Muskogee Pediatrics & Family Health Solutions

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1407; D6000: 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 a desk review of proficiency testing scores obtained from the CASPER 0155D report and WSLH (Wisconsin State Laboratory of Hygiene) proficiency testing evaluation records, the laboratory failed to successfully participate in a proficiency 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 -- testing program for three of four consecutive testing events in the specialty of Hematology for the analytes RBC (Red Blood Cells) and HCT (Hematocrit), resulting in a non-initial unsuccessful performance. Refer to D2130 and D2131. 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 review of proficiency testing scores obtained from the CASPER 0155D report and WSLH (Wisconsin State Laboratory of Hygiene) proficiency testing evaluation records, the laboratory failed to achieve satisfactory performance for the analytes RBC (Red Blood Cells) and HCT (Hematocrit) for three of four consecutive testing events in 2024 and 2025. Findings include: (1) A review of CASPER 0155D identified the following unsatisfactory scores: (a) RBC: (i) First Event 2024 - 0% (ii) Third Event 2024 - 60% (iii) First Event 2025 - 40% (b) HCT: (i) First Event 2024 - 0% (ii) Third Event 2024 - 40% (iii) First Event 2025 - 40% (2) A review of the proficiency testing graded evaluation records from WSLH for 2024 and 2025 confirmed the above findings. D2131 HEMATOLOGY CFR(s): 493.851(g) (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 review of proficiency testing scores obtained from the CASPER 0155D report, the laboratory failed to achieve satisfactory performance for the specialty of Hematology for three of four consecutive testing events in 2024 and 2025. Findings include: (1) A review of CASPER 0155D identified the following unsatisfactory scores for the specialty of Hematology: (a) First Event 2024 - 0% (b) Third Event 2024 - 76% (c) First Event 2025 - 76% (2) Refer to D2130 for the specific analyte failures. 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 scores obtained from the CASPER 0155D report and WSLH (Wisconsin State Laboratory of Hygiene) proficiency testing -- 2 of 3 -- evaluation records, the laboratory director failed to provide overall management and direction for three of four consecutive testing events in 2024 and 2025, resulting in a non-initial unsuccessful performance. 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; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the CASPER 0155D report and WSLH (Wisconsin State Laboratory of Hygiene) proficiency testing evaluation records, the laboratory director failed to ensure successful performance in an HHS approved proficiency testing program in the specialty of Hematology for the analytes RBC (Red Blood Cells) and HCT (Hematocrit) in three of four consecutive testing events in 2024 and 2025. Refer to D2130 and D2131. -- 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 national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1407; D6000: 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 a desk review of proficiency testing scores obtained from the CASPER 0155D report and WSLH (Wisconsin State Laboratory of Hygiene) Proficiency Testing Evaluation records, the laboratory failed to successfully participate in a 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 -- proficiency testing program for two of three consecutive testing events in the specialty of Hematology for the analytes RBC (Red Blood Cells) and Hematocrit. Refer to D2130. 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 review of proficiency testing scores obtained from the CASPER 0155D report and WSLH (Wisconsin State Laboratory of Hygiene) Proficiency Testing Evaluation records, the laboratory failed to achieve satisfactory performance for the analytes RBC (Red Blood Cells)and Hematocrit for two of three consecutive testing events in 2024, resulting in unsuccessful performance. Findings include: (1) A review of the CASPER 0155D report identified the following unsatisfactory scores; (a) RBC; (i) First Event 2024 - 0% (ii) Third Event 2024 - 60% (b) Hematocrit; (i) First Event 2024 - 0% (ii) Third Event 2024 - 40% (2) A review of the proficiency testing scores from WSLH for 2024 confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the CASPER 0155D report and WSLH (Wisconsin State Laboratory of Hygiene) Proficiency Testing Evaluation records, 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 scores obtained from the CASPER 0155D report and WSLH (Wisconsin State Laboratory of Hygiene) Proficiency Testing Evaluation records, the laboratory director failed to ensure successful -- 2 of 3 -- performance in an HHS approved proficiency testing program for the analytes RBC (Red Blood Cells) and Hematocrit in two of three consecutive testing events during 2024. Refer to D2030. