Cpn West Clinic

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/11,12/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant and testing person #5 at the conclusion of the survey. 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 a review of records and interview with the technical consultant, the laboratory failed to utilize the demonstrated reportable range for creatinine testing using the Nova Stat/Sensor creatinine/eGFR meter system put into use on 7/11/2023. Findings include: (1) On 06/12/2024 at 11:15 am, the technical consultant stated the laboratory began testing on the Nova Stat/Sensor for creatinine testing 07/11/2023; (2) A review of the performance specification records for the analyzer identified the laboratory had demonstrated the following reportable range: (a) Creatinine - 0.99 - 10.1 mg/Dl (3) Interview with the technical consultant 06/12/2024 at 11:15 am confirmed the laboratory was using the following manufacturer's reportable ranges instead of the ranges that had been demonstrated by the laboratory: (a) Creatinine - 0.3 - 12.0 mg/Dl 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 D0000 The recertification survey was performed on 05/02/2022. The findings were reviewed with the technical consultant at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to review and evaluate proficiency testing results for one of 16 events. Findings include: (1) On 05/02/2022, a review of 2021 and 2022 proficiency testing records and revealed the following biases (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) 2022 First Chemistry Core Event (i) Free Thyroxine - four of five results exhibited a negative bias (aa) Sample THY-01- SDI of -2.4 (bb) Sample THY-03- SDI of -2.4 (cc) Sample THY-04- SDI of -2.9 (dd) Sample THY-05- SDI of -3.1 (2) There was no evidence in the records proving the biases had been identified and addressed; (3) The records were reviewed with the technical consultant. The technical consultant stated on 05/02/2022 at 12:00 pm the biass had not been addressed. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as 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 -- determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to follow the manufacturer's instructions for verifying white blood cell flags for one of three patient reports. Findings include: (1) On 05/02/2022 at 11:00 am, the technical consultant stated the following: (a) Routine CBC (Complete Blood Count) testing was performed on the Sysmex XP-1000i analyzer. (2) A review of the manufacturer's instructions was performed for verifying morphology flags obtained on the analyzer. The following were examples of flags, with the corresponding instructions: (a) NRBC? - "Verify presence on slide, correct WBC count if necessary" (3) A review was performed of three patient records that contained flags from CBC testing. For one of the records, there was no evidence the laboratory followed the manufacturer's instructions for verifying the flags as follows: (a) Patient Sample #9806 - Testing was performed on 01/10/2022 at 09:19 am, with an NRBC? flag obtained. (4) The records were reviewed with the technical consultant, who stated on 05/02/2022 at 01:35 pm that the flag obtained for the patient had not been verified as shown above. 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, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to follow the manufacturer's instructions for weekly maintenance procedures for one of four months. Findings include: (1) On 05 /02/2022 at 11:00 am, the technical consultant stated the following: (a) Routine CBC (Complete Blood Count) testing was performed on the Sysmex XP-1000i analyzer. (2) A review of the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs: (a) Weekly: (i) Power Down IPU (3) A review of maintenance records for four months (January 2022 through April 2022) revealed the following: (a) There was no evidence the weekly maintenance had been performed (i) Between 03/18/2022 and 04/01/2022 (4) The records were reviewed with the technical consultant who stated on 05/02/2022 at 01:50 pm, the maintenance had been performed but not documented. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/14,15/2020. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant at the conclusion of the survey. 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 a review of records and interview with the technical consultant, the laboratory failed to evaluate the accuracy of testing when proficiency results had not been graded by the proficiency program. Findings include: (1) On the first day of the survey, the surveyor reviewed Hematology proficiency testing records for 2019 and 2020. The following was identified for 1 of 5 events: (a) First 2020 Event Educational Blood Cell Identification (i) % Basophil - The result for sample DIF-01 had not been graded by the proficiency testing program. The program's expected result was included on the report, which verified the laboratory's reported result of 2 did not agree with the "Expected Result" of 0-1. There was no documentation to indicate

