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Unlabeled Specimens cont.5. The SPR employee will then notify the client that we have received an unlabeledspecimen. If the client insists that the specimen be tested, a specimen releaseform is required via fax or courier from the client stating that they takeresponsibility for the results from an unlabeled specimen. Then accession thespecimen in RE in the following manner: client code, unlabeled. For example, anunlabeled specimen from a DAVID location will have the name DAVID,UNLABELED. Never accession an unlabeled specimen with the alleged patient’sname, birth date, social security number or the chart number. The SPR employeeshould explain to the client that the results will contain no patient identifier, andthat the client and not the patient will be billed. In order for the lab to crossreference unlabeled orders, LREV should be ordered on both the originalcredited accession number and the newly created “unlabeled” accession number.BOTH accession numbers should be listed on each LREV comment.6. Finally, all requests for testing on unlabeled specimens must be reviewed prior totesting by a supervisor or lead tech. These charge personnel must ascertain thatthe test requested is a screening test and not a diagnostic test. Examples of teststhat would never be performed on unlabeled specimens are cancer antigenssuch as PSA, CA125, and CEA. We would also never perform HIV, hepatitistesting, and T4T8 on an unlabeled specimen. Technical judgment must beutilized in all cases.Page 2 of 2

Carolinas Laboratory NetworkCarolinas Medical CenterUnlabeled Specimen Release FormI (please print name) request that Carolinas Medical CenterLaboratory perform the following test(s) on an unlabeled specimen received from myfacility.1.2.3.I believe the patient’s identity to be (print name of patient) andwill assume responsibility for all results received on this patient. I understand that thelaboratory will not place a patient’s name on the specimen, but will accession andresult as “Unlabeled”.SignatureDatePlease fax completed form to 704-355-7721CMC Laboratory Supervisor Approval

CAROLINAS LABORATORY NETWORKSection 3Critical ValuesCritical Values ListCritical Values Notification Policy

Carolinas Laboratory NetworkCritical Values ListHematologyTestLower LimitHigher LimitWBC (White Blood Count)(This value not called if previousresult of 1,000 is documented ascalled) 1000 50,000 20.0 g/dl 6.0 g/dl(Greater than 2 weeks old)Hemoglobin 7.0 g/dl 24.0 g/dl(Newborn - 30 days)(Less than 2 weeks old) 20,000Platelets 1,000,000 30,000(Newborn to 30 days)Previously unreported blasts, intracellular organismsSmearCoagulationTestFibrinogenProthrombin Time (PT)PTTLower Limit 50 mg/dlHigher Limit 49.0 seconds 120 secondsUrinalysis and Body FluidsConditionTestPresence of malignant cells, blasts or microorganismsCSFKetonesMicroscopic ExamReducing SubstancePositive ketones in newbornsSpirochetes resembling Treponema pallidumNewborns - Positive reducing substance when glucose isnegativePresence of sperm in female under 13 years of ageSpermBlood GasesTestPCO2pHP02Lower Limit 20 mmHg 7.2 50 mmHgCopy of GEN.CLN.LT.9 02.v6.CriticalValList.081007.xlsHigher Limit 70 mmHg 7.6Page 1 of 4

Carolinas Laboratory NetworkCritical Values ListChemistryTestAlcohol - Ethanol (ETOH)Alcohol - Ethylene GlycolAlcohol - Volatile NonEthanolLower LimitPositive 18.0 mg/dlBilirubinCalciumHigher Limit 400 mg/dlPositive(Less than 2 weeks old) 6.0 mg/dl 14.0 mg/dl 6.3 ng/ml(Critical not called if previousresult of 6.3 ng/ml isdocumented as called)CKMBCO2Glucose (Blood)Glucose (CSF) 10 mmol/L 40 mg/dl 40 mg/dl 40 mmol/L 500 mg/dl 7.5 mmol/L(Less than 6 months old)K (Potassium) 2.5 mmol/L 6.5 mmol/L(Greater than 6 months old)Lead (Blood) - Public Health 10 μg/mlDept OnlyMagnesiumNA (Sodium)Phosphorous 1.0 mg/dl 120 mmol/L 1.5 mg/dl 4.7 mg/dl 160 mmol/LTroponin I(Critical not called if previous 0.5 ng/mlresult of 0.5 ng/ml isdocumented as called)Therapeutic wer LimitCopy of GEN.CLN.LT.9 02.v6.CriticalValList.081007.xlsHigher Limit 150 µg/ml 45 µg/ml 50 µg/ml 20 µg/ml 3 ng/ml 30 µg/ml 12 µg/ml 9 µg/ml 2 mmol/L 24 µg/ml 60 µg/ml 12 µg/ml 30 µg/ml 10 µg/ml 40 µg/mlPage 2 of 4

