PUB #681-NonDOH (July 2017) 1
POINT-OF-CARE TESTING GUIDELINES
Washington State Clinical Laboratory Advisory Council
Originally published: October 2000
Reviewed/Revised: March 2005/March 2009/Sept 2013/July 2017
INTRODUCTION
For many years, all or the majority of laboratory testing was performed in a central
laboratory. This was necessary due to the complexity of the testing. With advances in
technology, testing has emerged from the laboratory to the patient’s bedside, the
pharmacy, the physician’s office, the patient’s home and other non-laboratory sites. This
testing is called point-of-care testing (POCT) and is defined as testing at the point where
patient care is given, wherever that is located. With this move outside the laboratory
walls some problems occur that were not problems within the laboratory. Point-of-Care
testing often starts without knowing if the testing is appropriate for the setting. There
may be limited understanding of requirements for licensure, training, documentation, and
procedures. Soon there may be several types of instrumentation performing the same
testing in various areas of a facility. There may be no evaluation or comparison of the
values obtained from these different methodologies and they may not correlate well with
each other. Cost-savings that may be available through quantity purchasing may be lost.
It is important that a Point-of-Care Testing Program at any of the above sites is carefully
planned.
REGULATIONS
All sites performing laboratory testing are regulated under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) and must be licensed in order to perform any
testing. CLIA has granted deemed status to approved accreditation organizations and
exempt states, and allows these entities to accredit or license testing sites. All Point-of-
Care testing must be covered by a Washington State Medical Test Site (MTS) license.
Washington State recognizes those accreditation organizations listed in Table 2.
Many of the point-of-care testing procedures are identified by CLIA as waived while
others are moderately complex. A site performing only waived tests must have a
“Certificate of Waiver” license but will not be routinely inspected. They must however
adhere to manufacturer’s instructions for performing the test. “Good Laboratory Practice”
dictates appropriate quality testing practices as outlined in the CLIA moderate and high
complexity test requirements. These include training of testing personnel, competency
evaluation and performance of quality control. Accreditation organizations such as
Veteran’s Administration and the College of American Pathologists (CAP) have stricter
guidelines for waived and other point-of-care testing than the CLIA regulations. As of
2009, The Joint Commission (TJC) now has a chapter on POCT.
FOR EDUCATIONAL PURPOSES ONLY
This document is intended as a guide for facilities to use in setting up a Point-
Of-Care testing program.
PUB #681-NonDOH (July 2017) 2
POINT-CARE TESTING GUIDELINES
The following guideline is a step-by-step outline that can be used in the development of a
point-of-care program. Although the outline is directed to a hospital or large institution
point-of-care program, it may also be adjusted to smaller sites, such as a physician’s
office laboratory (POL). Recommendations will be included in the text covering
problems unique to physician’s office point-of-care testing.
OBTAIN AUTHORITY TO COORDINATE POINT-OF-CARE TESTING PROGRAM.
Hospital, institution or medical clinic point-of-care testing
Authority to form a defined point-of-care program in this type of setting is usually needed
since several departments and budgets are impacted. Regulatory agencies often mandate
coordinated programs that includes an oversight committee.
A Physician Office Lab (POL)
A physician may decide to perform laboratory testing in the office. As the physician is
ultimately responsible for his/her practice, the authority is implied.
SELECT MEMBERS OF POINT-OF-CARE COMMITTEE (POCC)
Nothing is more important than having the right people on this committee no matter the
size of the operation.
Hospital, institution or medical clinic point-of-care testing:
It is important to involve those who have the responsibility and authority to implement
the program. Members may include: a clinical pathologist as director or technical
director/consultant, a physician as a medical director, nursing managers, a laboratory
manager, educational coordinators, laboratory managers, quality assurance managers,
pharmacy managers, and others who are needed to train end users, implement the testing.
A specific Point-of-Care Supervisor/Coordinator is recommended for larger institutions
to monitor test results. Purchasing and information technology representatives should
serve as consultants to the committee.
POL
In a physician’s office not only the physician, but also the testing personnel should be
involved in selecting the method or equipment that they will be using. The physician
usually serves as the director; however, others who should be involved include the nurse,
physician’s assistant, and medical assistant. If there is a laboratory in the clinic, the
laboratory manager or a staff member should be involved.
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COMMITTEE DEVELOPS A POINT-OF-CARE-PROGRAM
Hospital, institution or medical clinic point-of-care testing:
A written Point-of-Care Program/Policy is important since point-of-care testing tends to
expand rapidly unless guidelines or policies are in place.
The “Program/Policy” should clearly define:
1. Who is responsible for each part of the program naming key people? For example:
Laboratory Point-of-Care Coordinator: keep database of testing personnel,
coordinate training of new personnel, choose testing methods, monitor quality
control and proficiency programs, provide ongoing coaching to testing personnel
in response to daily monitoring, consult on technical issues, and analyzer
meter/troubleshooting.
