Download handout 1 ( format)

Millersville University
Health Services
Laboratory Procedure Manual
The following 23 pages consist of some examples of laboratory policies. The first page is a list of
contents for most policies. The following policies generally have been examined by our state health
department on 7/11. The updates include recommendations made at that time and changes in the last
6 months as we moved to electronic health records. This change has not been reviewed by the state
examiner.
Chris Rooney RN BC [email protected]
6/08 Laboratory Procedure Manual
Millersville University
Health Services
Laboratory Procedure Manual
M.U. Health Services Laboratory
General Guidelines
Purpose:
The provision of laboratory services at Millersville University Health Services is integral to providing
quality clinical care for students. Laboratory testing is completed for diagnostic purposes and to provide
information for wellness initiatives upon MD/DO/NP order. General laboratory guidelines ensure
consistency of practice to ensure accurate results through collections of quality laboratory specimens.
Millersville University is licensed by the Pennsylvania Department of Laboratories as a moderately
complex laboratory and holds a Clinical Laboratory Certificate of compliance for CLIA 88. Policy and
procedure for laboratory activities are governed by state law and CLIA 88 requirements.
The use of “in-house” laboratory testing as well as testing at reference laboratories provides patients
with current, safe, accurate and affordable health care.
MU Laboratory Testing In-House
Directory of In-House Testing
Blood Glucose
Fecal Occult Blood
Koh/Wet Preps
Rapid Influenza A and B
Rapid Mononucleosis
Rapid Strep A
Urinalysis
Urine Microscopy
Urine Pregnancy
Each laboratory test has a procedure document that includes the following compliant with CLIA 88 and
the PA State Department of Laboratories.
a. Test name
b. Specimen collection requirements
c. Methodology with step by step directions and material required
d. Quality control procedure, criteria for and documentation, remedial action procedures for
unacceptable controls
e. Derivation of results and limitation of methodology
f. Normal/Expected ranges
g. Alert Values
h. Directions for preparation, storage of reagents, standards and controls
i. Safety precautions
j. Plan to follow if system inoperable with criteria for referral of specimens
k. Documentation requirements
l. Any special notes or references pertaining to test.
6/08 Laboratory Procedure Manual
Millersville University
Health Services
Laboratory Procedure Manual
The procedure manuals are physically present in the laboratory at all times as electronic documents,
with Laboratory Director signed copy on file. Each procedure manual is reviewed annually and signed
annually by the Laboratory Director. All staff will review and attest review on an annual basis. Updates,
changes and amendments are made as needed, then documented and signed by the Laboratory
Director. The Director will then convey the changes that were made to the laboratory staff by memo or
meeting.
Discontinued procedures are dated, signed and kept on file for two years from the date the procedure
was last performed.
All written test procedures will be supplemented with manufacturer’s package inserts, and/or
instrument operator’s manuals. Procedures do contain direct references to manufacturer’s literature.
Standing orders for all in-hours laboratory testing are reviewed and signed annually. See standing
orders.
MU Health Services Laboratory is enrolled in PaNEDDSS for the electronic processing of reportable
conditions.
A Quality Assurance Policy/Procedure manual fulfills the requirements for measuring and documenting
Quality Control. All test results include the patients name, date and time test performed and identity of
person performing test. All lab test results are maintained in the lab for two years. All quality control
documents are maintained electronically and retained for two years. Electronic documents are
password protected and backed up daily.
Proficiency Testing is done for the following analytes as indicated:
Blood Glucose (Waived)
Not required as of 6/18/12
Fecal Occult Blood (Waived)
Not required as of 6/18/12
KoH/Wet Preps (PPM)
Peer review 2 x year
Rapid Influenza A & B (Waived)
Not required as of 6/18/12
Rapid Mononucleosis (Waived)
Not required as of 6/18/12
Rapid Strep A (Waived)
Not required as of 6/18/12
Urinalysis (Waived)
Not required as of 6/18/12
Urine Microscopy (PPM)
AAB
Urine Pregnancy (Waived)
Not required as of 6/18/12
Proficiency documents are maintained for two years. Quality assessment is performed monthly,
reviewed by the Laboratory Director and documented.
6/08 Laboratory Procedure Manual
Millersville University
Health Services
Laboratory Procedure Manual
Reference Laboratories
MU Health Services utilizes three reference laboratories. Each laboratory provides a manual including a
directory of services, step-by-step instructions for specimen collection and transport/storage. Courier
services are provided by the reference laboratory. The reference laboratories are licensed in the State
of Pennsylvania and adhere to state regulations and are compliant with CLIA ‘88.
MU Health Service Laboratory uses an electronic tracking system for all labs sent out to a reference
laboratory. Tracking system includes date, patient identifiers, test performed, reference laboratory used
and status of reporting. This mechanism tracks which specimens are still pending from the reference
lab. Documentation is backed-up and maintained for two years.
See table below providing basic information regarding the three reference laboratories utilized by MU
Health Services.
