TH2-240 Rooney C 1

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
chris.rooney@millersville.edu
6/08 Laboratory Procedure Manual
Health Services
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.
Health Services
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 manufacturers package
inserts, and/or instrument operators manuals. Procedures do contain direct
references to manufacturers 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)
KoH/Wet Preps (PPM)
Peer review 2 x year
Rapid Influenza A & B (Waived)
Rapid Mononucleosis (Waived)
Rapid Strep A (Waived)
Urinalysis (Waived)
Urine Microscopy (PPM)
AAB
Urine Pregnancy (Waived)
Proficiency documents are maintained for two years. Quality assessment is
performed monthly, reviewed by the Laboratory Director and documented.
Health Services
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
ACM Medical
Laboratory
Manual
Printed/Electronic
Requisitio
n
Printed per
manual
Specimen
Label
Courier
Printed/Numeric
Printed/Electroni
c
Printed per
manual/Electroni
c
Handwritten
Person Pick-up
2:00 p.m. M-F
Fed Ex by 4:00
p.m. M-F
Schedule pickup
UPS
Weekly/Wed 2
pm
Reporting
Paper copy by
fax
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
Paper copy by
fax
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
Secure email/
printed
No Alert/Panic
Values
Provided/Reorder
PRN
Provided/Reorde
r PRN
Electronic
request/auto
Pani
c
Valu
es
Supplies
Center for
Disease
Detection
Printed/Electron
ic
Electronic
PERLL
Laboratory
Printed/Numeric
Printed/Bar
Code
Schedule pickup by calling
PERRL
717-691-1500
Paper copy/fax
Printed/Electro
nic
Printed
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
717-390-0754
Provided
/reorder
Health Services
Paper
Request/Faxed

Paper
request/faxed
inventory
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
PRN
Paper
Request/faxed
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
Health Services
Reference Lab
Selection by
Staff
NA
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 manufacturers
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
Supply
Ordering
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.
CDD STI testing $15
charged to student account
MUHS pays CDD
Clients informed of reference

lab choice. Basic general
cost estimates available
from reference lab for client.
It is the clients 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
Health Services
Staff Training
2.
3.
4.
5.
6.
minimums and stored per

manufacturers 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.

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.
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.
Health Services
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
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Laboratory Director
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Laboratory Director
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Laboratory Director
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Laboratory Director
QUALITY ASSURANCE
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Date
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Date
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Date
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Date
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Date
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Date
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 inservice/training is maintained in the personnel manual.
Health Services
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.
Quality Control Testing

Quality control on each test offered is completed according to manufacturers
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 manufacturers 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
YESReport Patient results
Health Services
Run new control, same lot#; Acceptable?

NO
YESReport patient results
Run new control, different lot#; Acceptable?

NO
YESReport patient results
Calibrate and/or perform maintenance; Acceptable?

NO
YESRerun Controls, Acceptable?
NO
YESRerun 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.
Calibrations and Maintenance of Instruments

