36C24219R0014-160.pdf

VA WESTERN NEW YORK HEALTHCARE SYSTEM

September 30, 2016 CENTER MEMORANDUM NO. 11-13

ESTABLISHMENT, REPORTING AND MONITORING OF

EMERGENT AND SIGNIFICANT UNEXPECTED PATHOLOGY AND

LABORATORY TEST RESULTS

1. POLICY: In addition to routine reporting of test results in the medical record, VA Western New York Healthcare System will establish a process for effective, timely and verifiable communication of emergent and unexpected significant test results by the Pathology and Laboratory Medicine Service to a responsible provider to ensure safe medical care.

A. Definitions:

(1) ANATOMIC PATHOLOGY (AP) RESULT: Any lab result that requires morphologic interpretation of cells or tissues by a pathologist (typically Surgical pathology, Cytopathology or Autopsy Pathology).

(2) CLINICAL PATHOLOGY (CP) RESULT: All lab results other than those requiring morphologic interpretation of cells or tissues by a pathologist.

(3) DIRECT COMMUNICATION: Verbal conversation either face-to-face or via telephone, and/or direct handoff of a printed result.

(4) RESPONSIBLE PROVIDER: A healthcare professional who can evaluate the patient and provide appropriate clinical care in the context of a laboratory result.

(5) RESPONSIBLE PROVIDER DESIGNEE: A healthcare professional approved by the medical staff to receive the results of emergent or unexpected laboratory results on behalf of the responsible provider in specific clinical care settings.

(6) VERIFIED RESULT: A laboratory test result that is visible in the patient’s electronic medical record after completion of all quality checks in the laboratory.

(7) ABNORMAL RESULT: A test value that does not fall within the reference range established for that analyte and requires review by a responsible provider, but not necessarily in an immediate time frame. These results may be communicated by either direct or electronic means.

(8) CRITICAL RESULT: A test value identified by the medical staff as requiring immediate evaluation of the patient. These results will be directly communicated to a responsible healthcare provider or designee whin the time frame approved by the medical staff.

(9) CRITICAL TEST: A test identified by the medical staff as requiring emergent communication of ALL results, whether normal, abnormal or critical.

D.19 ESTABLISHMENT, REPORTING AND MONITORING OF EMERGENT AND SIGNIFICANT

UNEXPECTED PATHOLOGY AND LABORATORY TEST RESULTS (CM 11-13)

CENTER MEMORANDUM NO. 11-13

(10) EMERGENT TEST RESULT (includes CRITICAL TESTS AND CRITICAL RESULTS): A laboratory test result that is associated with a high likelihood of poor patient outcome within a short time period unless immediate therapeutic intervention or close monitoring is performed. (Attachment A defines Clinical Laboratory critical and significant tests and results. Attachment B defines Anatomic Pathology critical and significant tests and results).

(11) UNEXPECTED SIGNIFICANT DIAGNOSIS: A CP test result or AP diagnosis that is not emergent but is clinically unusual or unforeseen, that a responsible provider needs to be made aware of as soon as practical (usually within 1 – 2 working days).

B. Responsibilities: This memorandum applies to all providers, registered nurses, and Pathology and Laboratory Medicine Service (PALMS) personnel.

(1) Medical Director, PALMS and the Executive Committee of the Medical

Staff:

a. determine the list of Critical tests

b. determine the list of critical results

c. determine the time frame within which critical tests and results must be communicated to a responsible provider

d. determine responsible provider designees in specific care settings

e. review these lists biennially and modify as needed.

(2) Executive Committee of the Medical Staff is responsible for approving:

a. this memorandum including the list of critical tests and critical results.

b. any exceptions to the process described in this memorandum (approved exceptions will be incorporated into an updated memorandum).

(3) PALM staff is responsible for recognizing the critical test result, verifying the result in the computer (so it will be available in the electronic medical record) and immediately starting to call the ordering provider.

(4) Monitoring of the timeliness of notification will be performed by the service contacting the provider (either Lab or Nursing) as per their approved protocol.

(5) The ordering provider (or covering provider, if the ordering provider is not available) is responsible for receiving critical test results on outpatients. For critical test results on a discharged ER patient, the patient’s PC provider (or covering PC provider) will be responsible for receiving the result.

(6) Each Clinical Service Chief is responsible for ensuring the availability at all times of accurate, updated call lists with contact numbers for responsible providers.

