Under the direction of the Director of Education and Training for Healthcare at Home, the CLIA Laboratory Director and Medical Director in Pathology for Healthcare at Home, and the Mass General Brigham (MGB) Pathology Administrative Director of Quality Assurance and Regulatory Compliance, the Technical Specialist (TS) for Point of Care Testing (POCT) and Lab Services assists in the management of the Healthcare at Home POCT program and supports all related laboratory services.  The TS, in their role as the Technical Consultant as defined by CLIA, is responsible for the operations and regulatory compliance of waived and non-waived POCT performed remotely in patients’ homes, and also supports offsite laboratory testing performed across the MGB laboratories. The TS for POCT works in collaboration with the leadership of Nursing, Paramedics, and Advanced Practice Providers to ensure accurate and reliable testing, competent staff, and compliance with all regulatory standards and agencies.

Responsibilities

• Ensures policies and standard operating procedures (SOPs) and associated forms meet regulatory compliance requirements and reflect current practice.  Creates and revises SOPs and forms on a continual basis.  In collaboration with Healthcare at Home Director of Education and Training and the CLIA Laboratory Director, ensures the annual review and signoff of SOPs in addition to any significant changes in real time.  Assists with the maintenance of the Clinical Laboratory POCT Manual. Supports SOP and practice standardization efforts across MGB POCT programs. 

• Provides training through collaboration with nurse educators, paramedics, and APP leadership to educate and orient all personnel performing POCT for initial, 6-months for new hires, and annual competency. Assists with HealthStream training module design, implementation, and revisions, as well as any other training documentation needed. Provides ongoing education on Joint Commission/CLIA requirements, quality control and good laboratory practices. Ensures training documentation is complete, reviewed and maintained.

• Collaborates with nurse educators, paramedics, and APP leadership, to ensure ongoing competency of all staff performing POCT.  Assists with creating annual schedules and competency assessment tools.  Ensures competency requirements by Joint Commission, CLIA and other regulatory agencies are met. Provides review and attestation that all areas of competency are met at the required frequency and associated documentation is completed for each testing personnel.  Ensures failed competencies are addressed appropriately and is timely in completing corrective action. Ensures competency documentation is reviewed, compiled, and maintained continually.

• Ensures the regulated and non-regulated Proficiency Testing (PT) programs for POCT is managed appropriately for each testing method, PT is rotated amongst staff, and annual renewals are completed and signed off by CLIA Laboratory Director. Maintains compliance with PT schedules and provides oversight of corrective actions. Compiles and maintains all documentation.

• Performs instrument linearity, calibration verification and biannual method comparisons. Schedules   offsite and POCT method comparisons; ensures compliance with testing performance schedules.   Compiles and maintains all documentation.

• Ensures daily, weekly, and monthly maintenance is performed and documented. Reviews temperature and maintenance logs. Ensures POCT instrument preventative maintenance is performed on schedule and documented.  Assists with the maintenance of vendor contracts, annual reviews, and renewals. 

• Performs POCT method evaluation and makes recommendations when new testing is requested or would be beneficial for the program. Validates new methods and devices, troubleshoots, and revalidates out of service devices.  Performs instrument cartridge and reagent validation prior to use as necessary with new shipments and lots.

• Reviews daily, weekly, and monthly quality control records for completeness and accuracy; documents noncompliance, implements corrective action plans in collaboration with POC area managers.  Maintains a working knowledge of manufacturers’ quality control recommendations and guidelines.  Assists with quality control as needed and monitors quality control trends. Reviews exceptions in error queues (e.g. Telcor) daily to correct any connectivity or patient identification issues in real time.

• Works with materials management to support the validation of new sequestered lots prior to distribution. Works cross-functionally to ensure sufficient on-hand inventory at all times while also minimizing potential expiration date-related wastage. Maintains adequate documentation and organization to ensure proper reagent labeling of expiration dates to prevent the use of any expired reagents; performs review of all reagent handling and preemptively removes any expiring reagents prior to testing; supports/performs all necessary ordering workflows. Supports MGB POCT efforts to improve efficiencies in reagent validation and distribution. Compiles and maintains all documentation, making it available across the network.

• Works closely with and supports MGB Pathology Information Systems and eCare teams in the build and validation of POC instrument interfaces and laboratory collection and testing workflows. Provides all necessary results and quality control result reports, supporting the documentation of all instrument data required. Provides initial and ongoing troubleshooting support for all Healthcare at Home users in the technical aspects of remote connectivity and data management.

• Works closely with the MGB Pathology Laboratories to ensure the ongoing quality of test ordering, specimen collection, testing and reporting workflows.  Collaborates with the MGB Pathology and MGB Pathology Systems teams to troubleshoot laboratory collection and reporting processes.
• Collaborates with nurse educators, paramedics, APP, and Quality Assurance and Regulatory Compliance leadership to ensure ongoing inspection readiness.  Using audit tools and checklists, organizes and performs tracer audits against CLIA and local standards at a minimum of twice per year.  Evaluates, summarizes, and reports findings to CLIA Laboratory Director, Healthcare at Home, and MGB Pathology leadership. Assists testing personnel leadership with addressing findings and completing corrective actions. Audits patient results in medical record.

• Assists with other Clinical Laboratory initiatives to include supporting other POC and laboratory services responsibilities, team projects, data collections, etc.

• Maintains effective working relationships and works collaboratively with coworkers, nurse educators, paramedics, APP, and POC testing personnel.  Exercises effective communication skills with all departments.

• Complies with all hospital safety requirements.  Is knowledgeable about hospital policies concerning fire drills, OSHA regulations, hazardous waste management and chemical hygiene.

• Performs all other duties as required. 

Skills/Competencies

• Must have analytical abilities necessary to perform waived and non-waived test procedures with a high degree of accuracy and an understanding of their relevance to specific patient conditions.
• Must have the ability to read, comprehend and follow written procedures, regulatory documents, and verbal instruction.  Must have the ability to perform arithmetic, algebraic and statistical calculations.
• Must have strong interpersonal and communication skills necessary to work effectively and collaborative with colleagues and patient care providers.
• Must have technical writing ability and computer skills.

Working Conditions

• Work in an office with adequate physical space under controlled conditions.

• Required to carry and respond to a pager.

• Required to travel to off-site locations.

• Must have demonstrated full competency and highly effective performance as a medical technologist.

• Must possess a bachelor’s degree in medical technology, or chemical, physical, or biological science from an accredited college or university or other qualifications as described in the Federal Register, 42 CFR, Subpart M 493. 1403-1495.  

• Five (5) years of Clinical Laboratory experience as required to serve as the CLIA Technical Consultant.

• MT (ASCP), CLS (NCA) or equivalent certification required.