Pocahontas Medical Clinic P A

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the lack of written policies and procedures and interview it was determined that the laboratory failed to have a procedure for monitoring temperatures, available to laboratory personnel during 2022 and to the date of the survey in 2023. Findings include: A. The laboratory failed to provide a written procedure for recording the temperature and humidity at the laboratory. B. During an interview on 11/15/2023 at 08:52 AM, the Technical Supervisor confirmed these findings that no procedure could be found in the Pocahontas Family Clinic Procedure Manual. 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 D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Through a review of the Medonic M-Series operator's manual, 2020 and 2021 calibration documentation for the Medonic hematology analyzer, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to perform calibration on the Medonic analyzer every 6 months as required by the manufacturer. Survey findings include: A. In Section 7: Calibration section of the Medonic M-Series operator's manual states (Pg. 59), it states, "It is recommended to calibrate the instrument every 6 months." B. A review of Medonic calibration documentation for 2020 and 2021 revealed that calibrations were documented on 2/21 /2020, 8/18/2020, 5/13/2021, and 11/12/2021. The time period between the calibration on 8/18/2020 and the calibration on 5/13/2021 was 9 months (3 months more than recommended by the manufacturer). C. In an interview, at 1:50 p.m. on 12/28/2021, the technical consultant (listed on the CMS-209 form as employee #9) confirmed the lack of calibration between 8/18/2020 and 5/13/2021. 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 -- 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. This STANDARD is not met as evidenced by: Through a review of the laboratory policy and procedure manual, a review of hematology quality control documentation for February, August, November, and December 2021, a review of the technical consultants quality assessment reviews, and through interviews with laboratory staff, it was determined the laboratory failed to correct problems identified in the analytic systems quality assessments. Survey findings include: A. The surveyor reviewed the laboratory policies and procedures. The procedure titled "Quality Control Protocol" states, "Control results should be investigated when a shift or trend is noted" and further states, "The Quality Control results are reviewed periodically by the technical consultant to observe for biases, shifts, or trends...A report noting the acceptability of the Quality Control data is filed after each visit by the technical consultant and sent to the Laboratory Director." B. A review of Levey-Jennings graphs for quality control performed in February 2021 revealed two of three levels of quality control were shifted above the mean all month (18 of 18 points for each control). The normal control was documented above the mean by an average of 1.5 SD (standard deviations) and the high control was above the mean by an average of 1.7 SD through the month of February 2021. C. A review of Levey-Jennings graphs for quality control performed in August 2021 revealed two of three levels of quality control were shifted above the mean. The normal control was documented above the mean on 21 of 22 points during August 2021, by an average of 0.9 SD and the high control was above the mean 22 of 22 points during August 2021 by an average of 1.4 SD. D. A review of Levey-Jennings graphs for quality control performed November through December 2021 revealed two of three levels of quality control were continuously shifted above the mean through both months (33 of 33 points for each control). The normal control was documented above the mean by an average of 1.0 SD and the high control was above the mean by an average of 1.4 SD through the months of November and December 2021. E. The technical consultant performs quarterly quality reviews during visits to the laboratory. The surveyor requested copies of the technical consultants reports and was provided three reports dated 3/2/2021, 7/21/2021, and 12/7/2021. The report dated 3/2/2021 included a statement that "Quality control data review for the Medonic M series showed a slight positive bias on Hemoglobin. The bias was not great enough to warrant an adjustment at this time. Will continue to monitor." The report dated 7/21/2021 stated, "Quality control data review for the Medonic M series showed various biases on several analytes. The biases were calculated, and the calibration factor adjusted to correct. The controls were tested post adjustment with improvement." The report dated 12/7 /2021 included, "Quality control data review for the Medonic M series showed a slight positive bias on RBC and Hemoglobin. The instrument was successfully calibrated November 12, 2021. Post calibration the hemoglobin still has a slight positive bias." The technical consultant identified the shifts in quality control for hemoglobin in all of the reports for 2021 but the shifts were never corrected. F. During an interview, on 12/28/2021 at 2:30 p.m. the technical consultant confirmed -- 2 of 3 -- the hemoglobin quality control was still shifted above the mean at the time of the survey and had remained shifted above the mean since February 2021 without being corrected. -- 3 of 3 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Through observations made during a tour of the laboratory at 10:35 am on 4/9/2019, and interviews with laboratory staff at the time of the tour, it was determined the laboratory failed to follow manufacturer's expiration instructions for the Multistix 10 SG urine dipsticks. Survey findings include: A. During a tour of the laboratory (10:35 am on 4/9/2019) the surveyor observed one container of Multistix 10 SG urine dipsticks (lot # 709087) on the laboratory counter by the microscope. The Multistix 10 SG (lot # 709087) expired on 3/31/2019, nine days prior to the date of the survey. One of six containers of Multistix 10 SG had exceeded the expiration date. B. In an interview at the time of the tour the technical consultant confirmed the container of Multistix 10 SG were currently in use and further confirmed that they had exceeded their expiration date. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- 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 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 -- 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: Through a review of the BIO-RAD Lyphochek Immunoassay Plus Control package insert, a review of Levey-Jennings Graphs for PSA, TSH, T4 Free, and T3 Total, and through interviews with laboratory staff, it was determined the laboratory failed to calculate target means, as required by the manufacturer, for new lots of quality control material for four of four tests which use BIO-RAD Lyphochek Immunoassay Plus Control as the control material. Survey findings follow: A. BIO-RAD Lyphochek Immunoassay Plus Control package insert states, "It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides." B. Target means listed on the BIO-RAD Lyphochek Immunoassay Plus Control package insert are as follows for Level 2 (lot #40362): PSA 2.44; TSH 5.11; T4 Free 2.88; and T3 Total 2.00. Target means listed for Level 3 (lot # 40363) are: PSA 14.3; TSH 33.1; T4 Free 3.92; and T3 Total 3.25. C. Levey-Jennings Graphs for quality control included the following means for BIO-RAD Lyphochek Immunoassay Plus Control Level 2 which were taken from the package insert instead of calculated by the laboratory: PSA 2.44; TSH 5.11; T4 Free 2.88; T3 Total 2.00. The Graphs also include the following means for Level 3 Control: PSA 14.3; TSH 33.1; T4 Free 3.92 (in use 7/31/2018 through 10/9/2018); and T3 Total 3.25. All means other than T4 Free are documented in use from the date the new control lot was started (7/31/2018) through the date of the survey (4/10/2019). D. In an interview (10:17 on 4/10/2019) the technical consultant (as listed on the form CMS-209) confirmed the laboratory had failed to establish it's own mean and had used the package insert mean for all tests in which the BIO-RAD Lyphochek Immunoassay Plus Control is used as control material. -- 2 of 2 --