Standard # | |||
---|---|---|---|
LB.1 | Laboratory services (LB) are available to meet patient needs, applicable to national standards | ||
LB.1.EC.2 | There is a written agreement with an accredited lab for the provision of special procedures and consultations | Document Review | |
LB.2 | A current laboratory policies and procedures manual are readily available to staff. Policy and procedure manual should be well structured | ||
LB.2.EC.1 | There is evidence of comprehensive, approved, and current policies and procedures manual that are available and well known to the staff | Staff Interview | |
LB.3 | The laboratory organization structure is defined and available | ||
LB.3.EC.1 | There is an updated and approved laboratory organization structure with sections and staff categories identified under the director supervision | Document Review | |
LB.3.EC.2 | Laboratory director is a qualified pathologist or a qualified clinical scientist | Personnel file | |
LB.4 | The laboratory space is adequate for its function, well-maintained, free of clutter and does not compromise the quality of work and personnel safety | ||
LB.4.EC.1 | There is adequate lab space, that must have: two sinks with one sink used exclusively for handwashing, machines attached directly to a wall socket, critical machines attached to the emergency socket, adequate control of temperature and humidity, and telephone facility | Observation | |
LB.5 | The laboratory establishes a documented safety program under the supervision of the laboratory director and consistent with the facility’s safety guidelines | ||
LB.5.EC.1 | There are fire and safety training records | Document Review | |
LB.5.EC.2 | There is an effective system for reporting and investigating occupational injuries and accidents | Document Review | |
LB.5.EC.3 | There is evidence of comprehensive, approved, and current safety manual that is available and well known to the staff | Staff Interview | |
LB.5.EC.4 | There are sufficient safety signs posted where appropriate | Observation | |
LB.5.EC.5 | Eye wash stations and emergency showers are available and checked at regular intervals | Observation | |
LB.6 | The laboratory implements all the rules and guidelines of infection control | ||
LB.6.EC.1 | There are records to support the immune status or vaccination for all lab personnel | Personnel file | |
LB.6.EC.2 | Personnel protective equipment are available and used when appropriate | Observation | |
LB.6.EC.3 | There is evidence of the implementation of policies on universal precautions and prohibition of eating and drinking in the lab | Observation | |
LB.6.EC.5 | There is evidence of negative pressure monitoring in microbiology | Observation | |
LB.6.EC.6 | There is evidence of clear designation of clean and contaminated areas | Observation | |
LB.7 | The laboratory publishes and distributes clear written instructions for proper collection, handling, transportation, and preparation of specimens | ||
LB.7.EC.1 | There is a laboratory specimen guide (LB.7.1-LB.7.7) distributed to all clinical departments | Observation | |
LB.8 | The laboratory keeps instrument and equipment in proper functional condition through the establishment of a system where equipment are properly operated, cleaned, quality controlled, monitored and maintained | ||
LB.8.EC.1 | Inspection and preventive maintenance records for all laboratory equipment are maintained | Document Review | |
LB.9 | Reagents and solutions are properly labeled, as applicable and appropriate | ||
LB.9.EC.1 | There are written policies and procedures for reagent preparation, labeling, storage, and expiration | Document Review | |
LB.9.EC.2 | Reagents are labeled in accordance with the laboratory policy | Observation | |
LB.10 | The laboratory has a clear system for results reporting | ||
LB.10.EC.1 | There are written policies and procedures for reporting panic values (critical results) | Document Review | |
LB.10.EC.2 | There is evidence of that TAT for all laboratory services is defined, communicated, and agreed upon by clinical departments | Staff Interview | |
LB.10.EC.3 | There are records in support of proper reporting of panic values | Observation | |
LB.11 | The laboratory must have a quality management program approved by the laboratory director and available for all laboratory personnel. The laboratory quality management program must be integrated with the center-wide quality program | ||
LB.11.EC.1 | There is a written quality management program satisfying all of the elements above | Document Review | |
LB.11.EC.2 | There is evidence of participation in external and/or internal proficiency testing program covering all laboratory analytes | Document Review | |
LB.11.EC.3 | There is evidence of using an efficient accident and adverse event reporting and investigating system | Document Review | |
LB.11.EC.4 | There is evidence of corrective and/or preventive measures taken when expected quality monitoring outcomes are not achieved | Document Review |