New Kingdom Healthcare

Summary Statement of Deficiencies D0000 . The New Kingdom Healthcare laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F. R. part 493) upon completion of the recertification survey performed on September 2, 2026. The following standard-level deficiencies were cited: 493.1252 Test systems, equipment, instruments, reagents, materials, and supplies 493.1254 Maintenance and function checks . D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 observation and interview with laboratory personnel, the laboratory failed to ensure sixteen blood collection tubes were not available for use for patient testing after the expiration had been exceeded in 2025 and 2026. Findings are as follows: 1. The laboratory supplied blood collection tubes for paitent testing performed at the refrence laboratory as confirmed by the laboratory director (LD) during a tour of the laboratory at 10:11 am on 09/02/2026. 2. Eight 6mL Vacuette pink-top dipotassium ethylenediaminetetraacetic acid (K2E EDTA) blood collection tubes with lot number 456279 and expiration date 08/07/2026, six 4mL BD Vacutainer green-top sodium heparin blood collection tubes with lot number 5076137 and expiration 07/31/2026, and two 4mL BD Vacutainer grey-top sodium fluoride potasium oxalate blood collection tubes with lot number 4073042 and expiration 07/31/2025 were observed as present and available for use in blood collection supplies trays during the tour. 3. A policy prohibiting the use of expired supplies was not found during review of the Laboratory Policy & Procedures Eden Prairie Clinic manual provided by the laboratory on the date of survey. 4. In an interview at 10:43 am on 09/02/2026 the LD 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 -- confirmed the above findings. The laboratory was unable to provide the number of patient specimens tested using expired blood collection tubes upon request. . D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) 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 do the following: This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform and document function checks (calibration) for one timer since 2016. Findings are as follows: 1. The laboratory performed moderate complexity Chemistry testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 10:11 am on 09/02/2026. 2. One Thermoscientific Traceable timer with serial number 140273931 and calibration expiration of 04/22/2016 was observed as present and available for use in the Chemistry department during the tour. 3. Documentation of timer calibration was not found in laboratory records reviewed on the date of survey. The laboratory was unable to provided the missing documentation upon request. 4. A procedure for timer calibration was not established in the Laboratory Policy & Procedures Eden Prairie Clinic manual provided by the laboratory on the date of survey. 5. In an interview at 10:43 am on 09/02/2026, the LD confirmed the above findings. . -- 2 of 2 --

Summary Statement of Deficiencies D0000 The New Kingdom Healthcare laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification) survey performed on August 27, 2024. The following standard-level deficiencies were cited: 493.1253 Establishment and verification of performance specifications 493.1289 Analytic Systems Quality Assessment 493.1291 Test report . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 observation, document review, and interview with laboratory personnel, the laboratory failed to complete required performance verification (PV) activities for one of one new analyzers implemented by the laboratory in 2024. Findings are as follows: 1. The laboratory performed moderate complexity Chemistry testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 10:05 a. m. on 08/27/24. 2. An Abbott Afinion 2 analyzer was observed as present and available for use during the tour. The laboratory director approved this replacement analyzer for Hemoglobin A1c (HbA1c) testing on 06/17/24. 3. PV documentation for HbA1c testing on the Afinion 2 analyzer, found in the Validation Studies manual, included an accuracy verification via method comparison. Precision and reportable range PV documentation was not found. The laboratory was unable to provide 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 2 -- missing documentation upon request. 4. 209 patient specimens received HbA1c testing since implementation on 06/17/24 through date of survey, 08/27/24 as indicated on the laboratory's HbA1c Patient Logs. See below. Month Patients tested June 38 July 87 August 84 5. In an interview at 2:25 p.m. on 08/27/24, the LD confirmed the above finding. . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the 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 observation, document review, and interview with laboratory personnel, the laboratory failed to follow the Quality Assessment Plan (QAP) in 2023 for one of two Individualized Quality Control Plans (IQCP) developed by the laboratory. Findings are as follows: 1. The laboratory performed moderate complexity Chemistry testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 10:05 a.m. on 08/27/24. 2. An Abbott Afinion 2 analyzer was observed as present and available for use during the tour. The laboratory performed Hemoglobin A1c (HbA1c) testing using this analyzer. 3. The laboratory implemented the IQCP for Afinion Dx Testing to reduce quality control requirements for HbA1c. The IQCP's QAP indicated the IQCP would be reviewed annually. 4. Documentation of 2023 annual IQCP review was not present in laboratory records. The laboratory was unable to provide documentation of the 2023 IQCP quality assessment review upon request. 5. In an interview at 12:45 p.m. on 08/27/24, the LD confirmed the above finding. . D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure one of one Chemistry reference intervals was consistent between a procedure and a patient test report in 2024. Findings are as follows: 1. The laboratory performed moderate complexity Chemistry testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 10:05 a.m. on 08/27/24. 2. An Abbott Afinion 2 analyzer was observed as present and available for use during the tour. The laboratory performed Hemoglobin A1c (HbA1c) testing using this analyzer. 3. The reference interval listed in the Hemoglobin A1c on the Alere Afinion HbA1c Dx procedure, located in the A1c Validation manual, was not consistent with that included on a patient test report from 05/02/24 as indicated below. Analyte Procedure Report HbA1c 4.8-6.0% 3-5.8% 4. In an interview at 2:20 p.m. on 08/27 /24, the LD confirmed the above finding. . -- 2 of 2 --