Patients Hospital Of Redding

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on observation of the Horiba ABX Micros 60 hematology analyzer in the laboratory, review of proficiency testing (PT) reports for 2023, Event 2, from API (American Proficiency Institute) and CMS (report 155, Individual Laboratory Profile) and laboratory proficiency testing records; and interview with Technical Consultant /Testing person-1, it was revealed that the laboratory failed to attain a score of at least 80% for RBC (Red Blood Cell Count). Findings included: a. CMS and API reported the score of 40% due to the laboratory's 3 unacceptable results (*) out of 5, as follows: PT sample ID Reported Acceptable ---------------------------------------------------------- HEM-06 4.39 * 3.80 - 4.29 HEM-07 5.38 * 4.75 - 5.37 HEM-09 5.40 * 4.73 - 5.35 b. Technical Consultant/Testing person -1 affirmed (7/24/24 at 11:30 AM) the aforementioned unacceptable results and score constituting unsatisfactory testing for RBC; and that the results for the remaining two PT samples were acceptable but on the high side. c. The quality and reliability of the Horiba to provide accurate RBC results during the timeframe April - August 2023 could not be assured. . . D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well 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 3 -- acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: . Based on observation of the EPOC analyzer, review of 2023 - 2024 laboratory test records, the lack of records, and interview with the Technical Consultant/Testing person-1, it was determined the laboratory failed to perform calibration verification procedures at least once every 6 months. Findings included: a. The laboratory used Siemens EPOC analyzer, serial number 47134, to test for 10 analytes, as follows: Sodium Glucose Potassium BUN Calcium Creatinine Chloride BUN/Creatinine CO2 (calculated) Hematocrit b. Records documented EPOC calibration and calibration verification performed on 5/30/23 and 2/14/24. c. The Technical Consultant/Testing person-1 affirmed (7/24/24 at 6:00 pm) the laboratory failed to calibrate and verify calibrations within 6 months of 5/30/24, by 11/30/23. d. Review of patients test records for the timeframe 11/30/24 to 2/13/24 revealed 39 patient specimen had each been tested for 10 analytes and reported. The quality and reliability of 390 out of 390 results reported could not be assured, when the EPOC had not been calibrated and calibrations verified. . D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation of the Siemens EPOC analyzer, review of 2024 EPOC laboratory test records, the lack of QC results, and interview with Technical Consultant/Testing person-1, it was determined the laboratory testing personnel failed to include two quality control materials of different values each day of testing patient specimens and failed to have an IQCP (Individualized Quality Control Plan). Findings included: a. The laboratory had a Siemens EPOC analyzer to test for chemistry analytes and hematocrit, as follows: Sodium Glucose Potassium BUN Calcium Creatinine Chloride BUN/Creatinine CO2 (calculated) Hematocrit b. Review of patients' test records for 2023 - 2024 revealed no records documenting QC performance, as follows: Date ID QC -------------------------------------- 4/26/24 32573 -- 2 of 3 -- none 7/23/24 32697 none c. The laboratory Technical Consultant /Testing person-1 affirmed (7/24/24 at 5:30 pm) that the laboratory implemented the practice of performing QC on a weekly basis instead of each day of testing, effective April 2024. d. The laboratory failed to provide for review the IQCP document establishing a customized QC plan for the EPOC test method and use, including required components, as follows: 1. Risk Assessments evaluating the potential for errors from five sources: i. Specimen, ii. the Test System, iii. Reagents, iv. the Testing Environment, and v. Testing personnel. 2. The Quality Control Plan establishing type and frequency of quality control materials based on analysis of historical consecutive days of QC data; 3. Quality Assessment processes for monitoring quality and detecting errors when QC is not performed each day of patient testing. e. The Technical Consultant/Testing person-1 affirmed (7/24/24 at 5:30 pm) the aforementioned lack of IQCP document. d. The quality and reliability of EPOC test results could not be assured for the timeframe beginning April 2024 to present, when QC was not performed with each day of testing and the IQCP had not been documented and approved for implementation. . D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: . Based on the deficiency cited at D5447, the Laboratory Director is herein cited for deficient practice in ensuring the quality control program is maintained or that the IQCP is established to assure the quality of testing. Findings included: a. The Laboratory Director had no process for overseeing, reviewing, or approving the IQCP for the EPOC. -- 3 of 3 --

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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Immunohematology constituting unsuccessful PT performance. (See D2162) 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 -- D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte in 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Compatibility Testing, as follows: 2021 2021 Q1 Q2 Compatibility testing 80% 0% Q1 = First testing event Q2 = Second testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT resulted in an initial unsuccessful performance for the analyte, Compatibility testing. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing High Complexity Testing: Laboratory director was not met. The laboratory director, high complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6089) D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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 desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, Compatibility Testing, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (see D2016 and D2162) -- 2 of 2 --

Summary Statement of Deficiencies 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 Surveyor review of laboratory's policy & procedure, quality control data and random patient testing records, and interview with the laboratory testing person, the laboratory failed to retain quality control records including instrument printouts documenting the analytic system activities for at least 2 years. The findings include: a. The laboratory reported an ABO/Rh typing and antibody screening test results on 03 /08/2018 for the patient record # 28475 / 278737. The laboratory did not provide any document showing that the quality control was performed on the day of patient testing. Due to the lack of quality control records, it could not be assured that the quality control was performed and the reported patient test result was accurate. b. On June 26, 2018 at 2:40 pm laboratory testing person affirmed that the laboratory did not have any quality control test records for the above date. c. The laboratory's testing declaration form, signed by the laboratory Director on June 6, 2018, stated that the laboratory performs 500 tests annually. 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) 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 -- 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 Surveyor review of laboratory's policy & procedure, random patient test records, and interview with the laboratory testing person, the laboratory failed to verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. The findings include: a. The laboratory reported a BUN test results on 06/19/2018 for the patient accession # 180301. The laboratory provided the reference range on the test report for BUN as 7 - 25 mg/dL. However, the test manufacturer's guideline values are 7.9 - 20.2 mg/dL. The laboratory did not provide any documentation of showing that the laboratory has established its own value or verified the manufacturer's provided value. b. On June 26, 2018 at 3:00 pm laboratory testing person affirmed that the laboratory did not verify the manufacturer's value. c. The laboratory's testing declaration form, signed by the laboratory Director on June 6, 2018, stated that the laboratory performs 2040 tests annually. 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 Surveyor review of patient testing records, lack of analytical data and documentation, and interview with the laboratory staff, the laboratory Director failed to assure compliance with the regulations. The findings include: a. See D3031 and D5421. -- 2 of 2 --