Memorial Hospital Of Lafayette County

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on survey review of laboratory records and procedures and interview the technical consultant, the laboratory director did not sign and date two of two new analyzer procedures prior to patient use. Findings include: 1. Review of the QuidelOrtho Vitros XT-7600 performance specification verification records showed the Vitros XT-7600 go-live date was June 28, 2023. 2. Review of the Sysmex XN-550 performance specification verification records showed the Sysmex XN-550 go-live date was July 10, 2024. 3. Review of the "Ortho Vitros XT-7600 Chemistry Testing Analyzer" procedure showed the laboratory director reviewed and signed the procedure in November 2023. 4. Review of "Sysmex XN-550 Hematology Analyzer Maintenance and Whole Blood Analysis" procedure showed the laboratory director review and signed the procedure in October 2024. 5. Interview with the technical consultant on November 12, 2024, at 2:50 PM confirmed the laboratory director did not sign and date new procedures prior to patient use. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures, observation of hematology quality control (QC) material and interview with the technical consultant, testing personnel did not label three of three opened QC vials with the open expiration date. Findings include: 1. Review of the "Sysmex XN-550 Hematology Analyzer Maintenance and Whole Blood Analysis" procedure stated under the "Quality Control" header: A. Preparation and Handling 1. XN-L Check are the three levels of controls, ordered from Sysmex that will be used on our XN-550. 2. The controls are stored at 2-8 until the expiration date on the vial. 3. Controls are good for 15 days after opening. 4. Continue to store in the refrigerator when not in use. 5. Label the vial with the date opened, and the 15-day expiration date when put into use. 2. Observation of the hematology QC in the laboratory refrigerator on November 12, 2024, at 1:05 PM revealed three vials of hematology quality control, Lot# 42841401, 42841402, and 42841403. Further observation of the vials showed an opened date of November 2, 2024, and no revised expiration date on the vials. 3. Interview with the technical consultant on November 12, 2024, at 1:05 PM confirmed the hematology QC expiration date changes when the vials are opened and testing personnel did not label the QC vials with the new expiration date after they were opened. 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: Based on surveyor review of laboratory records and interview the technical consultant, the laboratory did not perform calibration verification every six months for one of four required chemistry analytes on the QuidelOrtho Vitros XT-7600 chemistry analyzer. Finding include: 1. Review of calibrations performed on the QuidelOrtho Vitros XT-7600 chemistry analyzer showed 2-point calibrations for the Vitamin D, Total Iron Binding Capacity (TIBC), Hemoglobin A1C, and Beta-hydroxybutyrate analytes. 2. Review of QuidelOrtho Vitros XT-7600 calibration verification records showed calibration verification was performed every six months for the Vitamin D, -- 2 of 3 -- TIBC and Hemoglobin A1C analytes. Further review showed no calibration verification for the Beta-hydroxybutyrate analyte. 3. Review of test menu provided prior to the survey showed a volume of thirty-two patient tests for Beta- hydroxybutyrate. 4. Interview with the technical consultant on November 13, 2024, at 10:50 AM confirmed the laboratory did not perform calibration verification every six months for all required analytes on the QuidelOrtho Vitros XT-7600 chemistry analyzer. -- 3 of 3 --

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 off-site desktop review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing (PT) records, and interview with laboratory staff, the laboratory failed to successfully obtain an overall 100% satisfactory testing event score in PT for the Rh(D) analyte in the subspecialty of ABO Group/Rh Type within the specialty of Immunohematology for two out of two consecutive events for 2023-3 and 2024-1 (refer to D2162); and failed to successfully obtain an overall 100% satisfactory testing event score for the subspecialty of ABO Group/Rh Type within the specialty of Immunohematology for two out of two 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 -- consecutive events for 2023-3 and 2024-1(refer to D2163) resulting in unsuccessful PT performance. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on off-site desktop proficiency testing review of the federal Certification and Survey Provider Enhanced Reports (CASPER) proficiency testing reports and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records, and interview with laboratory staff, the laboratory failed to obtain an overall 100% satisfactory PT scores for two out of two consecutive events for the Rh(D) analyte in the ABO Group/Rh Type subspecialty within the Immunohematology specialty in events 2023-3 and 2024-1 which resulted in unsuccessful PT performance. Findings include: 1. Review of PT records in the federal CASPER reporting system on April 26, 2024 showed the laboratory had unsatisfactory performance for Rh(D) testing for PT events 2023-3 and 2024-1. Event 2023-3, score 80% Event 2024-1, score 80% 2. Desktop review of WSLH PT evaluation reports and phone interview with the laboratory director (Staff A) and laboratory manager (Staff B) on April 26, 2024 at 1: 30 PM, confirmed the unsatisfactory scores for Rh(D) testing for two consecutive PT events which results in unsuccessful performance in PT for Rh(D) testing. 