Ripley Medical Clinic

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on laboratory observation, review of patient test reports, staff interview, and electronic mail communication, the White Blood Cell differential was inaccurately reported on the final patient test report from the date patient testing began on the Sysmex XN 330 Complete Blood Count with White Blood Cell Differential (CBC w /Diff) instrument on 03/12/24 until the date of the survey on 11/12/24 with approximately 1,357 patients reported during the period. The findings include: 1. Laboratory observation on 11/12/24 at 8:40 a.m. revealed the Sysmex XN 330 instrument (serial number 16313) used for performing patient testing for CBC w/Diff. 2. A review of the first patient CBC w/Diff reported from the Sysmex XN 330 on 03 /12/24 for patient MRN 28142 revealed the following: The instrument printout from the Sysmex XN 330 contained WBC differential parameters for monocytes, eosinophils, basophils, and immature granulocytes. The final patient test report did not include the monocytes, eosinophils, basophils and immature granulocytes. The monocyte percent (%) and monocyte absolute count (#) from the instrument printout were reported under MXD% and MXD# parameters. 3. A review of patient MRN 32296, reported on 11/12/24 (the survey date), revealed the following: The instrument printout from the Sysmex XN 330 contained WBC differential parameters for 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 -- monocytes, eosinophils, basophils, and immature granulocytes. The final patient test report did not include results for monocytes, eosinophils, basophils, and immature granulocytes. The monocyte % and monocyte # from the instrument printout were reported under MXD% and MXD# parameters. 4. An interview with the technical consultant on 11/12/24 at 12:00 p.m. revealed that the laboratory implemented the Sysmex XN 330 instrument on 03/12/24. The final patient test report in the EMR was not updated to reflect the differential parameters reported by the Sysmex XN 330 instrument. This confirmed the survey findings. 5. According to an electronic mail communication received on 11/15/24 at 4:57 p.m., 1,357 patient WBC differentials were reported incorrectly from the time the laboratory began testing on the Sysmex XN 330 on 03/12/24 until the date of the survey on 11/12/24. Word Key: MRN=Medical Record Number EMR=Electronic Medical Record WBC=White Blood Cell -- 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 observation of the laboratory, review of complete blood count (CBC) quality control (QC) records, and staff interview, the laboratory failed to retain QC ranges used for each QC lot number from the date of the last survey on 03/23/22 until 09/19/23. The findings include: 1. Observation of the laboratory on 11/01/23 at 8 am revealed the Sysmex KX-21N CBC instrument in use for patient testing. 2. Review of the laboratory's quality control records revealed the following: Lot 2193 (Low, Normal and High) in use from 07/18/22 to 10/12/22. Lot 2361 (Low, Normal and High) in use from 01/11/23 until 04/03/23. The QC records did not include the QC ranges as set in the instrument during the periods when the lots were in use. 3. Interview with the technical consultant on 11/01/23 at 11:45 am revealed the following: The laboratory puts the QC limits calculated from the package insert in the instrument when the lots are placed into use. The daily printouts that are retained as the laboratory's QC records do not include the QC ranges. The laboratory could not provide proof of the QC ranges used for the selected lot numbers. The laboratory did not have records of QC ranges in use from the date of the last survey to 09/19/23 when the current lot was placed into use. This confirmed the laboratory failed to retain QC ranges for a period of at least two years. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory and staff interview during observation, review of the laboratory's quality control (QC) records, manufacturer instructions for calculating QC limits, patient CBC reports, the Centers for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116) and interview with the technical consultant, the laboratory failed to use correct manufacturer QC limits for twenty-four of twenty-four QC lots reviewed from 03/24/22 until the date of the survey on 11/01/23, with approximately 3,496 patients reported. The findings include: 1. Observation of the laboratory on 11/01/23 at 8 am revealed the Sysmex KX-21N CBC instrument in use for patient testing (Serial # A6173). Control lots observed in use were 3248 (Levels one, two and three). During observation, the lead testing person stated the laboratory uses the manufacturer package insert ranges for quality control. 