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PostHeaderIcon Blog

PostHeaderIcon Training and Competency Continued

PostDateIcon Tuesday, 15 June 2010 20:45 | PostAuthorIcon Author: Carol Wilhelm | PDF Print E-mail

New personnel should always be thoroughly trained regardless of experience or other jobs.

Training should emphasize that most errors occur in the pre-analytical phase.  This includees ordereing, patient preparation, positive patient ID, correct specimen and labelling.   Material should be inspected and checked for expiration date, equipment calibratation and maintenance should be reviewed.

During the analytical phase ensure that the new hire understands QC testing and documentation, how to perform the test and interpret it.  They should be given an overview of trouble shooting and problem solving.

The post-analytic phase needs to demonstrate clean up, waste disposal, specimen storage and reporting.  Don't forget to go over critical values and public health reporting.

Before any testing the trainee should read the procedure and package insert.  Train the employee how to check for changes in manufacturers instructions when opening a new kit.  Also any information specific to the sites operation should be communicated.  Reading the package insert will refresh why the test is being ordered, precautions, specimen type, materials, and interpretation.  Show the new hire where all necessary supplies are stored, then demonstrate the entire procedure, explaining each step as it is performed.  Go over every aspect of the test.  Have the trainee practice the procdure under direct observation.  Continue observation as long as it takes for the trainee to become confident and proficient enough to perform the test accurately on her own. 

There are many assessment tools that may be used to measure the employees performance against an established standard.  Direct observation and the testing of known specimens or previously analyzed specimens are the most commonly used.  Other tools include written and oral tests, case studies, or hypothetical problem situations.

Objectively evaluate the performance and provide feedback, including helpful tips and constructive criticism.  If the performance is less than satisfactory, she should be provided with additional instruction and follow up. 

Each step on the training checklist should be signed or initialed by both the trainer and trainee for documentation.  When the list is completed, it should be reviewed by the supervisor and retained according to the organizations policy.  Records should be kept in a location that is easily accessible to the employee, the supervisor, and lab director, and outside surveyors who verify the lab's regulatory compliance.

Last Updated (Tuesday, 15 June 2010 21:02)

 

PostHeaderIcon Training and Competency

PostDateIcon Thursday, 13 May 2010 13:55 | PostAuthorIcon Author: Carol Wilhelm | PDF Print E-mail

The lab plays a vital role in health care providing physicians with information.  70% of medical decisons are directly influenced by lab results.  With so many lives affected by lab results each day it is imperative to have proper training.

A thorough orientation and training program is a good indicator of a workplace that is qualtiy oriented.  Lack of structured training procedures should be a "red" flag.  Labs often add tests and change test methods and instruments.  These situation require extra training for everyone who will be performing the new test. 

Point of care testing requires personnel with limited experience and training.  The package insert must be followed.  Moderate complexity testing requires personnel with at least a high school diploma and documented sufficient training.  High complexity required a degree and formal training. 

After hiring the appropriately qualified person make sure there is sufficient orientation period to familiarize the employee with their new work environment and duties.  New testing personnel should always be thoroughly trained, regardless of the simplicity of the test to be performed, or previous experience.  Training cost the employer both time and money.  Improperly trained employees make more mistatkes, which take time and effort to rectify.  Making the initial investment of time and effort can end the cycle of frustrated staff and high turnover.  By giving the new hire a solid foundation to build upon, you will actually save time and money in the long run.

Begin with a general overview of the organizational structure, intoduce staff, and explace workplace policies.  The job description should be reviewed with the new employee and she should be given time to read the safety manual and other policies and procedures.  PPE should be provided.  An orientation/training checklist will be helpful inensuring that all aspects of the position are adequately covered.

Training should be provided by a qualified and experienced person who regularly performs the test procedure.  The trainer should be someone with good verbal skills, attention to detail and good lab practices, ability to objectively evaluate the effectiveness of the training and provide constructive feedback.

On the job training generally follows this basic format:   Trainee reads the testing instructions, Trainer demonstrates the steps for perfomring the test, Trainee perfomrs the test while trainer observes, Trainer evaluates the trainee's test performance and provides feedback, additional instruction and follow up evaluations to ensure effective training, Both trainer and trainee document completion of training.