Nurse Manager: enforce policies, schedule new employee training, take
disciplinary action, if necessary, and schedule annual point-of-care competency
evaluation of staff.
Education dept. (if it exists): new employee training and annual certification of
testing personnel, support committee with agenda and minutes of meetings.
Preferably training is done by those reviewing daily results and quality
monitoring.
Laboratory staff: new employee training, aid in annual certification of testing
personnel, download and/or review quality control data, verify equipment function
and maintenance.
2. Where the testing will be performed and by whom it will be performed.
3. For what purpose each type of point-of-care testing will be used, i.e., screening,
diagnosis, treatment.
4. Who will chose the methodologies used, i.e., lab, POCC?
5. What method validation procedures will be performed prior to implementation and
who will perform the validation.
6. Reporting procedures.
7. Staff training, continued competency programs, and feedback/communication with
the end users.
8. Quality assurance monitoring protocols including quality control protocols.
9. Proficiency testing program.
10.
Obtain and maintain appropriate licensure and compliance with regulations.
11.
Protocol for requesting new/additional services.
12.
Operational budget.
POL:
In the physician’s office the program should define:
1. Responsibilities for each part of the program naming key people.
2. For what purpose it will be used, i.e., screening, diagnostic, treatment.
3. Who will chose the methodologies used.
4. Validation of the point-of-care methods by comparing the results with a reference or
hospital laboratory where testing is also performed on their patients. This is for test
result verification to assure they are comparable methods. (This practice should take
place prior to implementing the test and should be in a written policy so it is not
overlooked.)
PUB #681-NonDOH (July 2017) 4
5. Staff training procedure
6. Reporting of results procedures
7. Quality assurance monitoring protocols including quality control protocols
8. Proficiency testing program, if performing moderate or high complex testing.*
9. Obtain and maintain appropriate licensure and compliance with regulations.
COMMITTEE REVIEWS ALL SITES FOR POINT-OF-CARE TESTING
Hospital, institution or medical clinic point-of-care testing:
Point-of-care testing in patient care areas may be unknown to the Point-of-Care
Committee members. Various methods throughout the institution may not give
comparable values or the method may not be appropriate for how the results are used.
All patient care areas should be reviewed for POCT testing such as urine dipsticks, occult
blood, urine pregnancy test, glucose testing etc. Areas should include emergency units,
admission units, intensive care units, operating rooms, outpatient clinics, specialty clinics
and all wards, and interventional units. Helpful tools are reports from material supplies
and also monitoring orderable tests available. Any additions or deletions in POCT
methodology must be communicated to the WA Department of Health Laboratory
Quality Assurance (LQA) office to update the MTS license.
POL:
This is not usually a problem due to the size and communication between those involved.
EVALUATION OF PROPOSED TESTING
Wherever the location of point-of-care testing, the following should be evaluated:
Purpose: Why is point-of-care testing performed instead of routine laboratory testing
i.e.: turn-around time, reduction of length of stay, patient convenience, improved
patient care management.
Volume: Although the test may appear to be beneficial, a low volume may results in
concerns about the proficiency of the testing personnel and cause reagents and
controls to outdate before reasonable usage thus escalating costs.
Methodology:
What methodology is used for each analyte
Is the method appropriate for the purpose
a) Sensitivity
b) Specificity
c) Precision
d) Batch vs. discrete technology
e) Reagent and control stability
f) Reagent and control storage requirements
g) Quality control requirements
Cost of the method:
Cost of a point-of-care program must look at the whole process of patient care, rather
than the cost of an individual point of care test method vs. the cost in the laboratory
test method. An appropriate point-of-care test in an emergency room may prevent the
admission of a patient into the hospital. Items that should be assessed include:
Cost of training the testing personnel and maintenance of competency
Labor associated with processing and analyzing the specimen
PUB #681-NonDOH (July 2017) 5
Labor associated with maintaining the equipment
Annual reagent, control, maintenance and depreciation costs
Costs of state licensing according to volume and test complexity
Costs of proficiency programs for testing performed
• Reporting: How will results be recorded? Elements that should be included with each
result include:
Date/time of collection
Who performed the test
Testing site
Reference range
• Other elements to consider:
When/how will confirmation testing be performed?
Will internal controls be documented along with the patient results (currently a
Joint Commission requirement)?
How will lot numbers be tracked?
Who will create order code and/or billing code?
Who will perform external quality control; how often; who will review?
