Quality Systems Laboratory Procedures and Policies

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1 Quality Systems Laboratory Procedures and Policies Subject: Critical Values Critical limits define the boundaries of the high and low life-threatening values of laboratory test results. Their primary objectives are to improve patient care and to use resources more efficiently. To ensure this information reached the physician, a telephone call will be made immediately and the licensed caregiver will be requested to "readback" the critical result for verification and documentation in the LIS. This is in compliance with Administrative Policy, , Critical Test Results. To ensure the timeliness of reporting and the timeliness of receipt by the responsible caregiver, the laboratory will annually measure and assess and, if appropriate, take action to improve the critical value reporting. In-Patient Test Results: 1. The laboratory will contact the patient's nurse or designated licensed charge person and will verbally report the critical result. 2. The caregiver will be requested to "readback" the critical result. 3. In the LIS, the technologist will document the Full Last name and initial of first name of the caregiver, the date and time reported, and that "readback" of critical result was obtained. Out-Patient Test Results: 1. The laboratory will contact the patient's physician, or 2. The laboratory will contact the appropriate office designee. 3. The physician or office designee will be requested to "readback" the critical result. 4. In the LIS, the technologist will document the name of the caregiver, the date and time reported, and that "readback" of critical result was obtained. 5. If there is no response from the physician or office designee, the lab will implement the following actions: Contact the physician exchange. If no response within 15 minutes, contact the exchange again. If no response within another 15 minutes (a total of 30 minutes from the original call), review the LIS patient demographics information for a possible alternate caregiver. Contact them directly or their exchange. If no response within another 15 minutes (a total of 45 minutes from the original call), contact the Lab Director. The final fail safe contact at the Mercy Hospital Washington is the Chief of Staff. Page 1 of 6

2 LIS Documentation a. All documentation of the critical call must use a template from the text editor to record the data. DO NOT use FREE TEXT. b. To Insert a Critical Call Comment on a single analyte with a template, when resulting the analyte with the critical result, right click on the analyte, select 'add a comment' and the text editor should open up. Hit "CTRL+T", type in "CALL, hit "CTRL+T". The editor should drop in the text = "Results called to at and read back verified. Hit "F3" to move to the underscore section of the template to enter the information "F5" will insert the current date/time into the template. c. To Insert a Critical Call Comment on a panel that contains multiple critical results,select the first critical result in the panel, right click on the analyte, select 'add a comment' and the text editor should open up. Hit "CTRL+T", type in "CALL, hit "CTRL+T". The editor should drop in the text = "Results called to at and read back verified. At the beginning of the template, enter the name of the analytes that were called to the caregiver, i.e., "Sodium and Potassium results called to at and read back verified. Hit "F3" to move to the underscore section of the template to enter the information "F5" will insert the current date/time into the template. d. For an analyte that is only called on the initial occurrence, and any subsequent critical result which occurs during the patients encounter, this critical result will be documented with a Result Comment indicating a persistent abnormal result. Be sure to review the Critical Values for the analytes that are eligible for this protocol. Do NOT use Free Text to append the comment. Next to each analyte that qualifies, right click on the analyte, select 'add a comment' and the text editor opens up. Hit "CTRL+T", type in "PABN", hit "CTRL+T". The text editor should drop in "Persistant Abnormal Result". The following tables list the critical limits which are phoned: Page 2 of 6

3 Table 1: Clinical Chemistry Critical Limits TEST UNITS IF LESS THAN OR EQUAL CALL IF GREATER THAN OR EQUAL CALL Bilirubin, Neonate mg/dl BUN 3 mg/dl Calcium mg/dl Calcium, Ionized mg/dl Carbon Monoxide % of Hgb Chloride mmol/l CK-MB 4 ng/ml -- Male > 6.8 Female >3.9 CO2 meq/l Creatinine 3 mg/dl CSF Glucose mg/dl Ethanol mg/dl Glucose, Neonate mg/dl Glucose, Adult mg/dl Lactic Acid mmol/l Magnesium mg/dl Methehemoglobin %of Hgb Osmolality mosml/kg pco2 mm Hg ph Phosphorus mg/dl po2, Adult mm Hg po2, Neonate mm Hg Potassium, Adult mmol/l Potassium, Neonate mmol/l Sodium meq/l Troponin T 4 ng/ml Uric Acid 3 mg/dl Except dialysis and known chronic renal failure patients 2 Except chronic renal failure patients with Phosphorus of >8.9 mg/dl, critical low Ca** is 5.1 mg/dl 3 Values are phoned only for new or previously unreported patients. Page 3 of 6

4 4 Current admission, first time elevated CKMB or Troponin CKMB >6.8(M) or >3.9(F) ng/ml Troponin T >0.03 ng/ml 5 SJMH only: OB Inpatients will have the first critical Mag+ called to nursing unit, consecutive critical Mag+ will be commented as Persistant Abnormal Result Table 2: Hematology Critical Limits NOTE: Critical Values will be phoned in the following situations: 1. New or unknown patients 2. Patient on whom critical values have not previously been obtained 3. Previous patients now showing a significant negative change TEST UNITS IF LESS THAN CALL IF GREATER THAN CALL Hematocrit, Adult % Hematocrit, Neonate % Hemoglobin, Adult g/dl Hemoglobin, Neonate g/dl Platelets x10 3 /ul WBC 2 x10 3 /ul CSF WBC, Adult /ul CSF WBC, Neonate /ul Kleihauer Stain % PT seconds PTT seconds Fibrinogen mg/dl Factor Activity (SLU) % QUALITATIVE CRITICAL RESULTS: New diagnosis or findings of leukemia Suspicious cells from body fluid Presence of malarial parasites Positive Monospot 2 WBC: Call outpaient critical WBC on 2 nd, 3 rd shift, weekends and holidays only if absolute neutrophil number is <800 for non-oncology patients. Call <500 for oncology patient. Page 4 of 6

5 Table 3: Qualitative Critical Limits BLOOD BANK: Incompatible Crossmatch MICROBIOLOGY: Page 5 of 6

6 CALL POSITIVE RESULTS FROM: AFB: culture/smear Amniotic smear Antigen testing: bacterial, fungal, viral or parasitic Blood culture Bordetella culture/pcr CSF: culture/smear Clostridium difficile toxin Group A strep screens Probes: N. gonorrhoeae or C. trachomatis Ova and Parasite exam Viral: culture/smear Significant pathogens from normally sterile fluids or placenta cultures CALL POSITIVE INITIAL ISOLATES OF: Any infectious organism that has the potential or may be implicated as an agent of mass destruction or bioterrorism (i.e. Bacillus anthracis, Brucella species, etc) Campylobacter Chlamydia trachomatis Corynebacterium diphtheriae Cryptococcus Ecoli O157:H7 Francisella tularensis Group A Beta Strep Group B from pregnant women or neonates Histo-Blasto-Coccidio Legionella Listeria monocytogenes MRSA Mycoplasma Neisseria gonorrhoeae Salmonella Shigella Ureaplasma Vibrio VISA/VRSA VRE Yersinia Fetal Fibronectin - positive URINALYSIS Strongly positive for both glucose (4+) and ketones (3+ or 4+) Presence of pathologic crystals (cysteine, leucine, or tyrosine) Page 6 of 6

7 Table 4: TDM TEST UNITS IF LESS THAN OR EQUAL CALL IF GREATER THAN OR EQUAL CALL Acetaminophen ug/ml Carbamazepine ug/ml Cyclosporine ng/ml Digoxin ng/ml Gentamicin, Peak ug/ml Gentamicin, Random ug/ml Gentamicin, Trough ug/ml Lithium mmol/l Methotrexate,24 Hr Methotrexate,48 Hr Methotrexate, 72 Hr umol/l umol/l umol/l Phenobarbital ug/ml Phenytoin (Dilantin) ug/ml Salicylate mg/dl Theophylline ug/ml Tobramycin, Random Tobramycin, Peak Tobramycin, Trough ug/ml ug/ml ug/ml Valproic Acid ug/ml Vancomycin, Random ug/ml Vancomycin, Trough ug/ml Page 7 of 7