TABLE OF CONTENTS - Catholic Medical Center

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Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102 TABLE OF CONTENTS MISSION GENERAL INFORMATION Contact Information Laboratory Accreditations Laboratory Scope of Service Quality Management Practices Laboratory Collection Stations - Patient Service Centers Contacting the Laboratory Test Results and Information Supplies Courier Service STAT Test Listing Reflex Testing Critical Value Policy Significant Results Notification Confidentiality and Disclosure of Results Confidentiality of Results Disclosure of Results ORDERING INFORMATION Priority Order Codes and Turnaround Time Routine STAT or ASAP Testing Timed Test Orders Ambiguous Orders Standing Orders Telephone Orders Add-On Orders Cancellation of Tests Completing a CMC Laboratory Requisition - Instructions Billing Policy Advanced Beneficiary Notice of Noncoverage (ABN) SPECIMEN COLLECTION AND MANAGEMENT Blood Collection Tubes BD Vacutainer® Tube Guide Collection Tube Code Master Listing BD Vacutainer™ Preparing a Quality Sample BD Vacutainer® Citrate Tube Volume Draw Guide Minimizing preanaltyic variables for Coagulation Testing Blood Collection Guidelines for collection BD guide Best and inappropriate sites for venipuncture BD guide Troubleshooting hints for blood collection BD Vacutainer® Order of Draw for Multiple Tube Collections

Transcript of TABLE OF CONTENTS - Catholic Medical Center

Page 1: TABLE OF CONTENTS - Catholic Medical Center

Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

TABLE OF CONTENTS MISSION

GENERAL INFORMATION Contact Information

Laboratory Accreditations

Laboratory Scope of Service

Quality Management Practices

Laboratory Collection Stations - Patient Service Centers

Contacting the Laboratory

Test Results and Information

Supplies

Courier Service

STAT Test Listing

Reflex Testing

Critical Value Policy

Significant Results Notification

Confidentiality and Disclosure of Results

Confidentiality of Results

Disclosure of Results

ORDERING INFORMATION Priority Order Codes and Turnaround Time

Routine

STAT or ASAP Testing

Timed

Test Orders

Ambiguous Orders

Standing Orders

Telephone Orders

Add-On Orders

Cancellation of Tests

Completing a CMC Laboratory Requisition - Instructions

Billing Policy

Advanced Beneficiary Notice of Noncoverage (ABN)

SPECIMEN COLLECTION AND MANAGEMENT Blood Collection Tubes

BD Vacutainer® Tube Guide

Collection Tube Code Master Listing

BD Vacutainer™ Preparing a Quality Sample

BD Vacutainer® Citrate Tube Volume Draw Guide

Minimizing preanaltyic variables for Coagulation Testing

Blood Collection

Guidelines for collection

BD guide – Best and inappropriate sites for venipuncture

BD guide – Troubleshooting hints for blood collection

BD Vacutainer® Order of Draw for Multiple Tube Collections

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Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

Proper Specimen Labeling

Patient Safety is in your hands

Guidelines for labeling

Specimen rejection due to labeling error

Retrievable specimens

Irretrievable or Precious specimens

BD Vacutainer® Labeling guide

Unacceptable Specimens

Specimen Processing

BD Vacutainer® Preparing a Quality PST sample for analysis

Specimen Packaging

Racking Specimens

Outpatient sample packaging

BD Guide to Special Handling of Specimens – Light Sensitive, Chilled

Specimen Stability Time Sensitive Tests Chart

Transporting and Tracking Specimens

TRANSFUSION SERVICE (BLOOD BANK) Pretransfusion Testing Information

Labeling Specimens For Blood Bank

Blood Products – General Information

Blood Products – Transfusion Record

PATHOLOGY Information Requirements for Pathology Specimens

Specimen Collection and Handling

Fine Needle Aspiration Cytology

Body Fluid Cytology

Breast Cytology

Bronchial Washing Cytology

Bronchial Brushings

Gastric Washing

Ocular Cytology

Spinal and Cyst Fluid Cytology

Oral Smears, Preparation and Collection

Sputum Cytology

Urine Cytology

Pelvic Wash

Surgical Pathology – Offsite Collection

MICROBIOLOGY Specimen Transport Guidelines

Collection of Microbiology Specimens

Storage and Transportation

TESTING INFORMATION Allergy Testing

Drug Testing

Drugs of Abuse in Urine

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Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