Carolinas Laboratory NetworkCritical Values ListTherapeutic Drugs (continued)TestTheophyllineTobramycinValproic AcidVancomycinLower LimitHigher Limit 25 µg/ml 12 µg/ml 200 µg/ml 60 µg/mlBlood Bank Any cord blood with positive direct coombs Any 2 or greater result for Anti-C3d/b Incompatible crossmatch with potential for lack of donor bloodTB/Mycology All positive acid fast smears from pulmonary secretions Dimorphic fungi recovered from any sourceMicrobiology All initial positive blood cultures All initial positive results (gram stain or culture) from the following normallysterile body fluids - Vitreous, CSF, Pleural, Pericardial, Peritoneal, Synovial Eye cultures positive for Neisseria gonorrhoeae , Pseudomonas , Bacillus,Aspergillus, or Fusarium species Isolates of Clostridium perfringens or Clostridium septicum recovered fromwounds or cultures of tissues (NOTE: Before phoning, discuss with medical director ofmicrobiology,or, in their absence, the on-call pathologist) Isolates of E.coli O157:H7 from stool cultures Isolates of Salmonella or Shigella from stool cultures (Public Health Dept Only) All possible agents of bioterrorism including the following: Bacillus anthracis,Francisella tularensis, Brucella spp., Yersenia pestis Highly unusual or significant organisms or those recovered with low incidence.(NOTE: Before phoning, discuss with medical director of microbiology, or, in their absence, the oncall pathologist)Special Microbiology/Immunology All positive acid fast smears from pulmonary secretions Positive CSF VDRLs All positive RSV cultures (where DFA or EIA was negative) Positive RPRs on cord blood All positive cryptococcal antigens All positive Pneumocystis (DFA) All positive Legionella urinary antigensCopy of GEN.CLN.LT.9 02.v6.CriticalValList.081007.xlsPage 3 of 4

Carolinas Laboratory NetworkCritical Values ListSpecial Microbiology/Immunology (Continued) All agents of possible bioterrorism, including Variola (Smallpox) virus Any positive viral cultures on children under 10 years of age Any positive rapid HIV result on maternity patients Any positive result for SARS (Severe Acute Respiratory Syndrome) Results providedby Public Health Dept.Copy of GEN.CLN.LT.9 02.v6.CriticalValList.081007.xlsPage 4 of 4

Carolinas Laboratory NetworkCritical Values and Test NotificationI.POLICY AND PURPOSETo ensure that critical tests and critical values are communicated properly and in a timelymanner in order to support the immediate and safe care of the patient. Critical values arethose abnormal test results that could potentially be life threatening. Critical tests arethose identified tests that require rapid communication of results, even if results arenormal. All critical values should be called immediately and all critical tests must be calledwithin timeframe noted on critical test list.II.PROCEDUREA. Critical Values1. The CLN Clinical Laboratory Critical Values is maintained in the LaboratoryInformation System (LIS) and posted in the laboratory. This document should bereferred to during LIS downtime.2. The LIS flags critical values when they are resulted in the computer:“Critical Value, Phone Physician”.3. Critical values are displayed as HH or LL in the LIS and **PANIC** inHBOC/STAR.B. Contacting Medical Professionals1. Results are called by the reporting laboratory directly to a medical professionalin the facility associated with the patient or client. If that medical professional isunavailable, you must then request the charge nurse of that location. Results arenot given to secretarial staff or laboratory staff from CHS Mecklenburg Facilities.Results for non-CHS Mecklenburg facilities may be called directly to thelaboratory. See item #4 below for special instructions on microbiology criticalvalues for the emergency department.Under no circumstances, are results to be reported to an answeringmachine.2. Phone numbers for patient locations are available via: phone list Sunquest searchFunction: MIQ, Option 12:Location/Room Number Inquiry CHS Voice Automated Operator systemGEN.CLN.P.9.00.Critical Value Notification REF Lab.06 01 04of 1Page 1

