Krohn Clinic Ltd

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: Based on surveyor review of calibration verification records for the Vitros 5600 analyzer in 2022 and 2023 and interview with the technical consultant, the calibration verification process for twelve of twelve analytes performed with MicroWell Range Verifiers did not include a mid-point value. Findings include: 1. Review of calibration verification records showed the laboratory used MicroWell Range Verifiers to perform calibration verification procedures in April and October of 2022 and 2023. 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 records showed personnel tested verifiers near the upper and lower limits of the reportable range for twelve analytes. The records do not show the results of a mid- point value for any of the twelve analytes. 2. Interview with the technical consultant on January 31, 2024, at 12:30 PM confirmed a mid-point value sample was not tested as part of the calibration verification process. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of quality control records and interview with the technical consultant, the laboratory did not include a negative quality control (QC) material for three of nine reagents reported with graded reactivity. Findings include: 1. Review of the 'Krohn Clinic Blood Bank QC Log' showed the routine QC process for blood bank reagents included a negative and graded positive test result for the following reagents: Anti-D, AHG (anti-human globulin), A cells, B cells, Screening Cells I and II. The log showed only graded positive evaluation of Anti-A, Anti-B, and Coombs Check Cells (CCC). 2. Interview with the technical consultant on January 30, 2024, at 3:45 PM confirmed the laboratory's procedures did not ensure personnel tested an expected negative quality control sample with Anti-A, Anti-B, and CCC each day of patient testing. -- 2 of 2 --

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 surveyor review of laboratory records and procedures and interview with the general supervisor, the laboratory did not have a procedure available for the Cepheid Gene Xpert 4-plex plus test process. Findings include: 1. Review of laboratory records showed the laboratory was performing the Cepheid Gene Xpert 4-plex plus test for influenza, respiratory syncytial virus (RSV) and SARS-CoV-2 (COVID-19) testing as of December 31, 2021. 2. Review of laboratory procedures showed the laboratory was using the manufacturer's standard operating procedure (SOP) template for testing performed on the Cepheid Gene Xpert. Further review showed the current approved SOP was for the 4-plex test for influenza, RSV and COVID-19 test (REF# XPCOV2 /FLU/RSV-10) and no procedure was available for the 4-plex plus test (REF# XP3COV2/FLU/RSV-10). 3. Interview with the general supervisor on March 23, 2022 at 1:20 PM confirmed the laboratory was performing the 4-plex plus test for influenza, RSV and COVID-19 testing and the SOP was not available in the laboratory. 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. 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 and interview with the general supervisor, the laboratory director did not approve, sign and date the procedure for the Cepheid Gene Xpert Chlamydia trachomatis (CT)/Neisseria gonorrhoeae(NG) test. Findings include: 1. Review of laboratory procedures revealed the laboratory was using the manufacturer's standard operating procedure (SOP) template for testing performed on the Cepheid Gene Xpert. Further review showed no documentation of approval by the laboratory director for the CT/NG procedure. 2. Interview with the general supervisor on March 23, 2022 at 1:20 PM confirmed the laboratory director did not approve, sign and date the procedure for the Cepheid Gene Xpert CT/NG test. 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 survey review of laboratory records and interview with the general supervisor, the laboratory director did not review and approve the performance specification verification records on the Cepheid Gene Xpert 4-plex plus analyte prior to reporting patient results. Findings include: 1. Review of laboratory records showed the laboratory started reporting patient test results for the Cepheid Gene Xpert 4-plex plus test on December 31, 2021. Further review showed no evidence the laboratory director had reviewed and approved the performance specification verification records on the Cepheid Gene Xpert 4-plex plus test. 2. Interview with the general supervisor on March 23, 2022 at 1:20 PM confirmed the laboratory director did not review and approve the performance specification verification records on the Cepheid Gene Xpert 4-plex plus analyte prior to reporting patient results. 