Clarinda Regional Health Center

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by interview with General Supervisor (GS) identifier #2 at 9:41 am on 09/27/2024, the laboratory failed to perform a self evaluation when the laboratory received seven ungraded PT scores from three out of five testing events from 01/01/2023- 09/27/2024. The findings include: 1. For 2023 3rd event, the laboratory received ungraded PT test scores for the following: * Hematology/Coagulation: Polymorphonuclear leukocytes (PMN) (CSF /body fluid)- specimen BFL-04 * Hematology/Coagulation: Vaginal Wet Prep- specimen VA-03 2. For 2024 1st event, the laboratory received ungraded PT test scores for the following: * Hematology/Coagulation: Nucleated red blood cells (RBCs)- specimen COU-02 * Microbiology: Gram stain morphology- specimen GS- 02 3. For 2024 2nd event, the laboratory received ungraded PT test scores for the following: * Hematology/Coagulation: Nucleated RBCs- specimen COU-06 * Hematology/Coagulation: Vaginal Wet Prep- specimen VA-02 * Microbiology: Gram stain morphology- specimen GS-08 4. At the time of the survey, GS #2 confirmed the laboratory did not perform a self evaluation for the ungraded PT test scores listed above. 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 D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's Individualized Quality Control Plans (IQCP) and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 02/10/2023, the laboratory failed to include a quality assessment plan as part of the IQCP for the following test systems: Alere Combo serum qualitative human chorionic gonadotropin (HCG), Abbott iStat, Cepheid GenXpert, Medtox Scan Profile V, and Alere Triage Meter. D5783

Summary Statement of Deficiencies 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 electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of temperature records and confirmed by testing personnel #1 (refer to the Laboratory Personnel Report) at approximately 10:15 am on 4/22/2021, the laboratory failed to document temperatures of the respiratory therapy refrigerator for 27 out of 31 days in December 2020. The findings include: 1. The respiratory therapy department stored i-STAT testing cartridges in the respiratory therapy refrigerator. 2. The laboratory did not document the temperature of the refrigerator on the following dates: 12/2 - 12/6/2020, 12/8 - 12/23/2020, 12/25 - 12/29/20 and 12/31/20. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of Cepheid GeneXpert maintenance records and confirmed by Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 8:45 am on 4/22/2021, the laboratory failed to perform and document daily maintenance on the Cepheid GeneXpert instrument for four out of 31 days of patient testing in December 2020. The findings include: 1. The Cepheid GeneXpert Maintenance log stated the laboratory must daily perform the following: *clean work area *close all module doors *discard used cartridges 2. At the time of the survey, the laboratory did not document daily maintenance for the following days of patient testing: 12/13/20, 12/15/20, 12/23/20 and 12/24/20. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on lack of function check records, review of the i-STAT operator's guide and confirmed with laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 10:15 am on 04/22/2021, the laboratory failed to perform and document thermal probe function checks on the respiratory therapy i-STAT analyzer every six months for three out of three time periods from 1/1/2020 - 4/22 /2021. The findings include: 1. The i-STAT operator's guide states that a thermal probe check must be performed every six months. 2. At the time of the survey, the laboratory did not perform the thermal probe check on the respiratory therapy from 1/1 /2020 - 4/21/2021. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the MIC Panel Quality Control procedure, Individualized Quality Control Plan, and antimicrobial susceptibility testing (AST) quality control (QC) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 4:45 pm on 04/21/2021, the laboratory failed to perform weekly gram positive and gram negative QC for one out of five weeks in December 2020. The findings include: 1. The MIC Panel Quality Control procedure and the Individualized Quality Control Plan stated AST quality controls would be performed weekly for gram positive and gram negative panels. 2. The laboratory -- 2 of 4 -- performed gram positive and gram negative AST quality controls every Wednesday. 3. At the time of the survey, the laboratory did not have gram positive and gram negative AST quality controls for the week of 12/23/2020. 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 review of the Laboratory Test List and Annual Volume report and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 9:00 am on 04/22/2021, the laboratory failed to perform comparison testing twice annually between the Dimension EXL and the i-STAT analyzers for the analytes: sodium, potassium, chloride, bicarbonate, ionized calcium, glucose, urea nitrogen and creatinine for three out of three time periods from 1/1/2020 - 4/22/2021. The findings include: 1. The Laboratory Test List and Annual Volume report listed the laboratory as performing sodium, potassium, chloride, bicarbonate, ionized calcium, glucose, urea nitrogen and creatinine testing on both the Dimension EXL and i-STAT analyzers. 2. At the time of the survey, the laboratory did not perform comparison studies between the Dimension EXL and i-STAT analyzers for the above analytes from 1/1/2020 - 4/22/2021. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 1:30 pm on 04 /21/21, the technical consultant failed to assess and document the competency of individuals performing moderate complexity testing at least annually for three out of three testing personnel (laboratory personnel identifiers #2, #8 and #9) in 2020. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and confirmed by the laboratory -- 3 of 4 -- personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11: 00 am on 4/22/2021, the laboratory director failed to ensure that the laboratory established and maintained a quality assessment program that included the four quality systems: general laboratory, pre analytical, analytical, and post analytical. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high 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 personnel records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 1:30 pm on 04 /21/2021, the technical supervisor failed to assess the competency of individuals performing high complexity testing at least semiannually during the first year the individual tests patient specimens for one out of six high complexity testing personnel. The findings include: 1. Testing personnel identifier #5 began performing patient testing on 2/3/2020. 2. At the time of the survey, the technical supervisor failed to perform a six month competency on testing personnel identifier #5. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 1:30 pm on 04 /21/2021, the technical supervisor failed to assess and document the annual competency of individuals performing high complexity for two out of two testing personnel (laboratory personnel identifiers #1 and #3) in 2020. -- 4 of 4 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of proficiency testing records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 9:30 am on 10/24/2018, the laboratory failed to enroll in an approved proficiency testing program for one out of one year for the subspecialty, bacteriology - Group A Streptococcus (molecular method). The findings include: 1. The laboratory installed a Cepheid GeneXpert instrument and began testing for Group A Streptococcus by molecular method in November 2017. 2. At the time of the survey, the laboratory failed to enroll in an approved proficiency testing program for subspecialty, bacteriology- Group A Streptococcus (molecular method) . 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) 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 -- -- (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: Based on review of calibration verification records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 12: 30 pm on 10/24/2018, the laboratory failed to perform calibration verification every six months on the Siemens Dimension EXL instrument for the analyte, glycated hemoglobin, for one out of two time periods from July 2017- July 2018. The findings include: 1. The laboratory installed a new Siemens Dimension EXL instrument in July 2017. 2. At the time of the survey, personnel identifier #2 confirmed that the laboratory had not done calibration verification for the analyte, glycated hemoglobin, since the installation of the new Siemens Dimension EXL in July 2017. -- 2 of 2 --