Who will work with purchasing?
a) Contracts and/or service agreements
b) Adding to purchasing system
c) Adding to stocking system
d) Ordering/stocking process once implemented
IMPLEMENTATION
All new point-of-care testing regardless of the site should follow the procedure
established by the Point-of-Care Committee. The Point-of-Care Committee meetings
should be kept to a minimum number and cover only topics that need to be addressed by
the whole committee. Otherwise members may feel their time is wasted and be less
inclined to support the program. Subcommittees should meet and address their specific
responsibilities, as needed. They should report to the Point-of-Care Committee on a
regular basis.
At a minimum, “waived tests’ must follow the manufacturers’ instructions. There are
additional regulatory requirements for sites that have their waived tests accredited by
TJC. TJC interprets the manufacturers “recommended” as a “must do”.
Implementation of a POCT program should include:
Method evaluation
Planning with unit/department managers and physician directors
New employee initial training, 6-month review, and annual staff certification
Color vision assessment for testing personnel as needed
(http://colorvisiontesting.com/ishihara.htm)
Staff competency evaluation
Result reporting protocol
Quality Assurance Program
Proficiency testing available from manufacturers and private proficiency programs.
These consist of unknown samples sent to the site for testing. The results are then
compared to all other participants. Evaluations are returned to the site. Corrective
PUB #681-NonDOH (July 2017) 6
actions must be taken when values do not fall within acceptable ranges. (Test
validations as described on page 4 may take the place of a proficiency program for
waived tests.)
Quality Improvement monitors should be performed continuously to analyze and
evaluate the program with actions taken when results do not meet expectations.
These could include: turn-around times of results from a reference lab, or
comparison of the point-of-care testing method results with those of the main or
reference lab or hospital.
Quality control performance, documentation and evaluation
Supply ordering
Feedback to the participants in the program
Follow-up at department meetings or nursing, management, and medical oversight
levels
For “moderate complex” POCT testing, in addition to the requirements listed above for
“waived tests”, instrument validation is required for each new instrument.
Initial implementation of this program could take over a year and then is an ongoing
process that evolves with experience, new technology and changing customer needs.
EVALUATION OF POINT-OF-CARE TESTING PROGRAM
A Point-of-Care Testing Program should be monitored and evaluated periodically in
order to assure that the program is meeting the needs of its customers, i.e., providers,
testing personnel and patients. The POCT Committee or provider may accomplish this by
using quality assurance monitors, patient surveys, and/or review of quality control and
proficiency testing results, utilization reports, and development of an Individualized
Quality Control Plan (IQCP).
Reference and Resources:
• To Test or Not to Test? Considerations for Waived Testing, CDC, July 2015.
• CDC Waived Testing Resources: https://wwwn.cdc.gov/clia/Resources/WaivedTests/
PUB #681-NonDOH (July 2017) 7
FORM A
Quality Assurance Monitor Report
Site: Date: ________________
Title of Report: ________________________________________________________
Type of Monitor: Accuracy Efficiency Timeliness
(Check all that apply) Appropriateness Safety Effectiveness
Aspect of Care: Hi Volume Hi Risk to patient Problem Prone
Project Leader: __________________________________________________________
Disciplines Involved:_________________________________________________________
Project Dates: :_____________________________________________________________
Description:
___________________________________________________________________________
___________________________________________________________________________
Reason for Performing Monitor: ____________________________________________
Acceptable Limits: _________________________________________________________
Data Source: ____________________________________________________________
Analysis of Data:
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
Conclusion of Analysis:
________________________________________________________________________
________________________________________________________________________
Action to Be Taken:
________________________________________________________________________
________________________________________________________________________
Assessment of Actions Taken (Improvement):
________________________________________________________________________
________________________________________________________________________
PUB #681-NonDOH (July 2017) 8
FORM B
EXAMPLE: PREGNANCY TEST LOG SHEET
LOCATION:
KIT NAME:
LOT NUMBER:
EXP. DATE:
EXTERNAL POSITIVE CONT. LOT#:
EXP. DATE:
EXTERNAL NEGATIVE CONT. LOT#:
EXP. DATE:
PERFORM EXTERNAL CONTROL
ONCE ON EACH KIT
DATE
POSITIVE
NEGATIVE
TECH
INIT.
KIT LOT#:
EXP. DATE:
KIT LOT#:
EXP. DATE:
KIT LOT#:
EXP. DATE:
DATE
PATIENT
NAME
Internal
Control
PATIENT
TEST RESULT
TECH
INIT.
DATE
PATIENT
NAME
Internal
Control
PATIENT
TEST RESULT
TECH
INIT.