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/11/2024. The laboratory was found out of compliance with the following CLIA Conditions: 493.1215; D5024: Hematology 493.1405; D6000: Laboratory Director The findings were reviewed with owner #1, owner #2, and testing person #2 at the conclusion of the survey. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records, observation of the laboratory, and interview with testing person #2, the laboratory failed to follow the manufacturer's instructions for expiration dates of waived testing materials. Findings include: (1) On 07/11/2024 at 11:52 am, observation of the laboratory identified the following expired materials which appeared to be available for use: (a) One box of Beckman Coulter Hemoccult slides, lot 1751, manufacturer's expiration date 08/2018; (b) One vial of Beckman Coulter Developer/15mL, lot 61777, manufacturer's expiration date 06/2019; (c) One box of Sekisui Diagnostic - Osom Mono test kit, lot B221405, manufacturer's expiration date 09/2023. (2) The findings were reviewed with testing person #2, who stated on 07/11/2024 at 11:57 am the test materials had expired and were available for use. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #2, the laboratory failed to ensure proficiency testing attestation statements had been signed by the laboratory director or designee and the analyst(s) for five of five hematology events reviewed in 2023 and 2024. Findings include: (1) A review of the first, second, third of 2023; and first and second of 2024 Hematology proficiency testing records identified the attestation statements had not been signed by the laboratory director or designee and the analyst(s); (2) The findings were reviewed with testing person #2 who stated on 07/11/2024 at 12:35 pm, the attestation statements had not been signed as stated above. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #2, office manager, and owner #1, the laboratory failed to participate in one of five proficiency testing (PT) events reviewed in 2023 and 2024. Findings include: (1) On 07/11/2024, a review of PT records for 2023 through 2024 identified the laboratory attained a 0% score for the analytes White Blood Cell Count, Red Blood Cell Count, Hemoglobin, Hematocrit, MCV (Mean Corpuscular Volume), Platelet Count, and White Blood Cell Differential, for the first 2024 Hematology event, due to a failure to participate; (2) A review of records with the office manager and testing person #2 identified the following: (a) No documentation to prove the samples had been tested in the laboratory (i.e., instrument printouts); (b) A WSLH Proficiency Testing Data Submission Report dated 03/11/2024 at 09:16 am, with dashes in the specimen results column instead of quantitative results; (c) No documentation to explain what occurred to cause the laboratory to not participate in the event. (3) Testing person #2 and owner #1 stated on 07/11/2024 at 03:00 pm the laboratory participated in the PT event, had submitted the results electronically on 03/11/2024 at 09:16 am, but the complete documentation could not be located during the survey; (4) Examples of patient Complete Blood Count testing performed during the time the laboratory did not -- 2 of 9 -- participate in proficiency testing are as follows: (a) Patient # 48 test performed on 03 /15/2024 (b) Patient # 49 test performed on 03/19/2024 (c) Patient # 50 test performed on 04/08/2024 (d) Patient # 51 test performed on 04/17/2024 (e) Patient # 52 test performed on 04/26/2024 (f) Patient # 53 test performed on 06/18/2024 (g) Patient # 54 test performed on 06/18/2024 D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records and interview with owner #1 and testing person #2, the laboratory failed to ensure the requirements were met for the specialty of Hematology for CBC testing during the review period of January 2023 through June 2024. Findings include: (1) The laboratory failed to ensure quality control (QC) materials were not used beyond the expiration date. Refer to D5417; (2) The laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures. Refer to D5429; (3) The laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process. Refer to D5441; (4) The laboratory failed to monitor and evaluate the overall quality of analytic systems and correct identified problems for each specialty and subspecialty of testing performed. Refer to D5791; (5) The laboratory failed to ensure patient test reports included the name, as stated on the CLIA certificate, address of the laboratory location where the testing was performed, unique patient identifier, and normal patient reference ranges. Refer to D5805. