Ephrata Community Hospital

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with the pathology assistant (PA), the laboratory failed to ensure that the verification of accuracy for macroscopic histopathology examinations were performed at least twice annually, as required for tests not included in subpart I from 12/1/2021 to 10/27/2023. Findings include: 1. The laboratory's College of American Pathologists Laboratory Activity Menu notes "surgical pathology gross evaluation, pathologist and surgical pathology gross evaluation, non-pathologist as scope of service/analytic method. Activities noted as scope of service/analytical method do not require PT or alternative assessment." 2. On the day of the survey, 01/17/2024 at 03:30 pm, the laboratory could not provide documentation for the verification of accuracy for macroscopic (grossing and inking) histopathology examinations performed at least twice annually from 12/01/2021 to 10 /27/2023. 3. The laboratory could not provide a procedure for performing verification of accuracy for required tests not included in subpart I. 4. The PA (CMS 209, personnel #25) confirmed the findings above on 01/17/2024 at 04:00 pm. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, lack of documentation, and interview with technical supervisor #1 (TS), the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problems for each specialty and subspecialty of testing performed from 12/01/2021 to 10/27/2023. Finding include: 1. The laboratory failed to evaluate the relationship between test results using different methodologies, and instruments. Refer to D5775. 2. The laboratory failed to establish performance specification when modifying an FDA-cleared or approved test system. Refer to D5423. 3. The laboratory failed to document positive and negative reactivity each time of use for immunohistochemical stains used for histopathology examinations. Refer to D5601. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with technical supervisor #1 (TS), the laboratory failed to establish performance specifications before reporting patient test results when modifying an FDA-cleared/approved test system for white blood cell (WBC) and platelet (PLT) counts performed on the Sysmex XN-10 from 12/01/2021 to 10/27/2023 Findings include: 1. The laboratory's Problem Specimens on the Sysmex XN-10 procedure states," Collect a specimen from the patient in a sodium citrated tube (blue-top). Run the citrated tube and calculate the Hgb and Hct first to check for proper dilution in the citrate tube. If the corrected Hgb matches the original EDTA hgb value +/- 0.5 g/dL, the WBC and PLT values may be corrected (X 1.11) and used. The original EDTA values for all parameters, except WBC and PLT must be reported with the correct WBC and PLT values from the citrate tube." 2. Review of the Sysmex XN-10 manufacturer's instructions for use states, "Whole blood should be collected in EDTA-2K or EDTA-3K anticoagulant and, serous and synovial fluids in EDTA-2K anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended." 3. On the day of the survey, 01/18/2024 at 02:25 pm, the laboratory could not provide documentation for the performance specifications established when performing WBC and PLT counts using sodium citrate anticoagulant (blue top tube) for 2 of 2 Sysmex XN-10 analyzers from 12/01/2021 to 10/27/2023 4. TS #1 confirmed the findings above on 01/18/2024 at 06:45 pm. D5601 HISTOPATHOLOGY -- 2 of 9 -- CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on the review of the Wellspan Ephrata Community Hospital IHC/Molecular Requests form and interview with the pathology assistant (PA), the laboratory failed to document positive and negative staining reactivity each time of use for 50 of 50 immunohistochemical (IHC) stains used for histopathology examinations from 12/01 /2021 to the date of the survey. Findings include: 1. On the day of the survey, 01/18 /2024 at 12:00 pm, review of the Wellspan Ephrata Community Hospital IHC /Molecular Requests log revealed that a control for negative and positive reactivity was not documented each time of use for the following 50 of 50 IHC stains used for histopathology examinations from 12/01/2021 to 10/27/2023: - BerEp4 - Mart-1 - Calretinin - S-100 - CDX2 - SOX-10 - CK20 - Helicobacter pylori - CK 5/6 - CD34 - CK7 - Myosin Smooth Muscle - E-cadherin - CD56 - GCDFP-15 - Chromogranin - GATA-3 - Synaptophysin - HepPar1 - bcl-2 - Ki67 - bcl-6 - Mammaglobin - CD10 - Napsin A - CD138 - NKX3.1 - CD15 (Leu-M1) - PAX8 - CD20 - P120 Catenin - CD3 - P16 - CD23 - P40 - CD30 - P53 - CD45 - P63 - CD5 - Pankeratin (AE1/AE3) - Cyclin D1 - TTF-1 - PAX-5 - WT-1 - CD68 - ER - PR - KI67 - HER2 2. Further review of the provided manufacturer's instructions for use of Estrogen Receptor (ER) IHC staining (page 3) revealed, "A positive tissue control must be run with every staining procedure performed. A negative reagent control must be run for every specimen to aid in the interpretation of results." 3. The PA (CMS 209, personnel #25) confirmed the findings above on 01/18/2024 at 01:00 pm. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with technical supervisor #1 (TS), the laboratory failed to evaluate twice a year the relationship between test results using different methodologies and instrumentation in immunohematology, and hematology from 12/01/2021 to 10/27/2023. Findings included: 1. On the days of the survey, 01/17 /2024 and 01/18/2024, the laboratory failed to provide documentation of the biannual comparison studies for the following immunohematology and hematology tests performed from 12/01/2021 to 10/27/2023: - automated body fluid analysis performed on 2 of 2 Sysmex XN-10 - manual white blood cell differentials vs. automated white blood cell differentials (Sysmex XN-10) - manual body fluid cell counts (hemacytometer) vs. automated body fluid cell counts (Sysmex XN-10) - Ortho -- 3 of 9 -- Provue vs. manual gel vs. manual tube method (blood typing, antibody screen and identification, antigen typing, direct and indirect antiglobulin testing). - Ortho Vision vs. manual gel vs. manual tube method (blood typing, antibody screen and identification, antigen typing, direct and indirect antiglobulin testing). 2. TS #1 confirmed the findings above on 01/18/2024 at 06:45 pm. 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 record review and interview with technical supervisor #1 (TS), the laboratory director (LD) failed to provide overall management and direction of the laboratory in accordance with 493.1445 from 12/01/2021 to 10/27/2023. Findings include: 1. The LD failed to ensure all proficiency testing reports received were reviewed by the appropriate staff to evaluate the laboratory 's performance and to identify any problems that require