Bmg Family Physicians Group Foundation, Inc

Summary Statement of Deficiencies D0000 During a recertification survey performed on July 21,2026, the laboratory was found out of compliance with the following conditions: D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; 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: A. Based on laboratory observation, a review of patient test records, testing personnel records, the laboratory's testing personnel policy, a staff interview, and electronic mail (email) communication, the laboratory's policy for testing personnel competency assessment was not in compliance with the requirements in Subpart M of the Clinical Laboratory Improvement Amendments (CLIA), as it did not require reassessment of competency when test methodology changed, resulting in 7 of 7 testing personnel without reassessment of competency for use of the new Sysmex XN-430 Complete Blood Count with Automated White Blood Cell Differential (CBC w/Diff) instrument, with approximately 540 patient reported since testing began on 06/16/26. The findings include: 1. Laboratory observation on 07/21/26 at 9:00 a.m. revealed the Sysmex XN-430 (serial number 22381) used to perform CBC w/Diff patient testing. The instrument was new since the last survey date. 2. A review of patient test records revealed that patient testing for CBC w/Diff on the new instrument model began on 06 /16/26, with patient medical record number 10159175. 3. A review of testing personnel records revealed that competency had not been reassessed for seven of seven testing personnel when the laboratory changed to the new CBC w/Diff 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 -- instrument model. 4. A review of the laboratory's testing personnel policy revealed that the policy did not require reassessment of competency when test methodology changes occurred. 5. The laboratory liaison confirmed the survey findings during an interview on 07/21/26 at 9:30 a.m. 6. A review of email communication received from the laboratory liaison on 07/28/26 at 3:05 p.m. revealed that approximately 540 patient CBCs w/Diff had been performed on the new instrument since patient testing began on 06/16/26. B. Based on a review of the laboratory procedure manual, a review of testing personnel (TP) competency assessment records, and staff interview, the laboratory failed to follow the policy for including all six competency assessment elements for 8 of 9 competency assessments reviewed from 2025 and 2026. The findings include: 1. A review of the laboratory's policy titled "PERSONNEL ASSESSMENT POLICY" revealed the following statement: "The following 6 procedures are required for assessment of competency for all testing personnel:" The policy listed the six elements required in Subpart M. 2. A review of testing personnel competency assessment documentation revealed the following: TP 2 did not have a documented review of worksheets, logs, quality control records, and maintenance records for the annual competency assessment completed on 09/18/25. TP 3 did not have a documented review of worksheets, logs, quality control records, and maintenance records for the annual competency assessment completed on 09/17/25. TP 4 did not have a documented review of worksheets, logs, quality control records, and maintenance records for the annual competency assessment completed in 2025. The competency assessment was not reviewed or signed by the laboratory director. The exact date the competency was completed was not recorded. TP 5 did not have a documented review of worksheets, logs, quality control records, and maintenance records for the annual competencies completed on 04/21/25 and on 04/08/26. TP 6 did not have a documented review of worksheets, logs, quality control records, and maintenance records for the six-month competency assessment completed on 03/03 /26. TP 7 did not have a documented review of worksheets, logs, quality control records, and maintenance records, nor was there an assessment of test performance using blind samples, for the six-month competency assessment completed on 08/26/25 or the annual competency completed on 03/03/26. 3. The laboratory liaison confirmed the survey findings during an interview on 07/21/26 at 10:15 a.m. 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 a review of the laboratory procedure manual, patient CBC w/Diff records, and a staff interview, the laboratory failed to follow the procedure for resolving CBC w/Diff results flagged by the instrument for four of six patients with flagged CBC w /Diff results in 2025 and 2026. The findings include: 1. A review of the laboratory procedure for the previous CBC w/Diff instrument (Sysmex XS-1000i) revealed the following: For the PLT Clumps Message: All capillary samples are to be checked for clots before they are run. Redraw specimen and repeat testing. For the WBC Abnormal Scattergram-"Confirm result by repeat testing. Recollect if Flags remain. Do not accept (verify) result." "Send to reference lab after notifying provider of results." For the Blasts flag: -"Confirm result by repeat testing. Recollect if Flags -- 2 of 9 -- remain. Do not accept (verify) result." "Send to reference lab after notifying provider of results." For the Immature granulocyte flag: "Verify result by repeat testing. Take result to provider for matching result to patient presentation. Follow provider instructions." 