Sanford Chamberlain

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 9/2/26. The Sanford Chamberlain laboratory was found not in compliance. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (b)(7) 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 record review and interview, the laboratory failed to maintain a copy of the required documentation related to the processing of 20 of 21 proficiency testing (PT) events reviewed (2025 Chemistry Core 1st, 2nd and 3rd events; 2025 Hematology /Coagulation 1st, 2nd and 3rd events; 2025 Microbiology 1st, 2nd and 3rd events; 2025 Immunology/Immunohematology 1st, 2nd and 3rd events; 2025 Chemistry Miscellaneous 1st and 2nd events; 2026 Chemistry Core 1st and 2nd events; 2026 Hematology/Coagulation 1st event; 2026 Microbiology 2nd event; 2026 Immunology /Immunohematology 1st event; 2026 Chemistry Miscellaneous 1st event). Findings include: 1. Review of the laboratory's 2025 and 2026 American Proficiency Institute (API) PT event records on 9/2/26 revealed that the laboratory had subscribed to PT events through API. PT specimens were processed, and the results were submitted electronically via the company's website upon completion of testing. The laboratory had the ability to print a copy of the final PT results that were submitted for evaluation. The laboratory did not retain copies of the final electronically submitted results for evaluation for the following events: 2025 Chemistry Core 1st, 2nd, and 3rd events; 2025 Hematology/Coagulation 1st, 2nd, and 3rd events; 2025 Microbiology 1st, 2nd, and 3rd events; 2025 Immunology/Immunohematology 1st, 2nd, and 3rd events; 2025 Chemistry Miscellaneous 1st and 2nd events; 2026 Chemistry Core 1st and 2nd events; 2026 Hematology/Coagulation 1st event; 2026 Microbiology 2nd 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 -- event; 2026 Immunology/Immunohematology 1st event; 2026 Chemistry Miscellaneous 1st event. Review of the laboratory's PT policy, last reviewed on 7/1 /25, revealed that a copy of the electronic upload should be printed and filed. Interview on 9/2/26 at 1:45 p.m. with general supervisor A revealed PT results were submitted electronically after they were processed. The laboratory was able to print copies of all final PT results submitted for evaluation. The laboratory did not print copies of the final submitted PT results for the PT events listed above. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure that one of seven laboratory personnel (technical consultant B) had received a competency evaluation in 2024, 2025, and through the date of the survey for the duties they had performed under the laboratory's certificate. Findings include: 1. Review of the employee competency records on 9/2/26 at 10:30 a.m. revealed technical consultant B did not have an annual competency assessment for their duties performed in 2024, 2025, and through the date of the survey. A request was made to general supervisor A for any additional documentation of an annual competency assessment completed for 2024, 2025, and 2026, and no additional documentation was provided. Review of the laboratory's competency assessment policy, last revised on 10/30/24, revealed the Laboratory Director would delegate duties in writing to qualified employees, including technical consultants. The delegated duties would have a performance assessment performed annually. Interview on 9/2/26 at 1:30 p.m. with general supervisor A revealed, technical consultant B did not have a competency assessment documented for 2024, 2025, and through the date of the survey. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the laboratory manager, the laboratory failed to achieve successful participation for the blood cell identification test method. Unsatisfactory results had been received in two of three PT testing events (American Proficiency Institute [API] Hematology/Coagulation 2024 third and 2025 second testing events) resulting in unsuccessful PT participation. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (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 record review and interview, the laboratory failed to achieve satisfactory proficiency testing (PT) performance for the blood cell identification test method in two out of three events (American Proficiency Institute [API] Hematology /Coagulation 2024 third and 2025 second testing events) resulting in unsuccessful performance. Findings include: 1. Review of the laboratory's CASPER Reports 153D and 155D on 9/1/25 revealed the API PT scores for the blood cell identification test method were less than the 80% required to pass an event per Clinical Laboratory Improvement Amendments requirements found at CFR 493.861(a): a. 2024 Hematology/Coagulation second event score had been 60%. *BCI-11 had been reported as platelet(s), giant. The acceptable identification had been polychromatophilic red blood cell (RBC). *BCI-14 had been reported as a monocyte. The acceptable identification had been neutrophil, band (stab). b. 2025 Hematology /Coagulation third event score had been 60%. *BCI-06 had been reported as a spherocyte. The acceptable identification had been polychromatophilic RBC. *BCI-07 had been reported as a monocyte. The acceptable identification had been metamyelocyte (juvenile). 