Quest Diagnostics
Manual
Requisition
Printed/Electronic
Printed per manual
Specimen
Label
Courier
Printed/Numeric
Reporting
Paper copy by fax
Person Pick-up 2:00
p.m. M-F
Panic Phone for panic
Values value – after office
hour reporting per
phone to ordering
clinician
Dr. Susan Northwall
717-538-8811, Jenny
Monn 717 2011539, Anne
Pryzbylkowski 717390-0754
Supplies
Provided/Reorder
PRN
Paper Request/Faxed
6/08 Laboratory Procedure Manual
ACM Medical
Laboratory
Printed/Electronic
Printed per
manual/Electronic
Handwritten
Center for
Disease Detection
Printed/Electronic
Electronic
PERLL
Laboratory
Printed/Electronic
Printed
Printed/Numeric
Printed/Bar Code
Fed Ex by 4:00 p.m.
M-F
Schedule pickup
Paper copy by fax
UPS Weekly/Wed 2
pm
Schedule pick-up
by calling PERRL
717-691-1500
Paper copy/fax
Phone for panic
value – after office
hour reporting per
phone to ordering
clinician
Dr. Susan Northwall
717-538-8811,
Jenny Monn 717
201-1539, Anne
Pryzbylkowski 717390-0754
Provided/Reorder
PRN
Paper request/faxed
Secure email/
printed
No Alert/Panic
Values
Electronic
request/auto
inventory
Phone for panic
value – after
office hour
reporting per
phone to ordering
clinician
Dr. Susan
Northwall 717538-8811, Jenny
Monn 717 2011539, Anne
Pryzbylkowski
717-390-0754
Provided /reorder
PRN
Paper
Request/faxed
Millersville University
Health Services
Laboratory Procedure Manual
Standard Operating Procedures
1. Test Management
Procedure
In House Testing
Client ID
By Name, Date of Birth, MU ID/SSN
Client Instruction
Precedes all testing including
Procedure, cost, normal result
Specimen Labeling
Specimen held for MD/DO/NP procedure
Labeled with name and timed if not
processed immediately
Includes date, time, test, specimen source
if applicable, client ID, results, testing
personnel initials, test kit number and
indication that internal controls were
acceptable if applicable, legible. Results
documented per procedure manual.
Documentation
Results Notification
All results given to client at time of testing.
Positive results reviewed by MD/DO/NP
Reference Lab
Selection by Staff
6/08 Laboratory Procedure Manual
NA
Reference Laboratory
Name, Date of Birth, SSN
(requested), Sex
Precedes all testing including
procedure, cost, method of results,
notification/expected time frame
Labeling per Reference lab manual
– name date, specimen source and
numeric label as applicable
Requisition includes date, time,
test, specimen source if applicable,
client ID, ordering practitioner,
legible, ICD codes and insurance
information included. Person
performing test initials order and
documents collection of specimen
in electronic health record.
Electronic documentation in EHR of
testing for results status.
Reference laboratory provides
report. Reviewed by ordering
practitioner. Client informed of
results as ordered; usually by
phone with three attempts
followed by email notification to
call for results. Unable to contact
referred back to ordering
practitioner. PANIC values – results
to MD/DO/NP or referral to
ER/Urgent Care/PMD immediately.
Patient notified of results is
documented on the scanned
laboratory result in the electronic
health record includes date, time,
special instructions from ordering
provider and name off person
notifying patient.
No refrigerated specimens to ACM.
PT and ESR to Quest/PERLL. CRP
substitute for ESR for ACM.
No insurance/cost concerns –
review both ACM/Quest for
student pricing, inform student.
Millersville University
Health Services
Laboratory Procedure Manual
CDD – STI testing $15 charged to
student account – MUHS pays CDD
Cost/Insurance
Client informed of cost. Given option of
Cash, Check, Marauder Gold or charge to
University Account. No insurance billing
done for in-house testing. Copy of
electronic walk-out statement with ICD
coding and CPT codes given to client. No
Guarantee made to student regarding
insurance reimbursement.
Controls
Performed by all staff per PADOH
Laboratory and manufacturer’s
recommendations on CLIA waived test kits.
Documentation of control results
maintained electronically for two years.
Proficiency Testing
Per PADOH Laboratory requirements.
Performed by all testing personnel. Results
reviewed by Laboratory Director.
Corrective Action is score below 80% with
documented evaluation.
Stock supplies of test equipment and
control solutions maintained and
monitored to maintain minimums and
stored per manufacturer’s specifications.
No expired supplies used.
New hire laboratory training with return
demonstrations & 6 month review. Yearly
procedure manual review and laboratory
in-service including blood borne pathogen
training. Staff informed of any lab changes
by memo or meeting.
Supply Ordering
Staff Training
6/08 Laboratory Procedure Manual
Clients informed of reference lab
choice. Basic general cost
estimates available from reference
lab for client. It is the client’s
responsibility to select reference
lab if concerned about insurance
payment. Insurance information
provided by client. All billing from
reference laboratory for ACM,
PERLL and Quest. CDD will bill MU
Health Services. Documentation of
client choice in client chart as
needed.
Centrifuge RPM checked twice
yearly and records maintained.
Refrigerator temperature checked
daily and recorded – to stay
between 2-8° C. Refrigerator
connected to emergency power
source.