2. A review of patient CBC w/Diff test records from randomly selected dates revealed the following: On 03/07/25- Patient 12280919, the instrument printout showed a message of PLT Clumps?. The results were reported without any evidence of repeat analysis. Patient 10816748-the instrument printout showed a message of Blasts?. The results were reported without any evidence of repeat analysis. Patient 10745341-the instrument printout showed a message of WBC Abn Scattergram. The results were reported without any evidence of repeat analysis. On 10/08/25- Patient 12328078- the instrument printout showed a message of "Immature Gran?" The results were reported without any evidence of repeat analysis. 3. The laboratory liaison confirmed the survey findings during an interview on 07/21/26 at 1:00 p.m. 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 values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on laboratory observation, lack of documentation, a review of patient test records, a staff interview, and review of an electronic mail (email) communication, the laboratory failed to verify the patient normal / reference ranges used by the laboratory for Complete Blood Count with Automated White Blood Cell Differential (CBC w/Diff) testing using the Sysmex XN-430 instrument, with approximately 540 patients reported since testing began on 06/16/26. 1. Laboratory observation on 07/21 /26 at 9:00 a.m. revealed that the Sysmex XN-430 (serial number 22381) was used to perform CBC w/Diff patient testing. The instrument was new since the last survey date. 2. A review of the instrument validation records revealed no documentation that a normal / reference range study had been performed to verify the ranges used by the laboratory. 3. A review of patient test records revealed that patient testing for CBC w /Diff began on 06/16/26 on the new instrument, with patient medical record number 10159175. 4. During an interview on 07/21/26 at 9:30 a.m., the laboratory liaison stated that the laboratory used corporate normal / reference ranges (separate for males and females) and had not conducted a study to verify those ranges on the new instrument. This confirmed the survey findings. 5. A review of email communication received from the laboratory liaison on 07/28/26 at 3:05 p.m. revealed that approximately 540 patient CBCs w/Diff had been performed since patient testing began on 06/16/26. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number -- 3 of 9 -- of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the laboratory's procedure for the Sysmex XN-430 instrument, quality control (QC) records, and a staff interview, the laboratory failed to ensure the manufacturer's QC package insert ranges were maintained in the instrument QC files for three of three lots reviewed since patient testing began. The findings include: 1. Laboratory observation on 07/21/26 at 9:00 a. m. revealed the Sysmex XN-430 (serial number 22381) used to perform CBC w/Diff patient testing. 2. A review of the laboratory's quality control procedure revealed that "As soon as the new QC lot is received, the new lot is analyzed in conjunction with the current QC. The BeyondCare quality Monitor program establishes the target and limit values for the new QC lot as soon as the first vial of each level gets analyzed." 3. A review of the laboratory's QC records for master lot 6122 (printed on 07/15/26) revealed the following: Lot numbers 61221401, 61221402, and 61221403 validation performed beginning 05/06/26; documented patient testing with the lots beginning 06 /16/26. The QC data printed from the instrument showed QC ranges that differed from those on the manufacturer's package insert for all three levels, as follows for randomly selected analytes: 61221401 (Level One): RBC (10^6/uL) Package insert = 2.17 - 2.40 Laboratory range = 2.14 -2.40 HCT % Package insert = 15.3 - 17.6 Laboratory range =15.4 -17.8 MCV (fL) Package insert = 67.7 - 76.4 Laboratory range = 69.4 - 76.8 Platelet (10^3/uL) Package insert = 36 - 86 Laboratory range = 34 - 84 WBC (10^3 /uL) Package insert = 2.07-2.80 Laboratory range = 2.16 - 2.72 61221402 (Level Two) RBC (10^6/uL) Package insert = 4.13 - 4.47 Laboratory range = 4.08 - 4.50 HGB g/dL Package insert = 11.3 - 12.3 Laboratory range = 11.1 - 12.1 HCT % Package insert = 31.2 - 35.2 Laboratory