events in the specialty of Hematology for a regulated analyte of Cell ID or WBC Diff for two of three proficiency testing events in 2024. (Refer to D2130 and D2131). Key: CMS=Center for Medicare and Medicaid Services I.D. =Identification WBC=White Blood Cell Diff=Differential D2130 HEMATOLOGY CFR(s): 493.851(f) 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 proficiency testing records obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with the proficiency testing company American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events in the specialty of Hematology for two of three proficiency testing events in 2024. The findings were: 1. Review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile revealed the laboratory failed to achieve an overall satisfactory performance (80% or greater) for two consecutive testing events in the specialty of Hematology for a regulated analyte of Cell ID or WBC Diff for two of three proficiency testing events in 2024. Cell ID or WBC Diff 2024 Event 2 Score: 0% 2024 Event 3 Score: 24% 2. Review of the proficiency testing company American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) CMS Cumulative Scores-Regulated Analyte, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events in the specialty of Hematology for two of three proficiency testing events in 2024. 2024 Event 2 WBC Differential: 0% 2024 Event 3 WBC Differential: 24% Key: PT=Proficiency Testing AAB-MLE= American Association of Bioanalysts Medical Laboratory Evaluation CMS=Center for Medicare and Medicaid Services I.D. =Identification WBC=White Blood Cell Diff=Differential 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 desk review of proficiency testing records obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) Report 153 Unsatisfactory (failed) and Unsuccessful (2 of 3) PT Report and Report 155 Individual Laboratory Profile, the laboratory failed to achieve an overall satisfactory performance (80% or greater) for two consecutive testing events in the specialty of Hematology for two of three proficiency testing events in 2024. The findings were: 1. Review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 153 -- 2 of 3 -- Unsatisfactory (failed) and Unsuccessful (2 of 3) PT Report revealed the laboratory failed to achieve an overall satisfactory performance (80% or greater) for two consecutive testing events for two of three proficiency testing events in 2024. 2024 Event: 2 Score: 66 Event: 3 Score: 74 2. Review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile revealed the laboratory failed to achieve an overall satisfactory performance (80% or greater) for two consecutive testing events in the specialty of Hematology for two of three proficiency testing events in 2024. Hematology 2024 Event 2 Score: 66% 2024 Event 3 Score: 74% Key: PT=Proficiency Testing AAB-MLE= American Association of Bioanalysts Medical Laboratory Evaluation CMS=Center for Medicare and Medicaid Services 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 proficiency testing records obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with the proficiency testing company American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), 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 records obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and verified with the proficiency testing company American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), the laboratory director failed to ensure successful testing performances in a HHS improved proficiency testing program for two of two consecutive testing events for the overall testing events in the specialty of Hematology and the analyte Cell ID, resulting in an initial unsuccessful performance. (Refer to D2130 and D2131). Key: ID= Identification -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the laboratory's calibration records from 2022 and 2023, and staff interview, it was revealed that the laboratory failed to have documentation of performing a calibration every six months on the: a) Sysmex XP-300 hematology analyzer in 2022 and 2023 b) Reichert Unistat bilirubinometer in 2022. Findings include: 1. A review of the laboratory's policies revealed the following: a) The laboratory's policy titled 'Sysmex XP-300' revealed the following: "Initial calibration is preformed during installation. Calibration is also required if one or more of the following occur: - Critical parts, such as manometers, apertures or detector circuit boards are replaced. - Controls show an unusual trend or are outside of acceptable limits and cannot be corrected by maintenance or troubleshooting. - When advised by Sysmex Field Service Representative. - Every six months." b) 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 -- laboratory's policy titled 'Reichert Unistat Bilirubin' revealed the following: "Calibration frequency The Reichert Unistat bilirubinometer requires calibration upon installation and then at least at six-month intervals, unless quality control data indicate the need for earlier calibration." 2. A review of the laboratory's calibration records from 2022 and 2023 revealed the following: a) Sysmex SP-300 hematology analyzer was calibrated in April 2022 b) Reichert Unistat bilirubinometer was calibrated in November 2022 3. Further review of the laboratory's calibration records revealed no documentation of the laboratory performing the following calibrations: a) Sysmex SP- 300 hematology analyzer-- October 2022 and April 2023 b) Reichert Unistat bilirubinometer-- May 2022 4. An interview with the technical consultant (as indicated on the CMS 209 form) on 5/11/23 at 9:45 a.m. in the break room, after review of the records, confirmed the above findings. 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 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 a review of the laboratory's quality control and calibration records, calibration verification records for the Reichert Unistat bilirubinometer from 2022, and staff interview, it was revealed that the laboratory failed to have documentation of performing one of two calibration verification procedures in 2022 for bilirubin testing on the Reichert Unistat bilirubinometer. Findings include: 1. A review of the laboratory's quality control and calibration records for the Reichert Unistat bilirubinometer revealed bilirubin was calibrated using 1 calibrator and the laboratory tested 2 levels of quality control once a day, thus calibration verification was required at least every 6 months. 2. A review of the calibration verification records from 2022 revealed the laboratory performed calibration verification procedures for bilirubin on the Reichert Unistat in November 2022. 3. Further review of the calibration verification records revealed the laboratory failed to have documentation of performing calibration verification procedures for bilirubin, six months prior, in May -- 2 of 4 -- 2022. 