Quality Assurance and Consulting


Stay in compliance with ever-changing rules and regulations.


Data and platform management for your comprehensive needs.

Our Technical Support Packages

Quality Assurance & Quality Management - Subscription Services

Tier 1 – Quality Assurance Monitoring Service

  • Monthly on-site visit
  • Comprehensive Quality Assessment of Pre-Analytical, Analytical, and Post-Analytical systems
  • Review Quality Control Records
  • Identify areas for improvement

Tier 2 – Quality Assurance Maintenance Service

  • Monthly on-site visit
  • Includes Quality Assurance Monitoring
  • Maintain and update policies and procedures
  • Create corrective action/preventative action (CAPA) plans

Tier 3 – Quality Management Service

  • Monthly on-site visit
  • Includes Quality Assurance Monitoring
  • Includes Quality Assurance Maintenance
  • Manage Proficiency Testing
  • Manage Personnel Records
  • Manage Document Control System

Inspection Plans

Tier 1 – Inspection Readiness Assessment Plan 

  • On-site assessment
  • Review Policies and Procedures
  • Personnel Records
  • Quality Management Plan
  • Maintenance Records
  • Quality Control Records
  • Test Method Validation and Verification
  • Information Systems
  • Laboratory Reports
  • Summation of Deficiencies

Tier 2 – Inspection Preparation Plan

  • Includes Inspection Readiness Assessment
  • Revision and/or creation of policies and procedures
  • Create correction action/preventative action (CAPA) plans

Tier 3 – Pre & Post Inspection Success Plan

  • Includes Inspection Readiness Assessment
  • Includes Inspection Preparation Plan
  • Create “Books of Evidence” for accreditation checklists
  • On-site/remote support on inspection day
  • Post- inspection correction of deficiencies
  • 1 month of Quality Assurance Monitoring post accreditation

Hiring and Training Plans

Tier 1- Scout and Hire Plan

  • Create and manage job postings
  • Conduct and evaluate interviews
  • New hire orientation
  • Create personnel file

Tier 2–  New Hire Training Plan

  • Includes Scout and Hire Plan
  • Identify technical training needs
  • Document training and competency assessments

Tier 3- New Hire Extended Training Plan

  • Includes Scout and Hire Plan
  • Includes New Hire Training
  • Conduct technical training

Additional On-site Visits Available

Individual Service Details

Regulatory Consulting

  1. APEX Professional Solutions helps our clients evade costly compliance oversights.
  2. Most labs that are found to be non-compliant lack the experience or resources to maintain a thorough Quality Management Plan..
  3. How We Support:
    1. Our team of industry specialists will lead you through the planning and preparation needed for laboratory accreditation.
    2. Expert support during the initial application process for CLIA and State licensure.
    3. Experienced resources
    4. Ultimate clarity on quality guidelines and how they pertain to your laboratory.

Inspection Preparation

  1. Our consulting team has helped clients pass inspections with zero deficiencies.
  2. We identify potential issues prior to laboratory inspections and serve as due diligence inspectors for those seeking to acquire an existing clinical laboratory. These deficiencies can corrected before your CLIA, CAP, COLA, JCAHO, or State inspections.
  3. How We Support:
    1. Provide onsite mock inspections and/or guide you through self-inspections.
    2. Supply comprehensive reports with recommendations for improvement and plans of corrective/preventative action
    3. Offer flexible service plan options based on your laboratory needs:
      1. Inspection Readiness Assessment
      2. Inspection Preparation
  • Post Inspection Support/Responding to Deficiencies

Application Processing

  1. APEX specializes in assisting startups and developing laboratories complete their applications for CLIA, COLA, CAP, JCAHO, and State certification and accreditation. We recognize that this process can be lengthy, multifaceted, and exasperating.
  2. With our wide-ranging proficiency, we streamline the process from launch to success.
  3. How We Support:
    1. APEX will help you navigate the regulatory landscape when opening a new lab or adding accreditations to your existing laboratory.
    2. Our comprehensive tactic includes recruiting a qualified Laboratory Director, shaping the test menu, registering with deemed agencies, ownership disclosures, validation plans, and filing applications.
    3. We consult and offer strategic guidance along the way to ensure our clients can rapidly and compliantly start testing.
      1. Application service rates:
        1. CLIA- Starts at $1,200
        2. CAP- $1,200
        3. COLA – $1,200
        4. JCAHO- $1,200
        5. State Licensing
          1. PA, RI, MD, NV- $3,000
          2. CA, FL, NY- $5,000

