ALERT VALUE PROTOCOL INITIAL EVALUATION: 1. Determine the category of the alert value by reviewing the Alert Value List.

Transcription

1 Alert Value Protocol: Page 1 of 14 ALERT VALUE PROTOCOL PURPOSE: Alert Values are categorized into three levels of notification requirements, Red, Orange, and Yellow, with respective Communication Time Limits. See current Alert Value List for appropriate category of each test result. The technical staff is responsible for initiating this protocol for every alert value resulted by this laboratory. INITIAL EVALUATION: 1. Determine the category of the alert value by reviewing the Alert Value List. 2. Determine the patient location. 3. Determine the Process to be employed: Location: Inpatients Outpatient: During Office Hours Outpatient: After Office Hours Red (and Intermediate) Immediate Notification Process Immediate Notification Process Immediate Notification Process Orange Immediate Notification Process Immediate Notification Process Delayed Notification Process Yellow Delayed Notification Process Delayed Notification Process Delayed Notification Process 4. Be prepared to give the recipient of the call two patient identifiers, i.e. Patient s full name and Date of Birth or Medical Record Number.

2 Alert Value Protocol: Page 2 of 14 IMMEDIATE NOTIFICATION PROCESS: 1. For Outpatients, other than Nursing Home, determine the attending physician. 2. Call the appropriate location: Results shall be given only to the following: Location: Red Orange Inpatient Facilities and Nursing Homes (without onsite labs or Licensed Caregiver 1 Licensed Caregiver after lab hours) Inpatient Facilities with onsite clinical labs (during lab operating hours) Other Outside Facilities Laboratory personnel Licensed Caregiver 6 (After hours: On-Call MD) Laboratory personnel Designated Office Personnel 2 Successful Notification: Request the recipient of the call to read back the test and the result. For general lab work: Document this action in the LIS 3. See the Callback System Protocol. For Microbiology: See Microbiology Manual. For Pathology: Document in the CoPath System. See the Pathology Manual. Unsuccessful Notification: 1. Print out an IRA. Obtain a Communication Failure Form for Alert Values. It is acceptable to staple the IRA to this form in lieu of completion of the patient Information Section. 2. Note the Start Time = Time of Result. 3. Record 1 st Notification Attempt. 4. A second attempt should be made in 10 minutes for inpatients, 15 minutes for outpatients. Record. 5. If unsuccessful, a third attempt should be made in another 10 minutes (i.e. 20 min from Start Time) for inpatients, another 15 minutes for outpatients (30 min from Start Time). Record. 6. If no notification has occurred by 25 minutes for inpatients or 45 minutes for outpatients since the Start Time, present the Form to the Section Supervisor or, if not immediately available, the Operations Coordinator. 7. He/she will attempt to notify the following as applies. Document. Inpatients and Nursing Homes: Nursing Supervisor. Outpatients: Attending physician or physician On-Call by alternative methods, eg. pager. 8. If a successful notification has not occurred within the following time limits, the pathologist covering the laboratory (business hours) or on-call (after-hours) must be notified. He/ she should review the attempts for communication thus far and work with the lab personnel to identify appropriate failsafe physician to notify if necessary. If the ordering physician is an NSMC staff physician, the failsafe physician should be the department Chairman or Associate Chairman (appendix 1). A failure to reach the failsafe physician after 2 attempts (15 minutes apart, so 30 minutes from initial attempt) should 1 Physician, Nurse, Physician Assistant, Nurse Practioner, or Respiratory Therapist (if Blood Gas Analysis) 2 Personnel who are authorized and delegated to receive Critical Value Results, such individuals should be identified as such by the lab personnel making the call. 3 Laboratory Information System

