1. Going for Gold – The Bridge to Patient Care
use these colors
Going for Gold – The Bridge to Patient Care
Stacy Olea, MBA, MT(ASCP), FACHE
Field Director

2. Objectives Learn about The Joint Commission Laboratory standards
Explain the unique features of a Joint Commission Laboratory survey
Understand what to expect during your survey
Learn what happens after the survey has been completed
Review how to use the available tools to assist you with continuous compliance
Present suggestions on how to resolve the top 10 findings

3. The Joint Commission’s Vision
All people experience the safest, highest quality, best- value health care across all settings.
The Joint Commission’s Mission
To continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value. 3

4. Reasons Organizations do not use The Joint Commission for Laboratory Accreditation
Employed Surveyor Cadre
Did not know The Joint Commission offered a laboratory program
The Joint Commission does not have standards in Forensic Drug testing
No checklist
Thought the laboratory surveyors where physicians and nurses

5. Reasons Organization use The Joint Commission for Laboratory Accreditation
Largest and oldest organization dedicated to survey process and risk evaluation for over 19,000 health care organizations
Professional surveyor cadre
Tracer methodology and system evaluation
Lab Advantage combined services option (PT, CE, and accreditation)
Organizational alignment for operational synergy
Cost is based on volume
More than one way to meet the standards
Annual procedure review can be done by signing one cover sheet
Ability to detect risks that were unknown prior to the visit
Onsite visit activities and findings added value to improving the quality of healthcare
Collaborative approach

6. Accreditation Standards
Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing (CAMLAB)
Free print copy
Electronic copy via E-dition
Focus on high quality, safe laboratory services
Expectations for performance – reasonable, achievable, surveyable
CMS recognizes Joint Commission accreditation as meeting CLIA requirements

7. Accreditation Standards
Surveyors use standards for evaluation
Patient tracer methodology
Follow samples from collection to result reporting
Organization-wide processes
Valuable component of a complex delivery system
Not an isolated department

8. Broad vs. Prescriptive Requirements
Processes (means to an end)
Many ways to accomplish goals
Processes designed by Organizations
Remains valid with changing science
Prescriptive
Specific requirements (specific outcome)
The only way
Evidence-Based
Readjustments are required with changing science

9. Unique Issues with Laboratory
Often uses prescriptive requirements
CLIA requirements
Industry convention
Avoid prescriptive requirements
Multiple effective methods may exist
Could stifle emerging practices
Tracers are a system review process (rather than task verification)
Allows standards to be nimble

10. Standards Development Process
Subject matter expert participation
Laboratory PTAC review
Comprised of members from industry association stakeholders
National Field Review
6 week public comment period
Board Committee (SSP) approves
6-month notification to allow preparation

11. Standards Development Process
New standards timeline (12-18 months)
Research, revisions
Public comment, pilot testing
CAMLAB updated (6 months)
Standards updates
Front matter/resource edits

12. Layout of CAMLAB Front Matter 13 Chapters Resources
How to Use this Manual
13 Chapters
Shared Chapters
Unique Chapters
Resources
Glossary
Standards Applicability Grid

13. Standards Chapters Chapters Unique to CAMLAB
DC - Document and Process Control
specimen collection, test orders, test procedures, reporting, record retention
QSA – Quality System Assessment for Nonwaived Testing
proficiency testing quality control, standards for specialties and subspecialties

14. Standards Chapters Chapters Shared with Other Programs
EC – Environment of Care
physical environment, equipment, hazardous materials/waste, fire safety, utilities
HR – Human Resources
staff qualifications, orientation, training, competence, performance
LD – Leadership
structure, relationships, organizational culture, operations
NPSG – National Patient Safety Goals
two patient identifiers, reporting critical results, hand hygiene

15. Anatomy of a Standard Standard Rationale/Introduction
Identifies a goal (i.e., participation in proficiency testing)
Rationale/Introduction
Explains why it is important to achieve the goal
Provides background information for requirement
Element of Performance (EP)
Outlines the steps needed to achieve the goal
Expectations for compliance