2. Review of the laboratory's current QC lot (32480-Level one, two and three) revealed the following manufacturer ranges and ranges in use by the laboratory for selected parameters: Level one (32480710) Manufacturer Laboratory White Blood Cell 3.0-4.0 2.5-4.5 Red Blood Cell 2.19-2.59 1.99-2.79 Hemoglobin 6.2-7.0 5.8-7.4 Hematocrit 16.9-19.7 15.5-21.1 Platelet 63-103 43-123 Level two (32480711) Manufacturer Laboratory White Blood Cell 6.5-7.9 5.8-8.6 Red Blood Cell 4.18-4.70 3.92-4.96 Hemoglobin 12.5-13.9 11.8-14.6 Hematocrit 33.6-38.2 31.3-40.5 Platelet 189-271 148-312 Level three (32480712) Manufacturer Laboratory White Blood Cell16.8-20.4 15.0-22.2 Red Blood Cell 5.10-5.62 4.84-5.88 Hemoglobin 16.2-17.8 15.4-18.6 Hematocrit 42.6- 49.8 39.0-53.4 Platelet 482-620 413-689 3. Review of a document provided by the manufacturer and received via email from the technical consultant on 11/03/23 at 9:12 am revealed specific instructions for calculation of QC limits. 4. Review of the manufacturer QC assay sheets revealed the laboratory used an incorrect method of calculating the QC ranges that were entered into the instrument from the date of the last survey to the current survey date (11/01/23) for the low, normal and high QC levels for each lot. The limits as calculated on the QC assay sheets were two times the correct limits. For Lot 2277, the assay sheet with the calculations also indicated the use of QC values for the POCHi instrument instead of the KX-21N instrument. Lot 2025 in use on 03/24/22 until 04/21/22 Lot 2029 in use from 04/22/22 until 07/15/22 Lot 2193 in use on 07/18/22 until 10/12/22 Lot 2277 in use on 10/13/22 until 01/10/23 (Use of values for POCHi instrument) Lot 2361 in use on 01/11/23 until 04/03/23 Lot 3080 in use on 04/04/23 until 06/27/23 Lot 3164 in use on 06/28/23 until 09/19/23 Lot 3248 in use on 09/19/23 until survey date 5. Review of patient CBC final test reports revealed reporting of patient CBC during periods when incorrect QC limits were in use as follows: Patient 28311 reported on 09/12/22 Patient 25994 reported on 03/07 /23 Patient 20206 reported on 08/04/23 6. Review of the Form CMS-116 revealed the laboratory reports approximately 184 patients per month, resulting in approximately -- 2 of 3 -- 3,496 patient CBCs reported during the period when incorrect QC limits were in use. 7. Electronic interview via text message received on 11/03/23 at 8:23 am confirmed the laboratory had incorrectly calculated the appropriate QC ranges according to manufacturer instructions since the last survey on 03/23/22 to the current survey date (11/01/23). D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies 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 of the laboratory, review of the verification of performance specification (VoPS) records, the complete blood count (CBC) patient records and interview with the technical consultant, the laboratory failed to perform the VoPS for the CBC instrument, prior to patient testing in 2018. The findings include: 1) Observation of the laboratory on March 6, 2019 at 1:51 p.m. revealed the Sysmex KX- 21N CBC instrument in use for patient testing. 2) Review of the VoPS records revealed the VoPS was performed on March 4, 2019. 3) Review of the CBC patient records revealed the first patient CBC was performed on September 28, 2018. 4) Interview on March 6, 2019 at 3:20 p.m. with the technical consultant confirmed the VoPS was preformed two days prior to the survey date. 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. 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 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the chemistry quality control (QC) records, the quality assessment (QA) records, the laboratory procedure policies and interview with the technical consultant, the laboratory failed to establish and follow a written policy for performing and documenting