 

 

PostHeaderIcon Customers and Suppliers

PostDateIcon Friday, 19 February 2010 15:36 | PostAuthorIcon Author: Carol Wilhelm | PDF Print E-mail

The lab fuctions as a supplier by offering products (reports), services (consulting), and information (collection procedures).  The lab is a customer of equipment and istruments, disposables, service (ref lab).

Supplier qualifation process evaluates whether or not a company, product or service is capable of fulfilling specific requiremnts. 

Qualified is the status given to a company,product or service when the capability of fulfilling the specified requirement has been demonstrated.

Identify critical supplies and services, establish criteria and apply, select and qualify suppliers, and approved supplier list is maintained.

A critical supply or service is one that is capable of affecting the quality of your lab products and services.  Identify critical supplies and services from reviewing pre-analytical, analytic, and post-analytic processes in the labs path of workflow and also the QSE's.

Successful outcome needs to take into consideration safety, quality, timeliness, appropriateness, usefulness, and cost-effectiveness.  Critical supplies would be items such as tubes, reagents and analyzers.  Critical services would be reference labs, software etc.

Select a supplier capable of providing the critical supplies and ensure the supplies are made according to applicable requirements.  Ask if the supplier can provide the service and supplies reliably.

After your laboratory has qualified the suppliers of currently used supplies and services, and has selected and qualified any suppliers of new supplies and services and their suitable alternatives, an approved supplier list can be developed.

 

The names of all reference laboratories used by your laboratory need to be on the Approved Supplier List!

 

The Approved Supplier list is a controlled document - meaning that your laboratory needs to keep it and all copies up-to-date.

 

Your laboratory also needs to share the current version of the Approved Supplier List with those in the organization who will order supplies and services.

  • Supervisors or staff with responsibility for completing purchase orders
  • Laboratory Director(s) with responsibility for completing purchase orders
  • Laboratory or organization's purchasing function (buyers or agents for your laboratory)

The approved supplier list controls the quality of the supplies and services you use to produce the labs product (results!)  Only order from a supply on the approved list.  If the supplier is not on your list they must be qualified.

Agreements:   Contracts clearly communicating each parties requirements and obligations.

1.  Lab and suppliers

2.  Lab and providers of reference lab services

3.  Lab and persons, services and facilities you provide results for.

The agreement should contain material specifications and contact information.   Also additional requirements, price, method and terms of payment, delivery method and time frame, length of contract term, termination clause, and confidentiality agreement.  Suppliers must notify of any changes in quality or safety of labs products and services and provide info is a product is not safe.

Reference Labs:

  • Agreements should include requirements including methods are defined, documented and understood. 
  • Assurance that reference labs can meet the requirements. 
  • Statement that any conflicts of interest are identified and resolved. 
  • Tests to be referred are appropriate for intended use. 
  • Definition of the respective responsibilities for interpretation of results.

Lab Services:

  • Defined requirements for your lab and referring facility that are documented and understood by both sides including list of methods used. 
  • Assurance that the lab has the capability and resources to meet the clients requirements. 
  • Assurance that the processes and procedures used meet the contract requirements and clinical needs of users. 
  • Conflicts of interest are identified and resolved. 
  • Discussion and documentation of amendments or changes to the contract.
  • Assurance that any deviations from the contract are communicated.

Review of Contracts:

  • At time of initial agreement
  • End of contract period for consideration of renewal
  • When amendments are made.

Identify:

  1. Requirements defined, documented and understood.
  2. Capabilities ans resources are assured.
  3. Clients informed of any deviations
  4. Amendments are documented, reviewed and communicated.
  5. Records of reviews and discussions maintained.

You should be providing feedback to your suppliers and a file for each supplier should include copies of complaints and problems.

Products:  choices, appearance, physical characteristics, quality, reproducibility

Service:  predictability, completeness, comflict management

Delivery:  timeliness, accuracy, dependability, cost

Price: lower appropriate price, value added service.

Technical Support:  ease of ordering, response capability, timeliness, consultation.

 

 

 
 

PostHeaderIcon Process for Validation

PostDateIcon Friday, 19 February 2010 14:22 | PostAuthorIcon Author: Carol Wilhelm | PDF Print E-mail

There must be a process to evaluate all new instrument and equipment to verify that they function properly before use.