2. Interview with the laboratory supervisor via email on 9/8 /25 revealed: a. She confirmed the unsuccessful PT performance. b. After the first unsuccessful PT event, she provided the technologist with education concerning the identification of blood cells and instruction on the correct method for PT result submission. c. After the second unsuccessful event the laboratory manager performed a root cause analysis. It was determined the technologists had interpreted the abnormal cell morphology incorrectly. *The technologists, who had participated in the unsuccessful PT events, completed a focused review of peripheral smear morphology using reference materials, hematology atlases, and internal teaching slides. A discussion of commonly misidentified cells had been included in the retraining. *Each technologist performed ten manual differentials on random patient specimens and re- identified ten previously validated PT slide/cell images to ensure accuracy of blood cell identification. All results were reviewed by the laboratory manager for acceptability. *The laboratory manager directly observed the technologists reviewing slides to ensure correct technique and accurate reporting. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 8/6/24. Sanford Chamberlain laboratory was found not in compliance with the following requirements: D5221, D6091 and D6127. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure proficiency testing (PT) results had been reviewed, evaluated, and those activities documented for 9 of 24 PT events reviewed (American Proficiency Institute [API] 2023 Hematology /Coagulation first and third event; 2023 Chemistry Core second event; 2023 Microbiology first and second events; 2024 Hematology/Coagulation first event; 2024 Chemistry Core first event; 2024 Chemistry Core Verification Comparative Evaluation first event; and 2024 Microbiology second event). The failure to identify the potential cause of the unacceptable and ungraded results could have led to a failure to identify inaccurate patient test results. Findings include: 1. Review on 8/6/24 of the API 2023 and 2024 PT event evaluations revealed: a. 2023 Hematology/Coagulation first event *Educational Blood Cell Identification DIF (manual differential- count of the various white blood cells present in the specimen) DF-01 (which included the following analytes Basophil %; Eosinophil %; Immature cell %; Lymphocyte %; Lymphocyte, reactive %; Monocyte %, Neutrophil, band %; Neutrophil, segmented or band %; Neutrophil, segmented %, NRBC[nucleated red blood cell]/100 %; and Unclassified Cell %) had been reported as not graded. *Blood Cell ID (Educational) ECI-01, 02, 03, 04, and 05 had been reported as not graded. b. 2023 Hematology /Coagulation third event *Vaginal Wet Preparation VA-03 had been reported as not graded. *Educational Blood Cell Identification (DIF) DF-03 (which included the following analytes Basophil %; Eosinophil %; Immature cell %; Lymphocyte %; Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Lymphocyte, reactive %; Monocyte %, Neutrophil, band %; Neutrophil, segmented or band %; Neutrophil, segmented %, NRBC[nucleated red blood cell]/100 %; and Unclassified Cell %) had been reported as not graded. *Platelet estimate (DIF) DIF-03 had been reported as not graded. *Blood Cell ID (Educational) ECI-11, 12, 13, 14, and 15 had been reported as not graded. c. 2023 Chemistry Core second event *BNP (B-type natiuretic peptide) CM-06 had been reported as 454.3 pg/ml (picograms /milliliter). The acceptable range was 548.2-912.3 pg/ml. The analyte had been graded as unacceptable. *BNP CM-09 had been reported as 644.3 pg/ml. The acceptable range was 1001.9-1613.1 pg/ml. *Documentation of the investigation of the unacceptable results had been, "BNP CM-06 and CM-09 reran and was." There had been no documentation of any further investigation. *Creatine Kinase CH-08 had been reported as 87 U/L (units/liter). The acceptable range had been 42-80 U/L. The analyte had been graded as unacceptable. d. 2023 Microbiology first event *Molecular Bacti-Blood Acintobacter sp. BCP-04 had been reported as detected. The acceptable response was not detected. The analyte had been graded as unacceptable. *Molecular Bacti-Blood Acintobacter baumannii BCP-04 had been reported as detected. The acceptable response was not detected. The analyte had been graded as unacceptable. *Molecular Resistance Genes-Blood BCP-01, 02, and 03 had been reported as not graded for the following resistance genes (genes which confer resistance in bacteria to specific antibiotics) CTX-M, IMP, KPC. *Molecular Resistance Genes-Blood BCP- 01, 02, 03, and 04 had been reported as not graded for the resistance gene mcr-1. *Molecular Resistance Genes-Blood BCP-01, 03, 04, 05 had been reported as not graded for the resistance gene mecA. *Molecular Resistance Genes-Blood BCP-01, 02, 03, 04, 05 had been reported as not graded for the resistance gene mecA/C. *Molecular Resistance Genes-Blood BCP-02 mecA had been reported as not detected. The acceptable response was detected. The analyte had been graded as unacceptable. e. 2023 Microbiology second event *Molecular Bacti-Blood BCP 06 Enterococcus sp. had been reported as not graded. *Molecular Bacti-Blood BCP-07 Listeria sp. had been resulted as not detected. The acceptable response was detected. The analyte had been graded as unacceptable. f. 2024 Hematology/Coagulation first event *Partial thromboplastin time (PTT) COA-01 had been resulted as 43 seconds. The acceptable range had been 25-35 seconds. The analyte had been graded as unacceptable. *PTT COA- 04 had been resulted as 53 seconds. The acceptable range had been 61-84 seconds. The analyte had been graded as unacceptable. *Body