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 surveyor review of the Individualized Quality Control Plan (IQCP), patient and quality control (QC) records and interview with the general supervisor, the -- 2 of 3 -- laboratory did not perform two levels of quality control on each day of patient testing and had not developed an IQCP for the Cepheid Gene Xpert 4-plex plus test cartridge. Findings include: 1. Review of the IQCP records showed an IQCP plan in place for the Cepheid Gene Xpert 4-plex test cartridge signed by the laboratory director on December 31, 2020. Further review showed no IQCP in place for the 4-plex plus test cartridge. 2. Review of patient records showed patient testing began on the Cepheid Gene Xpert 4-plex plus test cartridge on December 31, 2021. 3. Review of QC records for the Cepheid Gene Xpert 4-plex plus test cartridge showed QC was performed per the Cepheid Gene Xpert 4-plex test cartridge IQCP of monthly and with each new shipment and new lot. 4. Interview with the general supervisor on March 23, 2022, at 1:20 PM confirmed the laboratory did not perform two levels of quality control on each day of patient testing and had not developed an IQCP for the Cepheid Gene Xpert 4-plex plus test cartridge. -- 3 of 3 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and other laboratory records and interview with the technical consultant, the laboratory did not verify the accuracy of potassium hydroxide (KOH) testing performed on dermatology samples twice annually in 2019 or 2020. Findings include: 1. Review of PT records from 2019 and 2020 showed no evidence of evaluation of KOH testing for skin samples. 2. Review of other laboratory records showed no evidence of accuracy verification of KOH testing of skin or other dermatology samples. 3. Interview with the technical consultant on November 17, 2020 at 8:30 AM confirmed the laboratory performed KOH testing of dermatology samples. Further interview confirmed the laboratory had not developed a process to verify the accuracy of this testing twice annually. This is a repeat deficiency previously cited on April 6, 2010 and March 19, 2014. 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 surveyor review of maintenance logs and interview with the technical consultant, the laboratory did not document maintenance as defined 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 -- manufacturer of the Tosoh G8 analyzer and with at least the six-month frequency specified by the manufacturer. Findings include: 1. Review of maintenance logs for the Tosoh G8 analyzer from 2020 showed the laboratory had not documented the replacement of the fluid supply line filters every six months as required. 2. Interview with the technical consultant on November 17, 2020 at 11:50 AM confirmed the laboratory had not documented performance of the six-month maintenance for the Tosoh G8 analyzer. This is a repeat deficiency previously cited on March 9, 2018. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Center for Medicare and Medicaid (CMS) Form 209, Laboratory Personnel Report (CLIA), personnel records, and interview with the Technical Consultant, the Technical Consultant failed to document the semi-annual competency evaluation for one of two new Testing Personnel. Findings include: 1. Comparison of the current CMS Form 209 with the Form 209 from the March 2018 survey showed two new Testing Personnel listed on the current form. 2. Review of personnel records for Testing Personnel, staff A, showed no documented semi-annual competency assessment. Records for staff A showed records dated May 2018 identified as initial competency and the single set of records from 2019 identified as annual competency. 3. Interview with the Technical Consultant on November 16, 2020 at 3:45 PM confirmed the Technical Consultant had not evaluated semi-annual competency for one of two new Testing Personnel in the first year. This is a repeat deficiency previously cited on March 9, 2018. -- 2 of 2 --

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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to successfully participate in PT for the Activated Partial Thromboplastin Time (APTT) analyte in the Specialty of Hematology for events 2017-1, and 2017-3. Findings include: 1. Review of PT records in the federal CASPER reporting system shows that the laboratory failed two out of three PT events for the APTT analyte within the Specialty of Hematology- Event 2017-1, score 60% and Event 2017-3, score 60%. 2. Surveyor review of the API PT evaluation reports confirmed the failed 2017 PT scores which Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- results in a failure to successfully participate in APTT for Hematology. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and American Proficiency Institute (API) PT records, the laboratory failed to have successful performance in PT for the Activated Partial Thromboplastin Time (APTT) analyte in the Specialty of Hematology for events 2017-1, and 2017-3. Findings include: 1. Review of PT records in the federal CASPER reporting system shows that the laboratory failed two out of three PT events for APTT in the Specialty of Hematology- Event 2017-1, score 60% and Event 2017-3, score 60%. 