Colfax General Laboratory

Summary Statement of Deficiencies D0000 The following standard deficiences were cited as the results of a recertification survey on 01/11/2023 through 01/13/2023. This facility was found NOT to be in compliance with the CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. 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 the review of the CMS (Centers for Medicare and Medicaid Services) Personnel Report form 209, laboratory Quality Assurance Policy, personnel educational documents, laboratory personnel competency records, and staff interview, the Technical Consultant (TC) failed to assess annual competency, for 2 of 2 (TP#1- TP#2) testing persons in 2020, 2021 and 2022. Findings included: 1. Review of the CMS Personnel Report Form 209 identified 2 Testing Personnel (TP#1, TP#2). 2. Review of the personnel competency records for TP#1 and TP#2 revealed the Technical Consultant did not assess competency for the 2 testing personnel (TP#1, TP#2) for 2020, 2021 and 2022. TP#1 and TP#2 performed competency assessments on one another. 3. Review of educational documents for TP#1 and TP#2 revealed they did not meet the minimum requirements of a bachelor's degree in a chemical, physical, biological, clinical laboratory science or medical technology from an accredited institution, to qualify as technical consultants to perform competency assessments on one another. 4. During an interview on 1/13/2023 at 10:15 am, TP #1 stated that they did each other's competencies, and confirmed the above findings. 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 D0000 The following deficiencies are a result of a desk review of Proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The facility was found to be out of compliance with the conditions of the CLIA program to maintain certification. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 42 CFR 493.803: Successful Participation in a proficiency testing program 42 CFR 493.1403: Laboratory Director, Moderate Complexity 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: 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 -- Based on a desk review of proficiency testing records, it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Routine Chemistry for Total Cholesterol, blood analyte. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test 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 a proficiency testing (PT) desk review of Centers for Medicare and Medicaid (CMS) form 0155D and American Proficiency Institute (API) 2021 (3rd Event) and 2022 (1st and 2nd Event) records, it was revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in three consecutive testing events in the specialty of Routine Chemistry for the Total Cholesterol, blood analyte. Three consecutive unsatisfactory scores result in a non- initial unsuccessful PT performance. Findings included: 1. Review of the CMS 0155D report revealed the following results: Routine Chemistry 2021 - 3rd Event laboratory received an unsatisfactory score of 20% for Total Cholesterol, blood analyte. Routine Chemistry 2022 - 1st Event laboratory received an unsatisfactory score of 20% for Total Cholesterol, blood analyte. Routine Chemistry 2022 - 2nd Event laboratory received an unsatisfactory score of 20% for Total Cholesterol, blood analyte. 2. A proficiency desk review from American Proficiency Institute (API) for 2021 and 2022 proficiency testing records confirmed the above scores. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 Successful participation in a proficiency testing program 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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: 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 -- Based on a desk review of proficiency testing records, it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Routine Chemistry for the Total Cholesterol, blood analyte. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test 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 a proficiency testing (PT) desk review of Centers for Medicare and Medicaid (CMS) form 0155D and American Proficiency Institute (API) 2021 (3rd Event) and 2022 (1st Event) records, it was revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Routine Chemistry for the Total Cholesterol, blood analyte. Two consecutive unsatisfactory scores result in unsuccessful PT performance. Findings included: 1. Review of the CMS 0155D report revealed the following results: Routine Chemistry 2021 - 3rd Event laboratory received an unsatisfactory score of 20% for Total Cholesterol, blood analyte. Routine Chemistry 2022 - 1st Event laboratory received an unsatisfactory score of 20% for Total Cholesterol, blood analyte. 2. Review of proficiency test records from the American Proficiency Institute (API) for 2021 and 2022 confirmed the laboratory received the following results: API Chemistry Core 2021 - 3rd Event laboratory received an unsatisfactory score of 20% for Total Cholesterol, blood analyte. API Chemistry Core 2022 - 1st Event laboratory received an unsatisfactory score of 20% for Total Cholesterol, blood analyte. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D2016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as -- 2 of 3 -- required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2096 -- 3 of 3 --