3 Alert Value Protocol: Page 3 of 14 result in a second notification of the on-call pathologist, who will act as the failsafe physician. If the ordering physician is not an NSMC staff physician, the pathologist should act as the failsafe physician. Red (Inpatient) Red (Outpatient) Maximum Time Limit 30 minutes 60 minutes 9. Document this action. Completed form is to be submitted to the Laboratory Quality Improvement Coordinator. (Incorporate Pathologist s actions, if applicable.) DELAYED NOTIFICATION PROCESS: A designated person, eg. C-1 Tech in Chemistry or Client Services Representative will initiate the Notification Process by the following morning. 1. For Outpatients, other than Nursing Home, determine the attending physician. 2. Call the appropriate location: Results shall be given only to the following: Location: Orange Yellow Inpatient and Nursing Homes Licensed Caregiver 4 Licensed Caregiver Inpatient Facilities with onsite clinical labs (during lab Laboratory personnel Laboratory personnel operating hours) Other Outside Facilities Designated Office Personnel 5 Designated Office Personnel 7 Successful Notification: Request the recipient of the call to read back the test and the result. For general lab work: Document this action in the LIS 6. See the Callback System Protocol. For Microbiology: See Microbiology Manual. For Pathology: Document in the CoPath System. See the Pathology Manual. Unsuccessful Notification: 1. Obtain a Communication Failure Form for Alert Values. It is acceptable to staple the IRA to this form in lieu of completion of the patient Information Section. 2. Note the Start Time = Time of Result. 3. Record 1 st Notification Attempt. 4. If unsuccessful, at least two more attempts should be made within the Maximum Time Limit. Record. 5. If a successful notification has not occurred within the following time limits, the pathologist covering the laboratory (business hours) or on-call (after-hours) must be notified. He/ she should review the attempts for communication thus far and work with the lab personnel to identify appropriate failsafe physician to notify if necessary. 4 Physician, Nurse, Physician Assistant, Nurse Practioner, or Respiratory Therapist (if Blood Gas Analysis) 5 Personnel who are authorized and delegated to receive Critical Value Results. 6 Laboratory Information System

4 Alert Value Protocol: Page 4 of 14 If the ordering physician is an NSMC staff physician, the failsafe physician should be the department Chairman or Associate Chairman (appendix 1). If the ordering physician is not an NSMC staff physician, the pathologist should act as the failsafe physician. Orange* Yellow Maximum Time Limit 18 hours 7 days * Exceptions are noted on the Alert Value List (eg. Gentamycin). These must be communicated within 8 hours. 6. Document this action. Completed form is to be submitted to the Laboratory Quality Improvement Coordinator. (Incorporate Pathologist s actions, if applicable.) Note: It is important that processing of critical calls be completed within established times. Any calls pending during change of shift should be conveyed to the covering personnel to ensure that all critical calls are handled efficiently. At the close of the client service area, an interim report by accession number should be printed out and hand delivered to the Operations Coordinator. If unable to locate him/her, use the Partner Paging system. Hand-off must occur before personnel depart for the day. Alert Value Lists: Attached are the correct alert values, which have been formatted in consultation with the NSMC medical and nursing staffs and approved by the NSMC Medical Executive Committee. These values are also posted on the NSMC Intranet site under Clinical Resources. Any modifications to these lists must be approved by the NSMC Medical Executive Committee and the modification should be forwarded to the NSMC Webmaster so that the intranet site version is kept up to date. Microsoft Word (.doc) Document Control: Replaces Effective Date: version: Written By: Alert Value Protocol 2/01/14 2/01/14 Doreen McGovern Director of Laboratory Services: Chief of Laboratory Medicine: By: By: By: By: By: By: Reason Removed from SOP: APPROVED BY: (SIGNATURES ON FILE) Barry Jones Date: 3/3/15 Bruce Beckwith, MD Date: 03/02/15 REVIEWED BY: (SIGNATURES ON FILE) Date: Date: Date: Date: Date: Date: Date:

