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01 Introduction To Lab Standards

This document provides an overview of changes to laboratory standards in the new NHS, including changes to the survey process, scoring, and accreditation decision rules. It discusses essential safety requirements, track records, and the roles of laboratory surveyors. Significant changes are noted for the total number of laboratory standards and sub-standards, with more detailed standards for blood bank and transfusion services. The presentation outline lists topics to cover laboratory facilities, customer focus, quality indicators, purchasing, equipment management, anatomical pathology, point-of-care testing, documents, committees, test methods, nonconforming events, proficiency testing, and laboratory information systems.

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yousrazeidan1979
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231 views

01 Introduction To Lab Standards

This document provides an overview of changes to laboratory standards in the new NHS, including changes to the survey process, scoring, and accreditation decision rules. It discusses essential safety requirements, track records, and the roles of laboratory surveyors. Significant changes are noted for the total number of laboratory standards and sub-standards, with more detailed standards for blood bank and transfusion services. The presentation outline lists topics to cover laboratory facilities, customer focus, quality indicators, purchasing, equipment management, anatomical pathology, point-of-care testing, documents, committees, test methods, nonconforming events, proficiency testing, and laboratory information systems.

Uploaded by

yousrazeidan1979
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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INTRODUCTION AND OVERVIEW OF

LABORATORY STANDARDS
IN THE NEW NHS
Presentation Outline
 Survey Process changes
 Self-Assessment
 Survey Team and Survey Agenda
 ESR
 Track Records
 Scoring
 Accreditation Decision Rules
 Significant Changes in the Laboratory Standards.
Survey Process Changes
Self-Assessment
• Before Initial Accreditation
• Accreditation Maintenance
Survey Process Changes
Survey Team and Survey Agenda
• Survey Team Composition
• Survey Activities
Survey Process Changes
Essential Safety Requirements (ESRs)
• Total of 20 Standards assessed by 156 Survey
Activity (scorables).
• Facilities must be in satisfactory compliance to
be accredited.
• The laboratory surveyor will assess the lab
compliance against 36 Survey Activity
(scorables).
Survey Process Changes
ESRs (Continued)
• The Lab Surveyor is the sole evaluator of two ESR
standards (27 scorables).
• PC.25 (handling, and administration of blood products)
• LB.51 (Infectious diseases testing))
• The Lab Surveyor participate in the evaluator of three
ESR standards (9 scorables).
• HR.5 (staff credentials)
• QM.17 (patient identification)
• FMS.24 (fire safety)
Survey Process Changes
Track Records
• Initial Accreditation – Four Months
• Reaccreditation – 1st of January, 2016 onward
Survey Process Changes
Scoring
• “0” - < 50 % compliance
• “1” - ≥ 50 to < 80 %
• “2” - ≥ 80 % compliance
• “NA” Not Applicable
Track record period shorter than the required will
reduce the score proportionally.
Survey Process Changes
Scoring
• If the standard requires policy/plan” and it is not
approved/exist, the other related activities will be
scored “Zero”
• If the standard requires policy/plan” and it is
approved, but there is no evidence of implementation,
the policy and all other related activities will be scored
“Zero”
Survey Process Changes
Scoring of Outsourced Services
Outsources services shall meet the following conditions:
1. Service contract/agreement/memo of understanding (as
articulated in LD.21) specifying:
• The scope of service and the validity of the agreement
• Agreement conditions (including accreditation status and/or
accreditation standards).
• Agreement review and the right to conduct audits to confirm the
contracted party compliance.
1. There is documented evidence of regular contract review
and/or audits.
Survey Process Changes
Scoring of Outsourced Services
• If all of the above conditions are met, all of the technical standards
related to the outsourced services will be scored as “Not Applicable”.
• If there is no service contract/agreement/memo of understanding
and/or there is no documented evidence of regular review/audits and
the outsources service performed outside the facility, all of the
technical standards related to the outsourced services will be scored as
“Not Met”.
• If there is no service contract/agreement/memo of understanding
and/or there is no documented evidence of regular review/audits and
the outsources service performed inside the facility, all of the technical
standards related to the outsourced services should be surveyed as
usual and scored accordingly (as if the service not outsourced).
Survey Process Changes
Accreditation Decision Rules
1. Accredited:
• Overall score 85% or above and
• All essential safety requirements are in satisfactory
compliance and
• No other issues of concern related to the safety of patients,
visitors or staff.
Survey Process Changes
Accreditation Decision Rules
2. Conditional Accreditation:
• Overall score 75% or above and less than 85% and/or
• Some of the essential safety requirements (but not
exceeding 25% of them) are not in satisfactory compliance.
Survey Process Changes
Accreditation Decision Rules
3. Preliminary Denial of Accreditation:
Preliminary Denial of Accreditation (PDA) is a stage -
rather than a final accreditation decision- that precedes
denial of accreditation. The aim of allowing this stage, is
to give some additional time for review and/or appeal
before the determination to deny accreditation.
Survey Process Changes
Accreditation Decision Rules
3. Preliminary Denial of Accreditation:
• Presence of an immediate threat to safety
• Significant noncompliance with the accreditation standards
• Failure of timely submission of the post survey requirements
• Received conditional accreditation and was subjected to a
follow up focused survey but still could not meet the
requirements for accreditation.
• Reasonable evidence exists of fraud, plagiarism, or falsified
information
Survey Process Changes
Accreditation Decision Rules
Plagiarism:
Plagiarism is perceived by CBAHI as the deliberate use of other
healthcare facility original (not common-knowledge) material
without acknowledging its source.
Falsification:
Falsification is defined as the fabrication of any information (given
by verbal communication, or paper/electronic document)
provided to CBAHI by an applicant or accredited healthcare facility
through redrafting, additions, or deletions of a document content
without proper attribution.
Survey Process Changes
Accreditation Decision Rules
4. Denial of Accreditation:
• Significant noncompliance with the accreditation standards at
the time of the on-site survey.
• Preliminary denial of accreditation that have not been
resolved.
Significant Changes in the Laboratory
Standards.
 Total Lab Standards 76
 Total Lab Sub –Standards 214
 Sub-Standards from Other Chapters 110
 Total Survey Activities 653
QSE SUBJECT NUMBER OF SUB-STANDARDS
I Organizational Standards 12
II Customer Focus Standards 13
III Facility and Safety Standard 23
IV Personnel Standards 21
V Purchasing and Inventory Standards 12
VI Equipment Standards 19