Summary Statement of Deficiencies D0000 During a recertification survey completed on 09/23/2020 for 42 CFR part 493 Laboratory requirements, the facility was found out of compliance with the following condition: 42 CFR PART 493.1415 Clinical Consultant Moderate Complexity Testing 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: Based on the review of patient test logs, manufacturer instructions, Technical Consultant Reviews, and interviews with laboratory staff, the laboratory failed to follow the manufacturer's instructions to discontinue the use of recalled Prothrombin Time/INR (International Normalized Ratio - a calculated value used to standardize reporting of different test methods) test strips. 41 patients (COAG 1 - COAG 41) were tested August 2018-June 2019 using the recalled strips for a total of 260 tests. Findings are: A. Review of a Roche product recall notice dated 10/31/2018, published on the FDA (Food & Drug Administration) website, indicated: 1. The company had recalled CoaguChek XS PT Test Strips used for monitoring patients on oral anticoagulant therapy due to "inaccurately high INR test results." 2. "Patients taking warfarin (an anticoagulant or blood thinner that reduces the formation of blood clots) who receive inaccurate INR results above their target therapeutic range may be at risk for inappropriate therapeutic measures such as a warfarin dose reduction, interruption of warfarin use, or administration of vitamin K." 3. The updated recall notice included a series of lot numbers that were affected by the recall as well as the original notification date of the recall, 09/12/2018. B. Review of the laboratory records revealed 2 copies of recall notices. 1. Recall #1, dated 11/5/2018 and reviewed at the laboratory, indicated: a. It was an update to the notice sent on 09/12/2018. b. 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 7 -- affected lot numbers affected by the recall fell within a range, 27216700 through 33449899. Individual lot numbers were not listed on this copy of the recall notice nor was there any documentation indicating the laboratory had reviewed it. 2. Partial images of Recall #2, provided by the Laboratory Supervisor via text message on 09/17 /2020 and signed by him on 11/09/2018, also indicated the range of lot numbers, 27216700 through 33449899. This copy of the notice also listed specific lot numbers. An undated sticky note on the notice indicated, "Lab does not have any of these lot #'s." C. Review of the Roche website regarding the 2018 recall revealed, "Roche Diagnostics issued an Urgent Medical Device Correction (UMDC) in September 2018 instructing patients and healthcare practitioners to confirm any CoaguChek test results above an INR of 4.5 with another testing method. This UMDC was distributed to CoaguChek distributors, customers, healthcare professionals and patients via mail." D. Review of the Technical Consultant's quarterly reviews for the last six months of 2018 revealed no documentation indicating the laboratory had received the recall notices and performed any

Summary Statement of Deficiencies D0000 The following deficiency was cited as the result of a recertification survey on 08/27 /2018 for 42 CFR part 493 Laboratory Requirements. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of chemistry quality control records and interview with the laboratory supervisor, the laboratory failed to have an effective quality control program to monitor quality control over time. This deficient practice could likely result in a failure to identify quality control and instrument failures. Findings are: A. Review of the laboratory's chemistry quality control records revealed the laboratory did not have a system to monitor quality control results using a fixed acceptable quality control range and mean. 1. The laboratory manually entered the data points into an online statistics program to obtain the mean and standard deviation (SD) for that month. 2. There was no documentation indicating the technical consultant assessed the quality control data using the mean and SD for the entire lot of controls, not just the current month. B. Review of Alkaline Phospatase quality control data revealed a shift upward in values over 5 months. Precinorm U Plus (PPU) Lot 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 -- 20306004 expiration date 06/2019. The target mean (from the instrument printout since the lot was put into use) was 207 U/L and the SD was 13.32 for a 2 SD range 180.36 - 233.64. 1. April 2018 Monthly calculated PPU mean = 199.21 SD = 3.78 2 SD range 191.65 - 206.77 2. May 2018 Monthly calculated PPU mean = 201.55 SD = 7.88 2 SD rage 185.79 - 217.31 3. June 2018 Monthly calculated PPU mean = 203.06 SD = 7.35. 2 SD range 188.36 - 217.76 4. The actual mean (from the instrument printout for July 2018) was 207 U/L and the SD was 10.0. 2 SD range 187 - 227. 5. The actual mean (from the instrument printout for August 9 - August 27, 2018) was 210 U/L and the SD was 9.0. 2 SD range 192 - 230. C. Review of the laboratory's established quality control ranges indicated the laboratory had changed the Alkaline Phosphatase and other analyte ranges based on the monthly data. 1. The laboratory's quality control ranges were revised on 07/23/2018 and 08/08/2018 for the current lot of controls. The previous lot, 18634501, expired on 02/27/2018. a. On 7/23/2018, the mean for Alkaline Phosphatase was 201 U/L and the SD was 12 for an acceptable 2 SD range of 177 - 225. b. On 8/08/2018, the mean was changed to 207 and the SD remained 12 for an acceptable 2 SD range of 183 - 231. D. During interview on 08/27 /18 at 4:15 pm, the laboratory supervisor confirmed the following: 1. The laboratory did not establish the new chemistry quality control ranges prior to putting the new lots of controls into use. 2. The laboratory entered the monthly quality control data into an online statistics calculator and printed the results for review by the technical consultant. 3. The technical consultant did not review the quality control files from the COBAS C 111 chemistry analyzer. 4. The COBAS C 111 maintained only 2 months of quality control data onboard the analyzer. -- 2 of 2 --