Mcpherson Hospital

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 the review of the performance verification for ferritin, vitamin B12, and folate performed on the Vitros 5600 chemistry analyzer, and interview with technical consultant (TC) #1, the laboratory failed to verify the patient normal values for ferritin, vitamin B12, and folate were appropriate for the laboratory's patient population prior to reporting patient test results. Findings: 1. Request was made to review the performance verifications for the ferritin, vitamin B12, and folate performed on the Vitros 5600 chemistry analyzer serial number J5600-1999. 2. Review of the performance verification revealed no normal range value verification. No acceptability of the manufacturer's stated normal ranges statement was present. 3. TC #1 stated, and documentation confirmed patient testing began 10/23/22. A total of 629 ferritin, 779 B12, and 140 folate patient results were reported 10/23/22 to 3/28/23 for 3 of 3 analytes. 4. Interview with TC #1 on 3/28/23 at 1:25 p.m. confirmed, the laboratory failed to verify the patient normal values for ferritin, vitamin B12, and folate were appropriate for the laboratory's patient population prior to reporting patient test results. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of CMS form 209, competencies, patient test records, and interview, the technical consultant (TC) failed to document competency by direct observation of routine patient test performance, and assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples at least semiannually during the first year the individual tests patient specimens for 7 of 10 moderate complexity testing personnel (TP). Findings: 1. Review of the site's CMS for 209 for personnel revealed 10 new moderate complexity TP since last survey that had performed non-waived testing for 6 months. 2. Review of personnel 6 month competency records revealed 7 of 10 competencies lacked documentation of direct observation of routine patient test performance, and assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples for TP #14, TP#15, TP#18, TP#19, TP#20, TP#21, and TP#22 3. Review of patient test records revealed 864 test results for pH, pO2, and pCO2 had been reported from 7/1/21 to 3/28 /23 by the 7 TP listed in item #2. 4. Interview with the TC #1 on 3/28/23 at 9:05 a.m. confirmed, the TC failed to document competency by direct observation of routine patient test performance, and assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples at least semiannually during the first year the individual tests patient specimens for 7 of 10 moderate complexity TP. -- 2 of 2 --

Summary Statement of Deficiencies D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. 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 Immunohematology Suspected Transfusion Reaction reports, electronic medical record (EMR) search, Suspected Transfusion Reactions laboratory procedure, patient vital signs documentation during blood transfusions, post transfusion review notations made by General Supervisor (GS)#1 that suspected transfusion reaction criteria was met but not initiated by transfusing nurse, lack of timely remedial action documentation and interview, the laboratory failed to document the pathologist interpretation on 2 of 2 suspected transfusion reaction reports in the patients EMR and failed to document that all necessary remedial actions were taken to prevent reocurrences of the failure to conduct transfusion reaction investigations to ensure patient safety for 4 of 4 patients when being transfused. Findings: 1. Review of 2 of 2 Suspected Transfusion Reaction Reports reveals both listed the pathologist's interpretive comments for the results for the pre-transfusion and post-transfusion specimens tested and clerical checks. 2. Suspected Transfusion Reaction Reports are paper forms. Request was made to see the report in each of the related patients' EMR. 3. An electronic search of both patients' records by the 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 -- hospital's Health Information Management staff were unable to produce an electronic copy for 2 of 2 Suspected Transfusion Reaction reports containing the pathologist's interpretive comments for the results for the pre-transfusion and post-transfusion specimens tested and clerical checks. 4. GS #1 in interview on 6/10/21 at 1:40 p.m. confirmed, the laboratory failed to document the pathologist interpretation on 2 of 2 suspected transfusion reaction reports in the patients EMR. 5. Review of "Suspected Transfusion Reactions" laboratory procedure revealed under "The list of signs and symptoms.." Entered as number 2 "Blood Pressure - Arise or drop of 30mm/Hg or more fom the pre-transfusion Blood Pressure." 6. GS #1 provided 5 sets of patient vital signs documentation during 5 blood transfusions with post transfusion review notations made by GS#1. 7. Surveyor reviewed documents for 4 patients who received 5 units (one patient received 2 units). Hand written notations by GS#1 indicated that the suspected transfusion reaction criteria had been met. All 5 sets showed the change in blood pressure of 30mm/Hg or more from pre-transfusion values. Documents also showed that each of the transfusing nurse(s) did not initiate a suspected transfusion reaction workup to be completed by the laboratory and all 5 of the transfusions were completed without intervention. Transfusion dates were as follows: 9/29/2020 (2 units), 1/15/2021, 2/3/21, and 3/19/21. Dates of discovery provided were 10/28/20 for the 9/29/20 event, 2/25/21 for the 1/15/21 and 2/3/21 events and 4/17/21 for the 3/19 /21 event. 7. Request to review remedial actions taken to avoid reocurrence consisted of entries made into the hospital risk management system on 10/28/2020 for the 9/29 /2020 event. The other 3 events were all entered into the hospitial risk management system on 4/17/21. No documentation to coordinate with the dates of discovery were provided during survey to assess patient status, notify patient provider or notification of laboratory director. 8. A