Carolinas Laboratory Network3. During regular business hours of a client facility, notification attempts continue tooccur until successful. In the event a physician does not respond to a page afterhours, a second attempt occurs. If still no response, this is documented in the LISand held to the following business day for notification and final documentation.After hours CMC Clinic results (i.e. CMC Myers Park Clinics (Except OBGYN),CMC Northpark, CMC Biddlepoint, and CMC Eastland Family Practice) arecalled to the physician on call for the practice. For the CMC Myers Park OBGYNClinic, results are called to the medical resident on call as identified by the CMChospital operator. Phone: 704.355.2000After hours Carolinas Physicians Network and other private practice resultsare called to the physician on call listed by the answering service. Critical valuesfor specific physician offices are held until the next morning only upon writtenagreement between the physician office and CLN medical director.4. Emergency Department (Microbiology Critical Values only) CMC onlyCritical Values for microbiology results are communicated to the CMCEmergency Department in the following manner:Admitted PatientsResults are called to the admitting physician or nursing unit for follow-up.Discharged Patients 9am – 5pmAll critical values are reported directly to Rozella Bethea at 704-355-0506 orpager # 4309. If report cannot be given to her directly, the attendingemergency medicine physician must be contacted. For adults, the contactMajor Treatment Attending at 355-2157. For pediatrics, contact PediatricEmergency Medicine Attending at 355-6580.All Other TimesMicrobiology critical values must be called to an attending emergencymedicine physician immediately. For adults, the contact Major TreatmentAttending at 355-2157. For pediatrics (ages 0-17), contact PediatricEmergency Medicine Attending at 355-6580.C. Documenting Notification in LISDocumentation of critical value notification should be noted on the appropriate testline, simultaneously as results are called. If results are continuously attempted withno success or if results are phoned the following day, ONLY the contact call shouldbe documented on the Sunquest. Any attempt to contact, without response, shouldbe documented under the test code LREV in Sunquest under the same accessionnumber of the critical value. (See below for instructions)Documentation of critical tests results should be documented in Sunquest or CoPath.Failed attempts for tests resulted in Sunquest should be documented as noted aboveand critical tests that are resulted in CoPath should be documented in the report.GEN.CLN.P.9.00.Critical Value Notification REF Lab.06 01 04Page 2 of 2

Carolinas Laboratory Network1. After results are entered into the LIS, key in the appropriate comment codeCKDP (checked and called) or CALL (called to), then free text minimally: last name of the person notified phone number or extension called timeExample:8.0-CKDP-; S SMITH 52345 2020 (phone number extension)or8.0-CALL-; S SMITH 7045551212 2020 (full phone number)2. Results held to the following business day should include the date the result wascalled.Example:8.0-CKDP-;BEACHAM 7043555000 0800 3/033. Test Code: LREVLREV enables laboratory staff to free text any contact attempts or other relevantinformation about calling a critical value. This test code documentation is onlyvisible to laboratory staff and will not appear on the patient record. LREV shouldbe ordered as a test, in RE or REI, under the same accession number of thecritical value test. With completion of ordering the test, a prompt for result entryappears. Type a semicolon (;) and begin typing a free test message.Example:LREV: ;paged Dr Jones 2005 no response-; paged again at 2100 noresponse-; Left for calling in AMD. Reading Back Critical ValuesAll critical values and tests reported to a medical professional verbally or by phonemust be “read-back” by the medical professional receiving the information. “Readback” is required to ensure that the result was understood correctly.Documentation in Sunquest of a “read-back” should be included with other requiredcontact/notification information. This should be indicated, after time called, byentering the English text code “RBK” (“Lab value read back”). See example on nextpage.Example:8.0-CALL-;S SMITH 52020 1800-RBKGEN.CLN.P.9.00.Critical Value Notification REF Lab.06 01 04Page 3 of 3

Carolinas Laboratory NetworkIII.Critical Values in POC testing.Critical values obtained in POC testing must be documented and reportedimmediately. For iSTAT testing, the critical value must be communicated immediatelyand documentation of date, time and with whom you gave the critical value. Ifcommunication is verbal, readback must be incorporated and documented.IV.Critical TestsCritical tests are defined and handled in the same way as critical values. Results ofthese critical tests must be called within defined time range. The compliance ofcritical tests notification is reported monthly to the Patient Safety Steering committee.GEN.CLN.P.9.00.Critical Value Notification REF Lab.06 01 04Page 4 of 4

CAROLINAS LABORATORY NETWORKSection 4Sample Preparation and Handling

Carolinas Laboratory NetworkSpecimen Collection and HandlingI.PRINCIPLELaboratory test results are dependent on the quality of the specimen submitted. Patientsmust be properly prepared so that the best possible specimen can be collected. Thespecimen must be properly processed, packaged and transported to the laboratory in atimely manner and under environmental conditions that will not compromise the integrityof the specimen. Care, skill, and knowledge when preparing the patient and specimenare essential to the provision of the highest quality standards for testing and services.II.PROCEDUREA. Health and Safety PrecautionsOccupational Safety and Health Administration (OSHA) has developed guidelines forthe handling of clinical specimens. Every specimen should be handled as a potentialsource of infection. Healthcare personnel are required to comply withrecommendations, which enable the safety of both the patient and healthcarepersonnel. All specimens should be properly sealed prior to being transported.Leaking containers pose a health hazard. Do not submit needles attached tosyringes.B. Patient PreparationMany tests require that the patient be prepared in some specific way to ensure usefulresults. The best analytical techniques provide results that are only as good as thespecimen that has been submitted for analysis.Fasting requirementsFor the majority of tests performed on serum, plasma or whole blood, a fastingspecimen is preferred. The fasting specimen provides information that reflects thephysiological baseline of the patient. From a practical standpoint, non-fastingspecimens are often lipemic, containing high triglycerides from food, which caninterfere with many analytical procedures. Patients should fast for the duration oftime indicated by their physician.Blood, serum and plasma specimensMost blood specimens can be obtained using routine phlebotomy techniques;however, there are some exceptions. The patient’s posture, either sitting, standing orlying down, or the time of day relative to the patient’s sleep cycle can be importantfactors in some tests. Refer to the Test Listing and Specimen Requirements Listingfor specific patient preparation requirements.Specimen Processing.doc

Urine specimensMany urine tests also require specific preparation of the patient. For routine analysis,the first morning voided (concentrated) specimen is always best. For urine culturespecimens, prevention of contamination by normal vaginal, perineal and anteriorurethral flora is the most important consideration for collection of a clinically relevanturine specimen.C. Specimen LabelingEach submitted specimen must be labeled with the patient’s name and date ofcollection. When ordering tests in a series (e.g. glucose tolerance):1.2.3.4.Use one Test RequisitionLabel each specimen with the patient’s name, date and time of collection.Write the number of specimens on the Test Requisition.Submit all specimens within a series together in one specimen bag.D. Instructions for Packaging Specimens and Test Requisitions1. Complete the “Patient Information” (Patient Name, Date of Birth, Identificationnumber, SS number, Physician name (First and Last), Specimen Collection dateand time) and “Insurance Information” (Policy holder name, relation, Companyname and address, Employer name) sections and check ( ) which party will beresponsible for payment in the “Bill To” section of the requisition form. Enter theICD9 diagnosis codes that reflect the patient’s diagnoses.2. Collect the specimen(s) in proper transport container. (Refer to the Test Listingand Specimen Requirements worksheet for more information.)3. The specimen bag has two pouches. Place the specimen(s) in the front ziplockpouch (printed side) and the test requisition form in the back non-ziplock (unprinted side) pouch. This will protect the test requisition form from leakage.4. FROZEN specimens must be placed in a separate specimen bag along with aseparate test requisition form. Frozen specimens cannot be split for othertests.NOTE: PROPER SPECIMEN PACKING HELPS TO EXPEDITE ORDERS.E. Collection/Processing of Serum, Plasma, Whole Blood and UrineSerumThe use of serum separator collection tubes is recommended for most analyses.Please refer to the Test Listing and Specimen Requirements worksheet forrestrictions.When using a serum separator tube, follow these instructions:1. Perform venipuncture as with any other blood collection device.2. Invert the tube gently no more than five times. Further inversion may causealterations in sample integrity.3. Do not remove the stopper at any time. All

Manager, CMC Mercy Lab 704-304-6064: Kientzel, Terri: Manager, CMC Pineville Lab 704-667-0610: . 5. Unique Armband # or Manual Blood Bank Armband # Page 2 of 2 . . For microbiology, histol