Compliance and Competencies

Compliance and Document Auditing, Analysis and Alignment

Quality Assurance Plan

An intelligible and user-friendly Quality Assurance Plan provides a comprehensive outline for analyzing every aspect of laboratory operations. This can include:

Facilitate an annual review of policies and procedures to ensure they are up to date, effective, and accessible
Write and conduct an efficient competency review of all laboratory employees to ensure performance is in line with hospital, state, and federal regulations
Provide aids for corrective actions upon discovery of personnel misinterpretation of protocol, analyzer error, or proficiency testing failure.
Provide tools for annual assessment of turnaround times, accurate reporting, and testing reliability as required to meet quality assurance goals.

Quality Assurance oversight:
- Proactive monthly assessments shall be performed to verify adherence to the Quality Assurance plan
- Proficiency testing (CAP Surveys) assessments shall be monitored for accuracy and proper corrective action engagement
- Policies and Procedures will be monitored for effectiveness
- Development of Individualized Quality Control Plan as set forth by CLIA for the development of risk management to satisfy aspects of testing in which daily QC is not required.
- Annual evaluations of LIS calculated values
- Provide oversight of documentation for all Quality Assurance activities
- Quarterly evaluations of LIS calculated values

We Help Labs Achieve QA Objectives!

CLIA Final Rule Preparation

Lab Connections specializes in guiding laboratories through CLIA Final Rule preparation. Our experts conduct audits, recommend improvements, and streamline processes to ensure CLIA compliance. We offer personnel training, quality control setup, and proficiency testing assistance.

With our support, your lab can efficiently meet CLIA standards, maintain accurate records, and enhance patient care!

Antimicrobial Stewardship

In today’s evolving healthcare landscape, the threat of antibiotic resistance looms large, making antimicrobial stewardship a critical priority for laboratories worldwide. It’s a complex issue requiring careful navigation, meticulous planning, and a deep understanding of antimicrobial use and its implications. Labs play a crucial role in this initiative, working tirelessly to ensure accurate and timely results that inform appropriate antibiotic use.

We understand the challenges and intricacies of implementing a robust antimicrobial stewardship program. Our team is committed to guiding your lab through this vital transition, providing the tools, resources, and expertise needed to make informed decisions and promote responsible antibiotic use.

We’ve developed a comprehensive process to support labs in this crucial objective.

With Lab Connections by your side, you have a partner dedicated to helping you navigate this complex landscape, ensuring your lab plays a pivotal role in combating antibiotic resistance and safeguarding public health. Let’s work together to create a healthier future.

External Proficiency Testing Integrity

Lab Connections can aid with policies that support external proficiency testing processes by:

Establishing a systematic schedule for proficiency testing with the active participation of key operators
Assessing and defining Plans of Correction in response to inadequate testing results

Policies and Procedures

Policies and procedures provide a uniform roadmap of objectives utilized by laboratory staff.

This roadmap helps them determine workflow practices that meet standards of use set by manufacturer guidelines, CLIA regulations, safe practices as set by OSHA, and all other resources needed for testing profiles. Policies are usually required to be reviewed, updated and amended as necessary on a periodical basis. These are then edited as necessary and updated in the laboratory documentation library.

We assist with reviewing and writing:

By analyzing current Policies and Procedures on an individual basis and comparing them with vendor documentation to ensure compliance
For up-to-date Code of Federal Regulations requirements, and assist with submission to appropriate review and approval process
Latest acceptable specimen handling practices
Concisely written procedures formulated by bench scientists
Confirm testing limitations that are both relevant and comprehensible
A tutorial subsection that outlines how to adequately communicate with the technical support team
Assessable and user-friendly interpretation of results and reporting
Alternative testing procedures in instances of technical failure, interruption in supplies and/or other delays that could lead to interference in patient results
And much more!

Inspection Readiness

Lab Connections helps maintain inspection readiness for labs by making adjustments that achieve minimal interruption!

Assessment of staff qualifications and verify appropriate records are available
Review of competency documentation
Review of proficiency testing, corrective actions, and maintenance of records
Review of method comparisons
Review of calibration verifications
Review of equipment maintenance and documentation
Review of testing documentation
Review of quality assurance plan and documentation of operations monitoring, evaluations, and corrective actions as outlined in QA plan
Review of policies and procedures
Review of quality control plan for all testing methods
Review of reagent, QC and calibrator material handling and storage practices
Review of patient test results, critical value call policy, and documentation
Review of safety management
Review of documentation covering instrument performance evaluations: accuracy, precision, reportable range, sensitivity, specificity, and other relevant characteristics for all non-waived testing

Competency Review and Qualification

We provide assistance in the creation of training and competency resources that are sufficient and relevant.

Additionally, we oversee the adoption and execution of these resources. CLIA State Operations Manual, §493.1451 Standard, defines the mandates for compliance.

We help you ensure that your mandatory review framework meets these guidelines by:

Conducting direct observations of all testing processes, optionally incorporating remote viewing and teleconferencing technology
Ensuring that all employees are proficient with all aspects of testing, from specimen collection to the delivery of patient results
Verifying staff ability to inspect test results and identify correlation to clinical presentation, while monitoring for erroneous results of patterns indicating repetitive bias and delta checks
Confirming staff properly executes established procedures for record keeping and record retention of QC evaluation practices, protocols for addressing QC errors, proficiency testing and maintenance logs
Observing proper performance of instrumentation maintenance and function checks
Performing an audit of external proficiency testing events, as well as internal test performance evaluations, such as blind testing and patient result comparisons
Assessing the level of proficiency in troubleshooting skills

Allow our qualified staff to undertake your annual competency and verify these necessary objectives are met!

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Case Studies

Case Study: Quality Improvements

Quality improvements were achieved through collaboration between the Lab Connections team and Laboratory Staff, verifying the accurate transmission of patient results to healthcare providers and fostering staff confidence in delivering precise diagnostic testing. Statistical analysis of the Six Sigma metric, coefficient ratio, and standard deviation index from peer evaluations were employed to measure the progress […]

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Case Study: Calculated Cost Reduction

Lab Connections is pleased to announce that, with our guidance and collective efforts alongside lab management we have successfully demonstrated a marked improvement in quality while simultaneously realizing a reduction in operating costs over the period of February 1st to April 30th, 2023. This accomplishment has resulted in a measured cost reduction of $4900 in […]