Laboratory Regulations, Controls, and Compliance
Review cycle of SOPs. • Training system of SOPs. III. Types of SOP in for the Training of Laboratory. Personnel. Ann McLellan, Senior Compliance Analyst, R&D …Read more

Code: 4253 Title: REGULATORY COMPLIANCE & LABORATORY …
the principles and practices of medical laboratory technology and supervision. Skill in: developing regulatory compliance; training staff in regulatory compliance; selecting, developing and testing test methodologies; assigning, training and …Read more

UW Laboratory Employee Safety Training Checklist
laboratory supervisors are responsible for ensuring that all employees receive adequate training for most categories of hazards in the laboratory. EH&S strongly encourages and in some cases. requires that …Read more

PT Check UP POL Library
training and compliance. Appendix A contains an example safety checklist for a. physician office laboratory. Employee Orientation and Training. Each new employee should be oriented to laboratory safety. Training should include the that the training has occurred and the employee has reviewed this …Read more

Overview of Oregon Clinical Laboratory Regulations
of Compliance authorizes a high complexity laboratory to perform all levels of testing. medical technology and two years of laboratory training in non-waived testing and two years …Read more

Process Document – Contractor Control Procedure
the training of departmental staff who will be managing a working laboratory areas and There is a standard training package available for the training of all laboratory staff on …Read more

EHS Lab Safety Orientation
Safety compliance problems. No documented safety procedures. No regular training is not removed quickly enough. Unknowns. KU-EHS Lab Safety Orientation …Read more

November is Training and Compliance Awareness Month
During November, any training that is required on an annual basis will be conducted and completed by employees. Institutional acknowledgments that serve as critical support components to our compliance requirements must also be reviewed and signed. …Read more

5 Tips for Clinical Laboratory Directors and Their Respective Quality Systems

A clinical quality system under the Clinical Laboratory Improvement Amendments (CLIA) relies heavily on the influence of laboratory directors. In fact, laboratory directors are ultimately and personally responsible for many aspects of a clinical laboratory’s quality system. This article offers tips for clinical laboratory directors and their respective quality systems:

Tip #1: Continued CLIA Education

A clinical director has primary and at times absolute responsibility for quality systems associated with moderately complex, highly complex or moderately and highly complex laboratory environments. He or she also has primary responsibility for gaining and maintaining continued compliance with CLIA regulations which often acts as a mold for clinical laboratory quality systems. To ensure that a clinical laboratory quality system remains compliant with the “CLIA mold” laboratory directors should remain thoroughly educated regarding CLIA regulations. Related courses are available for both types of directors and should be taken from time to time for educative purposes.

Refer to the Centers for Medicare & Medicaid Services’ website for more information.

Tip #2: Take Employee Training Seriously

Under the CLIA regulations, documentation (i.e. policies and procedures) outlining written monitoring methods for determining employee competency and events or situations which may require further training and education is the responsibility of a clinical laboratory director. Training, though often complex, (especially in an environment with continuous needs for continued education) should be thoroughly documented and reviewed for information that could prevent inappropriate handling of laboratory testing. Although, careful and continuous training may mean more money upfront, in the long run, additional training pays off.

Web-based training solutions are also valuable tools as they electronically streamline the training process, make training reports and escalations easy to automate. A web-based training solution may potentially be integrated with other quality related solutions such as document control, deviations identification, change control and CAPA software options.

Tip #3: Take Customer Complaints Management Seriously

For a clinical laboratory quality system, customer complaints can provide a foundation for powerful change. In fact, CLIA regulations mandate that all customer complaints received by a clinical laboratory must be systematically recorded and effectively addressed when necessary. For clinical laboratory directors integrated software solutions can help to streamline and effectively automated the customer complaints process. For instance, a certain type of customer complaint iterated repeatedly may result in a CAPA investigation, which in turn becomes a change control order which in turn results in a series of training tasks. Laboratory directors should look for document control, customer complaints management, CAPA, change control and training solutions that can be easily implemented and integrated for best quality system results. Such a system can save laboratory directors and employees hundreds (if not thousands) of annual hours.

Tip #4: Delegate Applicable Responsibilities

Under CLIA regulations, clinical laboratory directors must accept responsibility for a variety of directive tasks associated with the management of a clinical laboratory quality system. However, some responsibilities may be delegated from time to time and should be delegated to ease the directive load. Some of the tasks that may be delegated to a clinical consultant should be written prior to delegation and are listed as follows:

• Performance of tests, AND

• Interpretation of test results

Delegation may also result in tasks assigned to a technical supervisor (over high complexity duties) or a technical consultant (over moderate complexity duties) consultant. Some of these tasks are listed as follows:

• Selection of Methodology for Testing

• Laboratory Enrollment in a PT (proficiency testing) program that is approved by the CMS, AND

• Other duties associated with PT assignments, samples or results

Tip #5: Consider a Coordinated Quality System

Many laboratory directors consider their quality systems to be coordinated but there are often extensive gaps during the transfer of information from one quality procedure to another (i.e. from customer complaints to a CAPA investigation) and laboratory documentation when controlled manually (i.e. paper-based) often results in lost, delayed, incomplete or difficult-to-find laboratory documentation slowing the entire quality system. Laboratory directors should consider automating document control and quality related processes for increased coordination and connection between quality processes, as well as decreased delays for product-to-market and testing operations.