Therapeutic Drugs

Detection of Genital Pathogens

Glucose Specialty Testing

Hepatitis Testing

Thyroid Cascade

Immunohistochemistry Markers - Pathology

ALPHABETICAL TEST LISTING

FORMS Completing a CMC Laboratory Requisition - Instructions

Clinical Laboratory Test Requisition

Pathology Requisition – GYN Cytology

Pathology Requisition – HPV Reflex Test Guidance

Pathology Requisition – Surgical and Non GYN Cytology

Laboratory Services Supply Order Form

Pathology Services Supply Order Form

Standing Order Request Form

Telephone Order Documentation Form

Patient Information Disclosure Form

Authorization to Release or Request Protected Health Information

Advanced Beneficiary Notice of Noncoverage (ABN)

PATIENT INSTRUCTIONS Fasting Collection

Postprandial Glucose Collection

Clean Catch Urine Collection – Male

Clean Catch Urine Collection – Female

Overnight Urine Collection

24-hour Urine Collection

Semen Collection

Sputum Collection

Stool Card Collection – Non Neoplasm Screening

Stool Card Collection x3 – Neoplasm Screening

Stool Culture Collection

Stool Collection for C. Diff

Stool Collection for Ova and Parasites

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Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

CONTACTING THE LABORATORY

TEST RESULTS AND TEST INFORMATION

Call the laboratory Customer Services department at 603-663-8031 (or internally

extension 8031) for medical test results, to inquire about adding a test to a previously

submitted specimen, or for assistance with specimen requirements. All calls will be

directed through the Customer Services phone line. Our knowledgeable staff works

closely with the clinical laboratory departments and will connect you with a Medical

Technologist, appropriate management staff, or Pathologist if interpretive data is needed.

Selecting option 4 on the Customer Services line will provide a complete listing of

Laboratory Patient Service Centers. During normal business hours our customer support

staff can also direct your call to any PSC.

You may also connect with the lab via Email:

Address for billing questions: [email protected]

Address for customer concerns: [email protected]

These emails will be reviewed and answered promptly.

SUPPLIES

Hospital units and CMC owned practices can order supplies from the CMC stock room.

This includes supplies for microbiology and pathology specimens. However all blood

culture bottles will be ordered through the lab.

Collection supplies for CMC clients that utilize the CMC laboratory are available from

the laboratory. A supply order form, available under the forms section of this manual,

should be submitted to the Customer Service department. The supplies will be delivered

by the CMC courier, within a 7 day turn around time.

As a compliance requirement, non CMC owned clients will be part an annual audit of

supplies requested and tests sent.

Please find the supply order form under the forms section of this manual.

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Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

CONTACT INFORMATION

LABORATORY SERVICES Laboratory Customer Service 603-663-8031 Lab Office Fax 603-625-4511 Courier Service 603-663-6713 Professional, Management and Support Services Weldon W. Sanford, MD, Laboratory Medical Director 663-8174 Roberta E. Provencal, MBA, MT (ASCP), Director, Laboratory Services 663-5362 Amy Schultz, BA, MT (ASCP), Laboratory Technical Operations Manager 663-6228 Lorrie Woodward, BS, MBA Lab Support Operations Manager 663-5373

Jennifer Howard, BS, MT (ASCP), LSS BB Lab IS Supervisor 663-8024 Geralyn Decker, MS, Laboratory Application Analyst 663-7804 Thomas Hebert, BS, Lab Customer Service Supervisor/Outreach Liaison 663-6425 Amanda Beckner, BS, Laboratory Evening/Night Shift Supervisor 663-7808 Linda Bayrd, BS, Transfusion Service Supervisor 663-6839 Sharon Williams, BA, Chemistry Supervisor 663-8118 Diane Belliveau, BS, Hematology Supervisor 663-8007 Monica Zukovic,MT(ASCP) MPH, Microbiology Supervisor 663-5368 Stephen Feher, MS, Pathology Supervisor 663-6707 Penny Lajoie, Phlebotomy, Registration, PSC Supervisor 663-8013 Kim Higgins, BS, Lab Point of Care Testing Coordinator 663-7805 Kyle Whitson, BS, Specimen Processing Supervisor 663-1974

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Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

LABORATORY ACCREDITATIONS

United States Department of Health & Human Services

Of the Health Care Financing Administration

CLIA ID Number: 30D0993032

College of American Pathologists

(CAP)

Laboratory Number: 3069802

American Association of Blood Banks

(AABB)

Joint Commission on Accreditation of Health Organization

Organization ID # 5467

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Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

LABORATORY SCOPE OF SERVICE

The Department of Laboratory Services is committed to providing comprehensive clinical

and anatomic pathology services to all members of the Catholic Medical Center community.