The installation function check and verify all applicable features.

Verification is a plan to challenge the claims of the manufacturer.  By documenting results of a new or modified process you can ensure the process works as intended and lets you obtain objective evidence.

Validation Process is for the analytic system itself and associated instruments.  Any measured or heat regulated instrument used anywhere in the new testing process must be validated.  Proof that it integrates with the LIMS and changes to computer programs to accomplish the above are documented.

Draft all applicable operating procedures and instruments and document validation.  A written validation protocol provides a temlate so all valid activities can take place and be documented.

Sample Outline for a Validation Protocol:

  • Description of the purpose of the validation
  • Description of the process or system to be validated
  • Description of who is responsible for these activities (preparation of validation plan, equipment installation qualification, operational qualification, process performance qualification, review of results obtained, writing the validation summary)
  • Performance of the installation qualification (unpacked, connected, utilities, environment, identification, operator's manual available, procedures, maintenance, calibration and troubleshooting, determine maintenance requirements, determin calibration requirements, schematics available, other unique features, acceptance criteria for installation qualification, initial calibration, record of whether criteria were met)
  • Performance of the operational qualification (electromechanical operations, temp of any heat-regulated devices, functionality of alarms or other audible signal, functionality of any visual signals, other unique features, limits and tolerances defined, acceptace criteria for operational qualification, performance using standard samples, record of whether criteria were met)
  • Performance of the process performance qualification (process flowchart and procedures, performance qualification plan to include test samples required, material to be used, testing conditions, data to be collected and ID of personnel who will perform the performance qualification.  Acceptance criteria defined, testing process and collection of data, record of where criteria were met and any follow up actions taken, review and approval of performance qualifications)
  • Conclusions Made (objective evidence obtained, interpretations, comments and actions, final conclusion, signatures of performers, reviewers and approvers.

Maintenance and calibration:

You must follow the manufacturer's instructions and any accreditation requirements.

Schedule:  what needs to be done, when and who does it.  Include daily, weekly, monthly, quarterly, semi-annually, and annually.

Instructions:  How to do it and how to record that it is done.  You can reference the manufacturers manual or write your own instructions from the manufacturers recommendations. 

Finalize and approve all process and procedure documents including maintenance and calibration.  Train all personnel.  Label equipment and indicate the status of calibration and when the next cal date is due.

Records of equipment history and equipment file contents were emailed to all Caribbean Diagnostic customers in January.

 

Last Updated (Friday, 19 February 2010 15:36)

 

PostHeaderIcon QSE: Equipment

PostDateIcon Friday, 19 February 2010 14:11 | PostAuthorIcon Author: Carol Wilhelm | PDF Print E-mail

A Quality Management System that incorporates Quality System Essentials (QSEs) enables your laboratory to:

  1.        Contribute to improving patient outcomes
  2.        Contribute to saving lives by reducing errors
  3.        Decrease potential malpractice risk and exposure through error reduction
  4.        Reduce cost by

       Improving operating efficiency

       Reducing the expense of dealing with errors and repeat testing

  1.        Meet current and future regulatory and accreditation quality requirements
  2.        Participate in pharmaceutical and clinical trials
  3.        Improve the health of the patients we serve

 

Without the right equipment that is accurate and reliable, your laboratory cannot provide test results that contribute meaningfully to patient care.

This Quality System Essential (QSE) is about taking the time to properly select the right equipment; install the equipment and validate its function; maintain and calibrate the equipment according to established requirements; solve and document equipment-related problems; and maintain all required records.

 

Equipment includes all analyzers, measuring equipment and heat regulating devices.

This section of your Quality Manual should include selection, installation, validation, maintenance, calibration, solve and documentation of equipment problems and maintenance records.

 

Selection:  Energy requirments, the environment and future disposal must all be considered.

Prior to purchasing the following items need to be considered

  • Load bearing capacity
  • Space requiremtns
  • Electrical requirements
  • Ventilation and air quality
  • Humidity
  • Temperature
  • Water Type and quality
  • Potential hazards
  • Other Manufacturers requirements

Each piece of equipment must be identified by serial number and if a larger organization a lab defined number.

Last Updated (Friday, 19 February 2010 14:22)

 
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