N/A
All staff responsible for monitoring
reference lab supplies. Supplies
provided by reference lab upon
request. No expired supplies used.
Yearly lab in-service to review
reference lab procedures. New
testing/equipment/changes per
meeting or memo.
Millersville University
Health Services
2.
3.
4.
5.
6.
Laboratory Procedure Manual
All testing per MD/DO/NP order/standing order.
Standing Laboratory Orders Millersville University Health Services
Rapid Strep
Urinalysis by dipstick or Clinitek Status
Urine Pregnancy
Rapid Mononucleosis
Rapid Influenza A & B
Blood Glucose by glucometer
Fecal Occult Blood
GC/Chlamydia by reference laboratory (urine)
All positive results are referred to MD/DO/NP; PMD, Reproductive Health or Urgent Care/ER as
applicable based on client condition.
All staff competent to perform all waived testing – yearly testing of competency. All
microscopy is provider performed.
Maintenance of Universal Precautions and basic lab safety maintained in lab.
MU Environmental Health and Safety Department maintains written plans for the health and
safety of all laboratory personnel. MSDS available.
Compliment/complaint forms are available and reviewed for corrective action by the Laboratory
Director. Documents are maintained 2 years and reviewed monthly.
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
6/08 Laboratory Procedure Manual
____________
Date
____________
Date
____________
Date
____________
Date
____________
Date
____________
Millersville University
Health Services
Laboratory Procedure Manual
Laboratory Director
Date
QUALITY ASSURANCE
Policies and Standards
It is the policy of the Millersville University Health Services Laboratory to follow the recommended
guidelines of the manufacturer of the test performed and those standards that are dictated by the
Commonwealth of PA and CLIA.
Each test performed in the MU Laboratory has a procedure document which addresses patient
preparation, sample collection, sample handling and storage, instructions for test performance, quality
control testing and calibration and maintenance of equipment.
Laboratory Training and Safety
Basic safety procedures are posted in the laboratory. Universal precautions are maintained. A MSDS file
along with a copy of the Right-To-Know law is maintained at MUHS. Each nurse is instructed in all
laboratory procedures upon hire, followed by demonstration of competency. Records of training are
maintained in the personnel manual. Yearly competency documentation is performed. See MU
Personnel Policies for 6 month Review for new hires. Laboratory competency is documented in the 6
month MU evaluation.
All staff performing tests in the MU laboratory will review each laboratory and procedure manual yearly.
Staff in-services will be done at least yearly including review of quality control and quality assurance
documentation, any changes to procedure or policy, and any staff concerns or suggestions.
Documentation of all in-service/training is maintained in the personnel manual.
Procedure Manuals
Each test performed has a procedure document that describes the specific steps for performance of that
test. Procedures are reviewed once a year and signed by the Laboratory Director. Changes in
procedures must be approved by the Laboratory Director and staff informed of changes via in-service or
memo. Competency testing will be done if procedural changes are significant.
6/08 Laboratory Procedure Manual
Millersville University
Health Services
Laboratory Procedure Manual
Quality Control Testing
Quality control on each test offered is completed according to manufacturer’s specification and state
requirements. The control testing for the glucometer is performed every day of patient testing with a
high and low control. Urinalysis controls for the Clinitek Status is performed once a week and with
every new bottle of reagent strips with a positive and a negative control. Positive and Negative controls
are run on the HcG Urine Pregnancy test with each new kit and monthly as per manufacturer’s
specifications. Manufacturer provided external controls are run on Strep A, Mononucleosis and
Influenza with each new test kit lot number. Each kit is assigned a number that is recorded on
corresponding test results. The internal control is monitored with every patient testing and
documented as “IC-OK” if Internal Controls are acceptable for patient testing. All test results include
the initials of the testing personnel. All nursing staff are proficient in performing and documenting
quality controls.
Quality Control Remedial Actions
Quality controls normally fall within the limits of test specification. Those outside set into motion the
dictated steps for correction. The following quality control remedial actions are outlined.
Observed control values acceptable?
NO
YES Report patient results

Controls, reagents, calibrators and/or kits expired?
NO
YES  Retest with acceptable materials

Rerun unacceptable controls; Acceptable?
NO
YESReport Patient results

Run new control, same lot#; Acceptable?
NO
YESReport patient results

Run new control, different lot#; Acceptable?
NO
YESReport patient results

Calibrate and/or perform maintenance; Acceptable?
NO
YESRerun Controls, Acceptable?

NO
YESRerun patient specimens, report new results

Call Manufacturer for technical assistance. Store or send out all patient specimens. No patient
testing is done if controls remain outside of acceptable limits.
Document all actions taken.
All quality control testing is recorded for each test. As new lot numbers of control or reagents are
introduced, information will be documented. Instrument maintenance records with corrective actions
are also maintained.
6/08 Laboratory Procedure Manual
Millersville University
Health Services
Laboratory Procedure Manual
Calibrations and Maintenance of Instruments
All laboratory testing equipment is calibrated per manufacturer’s specifications. Equipment with
automatic internal calibration is defined. Internal controls of HcG – Urine Pregnancy, Strep A,
Mononucleosis, Influenza and Fecal Occult Blood are recorded acceptable with each patient test result
with “IC OK”. Instrument maintenance is per manufacturer’s specification and recorded.