Services are provided 24 hours a day, seven days a week to patients of all ages, through

inpatient, outpatient and outreach modalities. The extent of services is determined by

evaluation of cost effectiveness, appropriateness, quality of results and availability of

suitably trained and educated staff and equipment resources. Implementation of services is

with the advice of and consultation with the Medical Staff and Hospital Administration.

Laboratory services unavailable at Catholic Medical Center, yet appropriate for the care of

patients, are referred to suitably accredited reference laboratories. Consideration in the

selection and use of reference laboratories is based on quality, cost and turnaround time.

The Department provides test turnaround times suitable to the clinical situation in which the

tests are requested. STAT testing is reported within one hour of receipt into lab, ASAP

testing is reported within the same shift of request and routine testing is reported daily or in

cases of esoteric testing, at a frequency which is appropriate to the test modality. A

Laboratory Services Handbook is provided amongst other information tools to delineate

which tests are available for the testing priorities. The Department undertakes internal

monitoring to assure compliance with standards not only with tests performed on-site, but

those performed at reference laboratories.

Testing is performed on all patients of all ages. Phlebotomy and Specimen Processing staff

are trained to be facile on newborns as well as the aged and will undergo annual assessment

for competency through direct observation, patient satisfaction surveys and internal

specimen collection monitors.

The Department works under the medical directorship of the Chief Pathologist / Medical

Director and pathologists. It is under the administrative leadership of the Director of

Laboratory Services. All are qualified under the regulatory umbrella of CMS (CLIA’88),

CAP, AABB, and JCAHO.

The Laboratory is staffed by a team of highly skilled technical and support personnel.

Laboratory personnel include managers, supervisors, coordinators, certified medical

technologists, certified medical laboratory technicians, histotechnologist, histotechnicians,

cytotechnologists, pathology technicians, phlebotomists, deiners, customer service

personnel, registrars, transcriptionist, information system analysts and administrative

personnel.

Services provided include the following:

A. Technical Services: Blood Bank, Chemistry, Hematology, Coagulation,

Microbiology, Mycology, Pathology, Phlebotomy, Serology, and Urinalysis.

B. Logistical Services: specimen procurement, specimen processing, result

reporting, quality of service / care monitoring and evaluation, and quality

control activities.

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Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

QUALITY MANAGEMENT PRACTICES

QUALITY

The commitment to quality at CMC Laboratory applies to all aspects of our service from

testing and technology to courier transport, specimen handling, and turnaround time. The

CMC Laboratory Quality Management Team, made up of our medical director,

laboratory director, managers, and technical supervisors, is responsible for overseeing

ongoing quality programs and directing the implementation of new procedures and

programs to continually improve the quality of testing and services provided. This

comprehensive approach includes the programs described below:

Test Request Validation – Quality checks to validate data entry of critical details

of the test request data are conducted daily. Critical information such as test(s)

ordered is verified. This mandatory procedure minimizes data entry errors, since

any discrepancies in the entries must be resolved before the test request will be

accepted.

Automated Specimen Processing – Automated specimen processing systems are

utilized by CMC Laboratory to ensure positive patient identification throughout

the pre-analytic phase. These systems receive, centrifuge, de-cap, aliquot, label,

sort, and archive specimens removing pre-analytic human error from the vast

majority of specimens handled by CMC Laboratory.

Intra-Laboratory Quality Control – Multi-level quality control material is utilized

to monitor daily assay performance. Quality control data is evaluated using

computerized plots and statistical analysis. All instruments are on a scheduled

preventative maintenance program. Secondary material such as aqueous-based

clinical standards traceable to The National Institute of Standards and Technology

and the College of American Pathologists (CAP) reference materials serve to

enhance the standardization of test results.

Inter-Laboratory Quality Control – CMC Laboratory actively participates in the

CAP Inter-laboratory Comparison Program.

