The pre-analytic phase of the Total Testing Process (T.T.P) begins with the encounter between the clinician and the patient,and includes verification of identity, specimen processing, specimen preparation, the posing of clinical question, test selection according to the questions, test ordering, patient/specimen identification, specimen collection, handling and transportation of the specimen, the preanalytical phase includes all processes from the time a laboratory test request is made and ordering by a physician until the sample is ready for testing (Smith, et al., 2013)
Source of errors in the pre-analytic phase are related to actions or processes that are completed before the specimen arrives to the laboratory including actions performed by both, the attending physician and the laboratory personnel; although the laboratory team is usually held responsible for them. Some of these errors are : obtaining inadequate or insufficient samples, samples taken from the wrong patients, wrong surgical procedure (in anatomic pathology: wrong procedure to obtain a tissue sample for biopsy), specimen placed in the wrong chemical/container or tube, ordering wrong test, identification problems related to the patient and the source of the specimen and lack of clinical information when required (Sirota, 2006)
Errors in the pre-analytical phase can occur either outside of the control of the laboratory or inside the laboratory itself. This leads to a further split this phase of sub-phases: the pre-pre-analytical phase, which begins with the selection of the test, requesting the test, patient/specimen identification, blood drawing, sample collection, and handling and transportation. Errors in the two “sub-phase” lead to high costs, increased risk of medical errors and injury because they can alter the quality of the entire TTP ( Holman, 2014). In Plebani, 2006, the inappropriateness of some tests is analyzed and shown in the following table.
Quality Assurance in the Pre-analytical Phase
-Unnecessary test repetition: it has been estimated that up to 30% of laboratory tests ordered each month are repeat tests. Examples from which errors emanates: Wrong test tube, wrong test ordered, insufficient amount of specimen
-Requests for multiple tests that are basically equivalent in their disease-detection capacity Examples from which error arises: Ordering physician is unfamiliar with lab test menu.
-Quick and easy access to laboratory directory as a result of the use of new technologies. Example by which error is limited: Provide test menu info for ordering physician so that informed test or the decision are made
-Use of obsolete tests that have been replaced by tests with a greater diagnostic efficacy. Examples from which error emanates: Lack of current laboratory test menu and educating the medical staff with respect to new diagnostic testing
-Little training of clinicians in understanding the diagnostic utility of laboratory tests Examples from which error emanates: Lack of current laboratory test menu and educating the medical staff with respect to new diagnostic testing (Plebani, 2012)
Comprehensive plan to prevent pre-analytical errors: 5 steps (Hammerling, 2012)
Development of test request protocols specific to pathology, using technologies
1. Recommendations from evidence-based clinical practice guidelines and based on mutual consensus between laboratories and clinicians.
2. Despite efforts made in recent years to implement the use of these guidelines, some studies have found clinician compliance to be scant
3. Establishing the use of diagnostic algorithms (reflex testing) in laboratories depending on the disease or the patient’s health status. Example: The use of expert systems that serve as a connection between the clinician and the laboratory and that act as an aid in appropriate test selection and interpretation. The implementation of computerized medical records connected to the Laboratory Information Management System (LIMS)quite useful in helping the physician to select the most relevant analytical tests. For example, attaching clinical practice guidelines to medical records improves the relevance of the requested tests.
4. Information provided by laboratory specialists to clinicians about diagnostic utility of the laboratory tests, removing obsolete tests from the laboratory’s menu of available tests and also those tests that have the same diagnostic value.
5. Highly trained lab team that is well versed in patients identifications, correct sample collection and appropriate specimen transport is key in completing the prevention of pre-analytical error
The compliance officer and/or lab supervisor could potentially review all the following items as quality indicators of the pre-analytic phase:
Quality indicator in the pre-analytic phase (Llopis, 2011)
|
Number |
Indicator |
Flags Review and quantify |
Corrective actions* |
|
Q1 |
Appropriateness lab of test request form |
Number of request with clinical questions (%) Number of request without physician’s identifications (%) Number of request without physician’s identifications (lack of name, signature phone number, fax number National Identification Number (NID) (%) Number of unintelligible request (%) No test ordered No patient demographic information(%) |
More than 90% of all lab request form should be acceptable If review of flags is below the cut off value a quality indicator is required* |
|
Q2 |
Samples |
Number of sample lost/non received (%) Specimen tracking and specimen transport (%) |
Tracking and transport system in place |
|
Q3 |
Samples |
Number of sample collected in inappropriate containers Wrong test tube, quantity not sufficient Incorrect specimen transportation |
Review of specimen collection procedure |
|
Q4 |
Samples |
Number of improperly labelled samples (%) |
Review of specimen collection procedure |
-
Threshold is the minimum accepted cut off value by laboratory, any indicator below this value is not accepted and quality monitor is indicated
POOR QUALITY SPECIMENS DELAY DETECTION OF DISORDERS IN NEWBORNS
All specimens received at the newborn screening laboratory are examined for specimen acceptability.