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 testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on off-site desktop proficiency testing review of the federal Certification and Survey Provider Enhanced Reports (CASPER) proficiency testing reports and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records, and interview with laboratory staff, the laboratory failed to successfully obtain 100% satisfactory PT scores for two out of two consecutive events for the ABO Group/Rh Type subspecialty within the Immunohematology specialty in events 2023-3 and 2024- 1 which resulted in unsuccessful PT performance. Findings include: 1. Review of PT records in the federal CASPER reporting system on April 26, 2024 showed the laboratory had unsatisfactory performance for ABO Group/Rh Type testing for PT events 2023-3 and 2024-1. Event 2023-3, score 90% Event 2024-1, score 90% 2. Desktop review of the WSLH PT evaluation reports, and phone interview with the laboratory director (Staff A) and laboratory manager (Staff B), on April 26, 2024 at 1: 30 PM, confirmed the unsatisfactory scores for two consecutive PT events which results in unsuccessful PT performance in the subspecialty of ABO Group/Rh Type within the Immunohematology specialty. D6076 LABORATORY DIRECTOR -- 2 of 3 -- 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 off-site desktop review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing (PT) records, the laboratory failed to obtain satisfactory PT scores for the Rh(D) analyte in the subspecialty of ABO Group/Rh Type within the specialty of Immunohematology for two out of two consecutive events for 2023-3 and 2024-1; and failed to successfully obtain satisfactory testing event scores for the subspecialty of ABO Group/Rh Type within the specialty of Immunohematology for two out of two consecutive events for 2023-3 and 2024-1 which resulted in unsuccessful PT performance. The laboratory director did not ensure the laboratory did not fail two consecutive PT events. (Refer to D6092). D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and interview with the general supervisor, the laboratory failed to attain satisfactory performance in PT for the Compatibility Testing subspecialty in the Immunohematology specialty for event three in 2019. Findings include: 1. Review of PT records in the federal CASPER reporting system showed the laboratory had unsatisfactory performance for Compatibility Testing subspecialty on event three in 2019. A score of 100% is required for satisfactory performance for compatibility testing. a. Event 2019-3: 80% 2. Review of WSLH PT evaluation report confirmed the unsatisfactory performance for compatibility testing subspecialty in the Immunohematology specialty for event three in 2019. 3. Interview with the general supervisor on April 14, 2021 at 10:30 AM, confirmed the laboratory did not attain satisfactory performance in PT for the Compatibility Testing subspecialty in the Immunohematology specialty for event three in 2019. 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 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory blood bank records and interview with the general supervisor, the coombs check cells used for testing on October 21, 2018 were expired. 1. Review of the blood bank testing log shows Ortho coombs check cells lot K526 with an expiration date of October 16, 2018, were used on October 21, 2018 for quality control and proficiency testing. 2. Interview with the general supervisor on November 15, 2018 at 1:00 PM confirms that expired coombs check cells were used past the expiration date as were available for patient testing. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. 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 laboratory record review and interview with the technical consultant, the laboratory director has not delegated in writing responsibilities to the technical consultant to perform specific delegated duties in which the technical consultant has been performing. Findings include: 1. Review of laboratory technical competency assessments, quality control, and new method evaluation records shows the technical consultant has reviewed and approved these records. 2. Review of laboratory records shows no written delegation by the lab director to the technical consultant to perform these responsibilities. 3. Interview with the lab director and technical consultant on November 14, 2018 at 10:30 AM confirms the lab director has not delegated in writing the duties and responsibilities of the technical consultant. -- 2 of 2 --