16. Standards Applicability Grid
Not all requirements apply to all specialties
Based on services provided by your laboratory
Specialties listed horizontally, standards vertically

17. Scoring Scoring Process
Category A EPs: relate to structural requirement
Category C EPs: frequency based that are scored based on the number of times an organization is found not to be compliant
Performance expectation
Score 2 = Satisfactory compliance
Score 1 = Partial compliance
Score 0 = Insufficient compliance
Track record achievements at the time of survey
Score 2 = 24 month
Score 1 = 6 to 23 months
Score 0 = Fewer than 6 months

18. Accreditation Decision
How accreditation decisions are made
Criticality model
The more immediate the risk the shorter the period of time given to address noncompliance
All partially compliant and insufficiently compliant EPs must be addressed

19. What is unique to our survey process?
Employed surveyor cadre
Priority Focus Process
Concentration on the operational systems that directly affect the quality and safety of diagnostic services
National Patient Safety Goals
Tracer Methodology

20. Employed Surveyor Cadre
Effective evaluators
Process is thorough, fair, and objective
Process identifies most critical safety and quality issues
Process is inclusive of mandatory (regulatory) and collaborative (inspirational) modes
Process is continuous, not event driven
Process is guided by surveyor experience and expertise, informed by data
Process looks at systems and integration, not a list of tasks
All have clinical laboratory management experience
A full time surveyor will evaluate approximately 60 laboratories a year
Anatomical pathologist surveyors are available upon request
Surveyor continual training and performance monitoring

21. Priority Focus Process
Data driven tool that provides surveyors with pre-survey information that has been developed using a standardized methodology
Helps surveyors evaluate health care organizations’ performance more consistently
Helps to focus the surveyors’ assessment on quality and safety issues specific to an individual laboratory
Sources used includes The Joint Commission, the laboratory and other public sources
PFP reports are posted to your extranet site quarterly and as changes warrant
The top four-to-five priority focus areas
The clinical/service groups

22. Operational Systems Approach
Our mission and vision drives us to look at how the laboratory is integrated into patient care
We will spend time outside of the laboratory
Nonwaived ancillary Point of Care Testing sites (cardiac cath labs, ORs)
A sampling of waived and PPMP Point of Care Testing sites
Transfusion administration and management
Perioperative Transfusion Services
Tissue storage and management
Hospital Integration

23. NPSG
Use at least two patient identifiers when providing laboratory services.
EP1 - Use at least two patient identifiers when administering blood or blood components; when collecting blood samples and other specimens for clinical testing; and when providing other treatments or procedures. The patient’s room number or physical location is not used as an identifier.
EP2 - Label containers used for blood and other specimens in the presence of the patient.

24. NPSG
Report critical results of tests and diagnostic procedures on a timely basis.
EP1 - Collaborate with organization leaders to develop written procedures for managing the critical results of tests and diagnostic procedures that address the following:
The definition of critical results of tests and diagnostic procedures
By whom and to whom critical results of tests and diagnostic procedures are reported
The acceptable length of time between the availability and reporting of critical results of tests and diagnostic procedures
EP2 - Implement the procedures for managing the critical results of tests and diagnostic procedures.
EP3 - Evaluate the timeliness of reporting the critical results of tests and diagnostic procedures.

25. NPSG
Comply with either the current Centers or Disease Control an Prevention (CDC) hand hygiene guidelines or the current World Health Organization (WHO) hand hygiene guidelines.
EP1 - Implement a program that follows categories IA, IB, and IC of either the current CDC or WHO hand hygiene guidelines.
EP2 - Set goals for improving compliance with hand hygiene guidelines.
EP3 - Improve compliance with hand hygiene guidelines based on established goals.

