36C24218R0402-035.pdf

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VA Western New York Healthcare System Pathology and Laboratory Medicine

SPECIMEN ACCEPTANCE / REJECTION

I. PRINCIPLE

A. The accuracy of laboratory results is highly dependent on the quality of the specimen.

Specimen collection requirements are listed in each individual standard operating procedure (SOP) and in VISTA under ^F60. Specimens lacking proper identification or an accompanying provider order should not be accepted into the laboratory.

B. This policy provides general guidelines for the acceptability of specimens; for the rejection of samples that are mislabeled, unlabeled, and/or incompletely labeled; and for samples that have been collected, transported, stored or processed incorrectly.

C. Additional specimen rejection criteria due to interferences are listed in each individual test methodology.

II. SPECIMEN ACCEPTANCE GUIDELINES

A. Specimen

1. Refer to Center Memo 113-13 for proper patient identification and specimen collection, labelling, handling and transport procedures.

2. At minimum, all specimens must be legibly labeled with:

a. Full patient name

b. Full social security number (SSN)

1) “Howdy” order labels used for specimens collected by the patient at home (such as 24 hour urine) will only have the last 4 SSN for confidentiality reasons. The lab order number or 9-digit CPRS detail number (a second unique identifier) will direct you to the electronic order that contains the full SSN.

Note: these order labels are NOT acceptable for Blood Bank.

c. Date and time of collection (if not specified see II C 4 below)

d. Type of specimen (if other than blood)

e. Initials of collector

3. The collector will be identified by one or more of the following

a. Initials on the sample label

b. The computer will track the identity of the phlebotomist when samples are collected as “lab collect” or “send patient.”

c. In addition, for type and screen/crossmatch requests, the signatures of the phlebotomist and the witness/verifier on TAS Lab Requisition (backup is SF518) are also required.

B. Requisition

1. The provider order (electronic or paper) must contain the following legible information, as applicable:

a. Full patient name and full SSN (must match the specimen label)

b. Patient location

c. Name of provider ordering the test

d. Order number and/or tests or assays requested

RFP 36C24218R0402

D.40 SPECIMEN ACCEPTANCE - REJECTION

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e. Time and date specimen wanted (when appropriate)

f. Source of specimen (when appropriate)

g. Clinical information (when appropriate)

C. Acceptance

1. Refer to section specific manuals (ex. Central Processing) for detailed accessioning instructions

2. When accessioning and/or accepting specimens into the lab for testing, the technologist must check for the items specified in II A and B, as well as for the following:

a. Agreement of sample and requisition

b. Correct specimen container/fixative if applicable was used

c. Proper storage/handling/ transport conditions were met

d. Sample integrity (not leaking, qns, etc.)

3. Note: when Central Processing accepts samples for another lab section (such as micro samples on non-ad shifts) they are responsible for verifying and matching requisition and specimen identification (2a above). The section performing the testing will ensure items listed above (2b-d).

4. The time the sample is received in the laboratory is documented in a variety of ways.

a. For samples collected and accessioned at off-site locations, the shipping manifest will show the time the samples were actually received in the lab for testing.

b. For samples that are accepted into the lab using WOE or MU, the lab arrival time is the time the sample is accepted / accessioned in the computer.

5. Sample collection times are also captured in a variety of ways.

a. When accessioned in the lab (WOE or MU), the actual collection time indicated on the sample must be used. When no collection time is indicated on sample or requisition, the lab will use “N” or “now”.

(Micro is the only section that can use “T @ U” at this point; they get a date only - no actual time nor 00:00.) To indicate that this is actually the sample arrival time, the expansion comment “UNK” must be entered into the result field (^EM). This expands to Collection Time Unspecified.

b. For specimens collected in an outpatient setting via “Howdy” software, the collection time is captured in Vista as the order is accepted by the phlebotomist.

c. For inpatient samples collected via the Lab Collect (LC) list, collection times default to 0600. Therefore blood team members are required to write the actual collection time on each specimen tube.

