Evidence Submission for Initial Assessment - Laboratory Medicine
Initial Assessment
Evidence Submission for Distance Review
Laboratory Medicine
Facility Name:
Introduction:
The facility’s Evidence Submission for Distance Review combined with the findings during the Initial Assessment visit, will be utilized to determine if the facility meets the DAP Initial Assessment Accreditation Standards. Provisional Accreditation with an expiry of one year will be awarded when the standards are met. Within one year of being awarded Provisional Accreditation, the facility will be subject to an On-site Survey.
The following sections outline the criteria and descriptors that will be assessed by evidence submission. Follow-up may be required during the Initial Assessment visit to determine if the evidence is implemented.
Instructions:
It is strongly recommended that the DAP Laboratory Medicine Initial Assessment Accreditation Standards 2010 are used in conjunction with the Evidence Submission form to understand the scope of each request.
1. Complete your “Facility Name” on cover of form.
2. Review the criteria, descriptors and “Guidance for Evidence Submission”. The “Guidance for Evidence Submission” is for guidance only and any applicable evidence may be submitted to meet the included criteria and criteria descriptors.
3. Gather the evidence. Complete the applicable box on the Evidence Submission Form (i.e. Evidence Attached, N/A, or No Evidence). If your response is “N/A” or “No Evidence”, provide an explanation.
4. Label the evidence, either electronically (file name) or manually, identifying the criteria descriptor that the evidence is associated. For example, when submitting the evidence for SCT3.1.9 in the Sample Collection, Transport, Accessioning and Storage section, ensure that the evidence for rejection criteria is clearly labeled with SCT3.1.9 (either manually or electronically).
5. Submit the evidence electronically or by courier, along with the completed Evidence Submission for Distance Review Form. Facilities should attempt to submit all documentation electronically. Electronic submissions are to be emailed to .
If unable to send the documentation electronically, please courier all forms and evidence to:
College of Physicians and Surgeons of British Columbia
Diagnostic Accreditation Program
#300-669 Howe Street
Vancouver, BC V6C 0B4
Governance and Leadership
Note: “M” indicates Mandatory / Guidance for evidence submission / Evidence Attached / Not Applicable / No Evidence / Explain
LGL 2.2 / Responsibility for the clinical oversight of laboratory quality and safety is assigned and supported by the organization. / Medical Leader position description.
LGL2.2.1 / M / A senior medical leader* is appointed with responsibility for the quality and safety of medical practice within the laboratory.
LGL 2.3 / There is documented and dated organizational structure that identifies: / Organizational Chart/Structure.
LGL2.3.1 / M / the management structure of the laboratory.
LGL2.3.2 / M / lines of accountability.
LGL2.3.3 / M / responsibility, authority and interrelationships of all staff.
LGL2.3.4 / M / relationship to any other organization that the laboratory is associated with (e.g. medical leadership located remotely, referral laboratories, etc.).
Medical Staff
Note: “M” indicates Mandatory / Guidance for evidence submission / Evidence Attached / Not Applicable / No Evidence / Explain
LMS 1.2 / Medical leaders must attend the laboratory to assess the quality and safety of service. / Log of the medical leaders visits to the facility/service, if remotely supervised.
At a minimum:
LMS1.2.1 / M / initially when medical leadership responsibility commences.
LMS 1.4 / Logs to record medical leader visits are maintained.
LMS1.4.1 / M / A log is kept to record the visit of the medical leader to the laboratory.
LMS1.4.2 / M / Recommendations for improvement or required follow-up are recorded in the log.
LMS1.4.3 / M / The log is signed by the person conducting the visit.
LMS 1.6 / The medical leader assumes responsibility for proficiency testing and quality control procedures. / Documentation describing responsibility for QC and PT programs including hierarchy of review, delegation and frequency and type of controls.
LMS1.6.1 / M / Quality control programs are the responsibility of the medical leader or designate.
LMS1.6.2 / M / The type and frequency of controls is established and approved by the medical leader in accordance with manufacturer’s and reference guidelines.
LMS1.6.4 / M / A hierarchy of quality control review is established that includes appropriate staff from technologists to medical leaders.
Medical Staff cont’d
Note: “M” indicates Mandatory / Guidance for evidence submission / Evidence Attached / Not Applicable / No Evidence / Explain
LMS 2.3 / Medical biochemistry services are provided by physicians: / Documentation of physicians licenses from the College of Physicians and Surgeons of British Columbia
LMS2.3.1 / M / licensed to practice Medical Biochemistry or General Pathology by the College of Physicians and Surgeons of British Columbia.
LMS 2.4 / Hematology services are provided by physicians:
LMS2.4.1 / M / licensed to practice Hematological Pathology or General Pathology by the College of Physicians and Surgeons of British Columbia.