(7) The Hospitalist/Medical Officer of the Day (MOD) is responsible for receiving emergent results during non-administrative hours on:

a. all outpatients (both Primary Care and Specialty Care)

b. Long Term Care inpatients.

(8) If no provider is reached after using the appropriate call lists the responsibility for receiving and acting on critical test results lies with the Chief of Service and ultimately with the Chief of Staff.

3. PROCEDURES:

A. Order entry:

(1) Electronic order entry (directly into the patient’s electronic medical record - CPRS) is always preferred.

(2) If for some reason, electronic order entry cannot be used, the manual laboratory requisition form must include the first and last name of the requesting provider, the ward or clinic location and a telephone extension and/or pager number to facilitate communication. (This is in addition to the required patient information)

B. Computer Notification:

(1) An "Electronic Alert" is generated upon "verification" of critical numeric lab results and transmitted to the ordering and attending providers.

(2) A view alert can also be generated for abnormal results if the provider chooses to set up his/her computer alert option in this fashion.

C. Direct Communication:

(1) All emergent test results (critical results and/or tests) must be transmitted to a responsible provider by direct communication.

a. Communication Timeline:

Critical results: within 30 minutes of result verification.

Critical tests: within 15 minutes after the specimen is received in the lab.

b. If the ordering provider is not reached within 10 minutes PALM staff will use the applicable flow sheets and flow charts to call the next responsible provider.

c. Critical lab values may be directly communicated to a Registered Nurse (responsible provider designee) in the following care settings:

i. Intensive Care Unit (ICU),

ii. Operating Room (OR),

iii. Emergency Room (ED),

iv. Potassium values from Dialysis

v. Blood gas results from a code.

d. Nurses staffing ICU, OR, ED and Dialysis will follow the protocols established in their department to act upon the critical test results or will provide information to the responsible licensed caregiver so the patient can be promptly treated.

e. Printouts of all blood gas results from an identified “code” may be handed to the person who delivers the sample to be delivered immediately to the provider running the code. However, the laboratory must still call and document all blood gas results from a code.

(2) Pathology and Laboratory Medicine personnel reporting critical test results will clearly identify the purpose of the notification, the laboratory test result(s), and any other pertinent information (i.e. sample hemolysis, lipemia, potential mis-draw, the normal or therapeutic range if requested, etc). A verification "read-back" is required by the person receiving the emergent test results (critical value) to confirm that the information was understood correctly.

(3) POINT OF CARE TESTS: Individuals performing ancillary testing are responsible for:

a. knowing the critical limits for each test performed

b. notifying the provider of the critical results within 30 minutes (unless other orders exist).

For example, providers must be notified of any glucose result that falls within the critical range of less than 50 mg/dl or greater the 450 mg/dl unless there is a treatment protocol in place defining what steps need to be taken to act on the critical value.

c. ensuring a verification "read-back" by the person receiving the point of care critical value to confirm that the information was understood correctly.

d. documentation of critical value notification in the medical record as per protocol (CM 113-9).

D. Direct Communication – Anatomic Pathology Results: see Attachment B.

E. Documentation:

(1) The laboratory staff member relaying the critical laboratory result will document the following in Vista under “comments” which are displayed with the test results: that read-back has been performed by using the code “CVCR” (critical value called, read back performed), the time and date of the notification, the name of the test, the name (and title) of the person to whom the results were given, and their initials.

(2) For ancillary testing the notification of the critical test result with read-back must be documented in the patient record according to protocol (refer to Center

Memorandum 113-9).

F. Monitoring: PALM and nursing service will each have a tracking process in place to measure and if necessary improve the timeliness of reporting and the timeliness of receipt by the responsible licensed caregiver to avoid any unnecessary delays in treatment.

5. REFERENCES:

a. Comprehensive Accreditation Manual for Hospitals: The Official Handbook

(CAMH),

b. VHA Directive 2009-019,

c. Center Memorandum 11-16 Intensive Care Unit (see attachments),

d. Center Memorandum 111-2 Hemodialysis Unit (Potassium Critical Values Protocol Attachment),

e. Center Memorandum 113-9 Fingerstick Glucose Testing Policy,

f. Laboratory Communication Policy (PALM SOP).