Poor quality specimens may not have enough blood to perform all the testing, may have been
collected improperly, and or may have been delayed in the mail. When the Newborn Screening
Laboratory determines a specimen to be poor quality, a same-day Fax report is sent to the
collecting facility and physician of record.
After being notified by fax that the sample is poor quality, it is imperative that arrangements are
made to recollect the newborn screen as soon as possible so that there is no delay in follow-up for
babies that may have an abnormal result.
Remember, if there is a question about suitability when collecting a specimen, it is best to start
over and recollect another newborn screening specimen. Instead of discarding the “ruined” or poor
quality specimen, write VOID across the front of the screening form and return it to the Newborn
Screening Laboratory along with the “good” newborn screening sample. You will be credited for the
VOIDED specimen form. By
recollecting the baby’s blood immediately, you will provide a timely newborn screening result and
avoid recalling the baby back after it has been discharged.
Examples of satisfactory and unsatisfactory blood spot specimens follow:
SATISFACTORY SPECIMEN:
Allow a sufficient quantity of blood to soak through to completely fill the preprinted circle on
the filter paper. Fill all the required circles with blood. Do not layer successive drops of blood
or apply blood more than once in the same collection circle. Avoid touching or smearing spots.
QUANTITY NOT SUFFICIENT:
Quantity of blood on filter not sufficient. Possible causes: Removing filter paper before blood has 
completely filled circle; not allowing an ample sized blood drop to form before applying to filter;
inadequate heel stick procedure.
INCOMPLETE SATURATION:
Uneven saturation; blood did not soak through the filter paper. Possible causes: Removing filter
paper before blood has completely filled circle or before blood has soaked through to opposite
side; improper capillary tube application; allowing filter paper to come in contact with gloved or
ungloved hands or substances such as hand lotion or powder, either before or after blood specimen
collection.
SPECIMEN ABRADED:
Filter scratched, torn or abraded. Possible causes: Improper use of capillary tubes. To avoid
damaging the filter paper fibers, do not allow the capillary tube to touch the filter paper.
Actions such as “coloring in” the circle, repeated dabbing around the circle, or any technique that
may scratch, compress, or indent the paper should not be used.
(FRONT)
(BACK)
LAYERED, CLOTTED OR SUPERSATURATED:
Possible causes: Touching the same circle on filter paper to blood drop several times; filling
circle on both sides of filter paper; application of excess blood; clotted swirl marks from
improper capillary application. Use of unheparinized capillary tube.
DILUTED, DISCOLORED OR CONTAMINATED:
Possible causes: squeezing or milking of area surrounding the puncture site; allowing filter paper
to come in contact with gloved or ungloved hands, or substances such as alcohol, formula,
antiseptic solutions, water, hand lotion, powder, etc., either before or after blood specimen
collection; exposing blood spots to direct heat; allowing blood spots to come in contact with
tabletop, etc. while drying the sample.
(Drying lines from tabletop)
SERUM RINGS:
Serum separated into clear rings around blood spot. Possible causes: Card dried vertically (on
side) instead of flat; squeezing excessively around puncture site; allowing filter paper to come in
contact with alcohol, hand lotion, etc.
BLOOD ON OVERLAY COVER:
Overlay cover came in contact with wet blood specimen. Sample is poor quality status because blood
soaked from back of filter onto the gold colored backing of the form. The filter circles are
designed to hold a specific quantity of blood. If the wet filter is allowed to come in contact with
the paper backing of form, blood can be drawn out of filter making the quantitative tests performed
by the Newborn Screening Laboratory invalid. Allow blood spots to thoroughly air dry for at least 3
hours in a horizontal position, away from direct heat and sunlight. Do not allow the blood to touch
any surface during drying, including other parts of the form.
FILTER AND FORM BARCODES DO NOT MATCH:
Bar code on filter does not match bar code on Newborn Screening Form. Collection forms contain
barcodes on demographic, hearing and filter portions. The barcodes may not be altered in any way.
If incorrect baby is sampled do not remove filter and attach to a different demographic portion. If
a sampling error occurs the entire form needs to be voided and sample needs to be recollected on a
new form. All barcodes must match on laboratory copy, submitter copy, newborn hearing screen, and
filter.
LABORATORY ACCIDENT:
Unable to test, sample damaged at laboratory.