Routine Turnaround Time (TAT) Analysis – Reports showing details of all

pending test requests and the length of time requests have been pending are

reviewed daily. Those requests which exceed the maximum TAT expected are

investigated for cause of delay. This monitor allows us to identify any specific

problems with a request and notify clients appropriately. It also allows CMC

Laboratory to identify trends and adjust them accordingly.

STAT TAT Analysis – STAT requests are reviewed on a regular basis for TAT,

calculated from time of test request entry to results release.

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Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

LAB COLLECTION STATIONS – PATIENT SERVICE CENTERS

Notre Dame Pavillion 87 McGregor Street, Suite 1200, Manchester, NH 03102

Monday –Friday 6:30 AM to 6 PM

Saturday 6:30 AM to Noon

Family Health & Wellness Center 188 Route 101, Bedford, NH 03110

Monday, Wednesday, Friday 6:30 to 10 AM

Family Physicians of Manchester 57 Webster Street, Manchester, NH 03104

Monday – Friday 6:30 AM to Noon

Goffstown Primary Care 17A Tatro Drive, Goffstown, NH 03045

Monday – Friday 6:30 to 10 AM

Hooksett Primary Care Riverside Park, 11 Kimball Drive, Hooksett, NH 03106

Monday – Friday 6:30 to 10 AM

Medical Group of Manchester 775 South Main Street, Manchester, NH 03102

Monday – Friday 6 AM to Noon and 1 to 3:30PM

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Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

COURIER SERVICE COURIER SERVICE Catholic Medical Center’s Transport Department offers courier service to our CMC owned practices and clients, as well as supporting intra hospital transport. The couriers are responsible for the daily pick up of specimens and the delivery of reports and supplies to our outside customers. The couriers are trained to handle the specimens, maintaining the appropriate temperatures during transport and delivering specimens in a timely fashion to the lab. The courier logs the number of specimens at each stop, as well as the time and date of the stop. Reports are delivered directly to the office staff, never left in an outside specimen box. All information is treated confidentially. The CMC courier service is staffed to meet the stat turnaround time for specimens collected out side of the immediate hospital area. The courier department works with the client to establish convenient pickup times to meet their needs. This service is available Monday through Friday, 7am to approximately 6:00pm. Members of the inhouse transport team also carry specimens to the lab when asked. CMC has contracted with an outside courier service to support requests that may fall outside the scope of the CMC Transport department.

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Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

STAT TEST LISTING

The CMC Laboratory goal for STAT testing:

To have results available within one (1) hour of receipt of the specimen into the Laboratory.

All STAT testing listed is performed at CMC Laboratory.

For information regarding referral testing, please call

the Laboratory Customer Service Department at ext 8031 or 603-663-8031.

Test Name Test Name

Acetaminophen (Tylenol) HIV, rapid (source needlesticks and MOMs only)

Acetone Indirect Coombs

Albumin Infectious Mono Screen

Alcohol (serum) Influenza A & B

Alkaline Phosphatase Phosphorous

ALT (SGPT) Kleihauer- Betke **

Amylase KOH Prep

Antenatal RhIg Lactic Acid

AST (SGOT) Legionella Urine Antigen

Basic Metabolic Panel Lipase

Beta HCG Myoglobin

Beta Hydroxy Butyric Acid Osmolality (serum or urine)

Bilirubin- Total, Indirect, Direct Partial Thromboplastin Time

Blood Type Phenytoin (Dilantin)

Blood Urea Nitrogen (BUN) Platelet Count

Brain Naturietic Peptide (BNP) Post Partum RhIg

Calcium Potassium

Carbamazepine Pregnancy, Quantitative

Chloride Pregnancy, Qualitative

Total CK , CKMB Protein, Total

CO2 Prothrombin Time

Complete Blood Count (CBC) w/diff (reflex) PTH- Surgery

Comprehensive Metabolic Panel Rapid Strep

Cord Blood Renal Function

Creatinine Respiratory Syncytial Virus (RSV)

Crossmatch Salicylate

Cryptococcal Antigen (serum) Sodium

Cryptococcal Antigen (csf) Spinal Fluid Cell Count

D-Dimer, quantitative Spinal Fluid Glucose

Digoxin Spinal Fluid Protein

Dilantin (Phenytoin) Streptococcus pneumoniae urine Antigen

Direct coombs Theophylline

Elecrolyte Panel Thrombin Clot Time

Erythrocyte Sedimentation Rate Tobramycin

Estradiol Transfusion Reaction Workup

Fetal Blood Screen Troponin

Fetal Fibrinectin Type and Screen

Fibrinogen Uric Acid

Gentamicin Urinalysis

Glucose Urine Protein (dipstick)