5 Alert Value Protocol: Page 5 of 14 See attached addendum

6 Alert Value Protocol: Page 6 of 14 Absolute Neut. Count (ANC) APTT Blasts on Peripheral Smear CSF Cell Count (see note 4) Fibrinogen Hematocrit (Hct) Hemoglobin (Hgb) HIT (Heparin Induced Thrombocytopenia) Assay INR RED VALUES: ADULTS Notify Immediately, Anytime 500/ul (1 st finding within 3 day period) 100 seconds Hematology Alert Value Color Chart RED VALUES: PEDIATRICS 1 Notify Immediately, Anytime 500/ul; > 30,000/ul <1500/ul (0 30d) (1 st finding within 3 day period) 100 seconds > 60 seconds (0 30d) Present (new finding) > 10 wbc/mm 3 > 10 wbc/mm mg/dl (1 st finding within 3 day period) 20% (if no low value in prior 30 days) 100 mg/dl (1 st finding within 3 day period) 25%; >65% < 6.5 g/dl 8 gm/dl >21 gm/dl positive positive ORANGE VALUES 2 : ADULTS Notify ASAP during day, 1 st thing next am after hours EXCEPTIONS NOTED 30,000/ul (if no value 30,000 in prior 30 days) Present (new finding) Adult and Pedi: between 15 and 20 AND a drop of 3, OR < 15 AND a drop of Platelets 10,000/ul 30,000/ ul 30,000/ul Sed Rate 40 mm/hr WBC 1,000/ul (1 st finding within 3 day period) 1,000; 20,000/ul (1 st finding within 3 day period) 150,000/ ul (if no prior value 150,000 in prior 30 days) ITNR (immature total 0.20 neutrophil ratio) Revised 7/30/10 YELLOW VALUES: ALL AGES Acknowledged notification within 1 week

7 Alert Value Protocol: Page 7 of 14 MICROBIOLOGY ALERT VALUE COLOR CHART RED VALUES: PEDIATRICS 1 Notify Immediately, Anytime RED VALUES: ADULTS Notify Immediately, Anytime Blood Culture CSF Culture Culture Results: M. Tuberculosis, N. Meningitidis *Infection Control also notified *Infection Control also notified Culture or Antigen Results: VRE, MRSA, ESBL, * (inpatients) *Infection Control * (inpatients) *Infection Control C-difficile Gram Stain / KOH Prep Malaria, Babesia, Erlichia on smear Rapid antigen: Crypto, H. Flu or N. Meningitidis also notified Any positive CSF, blood, joint fluid *Infection Control also notified (inpatients) also notified Any positive CSF, blood, joint fluid *Infection Control also notified (inpatients) Stool Culture Urine Culture Revised 01/10/12 AGE:<=36 months 5 ORANGE VALUES 2 : ADULTS Notify ASAP during day, 1 st thing next am after hours EXCEPTIONS NOTED (outpatients) YELLOW VALUES: ALL AGES Acknowledged notification within 1 week

