SILETZ COMMUNITY HEALTH CLINIC (2025)
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SILETZ COMMUNITY HEALTH CLINIC
POLICY
Laboratory
TABLE OF CONTENTS
Page
15A
General Laboratory
1
15B
General Laboratory Equipment and Supply
5
15C
Laboratory Quality Assurance
10
15D
Laboratory Quality Control
16
15E
Laboratory Safety
22
15F
Laboratory Specimens
30
15G
Retention of Records and Specimens
36
15H
Test Requisition and Order
38
15I
Reporting Test Results and Error Correction
40
15J
Unlabeled or Improperly Labeled Specimens
43
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
General Laboratory
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
Part 15A
General Laboratory
I.
POLICY
It is the policy of the Siletz Community Health Clinic (SCHC) that all laboratory staff adheres to
the General Laboratory policy and procedures.
II.
EMERGENCY REDUCTION IN LABORATORY STAFFING
A.
If one technologist is available for coverage during clinic hours the delivery of services
may be affected. Contingency measures are in place to provide continuing patient care.
1.
Every effort will be made to cover requests for STAT PICCoLO’S, STAT Urinalysis,
and other STAT blood draws.
2.
In extreme cases STAT and ASAP requests may need to be referred to the local
reference laboratory.
3.
The laboratory may request the help of nursing services for phlebotomy and
handling of patients.
4.
The primary laboratory technologist will work with the Medical Director to ensure
laboratory operations continue with minimal interruptions to patients.
.
III.
LABORATORY DOWNTIME
A.
In the event of instrument or test system failure the following steps shall be taken:
B.
1.
Log problem in appropriate Problem/ Corrective Action Log.
2.
Notify providers of delay in testing.
3.
Determine the urgency of test reporting by consultation with provider, and handle
appropriately.
4.
If it is anticipated that the problem will be resolved in a timely manner (usually by
the next day), save the patient specimens for testing at that time.
5.
If longer resolution of the problem is anticipated, send specimens to the reference
laboratory with other send-out tests.
6.
If “STAT” turn-around time is necessary, send the patient to the local reference
laboratory at Samaritan Pacific Communities Hospital.
In the event of failure of the Lab Module in NextGen:
1
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
General Laboratory
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
C.
1.
Have the ordering personnel use the Downtime Laboratory Test Requisitions to
order all requested tests.
2.
Run testing as requested, give a copy of the results to the providers, and keep a
copy of the results, and enter manually into the computer when available.
In the event of an interruption in power:
1.
There are battery backup power sources for all the machines in the laboratory,
which allows the on board reagents to remain at their proper temperatures. Most
power outages in this area last for less than ten minutes. This provides ample time
to activate the secondary backup system handled through the maintenance
department.
2.
There is a generator backup system which can power the laboratory equipment
for approximately eight hours. Any measures required beyond this time frame
require a temporary suspension of service.
IV.
LABORATORY TEST MENU
A.
The laboratory provides testing which is routinely performed in house. These tests include
the following:
1.
Chemistries
Finger Stick Glucose
BMP (Na, K, Cl, ECO2, BUN, Creat, Glu, Ca, ALKP, AST, ALT, T. Bili. TP, ALB) Piccolo
Xpress chemistry analyzer.
2.
Urine Drug Screen
Amphetamine, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, MDMA,
Methamphetamine, Methadone, Opiates, Oxycodone, PCP, Tri-Cyclic AntiDepressants, THC,
3.
Hematology
Hemocue Hb 201 hemoglobin
4.
Coagulation
INR Point-of-Care
5.
Urine
UA without microscopic
2
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
General Laboratory
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
Urine HCG (Urine Pregnancy Test) Point-of-Care
6.
Rapid Strep Screens for Group A Strep Antigen Point-of-Care
7.
Lead level testing
8.
Influenza A & B Rapid Point-of-Care
9.
H.Pylori Rapid Point-of-Care
10.
COVID-19 Point-of-Care
11.
RSV Point-of-Care
12.
Mononucleosis Point-of-Care
13.
Tests Available as STAT’s
The following tests are available on a STAT basis. These should be ordered STAT,
ONLY when the provider cannot proceed with treatment of the patient without the
results. All STAT requests will be handled as emergencies and given priority over
any other test.
a.
CMP
b.
INR
c.
URINALYSIS
V.
TURN-AROUND TIME
A.
Most in-house test results are reported to the provider within 30 minutes, Turnaround
times will be lengthened if there is a staffing shortage or heavier than usual workload.
B.
All tests drawn to be sent out to LabCorp (SCHC reference laboratory) will be sent out the
same day collected whenever possible.
C.
Routine reference laboratory tests are normally returned in one to two days. These are
sent electronically to NextGen
D.
PAP tests take about one week.
E.
Cultures require one to three days.
F.
When necessary patients might be sent to another local laboratory to collect and process
tests the SCHC laboratory is unable to complete, or per provider preference if STAT
3
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
General Laboratory
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
laboratory results are required for treatment decision making. Those test results will be
obtained by provider’s team by logging into EPIC and pulling results to scan into NextGen.
G.
State laboratory results are returned in about 1-2 weeks.
VI.
LABORATORY DRESS CODE AND PPE
A.
All laboratory personnel are required to dress in appropriate workplace attire. The scope
of work in the laboratory requires lifting, squatting, dusting, and decontamination of
environmental surfaces and work areas frequently throughout the day. Strict business
attire is not conducive to the daily activity requirements. Clothing must be clean and free
of holes, tears, stains, etc.
B.
Appropriate attire includes items such as:
C.
1.
Scrubs
2.
Pants or dark jeans on Fridays only
3.
Tops which are not revealing
4.
Dresses which are at or below the knee
5.
Shoes which have closed toes
6.
Clean laboratory coats
Personnel Protective Equipment (PPE)
PPE such as laboratory coats or gown, gloves, masks, etc., must be worn whenever
handling blood and body fluids where the possibility of contamination exists following the
Standard Precautions Policy.
D.
Gloves
Gloves must be worn when drawing blood and changed after each patient. Gloves must
also be worn when handling and processing all laboratory samples. Laboratory personnel
will wash their hands between patients following the Hand Hygiene Policy
4
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
General Laboratory Equipment and Supply
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
Part 15B
General Laboratory Equipment and Supply
I.
PURPOSE
To outline the General Laboratory Equipment and Supply policy at the SCHC.
II.
FACILITIES
A.
The environment in the working area of the laboratory will be controlled by the commonly
used heating, air conditioning, and ventilating equipment used throughout the entire clinic,
which will maintain a working temperature of 65⁰ - 77⁰ F.
B.
The refrigerator will be in working order in the laboratory to maintain a temperature of
35⁰ - 45⁰F or 2⁰ - 8⁰C. Freezers will maintain a temperature of -0⁰ to -20⁰C or lower. Only
reagents supplies, biologicals, and specimens will be stored in the refrigerators or freezers.
No food or beverages will be stored in the laboratory refrigerator or freezer. A separate
refrigerator in the employee breakroom is provided to store food or beverages for personal
use. Temperature logs are kept in the Lab Temperature Binder.
C.
Humidity will be monitored and recorded daily. Normal range is 12-80. Kept in Lab
Temperature Binder.
D.
Proper lighting will be maintained. Any burnt out bulbs will be replaced as soon as
reasonably possible with new bulbs. Maintenance will be notified as soon as possible that
a replacement is needed.
E.
OSHA regulations and CDC guidelines will be followed in the laboratory. Refer to the
infection control policy regarding waste-management, personal protective equipment, and
other safety policies. Laboratory coats are to be worn only in the immediate clinic area.
III.
TEST METHODS AND EQUIPMENT
A.
The Lab Director will be responsible for making the final decision on the test systems,
equipment, and methodologies used in the laboratory.
B.
The Lab Director will ensure that proper test validation, if necessary, has been conducted
on all tests performed in the laboratory before reporting any patient results. The Lab
Director will decide the number of tests performed to validate the instrument or test
system. To do this, the laboratory supervisor will consult with the manufacturer or its
representative for guidance, seek the reference laboratory technical consultant, and
determine the clinical pertinence and clinical requirements for accuracy to determine the
scope of test validation. The Lab Director will also determine the performance
specifications for all tests performed in the laboratory after consultation with the
instrument or test system manufacturers.
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SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
General Laboratory Equipment and Supply
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
C.