6. Samples that do not meet labeling requirements but where a delay in analysis would compromise specimen integrity may be processed and analyzed immediately, but results should not be reported until all conflicting information has been resolved.

Refer to section specific testing policies for complete instructions. (does not apply to micro)

a) If mislabeling is discovered after results are completed /verified, go to ^EM and cancel the incorrect results using “*”. This replaces all the results with

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“cancel”. This is viewable to providers via the electronic medical record.

The reason for cancelation must be explained in the comments.

D. Processing

1. If a sample is to be further processed, shared, diluted or aliquoted, ensure adequate labeling as in II A above. Verify the same 2 identifiers on each tube label before pouring off.

a. Initials of person aliquotting must be included and must not obscure bar code.

b. If multiple aliquots are created from the same parent tube or from another aliquot tube, the technologist will ensure proper sample requirements are met for all tests involved (eg. cross-contamination for sterility or dilution factors)

2. Inspect for hemolysis, sufficient quantity, lipemia and clots if applicable.

3. See individual testing SOP’s to determine other interferences or contraindications for use

4. Refer to individual section manuals for processing instructions (centrifugation, etc)

III. SPECIMEN REJECTION GUIDELINES

A. General documentation -

1. Documentation of specimen problems is a critical part of the testing process.

Any rejected specimen, lost specimen, or specimen quality concern requires documentation as indicated in #A2 below. Serious problems, which may result in patient harm, should immediately be brought to the attention of the section supervisor, lead tech and/or Lab QA. For these serious problems, a Close Call Report or an Incident Report may be submitted, as per the Laboratory Quality Management System and the Laboratory Problem Occurrence Reporting SOP.

The Laboratory Medical Director will be made aware of all serious incidents.

2. The Laboratory Problem Form is one method that may be used to document problems with a specimen or requisition. Some lab sections may document specimen problems on a detailed log sheet.

3. Receipt of hemolyzed and/or QNS samples is documented in Vista using the appropriate expansion comment codes. (see G below)

4. Specimen issues will be documented, investigated, tracked, and trended, and corrective/preventive action may be developed as appropriate, including education of personnel who collect specimens.

B. Reject (use NP – not performed) re-collectable specimens such as serum, urine, sputum, fecal occult blood, and thin preps that have the following problems.

1. Sample / patient identification problems

2. Labels in bag / not affixed to sample (note: these must be accepted and then rejected in Vista to document their receipt in the lab)

3. Unlabeled samples (collection staff may NOT come to lab to label!)

4. Specimen label does not match requisition

5. Partial identifiers (i.e. last 4 SSN or last name and first initial only)

6. Leaking samples to include blood gases, blood samples and urine

7. Specimen integrity issues: contamination, specimen integrity exceeded, clotted, QNS (quantity not sufficient), hemolyzed, wrong specimen, tube expired, etc.

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C. Blood bank samples for type and screen and/or crossmatch that are missing phlebotomist initials, date/time of collection, or phlebotomist or witness signatures will be rejected and must be recollected.

D. Samples without orders - make a phone-call before discarding if:

1. There was an order but it was cancelled by provider or by auto-discharge

2. Samples received without any order

E. Notification/ Cancellation of testing: See Flowcharts Attachment A-1 and A-2.

1. Lab cancelling testing of any lost or rejected specimen using the criteria listed above (B), must notify the patient’s provider or healthcare team member as follows:

a. Direct: The provider or another member of the healthcare team (nurse) must be notified directly by lab staff if we cannot perform testing on an inpatient, or STAT outpatient ordered sample or an un-recollectable specimen. This notification must be documented as a “Reason Not Performed” comment. Expansion comment codes as in G below may be used (eg: “IMP”, Dr. X notified on 1/12/13 @0046, initials).

If the testing cannot be performed due to an avoidable issue or error by OP Lab staff, the tech will contact the responsible OP Lab phlebotomist to contact the patient to return for a recollection of the specimen. If the OP Lab testing had been requested STAT, the OP Lab phlebotomist will also contact the provider/ clinic to inform them that a recollection will be needed.