range = 31.3 - 35.7 MCV (fL) Package insert = 72.6 - 81.8 Laboratory range = 74.5 - 81.9 Platelet (10^3/uL) Package insert = 182 - 256 Laboratory range = 173 - 251 WBC (10^3/uL) Package insert = 6.12 - 7.49 Laboratory range = 6.24 - 7.40 61221403 (Level Three) RBC (10^6/uL) Package insert = 5.05 - 5.48 Laboratory range = 5.00 - 5.52 HGB g/dL Package insert = 15.4 - 16.7 Laboratory range = 15.3 - 16.5 HCT % Package insert = 41 - 46.2 Laboratory range = 41.6 - 47.0 MCV (fL) Package insert = 77.8 - 87.8 Laboratory range = 80.3 - 87.9 Platelet (10^3/uL) Package insert = 463 - 590 Laboratory range = 452 - 574 WBC (10^3/uL) Package insert = 14.95 - 17.91 Laboratory range = 15.1 - 17.51 Word Key: HCT=Hematocrit HGB=Hemoglobin MCV=Mean Corpuscular Volume PLT=Platelet Count RBC=Red Blood Cell WBC=White Blood Cell 10^3 /uL=thousand/microliter 10^6/uL=million/microliter g/dL=grams/deciliter %=percent fL=femtoliters 4. The laboratory liaison stated during an interview on 07/21/26 at approximately 1 p.m. that the ranges in the instrument are updated and changed automatically using data from the Sysmex Beyond Care System and are not controlled by the laboratory. This confirmed the survey findings. D5803 TEST REPORT CFR(s): 493.1291(b) (b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. -- 4 of 9 -- This STANDARD is not met as evidenced by: Based on laboratory observation, a review of final patient test reports, a lack of documentation, a staff interview, and review of an electronic mail (email) communication, the laboratory failed to ensure the final patient test results in the electronic medical record for Immature Granulocyte % did not flag as increased when the value was within the laboratory's normal range. The laboratory began reporting the parameter on 06/16/26, with approximately 540 CBC patient tests reported since testing began. The findings include: 1. Laboratory observation on 07/21/26 at 9:00 a. m. revealed the Sysmex XN-430 (serial number 22381) used to perform CBC w/Diff patient testing. 2. A review of final patient test reports in the electronic medical record revealed the following: Patient medical record number 10159175, performed on 06/16 /26 (first patient on instrument): Immature Granulocyte percent result of 0.1 was flagged as increased; the normal range was 0.0-1.0%. Patient medical record number 12330861, performed on 07/21/26 (most recent patient): Immature Granulocyte percent result of 0.3 was flagged as increased; the normal range was 0.0-1.0%. 3. There was no documentation that the laboratory had validated the electronic medical record results prior to patient testing that began on 06/16/26 with patient 10159175. 4. The laboratory liaison confirmed the survey findings during an interview on 07/21/26 at 1 p.m. 5. A review of email communication received from the laboratory liaison on 07/28/26 at 3:05 p.m. revealed that approximately 540 CBC patient tests had been performed since testing began on 06/16/26. Word Key: %=Percent 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 laboratory observation, a review of the Sysmex XN-430 CBC w/Diff validation records, a review of patient CBC w/Diff test records, a review of an electronic mail communication, lack of documentation, a review of the laboratory's testing personnel competency assessment policy, a review of testing personnel records, a review of current and previous CBC w/Diff procedures, review of QC records, and staff interviews, the laboratory director failed to perform onsite laboratory visits (Refer to D6005), failed to review and approve instrument validation records (Refer to D6013), failed to ensure testing personnel were performing patient testing according to established procedures (Refer to D6014), failed to review calibration records (Refer to D6023 A), failed to ensure QC acceptable ranges were maintained (Refer to D6023 B), failed to ensure competency assessments were conducted according to established policies and procedures and failed to ensure the current policy was in compliance with the regulations in Subpart M (Refer to D6030). D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the -- 5 of 9 -- laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on laboratory observations, lack of documentation, and staff interviews, the laboratory director failed to conduct on-site laboratory visits at least every six months with four months between the minimum two on-site visits in 2025 and 2026. The findings include: 1. Laboratory observation on 07/21/26 at 9:00 a.m. revealed that the Sysmex XN-430 (serial number 22381) was used to perform CBC w/Diff. 2. On the survey date, there was no documentation showing that the laboratory director had conducted on-site laboratory visits in 2025 or 2026. 3. The laboratory liaison confirmed the survey findings during an interview on 07/21/26 at 11:25 a.m. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the Sysmex XN-430 Complete Blood Count with Automated White Blood Cell Differential (CBC w/Diff) validation records, a review of patient test records, a staff interview, and a review of an electronic mail communication, the laboratory director failed to review and approve instrument validation studies for the Sysmex XN-430, with approximately 540 patients reported since testing began on 06/16/26. The findings include: 1. Laboratory observation on 07/21/26 at 9:00 a.m. revealed that the Sysmex XN-430 (serial number 22381) was used to perform CBC w/Diff patient testing. The instrument was new since the last survey date. 2. A review of the instrument validation records revealed that the accuracy, precision, and reportable range studies had not been reviewed or approved by the laboratory director. 3. A review of patient test records revealed that patient testing for CBC w/Diff began on 06/16/26 for the new instrument model, with patient medical record number 10159175. 4. The laboratory liaison confirmed the survey findings during an interview on 07/21/26 at 9:30 a.m. 5. A review of email communication received from the laboratory liaison on 07/28/26 at 3:05 p.m. revealed that approximately 540 patient CBCs w/Diff had been performed since patient testing began on 06/16/26. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (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 the laboratory procedure manual, patient CBC w/Diff records, and a staff interview, the laboratory director failed to ensure testing personnel were performing patient testing according to established procedures. Refer to D5401. -- 6 of 9 -- D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: A. Based on a review of the previous CBC w/Diff instrument calibration records and a staff interview, the laboratory director failed to review three of three calibrations performed on the Sysmex XS-1000i instrument in 2025 and 2026. The findings include: 1. A review of the calibration records for the previous CBC w/Diff instrument (Sysmex XS-1000i, serial number 74777) revealed the calibrations had not been reviewed by the laboratory director. Calibration dates were 03/12/25, 08/12/25, and 02/05/26. 2. The laboratory liaison confirmed the survey findings during an interview on 07/21/26 at 1:00 p.m. B. Based on laboratory observation, a review of the laboratory procedure manual, a review of the CBC w/Diff quality control (QC) records from the first date of patient testing (06/16/26) for the new Sysmex XN-430 instrument, and interview with the laboratory liaison, the laboratory director failed to ensure the establishment and maintenance of acceptable levels for QC testing on the Sysmex XN-430 instrument from 06/16/26 to the survey date on 07/21/26. Refer to D5469. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on a review of the laboratory's testing personnel competency assessment policy, a review of testing personnel records, and staff interview, the laboratory director failed to ensure testing personnel competency procedures were in compliance with Subpart M (Refer to D5209 A), and failed to conduct competency assessments according to established policies and procedures for 8 of 9 competency assessments performed in 2025 and 2026 (Refer to D5209 B). D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: -- 7 of 9 -- Based on a review of testing personnel competency assessment records, lack of documentation, and staff interview, testing person three did not meet the educational requirements to perform technical consultant duties. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; AND (b)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i)(A) Hold an earned doctoral or master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(3)(i)(B) Meet either requirements in 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or (C); AND (b)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(4)(i)(B) Meet 493.1405(b)(5)(i)(B); and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(5)(i) Have earned an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and (b)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. (b)(6) For blood gas analysis, the individual must- (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3) or (4) of this section; or (b)(6)(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (b)(6)(ii)(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis; or (b) (7) Notwithstanding any other provision of this section, an individual is considered qualified as a technical consultant under this section if they were qualified and serving as a technical consultant for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. This STANDARD is not met as evidenced by: Based on a review of testing personnel competency assessment records, lack of documentation, and staff interview, testing person three