All equipment used in the laboratory will be maintained according to manufacturer’s
recommendations. Records will be kept on all maintenance functions performed in the
laboratory. These records will be reviewed by the laboratory supervisor or Lab Director on
a quarterly basis and will be signed and dated by the Lab Director at least once a year.
IV.
METHOD VERIFICATION
The laboratory will verify any new test methodology instituted, unless waived by the
manufacturer. It must perform validation studies, including reproducibility studies and split
sample testing. The results of these studies must be comparable to those stated by the
manufacturer before patient test results will be reported. The Lab Director will review the data
generated by these studies and make the final decision as to the adequacy and comparability of
the data. All these activities will be documented and records maintained for the life of that specific
methodology plus at least two years.
V.
TEMPERATURE LOGS
A.
Temperature logs will be maintained for ambient temperature, refrigerator, and freezer
temperatures.
B.
Temperatures will be taken each day an employee is in the laboratory and recorded in the
appropriate log. If a temperature is outside the desired range, the Lab Director is notified.
If the temperature must be adjusted at the beginning of the workday, it must be checked
at a later time of the day to assure proper temperature is maintained. Appropriate
corrective action will be taken and documented if the temperature continues to be out of
range. It is the responsibility of the Lab Director to determine the severity of the problem
and the effects of the testing process. Laboratory reagents may be moved to another
refrigerator or freezer within the clinic if the problem persists or until the problem can be
solved.
VI.
REAGENTS, MATERIALS, AND SUPPLIES
A.
The lead laboratory technologist will confirm that sufficient supplies are always on hand
in the laboratory, a system is in place to monitor current dating of supplies, and supplies
are stored properly. Flammable materials will be limited to only working quantities.
B.
All reagents, solutions, culture media, control materials, calibration materials, and other
supplies must be labeled with the following information:
1.
Identity
2.
Recommended Storage Requirements
3.
Preparation and Expiration Date
4.
Safety Data
6
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
General Laboratory Equipment and Supply
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
5.
Date Received
6.
Date Opened
7.
Other Pertinent Information
C.
Reagents, solutions, culture media, control materials, calibration materials, and other
dated supplies will not be used when they have exceeded their expiration date, have
deteriorated, or are of substandard quality. Once they have exceeded their expiration
date, they will be disposed of properly. Components of reagent kits with different lot
numbers will not be interchanged unless the manufacturer specifically allows this
procedure.
VII.
EQUIPMENT PREVENTATIVE MAINTENANCE
A.
It is the general responsibility of all laboratory personnel to ensure that preventative
maintenance schedules are followed. The schedule must be contemporaneously
completed and appropriately dated and initialed. The manufacturer’s schedule must be
adhered to.
B.
It is the specific duty of the lead technologist to:
C.
1.
Perform all scheduled preventative maintenance
2.
Identify any problem areas and report them to the or Medical Director
3.
Ensure that any problems are adequately resolved
4.
Document the solutions to the problem
5.
Document that preventative maintenance has been performed. The data is placed
in the maintenance log binder.
It is the specific responsibility of the Laboratory Supervisor or Lab Director to:
1.
Ensure that periodic equipment maintenance and function checks are performed
as required by the manufacturer or determined by the technical consultant.
2.
Ensure that all preventative maintenance schedules are followed and
documented.
3.
Make sure that all instruments have maintenance records containing at least the
minimum amount of maintenance required by the manufacturer’s
recommendations.
4.
Solve problems as they arise.
7
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
General Laboratory Equipment and Supply
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
D.
5.
Document how problems are resolved.
6.
Provide documentation showing that these checks have been performed.
These records will be maintained for the life of the instrument plus two years.
The specific requirements will be delineated in the instrument maintenance
section of the policy manual. Placed in maintenance log binder.
7.
Any deviations and corrective actions shall be documented and reviewed by the
Lab Director.
Facilities management, on their own or with an outside contract, shall be responsible for
maintenance such as:
1.
Electrical checks for proper grounding
2.
Eyewash station checks
E.
Miscellaneous equipment not covered by the manufacturer’s warranty or service
agreement will be checked on an annual basis by a certified Bio-Medical Inspector.
Documentation of these inspections is located in the Quality Improvement Coordinator’s
office.
F.
Thermometers are continuous logging and cloud based. Staff monitors all temperature
data loggers and has access to the cloud storage website. Data loggers are re-calibrated
every two years.
VIII. PREVENTATIVE MAINTENANCE LOGS
A.
The Preventative Maintenance Logs (PM Logs) of all equipment in the laboratory are
intended to contain all the information and forms to verify the proper functioning and
maintenance of all instrumentation.
B.
Any preventative maintenance, including manufacturer recommended procedures for daily
start-ups and shut-downs, must be logged in the maintenance log binder. Corrective
actions and periodic troubleshooting will also be documented.
C.
Records of scheduled maintenance programs provided by the distributor/manufacturer as
well as service records (to include problems, corrective actions, parts, service contracts,
repairs made by company representatives, and bills) must be kept on file. In-house repairs
made by facilities management may also be kept with the PM Logs.
IX.
INVENTORY MANAGEMENT
A.
A routine schedule for checking supplies (reagents, solutions, culture media, controls,
calibrators, and other laboratory supplies) on hand are assigned to all personnel. A
contingency plan identifying the back-up supply source is in place to ensure availability of
8
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
General Laboratory Equipment and Supply
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
appropriate materials in case of an emergency. Tubes and containers purchased from
LabCorp. In an emergency order from Henry Schein.
B.
The supervisor should be notified anytime a shortage is anticipated. All laboratory
personnel are responsible for this notification in their assigned work areas.
9
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Quality Assurance
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
Part 15C
Laboratory Quality Assurance
I.
PURPOSE
A.
The purpose of the Siletz Community Health Clinic Laboratory Quality Assurance (QA)
Program is to improve reliability, efficiency, and quality of laboratory services. The
laboratory program is designed to monitor and evaluate the ongoing and overall quality
of the total testing process (pre-analytic, analytic, and post-analytic) activities. The QA
program assures the accurate, reliable, and prompt reporting of test results; provides
methods to evaluate the effectiveness of its policies and procedures; provides methods to
identify and correct problems; and provides methods to assure the adequacy and
competency of the staff. A laboratory quality assurance program is an accreditation
requirement. The laboratory must meet the standards as they apply to the services
offered, complexity of tests performed, and test results reported. The laboratory must
also initiate corrective action when problems occur and document all quality assurance
activities.
B.
The continuous quality improvement (CQI) activities are used in conjunction with the QA
Program, and CQI documentation is used to support QA elements.
C.
The QA Program covers the following:
II.
1.
Selection of test methods approved by the Medical Staff
2.
Quality Control (QC) Program to monitor precision of laboratory performance
3.
Proof of participation in a proficiency testing program
4.
An instrument maintenance program-data kept in maintenance binder
5.
Continuing education for laboratory staff
6.
Documentation of laboratory functions
7.
Self-assessment of quality laboratory performance-completed with annual
proficiency test.
POLICY
It is the policy of the Siletz Community Health Clinic (SCHC) that all personnel implicitly adhere
to the policies and procedures regarding the laboratory.
10
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Quality Assurance
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
III.
GOALS
A.
The goals of the QA Program are to:
1.
Assess the effectiveness of the laboratory’s policies and procedures.
2.
Identify and correct problems.
3.
Assure the accurate, reliable, and prompt reporting of test results.
4.
Assure the adequacy and competency of staff.
B.
The laboratory must revise policies and procedures based on the reviews.
C.
Quality assurance reviews are conducted:
1.
Routine, scheduled, quarterly reviews of major elements of laboratory functions.
2.
Immediate, focused reviews in response to identified problems, complaints, errors
or incidents.
IV.
QUARTERLY REVIEW
A.
The routine scheduled review will examine 12 major elements of laboratory function that
have been determined by their relevance to the three components of the total testing
process:
1.
2.
Pre-Analytical
a.
Personal performance evaluation and continuing education
b.
Requisitioning of tests
c.
Specimen collection, handling, or specimen rejection
d.
Complaints and communications breakdowns
Analytical
a.
Instrument calibration and maintenance
b.
QC corrective action and follow up
c.
Proficiency testing
d.
Appropriate reference ranges
11
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Quality Assurance
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
3.
Post- Analytical
a.
Result reporting
b.
Critical values
c.
Report format
d.
Turn-around time
B.