Microscope – Weekly cleaning and yearly maintenance check is performed. See Equipment
maintenance manual for detailed explanation.
Centrifuge – provided by reference laboratory. Semiannual recording of RPM’s by visual tachometer.
Weekly cleaning performed.
Specimen Refrigerator – Daily recording of temperature to maintain between 2and 8 C is documented
and adjusted as needed. Refrigerator connected to Emergency Power source in the event of a power
failure.
Record Keeping
All records of calibration and daily control testing are maintained for two years as required by the PA
State Dept. of Laboratories and CLIA.
Participation in Proficiency Testing Programs
MU Laboratory is enrolled in the American Association of Bioanalyists, (AAB) Brownsville, Texas for
Urine Sediment. Unknowns are sent quarterly for testing. All MD/DO/NP participate in proficiency
testing on a rotating basis. Unknown results and final scores are documented in the Proficiency Testing
Manual in the Laboratory. Scores are reviewed by the Laboratory Director. Any score below %100 is
reviewed and evaluated. The corrective Action Checklist Form and Corrective Action Form are utilized
per direction of the Laboratory Director. (See Attached.) Corrective actions are evaluated when next
quarterly proficiency test scores are received. Corrective Action Forms are maintained in the Proficiency
Testing Notebook. Peer review for Vaginal Wet Mounts and KOH Prep are performed by each provider
performing provider performed microscopy two times every 6 months and documented.
Proficiency testing for waived testing of Urinalysis, Strep A, Whole Blood Mononucleosis, Whole Blood
Glucose, HcG Urine Pregnancy, Fecal Occult Blood is not required per the Pennsylvania State
Department of Laboratories as of May 18, 2012, and CLIA “88.
____________________________________
Laboratory Director
________________
Date
____________________________________
Laboratory Director
________________
Date
____________________________________
Laboratory Director
________________
Date
6/08 Laboratory Procedure Manual
Millersville University
Health Services
Laboratory Procedure Manual
Blood Glucose
Blood glucose measurement is done following MD/DO/NP order or when necessary by nursing
protocol/standing orders.
Capillary blood drawing procedure is explained to patient. Advise patient that a finger stick must be
done using a lancet in order to obtain one droplet of bleed. Universal precautions for blood borne
pathogens are maintained while handling specimen. Test procedure is per manufacturer’s specification.
See package insert.
Order and result are documented in the patient’s electronic medical record with patient name, date,
time, result, time since last PO intake and testing personnel initials (documented in the comments
section when adding results). Testing will only be performed if automatic calculation by glucometer is
acceptable.
Specimen rejection would be for insufficient droplet of blood used on test strip or improper seating of
test strip into machine.
Microscopic examination is not performed. No calculations are necessary. For step by step procedure,
see instruction manual for glucometer. Machine calculates and displays results. Preparation and
storage of test materials is listed on package inserts.
Package insert describes control procedures, test methods, storage of test strips and control solution.
The reportable control ranges are listed on test strip container and control solutions. External quality
controls will be done every day of patient testing. Results documented on control log with glucometer
and transferred to electronic quality control log every 6 months.
See package insert for remedial action procedures for Quality Control Remedial action is per MU
Laboratory QA/QC policy. If remedial action fails to bring controls within acceptable range – no patient
testing is performed.
Limitation and interfering substances are listed in package insert. Reference literature can be found in
the glucometer manual, package inserts for test strips and control solutions.
Normal range for patient population is 65 – 99. Correlating with patient symptoms. Panic values (less
than 60 or greater than 400.) MD/DO/NP informed of panic values and if unavailable patient is referred
to ER/Urgent Care or PMD.
No proficiency testing required per PA Dept. of Laboratories as per CLIA ’88.
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
6/08 Laboratory Procedure Manual
____________
Date
____________
Date
____________
Date
Millersville University
Health Services
Laboratory Procedure Manual
Fecal Occult Blood
Fecal Occult Blood testing is performed according to package insert and with nursing standing order or
MD/DO/NP order. Package insert attached. Specimen collection, processing and rejection are per
package insert. Patient instructions for collection are attached.
Internal controls are per package insert and are documented with results as “IC OK” in comment section
of electronic results. No patient testing is reported if internal controls are not acceptable. If internal
controls are unacceptable, remedial actions is per MU Laboratory Quality Assurance policy including
remedial action. Reference laboratories will be used for testing as needed.
Order for fecal occult blood and results are documented in electronic health record including result as
“positive” or “negative,” name, date, time and initials of clinician performing test. Results are reported
to ordering clinician.
No calculations are required. Negative is normal result. No panic values are noted. Limitations and
interfering substances are per package insert. Preparation and storage of materials is per package
insert.
Proficiency testing is not required per PA State Department of Laboratory and CLIA ’88 as a waived test.
