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Laboratory Specialists

Quality Systems and Compliance has a very unique approach with our clients by working with each client on an individual and personal level. This approach helps us understand each client’s business process and goals. With this information Quality Systems and Compliance can produce a customized and compliant laboratory program that will meet the needs of your organization.

We offer over 20 years of experience and have a proven track record based on our ability to keep our clients’ laboratories compliant and successful.

If you are interested in learning more about Quality Systems and Compliance, contact us or for more information submit an online information form.

Laboratory Compliance

Unlike other consultants, QSC offers regulatory and quality services including, new laboratory installation, documentation, auditing, training, workflow assessment and ongoing support to your lab. Compliance services include:

Compliance services include:

  • New Laboratory Installation
  • Technical Consultant/Supervisor duties and responsibilities
  • Training, Support and In-services
  • Documentation Needed for Compliance with CLIA/COLA/CAP/ISO and State Regulations
  • Quality Assurance/Assessment Reviews and Pre-Inspection Audits
  • Troubleshooting, Corrective and Preventative Actions
  • Routine Workflow Assessments
  • POCT (Point-of-Care Testing)
  • QSC on Demand/On Call Services

Education & Training

QSC offers training programs that can be customized for your laboratory, which can include on-site training, classroom-style training, virtual training, and onboarding protocols.  These programs are designed to offer education and training for Medical Assistants, Nurses, Laboratory Professionals, and other personnel testing in various environments such as physician offices, clinics, urgent care facilities, multiple-site hospital locations, nursing homes, patient service centers, and education facilities. 

We can offer log sheets, records, forms, general policies, procedures, and quick reference guides to aid in training and education for the tests being performed within your facility, along with quality assurance and ongoing compliance information.

Please contact us for details on how QSC can help with your training and educational needs.

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Point Of Care Testing (POCT)

The testing and analyses of patient samples is no longer confined to the walls of a laboratory. Robust technology has propelled testing from lab environment to patient-side. Decentralized testing, Near Patient Testing, and Point of Care Testing can become integrated, cost-effective segments of your growing lab’s portfolio of services. On-site testing delivers efficient triage, rapid turn-around times, and same-day treatment plans that benefit both the patient and your bottom line. 

How QSC can help you with POCT:

  • On-boarding tests
  • Establish POCT protocols
  • Validation procedures
  • Employee training
  • Quality Assurance/Assessment
  • Public Health and Pharmacy testing consultation
  • Reporting procedures/reviews

Auditing Services

Are you sure your lab is 100% compliant?

While your lab may be running smoothly, the requirements for compliance are ever-changing. Are you up to speed on the latest regulations?

With droves of state mandates and Federal CLIA (Clinical Laboratory Improvement Amendment)/COLA, CAP and ISO regulatory requirements, Quality Systems and Compliance can audit your facility to ensure compliance.

Whether you are a CAP or COLA accredited lab, seek ISO certification or maintain the CLIA requirements, there are times a fresh set of eyes can help you detect potential issues prior to your inspection or survey.

Why wait for a deficiency to become a citation, when Quality Systems and Compliance can help identify problem areas and help you implement a plan of correction.

Quality Systems and Compliance will:

  • Review current processes
  • Review current policies and procedures
  • Ensure proper documentation is in place
  • Ensure COLA/CAP/ISO and CLIA requirements are met
  • Review personnel requirements and competency
  • Prepare an Audit Report Including Gap Analysis, recommendations for improvement and plans for corrective and preventive action
  • Submit a corrective action plan
  • Certified in ISO 19011 auditing

Operational Improvements and Custom Services

QSC is committed to providing our clients with frequent operational assessments and enhancements. Our consultation extends to helping you maintain successful performance throughout the growth of your laboratory.

Operational improvements and customizable services offered:

  • We IDENTIFY dormant opportunities, areas of improvement, and assess compliance.
  • We ANALYZE lab workflow—pinpointing what’s roadblocking or bottlenecking the process.
  • We PROVIDE perceptive solutions to ensure a smooth transition, from beginning phase to daily operations.
  • We KNOW HOW to jump the hurdles of time and logistics to create your new or improved lab.
  • We TEAM with you and your staff to implement these recommendations.