OLD SPECIMEN:
Specimen greater than 15 days old when received at State Public Health Laboratory. The collection
card should be transported or mailed to the Newborn Screening Laboratory within 24 hours after
specimen collection. Avoid the practice of holding onto specimens to wait for more to accumulate
before mailing, also referred to as
“batching” the specimens. Although batching may seem more efficient, it’s not worth it in the long
run because a delay in screening and treatment can cause irreparable damage to a child with
metabolic disease.
NO BLOOD:
Filter submitted without blood.
OLD FORM:
Sample received on expired newborn screening form.
DAMAGED SPECIMEN:
Specimen damaged in transit.
MISSING OR INCOMPLETE PATIENT INFORMATION:
Missing or incomplete name on sample.
WET SPECIMEN:
Specimen submitted before drying thoroughly. Allow blood spots to thoroughly air dry for at least 3
hours in a horizontal position, away from direct heat and sunlight. Do not allow the blood to touch
any surface during
drying, including other parts of the form.
Per Quest diagnostics:
Generally, the specimen requirements are written in a format that specifies the requested volume, storage temperature, and any special handling notes. The requested volume is an amount sufficient to allow at least two performances of the assay either singly or in duplicate. The minimum volume allows one single analysis including instrument dead volume. Storage temperature is specified as room temperature (15 – 30°C), refrigerated (2 to 10°C) or frozen (-20°C or colder). When temperature is not indicated, the sample may be stored and shipped in the most convenient manner for the client.
For panels or multiple assay requests, the sample should be submitted with the physician’s priority of determination on the Test Request Form. Tests will be performed in the order of that priority. If the volume is insufficient to run all the tests requested, our Client Services department will contact the physician.
Specific specimen requirements for each test are listed in the Test Directory. Specimen requirements include information such as specimen volume, collection and transport containers as well as transport temperature. If additional information is needed for the interpretation of the test results or there are specific instructions for patient preparation, they are listed along with specimen requirements. It is critical that an adequate specimen volume is submitted for analysis. The volume requested in this directory is enough for initial analysis as well as for any confirmatory tests that must be performed. If an inadequate specimen is submitted, we may not be able to perform the initial test or required confirmatory procedures.
If repeat or confirmatory tests cannot be performed, the report will indicate that the specimen quantity submitted was “QNS” (Quantity Not Sufficient) for additional testing. When serum or plasma is to be submitted for analysis, it is good practice to collect a volume of blood that is 2 to 2.5 times the volume of serum or plasma needed for the test. As an example, if 4 mL of serum or plasma is needed for a test, collect 8 to 10 mL of blood. When an inappropriate specimen or unclear test request has been submitted, you will receive notification with instructions for resolving the problem.
We generally request 1 tube per test to avoid delays in processing and to expedite turnaround time. To minimize specimen volume requirements for small children, however, only one tube is required even when multiple tests are ordered.
For pediatric specimen tubes, wrap the label around the tube just below the screw cap so the ends of the label adhere to each other and the information stipulated above can be read.
Bright orange, self-adhesive “Pediatric Sample” labels are provided. Please place one of these labels in a blank area of the Test Request Form. The Test Request Form, properly filled out and labeled, should be folded and inserted in the pediatric specimen bag.
Some tests require the patient to ingest a substance. The most common are the Glucose Tolerance Tests where the patient drinks a solution containing glucose, and blood specimens are obtained before and at various times after the drink, to measure the concentration of glucose in plasma or serum. In the standard Glucose Tolerance Tests, adults ingest 75 g (10 ounces) of a glucose solution (Glucola™). Children ingest an amount of glucose proportional to their body weight (1.75 grams of glucose per kilogram of body weight, up to 75 g of glucose).
All specimens should be labeled at the time of collection with at least two patient identifiers.
- The patient’s name (full last name, then full first name or initial) or a unique ID code is always required.
- The second patient identifier may be one of the following:
- Date of birth (month/date/year)
- Other unique patient identifier that is also on the test requisition, e.g. hospital or office ID code or file number
- Quest Diagnostic’s requisition number or specimen barcode label
- Other barcode labels can be used if barcode matches the unique identifiers on the printed requisition (the barcode does not need to be human readable)
NOTE: Location-based identifiers are NOT acceptable, e.g. hospital room number or street address
Each specimen must have a securely affixed label with the following information:
- the patient’s name written exactly as it appears on the test requisition (e.g., Doe, Jane)
- a second patient identifier as noted above
- your account number
- date of collection
If the label is hand-written, use a ballpoint pen–do not use a felt tip pen. If glass slides are submitted, use a pencil for labeling the frosted end–two identifiers are preferred although patient’s name alone is acceptable.