8 Alert Value Protocol: Page 8 of 14 CHEMISTRY ALERT VALUE COLOR CHART RED VALUES: ADULTS RED VALUES: PEDIATRICS 1 Notify Immediately, Anytime Notify Immediately, Anytime Acetaminophen >50 mg/dl >50 mg/dl 1000 IU/L AST/ALT (if no prior value 1000 in prior 30 days) ORANGE VALUES 2 : ADULTS Notify ASAP during day, 1 st thing next am after hours EXCEPTIONS NOTED 1000 IU/L (if no prior value 1000 in prior 30 days) Amylase > 500 IU/L > 500 IU/L Arterial Blood Gas Ph < 7.3, > 7.6; PO2 < 50mmHg; PCO2 > 60mmHg C02 < 10 mmol/l < 10 mmol/l or > 40 mmol/l < 12 mmol/l Calcium < 6.5 mg/dl < 6.5 mg/dl 12 mg/dl 12 mg/dl Calcium, free <0.69 mmol/l <0.69 mmol/l >1.52 mmol/ll >1.52 mmol/l Carbamazepine >20 ug/ml > 14 ug/ml > 14 ug/ml CK >5000 IU/L >5000 IU/L (outpatients only) (outpatients only) Co-Oximetry Carboxyhemoglobin >10% Methemoglobin >5% Carboxyhemoglobin >10% Methemoglobin >5% Creatinine > 2.0 mg/dl > 4.0 mg/dl (see note 3) CSF Chemistry Protein > 80 mg/dl Glucose < 30 mg/dl or >300 mg/dl Glu < 80; Prot > 45 (All CSFs are performed & reported stat) Digoxin > 2.8 ug/ml > 2.5 ug/dl Dilantin > 30 ug/ml > 25 ug/dl Fecal Occult Blood Gentamycin Glucose HCG HIV 500 mg/dl 45 mg/dl > 12 ug/ml (peak) > 2.5 ug/ml (trough) < 40 mg/dl (0-3 days) 60 mg/dl(>3 days) 200 mg/dl(0-30 days) 500 mg/dl (> 30 days > 12 ug/ml (peak) > 2.5 ug/ml (trough) NOTIFY WITHIN 8 HR Lactate > 5.0 mmol/l > 5.0 mmol/l Lithium >1.8 meq/l > 1.8 meq/l Magnesium < 1.0 or > 7.0 mg/dl < 1.2 or > 5.0 mg/dl if < 1 year old Phenobarb > 60 ug/ml > 50 ug/ml Phosphorus < 1.0 mg/dl < 1.5 mg/dl < 1.5 mg/dl Potassium PSA < 3.0 mmol/l > 6.0 mmol/l < 3.0 mmol/l > 6.0 mmol/l 7 mmol/l (0-3days) Salicylate > 50 mg/dl > 50 mg/dl < 120 mmol/l < 125 mmol/l Sodium >160 mmol/l >155 mmol/l Theophylline >20 ug/ml >20 ug/ml < 125 mmol/l >155 mmol/l YELLOW VALUES: ALL AGES Acknowledged notification within 1 week > 200,000 (first elevated value in 3 month period) First or Indeterminate > 10 ng/ml (if no value current value prior 6mos)

9 Alert Value Protocol: Page 9 of 14 >15 ug/ml (0 30 days) 14.0 mg/dl Total Bilirubin (0-30 days only) Troponin-I 1st positive within 3 day period ( 0.4 ng/ml) Urine Glucose 3 + Revised : 3/06/14

10 Alert Value Protocol: Page 10 of 14 Laboratory General Policy Manual Cytology Specimens PAP Smear Surgical Pathology RED VALUES: ADULTS Notify Immediately, Anytime Significant unexpected finding that requires urgent clinical action 1. Temporal artery w/active vasculitis. 2. POC w/absence of fetal or placental tissue. 3. Placenta from live-born infant with significant chorioamnionitis; call to covering neonatologist (not Partners pager 10 # Significant unexpected finding that requires urgent action. PATHOLOGY ALERT VALUE COLOR CHART RED VALUES: PEDIATRICS 1 Notify Immediately, Anytime ORANGE VALUES 2 : ADULTS Notify ASAP during day, 1 st thing next am after hours EXCEPTIONS NOTED YELLOW VALUES: ALL AGES Acknowledged notification within 1 week 1. New diagnosis of primary or metastatic malignancy or suspected malignancy. 2. Significant unexpected finding that does not require urgent clinical action. AGC, AGC-N, ASC-H, HSIL, malignancy, or suspected malignancy. 1. New diagnosis of primary or metastatic malignancy or suspected malignancy*. 2. Significant unexpected finding that does not require urgent clinical action. *Except non-melanocytic cutaneous malignancies. Revised 04/01/09 Added the words "primary or metastatic" to the yellow values column under Cytology specimens and Surgical Pathology. Revised 01/30/13: Added AGC, AGC-N, ASC-H to pap smear Revised 04/15/15: Added *except non-melanocytic cutaneous malignancies to Surgical Pathology Yellow values.