did not meet the educational requirements to perform the technical consultant duty of assessing testing personnel competency in 2025 and 2026. The findings include: 1. A review of testing personnel competency assessment records from 2025 and 2026 revealed the following: The -- 8 of 9 -- 2025 annual competency assessment for testing person four did not include the name of the person who performed it. The 6-month competency assessment for testing person six (dated 03/03/26) revealed that "Competency assessment performed by: [testing person three]", and then signed by the laboratory director. The 6-month and annual competency assessments for testing person seven, completed on 08/26/25 and 03/03/26 respectively, revealed that "Competency assessment performed by: [testing person three]", and then signed by the laboratory director. 2. There was no documentation that qualified testing person three to perform the technical consultant duty of assessing testing personnel competency. 3. The laboratory liaison confirmed the survey findings during an interview on 07/21/26 at 9:30 a.m. -- 9 of 9 --

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 verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CUA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review from the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and the laboratory's College of American Pathologists (CAP) 2024 and 2025 proficiency testing (PT) records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in PT for the analytes Red Blood Cell (RBC), Hematocrit (HCT), and Hemoglobin (HGB), and the specialty of Hematology. 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 PT desk review of the CASPER 0155 report and the laboratory's CAP PT records, the laboratory failed to achieve an overall satisfactory performance (80% or better) for the RBC, HCT, and HGB analytes for two of three testing events. The findings include: 1. A review of the CASPER 0155 report revealed the following results: Hematology 2024 Event Three: A score of 60% for the RBC analyte. A score of 60% for the HCT analyte. A score of 60% for the HGB analyte. Hematology 2025 Event Two: A score of 0% for the RBC analyte. A score of 0% for the HCT analyte. A score of 0% for the HGB analyte. 2. A review of the laboratory's CAP PT records 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 PT desk review of the CASPER 0155 report and the laboratory's CAP PT records, the laboratory failed to achieve an overall satisfactory performance (80% or better) for the specialty of Hematology for two of three testing events. The findings include: 1. A review of the CASPER 0155 report revealed the following results: The laboratory received an overall score of 70% for Hematology for 2024 Event Three. The laboratory received an overall score of 0% for Hematology for 2025 Event Two. 2. A review of the laboratory's CAP proficiency testing records confirmed the laboratory received the above results. 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: -- 2 of 3 -- Based on a proficiency testing desk review of the CASPER 0155 report and the laboratory's CAP 2024 and 2025 PT records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. 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 proficiency testing desk review of the CASPER 0155 report and the laboratory's CAP 2024 and 2025 PT records, the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130 and D2131. -- 3 of 3 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the patient exam rooms, and staff interview, the laboratory failed to label the saline used for collecting and transporting patient samples for vaginal wet prep testing on the date of the survey (11/08/2024). The findings include: 1. Observation of the patient exam rooms (two of two observed) on 11/08/2024 at 1: 20 pm revealed plastic transport tubes used for collection and transportation of patient samples for vaginal wet prep testing partially filled with clear liquid. The vials were not labeled. During the observation, nursing personnel stated that vaginal swabs were placed in the transport tubes and taken to the laboratory for testing. The nursing personnel stated that the tubes contained saline that was obtained from a master container located in the laboratory. 2. An interview with testing person six and the laboratory liaison on 11/08/2024 at 1:30 pm confirmed that the laboratory failed to label transport tubes in the patient exam rooms in 2024. 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 --

