K & S Clinical Diagnostics

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 03, 2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 Proficiency Test (PT) document review and staff interview, the laboratory failed to enroll in a CMS approved PT program OR peer review program in the second quarters of 2024 and first quarter of 2025. Findings: 1. Review of Proficiency Testing (PT) documents revealed the laboratory failed to enroll in a CMS approved PT testing program OR peer review program for Alcohol Testing in the second quarter of 2024 and 1st quarter of 2025. Alcohol testing was performed in April, May and June of 2024. 2. (PT) peer review documentation was available only in the 3rd quarter of 2024 (12/16/2024 with a lab in Michigan). 3. An interview with the Technical Supervisor(TS) (TP #3 CMS 209) in the lab review room at approximately 11:30 PM on 07/03/2025, confirmed no enrollment in a CMS approved PT OR peer review program in the second quarter of 2024 and 1st quarter of 2025. 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 -- D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on documents review and interview with general supervisor (GS), the laboratory director failed to ensure that all phases of testing (preanalytic, analytic, post analytic and proficiency testing (PT) guidelines were followed to identify and fix problems in the laboratory from June 2023 through the date of survey July 03, 2025 as required by Clinical Laboratory Improvement Amendments (CLIA). Findings: 1. (QA) documents review revealed the lab director who is also the technical supervisor (TS) had a monthly QA checklist dring the months of testing but failed to realize proficiency testing (PT) records were missing for 3rd quarter 2023, 1st and 2nd quarters 2024, 1st and 2nd quarter of 2025. 2. An interview with the laboratory's (GS) (TP# 3 CMS 209) in the lad review room on 07/03/2025 at approximately 12:20 PM, confirmed the lab director failed to ensure proper oversight of the laboratory from June 2023 thru the date of survey 07/03/2025. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 25, 2023. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 CAP (College of American Pathology ) Proficiency Test (PT) document review and staff interviews, the laboratory failed to enroll in a CMS approved PT program in the first and second quarters of 2023. Findings: 1. Review of (CAP) Proficiency Testing (PT) documents revealed the laboratory failed to enroll in PT testing during the first and second quarter of 2023 resulting in FAILURE to participate in both events. 2. An interview with the Technical Supervisor(TS) (TP #4 CMS 209) in the review room at approximately 12:20 PM on 05/25/2023, confirmed no enrollment in a CMS approved PT program in 2023. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on documents review and interview with the Technical Supervisor (TS), the Lab Director(LD) failed to ensure that ALL Quality Assurance (QA) guidelines were followed to identify and fix problems in the laboratory in 2023 as required by Clinical Laboratory Improvement Amendments (CLIA). Findings: 1. Monthly QA document review revealed the Lab Director and the Technical Supervisor (TS), did NOT realize that the laboratory's CAP Proficiency Testing (PT) enrollement fees were not paid in 2023. 2. An interview with the laboratory's (TS) (TP# 4 CMS 209 in the review room on 05/25/2023 at approximately 12:35 PM, confirmed the Lab Director failed to ensure proper oversight of the laboratory as it concerns PT enrollemnt in 2023. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 1, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the review of College of American Pathology (CAP) Proficiency Testing (PT) records and interviews with the Technical Supervisor(TS), the laboratory director failed to review and attest that PT samples were tested in the same manner as patient specimens in 2019, 2020 and 2021. Findings include: 1. Review of (CAP) PT records revealed the laboratory failed to provide or retain signed attestation forms by the laboratory director for all events in 2019, 2020 and 2021. 2. All Proficiency Testing (PT) documents were signed by the Technical Supervisor (TS) without a delegation letter from the laboratory director at the time of survey. 3. An interview with the (TS) and on 07/01/2021 at approximately 12:30 pm in the review room confirmed that (CAP) PT documents were not reviewed and signed by the laboratory director in 2019, 2020 and 2021. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. 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 College of American Pathology (CAP) Proficiency Testing (PT) documents review and an interview with the Technical Supervisor (TS), the laboratory failed to document

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 8, 2019. The laboratory was found not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: A review of the procedure manual and interview with the Technical Supervisor (TS), determined that the laboratory failed to have a comprehensive competency assessment for their testing personnel for the specialty of Toxicology panel from November 2017 through July 2019. The findings include: 1. A review of testing personnel records revealed that a competency assessment was performed on testing personnel, but the assessment was not specific to the laboratory's toxicology panel testing from November 2017 through July 2019. 2. The laboratory must monitor each individual's competency and identify remedial training for each test procedure performed in the laboratory. 3. The TS confirmed on July 8, 2019 at 12:45 PM, in the office, that the laboratory failed to have a competency assessment that was specific to their toxicology panel testing. 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 A proficiency testing desk review was completed on January 2, 2018. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (1st and 3rd events of 2017), resulting 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 -- in the first unsuccessful occurrence for creatine kinase (CK) analyte # 385. Findings include: Refer to D 2097 D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (1st and 3rd events of 2017), resulting in the first unsuccessful occurrence for creatine kinase (CK) analyte # 385. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 385, CK on event 1 of 2017 with a score of 0% and event 3 of 2017 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from the College of American Pathology (CAP) confirmed the laboratory failed CK on events 1 and 3 of 2017 resulting in the first unsuccessful performance. -- 2 of 2 --