The Laboratory Supervisor, Lead Technician and Lab Director perform the quarterly QA
review. When incidents, problems or opportunities for improvement are identified, a Plan
Do Study Act (PDSA) worksheet is completed to document action taken.
V.
PROCEDURE MANUAL
A.
Written procedure manuals containing procedures for all activities of the laboratory are
maintained and readily available at all times the laboratory is in operation. The procedure
manual contains procedures for patient preparation, specimen collection, specimen
storage and handling, test performance, test result reporting, quality control, calibration,
and proficiency testing.
B.
The Lab Director approves the procedure manual when first written, with notation of
approval by signature and date. The Lab Director will review the procedure manual
annually and sign the signature page at that time to indicate all procedures have been
reviewed. If the directorship of the laboratory changes, the new lab director will review
the procedure manual within 30 days of taking the position and note approval by signature
and date. If a procedure requires a change, a new procedure will be written, approved by
the Lab Director, Planning and QI Committee, and Executive Health Director, and inserted
in the manual. The old procedure will be retained in a file for outdated documents for a
period of at least two years. All laboratory personnel will review the procedure manual on
a regular basis. New personnel will read the entire manual within 30 days of hire. Notations
will be made in the personnel records and on the manual of the reading and review.
VI.
QUALITY CONTROL ASSESSMENT
A.
The Lab Director will review all proficiency testing completed quarterly. All out-of-control
situations not resolved by a simple repeat analysis will be reviewed by the Lab Director as
soon as practical after the event. The Lab Director will review the corrective action to
ensure that appropriate action was taken and proper procedures were followed.
B.
A corrective action will be documented in the corrective action logs whenever a problem
arises in calibration or when an out-of-control situation occurs that is not resolved by a
simple repeat analysis. All corrective actions will be initialed by the Lab Director and
brought to the next quality assurance meeting if deemed appropriate. All corrective actions
will be initialed by the Lab Director upon review. Specific specimen preservation and
12
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Quality Assurance
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
processing requirements are listed in the procedure for each test performed in-house. For
send-outs, this information is provided by the reference laboratory in their procedure
manual or on the reference laboratory website.
VII.
COMPARISON OF TEST RESULTS
The Laboratory Supervisor will ensure that instrument correlation studies are performed at least
twice a year on tests for which the laboratory has more than one instrument system or
methodology. Any test performed in the laboratory for which proficiency testing is not available
will be verified at least twice a year and the results will be reviewed by the Lab Director.
VIII. RELATIONSHIP OF PATIENT INFORMATION TO TEST RESULTS
The Laboratory Supervisor will ensure that all personnel in the laboratory monitor test requisitions
for appropriateness to the patient's age, sex, and diagnosis. The results should also be compared
to other readily available laboratory data on that patient. If any requisitions or results appear
inappropriate, proper consultation should be obtained.
IX.
RESULTS VERIFICATION
A.
Technologists are expected to be diligent in their work and to check result entries before
results are reported as final. The latter is very important in that manually entered results
may have clerical errors, especially at extremely busy times.
B.
The Laboratory staff will review abnormal and critical results in the Electronic Health
Record (EHR) system. Results will be checked twice a week to ensure all tests ordered
are resulted in patient’s EHR. Critical results, cultures, and biopsies will be brought to
provider’s attention as soon as possible. Person receiving the results is documented in the
lab result comments. Any errors or discrepancies in the EHR will be addressed and any
test result requiring a change will be documented and the provider notified.
X.
PERSONNEL ASSESSMENT
A.
The Lab Director or Supervisor will conduct ongoing evaluation of staff competence using
most or all of the following methods:
1.
Proficiency testing results;
2.
Results of quality control charts;
3.
Maintenance logs;
4.
Instrument function checks and calibration;
5.
Recording and reporting of test results;
13
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Quality Assurance
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
6.
Personal observation of routine patient test performance, including patient
preparation;
7.
Repeat testing of patient samples, proficiency test samples and/or controls;
8.
Observation of trouble-shooting skills on instruments, test methods, and data
processing;
9.
Concerns from the medical staff on performance.
B.
Evaluations will include competency as an element in the staff member’s Standards of
Performance.
XI.
COMMUNICATIONS
The Lab Director will monitor the requisitioning and results of testing performed in the laboratory
to ensure that any communication problems are corrected as soon as reasonably possible. A
corrective action form should be completed if a significant incident occurs.
XII.
QUALITY ASSURANCE REVIEW WITH STAFF
The Lab Director will discuss with the staff, on at least a quarterly basis, the results of quality
assurance reviews and ways the laboratory can improve the quality of its work. This review can
take place on an informal basis.
XIII. CONTINUING EDUCATION
A.
Staff is encouraged to take advantage of continuing education opportunities.
B.
In-house continuing education is occasionally offered by the clinic. This training is provided
by staff, outside consultants, and others. Laboratory staff is required to participate in the
training.
XIV.
COMPLAINT INVESTIGATION
A.
If there are complaints or unusual occurrences concerning the laboratory:
B.
1.
Incident forms are given to the Quality Improvement Coordinator.
2.
The person with a verbal complaint shall be directed to the Medical Director or
Laboratory Supervisor.
3.
The Medical Director will investigate the complaint and take corrective action.
The Laboratory Supervisor maintains a quality assurance log where information about
laboratory operations (problems, incidents, errors) is recorded. Details about problems
14
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Quality Assurance
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
encountered are recorded initially in that log, and it serves as a useful resource and
reminder when completing the quarterly review. Copies of complaints reported to Risk
Management shall also be logged here. Reports are tracked by the Quality Assurance/Risk
Management Officer.
C.
Quality assurance records are retained in the laboratory for two years in a manner that
makes them easily retrievable for review.
15
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Quality Control
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
Part 15D
Laboratory Quality Control
I.
POLICY
It is the policy of the Siletz Community Health Clinic (SCHC) that the laboratory maintains a
Quality Control (QC) program to ensure accuracy of results reported. All laboratory staff must be
familiar with and adhere to the Laboratory policy and the Quality Improvement policy.
II.
GENERAL STATEMENT
The quality control program involves following the manufacturer’s instructions for instrument or
test system operation and test performance; having and using a procedure manual; performing
calibration and calibration verification; performing control procedures; performing remedial
actions; and documentation of all these activities. Patient results will not be released until quality
control is satisfactory.
III.
FOLLOWING MANUFACTURER’S INSTRUCTIONS
Following the manufacturer’s instructions includes performing instrument maintenance, using
approved reagents and controls; following environmental requirements (proper space,
temperature, electrical, etc.); following storage requirements for reagents and other supplies;
following calibration procedures; and any other instructions the manufacturer has included in the
instruction manual or package insert.
IV.
CALIBRATION AND CALIBRATION VERIFICATION
A.
The recommendations of the manufacturer will be followed in the calibration of the
instruments in the laboratory. The calibrator material that is used is recommended by the
manufacturer.
B.
Instruments in the laboratory will be calibrated according to the following guidelines:
C.
1.
When a lot number of a reagent changes, if required by the manufacturer.
2.
As recommended by the manufacturer.
3.
When an “out of control” situation exists and cannot be resolved by other measures.
4.
When major preventative maintenance or replacement of critical parts that may
influence test performance is done.
The recommendations of the manufacturer will be followed in calibration of the
instruments in the laboratory. The calibrator material that is used is recommended by the
manufacturer. Calibration verification will be performed according to the
16
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Quality Control
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
recommendations of the manufacturer using calibration materials specified by the
manufacturer.
V.
CONTROL PROCEDURES
A.
The laboratory will follow manufacturer’s recommendations when running control
specimens. Only assayed control material meeting the manufacturer’s specifications will
be used. Control specimens will be treated the same as patient specimens. Control
specimens will be run in the time frame outlined in the manufacturer’s instructions or as
outlined in this policy.
B.
When an “Out of Control” situation occurs, the steps delineated in the procedure manual
will be followed. Results from control specimens will be recorded in the appropriate quality
control log. Control material will be reconstituted (if necessary) and stored according to
the manufacturer’s directions. No patient test results will be reported unless the test
system has produced adequate control results on the day the patient test has been
performed. All of the above actions will be documented.
VI.
REMEDIAL ACTIONS
Any remedial action taken by the laboratory will be documented on the corrective action form, in
QC logs or the instrument log, and reviewed by the and the Lab Director. These records will be
kept for the period of time required by the nature of the problem.
