Table 1 CBAHI Standards and Evidence of Compliance. This table summarizes the 11 CBAHI standards that are under the Laboratory (LB) Chapter for primary healthcare centers presented with their evidence of compliance (EC) and method of inspection. For simplicity, the 56 sub-standard were not included, however they can be found by refereeing to the original document CBAHI PHC standards guide (Version 3, 2017)

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