Quality Assurance and Quality Management

  1. APEX knows how to cover all phases of laboratory quality.
  2. CLIA, state regulating agencies, and other accrediting bodies have quality standards to which all labs must adhere. Our Quality Assurance and Quality Management (QA/QM) solutions will keep your lab in compliance and inspection ready.
  3. How We Support:
    1. On-site assessments
    2. Pre-analytical, Analytical, and Post-Analytical Quality Monitoring
    3. Create corrective action, preventative action (CAPA) plans
    4. Review quality control records
    5. Update policies and procedures
    6. Validation summaries
    7. Implement safety plans
    8. Manage personnel records
    9. Monthly Quality Subscription Service Plans

Remote Data Review & Analysis

  1. Operating a lab generates a large amount of data used for your results, quality control, and testing failures. Remote Data Review & Analysis from APEX Professional Solutions guarantees your clients receive quality results.
  2. How We Support:
    1. Provide remote data analysis to eliminate long, on-site shifts and maintain satisfactory report turn-around-times.
    2. Deliver around- the-clock coverage to meet the reporting demands of your clients.
    3. QC documentation and management
    4. Swift identification of system failures and faster troubleshooting time
    5. Qualifies candidates that meet the licensing requirements for your state

Hiring and Training

  1. APEX will help you with scouting and hiring professionals best suited to your operational needs
  2. Our technical team can provide training for software, operating instruments, toxicology data review, lab management, and more. Training can be remote or on-site.
  3. How We Support:
    1. Scout and Hire
    2. Conduct job interviews
    3. Identify training needs
    4. Technical training
    5. Flexible Training Plans

Instruments & Supply Selection

  1. Let APEX find economical options for your lab instruments, consumables, & reagents.
  2. Our favored relationship status with key vendors allows us to provide better pricing and a secure supply chain to our customers. Our involvement building laboratories enables us to level vendor quotes against industry standards and negotiate beneficial pricing on equipment, consumables, and reagents.
  3. How We Support:
    1. Avoid excessive expenses
    2. Recommend the equipment that is the most cost-effective & best fit for your lab.
    3. Coordinate with vendors to give you the best options.
    4. Procure discounted rates for laboratory owners on popular equipment brands.
    5. Present you with various options on the most cost-effective equipment, with the option to purchase or lease equipment.
    6. APEX can help you select a Laboratory Information System (LIS) that will integrate with your instrumentation, as well as Electronic Medical Records (EMR) – both cloud-based and server-based options.

Lab Buildout & Design

  1. Our team will work with your contractors and instrument manufacturers to design a laboratory with ideal workflow & top efficacy. We study every aspect and make sure you are happy every step of the way while receiving reasonable pricing.
  2. How We Support:
    1. Deliver site acquisition target criteria based upon your lab’s test menu, throughput, and growth plans.
    2. Design the laboratory layout according to lean process management to ensure optimum placement of instruments, centrifuges, tables, freezers, refrigerators, benches, sinks, hand and eye-wash stations, and other equipment.
    3. Suggest direction on the appropriate interface, HVAC, electrical, plumbing, and ventilation hood placement to warrant compliance with manufacturer guidelines and all local, State, and Federal regulations.

Test Menu Creation

  1. A well-planned test menu can directly impact your lab’s success.
  2. Several elements need to be considered when defining your lab’s test menu and panels. Bigger is not always better and not all tests should be run in-house. APEX assists clients with drafting a test compendium that sets them up for success.
  3. How We Support:
    1. Provide options ranging from standard test list or a completely customized test menu
    2. Careful selection of test menu additions
    3. Reimbursement consultation
    4. Guidance on industry trends

APEX Professional Solutions, LLC

Grow With the APEX Pros!

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