26. Tracer Methodology
Uses actual patients as the framework for assessing standards compliance
Individual tracers follow the experience of care through the entire health care process in the organization
System tracers evaluate the integration of related processes
Coordination and communication among disciplines and departments
In-depth discussion and education regarding the use of data in performance improvement
Reference document available at

27. Tracer Methodology Common starting points for tracers
Sample Collection
Critical results
Transfusion Medicine
Point of Care Testing
Frozen Sections
Documents reviewed during tracers
Order
Instrument maintenance records, calibration verification, quality control
Policies and Procedures
Employee competency
Blood Utilization Review
Process Improvement
Patient Medical Records
Staff interviews and Direct Observations

28. Joint Commission Survey Options
Pathologist
Corporate Surveys
Dedicated Team
Orientation to your Organization
Annual Summation
Simultaneous Surveys
Other Programs
Sister facilities
Concurrent Surveys

29. On-Site Survey Activities
Surveyor photo, bio and survey agenda are posted to the extranet site at 07:30 local time (mobile app)
Depending on the complexity of the organization a survey may last more than one day and could involve a team of surveyors
Once the surveyor arrives, the organization’s extranet must be checked for confirmation of the survey and identification of the surveyor
Preliminary Planning Session
Opening Conference
Orientation to the Organization

30. On-Site Survey Activities
A Daily Briefing occurs every morning of a multiday survey, with the exception of the first day
Competency Assessment
Personnel education/qualification verification
Regulatory Review
Proficiency Testing Validation/Performance Improvement Data Review
Individual Tracers
Physical Environment
Survey Report Preparation
CEO Exit Briefing and Organization Exit Conference

31. Required Documentation
Documentation list for your survey
The 24 month reference in the following items is not applicable to initial surveys, except for proficiency testing data.
For initial surveys, a minimum of 4 months of data must be available for review.

32. Required Documentation
As a laboratory, you should have the following information and documents available for the surveyor to review during the Surveyor Planning Session
Name of key contact person who can assist in planning tracer selections
CLIA Certificates, Specialties and Subspecialties, State Licenses, and personnel license or certification if required by the state or organization policy
An organizational chart and map of the facility
Ability to retrieve testing records for patients who have had laboratory tests or other services for the past 24 months (4 months if an initial survey)
Performance improvement Data for the past 24 months (4 months if an initial survey)
Proficiency data by CLIA number for the past 24 months

33. Required Documentation
As a laboratory, you should have the following information and documents available for the surveyor to review during the Surveyor Planning Session
Results of periodic laboratory environment inspections from the safety committee or safety officer
Manifests for the disposal of hazardous waste for the past 24 months (4 months if an initial survey)
A list of specialties and subspecialties performed by the lab
A list of tests performed (test menu) and instruments used including all ancillary and point of care sites
Measures of Success (MOS) identified in the Plan of Action from the Periodic Performance Review
Employee personnel files will be reviewed, including employee education records, competency documentation, and employee health information
Note: Surveyors may need to see additional documents throughout the survey to further explore or validate observations or discussions with staff.

34. From Survey Report to Accreditation Decision
A preliminary report is available on the extranet until midnight of the day the survey has been completed.
The accreditation decision is not made until all of your organization’s post-survey activities are completed
The final summary of survey findings report will be posted on your extranet site.
It will include which findings require an Evidence of Standards Compliance (ESC) submission within 45 days (direct impact standards) and/or 60 days (indirect impact standards)
Upon approval of your organization’s last submitted ESC, your accreditation decision is posted to your extranet site and to Quality Check (

35. Standards Clarification
Organizations have the opportunity to submit a clarifying ESC if they believe that their organization was in compliance with a standard at the time of the survey
The clarification must be submitted within 10 business day following the posting of the organization’s report to the extranet.
When submitting clarifying ESCs after a survey event, it is important to follow the directions in the submission tool. You need to address the EP as well as the actual surveyor observation.
The submission of a clarification does not negate the requirement for submission of a corrective ESC within 45 or 60 days if the RFI continues, nor does it provide an organization with additional time to submit its ESC.

