Summary:
Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the Micro-Pipetting Procedure and Maintenance policy, and Centrifuge Procedure and interview with Laboratory Director (LD), the required documentation of maintenance could not be produced. Findings include: 1. Upon request for written evidence of centrifuge and micro-pipetting maintenance checks, none could be produced for years 2024 and 2025 to date. 2. Interview with the LD at 9:30am confirmed the laboratory failed to maintain documentation of the centrifuge and micro-pipette maintenance checks. 3. The laboratory reports performing 1633 high complexity toxicology tests annually. D6076 LABORATORY DIRECTOR 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 review of laboratory records submitted for review and interview with 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 3 -- Laborator Director (LD), the LD failed to fulfill the duties of the LD. Findings include: 1. See D6083, D6086, D6093 D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) (e)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and This STANDARD is not met as evidenced by: Based on review of the Maintenance policy and interview with Laboratory Director (LD), the temperature monitoring policy was not being followed, including written daily temperature recordings. Findings include: 1. Upon request for written temperature monitoring documentation, none could be produced for 2024 and 2025 to date. 2. Interview with the LD at 9:30am confirmed the laboratory failed to document the temperatures on the Daily Lab Tasks Checklist. 3. The laboratory reports performing 1633 high complexity toxicology tests annually. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on review of the laboratory's policy for Quality Control (QC) and Proficiency Testing (PT), and interview with the Laboratory Director (LD), the LD failed to ensure the policy for QC Qualification and PT was being followed and written documentation of QC Qualification and QC trends were recorded and records of this were retained for at least two (2) years. Findings include: 1. Upon review of the laboratory's policy titled QC and PT, for the SCIEX API - 4000 LC/MS instrument (liquid chromatography/mass spectrometry), it was noted in this policy, under the sub- title "Procedure", #3, that QC Qualification must be performed with each new lot # of QC prior to the expiration date of the current QC lot. 2. Upon request for written evidence of QC Qualification and QC trends records for the SCIEX API 4000, as described in the QC and PT policy, for each change in QC lot numbers, prior to the expiration date of the current lot number, no written evidence of QC Qualification or QC trends could be produced. 3. Interview with the LD at 10:00 am confirmed the LD failed to perform and record written documentation for the activities required for QC Qualification and QC trends, as detailed in the procedure for QA and PT policies. 4. The laboratory reports performing 1633 high complexity toxicology tests annually. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and 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: -- 2 of 3 -- Based on review of the laboratory's procedure manual and interview with Laboratory Director (LD), the LD failed to ensure a current and approved Quality Assessment (QA) plan was established for this laboratory. Findings include: 1. Upon review of the laboratory's procedure manual presented during the survey, no QA plan with quality monitors could be produced. 2. Request for evidence of QA monitoring events from the LD failed to yield any written evidence of QA monitoring events for 2024 and 2025 to date. 3. Interview with the LD at 10:00 am confirmed there was no written procedure for QA monitoring. 4. The laboratory reports performing 1633 high complexity toxicology tests annually. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on review of the current procedure manual, testing personnel competency assessements, and interview with the laboratory director (LD), also the technical supervisor (TS), the TS failed to fulfill the duties of the TS. Findings include: 1. See D6120 D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 written competency assessments and interview with Laboratory Director (LD), the technical supervisor (TS) failed to complete 2024 and 2025 competency assessments for one (1) testing personnel (TP). Findings include: 1. Upon request for written evidence of competency assessments for one (1) TP, none could be produced for 2024 and 2025 to date. 2. Interview with the LD at 10:00am confirmed there was no written document for competency assessments for 2024 and 2025 to date. 3. The laboratory reports performing 1633 high complexity toxicology tests annually. -- 3 of 3 --