Fluid Cell Count-C polymorphonuclear cells % had been reported as not graded. *Educational Blood Cell Identification (DIF) DF-01 (which included the following analytes Basophil %; Eosinophil %; Immature cell %; Lymphocyte %; Monocyte %; and Neutrophil, segmented or band % had been reported as not graded. *Platelet estimate (DIF) DIF- 01 had been reported as not graded. *RBC (red blood cell) Morphology (DIF) DIF-01 had been reported as not graded. *Blood Cell ID (Educational) ECI-01, 02, 03, 04, and 05 had been reported as not graded. g. 2024 Chemistry Core first event *Bilirubin, total CH-02, 03 and 05 had been reported as not graded. h. 2024 Chemistry Core Verification Comparative Evaluation first event *Troponin CM-01 was resulted as 19.69 ng/ml (nanograms/milliliter). The acceptable range had been 32.76-58.05 ng/ml. Documentation of the investigation of the unacceptable result had been "(testing personnel C) completed will follow up with him." There was no further documentation the unacceptable result had been investigated. i. 2024 Microbiology second event *Gram Stain GS-08 was reported as not graded. Review of the laboratory's PT reports revealed: *There had been no investigation of the unacceptable or ungraded results for the above listed samples to determine if the potential cause could have affected patient test results. *Technical consultant D had reviewed and initialed the evaluation reports for the PT testing events listed above. Review on 8/6 /24 of the laboratory's CMS form 209, Laboratory Personnel Report (CLIA), revealed -- 2 of 6 -- technical consultant D was designated as the technical consultant for the laboratory. Review on 8/6/24 of the laboratory's Delegation of Responsibilities- Chamberlain policy, last updated 8/2/24, revealed: *Technical consultant D was designated as the technical consultant and technical supervisor. *6.2 Technical Consultant/Technical Supervisor responsibilities: 6.2.3.3. PT results are reviewed with the appropriate staff. 6.2.3.4.

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the laboratory supervisor, the laboratory failed to achieve successful participation for the Protime and Partial Thromboplastin Time test methods. Unsatisfactory results had been received in two of three PT events (2019 1st and 2nd Hematology/Coagulation testing events) resulting in unsuccessful PT participation. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER Reports and interview with the laboratory supervisor, the laboratory failed to achieve satisfactory proficiency testing (PT) performance for the Protime and Partial Thromboplastin Time test methods in two out of three events (Hematology/Coagulation 2019 1st and 2nd events) resulting in unsuccessful performance. Findings include: 1. Review of the laboratory's CASPER Reports 153D and 155D revealed the American Proficiency Institute PT scores for the Protime test method were less than the 80% required per CLIA requirements found at CFR 493.861 (a): a. 2019 Hematology/Coagulation 1st event Protime score = 20% (COA- 01, 03, 04, and 05 were graded as unacceptable). b. 2019 Hematology/Coagulation 2nd event Protime score = 20% (COA-07, 08, 09, and 10 were graded as unacceptable). 2. Review of the laboratory's CASPER Reports 153D and 155D revealed the American Proficiency Institute PT scores for the Partial Thromboplastin Time (APTT) test method were less than the 80% per CLIA requirements found at CFR 493.861(a): a. 2019 Hematology/Coagulation 1st event APTT score = 60% (COA- 01 and 04 were graded as unacceptable). b. 2019 Hematology/Coagulation 2nd event Protime score = 40% (COA- 06, 07, and 09 were graded as unacceptable). 3. Interview with the laboratory supervisor on 8/19/19 confirmed the failure. He stated they were aware of the issue. He stated this was a repeat clerical issue. The analyzer was incorrectly selected when the API surveys were reported. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 8/13/18 through 8/14/18. The Sanford Chamberlain laboratory was found not in compliance with the following requirement: D5435. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the immunohematology maintenance records, annual test volume survey form, and interview with the laboratory supervisor, the laboratory failed to calibrate the bloodbank centrifuge to ensure proper centrifugation and accurate interpretation of the ABO Rh typing and immediate spin crossmatch test methods. Findings include: 1. Review of the immunohematology maintenance records revealed the bloodbank centrifuge had been calibrated 7/21/16 to determine the combination of speed and timing of the bloodbank centrifuge to ensure an optimum blood cell dot formation had been formed. That test method had been used as part of the ABO RH typing and immediate spin crossmatch procedure for determining patient blood type and compability with donor blood units. There was no documentation the centrifuge had been calibrated since that date. Review of the annual test volume survey form revealed 214 ABO Rh blood typings and 150 immediate spin crossmatches had been performed on patient specimens during 2017. Interview with the laboratory supervisor 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 -- at 8:20 a.m. on 8/14/18 revealed the centrifuge calibration to determine optimum timing and speed was normally completed in August of each year. He was not sure why there was no documentation for the August 2017 calibration. The calibration had not yet been performed for 2018. -- 2 of 2 --