When using an electronically generated Quest Diagnostics test requisition, place the label lengthwise on the tube. When submitting a specimen in a container other than the tube used to draw the sample (e.g., transfer vials), also indicate specimen type on the label (e.g., serum, plasma, urine, etc.). When submitting specimens for microbiological testing (e.g., cultures, bacterial antigen, microscopic examination), the nature and anatomic source of the sample and the specific organism(s) to be detected, if any, should be specified.
Test Requisition
Specimens must be accompanied by a paper requisition, prepared either by hand or printed from an electronic ordering system. The requisition, at a minimum should contain the following information:
- Adequate patient identification information (e.g., name, address, telephone number, medical record number
- Patient gender
- Patient date of birth, or age
- Name and address of physician ordering the test
- Test(s) requested
- Date of specimen collection, when appropriate
- Source and type of specimen and time of collection, when appropriate
- Clinical information, when appropriate
Complete the “Patient Information” and “Insurance Information” sections on the requisition. Select the tests to be performed. Legibly print patient information and indicate with a check mark which party will be responsible for payment in the “Bill To” section of the requisition. Enter the ICD diagnosis code that reflects the patient’s symptoms, condition, or diagnosis and provide medical justification for the tests ordered. Complete billing information.
When ordering tests in a series (e.g., growth-hormone stimulation, glucose tolerance, etc.):
- Use one test requisition.
- Label each specimen with the patient’s name, date and time of collection, or site (if applicable).
- Write the number of specimens on the test requisition.
- Submit all specimens within a series together in one specimen bag.
Improperly labeled specimens will be rejected.
PACKAGING
- Ensure that all specimen container caps and lids are properly tightened to prevent leakage.
- Properly complete the requisition.
- Collect the specimen(s) and transfer to a proper transport container, if needed. Double check the specimen container to ensure that the device is not beyond its stated expiration date.
- If using a manual test requisition, remove a -self–stick label from the bottom of the pre-printed paper test requisition and affix this label to the specimen transport container. Place on the container so that the label does not cover the handwritten patient name.
- Fold the top copy (original) of the test requisition in half widthwise (top to bottom) with the patient’s name and bar code facing out. Retain the second copy for your files.
- The specimen transport bag has two pouches. Place the specimen container(s) in the front pocket. Insert the requisition into the rear pocket with the bar code visible in the bottom corner of the bag.
- Frozen specimens should be transported in plastic -screw–cap containers only. Frozen specimens must be placed in a separate specimen bag along with a separate test requisition. Frozen specimens cannot be split for other tests. If more than one test is ordered on a single frozen sample, we will call you to authorize which of the tests ordered you want performed before testing can proceed.
- Remove the protective strip and seal the specimen bag. The protective strip must not obstruct the bar code. This will protect the test requisition from leakage and help ensure that the patient information can be entered directly into the laboratory computer by scanning of the bar code.
- If the specimen has been classified as an “infectious substance,” transport in a box designed to withstand 95kPa of pressure to meet the ICAO/IATA and DOT requirements. These boxes are available from the local laboratory (See the Transporting Specimens to Quest Diagnostics section). Please inform Quest Diagnostics prior to, or at the time of our Logistics Representative -pick–up, so that proper transport arrangements can be made.
- Any updates to these guidelines (or to the specimen transport supplies) will be communicated through your local Quest Diagnostics sales representative or Logistics Representative.
PROPER SPECIMEN PACKING HELPS TO EXPEDITE YOUR ORDER.
Air carrier: Follow any additional packaging and documentation requirements according to carrier’s instructions and/or those issued by the IATA, including Packing Instruction.
U.S. Postal Service: Label, package and document according to U.S.Postal Service instructions (note that the U.S. Postal Service may not accept certain types of specimens).
Because different parts of the U.S. Department of Transportation (DOT) regulations apply based upon the mode of transport, check with your carrier or transportation expert about application of the DOT rules prior to submitting.
Packages originating outside of the United States must meet any applicable legal requirements of the country of origin and the U.S. Customs and/or CDC requirements for entry into the United States.
Quest Diagnostics and its affiliates will not be responsible for any liability attributable to the shipper’s improper actions or failure to comply with any applicable legal requirements. The outline of transportation requirements herein is only a summary of current law. It is provided with the understanding that you seek competent expert or legal advice about regulatory compliance, when applicable. In some cases, these requirements include employee training on these regulations. Quest Diagnostics cannot be responsible for this training. Quest Diagnostics reserves the right to refuse to accept any shipments that fail to meet legal requirements and those that pose a safety hazard to its employees.
