Around the lab

Around the lab

The importance of traceability

Behind every tube there is a patient that deserves correct reports and answers, in the shortest time possible.

Literature states that around 60% of overall Lab mistakes happens before tubes arrive in the lab*. Our ProTubeTM suite extends the benefit of traceability at the collection point thanks to the positive identification of patient/tube/label and helps solving these frequent cases:

  • patient misidentifications,
  • mislabeled samples,
  • the wrong tube for specific tests,
  • incorrect collection time and missing tubes. 

 

*Carraro, Plebani - Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem. 2007 Jul

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ProTube* is the ideal solution to avoid pre-lab errors. It ensures full traceability of the biological sample collection process and simplifies the life of nurses, phlebotomists, lab managers and patients whilst increasing performances and safety.

* Patented solution for a reliable labelling machine for containers of biological samples (US Patent N.9519847)

What are the benefits for your Lab?

  • Traceability: ProTube keeps track of all events, from phlebotomist identification all the way to samples check-in in the lab
  • Safety: ProTube ensures positive patient identification preventing samples mismatch
  • Error prevention: ProTube guides the phlebotomist step-by-step during the sample collection process thus limiting risky manual operations
  • Quality: ProTube supports the laboratory with compliance certification for the sample collection phase (ISO 15189)
  • Cost saving: ProTube labels flawlessly the tubes, thus avoiding sample reworking at the laboratory
  • Optimization: ProTube optimizes the workflow thanks to the real time monitoring of the collection points activities

Right patient

The patient is always at the center of care: correct patient identification is crucial.

Benefit for the patient: improved reliability.
Therapeutic decisions are based on lab test results. It is mandatory that they are matched to the right patient.

Benefit for sampling: absolute precision.
An error-free process is the basis for maximal quality and reliability.

ProTube™ ensures positive patient identification.

Right tube

Prescription verification and appropriate tube selection require time and attention.

Benefit for the patient: improved reliability.
Blood samples are always collected in the correct tubes.

Benefit for sampling: improved efficiency.
Appropriate tube selection reduces sampling repetitions.

ProTube™ automatically receives the prescription and ensures that the correct tube is used.

Right label

Correct label positioning is key for flawless tube recognition by all lab equipment.

Benefit for the patient: improved reliability.
Labeling the biological sample in front of the patient before collection prevents tube mismatches.

Benefit for sampling: efficient use of resources.
The automatic system avoids inaccurate or twisted labels and, once at the laboratory, biological samples can be automatically identified and routed.

ProTube™ prevents problems by automatically labeling tubes in front of the patient, immediately before sample collection.

Right data

Traceability and data analysis are key enablers for the quality of diagnosis

Benefit for the patient: improved reliability.
Biological sample history is always available, validating diagnostic reliability and ensuring the chain of custody.

Benefit for sampling: resource optimization.
Stored data allow business intelligence analyses for accurate decisions and avoids processing samples that are no longer diagnostically reliable.
 

ProTube™ traces every event along the process.

The ProTube solution is composed by elements that can complete the basic equipment, according to the needs of the Lab.

Stationary ProTube

It is the stationary configuration that makes the sample collection safe and secure in blood collection centers, general practitioners and small ambulatories.

Shuttle

A smart mobile cart that brings the maximum level of security for the blood collection at the bedside on hospital floors.

Smart Transport Rack

For the full traceability of the transportation phase (time, temperature, light exposure, forces and position) and the complete chain-of-custody.

Clinical Business Intelligence

A powerful data analysis tool for the complete control of the entire process of blood collection and transportation.

The pre-pre analytical area of the laboratory process it is ever more demanding in terms of reliability and efficiency. Studies from prestigious institutions are carried out in order to evaluate different solutions and to identify the most efficient and reliable one. At the University Hospital of Padova, a study* to compare workflow between a centralized system and a decentralized was carried out using ProTube. A number of parameters were examined and compared.

Efficiency

  • ProTube enables to care for more patients: ProTube assured an increase of 40% more patients per hour
  • ProTube took collection time down from over 5 minutes to just 3 minutes

Flexibility

  • ProTube is able to manage an unlimited number of tube types

Safety

  • ProTube prevents the errors associated to tube selection: all tube selection errors identified and avoided
  • ProTube ensures correct labelling: all the tubes correctly labelled
* Elisa Piva; Francesca Tosato; Mario Plebani: Pre-analytical phase: The automated ProTubeTM device supports quality assurance in the phlebotomy process - Clinica Chimica Acta 451 (2015) 287–291.

The ProTube system is compliant with all major international standards and guidelines and it is FDA registered for the US market and CE IVD marked for EU.

The ProTube Software is classified as In Vitro Diagnostics Medical Device.

The overall ProTube System is developed and maintained according to the European Directive 98/79/EC, the International Quality System Standard ISO 13485 and the Quality System FDA Regulation 21 CFR 820.

ProTube offers a simplified and automated way to be complaint with parts of the International standards and guidelines, ISO 15189, CLSI AUTO 12-A and Joint Commission.

Main features by each standard:

ISO 15189:

  • Patient identification – ProTube displays all the patient information provided by the LIS
  • Primary Sample – ProTube displays type of primary sample
  • Examinations requested - ProTube displays the requested examinations
  • Clinical relevant information – ProTube displays any relevant information as provided by the LIS
  • Time stamp – ProTube keeps trace of date and time of sample collection automatically
  • Keep trace of the operators – ProTube keeps track of the operators using the system at any time automatically
  • Instructions for labelling o primary samples – ProTube guides operators throughout the process and avoids mistakes
  • Instruction for patients preparation – ProTube displays all necessary information
  • Instructions for sample transportation – ProTube can provide information on sample handling post collection

 

Joint Commission, National Patient Safety Goals:

  • Use at least two patient identifiers when providing laboratory services -  ProTube allows up to  5 different identification methods with any combination of those
  • Label containers used for blood and other specimens in the presence of the patient -  ProTube labels containers in front of the patient automatically

 

CLSI AUTO 12-A:

  • Label size, format, fixing of tubes etc - ProTube is able to print labels in compliance with AUTO12-A for what concerns content and Location, Fonts, and Label Orientation

HL7/IHE:

  • ProTube is compliant with HL7 standards for the interface to LIS (transactions LAB-61, LAB-62 and LAB-63)