6. RESCISSION: Center Memorandum No. 11-13, dated January 15, 2015

7. AUTOMATIC REVIEW DATE: September 1, 2019

8. FOLLOW-UP RESPONSIBILITY: Director, Pathology & Laboratory Medicine (113)

//s//

BRIAN G. STILLER

Medical Center Director

Attachment: A & B

DISTRIBUTION: 1 copy each (00, 00QM, 11, 113)

ATTACHMENT A- CRITICAL & SIGNIFICANT CLINICAL PATHOLOGY (CP)

TESTS AND RESULTS

Significant or unexpected CP Result: Any lab result called by a reference lab to VAWNY lab.

Critical CP Test: An Arterial Blood Gas collected during a cardiac arrest (code).

Critical CP Results:

A. CHEMISTRY:

Less than or equal to Greater than or equal to

Glucose 50 mg/dl 450 mg/dl

Sodium 120 mEq/L 160 mEq/L

Potassium 3.0 mEq/L 6.2 mEq/L

Calcium 6.6 mg/dl 12.5 mg/dl

Magnesium 0.8 mg/dl 4.0 mg/dl

Blood Gas pH 7.25 7.5

Blood Gas PO2

(arterial or unspecified)

50 mmHg ------

Blood Gas PCO2

(arterial or unspecified)

------ 65 mmHg

Lactate ------ 4 mmol/L

Troponin ------ 0.4 ng/ml

B. HEMATOLOGY:

WBC 2 K/mm3 40 K/mm3

Neutrophils, ABS 0.5 K/mm3 ------

Hemoglobin 6.6 g/dl 20 g/dl

Hematocrit 20% 60%

Platelets 20 K/mm3 1,000 K/mm3

INR ------ 4.5

ATTACHMENT A CONTINUED

Partial Thromboplastin ------

Time (PTT)

115 seconds

Spinal Fluid Cell Count ------

(NFC=nucleated fluid cells)

100 NFC/mm3

C. TOXICOLOGY:

D. MICROBIOLOGY:

(1) Bacteria or fungi recovered from a sterile body site (i.e. positive sterile body fluid including CSF – smear or culture, positive blood culture)

(2) Positive Acid Fast Bacilli (AFB) – smear or culture.

(3) Positive blood or tissue parasites including malaria.

Acetaminophen ------ 150 mcg/ml

Digoxin ------ 2.5 ng/ml

Ethanol ------ 400 mg/dl

Carbamazepine ------ 15 mcg/ml

Gentamycin peak ------ 12 mcg/ml

Lithium ------ 2 mEq/L

Phenobarbital ------ 60 mcg/ml

Phenytoin ------ 25 mcg/ml

Quinidine ------ 6 mcg/ml

Salicylates ------ 30 mg/dl

Theophylline ------ 25 mcg/ml

Valproic Acid ------ 125.1 mcg/ml

Vancomycin peak ------ 40 mcg/ml

Vancomycin trough 20.0 mcg/ml ------

ATTACHMENT A CONTINUED

E. BLOOD BANK:

(1) Suspected hemolytic transfusion reaction or bacterial contamination

(2) Significant delay in blood or blood product availability.

(3) Positive Direct Antiglobulin Test

F. SEROLOGY:

(1) Positive Cryptococcal Antigen

ATTACHMENT B – CRITICAL & SIGNIFICANT ANATOMIC PATHOLOGY (AP)

TESTS AND RESULTS

Anatomic Pathology tests may take several hours to a day or more to complete, and this processing time alters the temporal impact of an AP critical call on patient management.

Therefore an emphasis on reporting them in the same time frame (usually less than 30 minutes) as a critical result in Clinical Pathology often does not add clinical value.

In addition, the significance of Anatomic Pathology diagnosis may vary with the clinical context and is heavily dependent on the pathologists’ judgement as a physician.

A. Communication Timeline: Expedited communication of AP results will occur within one of three time frames:

(1) Critical AP Tests will be verifiably communicated within 20 minutes of specimen receipt in the lab for single routine cases (ie: those not requiring additional processing).

(2) Critical AP results will be verifiably communicated within 1 hour of diagnosis

(or suspected diagnosis, based on the pathologist’s judgement).

(3) Unexpected Significant AP Diagnoses will be verifiably communicated on the day of diagnosis, or on the next working day, depending on the clinical urgency of the findings, as determined by the pathologist.

In all cases the pathologist will document the communication in the pathology report, including the name of the responsible provider contacted as well as the date & time of the communication.

B. Method of Communication and documentation:

(1) The Pathologist will directly communicate via telephone or in person with the responsible provider and this communication will be documented in the

Pathology report.