LMS 2.5 / Microbiology services are provided by physicians:
LMS2.5.1 / M / licensed to practice Medical Microbiology or General Pathology by the College of Physicians and Surgeons of British Columbia.
LMS 2.6 / Transfusion Medicine services are provided by physicians:
LMS2.6.1 / M / licensed to practice Transfusion Medicine, Hematological Pathology or General Pathology by the College of Physicians and Surgeons of British Columbia.
Medical Staff cont’d
Note: “M” indicates Mandatory / Guidance for evidence submission / Evidence Attached / Not Applicable / No Evidence / Explain
LMS 2.7 / Anatomic Pathology services are provided by physicians:
LMS2.7.1 / M / licensed to practice Anatomical Pathology or General Pathology by the College of Physicians and Surgeons of British Columbia
LMS 2.8 / Cytology services are provided by physicians:
LMS2.8.1 / M / licensed to practice Anatomical Pathology or General Pathology by the College of Physicians and Surgeons of British Columbia.
LMS 2.9 / Cytogenetic services are provided by physicians:
LMS2.9.1 / M / licensed to practice General Pathology by the College of Physicians and Surgeons of British Columbia.
LMS 4.1 / Delegated medical acts are clearly defined. / A list of delegated medical acts performed within each laboratory discipline.
The competency requirements for each delegated medical act.
Note: Refer to Anatomic Pathology Standards AP 1.2.1 and AP 5.4.3 for information on delegation of acts specific to autopsy services and gross pathology.
LMS4.1.1 / M / Each delegated medical act is clearly defined and circumscribed.
LMS4.1.2 / M / The degree of medical supervision required is identified.
LMS4.1.3 / M / Competency requirements to perform the delegated medical act are clearly identified.
Medical Staff cont’d
Note: “M” indicates Mandatory / Guidance for evidence submission / Evidence Attached / Not Applicable / No Evidence / Explain
LMS 4.2 / The delegation of medical acts has been approved and accepted. / The approval and acceptance of the delegated medical act.
LMS4.2.1 / M / There is consensus from the medical community that the delegation of the medical act is appropriate.
LMS4.2.3 / M / The delegation of the medical act has been accepted by the individual(s) who will perform the delegated medical act.
LMS4.2.4 / M / Agreement from the governing body/ownership of the organization has been obtained prior to the delegated medical act being carried out in the organization.
Medical Staff cont’d
Note: “M” indicates Mandatory / Guidance for evidence submission / Evidence Attached / Not Applicable / No Evidence / Explain
LMS 4.3 / Delegated medical acts are performed by competent individuals. / Competency assessment template.
Records of staff competency assessments for those that perform delegated medical acts.
LMS4.3.1 / M / Additional training is provided to individuals performing the delegated medical act.
LMS4.3.2 / M / An assessment of the competence of the individual to perform a specific act is conducted by a physician.
The record of the assessment of competence for each individual:
LMS4.3.3 / M / identifies the name of the individual, and
LMS4.3.4 / M / the date of the assessment, and
LMS4.3.5 / M / the specific act(s) being assessed, and
LMS4.3.6 / M / the name of the physician conducting the assessment, and
LMS4.3.7 / M / the signature of the physician attesting to the competence of the individual performing the specific act(s).
Human Resources
Note: “M” indicates Mandatory / Guidance for evidence submission / Evidence Attached / Not Applicable / No Evidence / Explain
LHR 3.1 / Technical staff providing laboratory services:
LHR3.1.1 / M / are certified with the Canadian Society for Medical Laboratory Science (CSMLS) in the specific discipline(s) that they work; or, are graduates from a recognized Medical Laboratory Science program and are eligible to write the CSMLS certification examinations; or, are certified Combined Laboratory/X-ray Technologists (CLXT). / List of staff that are not certified by the Canadian Society for Medical Laboratory Science (CSMLS) in the specific disciplines(s) that they work.
For clinical genetics:
LHR3.1.2 / M / certification in Clinical Genetics from the Canadian Society for Medical Laboratory Science . / For clinical genetics: list of clinical genetics staff, photocopy of certificate in Clinical Genetics from CSMLS and of baccalaureate degree from an appropriate field.
LHR3.1.3 / M / a baccalaureate degree in an appropriate field.
For diagnostic cytology:
LHR3.1.4 / M / certification in Diagnostic Cytology from the Canadian Society for Medical Laboratory Science. / For diagnostic cytology: list of cytology staff, photocopy of certificate in Diagnostic Cytology from CSMLS.
Human Resources cont’d
Note: “M” indicates Mandatory / Guidance for evidence submission / Evidence Attached / Not Applicable / No Evidence / Explain
LHR 3.2 / There is a defined scope of practice for CLXT staff. / Scope of practice for CXLTs.
LHR3.2.1 / M / The scope of practice is in alignment with their certification.
LHR 3.3 / Scientific staff providing laboratory services: / Education and scope of practice for scientific staff.