Summary Statement of Deficiencies D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing records, random patient test report review, staff interview, and proficiency testing customer service staff interview, the laboratory director failed to ensure the laboratory was enrolled in an HHS approved proficiency testing program for event one in 2023 for the complete blood count (CBC) regulated analytes to include white blood cell (WBC), red blood cell (RBC), platelet (PLT), hemoglobin (HGB), hematocrit (HCT), and WBC differential (WBC Diff). The findings include: 1. Review of the laboratory proficiency records revealed there was no documentation of participation in event one for 2023 for the regulated analytes WBC, RBC, PLT, HGB, HCT, WBC Diff. 2. Random patient final test report review for patient number 13800108 revealed patient testing for CBC performed on 02/13/2023. 3. Interview on 08/07/2023 at 1:30 pm confirmed the laboratory did not participate in event one for 2023 for moderate complexity CBC hematology testing regulated analytes. 4. Phone interview on 08/11/2023 at 12:57 pm with Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing customer service representative for agency transfers confirmed the laboratory was not enrolled in WSLH for moderately complex hematology CBC regulated analytes testing for event one in 2023. D6063 LABORATORY TESTING PERSONNEL 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): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), review of testing personnel records, and staff interview, testing person (TP) four did not qualify as a testing person for moderate complexity patient testing due to lack of documentation of highest level of education. (Refer to 6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the FORM CMS-209, review of testing personnel records, and staff interview, testing person four failed to have documentation of the highest level of education on the date of the survey (08/07/2023). The findings include: 1. Review of the FORM CMS-209 revealed TP four (one of ten) listed as performing moderately complex patient testing. 2. Review of testing personnel records revealed there was no documentation of the highest level of education for TP four. 3. Interview with the laboratory liaison on 08/07/2023 at 1:30 pm confirmed that TP four did not have evidence of highest level of education for performing moderately complex patient testing in 2021, 2022, or 2023. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory liaison, the laboratory director failed to sign proficiency testing attestation statements for five of eight proficiency testing events in 2019, 2020, and 2021. The findings include: 1. Review of the laboratory's proficiency testing attestation statements revealed the laboratory director did not sign proficiency testing attestation statements for five of eight proficiency testing events. Events not signed include 2019 events one, two, and three, 2020 event one, and 2021 event two. 2. Interview with the laboratory liaison on October 25, 2021 at 4 pm confirmed the laboratory director did not sign five of eight proficiency testing attestation statements in 2019, 2020, and 2021. 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 review of the laboratory procedure manual, laboratory records and interview with the laboratory liaison, the laboratory failed to test proficiency testing samples the same number of times it would a patient sample for one of eight proficiency testing events in 2019. The findings include: 1. Review of the laboratory procedure titled 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 -- "Alert Value Procedure" revealed that repeat Complete Blood Count (CBC) patient testing is performed based on defined alert criteria. 2. Review of laboratory proficiency testing records for 2019 event one revealed repeat testing of proficiency testing samples that did not meet the laboratory's criteria for an alert value. 3. Interview with the laboratory liaison on October 25, 2021 at 4 pm confirmed the laboratory tested proficiency testing samples more times than it would a patient with the same values for 2019 event one (two of five samples); one of eight survey events reviewed. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory liaison, the laboratory failed to retain Complete Blood Count (CBC) quality control (QC) records in 2021 (one of nine lots reviewed). 1. Review of QC records for the Sysmex XS- 1000i CBC instrument revealed no retention of Level 2 quality control data for Lot 03500805 to include daily QC performance as compared with expected ranges or daily quality control graphed on the Levy-Jennings plot. The lot was in use through 03 /05/2021. 2. Interview with the laboratory liaison on 10/25/21 at approximately 4 pm confirmed the laboratory failed to ensure retention of QC records for at least two years in 2021. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, testing personnel records, and interview with the laboratory liaison, the laboratory failed to follow the competency assessment policy for three of six testing personnel in 2019 and 2020. The findings include: 1. Review of the laboratory's competency assessment policy revealed that competency would be performed to include all six required elements as defined in Subpart M of the Clinical Laboratory Improvement Amendments (CLIA) regulations. 