6/08 Laboratory Procedure Manual
Millersville University
Health Services
Laboratory Procedure Manual
INFLUENZA A & B
Influenza A & B testing is done per MD/DO/NP order or as deemed necessary by nurses according to
nursing protocol and standing orders. Patient is informed of influenza testing procedure requiring a
nasal swab (see Nasal Swab Procedure.) Universal precautions are maintained during procedure. Test
is performed immediately on collection of specimen. Specimen rejection is per package insert and may
include contamination of swab. Specimen is discarded according to OSHA regulations.
Order and results are documented the patient’s electronic health record. Documentation also includes
that procedural or internal controls were monitored and according to manufacturer’s specifications
were acceptable with “IC OK.” The Test Kit number, IC OK monitoring and initials of performing clinician
are documented in the comment section of the electronic lab result section of the electronic record.
Test procedure is according to manufacturer’s specifications. See attached copy of insert. A copy of this
report is maintained as a lab copy.
MD/DO/NP is informed of results if available, nursing may provide care per Nursing Standing Orders. If
clinical condition warrants, patient will be referred to PMD or ER/Urgent Care for evaluation.
Manufacturer provided controls are run and documented each new lot number of kits. External controls
are performed according to manufacturer specifications and documented in electronic control logs. Kits
are numbered sequentially and this number is documented on the Quality Control Log and with each
patient test result.
Remedial action for unacceptable results for quality control is per Q. C. Remedial actions sheet. See
attached and documented electronically on Remedial Action Log.
Normal result is negative, panic/alert not applicable. No calibration or calculation required. All positive
results are documented on Influenza Positive Log (attached) to facilitate mandatory electronic reporting
to the Pennsylvania Department of Health.
Enrollment in Proficiency testing is not required per the Pennsylvania Department of Laboratories and
CLIA ‘88.
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
6/08 Laboratory Procedure Manual
____________
Date
____________
Date
____________
Date
____________
Date
____________
Date
____________
Date
Millersville University
Health Services
Laboratory Procedure Manual
Microscopic Examination of Urine
Microscopic examination of urine is performed by MD/DO/NP on a clean catch specimen of urine as
ordered by MD/DO/NP or per nursing protocol, Physician Standing Orders. The urine specimen is
collected per clean catch procedure and universal precautions. See Urinalysis procedure. Prior to
microscopic examination, urinalysis is performed on the Seimens Clinitek Status. See Urinalysis
Procedure.
The microscopic examination is done immediately after collection and routine urinalysis. If not done
within two hours of collection, specimen is refrigerated. Specimens left unrefrigerated for more than
two hours are unacceptable. Minimum volume for microscopic examination is 1 milliliter. Centrifuged
volumes less than 10 milliliters are indicated in the comment section of the lab result of the electronic
health record.
The urine specimen is prepared for examination by transferring 10 milliliters of urine into a disposable
centrifuge tube. Urine is centrifuged for 5 minutes. The supernatant fluid is poured off, leaving 1 cc of
sediment. If staining, one or two drops of Sedi-Stain are added to the precipitate. The Precipitate is
rotated and re-suspended. One drop form the precipitate is placed on a glass slide using a pipette and
covered with a glass cover slip.
A microscopic examination using low/high power is carried out. Normal and abnormal finding are noted
which include cells, crystals, casts, bacteria, etc. These findings are recorded in the lab result of the
electronic health record. Comment section includes the initials of the examiner. The MD/DO/NP is
performing the examination and will treat based on microscopic findings.
Proficiency testing of microscopic urine sediment is done quarterly according to Pennsylvania
Department of State Laboratories and performed by a certified Proficiency Testing agency. Quality
assurance is per MU Health Services QA/QC protocol.
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
6/08 Laboratory Procedure Manual
____________
Date
____________
Date
____________
Date
____________
Date
____________
Date
____________
Date
Millersville University
Health Services
Laboratory Procedure Manual
Whole Blood Mononucleosis
Testing is done following MD/DO/NP request or when necessary according to nursing protocol and
Physician Standing Order. Patient is informed of Mono testing procedure requiring a finger stick blood
sampling. Test is performed immediately upon collection of specimen per manufacturer’s specifications
using the CLIA waived whole blood method. See package insert attached. Universal precautions for
blood borne pathogens are maintained during testing procedure. Specimen rejection is per
manufacturer’s specification and may include inadequate amount or clotting.
Order for and results are documented in the patient’s electronic health record. Documentation includes
patient name, date, time, result as Positive or Negative, with indication that internal procedural control
is acceptable with “IC OK,” box lot number and initials of testing personnel in the comment section of
the electronic result. MD/DO/NP informed of test results; if not available, patient is referred to PMD or
ER/Urgent Care as warranted by clinical condition and nursing standing orders.
Test procedure is according to manufacturer’s specification. Testing is done only with whole blood, no
serum or plasma testing is done at MUHS. See copy of testing insert. Storage and preparation of
testing material is per package insert.
External controls are run and documented with each new lot number of kit and each new operator as
per manufacturer’s specifications. See electronic control log for documentation of external controls.
Remedial action for unacceptable results for quality control is per Q.C. Remedial actions sheet. See
QC/QA policy. No patient testing is done if controls are unacceptable. Specimen may be referred to
reference laboratory.
