REPORTING OF RESULTS FOR SURGICAL PATHOLOGY REPORTS

Surgical Pathology reports conform to standards recommended by the Association of Directors of Anatomic and Clinical Pathology, as published in the American journal of Surgical Pathology 16:84-86, 1992.

A.     Final Report ^{ANP. 12200}

Information in reports must include:

• Name, Gender, Age and/or Date of Birth of patients
• NIH Identification Number, if applicable, Protocol Number, if known.
• Surgical Pathology Number
• Date Specimen received
• Description of Material Received (Gross Description)
• Diagnosis
• Note or Comments regarding the diagnosis and/or use of specialized techniques, when applicable. ^{ANP. 12425}
• FDA Disclaimer concerning Immunohistochemistry stains ^{ANP. 12425}
• Responsible attending pathologist and resident or fellow.
• Comments regarding intradepartmental or interdepartmental consultations obtained.
• Copy of the outside consultation pathology report when pertinent.
• Date Case was Dictated and Verified, and Reported verbally, if applicable.
• Distribution of Reports ^{ANP. 12200}       
  

B.    Turnaround Times  

LP’s QA Committee in coordination with the Surgical Advisory Committee determined the LP’s turnaround times for:

• • Routine biopsies (SBs) should be 5 – 7 days from accession; and,
  • Large or complex cases (Sis) should be 7 – 10 days from accession.

Quality Assurance:

• • Each Attending and Resident receives a 5 day and greater pending list every Monday and Friday. Attending faculty are ultimately responsible for working with the residents to sign out cases within the established turnaround time thresholds.
  • How LP established SB and SI turnaround times:  A 2012 College of American Pathologists QProbe study of 56 government, university, community and private hospitals reported a median turnaround time for 2.72 calendar days for large or complex pathology cases, with government facilities reporting a median of 6.06 days for large surgical cases.

C.    Immediate Notification of Clinical Staff of significant and unexpected surgical pathology findings should abide

        by the following guidelines:  ^ANP.12175

In any case in which the final diagnosis is considered significant and/or unexpected (for example, significantly different from the submitting diagnosis or preoperative diagnosis, change of a frozen section diagnosis after review of permanet sections), the resident and/or staff pathologists responsible for the case should contact the submitting physician and notify him/her of the findings.  In case of discrepant frozen sections, the attending who read the frozen section should contact the surgeon and discuss the case. There should be a reasonable effort to ensure that such diagnoses are received by the clinician/surgeon by means of telephone, pager, or other system of notification. Because physicians may not promptly receive copies of reports, it is especially important that we document notification of physicians to significant and/or unexpected pathology findings.

If you are unable to contact the submitting physician, a message should be left with the Clinical Branch Chief or the Clinical Director’s office of the Institute involved. There should be written documentation of notification, including the name of the physician contacted, the name of the person making the contact, and the date and time of the contact.  Notification can be made by the resident, hot seat resident, or staff.

Examples of cases in which notification would be required are as follows:

1.     Unsuspected positive tumor diagnosis.
2.     Unsuspected negative tumor diagnosis.
3.     Unexpected infectious disease.
4.     Change in tumor diagnosis, including change in frozen section diagnosis upon review of permanent sections, which might result in alteration of therapy.
5.     Diagnosis rendered significantly different from preoperative diagnosis.  It is not possible to itemize all instances in which notification would be required.  Staff and residents are urged to consider if notification is advisable when cases are signed out.
6.     Neoplasms causing paralysis
7.     Fat in endometrial curretings or in GI biopsies

All verbal reports require read back of patients name, medical record, diagnosis and unexpected findings.

When the final pathology report is processed, include in the NOTE the information regarding documentation of communication of these diagnosis.  Frozen sections discrepancies should be documented in the surgical pathology report as well as in the LP quality Management files.

D.        Copies of final reports will be filed and retained in the laboratory of Pathology records, in the electronic patient card file, and in Medical records (for NIH Patients).

E.        Immediate or Rush reports will be documented in writing and the information incorporated later in the final report as well as the name of the person contacted and date.

FE.        Immediate or Rush reports rendered for emergency cases not yet accessioned will be documented on an NIH consultation report (SF 513).  A copy of the report will be incorporated into the patient’s chart, and the original will be kept for the Surgical Pathology files.  The reporting of emergency diagnoses will be documented in the final report.