VII.
URINALYSIS QUALITY CONTROL
SIEMENS Multistix®10SG Urine Test strips are tested daily with Quantimetrix Dropper Controls 1
and 2, (normal and abnormal).
VIII. CHEMISTRY QUALITY CONTROL
A.
External chemistry controls will be performed using human liquid assayed or control serum
to monitor the precision of laboratory testing. Controls for the Abaxis Piccolo Xpress will
be ran using BRT chemistry control liquid once a month, with each new lot of reagent
discs, a new operator, if test results do not match patient symptoms, or a change in
laboratory conditions. When an “Out of Control” situation occurs, the steps delineated in
the procedure manual will be followed.
B.
For Blood Glucose Testing three levels of True Metrix PRO with every lot change, when
opening a new vial of test strips, if vial has been left open or exposed to extreme heat or
cold or humidity, or results seem unusually high or low based on patient’s condition. When
an “Out of Control” situation occurs, the steps delineated in the procedure manual will be
followed.
17
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Quality Control
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
IX.
COAGULATION (INR) QUALITY CONTROL
Two levels of CoaguChek XS Pro PT Control Strips are run once a month and with each box of
test kits, with each shipment, or with a lot change. When an “Out of Control” situation occurs,
the steps delineated in the procedure manual will be followed.
X.
URINE DRUG SCREEN CONTROL
Two levels of Alere iScreen Urine Drug Controls are run with every new lot number or new
shipment of testing devices and monthly to test the reliability of products in storage. When an
“Out of Control” situation occurs, the steps delineated in the procedure manual will be followed.
XI.
DCA SYSTEMS QUALITY CONTROL
Two levels of DCA Analyzer controls are run once a month, with each new lot number or new
shipment of test cartridges, with new user training, and if results do not match patient’s clinical
condition. When an “Out of Control” situation occurs, the steps delineated in the procedure
manual will be followed.
XII.
RAPID INFLUENZA A & B
Two levels of controls are included with each kit. Positive and negative controls should be run
with each new lot or shipment, each new operator, and monthly. When an “Out of Control”
situation occurs, the steps delineated in the procedure manual will be followed.
XIII. H. PYLORI
H. Pylori kit has internal and external controls. Positive and negative controls are located with
each kit. These should be run every 20 tests or once a month, whichever is sooner. They should
also be run with each new lot number or shipment.
XIV.
HEMOCUE Hb 201+
Hemocue Eurotrol contains three levels of control solution. Three levels of control must be run
monthly and with each new lot number of micro cuvettes or shipment. As there is not a
proficiency test for this machine, instrument correlation between the two machines will be done
at least twice a year.
XV.
TABLE OF QUALITY CONTROLS
TEST
Urinalysis
INSTRUMENT
Clinitek Status
Urine HCG
Rapid test kit
QC MATERIAL
Quantimetrix
Level 1 and 2
Quantimetrix
Level 1 and 2
QC FREQUENCY
2 levels each day and
with lot change
new shipment
or lot change and once
a month
18
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Quality Control
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
TEST
CMP
INSTRUMENT
Piccolo
QC MATERIAL
BRT Chemistry Control
liquid assayed
DCA control solution
2 levels
Coaguchek
XS
+
controls
HgbA1C
DCA Analyzer
INR
CoaguChek XS+
Fingerstick Glucose
True Metrix PRO
Rapid Group A Strep
Rapid test kit
Urine Drug Screen
Rapid test kit
Hemoglobin
Hemocue
Rapid Influenza A & B
Rapid test kit
Lead level
Lead Care II
H. Pylori
Waived
2 controls located with
kit
Covid-19
Abbott ID NOW
Included in kit
Covid-19
Binax
Included in kit
True Metrix PRO 3
levels
2 controls located with
kit
Alere iScreen
2 controls located with
kit
Included in kit
QC FREQUENCY
Each new lot number
and once a month
With new lot number
and once a month
2 levels with every new
shipment or lot change
and once a month
With each new vial of
strips opened
Monthly and with each
new lot or shipment
Two levels with each
new lot of tests and
once a month
Each new lot of cuvettes
and once a month
Each
new
lot
or
shipment and monthly
Each new box, once a
month, or question of
validity of results, and
new users.
Every 20 tests or once a
month
whatever is
sooner
Monthly and with new
lot number
Monthly and with new
lot number
XVI.
CONTROL INTERPRETATION
A.
When a control test result is within acceptable limits (2 SD from the mean) it is considered
to be “In-Control.” Once the control result is acceptable, patient specimens can be tested.
When the control result is outside the acceptable limits it is considered to be “Out of
Control.” When an Out of Control situation occurs, steps must be taken to determine why
the result was not acceptable. When a result is out of control the appropriate action is:
1.
Check the reagents for proper dating and/or deterioration. All the reagents used
in the testing process including the control specimens should be examined to make
sure they have not exceeded their expiration dates, to make sure there is no visual
evidence of deterioration, and even to make sure that they have been stored
properly.
2.
Check instrument to make sure it is working properly. Perform a visual check of
the instrument to make sure it has been maintained properly, make sure all lights
19
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Quality Control
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
are working properly, that all mechanical parts are working properly, and that
there are no error messages
3.
Use new controls. If the result is within acceptable limits and if both results are
“In-Control,” proceed with patient samples. Discard the first vial of control material
as it is no longer reliable.
4.
If all of the above actions still do not produce acceptable results, there is probably
a problem with the test system (instrument, reagents, or technologist) and further
investigation of the source of the problem is necessary. This may involve having
another technologist perform the test, rechecking the procedure manual for proper
technique or troubleshooting, checking the electrical supply, recalibrating the
instrument, or contacting the manufacturer. Document all problems in the
Problem/Corrective Action Log and notify the supervisor.
5.
No patient specimens can be processed until the problem has been resolved.
Whatever steps are taken to resolve the problem must be documented in the
appropriate log.
XVII. PROFICIENCY TESTING
A.
The laboratory is enrolled in the American Association of Bioanalysts (AAB) and obtains
challenges for all tests performed, when such challenges are available. The laboratory will
test proficiency specimens in the same manner as patient specimens.
B.
Communication with other laboratories to discuss proficiency results is prohibited prior to
cut-off date for submission of the test results. It is also prohibited to send Proficiency
Testing samples to another laboratory for analysis.
C.
Follow the instructions for sample preparation. Initial and retain the printouts from any
instrumentation. Fill out the report form and make a copy for the laboratory file. All
printouts should be stapled to the copy and filed in the Proficiency Testing notebook.
Record all results exactly as a patient would be entered. All personnel performing the
testing will sign and turn the report over to the Lab Director for signature and mailing.
D.
Proficiency tests will be reviewed with the technologists and Lab Director. Corrective action
for any unsatisfactory test result will be documented on the report from the AAB program
with corrective actions listed. The results of any unsatisfactory proficiency testing will be
discussed with the quality assurance committee should the error warrant further action
not taken by corrective actions initiated.
XVIII. CORRECTIVE ACTIONS
A.
Corrective action must be applied as necessary to maintain the laboratory’s operation for
testing patient specimens in a manner that assures accurate and reliable results and
reports. All corrective actions must be documented for the following conditions:
20
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Quality Control
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
1.
Test systems do not meet the laboratory’s established performance specifications
as explained in the method verification section.
2.
Results of control and calibration materials fail to meet the laboratory’s criteria.
3.
Patient results cannot be reported within the time frames established.
4.
Errors in reported patient results are detected.
B.
The corrective action logs are used to document problems and corrective action taken to
correct them.
XIX.
QUALITY CONTROL RECORDS
All records of quality control activities must be maintained and retained for at least two years.
21
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Safety
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
Part 15E
Laboratory Safety
I.
PURPOSE
To ensure the safety of all staff and the community and to be as transparent as possible about
conducting high-quality laboratory testing and patient care.
II.
FIRE SAFETY
A.
Work site and laboratory fires pose a potential hazard to laboratory staff and patients.
All laboratory staff shall follow the general laboratory fire safety guidelines listed below.
B.
Guidelines
1.
Smoking is prohibited in the laboratory (SCHC campus is smoke free).
2.
Flammable or combustible liquids and chemicals will be stored in approved
containers.
3.
Laboratory exits will be unobstructed by equipment, supplies, or trash in order to
provide adequate escape routes.
4.
Flammable solvents will be disposed of in metal containers.