11 Alert Value Protocol: Page 11 of 14 Laboratory General Policy Manual Notes: 1 Pediatric patients are defined as Mass General for Children at NSMC patients, Salem Hospital nursery patients, or any patient < 18 years of age. 2 Orange values apply primarily to outpatients and private doctor office patients. All Orange inpatient (including Emergency Department) and Nursing Home patient results must be communicated immediately, 24 hours a day, seven days a week. 3 Critical Creatinine results (>4.0 mg/dl) will be treated as an ORANGE level critical value if (1) there is no value in the past 90 days, OR (2) the previous Creatinine meets the criteria listed below. New Creatinine Result Treat as Critical Value if the Creatinine Within Previous 90 Days is Less Than: mg/dl * > Applies to non bloody tap; WBC must be corrected for bloody tap with ratio of 1 WBC: 1000 RBC. 5. For patients 36 months of age or less, positive urine cultures will be treated as a RED value for inpatients and an ORANGE value for outpatients. *Revised 1/23/12: change range from to

12 Alert Value Protocol: Page 12 of 14 Laboratory General Policy Manual Amitriptyline and Nortriptyline Butabarbital Butalbital Caffeine Carbamazepine,- 10,11 Epoxide Calcium Free (ionized calcium) Cyanide, Blood Desipramine Disopyramide Ethosuximide Ethylene Glycol Imipramine and Desipramine Lidocaine, Plasma Lead, Blood 0-15 yrs Lead, Blood 16 yrs Methanol (Volatile Screen) Nortriptyline Phenytoin, free Primidone Procainamide and NAPA Procainamide, Plasma Quinidine Valproic Acid, Free REFERENCE LAB ALERT VALUE COLOR CHART RED VALUES: 1 Notify Immediately, Anytime 2.0 ug/ml Any value detected meq/l >=10 mg/dl ORANGE VALUES 2 : ADULTS Notify ASAP during day, 1 st thing next am after hours EXCEPTIONS NOTED 300 ng/ml 40 ug/ml 10 ug/ml 30 ug/ml 8.0 mcg/ml < 1yrs old: <2.0 mg/dl >6.0 mg/dl 1 yrs old: <2. mg/dl, >6.5 mg/dl 300 ng/ml 7 mcg/ml 101 mcg/ml 300 ng/ml 6.0 ug/ml 20 ug/dl 70 ug/dl 300 ng/ml >=2.5 ug/ml >=15 ug/ml >30.0 ug/ml >16.0 ug/ml >=6.0 mcg/ml 15 ug/ml Revised 04/03/12

13 Alert Value Protocol: Page 13 of 14 Laboratory General Policy Manual MICROBIOLOGY REFERENCE LABORATORY ALERT VALUES TEST Critical Value/ Critical Result Fungal Smear or Fungal culture or PCR Identification of a Zygomycete, dimorphic pathogen, Cryptococcus neoformans/c. gattii or Pneumocystis jiroveci Fungal Culture or Mycobacterial Culture result from CSF or blood Viral culture or PCR Herpes simplex virus from CSF, amniotic fluid or ocular Viral Culture or PCR result from CSF on infant <12 months Acanthamoeba/Naegleria Direct exam or culture Identification of Acanthamoeba spp. From CNS or ocular. Identification of Naegleria spp. From CNS Babesia PCR or smear result from blood Malaria/Filaria/Trypanosome PCR or smear result from blood Toxoplasma gondii PCR result from CSF or amniotic fluid 7/30/10

14 Alert Value Protocol: Page 14 of 14 Laboratory General Policy Manual APPENDIX 1 DEPARMENT CHAIRS: Anesthesia: Family Practice: Medicine: Medicine (Hospitalists): OB/GYN: Orthopedics: Pediatrics: Psychiatry: Radiology: Surgery: Dr. Johanna O Connor Dr. Keith Nobil Dr. David Roberts Dr. Hans Jeppesen Dr. Allyson Preston Dr. Todd O Brien Dr. Mark Mandell Dr. Mark Schechter Dr. Chris Semine Dr. Marc Rubin 1/12/15 bb