36. Corrective ESC
An acceptable corrective ESC report must detail the following:
Action(s) that the organization took to bring itself into compliance with a standard
The title of the person(s) responsible for implementing the corrective actions or approving a revised policy, procedure, or process
Compliance at the EP level and include a Measure of Success (MOS) if applicable
There may be times when an ESC will also be conducted on site by a surveyor
Provides the opportunity to evaluate the organization’s success in correcting issues
Allows the surveyor to provide coaching and guidance to the organization supporting its efforts to achieve and maintain compliance

37. Measure of Success (MOS)
A numerical or quantifiable measure, usually related to an audit to determine if action was effective and sustained
Due four months after notification of an acceptable ESC
Not required for all ESCs

38. Help us improve the survey process
Customer Value Assessment
Before the survey happens
Allows you to set expectations
After the survey is over to evaluation our performance
HCO Evaluation
Your opportunity to provide us with feedback on the survey process and the surveyor(s)
Exceed Expectations, Meets Expectations, Below Expectations, Not Observed
14 questions with room for comments
Additional line to enter your information if you want someone from The Joint Commission to contact you

39. Accessing Standards Via E-dition

40. Standards Interpretation Group (SIG)
Phone:
Option 6
Online:
FAQs:

41. Intracycle Monitoring
Located on your Joint Commission extranet site
Required on your off cycle year and can be accessed before your first survey
Three options available
Opportunity to ask questions and develop plans of action in a non-punitive manner

42. Leading Practice Library
Opened to all of our accredited organizations
Database to formally identify and share leading practices (including case studies, white papers, tools, policies, etc.) which reflect excellent compliance with Joint Commission standards and National Patient Safety Goals.
Sort by program

43. Center for Transforming Healthcare
Formed in 2009 to find solutions to pressing health care issues identified by CEOs
Uses DMAIC principles to analyze and identify root causes which vary by institution
One size does not fit all for persistent issues!
Projects include:
Hand hygiene
Hand off communications
Wrong Site surgery
Surgical Site infections (with ACS)
Safety Culture
Solutions database available from Joint Commission to enter your own data and perform your own project to improve care

44. Lab Central New customer portal that improves accreditation:
Allows organizations to organize files in one place to make surveys more efficient
Surveyors can review data before the survey to get better snapshot of organization
Data available for ICM discussion with SIG
Provides a place for private document management
Mandatory use starting January 1, 2013

49. From Accreditation to Continuous Compliance
Concentrate on incorporating the frameworks and concepts of standards and EPs into day-to-day work rather than viewing the concepts as rules that must be followed
Read Perspectives each month to identify new/updated standards, scoring, standards interpretation
Sign up for E-Alerts
Complete your intracycle monitoring
Contact SIG to submit standard questions
Enter your information into Lab Central

50. Resources and Tools Resources and Tools available CAMLAB
Perspectives monthly publication
Joint Commission Center for Transforming Healthcare
Account Executive
Joint Commission extranet site
Leading Practice Library
BoosterPaks
E-dition web-based manual
Lab Central
Joint Commission webpage
CLSI crosswalk
Standards’ Frequently Asked Questions
Tracer Methodology 101 article
Sign up for E-Alerts
Lab Focus
Free audio conferences

51. Resources on the Web Centers for Medicare & Medicaid Services (CMS)
CLIA:
COPs:
Centers for Disease Control and Prevention (CDC)
Food and Drug Administration CLIA Database Search
CLSI-Joint Commission Crosswalk
CrosswalkWEB.pdf

52. Top 10 Initial Survey Findings Top 10 Overall Survey Findings
Top 10 Findings
Top 10 Initial Survey Findings
DC EP2
WT EP3
QSA EP3
QSA EP2
WT EP4
QSA EP5
QSA EP6
NPSG EP3
DC EP1
QSA EP2
Top 10 Overall Survey Findings
QSA EP5
QSA EP3
WT EP3
QSA EP2
QSA EP2
DC EP2
QSA EP6
QSA EP6
QSA EP7
WT EP5

53. Initial and Overall Top 10
DC The laboratory report is complete and is in the patient’s clinical record. EP2 - The laboratory report includes the name and address of the laboratory performing the test.
QSA The laboratory performs calibration verification. EP3 – Calibration verification is performed every six months. See CAMLAB for additional Notes.
QSA The laboratory performs correlations to evaluate the results of the same test performed with different methodologies or instruments or at different locations. EP2 – The laboratory performs correlations at least once every six months. The correlations are documented.