5.
Trash will be segregated from heating instruments and open flames.
6.
Flammable liquids will not be used in the presence of ignition sources.
III.
ELECTRICAL SAFETY
A.
Unsafe electrical use and maintenance may result in serious injury or other dangers for
patients and staff. A preventive approach to electrical concerns maximizes safety. All
laboratory staff shall follow the general laboratory electrical safety guidelines listed
below.
B.
Guidelines
1.
Assure proper wiring, permanent or temporary, is installed for all equipment. If
doubt exists, consult with maintenance.
2.
Assure that all 3-wire equipment is properly grounded. Plug adapters (three-prong
to two-prong adapters) known as "cheaters" will be avoided.
3.
New electrical equipment and installations must be installed and maintained by
maintenance before put into use.
22
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Safety
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
IV.
4.
Flexible extension cords will be used only as temporary extensions for portable
equipment and will be approved by maintenance prior to use.
5.
Extension cords will be examined periodically. Extension cords will not be
arranged so as to impose an impediment or hazard to personnel movement.
6.
Two-wire extension cords will be avoided.
7.
Do not use extension cords in wet locations.
8.
Extension cords must not be plugged into multiple adapters or other extension
cords.
9.
Grounding and voltage checks of all electrical outlets, along with an electrical
safety inspection, are done by maintenance.
10.
Electrical instruments will be unplugged before attempting to repair them.
11.
Avoid handling an electrical device that is connected to a power line while hands
are wet.
12.
Unplug electrical equipment that causes a vibratory or tingling sensation when
touched. Notify maintenance to evaluate the origin of this potential malfunction.
13.
Blown fuses will be replaced with the same type and size fuse. Investigate the
possibility of a short circuit or overload if the instrument fuses blow frequently.
Never insert fuses in a live circuit.
14.
Surge protection features will be used on computerized equipment and will be
approved by the IS department.
15.
Cube taps (plug in multiple adapters not affixed to an outlet) and multiple outlet
adapters attached to a receptacle, but not fused internally, will be avoided.
ELECTRICAL SHOCK
The appropriate and rapid response to an electrical shock accident may save the life of another
individual. Frequently, the victim may be unable to free himself from contact with the "live"
electrical source. The victim should be promptly removed from the electrical source, but only if
precautions are taken to ensure the responding staff member is not shocked also. Do not touch
the victim until the current/circuit has been shut off. If the current cannot be turned off, a wooden
stick or other insulated device may be carefully used to push the victim from the electrical contact.
Take caution to refrain from contacting the wires. Once safely removed from the electrical source,
assess the victim, call for help, and initiate basic CPR if necessary.
23
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Safety
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
V.
CHEMICAL HAZARDS AND SAFETY
A.
Laboratories may contain many caustic, toxic, flammable, and unstable reagents. A basic
knowledge of the potential hazardous chemicals used in the laboratory is a first step to
maintaining a safe work site. Proper disposal of these used chemicals is also important to
protect staff, other individuals, and the environment. All laboratory staff shall follow the
general laboratory chemical hazards and safety guidelines listed below and will refer to
OSHA or the CDC for the most current guidelines.
B.
Guidelines
1.
Staff has a right to receive information about the hazardous chemicals to which
they may be exposed. The employer has the obligation to inform employees about
potentially hazardous chemicals ("Right to Know" legislation).
2.
Federal regulations require all chemical containers to be labeled with a health
hazard rating, a flammability rating, a reactivity rating, and a category or
instructional message. A diamond-shaped placard or danger sign, informing of the
type of hazard, may be used to alert individuals of potential hazards.
3.
Chemical labels must include the name, statement of health hazards, precautions,
effective overexposure, and pertinent first aid procedures. Laboratory staff will be
instructed how to properly identify and interpret chemical labels.
4.
Federal and state laws require all hazardous chemical manufacturers to provide
the purchaser with a safety data sheet (SDS). The SDS provides information about
the product, hazardous ingredients, physical data, fire and explosion data,
potential health hazards, reactivity, spill/leak and disposal procedures, protective
information, and handling and storage precautions.
5.
All laboratory staff will be instructed about the availability and proper use of SDS
forms.
6.
All SDS forms must be kept on file in the laboratory and is freely available to all
staff. Information is obtained by phoning the company or visiting their website and
supplying the product name, manufacturer, and product number.
7.
Suitable personal protective equipment (gloves, eye and face shields, laboratory
clothing, etc.) must be worn by staff when handling potentially hazardous
chemicals.
8.
An eye wash station is available to staff.
9.
Bottles of acid, caustic materials, or other reagents will be held firmly around the
body of the container with both hands.
24
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Safety
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
10.
Mouth pipetting must never be performed in the laboratory.
11.
All broken skin (cuts, abrasions, etc.) must be suitably covered for protection with
gloves, gowns, eyewear, or laboratory coats.
12.
Eating and drinking are not permissible in the laboratory except in designated
clean, non-patient care areas.
13.
Smoking is not allowed in the laboratory.
14.
Always add acids slowly to water while mixing when diluting acids. Water will never
be added to concentrated acids because thermal generation may result.
15.
When pouring water-soluble reagents into a drain, flush with large amounts of
water.
16.
Never pour several reagents into the sink simultaneously.
17.
Never pour ether or other petroleum solvents into the sink. Flammable substances
must be disposed of in a safety container labeled as "organic solvent disposal
container."
18.
Carefully flush solutions containing sodium azide with large quantities of water.
19.
Highly toxic, reactive chemicals will be neutralized prior to sink disposal.
20.
Accidents happen and precaution will be exercised when cleaning up a chemical
spill. Appropriate personal protective equipment and cleaning materials must be
readily available. Neutralizing agents, such as sodium bicarbonate or sodium
bisulfate, vermiculite, sand, or other substances may be helpful. A spill kit is kept
in lab at all times.
21.
Follow these steps when cleaning up a chemical spill.
a.
Notify co-workers and Lab Director immediately.
b.
Use appropriate personal protective equipment (gloves and protective
clothing).
c.
Eliminate all sources of ignition if the substance is flammable.
d.
Maintain proper ventilation in the area.
e.
Cover the spilled chemical with an appropriate neutralizing agent. Chemical
spill kits are located in a labeled cupboard or available from maintenance.
Absorb all liquid with appropriate agents found in spill kits.
f.
25
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Safety
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
g.
Dispose of neutralized waste by bags provided in the spill kits.
h.
The area of the chemical spill will be washed with soapy water and dried.
VI.
EYE SAFETY
A.
Eyes may be the most important sensory organ. Care should be taken to protect the eyes
while working in the laboratory. Use appropriate Personal Protective Equipment (PPE)
following the Standard Precautions Policy
B.
Standard Precautions
1.
Eye protection or face shields must be worn when working with chemicals,
potentially aerosolized fluids containing infectious organisms, or when there is risk
of being struck by a flying object, spray, or splash of other materials. Goggles or
face shields should be made available to each employee.
2.
All staff will have knowledge of the location and operation of eye wash stations.
3.
Eye wash stations must be available for use in the emergency flushing of the eyes
if a chemical, caustic, corrosive, or other hazardous solution is accidentally
splashed into the eyes. There is an eye wash station in the laboratory.
4.
If a substance enters your eye, proceed to the eye wash station and obtain
assistance. The upper and lower eyelids will be held open and the eyes will be
flushed with water for a period of not less than 15 minutes. Topical ocular
anesthetics may comfortably facilitate this procedure.
5.
Eye wash stations will be activated once a month to clean debris or accumulated
rust from the pipe.
VII.
CENTRIFUGE SAFETY
A.
Interference with an activated centrifuge by an impatient staff member can result in bodily
injury in the form of direct trauma or aerosolization of hazardous droplets. All laboratory
staff shall follow the general laboratory centrifuge safety guidelines listed below and shall
refer to the instrument manual for additional information.
B.
Guidelines
1.
Centrifuges must never be operated without a cover in place.
2.
Uncovered specimen tubes must not be centrifuged.
3.
Centrifuges must never be slowed down or stopped by grasping the device with
your hand or by applying another object against the rotating equipment.
26
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Safety
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
4.
Be sure the centrifuge is appropriately balanced before activating. If an abnormal
noise, vibration, or sound is noted while the centrifuge is in operation, immediately
stop the unit (turn off the switch) and check for a possible load imbalance.
5.