NOTE: If the provider or healthcare team member insists that results be released on a specimen of compromised integrity, the tech is to contact the Lab Director or a Pathologist, who will then contact the provider or healthcare team member. The Pathologist will follow up with the tech with further instructions. For non-administrative hours, the on-call Pathologist will be contacted. If the requesting provider claims that it is an emergency and the lab is unable to reach a Pathologist timely, results may be released after the responsible provider signs the “Request to Correct/Test a Compromised Specimen Form” (refer to section F below).

b. Electronic: If the sample does not meet the criteria as in # 1a above then electronic notification is sufficient. If the lab is unable to perform a test as requested for any reason, the accession should be marked as not performed (NP) using one of the following computer options “delete test from an accession, remove an accession, or delete entire order or individual tests” with the appropriate comment codes indicated (See G below). Individual tests may also be deleted as needed. This information will be captured by CPRS software and is viewable to providers via the electronic medical record. Do not “save” an accessioned order on a rejected specimen and use it for the “re-draw” sample. The order must be cancelled and a new order must be placed because the collection times will not match and then there would be no documentation of the rejected sample.

2. Lab may also discontinue / delete (cancel):

a. An order that has not yet been accepted, for example when a provider selects a test from another facility, attempts should be made to contact the provider

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b. Outpatient duplicate orders (same testing for the same date of service) may be discontinued. No provider notification required. Cancellation comment must be added referencing the other test order # to use.

c. Testing which has been activated/accessioned in error. Orders will need to be cancelled and then re-entered as detailed in #3 below.

3. If cancelled OP orders need to be put back in for immediate use, notify Lab QA (1st), LIM (2nd) or a Lab Supervisor (3rd) who will re-enter the order. For routine OP orders that can be re-entered on the next administrative day, inform Lab QA to enter order. For cancelled inpatient orders that need to be re-entered, the floor should be notified to put order back in.

4. Lab QA must be notified of any rejected specimen or specimen quality issues (via documentation using the Lab Problem Report Form).

5. Lab QA will check on the next administrative day if proper protocol was followed regarding the specimen issue and if the provider or other member of an outpatient’s healthcare team ordering the non-STAT test with a specimen issue, was notified that a recollection may be indicated.

6. Lab QA will follow up with nurse managers on specimen collection issues attributed to staff in their locations, documenting discussed measures to be taken to avoid recurrence.

F. Specimens that cannot be re-collected (i.e. are un-recollectable) include those collected at a specific prognostic “point in time” or from an invasive procedure and may include blood gas from a code, cultures before antibiotics given, CSF, fluids, and/or tissues. The Laboratory Director or pathologist on call will determine when/if correction of the information on specimen labels or sample integrity problems is permitted on a case by case basis as described below. A record of all such corrections will be maintained in the EMR, facility Patient Safety and in PALM QA Office.

1. Labeling or sample integrity problems on specimens that cannot be re-collected may require the judgment of the ordering provider to balance the risks and benefits in an individual circumstance. The provider must be contacted so that they can decide whether or not to continue the testing and/or use this information when interpreting patient results. If the ordering (or covering) provider insists that an un-recollectable sample be analyzed they must first sign a “Request to Correct/Test a Compromised Specimen Form” Attachment B.

2. The tech or their supervisor should fill out a “Request to Correct/Test a Compromised Specimen form” with as much information as is available before seeking provider’s signature

3. By signing the form the ordering provider accepts responsibility for the testing of this sample.

a) A pathologist is always available for consultation or support if needed

4. The completed form will be left for the supervisor who will ensure it gets reviewed and signed by the Lab Medical Director or pathologist on call on the next business day. Lab QA will document the occurrence in error tracking software for tracking and trending, and submit it to Patient Safety. Review of these reports will be included in the monthly “Error/ Incidents Quality monitor.

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5. Using the information from the form an appropriate comment of what was done and why must be entered in the result field of the patient electronic medical record.