Process Management Standards


• General Lab (12)
• Specimen and Requests (13)
• Result Reporting (7)
VII 173
• Donor Collection (25)
• Components Production (59)
• Pre-Transfusion and Compatibility Testing (41)
• Anatomic Pathology (16)

VIII Documents and Records Standards 18


IX Information Management 9
X Nonconforming Event Management Standards 6
XI Assessments Standards 8
XII Continual Improvement Standards 10
Significant Changes in the Laboratory
Standards.
 Audit Trail
 Validations; Equipment and Test Methods
 Correlations; Equipment and Test Methods
 Assessments; Internal and External
 Retention; Documents, Records and Specimen
 Detailed Blood Bank and Transfusion Services Standards
TOPICS PRESENTER
2 Laboratory Facility and Safety Javed Akhter
3 Laboratory Customer Ghiwa Elnajar
4 Laboratory Quality Indicators Javed Akhter
5 Laboratory Role in Purchasing and Inventory Ghiwa Elnajar
6 Donor Center Activities Abdulla Alkhahan
7 Component Processing Activity Abdulla Alkhahan
8 Transfusion Service Activities Abdulla Alkhahan
9 Laboratory Role in Equipment Management Najwa Adlan
10 Anatomical Pathology Khalid Alzahrani
12 Point-of Care-Testing Najwa Adlan

12 Document and Records Control Khalid Alzahrani


13 Laboratory Role in the Blood Utilization and Tissue Review Committees Abdulla Alkhashan

14 Control of Test Methods Saeed Alghamdi

15 Nonconforming Event Management Abdulla Alkhashan

16 External Quality Assessment (Proficiency Testing) Saeed Alghamdi

17 Laboratory Information System Abdulla Alkhashan

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