4. An interview with the technical consultant (as indicated on the CMS 209 form) on 5/11/23 at 11:15 a.m. in the break room, after review of the records, confirmed the above findings. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the laboratory's quality control records for the Sysmex SP-300 hematology analyzer from October and November 2022, a review of patient test records, and staff interview, it was revealed that the laboratory failed to have documentation of running two levels of quality control material each day of patient testing for two of sixty one days on the Sysmex XP-300 hematology analyzer. Findings include: 1. A review of the laboratory's policy titled 'Sysmex XP- 300' revealed the following: "Frequency of Control Use and QC Data Review - Three levels of controls are analyzed each day of patient testing." 2. A review of the laboratory's quality control records for the Sysmex XP-300 hematology analyzer from October and November 2022 revealed the laboratory failed to have documentation of running two levels of quality control material each day of patient testing for following two days: 10/21/22 11/4/22 3. A review of patient test records revealed the following 12 patient's samples were resulted on the days when there was no documentation that quality controls were run: Date: 10/21/22 Patient Accession #s: 11139, 11140, 11134, 11136, 11141, 11144, 11145, 11147 Date: 11/4/22 Patient Accession #s: 11215, 11216, 11219, 11220, 11221, 11222, 11223, 11224, 11225, 11226, 11229, 11230 4. An interview with the technical consultant (as indicated on the CMS 209 form) on 5 /11/23 at 10:05 a.m. in the break room, after review of the records, confirmed the above findings. Key: QC = Quality Control 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 a review of the laboratory's submitted CMS 209 form, the laboratory's personnel records, and staff interview, it was revealed that the laboratory failed to have documentation of the technical consultant performing a competency assessment, at least semiannually during the first year of testing, for two of four testing personnel in 2022 for all moderate complexity testing performed in the laboratory. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed the laboratory identified four testing person performing moderate complexity testing. 2. A review of the laboratory's personnel records revealed the following testing personnel, their hire date, and date(s) a competency assessment was performed by the technical -- 3 of 4 -- consultant for Complete Blood Count (CBC) testing on the Sysmex XP-300 hematology analyzer and Bilirubin testing on the Reichert Unistat bilirubinometer: a) Testing person #3 Hire date: 2/18/22 Competency assessment: 2/18/22 Based on the hire date, testing person #3 should have had at least 2 competency assessments performed prior to 2/2023. b) Testing person #4 Hire date: 2/8/22 Competency assessment: 2/8/22 Based on the hire date, testing person #4 should have had at least 2 competency assessments performed prior to 2/2023. 3. Further review of the personnel records revealed the laboratory failed to have documentation of the technical consultant performing a competency assessment for the following testing: a) Testing person #3 - No documentation of a second competency assessment prior to 2 /2023 for CBC testing on the Sysmex XP-300 hematology analyzer b) Testing person #4 - No documentation of a second competency assessment prior to 2/2023 for CBC testing on the Sysmex XP-300 hematology analyzer and Bilirubin testing on the Reichert Unistat bilirubinometer 4. An interview with the technical consultant (as indicated on the CMS 209 form) on 5/11/23 at 11:09 a.m. in the break room, after review of the records, confirmed the above findings. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of the laboratory's submitted CMS 209 form, the laboratory's personnel files, and staff interview, it was revealed that the technical consultant failed to perform a competency assessment on two of four testing personnel in 2022 for Complete Blood Count (CBC) testing on the Sysmex SP-300 hematology analyzer. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed the laboratory identified 4 testing personnel performing moderate complexity testing. 2. A review of the laboratory's personnel records revealed no documentation of the technical consultant performing a competency assessment for CBC testing on the Sysmex SP-300 hematology analyzer for the following personnel: - Testing person #1 in 2022 - Testing person #2 in 2022 3. An interview with the technical consultant (as indicated on the CMS 209 form) on 5/11/23 at 11:09 a.m. in the break room, after review of the records, confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory and patient test records from 2020-2021, and confirmed in interview, the laboratory failed to report 7162 SARS-CoV-2 negative Antigen test results as required by 400.200 for 13 of 13 months reviewed from 10/01/2020 to 10/31/2021. Findings were: 1. Review of the laboratory test records from 2020 to 2021 revealed the laboratory started SARS-CoV- 2 Antigen patient testing using Quidel Sofia2 Flu + SARS Antigen diagnostic test on 07/2020. 2. Review of the laboratory policies available revealed no documentation of a policy/procedure related to SARS-CoV-2 test reporting. 3. Review of the laboratory SARS-CoV-2 Antigen patient test records from 2020 and 2021 revealed no 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 -- documentation the laboratory reported 7162 of 7162 patient negative test records for 13 of 13 months of testing. Refer to Covid Antigen Patient Alias list. 4. An interview with the technical consultant on 11/19/21 at 1140 hours in the office confirmed the above findings. D5783

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory and patient test records from 2020-2021, and confirmed in interview, the laboratory failed to report 7162 SARS-CoV-2 negative Antigen test results as required by 400.200 for 13 of 13 months reviewed from 10/01/2020 to 10/31/2021. Findings were: 1. Review of the laboratory test records from 2020 to 2021 revealed the laboratory started SARS-CoV- 2 Antigen patient testing using Quidel Sofia2 Flu + SARS Antigen diagnostic test on 07/2020. 2. Review of the laboratory policies available revealed no documentation of a policy/procedure related to SARS-CoV-2 test reporting. 3. Review of the laboratory SARS-CoV-2 Antigen patient test records from 2020 and 2021 revealed no 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 -- documentation the laboratory reported 7162 of 7162 patient negative test records for 13 of 13 months of testing. Refer to Covid Antigen Patient Alias list. 4. An interview with the technical consultant on 11/19/21 at 1140 hours in the office confirmed the above findings. D5783

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --