MidMichigan Health LABORATORY POLICY Title: Effecti ve te: Key Words: places: Category: Applicability: reference laboratory

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1 Page 1 of 5 PURPOSE This policy describes the responsibilities for determining which tests performed and or provided by the MidMichigan Health Laboratories fulfill the criteria for critical values / critical results/ significant findings and describes the processes for notification, readback and report documentation of those results. NOTE: Once MidMichigan Laboratories have been notified of a critical or significant result from a reference laboratory, the result will be reported and handled according to this policy DEFINITIONS A critical value is defined as a value that represents a pathophysiological state at such variance with normal (expected values) as to be life-threatening unless something is done promptly and for which some corrective action could be taken. POLICY 1. After evaluation of the flag, the Technologist/ Technician verifies the accuracy of the result and before the result is finalized, makes personal contact with an authorized person responsible for the patient s care. In certain locations, the Technologist/Technician calls the result to the Customer Service Department whom is then responsible to make the personal contact with the authorized person. 2. Notification: The patient care provider (Ordering provider, his/her designee, a licensed caregiver or appropriate nursing unit) is notified when critical limits of specified test results are exceeded and/or critical results are obtained. In addition to the usual normal results reporting process (e.g. fax, computer interface), Laboratory staff will telephone the ordering physician or designee within 60 minutes following laboratory release of the critical result(s) according to established procedures. In the event that contact is not made within the 60- minute period, MidMichigan Laboratory staff will continue to telephone until the designated party is reached and the result is conveyed. a. Inpatient/ER: When the result is finalized (Accept prompt is utilized), the report will transmit immediately into the appropriate electronic medical record. b. Outpatients: Telephone and pager are suggested methods of contact c. After hours the Hospital Operator can provide after hour pager and contact information for MidMichigan Health Physicians.

2 Page 2 of 5 d. If, for any reason, the Laboratory is unable to report a critical value within the specified time frame he/she will consult with the house supervisor, pathologist, or manager as appropriate. e. Delays in reporting will be reported to the department Manager, who will determine the applicability of a variance report and further actions. 3. Read-Back of Critical Value / Critical Results: To verify the accuracy of patient information communicated via the telephone, the physician or designee responsible for patient care is required to read-back the patient name, unique patient numeric identification, and the critical test result(s). 4. Documentation: The critical high and low values are documented in the laboratory s standard operating procedure and defined in the laboratory computer information system. NOTE: The identity of the provider or designee will be documented as part of the record of notification and read back statements are documented according to established procedures. CRITICAL RESULT TABLE LABORATORY SERVICES-MIDMICHIGAN HEALTH CHEMISTRY ARTERIAL BLOOD Ammonia > 60 μmol/l ph < 7.3 and > 7.5 Β- hydroxybutyrate > 7 mg/dl pco2 < 20 and > 60 mmhg Bilirubin, cord > 3.5 mg/dl po2 > 150 mmhg blood Bilirubin, neonatal > 15 mg/dl Calcium, ionized < 2.0 and > 6.0 mg/dl BUN > 80 mg/dl Hemoglobin, total < 6.0 and > 20 g/dl Calcium < 6 and > 13 mg/dl Carboxyhemoglobin > 15% Chloride < 80 and > 130 mmol/l CO 2, total < 10 and > 40 mmol/l VENOUS BLOOD Creatinine > 7 mg/dl ph < 7.3 and > 7.5 Glucose < 50 and > 500 mg/dl Calcium, ionized < 2.0 and > 6.0 mg/dl Lactate > 4.0 mmol/l Hemoglobin, total < 6.0 and > 20 g/dl Magnesium < 1.0 and > 4.9 mg/dl Carboxyhemoglobin > 15%

3 Page 3 of 5 Phosphorus < 1.2 and > 9.0 mg/dl Potassium < 2.8 and > 6.2 mmol/l MICROBIOLOGY Sodium < 120 and > 160 mmol/l CSF or Blood (+) Gram stain/culture Troponin > ng/ml HEMATOLOGY MEDICATIONS Fibrinogen < 100 mg/dl Acetaminophen > 200 mcg/ml Hemoglobin, cord < 12.0 g/dl Carbamazepine > 20 mcg/ml blood Hemoglobin, adult < 6.0 and > 20 g/dl Digoxin > 2.1 ng/ml Hemoglobin, pediatric < 6.0 and > 20 g/dl Gentamicin > 2 mcg/ml (trough) Hematocrit, all ages < 18.0 and > 60% Lithium > 1.5 mmol/l Hematocrit, < 15 < 36 and > 60% Phenobarbital > 45 mcg/ml days old INR > 5.0 Phenytoin > 30 mcg/ml Platelet count < 40 and > 1,000 Salicylate > 30 mg/dl Platelet (oncology < 15 Tacrolimus > 20 ng/ml patient) aptt > 130 seconds Theophylline > 20 mcg/ml WBC < 2.0 and > 30 k/μl Tobramycin > 2 mcg/ml (trough) WBC (oncology < 0.8 Valproic acid > 125 mcg/ml patient) Vancomycin > 30 mcg/ml (trough) SIGNIFICANT FINDINGS Microbiology Red = Revisions since 2014 Critical Values Policy Reviewed by Bryan Cross, Director of Pharmacy Synonymous with University of Michigan M Labs critical values MidMichigan Health Laboratories will notify the provider of positive results for any of the following tests, immediately upon verification of accuracy. Note: As a courtesy the provider may be notified of the results of other Microbiology tests not listed below at the technologist s discretion or provider request. Clostridium perfringens Clostridium septicum

4 Cryptococcus Antigen Screen Fusobacterium necrophorum (positive head or neck culture) Joint Fluid (positive stain and/or culture) Staphylococcus aureus (Vancomycin intermediate or resistant) Tissue Culture-internal tissue, bone marrow Positive C difficile test Page 4 of 5 Blood Bank Positive Antibody Screen Incompatible Crossmatch Urinalysis Positive glucose with ketones Anatomic Pathology MidMichigan Health Laboratory Services will notify the provider of any anatomic pathology result with potential to negatively impact patient care if not communicated in an urgent or timely fashion Any significant or unexpected diagnosis of malignancy Any significant disagreement with outside interpretation of general and subspecialty surgical pathology (TS) cases Any significant difference in final versus frozen section diagnosis Any amended report reflecting a significant change in diagnosis Bacteria or fungi in CSF Pneumocystis, fungi or viral cytopathic changes in Bronchoalveolar lavage (BAL), wash, or brush Discovery of clinically significant infections Unexpected absence of chorionic villi in uterine curettings Suspicion of wrong site surgery

5 Malignancy (suspected or not) in critical places in any cytology specimen Disagreement between immediate interpretation and final interpretation in fine needle aspirate specimen Page 5 of 5 Audit Process When a critical value is not documented as called, it remains pending on the call back board. When noted, a call center representative immediately makes contact with the Provider or designee and documents appropriately. The delay is communicated to the Core Laboratory Manager and the Manager of Support Services. The appropriate Manager provides coaching or counseling of the employee who failed to communicate the result according to this policy. References: 1) Critical Limits of Laboratory Results for Urgent Clinician Notification, ejifcc vol 14 no 1: 2) The University of Michigan Health System M Labs Critical Value Table (12/5/16) 3) Table of Critical Limits/MLO/ ( )(modified from JAMA, Vol. 263, pp , 1990) 4) What Alert Thresholds Should Be Used to Identify Critical Risk Results: A Systematic Review of the Evidence. Campbell CA, et. al. Clinical Chemistry 62: 11: (2016) 5) CAP Standard, COM 30000