"OK"
(POS, NEG)
"OK"
(POS, NEG)
1
14
2
15
3
16
4
17
5
18
6
19
7
20
8
21
9
22
10
23
11
24
12
25
13
REVIEWED BY:
DATE:
PUB #681-NonDOH (July 2017) 9
FORM C
QUALITY CONTROL SHEET
SITE/ UNIT: CONTROL LOW: LOT#
EXP. DATE:
TEST: CONTROL HIGH: LOT#
EXP. DATE:
MONTH/ YEAR: TEST STRIPS: LOT#
EXP. DATE:
UNACCEPTABLE
<ACCEPTABLE RANGE >
UNACCEPTABLE
CLEAN
ACTION
RANGE (LOW)
- 2SD
- 1SD
mean
+ 1SD
+ 2SD
RANGE (HIGH)
METER
TAKEN
NO
LOW
Control
Strip
#
CK
strip
tests
this
HIGH
Control
DATE
OK
OK
day
Initial
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
PUB #681-NonDOH (July 2017) 10
FORM D
TEMPERATURE CHART
Month/Year _____________
Dept._____________ 36-46°F
Refrigerator acceptable = 2-8°C
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Hi
46F
8C
45F
7C
43F
6C
41F
5C
39F
4C
37F
3C
36F
2C
Lo
64-86°F
Room Temp acceptable = 18-30°C
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Hi
86F
30C
82F
28C
79F
26C
75F
24C
72F
22C
68F
20C
64F
18C
Lo
*initial in the square corresponding with the date and temperature. For Hi or Lo put initial/ and one of the following:
A – closed door and waited ½ hour to recheck B – down for repair
C – adjusted temp control, waited ½ hour to recheck D – defrosted refrigerator
E – Biomed called O – other written on back of sheet
PUB #681-NonDOH (July 2017) 11
TABLE 1
Licensing/Accreditation Requirements
Waived Testing
Accreditation Requirements for Waived Testing
Accreditation Inspection Organizations/Agencies
TJC*
CAP*
MTS/CLIA*
COLA*
1. Evaluate Waived Testing during inspection process
YES
YES
NO
NO
2. Test Method/Performance Verification for Accuracy/ Precision/Reference Range
YES
YES
Adhere to Good Laboratory Practice and Follow Manufacturers’
Instructions
3. Daily Quality Control (QC)
Depends
YES
4. Specific Education Requirement for POCT
YES
YES
5. Personnel Training
YES
YES
6. Identify Testing and Supervisory Personnel for POCT
YES
YES
7. Initial and Annual Competency Assessment
YES
YES
8. Performance Appraisal Process
YES
YES
9. Continuous Quality Improvement/TQM Program
YES
YES
10. Written Standard Operating Procedures (SOP) for:
a. Specimen Collection & Preservation d. Instrument Calibration
b. QC e. Problem & Remedial Action
c. Equipment Performance Maintenance f. Test Performance
YES
YES
11. Annual Review of SOP by Director and/or Supervisor of Testing and Laboratory
YES
Site-No
Lab-YES
12. Patient Test Result Reporting
YES
YES
13. Audit Trail Linking Test Results Across to Analyst to QC and to Instrument
Problem
YES
YES
14. Correlation of Test Results Across Different Instruments and Different Sites
YES
(Semi-Annual)
YES
15. Proficiency Testing
NO
YES
16. M.D. or Ph.D. Scientist with Training is Responsible for Testing
NO
YES
17. Monitor Quality and Stability of Reagents
YES
YES
18. Linearity and Calibration Verification
NO
YES
* CAP: College of American Pathologists MTS: Washington State Medical Test Site Law COLA: Commission on Office Laboratory Accreditation
TJC: The Joint Commission CLIA-88; Waived Testing Chapter: January 2012:
Adhere to Good Laboratory Practice and Follow
Manufacturers’ Instructions
PUB #681-NonDOH (July 2017) 12
TABLE 2
APPROVED PROFICIENCY TESTING PROVIDERS
Name Telephone Number
Accutest (800) 665-2575
American Academy of Family Physicians (800) 274-7911
American Association of Bioanalysts (800) 234-5315
American Proficiency Institute (800) 333-0958
ACP (American College of Physician
Medical Lab Evaluation) (800) 338-2746
California Thoracic Society (714) 730-1944
College of American Pathologists (800) 323-4040
EXCEL (CAP) (800) 323-4040
WSLH (Wisconsin State Laboratory of Hygiene) (800) 462-5261
WASHINGTON STATE APPROVED ACCREDITATION BODIES
Washington State Department of Health Office of Laboratory Quality Assurance
Website: http://www.doh.wa.gov/lqa.htm
• American Association of Blood Banks
Website: http://www.aabb.org.
• American Osteopathic Association
Website: http://www.aoa-net.org
• American Society of Histocompatibility and Immunogenetics
Website: http://www.ashi-hla.org
The College of American Pathologists (CAP).
Website: http://www.cap.org
The Joint Commission
Website: http://www.jointcommission.org
COLA
Website: http://www.cola.org