Documentation must include:

a) “ALERT” and “XCEPT” expansion comments

b) Identity of the approving provider

c) Nature of problem (sample condition) and, if known, the possible effect on results.

d) Date and time of contact

G. Specimen rejection/cancellation expansion codes (Refer to flowchart for use of comments.):

ABNH Results are cancelled due to hemolysis.

ABNL Results are cancelled due to lipemia.

AIE ACCESSIONED IN ERROR

ALERT Compromised sample submitted - interpret result with caution

CLP CLUMPED PLATELETS - UNABLE TO PROVIDE ACCURATE COUNT

DIST Delay in sample transport

DTRM DELAY IN TRANSPORT, RESULTS MAY BE COMPROMISED

H2 SPECIMEN CLOTTED, COUNT CAN'T BE DONE ACCURATELY

H4 IMPROPER TUBE SUBMITTED,CANNOT DO TESTING

H10 Hemolyzed specimen, results may be spurious H12 Lipemia present, therefore not all results reported.

ICTN2 Possible interfering substance present.

ID1 Specimen received in the lab improperly or incompletely labeled.

ID2 Results may be questionable for diagnosis/treatment decisions.

IMP Improperly labeled - reject specimen for testing

IOP INCORRECTLY ORDERED BY PROVIDER

IST INCORRECT SAMPLE TYPE RECEIVED

NO-PP PATIENT UNABLE TO VOID

NSR No specimen received.

QNS1 QUANTITY NOT SUFFICIENT - PLEASE RESUBMIT

XCEPT The provider named below gave approval to test this specimen GHEMO Specimen grossly hemolyzed. Results may be affected.

MHEMO Specimen moderately hemolyzed. Results may be affected.

SHEMO Specimen slightly hemolyzed. Results may be affected.

SC SPECIMEN CLOTTED, WARD NOTIFIED

2SCU therefore test cancelled.

UNK Date and time of collection unspecified.

IV. REFERENCES

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A. College of American Pathologists Laboratory Accreditation Program General Lab checklist

B. Center Memorandum 11-3 Execution of Providers Orders C. Center Memorandum 113-13, Guidelines for Collection, Handling and Transport of

Laboratory Specimens D. VHA Directive 2009-035 Data Collection on Mislabeled Specimens for PALM Service

V. ATTACHMENTS

A. Flowcharts – Attachments A-1 and A-2 B. Request to Correct/Test a Compromised Specimen form

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IV. HISTORICAL RECORD

DATE

(Enter date put into service,revised,reviewed or removed)

WRITTEN/

REVISED

BY

STAFF

EDUCATION

METHOD

SUPERVISOR

REVIEW

MD REVIEW

Put into Svc: 6/7/97 e-mail, competency quiz

P. Buziak See original doc.

Revised 3/1/99 P. Buziak “ “ Reviewed 3/15/00 J. Clifford Reviewed 3/15/01 “ Reviewed 3/15/02 “ Reviewed 3/15/03 “ Revised 10/14/03 J. Minderler Staff meetings “ Reviewed 9/21/04 “ Revised 10/05 J. Minderler Staff meetings and e-mail

Revised 6/07 (minor reformat)

J. Minderler Valerie McDowell

Reviewed 8/21/08 Valerie McDowell Reviewed 12/11/08 Manola DeMunda Rana Samuel, MD 12/29/08

Reviewed 3/12/2010 Manola DeMunda Reviewed 4/15/11 Manola DeMunda Revised 5/2012.

Formatting, added specific examples and clarification, Request to Correct/Test a Compromised Sample form

J. Minderler Staff meetings, comp assessment quiz

Revised 5/2015.

Revised flowchart Att. A-1 (previously Attachment A) and added additional flowchart for process clarification. Written policy revised to add specific examples and process detail.

J. Vona QMM Meeting

Staff meetings

Manola DeMunda Rana Samuel, MD

Revised 10/12/2016 to provide direction for reporting lab results when specimens appear compromised – J. Vona

J. Vona 10/12/16

Email to staff Manola DeMunda 10/12/2016

Rana Samuel, MD

10/12/16

Revised 1/16/2018 to include signature of reviewing pathologist and use of CPRS detail number as an identifier. – C.Ander

C.Ander 1/16/2018

E-mail to staff Manola DeMunda 1/16/2018

Rana Samuel, MD

1/16/2018

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ATTACHMENT A-1

SPECIMEN ACCEPTANCE AND /OR

REJECTION

Specimen is received in lab

Is the specimen and/or requisition acceptable as per

SOP?