Clean the centrifuge periodically with an EPA approved disinfectant. Broken tubes
or liquid spills must be cleaned immediately.
6.
Do not disconnect the centrifuge cover safety interlock for any reason.
7.
Jewelry, hair, clothing, and hands must be kept away from the centrifuge when
activated.
VIII. WASTE MANAGEMENT
A.
The responsibility for proper waste management belongs to the laboratory producing the
waste. Recent OSHA guidelines direct the proper techniques of waste management. The
Environmental Protection Agency (EPA) also has regulations concerning waste
management.
B.
Consult safety data sheets (SDS), reagent manufacturers, local health departments, or
safety officer for additional information about waste disposal.
C.
The laboratory will adhere to specific waste disposal procedures to minimize the risk to
employees in the laboratory and those individuals disposing of the waste materials.
D.
Waste will be segregated by specific type and will be suitably labeled. The labels will
indicate the specific potential hazards and contact person to notify in case of a hazardous
spill.
E.
Waste segregation categories include paper and domestic waste, hazardous non-chemical
solid waste (sharp items like glass, needles), bio-hazardous waste (infectious or potentially
infectious specimens, blood contaminated products, or microbiology cultures), and
chemical waste (by-products of diagnostic reactions and equipment drainage).
F.
Paper or domestic waste may be handled by local trash disposal procedures and buried in
a landfill or incinerated.
G.
Hazardous non-chemical solid waste (broken glassware, slides, needles, or any sharp
item) must be collected separately from domestic (paper) waste and packaged in rigid
sharps containers to prevent accidental injury. Waste of this type is collected by the
maintenance department. This waste is boxed and stored for contractor to pick up and
incinerate.
H.
Regulated or bio-hazardous waste contains blood or pathogens with sufficient virulence
and quantity that exposure could result in acquiring an infectious disease for a susceptible
individual.
27
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Safety
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
1.
Warning "Biohazard" labels must be affixed to containers of blood or other
potentially infectious material. The label must be fluorescent orange or orangered, with lettering or symbols in a contrasting color. Labels will be secured to the
container in a manner to prevent unintentional removal. Red bags or red
containers may be substituted for labels. Note: Waste that has been previously
decontaminated need not be labeled or color-coded.
2.
Any contaminated sharps will be placed in a rigid sharps container and incinerated
or buried in a landfill. The container will be a closable, puncture-resistant, labeled
or color-coded red, and leak-proof on the sides and bottom.
3.
The sharps container must be easily accessible and positioned near the location
where sharps are used.
4.
The container must be maintained upright and replaced routinely when full.
5.
Prior to moving the sharps container for disposal, close the container to prevent
spillage or protrusion of contents during handling and transport. If leakage is
probable, the sharps container will be placed into a larger second container. If
contamination occurs on the outside of the initial sharps container, it will be placed
into a second container. The second container should be designed and suitably
labeled as the initial container.
6.
Materials normally excreted by patients may be disposed of into the sewer system.
I.
Chemical waste or hazardous waste must be disposed of in compliance with EPA
regulations. Hazardous chemicals are not normally used in the laboratory; however, many
low hazardous chemicals are in use. Many liquids, such as acid solutions, peroxide, or
reagent solutions may be disposed of in a landfill or by the sanitary sewer provided they
are flushed with large amounts of water.
J.
All laboratory personnel must:
IX.
1.
Identify and classify waste.
2.
Determine the appropriate collection and packaging methods.
3.
Follow and abide by local, state, and federal waste management regulations.
4.
Ensure safe handling and proper disposal of all laboratory waste; based on existing
regulations.
SAFETY INSPECTIONS
The laboratory will be surveyed or inspected regularly by the Infection Control Officer and
Safety/Infection Control Committee to ensure proper safety practices and procedures have been
28
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Safety
Date Approved
12/21/18
Date Revised
06/18/21; 02/20/2025
implemented and complied with fully. Noncompliant safety practices must be identified,
documented, and corrective action taken to attain complete laboratory safety compliance. The
Infection Control Officer is responsible for conducting inspections in the facility.
X.
INFECTION CONTROL
The laboratory will follow the Infection Control Policy and will participate in all infection control
trainings required by the SCHC.
29
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Specimens
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
Part 15F
Laboratory Specimens
I.
PURPOSE
To provide an overview of specimen collection, processing, accessioning, rejection, and reference
testing.
II.
SPECIMEN COLLECTION
Appropriate patient preparation and specimen collection are performed for each test ordered.
Specific requirements are a part of written test procedures. Only adequately trained individuals
may perform venipuncture procedures or capillary punctures.
III.
SPECIMEN LABELING
All patient specimens are labeled at the time of collection. Label blood tubes with the appropriate
computer generated label. Labels will show the patient name, DOS, and PRO number. Perform
dual patient verification prior to labeling specimen tubes.
IV.
REFERENCE LABORATORY PROCESSING
A.
All specimens referred to the reference laboratory must be ordered and accessioned in
the Electronic Health Record (EHR).
B.
A hard copy of the requisition is required to accompany each test request with complete
patient information including chart number, date of birth, patient’s sex, test requested,
specimen source, date and time of collection, and the provider requesting the test.
C.
Specimen collection requirements are checked on an as needed basis for variances in
handling, storage, and requirements for appropriate tubes, etc. as specified in the Lab
Corp Reference Laboratory Guide or the LabCorp Website.
1.
Specimens, which require freezing, are frozen completely and then placed into a
frozen storage transport container, which is provided by the reference laboratory.
2.
Specimens, which require refrigeration, are double bagged with an ice pack.
D.
All specimens are placed in the appropriate container located in the employee entrance
stairwell at the end of each workday. These specimens are then picked up between 5:30
pm-6:00 pm by the LabCorp courier service.
E.
LabCorp has an interface with the EHR. LabCorp automatically sends results across the
interface twice daily. LabCorp also sends the patient test results to the laboratory printer.
These results are verified and checked to ensure they are in the EHR.
30
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Specimens
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
F.
All laboratory results are screened for critical values and referred directly to the provider
who ordered the test for appropriate action as soon as possible. If the primary provider
is unavailable, the results will be given to the Lab Director and/or Medical Director.
G.
The laboratory staff will ensure all reportable results involving positive STD’s, HIV related
testing, or other reportable diseases are given to the ordering provider’s registered nurse
as soon as possible.
H.
A “Sendout Requisition Log” will be reviewed daily to keep track of the specimens that
have been sent to LabCorp. Tests that have been incomplete for more than three days
will be followed up on by a phone call to LabCorp.
I.
Cytology specimens, including tissue biopsies and PAP smears, are referred to LabCorp.
They must be accompanied with a hard copy of the test requisition with all of the patient
information listed above. In addition, these types of specimens should also include clinical
information appropriate to the site.
V.
REFERENCE LABORATORY INTERFACE
A.
The Laboratory / Reference Laboratory Interface is monitored daily for completeness of
data retrieval, as well as any problems with the interface. The interface is monitored by
Information Services staff. They will notify laboratory staff of any test results not coming
through and work with LabCorp to resolve the issue. Test results are verified in NextGen
by laboratory staff.
B.
Scanning of Esoteric Test Results into EHR
While most tests are already built into the laboratory interface, occasionally an esoteric
test will not cross the interface. In order to minimize the delay in receiving the results,
contact LabCorp to fax the result. Use the Medical Records fax # 541-444-9695. The faxed
results will be submitted to Medical Records and scanned into the patient’s EHR.
VI.
APPROVED REFERENCE LABORATORIES
A.
Below is a list of reference laboratories that have been approved by the Medical Staff to
perform tests:
1.
LabCorp, Seattle, Washington
2.
Oregon State Health Laboratory, Portland, Oregon
3.
Samaritan Pacific Communities Hospital, Newport Oregon
4.
Emerald National Laboratory, Corvallis Oregon
31
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Specimens
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
B.
The reference laboratories are accredited and licensed under CLIA ’88. Proof of
current accreditation is filed in the Quality Improvement Coordinator’s office.
C.
All tests performed by the approved reference laboratories shall have the name and
address of the reference laboratory on the test report which is transmitted electronically
into the patient’s EHR. Results which are faxed copies are scanned into the EHR by
medical records staff.
D.
Laboratory staff will enter reference laboratory results into EHR and verify that all the
tests, which were sent out, have been completed.
VII.
TRANSPORTATION OF SPECIMENS TO THE REFERENCE LABORATORY
A.