Negative is normal result, panic alert not applicable.
Preparation and storage of testing material and controls is per package inserts.
Enrollment in proficiency testing is not required per PA State Department of Laboratories in accordance
with CLIA ’88 as this kit is CLIA waived for whole blood.
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
6/08 Laboratory Procedure Manual
____________
Date
____________
Date
____________
Date
____________
Date
____________
Date
____________
Date
Millersville University
Health Services
Laboratory Procedure Manual
Urine HcG Pregnancy
Testing is done following MD/DO/NP request or as deemed necessary by nurses according to nursing
protocol and standing orders. Patient is instructed in collection of urine specimen, first AM voided
specimen is preferred. Universal precautions are maintained during procedure. Test is performed
immediately upon collection of specimen. Specimen rejection is per package insert .
Order for and results are documented in the patient’s electronic medical record. MD/DO/NP is
informed of positive results if available. Nursing care for positive result is per Nursing Policy and
Procedure manual. If clinical condition warrants, patient will be referred to PMD or ER/Urgent Care for
evaluation. Specimen is discarded according to OSHA regulations. Documentation in electronic medical
record includes patient name, date, time, and result as either positive or negative. Indication that
internal control was acceptable per manufacturer’s specifications with “IC OK,” assigned box number
per electronic control log and initials of testing personnel is documented in the comment section of the
electronic results.
Referral to reference lab for confirmatory testing is per MD/DO/NP or standing orders.
Test procedure is according to manufacturer’s specifications. Storage and preparation of materials is
per package insert. See attached.
Manufacturer provided external controls are performed per manufacturer’s specifications. External
controls are documented for each lot of test kits and monthly. Each kit is assigned a number and
documented on the electronic HcG Control Log and with each result. Remedial action for unacceptable
results for quality control is per QC/QA procedure manual. See remedial action sheet.
Normal result is negative. Panic/alert is not applicable. No calibration or calculation is required.
Enrollment in proficiency testing is not required as of May 18, 2012 per the Pennsylvania State Dept. of
Laboratories and CLIA’88 for waived testing.
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
6/08 Laboratory Procedure Manual
____________
Date
____________
Date
____________
Date
____________
Date
____________
Date
____________
Date
Millersville University
Health Services
Laboratory Procedure Manual
Strep A
Testing is done following MD/DO/NP request or as deemed necessary by nurses according to nursing
protocol and standing orders. Patient is informed of Strep procedure requiring a throat swab. Universal
precautions are maintained during procedure. Test is performed immediately upon collection of
specimen. Specimen rejection is per package insert and may include contamination of swab by touching
tongue.
Order for and results are documented in the patient electronic medical record. MD/DO/NP is informed
of positive results. Nursing care for positive result is per Nursing Policy and Procedure manual. If clinical
condition warrants, patient will be referred to PMD or ER/Urgent Care for evaluation. Specimen is
discarded according to OSHA regulations. Documentation in patient electronic medical record includes
patient name, date, time, result as either positive or negative. The results comment section includes the
performing technician’s initials, indication that internal control was acceptable per manufacturer’s
specifications with “IC OK,” and assigned box number per electronic control log.
Referral to reference lab for throat culture is per MD/DO/NP or standing orders.
Test procedure is according to manufacturer’s specifications. Storage and preparation of materials is
per package insert. See attached.
Manufacturer provided external controls are performed per manufacturer’s specifications. External
controls are documented for each lot of test kits. Each kit is assigned a number and documented on the
electronic Strep A Control Log with result. Remedial action for unacceptable results for quality control is
per QC/QA procedure manual. See remedial action sheet.
Normal result is negative. Panic/alert is not applicable. No calibration or calculation is required.
Enrollment in proficiency testing is not required as of May 18, 2012 per the Pennsylvania State Dept. of
Laboratories and CLIA’88 for waived testing.
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
6/08 Laboratory Procedure Manual
____________
Date
____________
Date
____________
Date
____________
Date
____________
Date
____________
Date
Millersville University
Health Services
Laboratory Procedure Manual
Throat Swab
Purpose
A throat swab is a technique for identifying disease bacteria in material taken from the throat.
Most throat cultures are done to rule out infections caused by beta-hemolytic streptococci which cause
strep throat. Hemolytic means that these streptococci destroy red blood cells.
Equipment
Gloves
Tongue Blade
Light as needed for Visualization
Throat Swab or Culturette
Rapid Strep Kid
Waste Container
Procedure:
1. Identify Patient
2. Explain procedure and purpose of
testing.
3. Wear gloves and maintain Universal
Precautions
4. The patient is instructed to tilt head back, open mouth wide and breathe out slowly trough
mouth saying “Ah.”
5. With the tongue depressed with the tongue blade, swab the back of the throat and the
tonsils with the sterile swab. The swab is applied to any area that appears wither very red
or discharging pus.
6. The swab is removed gently without touching the teeth, gums or tongue.
7. The swab is immediately placed into the Rapid Strep cassette or the culturette container.
The procedure is continued per Strep A Procedure or per Reference Lab Manual for throat
culture with culturette.