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 a review of records and interview with testing person #2, the laboratory failed to ensure quality control (QC) materials were not used beyond the expiration date for three of 15 lot numbers reviewed. Findings include: (1) On 07/11/2024 at 12: 45 pm, testing person #2 stated the following: (a) The laboratory performed CBC (Complete Blood Count) testing using the Medonic M-Series analyzer; (b) Three levels of Boule Conn-Diff Tri-Level QC (Quality Control) materials were tested each day of patient testing. (2) A review of records for 15 lot numbers of QC materials used from 03/29/2023 through 12/29/2023 identified controls had been used beyond the manufacturer's expiration date for three of 15 lot numbers reviewed as follows: (a) Low control lot #22308-01 ran on 12/27/2023, 12/28/2023, and 12/29/2023. The manufacturer's expiration date was 12/22/2023; (b) Normal control lot #22308-02 ran on 12/27/2023, 12/28/2023, and 12/29/2023. The manufacturer's expiration date was 12/25/2023; (c) High control lot #22308-03 12 ran on 12/27/2023, 12/28/2023, and 12 /29/2023. The manufacturer's expiration date was 12/26/2023. (3) A review of patient -- 3 of 9 -- records confirmed patient CBC results had been reported on the following dates when the laboratory had used expired QC materials to assess the acceptable performance of the analyzer: (a) Patient # 24 testing performed on 12/28/2023, and 12/29/2023 (b) Patient # 30 testing performed on 12/27/2023 (c) Patient # 31 testing performed on 12 /27/2023 (d) Patient # 32 testing performed on 12/27/2023 (e) Patient # 33 testing performed on 12/28/2023 (f) Patient # 34 testing performed on 12/29/2023 (g) Patient # 35 testing performed on 12/29/2023 (4) Findings were reviewed with owner #1 and testing person #2 who stated on 07/11/2024 at 03:00 pm, the controls had been used beyond the expiration dates. 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 records and interview with testing person #2, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures on the Medonic M-Series analyzer during the review period of January 2023 through June 2024. Findings include: (1) On 07/11/2024 at 12:45 pm, testing person #2 stated CBC (Complete Blood Count) testing was performed using the Medonic M-Series analyzer; (2) A review of the manufacturer's instruction manual titled, "Medonic M-series User's Manual", Section 8, required the following maintenance procedures: (a) Monthly: (i) Clean using hypochlorite solution and perform clot prevention using enzymatic solution (b) Six Months: (ii) Clean using hypochlorite solution, enzymatic solution, and detergent cleaner (3) A review of maintenance logs from January 2023 through June 2024 identified maintenance had not been documented as performed for the following: (a) Monthly: (i) Between 02/01 /2023 and 04/01/2023 (ii) Between 04/01/2023 and 06/01/2023 (iii) Between 07/10 /2023 and 09/01/2023 (b) Six Months: (i) Between 01/01/2023 and 11/01/2023 (ii) Between 11/01/2023 and 06/30/2024 (4) The records were reviewed with owner #1 and testing person #2 who stated on 07/11/2024 at 04:45 pm, maintenance procedures had not been documented as performed as stated above; (5) Refer to D5441 for examples of patient testing performed when maintenance had not been documented as performed. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. -- 4 of 9 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with owner #1 and testing person #2 the laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process for 17 of 17 months reviewed for the testing performed using the Medonic M-Series analyzer. Findings include: (1) On 07/11/2024 at 12:45 pm, testing person #2 stated the following: (a) The laboratory performed CBC (Complete Blood Count) testing using the Medonic M-Series analyzer; (b) Three levels of Boule Conn-Diff Tri-Level QC (Quality Control) materials were tested each day of patient testing. (2) A review of records from February 2023 through June 2024 identified no evidence, such as Levey-Jennings graphs and cumulative statistical data, to prove that QC results had been monitored for variances (i.e., biases, shifts, or trends); (3) Interview with owner #1 and testing person #2 on 07/11/2024 at 3:51 pm confirmed that QC data to include Levey-Jennings graphs and cumulative statistical