Specimens which are sent out will be ready and placed in the lock box located in the staff
entrance at the end of each workday (5:00 pm-5:15 pm). These specimens are then
picked up between 5:30 pm- 6:00 pm by the LabCorp courier service. If there are no
specimens for a particular day or if the clinic will be closed, laboratory staff will call
LabCorp at 1-800-598-3345. SCHC has two accounts with LabCorp to process and bill for
tribal and non-tribal patients.
B.
All specimens with corresponding paperwork will be placed in the appropriate biohazard
bags provided by LabCorp, which are properly labeled with biohazard information. If there
are any problems with leaks or spillage, notify LabCorp for further instructions.
C.
Specimens requiring room temperature storage will be placed in the “ROOM TEMP” labeled
insulated lockbox without any ice bags.
D.
Frozen specimens will be labeled as such and placed in a frozen specimen transport bottle
provided by LabCorp then placed in a biohazard bag and placed in the Styrofoam insulated
refrigerated/frozen labeled lockbox.
E.
Refrigerated specimens will be labeled as such, double bagged with an icepack and placed
in the insulated refrigerated/frozen labeled lockbox.
F.
For security, the storage containers are behind key card locked door only accessible with
authorized key card.
VIII. UNACCEPTABLE SPECIMENS
Specific specimen requirements are listed for each analyte tested in the test procedures. The
condition and disposition of unacceptable specimens is reported to the provider and recollection
is requested. If the reason for rejection is known, that information should be documented in the
comments section of the original order. If a specimen is reported unacceptable from LabCorp or
other reference laboratory, the test is cancelled in the computer with a comment indicating
recollection is necessary. If the test is performed and results are reported on less than optimal
32
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Specimens
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
specimens, the condition of the specimen is also recorded on the patient’s report form and in the
computer.
Fill out the improper labeling of specimen work sheet. See procedure.
IX.
STANDARD PRECAUTIONS FOR SPECIMEN COLLECTION
A.
All specimens must be handled as potentially infectious. Practice standard precautions
provided in the Infection Control Policy.
B.
Standard precautions apply to:
C.
D.
1.
Blood
2.
Semen and vaginal secretions
3.
Fluids (CSF, synovial, peritoneal, amniotic)
4.
Tissues
5.
Feces and vomitus, unless visibly bloody
6.
Nasal secretions, sputum, urine, saliva, and tears, unless visibly bloody
Use appropriate Personal Protective Equipment (PPE)
1.
Wear gloves for all blood specimen collection
2.
Wear gowns, masks, and eye wear when splatters, sprays, and aerosolization
are possible
Wash hands following the Hand Hygiene Policy using soap and water or an alcohol
based hand rub:
1.
Before having direct contact with patients.
2.
Between patients.
3.
When hands are visibly dirty or are visibly soiled with blood or other body fluids.
4.
Before eating and after using a restroom.
5.
After providing care to a patient with a diarrheal episode or with known or
suspected C. difficile infection.
33
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Specimens
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
6.
When moving from a contaminated body site to a clean body site during
patient care.
7.
After removing gloves.
8.
When leaving the work area.
E.
Safely dispose of contaminated waste and sharps.
F.
Keep work surfaces, counter tops, and drawing stations clean.
X.
1.
Wipe down all counters and surfaces with an approved EPA registered
disinfectant daily and when surfaces become soiled.
2.
Wipe down the drawing station and phlebotomy chair in between patients with
an EPA registered disinfectant.
3.
Wipe down any surface with an approved EPA registered disinfectant if it
becomes visibly soiled or contaminated.
SPECIMEN TYPES AND VOLUMES
For specimen types refer to the “Test Description Information” in the manufacturer’s instructions
or machine manual provided by the manufacturer. Citrated plasma is used for Coagulation. For
reference laboratory testing, refer to the LabCorp Reference Guide
XI.
VENIPUNCTURE
Blood is the most frequent body fluid used for analytical purposes. The relative ease of obtaining
venous blood makes this a primary source of specimen for clinical laboratory analyses.
Venipuncture is accomplished via a syringe or a vacutainer needle attached to vacuumpressurized plastic tubes. All venipunctures shall be performed following Standard Precautions
XII.
FASTING AND GLUCOSE TOLERANCE SPECIMENS
A.
Fasting specimen means no oral ingestion from midnight to the time the specimen is
drawn. Ingestion of water is allowed in most cases. For lipid studies, periods of fasting
for 12 hours are ideal. If the patient is fasting or not, make a note in the string questions
in order module.
B.
Glucose Tolerance Specimens
1.
Patient must be free of recent surgery, trauma, or illness for two weeks
2.
Normal carbohydrate intake three days prior to testing is recommended
34
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Laboratory Specimens
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
C.
3.
Patient should be fasting for no less than eight hours and no more than 16 hours
4.
Test should start between 7:30 am and 9:00 am
5.
During test, patient must not smoke, drink coffee, or exercise
Test specific requirements
Specific specimen requirements depend on the test ordered. Refer to each individual
test procedure for specific specimen requirements.
XIII. GENERAL GUIDELINES FOR NON-BLOOD SPECIMEN COLLECTION
All non-blood specimen collection done by the nursing staff (Paps, throat swabs, GC cultures,
etc.) shall be properly labeled with the patient’s information and transported to the laboratory for
processing in biohazard labeled containers.
XIV.
GENERAL GUIDELINES FOR HANDLING AND STORAGE
A.
Serum specimen: Allow blood to clot for 20-30 minutes in a non-additive tube or for 15
minutes if a serum separator tube is used.
B.
Plasma or serum: Centrifuge for five minutes at 4000g.
C.
Refrigerate specimen if testing cannot be done within two hours or more.
D.
Freeze serum for longer delays (more than 24 hours).
E.
Refer to test procedure and the reference laboratory book or website for specific
specimen handling requirements for send out tests.
35
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Retention of Records and Specimens
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 12/21/18; 06/18/21; 02/20/2025
Part 15G
Retention of Records and Specimens
I.
POLICY
It is the policy of the Siletz Community Health Clinic (SCHC) to ensure laboratory records and
specimens are maintained in accordance with accrediting and regulatory agency requirements,
using the schedule set forth in this policy.
II.
RECORD KEEPING
A.
Record keeping is critical to providing quality patient care. Records will be kept complete
and up to date. The staff member performing the work is responsible to document
corrective actions and maintain daily logs to complete necessary records.
B.
Results of laboratory testing will be retained permanently in the patient’s Electronic Health
Record. This includes outside reference laboratory results. A printed copy of the order
requisition will be kept in a file organized by day of week until laboratory staff has verified
results have been received.
C.
Quality Control (QC) will be reviewed on a weekly basis and evaluated.
1.
Quality control logs will be kept for three years.
D.
Proficiency test results are filed in binders by year. These will be retained for the current
year plus two years.
E.
Maintenance logs and records will be maintained with the instrument binders for the life
of the instrument plus two years.
F.
Instrument calibration verification records are maintained for two years.
III.
RECORD REVIEW
Laboratory records will be reviewed completely each quarter. The Lab Director shall review all
records on a regular basis with the lead laboratory technologist. All QC records will be initialed
along with comments. Both the Lab Director and lead laboratory technologist will review and
initial proficiency test results along with corrective action or comments.
IV.
DISPOSAL OF CONFIDENTIAL RECORDS
A.
All records which contain patient information or test results must be handled in a
confidential manner. These records must be discarded in a manner which leaves them
indecipherable.
36
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Retention of Records and Specimens
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 12/21/18; 06/18/21; 02/20/2025
B.
Papers and labels to be discarded, which contain patient information and/or laboratory
results, are placed in a special shred pile after removing any staples or paper clips. These
papers are removed at least weekly and taken directly to the shredder for shredding.
Examples of such records are patient lists, incomplete reports, messages with patient
information, extra copies, labels, etc.
V.
SPECIMEN RETENTION
A.
Blood and urine obtained for testing will be stored for one week past the day testing was
performed.
B.
No records should be destroyed without the approval of the Lab Director.
37
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Test Requisition and Order
Date Approved
04/02/12
Date Revised
12/21/18; 06/18/21; 02/20/2025
Part 15H
Test Requisition and Order
I.
AUTHORITY TO ORDER TESTS
A.
Tests can be ordered by physicians, dentists, optometrists, and other licensed providers.
