Summary:
Summary Statement of Deficiencies D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on the surveyor's review the the laboratory's records, proficiency testing (PT) reports, and an interview with the laboratory supervisor; the laboratory failed to participate in testing events and received unsatisfactory performance scores of '0' for two testing events in the subspecialty of Routine Chemistry. Findings: 1. The CASPER Individual Laboratory Profile (Report 0155) showed that the laboratory received an unsatisfactory performance score of '0' for Routine Chemistry analysis during 2016 and 2018. 2. The laboratory's PT reports confirmed the scores of '0' for Blood Gas (analytes pH, PO2, PCO2, Potassium & Sodium) testing for the following events due to late submissions: a). Event #3 of 2016 and b). Event #1 of 2018. 3. On a Recertification survey conducted on 08/23/2018 at 2:00 PM, the laboratory supervisor confirmed the above findings. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system 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 -- 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 the surveyor's review of the laboratory's manual, records, and an interview with the general supervisor (GS), the laboratory failed to - (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. prior to testing patients, affecting 335 patients' tests. Findings: 1. On 08/23/2018 at 11:55 AM during an interview with the GS, the GS informed the surveyor that the laboratory changed from the IRMA chemistry blood gas analyzer (which became inoperable) to the OPTI CCA-TS2 chemistry blood gas analyzer in July of 2017. Since testing began in July of 2017, the laboratory has used 3 different OPTI analyzers to perform for patient testing . 2. The calibration, quality control, and maintenance records revealed the following: a). The laboratory received a new analyzer in July of 2017, a temporary replacement analyzer in January of 2018, and a new analyzer May 11, 2018; b). No performance verifications were performed after receiving the temporary analyzer and the second new analyzer, prior to testing patients. c). The documents received were 2 linearity studies; both dated "July 18"; both with the name "Prism Health Care"; one states "TS2 s/n 2596" and the other states "TS2 s/n 2596 (Returned Unit)". No other documented proof was presented as evidence, the manufacturer's performance specification were verified, once the analyzers were received in the laboratory, prior to testing patients. 3. The manufacturer's manual states the following: "Calibration verification allows for the validation of the blood gas analyzer's ability to recover know values at various points within the reportable range of all parameters and may be required by various regulatory agencies." 4. The test volume worksheet reports that 335 patient tests were performed from July 2017 through July 2018, using these analyzers. 5. On a Recertification survey conducted on 08/23/2018 at 2:00 PM, the GS confirmed the above findings and stated that the performance verification for their instruments were conducted at a different central location. 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 the surveyor's review of the laboratory manuals, records and an interview with the general supervisore (GS); the laboratory failed to have a director (LD) who is providing overall management and direction in accordance with 493.1407 in the -- 2 of 3 -- subspecialty of Routine Chemistry, affecting 335 patients tests. Findings: 1. The LD failed to ensure that the test methodologies selected have the capability of providing the quality of results required for patient care. See D6012. D6012 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) The test methodologies selected have the capability of providing the quality of results required for patient care; This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's manual, records, and an interview with the general supervisor (GS); the laboratory director (LD) failed to ensure that- The test methodologies selected have the capability of providing the quality of results required for patient care, prior to testing patients, affecting 335 patients. Findings: 1. The laboratory used 3 different analyzers beginning in of July 2017 to August of 2018. The LD failed to ensure verification procedures were performed to determine if the accuracy, precision, and other pertinent performance characteristics of the method to be used is adequate. 2. The LD failed to establish written verification procedures for the laboratory when it receives new or replacement analytic equipment. -- 3 of 3 --