8. Remove gloves, discard supplies in waste container per universal precautions.
9. Document procedure in electronic health record. Inform student of date of expected results
and verify method of contacting student to inform of Culture results.
_____________________________________
Laboratory Director
____________
Date
_____________________________________
Laboratory Director
____________
Date
_____________________________________
Laboratory Director
____________
Date
6/08 Laboratory Procedure Manual
Millersville University
Health Services
Laboratory Procedure Manual
Urinalysis
Test is done per MD/DO/NP order or standing order. See Standing Orders. Patient is given clean cup for
urine specimen. Patient informed of clean catch urine procedure per Urine Collection Procedure.
Universal Precautions are maintained throughout procedure. Test is performed immediately upon
collecting specimen. Reagent stick urinalysis is then performed with the Seimens Clinitek Status.
Testing is performed per manufacturer’s instructions – see attached Seimens Clinitek Status
documentation.
Order for and results are documented in the patient’s electronic medical record. Documentation
includes patient name, date, time, and test results. Electronic results include the initials of the
performing clinician. Control log maintains inventory for testing materials. Labeled specimen is then
centrifuged for five (5) minutes if microscopic analysis of urine sediment is ordered. Spun urine is given
to provider for further preparation and examination per policy. A specimen would be rejected for the
following (a) inadequate amount or (b) contamination. Specimen is disposed per OSHA regulations
Test procedure is per manufacturer’s specifications. Preparation and storage of testing materials are
per manufacturer’s insert. See insert.
The Seimens Clinitek Status is self-calibrating by computer stored module. Problems with the automatic
calibration are referred to manufacturer. No patient testing per Seimens Clinitek Status if calibration
failure is not resolved. Dip stick urine with Seiman’s Multistix 10 SG is permissible in the event of
Seimens Clinitek Status failure. See Seiman’s Multistix 10 SG package insert for test procedure
specifications, limitations and interfering substances.
External controls (positive and negative) are run once a week for Seimens Clinitek Status and with every
new bottle of Seimen’s Multistix as per manufacturer recommendations. Controls are performed in
same manner as procedure and documented in electronic control log. Remedial actions for
unacceptable results for quality control are per QC remedial action sheet/QA/QC policy.
No panic/alert values. No calculation or calibration is done. Referral to reference laboratory is per
MD/DO/NP order/standing order. Reference ranges for patient population are listed on the electronic
result. No calculations or derivations are required.
Enrollment in proficiency testing is not required by Pennsylvania Department of Laboratories as of May
18, 2012 and CLIA ’88.
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
6/08 Laboratory Procedure Manual
____________
Date
____________
Date
____________
Date
____________
Date
Millersville University
Health Services
Laboratory Procedure Manual
Wet Mount/KOH Procedure
Definition/Purpose
A sample of vaginal discharge is mixed with a salt solution on a microscope slide. The slide is checked
for bacteria, white blood cells, and unusual cells called clue cells. If clue cells are present, it means
bacterial vaginitis is present. KOH (potassium hydroxide) medium is used to enhance the recovery of
fungi. Body fluid pH is calculated with the use of pH paper.
The direct examination of a clinical specimen is the most rapid, cost-effective diagnostic aid in the
laboratory. Microscopic examination of a sample is used to identify the motility and morphology of
microorganisms, fungal elements, protozoan trophozoites and helminthes eggs and larvae. The visual
examination assists the laboratory and the clinician in quickly identifying the causative agent of infection
so treatment may begin. Proper sample collection is important in diagnosing infection. Samples may be
treated with potassium hydroxide (KOH) to enhance the recovery of fungi or stained with iodine to
enhance the recovery of trophozoite nuclei and vacuoles. Wet mount samples may be obtained from
various clinical sites and sources.
Equipment:
Exam gloves
Cotton tipped swabs (2) and Kova Tubes (2)
Specimen (obtained during speculum examination for vaginal secretions or by clinician for other
sources)
Normal Saline, KOH, Sedi Stain (KOH – Protect from light)
2 clean microscope slides with cover slips
Microscope
pH paper
Scalpel, tongue blade, skin curette, or other blunt object (Skin Scrapings)
Red Hazardous Waste Container
6/08 Laboratory Procedure Manual
Millersville University
Health Services
Laboratory Procedure Manual
Procedure:
Vaginal Wet Mount
1. Put on gloves.
2. Obtain the specimen with cotton tipped applicator. See Pelvic Exam Procedure.
Specimens should be examined within two hours of collection. The sample should remain at
room temperature. Proper specimen collection and handling of vaginal samples is crucial
for accurate results. The vaginal vault and walls should be swabbed using one or two swabs.
If any fluid has pooled in other areas, these areas should be swabbed as well. Use of vaginal
lubricants, douches, tampons, contraceptive jelly, and medications may interfere with the
examination. Patients should avoid using these items before sample collection. In some
cases, the gram stain may be used to aid in the diagnosis of these patients.