All laboratory testing equipment is calibrated per manufacturers 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 manufacturers 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 RPMs by
visual tachometer. Weekly cleaning performed.
Specimen Refrigerator Daily recording of temperature to maintain between 2and
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
Health Services
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
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Laboratory Director
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Date
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Laboratory Director
________________
Date
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 manufacturers specification. See package insert.
Order and result are documented in the patients 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.
Health Services
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
Fecal Occult Blood
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Date
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Date
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Date
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.
Health Services
Proficiency testing is not required per PA State Department of Laboratory and CLIA
88 as a waived test.
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 patients electronic health record.
Documentation also includes that procedural or internal controls were monitored
and according to manufacturers 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 manufacturers specifications.
See attached copy of insert. A copy of this report is maintained as a lab copy.
Health Services
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
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Date
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Date
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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.
Health Services
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 resuspended. 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
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Date
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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 manufacturers 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 manufacturers specification and may include inadequate amount or
clotting.
Health Services
Order for and results are documented in the patients 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 manufacturers 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 manufacturers 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
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Date
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Date
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Date
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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 .
Health Services
Order for and results are documented in the patients 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 manufacturers 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 manufacturers specifications. Storage and
preparation of materials is per package insert. See attached.
Manufacturer provided external controls are performed per manufacturers
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 CLIA88 for waived testing.
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
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Date
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Date
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Date
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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
Health Services
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 technicians initials, indication that internal control
was acceptable per manufacturers 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 manufacturers specifications. Storage and
preparation of materials is per package insert. See attached.
Manufacturer provided external controls are performed per manufacturers
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 CLIA88 for waived testing.
_____________________________________
Laboratory Director
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Laboratory Director
_____________________________________
Laboratory Director
_____________________________________
Laboratory Director
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Laboratory Director
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Laboratory Director
Throat Swab
Purpose
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Health Services
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 betahemolytic 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.
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Laboratory Director
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Laboratory Director
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Laboratory Director
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Urinalysis
Health Services
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 manufacturers instructions see attached Seimens Clinitek Status
documentation.
Order for and results are documented in the patients 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 manufacturers specifications. Preparation and storage of
testing materials are per manufacturers 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 Seimans Multistix 10 SG is permissible in the event of Seimens Clinitek
Status failure. See Seimans 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 Seimens 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.
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Laboratory Director
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Laboratory Director
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Health Services
Laboratory Director
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Laboratory Director
Wet Mount/KOH Procedure
Date
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Date
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
Health Services
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 cottontipped 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.
Health Services
4.
5.
6.
7.
8.
9.
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.
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 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.
Health Services
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.
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
manufacturers 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
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Laboratory Director
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Date
_____________________________________
Laboratory Director
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Date
Health Services
_____________________________________
Laboratory Director
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Date
_____________________________________
Laboratory Director
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Date
_____________________________________
Laboratory Director
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Date

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Millersville University

Laboratory Procedure Manual

6/08 Laboratory Procedure Manual

Laboratory Procedure Manual

M.U. Health Services Laboratory

Directory of In-House Testing

6/08 Laboratory Procedure Manual

Laboratory Procedure Manual

6/08 Laboratory Procedure Manual

Laboratory Procedure Manual

6/08 Laboratory Procedure Manual

Laboratory Procedure Manual

Standard Operating Procedures

Precedes all testing including

Specimen held for MD/DO/NP

All results given to client at time of

6/08 Laboratory Procedure Manual

Laboratory Procedure Manual

Client informed of cost. Given

Performed by all staff per PADOH

Per PADOH Laboratory

6/08 Laboratory Procedure Manual

instructions from ordering

Clients informed of reference

All staff responsible for

minimums and stored per

Laboratory Procedure Manual

All testing per MD/DO/NP order/standing order.

6/08 Laboratory Procedure Manual

Laboratory Procedure Manual

Policies and Standards

Laboratory Training and Safety

6/08 Laboratory Procedure Manual

Laboratory Procedure Manual

Quality Control Testing

Controls, reagents, calibrators and/or kits expired?

Rerun unacceptable controls; Acceptable?

Laboratory Procedure Manual

Run new control, same lot#; Acceptable?

Run new control, different lot#; Acceptable?

Calibrate and/or perform maintenance; Acceptable?

Calibrations and Maintenance of Instruments

Laboratory Procedure Manual

6/08 Laboratory Procedure Manual

Laboratory Procedure Manual

Laboratory Procedure Manual

6/08 Laboratory Procedure Manual

Laboratory Procedure Manual

Microscopic Examination of Urine

Laboratory Procedure Manual

The urine specimen is prepared for examination by transferring 10 milliliters of urine

Whole Blood Mononucleosis

6/08 Laboratory Procedure Manual

Laboratory Procedure Manual

Urine HcG Pregnancy

6/08 Laboratory Procedure Manual

Laboratory Procedure Manual

Laboratory Procedure Manual

6/08 Laboratory Procedure Manual

Laboratory Procedure Manual

A throat swab is a technique for identifying disease bacteria in material taken

6/08 Laboratory Procedure Manual