data had not been printed and reviewed for the period stated above; (4) The following were examples of patient CBC testing performed during this timeframe: (a) Patient # 1 testing performed on 02/03/2023 (b) Patient # 2 testing performed on 02/15/2023 (c) Patient # 3 testing performed on 02/28/2023 (d) Patient # 4 testing performed on 03/01 /2023 (e) Patient # 5 testing performed on 03/13/2023 (f) Patient # 6 testing performed on 03/30/2023 (g) Patient # 7 testing performed on 05/05/2023 (h) Patient # 8 testing performed on 05/18/2023 (i) Patient # 9 testing performed on 05/26/2023 (j) Patient # 10 testing performed on 07/18/2023 (l) Patient # 11 testing performed on 07/21/2023 (m) Patient # 12 testing performed on 08/10/2023 (n) Patient # 13 testing performed on 08/23/2023 (o) Patient # 14 testing performed on 08/28/2023 (p) Patient # 15 testing performed on 09/05/2023 (q) Patient # 16 testing performed on 09/07/2023 (r) Patient # 17 testing performed on 09/12/2023 (s) Patient # 18 testing performed on 09 /19/2023 (t) Patient # 19 testing performed on 09/25/2023 (u) Patient # 20 testing performed on 10/12/2023 (v) Patient # 21 testing performed on 10/16/2023 (w) Patient # 22 testing performed on 10/19/2023 (x) Patient # 23 testing performed on 10 /30/2023 (y) Patient # 24 testing performed on 11/06/2023, 12/28/2023, and 12/29 /2023 (z) Patient # 25 testing performed on 11/15/2023 (aa) Patient # 26 testing performed on 11/28/2023 (bb) Patient # 27 testing performed on 12/11/2023 (cc) Patient # 28 testing performed on 12/13/2023 (dd) Patient # 29 testing performed on 12/21/2023 (ee) Patient # 30 testing performed on 12/27/2023 (ff) Patient # 31 testing performed on 12/27/2023 (gg) Patient # 32 testing performed on 12/27/2023 (hh) Patient # 33 testing performed on 12/28/2023 (ii) Patient # 34 testing performed on 12 /29/2023 (jj) Patient # 35 testing performed on 12/29/2023 (kk) Patient # 36 testing performed on 01/08/2024 (ll) Patient # 37 testing performed on 01/12/2024 (mm) Patient # 38 testing performed on 01/17/2024 (nn) Patient # 39 testing performed on 01/19/2024 (oo) Patient # 40 testing performed on 01/29/2024 (pp) Patient # 41 testing performed on 02/05/2024 (qq) Patient # 42 testing performed on 02/07/2024 (rr) Patient # 43 testing performed on 02/12/2024 (ss) Patient # 44 testing performed on 02/15/2024 (tt) Patient # 45 testing performed on 02/26/2024 (uu) Patient # 46 testing performed on 03/04/2024 (vv) Patient # 47 testing performed on 03/15/2024 (ww) Patient # 48 testing performed on 03/19/2024 (xx) Patient # 49 testing performed on 04/08/2024 (yy) Patient # 50 testing performed on 04/17/2024 (zz) Patient # 51 testing performed on 04/26/2024 (aaa) Patient # 52 testing performed on 06/18/2024 D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an -- 5 of 9 -- 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 a review of records and interview with owner #1 and testing person #2, the laboratory failed to monitor and evaluate the overall quality of analytic systems and correct identified problems for each specialty and subspecialty of testing performed during the review period of January 2023 through June 2024. Findings include: (1) It was determined the laboratory did not have an effective mechanism for performing analytic quality assessment because of the following issues identified during the survey: (a) The laboratory failed to ensure quality control materials were not used beyond the expiration date. Refer to D5417; (b) The laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures on the Medonic M-Series analyzer. Refer to D5429; (c) The laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process for the testing performed using the Medonic M-Series analyzer. Refer to D5441. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of records and interview with owner #1 and testing person #2, the laboratory failed to ensure patient test reports included the name, as stated on the CLIA certificate, address of the laboratory location where the testing was performed, unique patient identifier, and normal patient reference ranges for two of two reports reviewed. Findings include: (1) On 07/11/2024 at 12:45 pm, testing person #2 stated CBC (Complete Blood Count) testing was performed using the Medonic M-Series analyzer; (2) A review of the following patient reports identified the laboratory name, as stated on the CLIA certificate, address of the laboratory location where testing was performed, unique patient identifier, and the normal patient reference ranges were not included: (a) Patient # 52 testing performed on 06/18/2024 (b) Patient # 53 testing performed on 07/10/2024 (3) The findings were reviewed with owner #1 and testing person #2, who stated on 07/11/2024 at 04:49 pm, the laboratory name and address, unique patient identifier, and reference ranges had not been included on the patient test reports. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 6 of 9 -- 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 review of records and interview with office manager, owner #1, and testing person #2 the laboraory director failed to provide overall management and direction during the review period of January 2023 through June 2024. Findings include: (1) The laboratory director failed to ensure test methods were performed as required by the manufacturer to ensure accurate and reliable results. Refer to D6014; (2) The laboratory director failed to ensure attestation statements had been signed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H. Refer to D6016; (3) The laboratory director failed to ensure that proficiency results were returned by the timeframe established by the proficiency program. Refer to D6017; (4) The laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services. Refer to D6020; (5) The laboratory director failed to ensure a quality assessment program had been established and maintained. Refer to D6021; (6) The laboratory director failed to ensure test reports included pertinent information required for interpretation. Refer to D6026. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #2, the laboratory director failed to ensure test methods were performed as required by the manufacturer to ensure accurate and reliable results during the review period of January 2023 through June 2024. Findings include: (1) The laboratory director failed to ensure the manufacturer's instructions were followed for performing maintenance procedures on the Medonic M-Series analyzer. Refer to D5429. 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 review of records and interview with testing person #2, the laboratory -- 7 of 9 -- director failed to ensure attestation statements had been signed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for five of five events. Findings include: (1) The laboratory director failed to ensure proficiency testing attestation statements had been signed by the laboratory director or designee and the analyst(s). Refer to D2015. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of records and interview with owner #1 and testing person #2, the laboratory director failed to ensure that proficiency results were returned by the timeframe established by the proficiency program for one of five events reviewed in 2023 and 2024. Findings include: (1) The laboratory director failed to ensure the laboratory participated in a proficiency testing event. Refer to D2123. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of records and interview with owner #1 and testing person #2, the laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services during the review period of February 2023 through June 2024. Findings include: (1) The laboratory director failed to ensure quality control (QC) materials were not used beyond the expiration date. Refer to D5417; (2) The laboratory director failed to ensure the laboratory had control procedures to monitor the accuracy and precision of the complete analytic process. Refer to D5441. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and -- 8 of 9 -- maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of records and interview with owner #1 and testing person #2 the laboratory director failed to ensure a quality assessment program had been established and maintained during the review period of January 2023 through June 2024. Findings include: (1) The laboratory director failed to ensure the laboratory had an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) 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)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on a review of records and interview with owner #1 and testing person #2, the laboratory director failed to ensure test reports included pertinent information required for interpretation for two of two patient reports. Findings include: (1) The laboratory director failed to ensure patient test reports included the name, as stated on the CLIA certificate, address of the laboratory location where the testing was performed, unique patient identifier, and normal patient reference ranges. Refer to D5805. -- 9 of 9 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/25/2022. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the laboratory supervisor and medical assistant/testing person #3 at the conclusion of the survey. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on a review of records and interview with the medical assistant/testing person #3, the laboratory failed to test proficiency testing samples the same number of times that patient samples were tested. Findings include: (1) On 10/25/2022 at 11:00 am the medical assistant/testing person #3 stated CBC (Complete Blood Count) testing was performed using the Medonic analyzer; (2) A review of Hematology proficiency testing records for five events (First 2021, Second 2021, Third 2021, First 2022, and Second 2022 Events) identified the specimens had been tested in duplicate for five of five events as follows: (a) First 2021 Event (i) Sample HD-01 was tested on 03/17 /2021 at 12:09 pm and 03/17/2021 at 12:11 pm; (ii) Sample HD-02 was tested on 03 /17/2021 at 12:14 pm and 03/17/2021 at 12:15 pm; (iii) Sample HD-03 was tested on 03/17/2021 at 12:20 pm and 03/17/2021 at 12:21 pm; (iv) Sample HD-04 was tested on 03/17/2021 at 12:24 pm and 03/17/2021 at 12:26 pm; (v) Sample HD-05 was tested on 03/17/2021 at 12:29 pm and 03/17/2022 at 12:31 pm. (b) Second 2021 Event (i) Sample HD-06 was tested on 06/15/2021 at 10:03 am and 06/15/2021 at 10:04 am; (ii) Sample HD-07 was tested on 06/15/2021 at 10:06 am and 06/15/2021 at 10:07 am; (iii) Sample HD-08 was tested on 06/15/2021 at 10:09 am and 06/15/2021 at 10:11 am; (iv) Sample HD-09 as tested on 06/15/2021 at 10:13 am and 06/15/2021 at 10:15 am; (v) Sample HD-10 was tested on 06/15/2021 at 10:17 am and 06/15/2021 at 10:19 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 -- am. (c) Third 2021 Event (i) Sample HD-11 was tested on 10/14/2021 at 09:42 am and 10/14/2021 at 09:43 am; (ii) Sample HD-12 was tested on 10/14/2021 at 09:57 am and 10/14/2021 at 10:01 am; (iii) Sample HD-13 was tested on 10/14/2021 at 10:03 am and 10/14/2021 at 10:07 am; (iv) Sample HD-14 was tested on 10/14/2021 at 10: 19 am and 10/14/2021 at 10:37 am; (v) Sample HD-015 was tested on 10/14/2021 at 10:43 am and 10/14/2021 at 10:45 am. (d) First 2022 Event (i) Sample HD-01 was tested on 03/16/2022 at 12:52 pm and 03/16/2022 at 12:56 pm; (ii) Sample HD-02 was tested on 03/16/2022 at 12:58 pm and 03/16/2022 at 01:01 pm; (iii) Sample HD- 03 was tested on 03/16/2022 at 01:03 pm and 03/16/2022 at 01:05 pm; (iv) Sample HD-04 was tested on 03/16/2022 at 01:06 pm and 03/16/2022 at 01:11 pm; (v) Sample HD-05 was tested on 03/16/2022 at 01:13 pm and 03/16/2022 at 01:17 pm. (e) Second 2022 Event (i) Sample HD-06 was tested on 06/10/2022 at 12:07 pm and 06 /10/2022 at 12:08 pm; (ii) Sample HD-07 was tested on 06/10/2022 at 12:10 pm and 06/10/2022 at 12:11 pm; (iii) Sample HD-08 was tested on 06/10/2022 at 12:13 pm and 06/10/2022 at 12:156 pm; (iv) Sample HD-09 was tested on 06/10/2022 at 12:16 pm and 06/10/2022 at 12:18 pm; (v) Sample HD-10 was tested on 06/10/2022 at 12: 20 pm and 06/10/2022 at 12:21 pm. (3) Review of the records with the medical assistant/testing person #3 and interview on 10/25/2022 at 01:49 confirmed proficiency testing samples were routinely tested in duplicate, but patient specimens were routinely tested one time. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/12/2020. The findings were reviewed with laboratory owner/testing person #1, testing person #2, and testing person #3 during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 a review of records, written policy, and interview with the laboratory owner /testing person #1 and testing person #3, the laboratory failed to have a written employee competency policy that explained each component of a required competency for moderate complexity testing. Findings include: (1) On 11/12/2020, the surveyor reviewed the Laboratory Procedure Manual. The section that specified training and competency of testing personnel did not include the following components: (a) Direct observations of routine patient test performance, including patient preparation, specimen handling, processing and testing, required at 493.1413(b) (8)(i) - D6047; (b) Monitoring the recording and reporting of test results, required at 493.1413(b)(8)(ii) - D6048; (c) Review of test results or worksheets, quality control records, and proficiency testing records, required at 493.1413(b)(8)(iii) - D6049; (d) Direct observation of performance of instrument maintenance and function checks, required at 493.1413(b)(8)(iv) - D6050; (e) Assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples, required at 493.1413(b)(8)(v) - D6051; (f) Assessment of problem solving skills, required at 493.1413(b)(8)(vi) - D6052. (2) The surveyor asked the laboratory owner/testing person #1 and testing person #3 to explain what was included Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- in the evaluations. The laboratory owner/testing person #1 and testing person both stated on 11/20/2020 at 03:00 pm the laboratory did not have a competency assessment policy as indicated above. 