(2) The method of notification may be changed based on a written request from a responsible provider as long as the new method provides for active confirmation of receipt of the message from the pathologist. The entire communication, including confirmation of receipt by the responsible provider must be documented in the Pathology report. If confirmation of receipt is not received within 24 hours the pathologist will call and notify the provider and document both attempts in the pathology report.

(3) If the pathologist is unable to contact a responsible provider for a critical test or result the Chief of the treating service must be notified. If the service Chief cannot be contacted the Chief of Staff must be notified.

ATTACHMENT B CONTINUED

(4) If a responsible provider cannot be contacted the pathologist must use medical judgement to determine if the VA police need to be notified to immediately contact and transport any outpatient veteran with a significant diagnosis requiring emergent attention.

C. Critical Tests in Anatomic Pathology:

(1) Intraprocedure Pathology Consultations, including gross, cytologic or frozen section diagnosis of OR cases and adequacy assessment for CT guided Fine

Needle Aspiration Biopsy (FNAB).

D. Critical Results in Anatomic Pathology: The following list provides examples only and is neither comprehensive nor obligatory. The Pathologist must always exercise medical judgement to determine which diagnosis needs expedited communication to ensure safe patient care.

(1) Clinically unsuspected potentially life threatening infection (eg: endocarditis in a heart valve, bacteria or fungi in CSF cytology).

(2) Clinically unsuspected infection in an immunocompromised patient (eg:

CMV pneumonia; CMV colitis; pneumocystis, fungi or viral cytopathic change in Bronchoalveolar lavage, bronchial washings or brushings).

(3) Clinically unsuspected infection requiring prompt institution of infection control procedures (eg: necrotizing granulomas suspicious for mycobacterium tuberculosis [MTB] in a wedge biopsy for ‘lung tumor’; acid-fast bacilli identified in patient tissue)

(4) Unexpected tissue for the procedure (eg: portion of ureter in a colectomy specimen, fat in an endometrial biopsy).

(5) Expected tissue not identified (eg: absence of chorionic villi or Trophoblasts in uterine contents submitted as ‘Products of conception’)

E. Significant, Unexpected Diagnosis in Anatomic Pathology: The following list provides examples only and is neither comprehensive nor obligatory. The

Pathologist must always exercise medical judgement to determine which diagnosis needs expedited communication to ensure safe patient care.

(1) First diagnosis of a new malignancy (ie – no prior record in CPRS of the patient having that malignancy). A diagnosis of Squamous Cell Carcinoma or

Basal Cell Carcinoma of the skin is excluded from this requirement, but all other newly diagnosed malignancies, even those that are clinically suspected, must be communicated to a responsible provider no later than the next working day after the diagnosis is made.

(2) Herpes in cervical cytology specimens of near term or unknown term pregnant patients.

ATTACHMENT B CONTINUED

(3) Any significant discrepancy between a preliminary diagnosis and the final diagnosis on a patient.

(4) Any major (significant) discrepancy between the intraprocedure pathology diagnosis or adequacy assessment and the final diagnosis on a patient.

(5) Any major (significant) disagreement and/or change between the pathologist who signed out the report and a consulting pathologist (at either the original or consulting institution).

a. If the primary pathologist agrees with the consulting pathologist’s report, a Modified Pathology Report should be issued after calling the treating provider.

b. If the primary pathologist disagrees with the consulting Pathologist, the treating provider must still be called and made aware of the nature of the disagreement, and that a second consultation opinion is being obtained from a nationally recognized subject matter expert. A final report, modified as needed, must be issued documenting results of all the consultations obtained.

REFERENCES:

a. VHA Handbook 1106.1: January 29, 2016

b. VHA Directive 1088: October 2015

c. College of American Pathologists Laboratory Accreditation Program, Anatomic

Pathology Checklist 07.28.2015; ANP 12175.

d. College of American Pathologists Laboratory Accreditation Program, Cytopathology

Checklist 07.28.2015; CYP 06450

e. CLIA ’88 section 493.1234 Standard: Communications: The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results.

f. TJC: NPSG 02.03.01: Improve staff communication – Get important test results to the right staff person on time.

g. Consensus Statement on Effective Communication of Urgent Diagnoses and

Significant, Unexpected Diagnoses in Surgical Pathology and Cytopathology. Arch

Pathol Lab Med. 2012;136:148-154.