Valley Day And Night Clinic

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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's policies, a review of patient test records from August 2025 and September 2025, and staff interview, the laboratory failed to have documentation of suppressing the values of flagged CBC results for 2 of 6 samples reviewed. The findings included: 1. A review of the laboratory's policy to address flags on CBC (complete blood count) results determined the laboratory was to manually suppress the flagged results to ensure they were not reported to the provider. 2. A review of flagged CBC results from August 2025 and September 2025 identified 2 of 6 results were flagged values were not suppressed and subsequently reported to the provider. They were: a) August 25, 2025 ID: 24472 b) September 25, 2025 ID: 640093 3. Technical consultant number 1 (as listed on Form CMS 209) confirmed the finding in an interview conducted on 10/28/2025 at 1030 hours in the laboratory. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal 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 -- values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the laboratory's verification studies for the Medonic M-series hematology analyzer performed in September 2024 and staff interview, the laboratory failed to have documentation of verifying 2 of 3 sets of patient normal ranges. The findings included: 1. A review of the laboratory's verifications studies for the Medonic M-series hematology analyzer performed in September 2024 identified the laboratory implemented 3 sets of patient normal ranges. The laboratory failed to have documentation of verifying 2 of the 3 sets. They were: a) Normal range (6 months - 6 years) White blood cell 5 - 15 Lymphocyte Absolute count 0.6 - 4.1 Mid Absolute count 0 - 1.8 Granulocyte Absolute count 2 - 7.8 Lymphocyte percent 10 - 58.5 Mid Cells percent 0.1 - 24 Granulocyte percent 37 - 92 Red blood cell 4.2 -6.3 Hemoglobin 10.7 - 12.5 Hematocrit 31 - 36 Mean Corpuscular volume 80 - 97 Mean Corpuscular hemoglobin 26 - 32 Mean Corpuscular hemoglobin concentration 31 - 36 Red cell distribution width 11.5 - 14.5 Platelet 150 - 350 Mean Platelet volume 0 - 50 b) Normal Range (6 years - 18 years) White blood cell 4.5 - 13.5 Lymphocyte Absolute count 0.6 - 4.1 Mid Absolute count 0 - 1.8 Granulocyte Absolute count 2 - 7.8 Lymphocyte percent 10 - 58.5 Mid Cells percent 0.1 - 24 Granulocyte percent 37 - 92 Red blood cell 4.2 -6.3 Hemoglobin 11.5 - 16.0 Hematocrit 35 - 45 Mean Corpuscular volume 80 - 97 Mean Corpuscular hemoglobin 26 - 32 Mean Corpuscular hemoglobin concentration 31 - 36 Red cell distribution width 11.5 - 14.5 Platelet 150 - 350 Mean Platelet volume 0 - 50 2. Technical consultant number 1 (as listed on Form CMS 209) confirmed the findings in an interview conducted on 10/28/2025 at 0930 hours in the office. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of the laboratory's records February 2025 to September 2025 and staff interview, the laboratory director failed to ensure the monthly quality assessments were reviewed for 8 of 8 months. The findings included: 1. A review of the laboratory's Quality Assurance Plan (approved on 02/01/2025) under the section titled "Quality Assurance Review" determined: "Our laboratory uses this Quality Assurance Program to improve the laboratory services we provide to our physicians and patients. We will perform a quality review at least monthly and review the results with the Laboratory Director or Technical Consultant for their approval.... The record of our Quality Assurance review are filed with this plan and are available for review by the Director, Consultant, staff and Laboratory Surveyors. All records are dated and initialed by the staff performing the review, by the Technical Consultant and by the Laboratory Director." 2. A review of the laboratory's records from February 2025 to September 2025 identified the laboratory failed to have documentation of the laboratory director reviewing 8 of 8 quality assurance monthly reports. They were: February 2025 March 2025 April 2025 May 2025 June 2025 July 2025 August 2025 -- 2 of 3 -- September 2025 3. Technical consultant number 1 (as listed on Form CMS 209) confirmed the findings in an interview conducted on 10/28/2025 at 1130 hours in the office. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on December 6, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports, the laboratory failed 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 -- to achieve satisfactory performance in three of four testing events for the analyte total bilirubin, resulting in a non-initial unsuccessful performance. Refer to D2096. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports, the laboratory failed to achieve satisfactory performance for three of four events in 2023 and 2024 for the analyte of total bilirubin. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for the bilirubin in three of four events: 2023 AAB/MLE 3rd event 60% 2024 AAB/MLE 1st event 40% 2024 AAB/MLE 3rd event 40% 2. Based on review of the American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports , the laboratory received the following unsatisfactory performances for total bilirubin in three of four events: 2023 AAB/MLE 3rd event 60% 2024 AAB/MLE 1st event 40% 2024 AAB/MLE 3rd event 40% 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, 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 desk review of the Certification and Survey Provider Enhanced Reporting -- 2 of 3 -- (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for the analyte of total bilirubin for three of four events in 2023 and 2024, resulting in a non-initial unsuccessful performance. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced complaint investigation (TX00498723) was conducted on 05/16 /2024. The complaint was substantiated. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's specimen collection procedures, review of patient test records for patient #147760, review of the laboratory's patient specimen logs from April 9, 2024, and staff interview, the laboratory failed to following its procedures for recording specimen receipt. The findings included: A. A review of the laboratory's specimen collection procedure under the section titled "Record of Specimen Receipt" determined: "Maintain a patient specimen log that includes the date, patient name, chart number, tests ordered, disposition of unacceptable samples and the identity of the personnel who performed the test." B. Further review under the section titled "Test Records" determined: "The laboratory will maintain test records which included a specimen log and a copy of the original patient report must be kept on file for two years. Reports and logs must be organized as to allow for ready access to reports. Test results must be reported promptly to providers and released only to authorized persons. Test Record Logs will provide the following information: The patient identification number, name and date of birth. The date and time of specimen collection. The condition and disposition of specimen that do not meet the laboratory's criteria for specimen acceptability. Records of patient testing, including instrument 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 -- printouts must be retained for at least two years." C. A review of the test records for patient #147760 determined two samples - one for a complete blood count, one for a complete metabolic panel - were collected on 04/09/2024. D. A review of the patient specimen log from 04/09/2024 determined the information for patient #147760 was not documented on the log. E. The office manager confirmed the findings in an interview conducted on 05/16/2024 at 0945 hours in the laboratory. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assurance plan, review of the complete blood count orders in Labdaq for patient #147760, review of instrument results for patient #147760 tested on 04/09/024, and staff interview the laboratory failed to ensure the pending log was checked everyday. The findings included: A. A review of the laboratory's quality assurance plan revealed: "Supervisors for each location must:... 8. Check pending log at the end of the day." B. Further review of the laboratory's quality assurance plan revealed: "Procedure on how to clear the pending log everyday: 1. On the right side of the main Labdaq screen, Status (UA, microalbumin), Emerald (CBC), and Manual Entry (Fingerstick, Pregnancy Test, Strep, Flu AB, RSV, H.Pylori). 2. Click the icon and you can choose either pending by panel or pending by requisition. 3. Choose the date and location then press ok. the analyzer should be on default depending on location but there are instance where you see patients from other locations so just take care of you own patients. 4. Go to QQ and fix the problem like; duplicate entry when EMR is not transferring orders, patient did not submit a sample, was unable to draw patient, forgot to finalize a CBC flag." C. A review of the Labdaq records for patient #147760 determined the results for the complete blood count (CBC) on 05/16/2024 at 10:35 am were still pending in the information system. D. A review of patient test records on the Sysmex hematology analyzer on 05/16/2024 at 10:36 am determined the sample for patient #147760 was tested on 04/09/2024 at 9:54 am. The results were normal and had not transfered into the Labdaq information system. E. The complete blood cell results were released from the analyzer and sent to Labdaq at 10:38 am on 05/16/2024. F. The office manager confirmed the findings in an interview conducted at 10:38 am in the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE). The laboratory was found to be NOT in compliance with the conditions of participation of the CLIA program based on the following CONDITION LEVEL DEFICIENCIES: 493.803 Successful participation [proficiency testing] 493.1403 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: 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 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalyists Medical Laboratory Evaluation (AAB-MLE), the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory had unsuccessful participation in the specialty of chemistry for the analyte total Bilirubin (refer to D2096). 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 desk review of the CMS 155 report and proficiency testing records from American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Chemistry for the analyte total Bilirubin resulting in an initial proficiency testing failure. The findings include: 1. A review of the CMS 155 report revealed the laboratory received the following unsatisfactory scores (passing = >80%) for the analyte total Bilirubin: Third testing event 2023 60% First testing event 2024 40% 2. A desk review of the laboratory's American Association of Bioanalysts Medical Laboratory Evaluation's (AAB-MLE) results from the third event of 2023 and the first event of 2024 confirmed the proficiency testing scores: Third testing event 2023 60% First testing event 2024 40% 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, 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results, 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). -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalysts (AAB). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 satisfactorily participate in a proficiency testing program 493.1403 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: 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 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalysts (AAB), it was determined the laboratory had not satisfactorily participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not satisfactorily participate in the specialty of chemistry for sodium (refer to D2096). 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 desk review of the CMS 155 report and proficiency testing records from American Association of Bioanalysts (AAB), it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Chemistry for the analyte sodium. The findings were: 1. The laboratory received the following unsatisfactory scores (passing = >80%) for the analyte sodium: Second testing event 2022 60% First testing event 2023 0% 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 -- 2 of 3 -- laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure satisfactory participation in an HHS approved proficiency testing program (refer to D2096). -- 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. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the laboratory's maintenance records, and staff interview, it was revealed that the laboratory failed to have documentation of performing the required weekly maintenance procedures on the Vitros 350 chemistry analyzer for four of four weeks in September 2022. Findings include: 1. A review of the laboratory's policy titled 'Instrument Operation and Maintenance' revealed the following: "Maintenance of each piece of laboratory instrumentation shall be in accordance with the manufacture's recommendations. Document all maintenance performed on the test systems in use." 2. A review of the laboratory's maintenance records for the Vitros 350 chemistry analyzer revealed the laboratory failed to have documentation of performing the following required weekly maintenance procedures for all 4 weeks in September 2022: - Clean tray platform and transport arm - Clean cup retainer - Clean diluent bottles - Clean tip locator assembly - Clean control unit screen - Clean keypad cover - Inspect, clean, and/or replace air filter - Back up QC /Config/Calibration Data 3. An interview with the technical consultant (as indicated on the CMS 209 form) on 4/27/23 at 9:40 a.m. in the conference room, after review of the records, confirmed the above findings. D5439 CALIBRATION AND CALIBRATION VERIFICATION 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 -- 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 (linearity) records for the Vitros 350 chemistry analyzer from 2022, and staff interview, it was revealed that the laboratory failed to have documentation of performing two of two calibration verification procedures in 2022 for the analyte T3 Uptake tested on the Vitros 350 analyzer. Findings include: 1. A review of the laboratory's quality control and calibration records for the Vitros 350 analyzer revealed T3 Uptake was calibrated using 2 calibrators 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 failed to have documentation of performing calibration verification procedures, every 6 months, for T3 Uptake tested on the Vitros 350 analyzer. 3. An interview with the technical consultant (as indicated on the CMS 209 form) on 4/27/23 at 10:30 a.m. in the conference room, after review of the records, confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the entrance and exit conferences. The facility representatives 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. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was 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. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalysts (AAB). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; laboratory director 493.807 (a) Reinstatement after Failure 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: 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 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalysts (AAB), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of chemistry for sodium (refer to D2096). D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on desk review of proficiency testing scores retrieved from the CMS (Centers for Medicare and Medicaid Services) database and review of proficiency testing scores from American Association of Bioanalysts (AAB) found the laboratory failed to participate successfully for the analyte sodium. The findings included: 1. The laboratory received the following failing scores (passing = >80%) for the analyte sodium: Second testing event 2018 20% First testing event 2019 60% Second testing event 2019 20% 2. These failures result in a second unsuccessful performance (non- initial PT failure) for the analyte sodium. 3. The laboratory must demonstrate sustained satisfactory performance (>80%) on two consecutive testing events for reinstatement. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CMS 155 report and review of proficiency testing (PT) scores from American Association of Bioanalysts (AAB), found that the laboratory failed to attain a satisfactory score of at least 80% for the regulated analyte sodium. The findings included: 1. AAB 2018 - 2nd testing event the laboratory received the following unsatisfactory score: Sodium 20% 2. AAB 2019 - -- 2 of 4 -- 1st testing event the laboratory received the following unsatisfactory score: Sodium 60% 3. AAB 2019 - 2nd event the laboratory received the following unsatisfactory scores: Sodium 20% 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 desk review of the CMS 155 report and proficiency testing records from American Association of Bioanalysts (AAB), it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Chemistry for the analyte sodium. Two out of three unsatisfactory scores results in unsuccessful proficiency testing (PT) performance. The findings were: 1. The laboratory received the following unsatisfactory scores (passing = >80%) for the analyte sodium: Second testing event 2018 20% First testing event 2019 60% Second testing event 2019 20% 2. These three failures result in a second unsuccessful performance (non-initial PT failure) for the regulated analyte sodium. D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS 155 report and American Academy of Bioanalysts (AAB) proficiency testing (PT) records found that the laboratory failed to attain a satisfactory score of at least 80% for each analyte in the subspecialty of Endocrinology. The findings were: 1. The laboratory received the following unsatisfactory score for 2019 (event 2): TSH 20% D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Review of the CMS report 155 and American Association of Bioanalysts (AAB) proficiency testing records found that the laboratory failed to achieve a satisfactory score of at least 80% for the overall endocrinology testing event score. The findings were: 1. 2019 (event 1): The laboratory received an unsatisfactory event score of 73% for Endocrinology. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR -- 3 of 4 -- 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). -- 4 of 4 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalysts (AAB). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 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: 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 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalysts (AAB), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of chemistry for the analyte Sodium (Na). (Refer to D2096) D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS Form 155 and AAB (American Association of Bioanalysts) records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry for the analyte Sodium (Na). Findings: 1. AAB 2018 - 2nd event laboratory received the unsatisfactory score of 20% for Sodium. 2. AAB 2019 - 1st event laboratory received the unsatisfactory score of 60% for Sodium. 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 desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Chemistry for the analyte Sodium (Na). Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. AAB 2018 - 2nd event laboratory received the unsatisfactory score of 20% for Sodium. 2. AAB 2019 - 1st event laboratory received the unsatisfactory score of 60% for Sodium. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS Form 155 and American Academy of Bioanalysts (AAB) Proficiency Institute records found that the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the -- 2 of 3 -- subspecialty of hematology for the analyte WBC (white blood cell) Diff. Findings: 1. API 2018 - 3rd event the laboratory received an unsatisfactory score of 0% for WBC Diff. Key: CMS - Centers 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 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 a HHS approved proficiency testing program. (Refer to D2096) -- 3 of 3 --

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 --