Nurses, public health nurses, and pharmacists are allowed to order certain tests using
written standing order protocols. Providers will coordinate orders from outside providers
who are providing a service to clinic patients. Only labs which are approved by an inhouse provider will be performed. Contact the Lab Director if there are questions regarding
the authority to order tests.
B.
Patients and staff outside of those mentioned above are not allowed to order tests. Results
of tests are released to those staff members who are authorized to order tests.
II.
REQUISITIONS
A.
Requests for laboratory testing, either computer generated or hand written, must include
the following legible information:
1.
Patient’s Name
2.
Patient’s Chart Number
3.
Test Requested
4.
Ordering Provider
5.
Date of Birth
6.
Gender
7.
ICD 10 Code
B.
Most of the above information is normally provided when tests are ordered in the
laboratory module in the Electronic Health Record (EHR).
C.
The laboratory staff will ensure that the date and time is on the requisition when the
samples are received and accessioned into the computer.
D.
Special instructions are sometimes given to fax results or send copies to another physician.
The technologist who has performed or processed the specimen will assure that the results
are faxed or given to medical record staff for faxing.
E.
Specific requisitions are required for each reference laboratory for testing. More
information about reference laboratory testing is contained in the section on reference
38
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Test Requisition and Order
Date Approved
04/02/12
Date Revised
12/21/18; 06/18/21; 02/20/2025
laboratories in this policy. A complete manual from LabCorp is located in the laboratory
along with access to this information on their website at www.labcorp.com .
III.
PENDING ORDERS AND STANDING ORDERS
A.
Requests are sometimes ordered in advance for testing to be performed when it is
convenient to the patient or for a scheduled appointment. These orders are entered into
the laboratory computer via the EHR. On the day the tests are to be performed, the patient
must register at the main front desk, and present to the laboratory. The laboratory will
review the EHR for requested tests and perform testing as ordered.
B.
Occasionally, “Standing Orders” will exist for patient’s that require periodic laboratory
testing for monitoring of therapeutic procedures, (i.e. Coumadin therapy). Standing orders
are good for one year. After one year the order must be reviewed by the ordering provider
and if it is to continue an updated standing order must be received by the laboratory.
IV.
TEST ORDERING
A.
Tests are performed at the written or electronic request of an authorized person. Oral
requests are not permitted.
B.
Outside providers who call in test orders should be instructed to fax orders to the clinic
fax machine at 541-444-9695. When results come in laboratory technicians make a
comment that the results were faxed and to whom in the lab module.
C.
Test requisition forms will include the patient’s name, chart number, date of birth, and
sex; name and address or other unique identifier of person who ordered the test; date of
collection; ICD-10 code; time of collection; source of specimen, if pertinent; test name;
and any other relevant and necessary information for a specific test to assure accurate
and timely testing and reporting of results.
D.
For PAP smears, all the above will be included; in addition, the ordering requisition will
contain the date of the last menstrual period, indication of a previous abnormal report,
treatment or biopsy, if available, and specimen source.
39
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Reporting Test Results and Error Correction
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
Part 15I
Reporting Test Results and Error Correction
I.
POLICY
It is the policy of the Siletz Community Health Clinic (SCHC) to ensure that all laboratory tests are
performed and resulted in a timely manner, any errors found are corrected as soon as possible,
and all tests that are sent to the reference laboratory are tracked.
II.
TEST RESULTS
A.
All tests (except those specifically excluded) sent to the reference laboratory will have an
acceptable turn around time of 72 hours.
B.
A copy of the requisition is kept in the daily tracking folder until results are received.
C.
When it has been verified that the test result is in the patient’s Electronic Health Record
(EHR) the requisition copy is to be discarded in the confidential recycling bin.
D.
If test results are not back in 72 hours the laboratory staff will call LabCorp to check the
status of results. Any information received from LabCorp about result status will be
documented on the order requisition along with the date of the follow up phone call and
staff initials. Follow up will continue until results are received.
E.
All laboratory test results are reviewed by laboratory staff. A physical copy is printed on
the Lexmark lab printer.
F.
Test results from the reference laboratory are automatically generated into the provider’s
acceptance queue.
G.
If the results fail to print, first troubleshoot the printer. Usually rebooting it will re-establish
the connection to Beacon. If this does not solve the issue and no other issues are found
with the printer, LabCorp will be notified and they will remote access the computer to reestablish the interface connection. Laboratory reports should print every day.
H.
If you fail to see results coming in, this problem must be corrected within 48 hours.
Document the issue in the incident log along with what was done to correct issue.
III.
CRITICAL LABORATORY RESULTS
A.
Critical laboratory results will be automatically populated to provider’s acceptance queue
and printed. The printed copy will be taken directly to the provider or the team’s registered
nurse (RN.) If the ordering provider’s team is not available the critical results will be given
to the Medical Director. Documentation on the lab results on who it was given to, date
and time.
40
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Reporting Test Results and Error Correction
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
B.
Critical values are flagged by the reference laboratory (LabCorp).
C.
After hours reporting of critical results is done via the after hours answering service. Lab
Corp and other outside laboratories are able to reach an on call provider 24/7 to deliver
critical results.
IV.
COMMUNICABLE DISEASE AND POSITIVE CULTURES
A.
A copy of all positive screening tests for STI’s, Strep cultures, and wound cultures are
given to the ordering provider’s RN.
B.
The ordering provider’s RN is responsible for reporting positive STI results to the Lincoln
County Health Department STI Coordinator.
C.
In-house COVID-19 results, negative or positive, must be reported to Oregon Health
Authority within 24 hours of test. Reporting is completed via web portal for tests
completed on patients not in the EMR or is sent electronically for results entered in EMR.
D.
The reference laboratory, LabCorp, is responsible for reporting all communicable diseases
to the Oregon State Health Department. Refer to Infection Control Policy “Reportable
Diseases and Infections”.
E.
Lead results are sent to the Oregon Health Authority each week via fax, or the same day
for elevated lead level. See Lead Procedure for more details.
V.
FAXING TEST RESULTS
A.
Occasionally, requests are made to fax laboratory test results to other providers or
facilities. It is the responsibility of the laboratory to ensure that policies for sharing
personal health information follow HIPPA guidelines and maintain patient confidentiality.
B.
Outside Provider Requests:
1.
If the laboratory receives a written request for laboratory testing from a provider
outside the clinic, and a request that subsequent test results be faxed to their
facility, test results will be faxed from the laboratory, as the outside provider is
regarded as the ordering provider.
2.
If a verbal request or phone call is received requesting faxed copies of laboratory
results, and the requestor is not the ordering provider, the call will be transferred
to Medical Records, who can ensure that all proper release of information
documents are in order.
3.
The laboratory staff may not fax laboratory results to anyone other than the
ordering provider, unless the request is in writing and complies with HIPPA
requirements.
41
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Reporting Test Results and Error Correction
Date Approved
08/29/01
Date Revised
11/05/05; 05/02/09; 05/05/12; 12/21/18; 06/18/21; 02/20/2025
VI.
ERROR CORRECTION
A.
When an error in a laboratory result is discovered, the provider shall be notified and the
result shall be corrected as soon as possible.
B.
If a scanned laboratory result is entered into the wrong chart, staff will notify the Health
Information Lead immediately. That staff person can refile the scanned document to the
correct chart.
C.
If an in-house performed lab is entered incorrectly the staff member will go back to the
original encounter and make the correction. If the encounter is locked, the NextGen
Specialist will unlock the encounter and assist with correction. Ordering provider will be
notified as soon as possible of correct results.
D.
If a laboratory order is placed in the incorrect chart that order will be cancelled and a note
made “entered in error”. An order will be made in the correct chart.
E.
Results from LabCorp to NextGen will be held in the Rosetta Holding Tank if there are any
discrepancies between the order information and the resulting information. Information
Services staff will notify laboratory personnel if this occurs.
42
SILETZ COMMUNITY HEALTH CLINIC
Program
Laboratory
Policy
Unlabeled or Improperly Labeled Specimens
Date Approved
02/20/2025
Date Revised
PART 15J
Unlabeled or Improperly Labeled Specimens
I.
POLICY
SCHC has established a uniform policy for specimen acceptance/rejection that has a positive
impact on safe patient care, protects specimen quality to protect patients from adverse
errors made due to improperly labeled specimens. The lab requires that proper labeling
criteria are always met to prevent erroneous results.
43
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.