G.         A supplemental report will be issued if additional material and/or information is received regarding a finalized report. ^ANP.12175

H.        ^ANP.11850Intraoperative Consultations (“Frozen Sections”):  Intraoperative Consultations will be reported immediately after the consultations/frozen section is performed (within 5-10 minutes), through the phone or intercom system. ^{ANP. 11900} Case can also be discussed in person with the surgeon if he/she chooses to come to the Frozen Section Room.  Results will be written on NIH consultation report forms (SF 513). ).  The copies are sent with the specimen and slides to histology and dictated into the final pathology report. ^{ANP. 11900}. ^{ANP. 12000} Results of intraoperative consultations will be included in the final report, and will include the names of the physicians performing the consultation. ^{ANP.11850 ANP.12000}

I.        Verified reports are reported through the Clinical center CRIS system.  Copies of reports are e-mailed/faxed to requesting physicians.  Copies of reports on submitted surgicals may be also mailed to the outside pathologist (s).  Upon request, reports are faxed to requesting physicians.

JI.        ^ANP.12400Correlation of Results:  Attendings and Residents will correlate results of specialized studies, such as immunohistochemistry, nucleic acid probes, molecular studies, cytogenetics, flow cytometry, and any specizlized pathology testing while reviewing each case material.^ANP.12400 

^{ANP. 12350}Incorporation of Scientifically Validated Data Elements (SVDEs) in final Surgical Pathology Reports

• For specimens from definitive cancer resections, and in specific biopsies as outlined in the CAP Cancer Protocols all scientifically validated data elements (SVDEs) needed for standard systems of grading, staging and prognostication should be included in the final surgical pathology report.

• ^ANP.12385While the use of CAP Cancer Protocols and Checklists (reported in a synoptic format) are encouraged, they are not required at this time as long as all clinically relevant information (necessary for grading and staging) are included in the final surgical pathology report. ^ANP.12385

• For specimens with malignant diagnoses from definitive cancer resections and specific biopsies as outlined in the CAP Cancer Protocols pathology reports should be audited at least annually to ensure that all SVDEs are included in the final surgical pathology report. ^{ANP. 12350}

POLICY ON THE REPORTING OF BIOMARKERS- IMMUNOHISTOCHEMISTRY

The immunohistochemistry unit performs tests that provide independent predictive and/or prognostic information.  The reporting of these tests is done by Laboratory of pathology pathologists who are responsible for the reporting and scoring of the biomarkers, according to generally accepted criteria or by criteria mandated in pertinent clinical protocols.

The immunohistochemistry unit recommends use of the following guidelines when performing scoring for all biomarkers offered by the immunohistochemistry unit:

1. Provide the type of tissue fixation and processing (e.g.) formalin fixed paraffin embedded sections, air-dried imprints, etc).
2. Provide the antibody clone and general information regarding use.
3. Provide scoring criteria for positive and negative results or scoring system details (e.g. the percentage of cells positive)

Specific staining information and scoring recommendations for individual biomarkers including ER, PR, HER2/NEU, EGFR, C-Kit are encountered on the Immunohistochemistry Procedure Manual.

The final report for any breast case in which either ER/PR or Her2/neu has been done by immunohistochemistry MUST include the following:

Predictive Marker Methodology

For ER and PR, the following interpretation of staining is used (per ASCO guidelines, JCO 28: 2784; 2010):
Receptor Positive: At least 1% of tumor cell nuclei staining weakly positive.
Receptor Negative: Less than 1% of tumor cell nuclei staining.

For Her-2 staining on breast carcinoma and carcinomas from sites other than the stomach, tumor staining is scored following CAP/ASCO guidelines (J Clin Oncol 2013; 31: 3997-4013) as follows: 

• Score 0 (Negative): No Staining OR faint or barely perceptible, incomplete membrane staining ≤ 10% of tumor cells
• Score 1 (Negative): Faint or barely perceptible, incomplete membrane staining in > 10% of tumor cells
• Score 2 (Equivocal): Strong, circumferential membrane staining in ≤ 10% of tumor cells OR weak to moderate circumferential/incomplete staining in  > 10% of tumor cells
• Score 3 (Positive): Strong, circumferential membrane staining in > 10% of tumor cells