Summary Statement of Deficiencies D0000 The findings were reviewed with the technical consultant at the conclusion of the survey. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to ensure an analyzer was stored as required by the manufacturer. Findings include: (1) On the first day of the survey, the technical consultant stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed on the Sysmex 1000i analyzer; (2) On the second day of the survey, the surveyor reviewed the manufacturer's environmental requirements for the analyzer. The manufacturer required the relative humidity be maintained within the range of 30-85%; (3) The surveyor reviewed laboratory humidity records from March 2017 through March 2018 which verified the humidity readings were less than 30% for 6 of 13 months as follows: (a) March 2017 - 5 of 31 humidity readings were documented as less than 30% (days 1,2,3,8,15); (b) May 2017 - 1 of 31 humidity readings was documented as less than 30% (day 11); (c) September 2017 - 1 of 30 humidity readings was documented as less than 30% (day 22); (d) October 2017 - 2 of 31 humidity readings were documented as less than 30% (days 27,31); (g) December 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 -- 2017 - 12 of 31 humidity readings were documented as less than 30% (days 6,7,8,11,12,13,14,15,26,27,28,29); (h) January 2018 - 14 of 31 humidity readings were documented as less than 30% (days 3,4,5,8,12,15,16,17,18,19,25,29,30,31); (i) February 2018 - 12 of 28 days humidity readings were documented as less than 30% (days 1,2,5,6,7,8,9,12,13,22,23,26); (j) March 2018 - 8 of 31 humidity readings were documented as less than 30% (days 6,7,8,12,13,14,15,22) (4) The surveyor reviewed the records with the technical consultant who stated the humidity of the laboratory had been maintained below 30% as indicated above. 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, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to ensure equipment maintenace was performed as required by the manufacturer. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor microalbumin and creatinine testing were performed on the DCA Vantage analyzer; (2) The surveyor reviewed the 2017 (12 months) manufacturer's maintenance logs for the analyzer. The surveyor identified the following: (a) Weekly - Clean Barcode Window and Clean Exterior Window had not been documented as performed between: (i) 01/03/17 and 02/01/17 (ii) 03/01/17 and 04/03/17 (iii) 05/01/17 and 06/01/17 (iv) 07/03/17 and 08/01/17 (v) 09/01/17 and 10/02/17 (vi) 11/01/17 and 12/01/17 (3) The surveyor reviewed the records with the technical consultant who stated there was no evidence the above maintenance had been performed as required. 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. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to have control procedures that would detect immediate errors that would occur due to test system failure, adverse environmental conditions, and operator performance; and failed to have control procedures that monitored the accuracy and precision of the testing process. Findings include: (1) On the first day of the survey, the technical consutlant verified the following to the surveyor: (a) CBC -- 2 of 3 -- (Complete Blood Count) testing was performed using the Sysmex XS 1000i analyzer; (b) Three levels (low, normal, and high) of Sysmex e-check XS quality control materials were tested each day that patient testing was performed. (2) On the second day of the survey, the surveyor reviewed quality control records. The records verified that low control (lot #80160804), normal control (lot #80160805), and high control (lot #80160806) had been put into use on 3/28/18 and were currently in use. It appeared that the laboratory had failed to establish a target value for the lower limit of acceptability and utilized the low default setting of 0.0. In addition, the upper limit that had been entered was beyond the manufacturer's expected guideline ranges as follows: (a) Low Control (i) RBC (Red Blood Cell) - A target value of 2.34 and a control range of 0.0-4.68 was used. The manufacturer's guideline range was 2.23-2.47; (iii) Hemoglobin - A target value of 5.5 and a control range of 0.0-11.0 was used. The manufacturer's guideline range was 5.3-5.9; (iv) Hematocrit - A target value of 17.0 and a control range of 0.0-34.0 was used. The manufacturer's guideline range was 16.0-18.4; (b) Normal Control (i) WBC - A target value of 7.34 and a control range of 0.0-14.68 was used. The manufacturer's guideline range was 6.59-7.89; (vi) Platelet - A target value of 210 and a control range of 0.0-420.0 was used. The manufacturer's guideline range was 201-255. (c) High Control (i) RBC (Red Blood Cell) - A target value of 5.26 and a control range of 0.0-10.52 was used. The manufacturer's guideline range was 5.09-5.51; (iii) Hemoglobin - A target value of 16.3 and a control range of 0.0-32.6 was used. The manufacturer's guideline range was 15.8-17.2; (iv) Hematocrit - A target value of 47.7 and a control range of 0.0-95.4 was used. The manufacturer's guideline range was 44.9-50.7. (3) The records were reviewed with the technical consutlant. The technical consultant did not know where the above ranges came from, but stated they were not ranges that would not detect immediate error. -- 3 of 3 --