2. Surveyor review of the API PT evaluation reports confirmed the failed 2017 PT scores. This results in a failure to achieve an overall testing event score of satisfactory performance for two out of three testing events which is unsuccessful PT performance. 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 surveyor review of the laboratory policies and procedures and interview with the Ancillary Services Manager, the Laboratory Director failed to approve, sign and date the new competency assessment policy that is currently in use. Findings include: 1. Review of the "Competency Assessment" policy that is currently in use shows that the policy has not been approved and signed by the Laboratory Director. 2. Interview with Ancillary Services Manager on March 8, 2018 at 11:30 AM confirmed that the competency assessment policy that was in use had not been approved, signed, and dated by the current Laboratory Director. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of the manufacturer's instructions, laboratory procedures, and interview with the Ancillary Services Manager, the laboratory has not performed Immunohematology procedures according to the manufacturer's requirements when -- 2 of 5 -- performing Immunohematology testing. Findings include: 1. Review of the specific manufacturer's instructions for the ABO Grouping, Anti-D, and Direct Coombs testing state that the cell suspensions should be 3-4% for ABO Grouping and Anti-D testing and 3-5% for Direct Coombs Testing. 2. Review of the laboratory "ABO Grouping", "Anti-D", and "Direct Coombs" procedures state the cell suspensions used for patient testing should be 2-4%. 3. Interview with the Ancillary Services Manager on March 8, 2018 at 2:00 PM confirms that the procedures used for Immunohematology testing do not follow manufacturer's package insert instructions for reagents used for testing. This deficiency was previously cited April 15, 2008 and April 6, 2010. 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 surveyor review of the Maintenance Log Checklist, laboratory procedures, and interview with Testing Personnel, the laboratory has not performed maintenance on the Mini-Vidas analyzer as required. Findings include: 1. Review of the laboratory "Mini-Vidas Assay" procedure and the Maintenance Log Checklist show that the lab is to perform weekly cleaning of external surfaces of the Mini-Vidas analyzer. 2. Review of the Maintenance Log Checklist from January through December 2017 show the lab performed the required weekly maintenance 13 out of 52 weeks in 2017. 3. Interview with Testing Personnel A on March 8, 2018 at 2:30 PM confirmed that the maintenance on the Mini-Vidas analyzer is not being performed as required by the lab procedure. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of training documentation and interview with the Ancillary Services Manager, the laboratory director did not ensure new testing personnel had received training for all non-waived testing performed in the laboratory. Findings include: 1. Review of training records for Testing Personnel (TP) B and TP C, who started in the laboratory in January 2017 and December 2016 respectively, shows that training documentation was not completed for Immunohematology, Microbiology, Provider Performed Microscopy, and Urine Microscopy non-waived testing prior to patient testing. 2. Interview with the Ancillary Services Manager on March 8, 2018 at -- 3 of 5 -- 11:00 AM confirms the training documentation was not completed and signed prior to TP B and TP C performing patient testing. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the Ancillary Services Manager, competency assessment of four Testing Personnel listed on the Center for Medicare and Medicaid Services (CMS) Form 209 was not performed in 2016 and 2017. Findings include: 1. Review of personnel records shows no completed competency assessments for all non-waived testing for four of four Testing Personnel (TP A, TP D, TP E, and TP F) listed on the CMS Form 209 for 2016 or 2017. 2. Interview with the Ancillary Services Manager on March 8, 2018 at 11:30 AM confirmed no 2016 or 2017 competency assessments were available for Testing Personnel. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of Testing Personnel competency assessment records and interview with the Ancillary Services Manager, who is the Technical Consultant, the Technical Consultant failed to document the semiannual competency evaluation for two of two new Testing Personnel who performed patient testing. Findings include: 1. Review of competency assessment records for new Testing Personnel (TP) B and TP C, as listed on the identifier key, shows no semiannual competency assessment has been documented. 2. Interview with the Technical Consultant on March 8, 2018 at 11: 30 AM confirmed that new TP B and TP C have been performing patient testing for more than one year and that the semiannual competency evaluation for each TP was not documented in the first year. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures, chemistry quality control (QC) records,