2. Review of testing personnel competency assessments revealed that all six elements were not included for testing personnel numbers one, two and five in 2019 and 2020 (three of six testing personnel, six of thirteen competencies). 3. Interview with the laboratory liaison on 10/25/21 at approximately 4 pm confirmed the laboratory failed to follow the personnel competency assessment policy in 2019 and 2020. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other -- 2 of 3 -- supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory records, and interview with the laboratory liaison, the laboratory failed to label controls with open date and corrected expiration date in 2021. The findings include: 1. Observation of the laboratory on 10/25/21 at approximately 9:45 am revealed quality control (QC) material for the Sysmex Complete Blood Count (CBC) instrument that were in use and not labeled with open date and corrected expiration date. 2. Review of the manufacturer QC package insert revealed that controls are stable for 14 days after opening. 3. Interview with the laboratory liaison on 10/25/21 at approximately 4 pm confirmed the laboratory failed to label controls with open date and corrected expiration date in 2021. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services form 209 (CMS 209), the laboratory's proficiency testing attestation statements from 2017 and 2018 and interview with the laboratory coordinator, the laboratory failed to rotate proficiency testing among personnnel who routinely perform patient testing in 2017 and 2018. The findings include: 1. Review of the CMS form 209 revealed seven persons listed as testing personnel. 2. Review of the laboratory's proficiency testing attestation statements from 2017 and 2018 revealed the signatures of testing personnel (TP) number one and one previous testing person as follows: 2017 event 1-TP #1- microscopic, Other-CBC; 2017 event 2-TP #1-all, 2017 event 3-TP #1-micro, Other- CBC; 2018 event 1-TP #1-micro, Other-CBC; 2018 event 2-TP #1-all. 3. Interview with the laboratory coordinator on August 9, 2018 at 11:00 am confirmed seven personnel perform patient testing and did not participate in proficiency testing in 2017 and 2018. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- laboratory coordinator, the laboratory failed to retain all proficiency testing records for at least 2 years in 2016, 2017, and 2018. The findings include: 1. Review of the laboratory's proficiency testing records revealed the following: 2016 event two-no instrument printouts, no attestation statements; 2016 event three-no instrument printouts, no attestation statements, no data submission reports; 2017 event two-no data submission report; 2018 event one-no data submission report; 2018 event two-no data submission report. 2. Interview with the laboratory coordinator on August 9, 2018 at 11:00 am confirmed the laboratory failed to retain all proficiency testing records for at least 2 year in 2016, 2017, and 2018. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's testing personnel assessment policy and interview with the laboratory coordinator, the laboratory's policy for competency assessment of testing personnel failed to include the six required elements for competency assessment. The findings include: 1. Review of the laboratory's testing personnel assessment policy revealed that none of the six required elements for competency assessment were included in the policy. The six required elements include: Direct observation of patient testing, including patient preparation, if applicable, specimen handling, processing and testing; Monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventive maintenance records; Direct observation of performance of instrument maintenance and function checks; assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and assessment of problem solving skills. Competency assessment is the responsibility of the technical consultant. 2. Interview with the laboratory coordinator on August 9, 2018 at 12:00 pm confirmed the laboratory 's policy for testing personnel competency assessment failed to include the six required elements for competency assessment. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing evaluation reports and interview with the laboratory coordinator, the laboratory failed to evaluate non-graded scores for complete blood count (CBC) for 2016 event three, and urine microscopy, and wet prep for 2017 event two. The findings include: 1. Review of the laboratory's 2016 event three proficiency testing evaluation report for CBC revealed the following -- 2 of 3 -- for all CBC parameters: "Not Graded-Changed Instrument/Module/Method"; score of Pass, with no documented review or