54. Initial and Overall Top 10
QSA The laboratory participates in Centers for Medicare & Medicaid Services (CMS) approved proficiency testing programs for all regulated analytes. EP5 – For each specialty, subspecialty, analyte, or test, the laboratory’s proficiency testing results meet satisfactory performance criteria in accordance with law and regulation. See CAMLAB for additional Notes.
QSA The laboratory evaluates instrument-based testing with electronic or internal systems prior to using them for routine quality control. EP6 – The laboratory performs external quality controls at the following frequencies:
As defined by the evaluation (either weekly or monthly)
According to the manufacturer’s recommendations
With each new lot number, shipment, or package of reagents
The external quality control results are documented.

55. Initial and Overall Top 10
QSA The laboratory maintains records of its participation in a proficiency testing program. EP2 – For individual unacceptable proficiency testing results, the laboratory conducts an investigation of all potential causes, provides evidence of review, and performs corrective action sufficient to address and correct the issues identified in the investigation. These actions are documented. See CAMLAB for additional Notes.

56. Initial Top 10
WT The organization maintains records for waived testing.
EP3 – Quantitative test result reports in the patient’s clinical record for waived testing are accompanied by reference intervals (normal values) specific to the test method used and the population served. See CAMLAB for additional Notes.
EP4 – Individual test results for waived testing are associated with quality control results and instrument records. See CAMLAB for additional Notes.
NPSG Report critical results of tests and diagnostic procedures on a timely basis. EP3 – Evaluate the timeliness of reporting the critical results of tests and diagnostic procedures.

57. Initial Top 10
DC The laboratory has procedures for each laboratory test. EP1 – Written laboratory procedures for each test meet the following requirements:
They contain a complete description of the test.
They include detailed instructions for performing the test.
They adhere to manufacturers’ instructions (preanalytical, analytical, and postanalytical phases of testing).
They include the date of implementation.
They reflect the laboratory’s current practice.
They are readily available to staff performing the testing.
See CAMLAB for additional Notes.

58. Overall Top 10
WT Polices and procedures for waived tests are established, current, approved, and readily available. EP3 – If manufacturers’ manuals or package inserts are used as the policies or procedures for each waived test, they are enhanced to include specific operational policies (that is, detailed quality control protocols and any other institution specific procedures regarding the test or instrument).
QSA The laboratory participates in Centers for Medicare & Medicaid Services (CMS) approved proficiency testing programs for all regulated analytes. EP6 – The laboratory’s proficiency test performance is successful for each specialty, subspecialty, analyte, or test, as required by law and regulation. See CAMLAB for additional Notes.

59. Overall Top 10
QSA The laboratory evaluates instrument-based testing with electronic or internal systems prior to using them for routine quality control. EP7 – The laboratory performs external quality controls at the number of levels specified by the specialty and subspecialty requirements (for example, blood gases require three levels of quality control). The external quality control results are documented.
WT Staff and licensed independent practitioners performing waived tests are competent. EP5 – Competency for waived testing is assessed using at least two of the following methods per person per test:
Performance of a test on a blind specimen
Periodic observation of routine work by the supervisor or qualified designee
Monitoring of each user’s quality control performance
Use of a written test specific to the test assessed

60. Objectives Learn about The Joint Commission Laboratory standards
Explain the unique features of a Joint Commission Laboratory survey
Understand what to expect during your survey
Learn what happens after the survey has been completed
Review how to use the available tools to assist you with continuous compliance
Present suggestions on how to resolve the top 10 findings

61. Demonstration of the Extranet and The Joint Commission Webpage