3. Do one/or more of the following:
a. Put one drop of normal saline in Kova tube; insert cotton-tipped applicator with
specimen. Vigorously mix the swab (s) in and out of the saline making sure to
collect all the material adhering to the side of the tube. Remove the swab from the
saline and depress onto a clean, dry microscope slide expressing a small amount of
fluid.
b. Insert cotton-tipped applicator with specimen into dry Kova tube. Put one drop of
potassium hydroxide (KOH) on the right third of the slide. Mix the sample of vaginal
discharge on the wooden end of the cotton-tipped applicator with the drop of KOH
on the slide. Use both a rolling and a stirring motion to mix the vaginal discharge
with the drop of solution.
c. Place cotton-tipped applicator with specimen in Kova tube. Use two clean
microscope slides and put one drop of normal saline on the middle of one slide and
one drop of potassium hydroxide on the middle of the second slide. Roll the plain
wooden end of a cotton-tipped applicator in the specimen of vaginal discharge. Mix
the sample of vaginal discharge on the wooden end of the cotton-tipped applicator
with drop of normal saline on the slide. Repeat and mix the sample with the drop of
potassium hydroxide if both solutions are being used. Use a rolling and a stirring
motion to mix the vaginal discharge with the drop of solution.
4. The pH and the amine (“whiff”) test often are performed before the microscopic
examination. The clinician test the pH at the time of sample collection a pH greater than
4.5 may indicate bacterial vaginitis (BV) or trichomoniasis. The amine test is performed
prior to cover slipping the saline preparation. The fishy or amine odor is characteristic in the
presence of Trichomonas vaginalis and Gardnerella vaginalis.
5. Cover the mixture of specimen sample and solution with a cover glass (coverslip) by sliding
the coverslip onto and over the specimen. This is accomplished by putting the edge of one
side on the coverslip into the mixed specimen/solution and drawing it to the longitudinal
6/08 Laboratory Procedure Manual
Millersville University
Health Services
6.
7.
8.
9.
Laboratory Procedure Manual
edge of the slide. When the specimen/solution is under the entire edge of the side of the
coverslip, slide the coverslip over the rest of the mixed specimen/solution on the slide.
The wet smear slide of vaginal secretions is now ready for microscopic evaluation.
Examine secretions. The saline slide should be examined first to allow the KOH to properly
digest other cellular elements in the sample such as epithelial and blood cells.
8. Begin the microscopic review of the slide by examining the saline preparation. The
examination should begin using the 10x objective noting cellular distribution and obvious
cellular and fungal elements. The 40x objective is used to identify the cells, motile
Trichomonas, yeasts, and fungal hyphae. The KOH slide should be examined with the 10x
objective for any yeast and hyphae.
Discard slides in Red Hazardous Waste Containers and maintain universal precautions in
glove disposal and hand washing.
Skin Scrapings
Skin scraping examinations are used to identify fungal infections of the skin, mouth and nails. Fungus
lives in the stratum corneum layer of the skin. KOH is used to digest this layer of skin so that the fungal
growth with its visible hyphae and spores is exposed. Skin scraping examinations are indicted in areas of
broken hair or baldness, presence of scaly lesions on the skin, crumbling or scaly nails or nail beds, and
white plaque in the mouth.
The proper collection of a skin scraping sample is crucial to the recovery of the fungus. In obtaining and
preparing the sample:
10. Clean the infected area with 70% alcohol. Scrape the infected area using a scalpel, skin
curette, tongue blade, or other blunt object. Infected nails may require a portion of the
infected nail to be clipped.
11. Place the sample on a microscopic slide and coverslip.
12. Apply gently heat (if practitioner desires) to enhance the digestive capabilities of the KOH. If
40% dimethyl sulfoxide (DMSO-KOH) is used, heating the sample is unnecessary.
13. Let the slide sit for 10 minutes to allow for KOH digestion.
14. Examine the slide using teh10x objective. All suspicious areas should be examined using the
40x objective.
15. Keep the light intensity of the microscope low. I the light intensity is too high, the fungal
elements may not be seen.
16. Discard slides in Red Hazardous Waste Containers and maintain universal precautions in
glove disposal and hand washing.
6/08 Laboratory Procedure Manual
Millersville University
Health Services
Laboratory Procedure Manual
Documentation
Order for vaginal wet mount (vaginal wet prep) and results are documented in the patient electronic
health record. Documentation includes the patient name, date, time, specimen source, and findings.
The comment section of the result includes the initials of the examining clinician.
Preparation and Storage of solutions (KOH and Sedi Stain) and pH paper is per manufacturer’s
recommendation. See package inserts. MSDS on file.
No calibration is required.
No alert values.
Specimens may be referred to a reference lab for testing as ordered.
Quality Control
Every 6 months clinicians will compare results from two patient specimens and document findings for
peer review. Discrepancies will be discussed, comments will be documented. Laboratory Directory will
review and sign Peer Review for Vaginal Smear Wet Mounts. (See attached copy.)
_____________________________________
Laboratory Director
____________
Date
_____________________________________
Laboratory Director
____________
Date
_____________________________________
Laboratory Director
____________
Date
_____________________________________
Laboratory Director
____________
Date
_____________________________________
Laboratory Director
____________
Date
_____________________________________
Laboratory Director
____________
Date
6/08 Laboratory Procedure Manual