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 review of proficiency testing records the laboratory failed to successfully participate in proficiency testing from American Proficiency Institute for the ABO group and Rh typing (overall testing event) for two out of three consecutive proficiency testing events: 2019 event 1 and event 3 (refer D2163). D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) Failure to achieve an overall testing event score of satisfactory for two consecutive 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 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of 2019 proficiency testing (PT) records and test menu, the laboratory failed to achieve satisfactory PT performance for the overall testing event score for two out of three PT events for the analytes ABO group and Rh typing. The laboratory received unsatisfactory performance scores of 90% as the overall testing event score for the analytes, ABO and Rh typing, for 2019 event 1 and event 3. -- 2 of 2 --

Summary Statement of Deficiencies 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 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: A review of calibration verification records for the Ortho Vitros 5600, and interview with staff revealed that the laboratory failed to perform calibration verification once every six months. Finding were as follows 1. Review of the Ortho Vitros 5600 calibration verification documentation revealed the laboratory failed to perform calibration verification at least once every six months on analytes: NA, K, Cl and Vitamin D. The laboratory performed a calibration verification on April 5, 2018 but 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 -- failed to perform the calibration verification that was due in October 2018. This was confirmed in interview with Testing person #2 on June 13, 2019 at 11:00 hrs. -- 2 of 2 --

Summary Statement of Deficiencies D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: A review of McPherson Hospital blood bank maintenance policy, the blood bank maintenance records, the serofuge centrifuge equipment in blood bank, and interview with general supervisor #1 found the laboratory failed to retain serofuge equipment records. Findings were: 1. Blood bank procedure manual stated that serofuge centrifuge equipment maintenance checks were to be performed every six months. 2. At the time of the survey, the surveyor observed the serofuge centrifuge equipment in blood bank labeled with serofuge timer readings without date of measurements: Immediate spin 20 seconds Wash 60 seconds Coombs 20 seconds Enhancement 20 seconds 3. The serofuge centrifuge was used during the last twelve months to perform 327 ABO RH types, antigen type 3 red blood cell units, and perform 22 cord types. 4. Interview with general supervisor #1 at 2:15 on July 12, 2018, verified that at the time of the survey the lab had no records documenting the serofuge centrifuge times and the above findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions 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 2 -- electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: A review of Temperature and humidity logs and interview with staff revealed the laboratory failed to document the humidity for the laboratory as the XT-4000i hematology analyzer requires and Vitros 5600 failed to document. Findings were as follows: a. Based upon review of manufacture's guide for the XT-4000i (Hematology analyzers) the laboratory failed to document the humidity 30% to 85% . The laboratory failed to define the acceptable humidity range according to the manufacture's range . b Based upon review of manufactures's guide for the Vitros 5600 (chemistry analyzer) for the humidity range 15 to 75 % the laboratory failed to document. c. This was confirmed by the Technical Supervisor on 07/12/2018 at 14::00 hrs D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: A review of documentation and staff interview for the manual check of the International Normalized Ratio (INR). The Laboratory failed to document a manual check for 2016, and 2017. Finding were as follows: 1. At the time of the survey 07/12 /2018 the laboratory failed to provide documentation that a manual check was performed this was confirmed in interview with General Supervisor # 1 from the CMS form 209 at 11:00 hrs. D5783