LHR3.3.1 / M / have university level education specific to the laboratory discipline they are working; and
LHR3.3.2 / M / have a specific scope of practice as defined by the medical leader.
LHR 3.5 / Pathologists’ Assistants providing services: / List of Pathologists’ Assistants, photocopy of certificate from a recognized university-based Pathologists’ Assistant Program.
LHR3.5.1 / M / have graduated from a recognized university-based Pathologists’ Assistant Program.
LHR 12.1 / The Information Systems Specialist
(e.g. Telepathology Coordinator): / Job/Position description of Information Systems Specialist.
LHR12.1.3 / M / is identified and appointed by the laboratory.
LHR12.1.4 / M / has defined responsibilities. / A list of Information Systems Specialists.
LHR 13.1 / Service and maintenance personnel: / Job/Position description of Service and Maintenance personnel.
A list of service and maintenance personnel.
LHR13.1.1 / M / have specific knowledge and training in the repair and maintenance of laboratory equipment.
Human Resources cont’d
Note: “M” indicates Mandatory / Guidance for evidence submission / Evidence Attached / Not Applicable / No Evidence / Explain
LHR 17.1 / Orientation is provided to all new staff. / Orientation documentation for new staff members (e.g. orientation checklists, information packages, etc.).
Orientation and initial training about the organization, laboratory, and the staff’s position includes the following information:
LHR17.1.1 / mission, vision, values, goals and objectives.
LHR17.1.2 / programs and services.
LHR17.1.3 / roles and responsibilities of the individual and key staff.
LHR17.1.4 / policies of the organization and laboratory and the responsibility for staff to comply.
LHR17.1.5 / relevant policies and procedures related to performing the duties of the position.
LHR17.1.6 / protecting patient confidentiality.
LHR17.1.7 / protecting patient rights, including understanding ethical aspects of care, procedures, and services.
LHR17.1.8 / sensitivity to cultural diversity as it applies to the responsibilities of the position.
LHR17.1.9 / quality improvement and risk management practices.
Human Resources cont’d
Note: “M” indicates Mandatory / Guidance for evidence submission / Evidence Attached / Not Applicable / No Evidence / Explain
LHR 17.1
Cont’d / Orientation provides training and information about safety that includes: / Orientation documentation for new staff members (e.g. orientation checklists, information packages, etc.).
LHR17.1.10 / M / management of aggressive behavior.
LHR17.1.11 / M / violence and harassment in the workplace.
LHR17.1.12 / M / sharps handling and disposal.
LHR17.1.13 / M / fire safety.
LHR17.1.14 / M / management of infectious material including routine precautions, needle stick injury protocol, staff personal protective equipment and other safety equipment.
LHR17.1.15 / M / management of cardiac and respiratory arrest.
LHR17.1.16 / M / musculo-skeletal injury prevention.
LHR17.1.17 / M / WHMIS and other local, provincial and federal requirements.
LHR17.1.18 / M / emergency response codes.
LHR17.1.19 / M / disaster response.
LHR17.1.20 / M / the need and ways to report staff injuries.
LHR17.1.21 / M / the principles of patient safety.
Human Resources cont’d
Note: “M” indicates Mandatory / Guidance for evidence submission / Evidence Attached / Not Applicable / No Evidence / Explain
LHR 18.2 / The competency of individual staff is assessed. / Example of a competency assessment template for new staff.
Example of a competency assessment template for existing staff.
LHR18.2.1 / M / Competency of new staff is assessed at the completion of a probationary and/or orientation period.
LHR18.2.2 / M / Competencies of existing staff is assessed when new technology and/or procedures are introduced.
Patient and Client Focus
Note: “M” indicates Mandatory / Guidance for evidence submission / Evidence Attached / Not Applicable / No Evidence / Explain
LPC 1.3 / Service standards of the laboratory are defined and documented. / List of stat tests that have defined targets for turnaround times.
List of urgent tests that have defined targets for turnaround times.
LPC1.3.1 / M / Definitions of “stat”, “emergent/urgent” and “non-emergent/routine” are available and indicate the expected result/report turnaround time.
LPC1.3.8 / M / Tests available on a “stat” basis are identified and this is communicated to referring practitioners.
LPC1.3.9 / M / Turnaround times for specific tests are defined for each discipline (e.g. blood gasses from the OR).
LPC 1.4 / Final reports are provided in a manner that meets the needs of patients and clients. / Pathologist response time for intra-operative consultations.
LPC1.4.9 / M / For intra-operative consultations there is an established pathologist response time.
LPC 3.4 / The laboratory ensures that patients are provided with the information necessary to make informed decisions to give or withhold consent. / Ref next page
LPC3.4.1 / M / The laboratory identifies the specific tests, procedures, or services that require informed consent as well as the circumstances that would allow for exceptions to it.
Patient and Client Focus cont’d