Continue processing as per applicable SOP

Is the condition of the accessioned specimen acceptable for the test requested?

Is a Comment necessary? (i.e. slightly hemolyzed, lipemic, etc)

Document possible problems and/or condition of specimen in

Comments.

Run test, verify results.

yes yes no

Is patient identification questionable as per SOP? (i.e. partial, illegible, not affixed to sample)

Is the specimen re-collectable (i.e. serum, urine) and/or is it a transfusion request?

Consult with provider who must weigh risks/ benefits of specimen testing.

Is the specimen inappropriate for the test ordered as per SOP?

Is there a transport or storage issue?

Is the date and/or time missing or incorrect?

See Flowchart Attachment A-2- Cancellation of

Specimen Testing

Is there an appropriate specimen available from the same collection?

(check all labs)

Determine which test(s) will be adversely affected and NP* that test. Run remaining tests. Enter appropriate comment.

Use lab arrival time (now) and enter comment that date and time of collection unspecified.

no no yes yes no yes

Reprint an accession label and prepare an aliquot as per SOP. Run test.

no yes yes no yes yes no

Have them sign a Compromised

Specimen Correction form no

Does provider insist that the sample be run?

yes nono

See Flowchart Attachment A-2- Cancellation of

Specimen Testing

ATTACHMENT A-2

CANCELLATION OF SPECIMEN TESTING

Testing cancelled by lab technical staff w/appropriate comments

Notify Lab QA(1), LIM(2) or a Lab Supervisor(3) to put orders back in

Call floor to have reordered and recollected

INPT OUTPT

Lab QA to follow up next administrative day

• Check cancelled orders and if reorder and recollect needed

• Notify provider of OP non-stat recollects, if needed

• Document, monitor, provide follow up on specimen rejection/ cancellation issues

CBOC

Tech to complete Lab Problem Form

Bu OP Lab

Tech contacts OP Lab to notify the patient for recollect. If STAT, OP Lab will also contact PC provider/ clinic.

Tech to call provider/ CBOC Lab that recollection needed.

Cancellation of specimen testing as per Attachment A-1

No

Yes

Was cancellation due to avoidable issue or error by OP Lab staff?

In-patient or out-patient?

During administrative hours?

Bu-OP Lab or

CBOC

patient?

Orders need to go back in ASAP?

Yes

No

Is test STAT or a Sero, Blood Bank, or Micro test?

ATTACHMENT B

VAWNYHS PALM

REQUEST TO CORRECT / TEST A COMPROMISED SPECIMEN Form

Specimen Identification (lab should provide as much information as possible)

Specimen Labeled as______________________________________ SSN#______________________

Actual/Correct Name______________________________________ SSN#______________________

Patient Location or Service______________________________

Name of Person Contacted______________________________

Name of Lab Employee: ________________________________

Sample: _____________________ Tests Ordered: _____________________________

Type of Error (circle one):

Mislabeled Unlabeled Missing/Incorrect Information Other (specify)__________________

Date/Time_____________________________________

Ordering/ Covering Provider PLEASE READ AND SIGN THE STATEMENT BELOW:

I understand the risks of using test results from less than optimal specimens or from samples with questionable identity but I believe that this patient’s care will be seriously compromised without the information obtained from testing this sample. I also understand that my name and a comment indicating that the specimen was compromised in some way will appear in the patient’s medical record to document the incident. I attest that this sample is from the patient referenced above (for labeling problems).

Comments:_________________________________________________________________________

PRINT NAME SIGNATURE DATE

The pathologist on duty has also been made aware of this situation.

Name of Pathologist notified Signature Date and time

This completed form will be forwarded to PALM QA and VAWNYHS Patient Safety.