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 a review of the policy and procedure manual and interview with the laboratory owner/testing person #1 and testing person #3, the laboratory failed to follow written procedures for CBC (Complete Blood Test) testing performed. Findings include: (1) On 11/12/2020 at 10:00 am, the laboratory owner/testing person #1 and testing person #3 stated to the surveyor CBC (Complete Blood Count) testing was performed on the Medonic M-Series analyzer; (2) The surveyor reviewed written laboratory procedure titled, "*Policy and Procedure for Medonic Maintenance*" which stated, (a) "9. Opening new lot # for the controls must be run 5 days prior to using them with the current lot number that is already being used. That is to be done only once in the morning together to ensure they are of good quality." (3) The surveyor reviewed 15 QC (quality control) lot numbers. For 6 of 15 lot numbers there was no indication the laboratory staff followed their written procedure as follows: (a) Lot# 2200601 ran 2 times before put into use on 08/07/2020 (b) Lot# 2200602 ran 2 times before put into use on 08/07/2020 (c) Lot# 2200603 ran 2 times before put into use on 08/07/2020 (d) Lot# 2200821 ran 2 times before put into use on 09/17/2020 (e) Lot# 2200822 ran 2 times before put into use on 09/17/2020 (f) Lot# 2200823 ran 2 times before put into use on 09/17/2020 (4) The surveyor reviewed the findings with the laboratory owner/testing person #1 and testing person #3. Both stated on 11/12 /2020 at 03:10 pm that the procedure had not been followed as indicated above. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory owner/testing person #1 and testing person #3, the laboratory director failed to ensure personnel had the appropriate training for performing moderate complexity testing. Findings include: (1) On 11/12/2020, the surveyor reviewed personnel records for 3 persons who had been hired to perform moderate complexity testing. There was no documented training for -- 2 of 3 -- 2 of the 3 persons as follows: (a) Testing Person #1- 05/01/2020 (b) Testing Person #2 - 05/01/2020 (2) The surveyor reviewed the records with the laboratory owner/testing person #1 and testing person #3. Both stated on 11/12/2020 at 03:05 pm there was no documentation to prove the above persons had been trained. Moderate complexity test systems performed in the laboratory: 1. Medonic M-Series- CBC (Complete Blood Count) -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the office manager and testing person #1 at the conclusion of the survey. 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 a review of records, policies and procedures, and interview with the office manager and testing person #1, the laboratory failed to follow its written policy and procedure for the testing performed. Findings include: (1) At the beginning of the survey, the office manager and testing person #1 stated to the surveyor the laboratory used the Medonic M-Series analyzer to perform patient CBC testing (Complete Blood Count) (e.g., WBC-White Blood Count, RBC-Red Blood Count, Hemoglobin, Hematocrit, and MCHC-Mean Corpuscular Hemoglobin Concentration, etc.); (2) In addition, the office manager and testing person #1 stated to the surveyor the laboratory analyzed 3 levels (1,2, and 3) of CDS Boule Con-Diff QC (Quality Control) materials each day of patient testing. The office manager and testing person #1 also stated patient test results could only be reported if the results of the 3 levels of QC were within the acceptable limits; (3) The surveyor reviewed the laboratory's QC policy and procedure for hematology testing, which stated that, "Our policy is that all 3 controls have to pass before testing patient samples."; (4) The surveyor then reviewed records from 7 months (January, April, August, and December 2017; January, April, and May 2018) for the 21 QC lot numbers used during the review period. From the records, the surveyor identified on 04/27/18 the results of 1 of the 3 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 -- QC lot numbers (Level 1, lot #2180221, in use January 2017-April 2017) were unacceptable, as follows: (a) 09:53 AM - Level 1 was analyzed. The WBC, RBC, and Hemoglobin results were unacceptable; (b) 09:55 AM - Level 1 was repeated and the WBC result remained unacceptable. The