Gram Stain Urine Specific Gravity

Hematocrit Urine Tox Screen..with Tricyclic

Hemoglobin Valproic Acid

Hepatic Function Vancomycin

Hepatitis B surface Antigen * MOMs only Wet Prep

* reported within 24 hours ** reported within 2 hours

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Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

REFLEX TESTING

Approved by Medical Executive Committee Date: 11/15/2011

Reflexed Laboratory Tests Test Criteria For Reflex Reflex Test Performed

ANA IFA Screen Positive ANA Titer and Pattern

ANA Titer 1:80 or greater dsDNA

Antibody ID Clinically Significant Antibodies Antibody Titer (MOMS)

Antigen Typing

Antibody Screen Positive for Antibodies

Antibody Identification and prepare 2 red cells

leukoreduced. DAT if auto control positive.

CBC w/Auto Differential Auto Differential results outside of

set limits ** See next page for the set limits.

Manual Differential

CSF WBC > 5 WBC CSF Differential Culture Growth of Pathogenic Organisms Sensitivity as indicated

DAT Positive Elution if Indicated

ED Cardiac Panel Biosite Positive Troponin Troponin colorometric

immunoassay

HBSAG Reactive HBSAG Confirmation HIT ( HDA Heparin

Dependent Ab) Positive

Serotonin Release Assay to Quest

HIV Antibody Positive Western Blot Lyme Antibody Screen EIA Positive Western Blot IgG and IgM

Malarial Smear Positive Confirmation by state Lab

PFEPI (Platelet Function

Epinephrine) >183 seconds

ADP (Adenosine-5" Diphosphate)

Post Partum RhoGam Workup

Fetal Screen Positive Kleihauer-Betke

Rheumatoid Factor Screen Positive Titer Anti CCP Antibody

RPR Reactive RPR Titer and Treponema

Pallidum Antibody

Strep Screen* *can order Rapid Strep

Only, no reflex to culture. Rapid Strep Negative Culture

Thyroid Cascade TSH abnormal

Free T4 normal or high Free T4 normal

Free T4 performed Free T3 performed

Anti- TPO performed

Total CK 100 Total CK = >100 U/L CKMB Total CK 800 Total CK = >800 U/L CKMB

UA reflex microscopic and culture if indicated

Positive protein, blood, nitrates or esterase for microscopic. Positive

nitrates or esterase for culture.

Urine Microscopic and/or Urine Culture

UA relex microscopic Positive protein, blood, nitrates or

esterase Urine Microscopic

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Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

REFLEX TESTING

Approved by Medical Executive Committee Date: 11/15/2011

Criteria for Manual Differential Actions and Review WBC <2.0 K/uL Manual diff WBC >30.0 K/uL Manual diff

Neut% >75 with Left Shift Flag Manual diff Neut% >85 Manual diff

Lymph% >70 Manual diff Mono% >20 Manual diff Eos% >20 Manual diff

Baso% >3 Manual diff Reflex Testing for Reference Lab Tests determined by test name and or description.

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This list was approved by the MEC 05/15/07. Updates approved 11/07. Updates approved 10/08. Updates approved 11/08. Annual

review and revisions approved by MEC 02/18/2009, March 16, 2010, March 15, 2011.

Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

CRITICAL VALUE POLICY

Critical CMC Critical Results

Results

called 24 hrs/day, 7 days/wk

Testing Performed On Site *** first instance only

Dept/Test Units low high

CHEMISTRY

ALT- MOMs Place U/L >40

AST-MOMs Place U/L >50

Amylase*** U/L >300 ***

BUN*** mg/dL >100***

Calcium mg/dL <6.5 >12.5

CO2 mEq/L <10 ≥45

CPK*** U/L >1000 ***

Creatinine*** mg/dL >3.5***

Creatinine –MOMs Place mg/dL >1.5

Glucose mg/dL <60 >500

Glucose- MOMs Place mg/dL <65 Glucose

(Pedi up to 17yrs) mg/dL <60 >300 pedi

Neonatal Glucose (up to one month old) mg/dL < 40 >150

Glucose, CSF mg/dL <40 >400

Lactic Acid mmol/L >2.2 mmol/L

Magnesium mg/dL <1.0 >5.0

Phosphorus mg/dL <1.0

Potassium mEq/L <3.0 >6.0 No Upper criticals defined 0-1yr

Protein, CSF mg/dL >100 No Upper criticals defined 0-14 day

Sodium mEq/L <120 >160

Total Bilirubin Adult *** mg/dL >15.0 ***

Total Bilirubin –MOMs Place Indirect Bilirubin-MOMs Place mg/dL

>1.2 >0.7

Neonatal Bilirubin (up to 2 weeks old)

Total Bilirubin (up to 19 years) mg/dL >12.0

Troponin*** ng/ml

>0.6 *** and

All Positives on the ED panel

COAGULATION

Fibrinogen mg/dL ≤100 ≥700

INR INR ≥5.0

PTT sec. ≥110 Heparin Dependent Antibody

Screen All Positives

HEMATOLOGY

WBC # *** (age greater than 30 days) x 10 ≤2.0*** ≥30.0***

WBC*** (age 0- 30 days) ≤5.0 ≥35.0

Absolute Neut*** ≤0.5***

Absolute Neut*** Ascitis Fluid ≥249***

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This list was approved by the MEC 05/15/07. Updates approved 11/07. Updates approved 10/08. Updates approved 11/08. Annual

review and revisions approved by MEC 02/18/2009, March 16, 2010, March 15, 2011.

Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

Bands*** >20% *** when WBC is less than

11.0

Blast Cells*** any cells reported***

Hematocrit < 21 >60

Hemoglobin g/dL ≤7.0 ≥20.0 Neonatal Hemoglobin (up to

one month old) g/dL ≤7.0 ≥23.0

Platelet Count*** x 10 ≤30 *** ≥1,000***

Platelet Count***-MOMs Place x 10 <100 ***

Fetal Fibronectin All Positives

Malarial Slides*** All Positives

CRITICAL VALUE POLICY, CONTINUED ON NEXT PAGE

Page 16: TABLE OF CONTENTS - Catholic Medical Center

This list was approved by the MEC 05/15/07. Updates approved 11/07. Updates approved 10/08. Updates approved 11/08. Annual

review and revisions approved by MEC 02/18/2009, March 16, 2010, March 15, 2011.

Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

CRITICAL VALUE POLICY

Critical CMC Critical Results

Results

called 24 hrs/day, 7 days/wk

Testing Performed On Site *** first instance only

Dept/Test Units low high

TDM

Acetaminophen ug/mL >100

Carbamazepine ug/mL >20

Digoxin ug/mL >2.5

Dilantin ug/mL >40

Gentamicin ug/mL >12.0

Lithium mEq/L >2.0

Phenobarbital ug/mL >60

Salicylate mg/ml >30

Theophylline ug/mL >25

Theophylline-neonatal ug/mL >20

Tobramycin ug/mL >10.0

Valproic Acid ug/mL >200

Vancomycin (random, and trough) ug/mL >20

Vancomycin (peak) ug/mL >40

Blood Bank

Antibody Screen*** All positives***

Direct Antiglobulin *** All positives***

Kleihauer-Betke All Results All Results

Microbiology

Blood Cultures (initial gram stain) All Positives

CSF gram stain or culture All Positives

H. Influenza B (pediatric) All Positives

Strep. Group B vaginal (Labor and Delivery patients

only) All Positives

Newborn, gastric aspirates, gram stain, cultures All Positives

Cryptococcal Antigen All Positives

Testing done Off Site

Quest Diagnostics will use reasonable efforts to promptly communicate24/7 the results of "critical"

tests according to the definition of the Clinical Laboratory Amendment of 1988 (CLIA; CFR493.11109f) and the College of American Pathologists (CAP) Laboratory Inspection Program, which performs laboratory accreditation on behalf of the Centers for Medicare and Medicaid(CMS).

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Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

11/20/2014

SIGNIFICANT RESULTS NOTIFICATION Catholic Medical Center recognizes that the results of certain laboratory tests can have major clinical impact on patient care and that notification to the health care provider should not wait until a printed report is available. The following results are those considered to have important but not life threatening significance. These will be called to the health care provider, floor, Emergency department or nursing home as indicated below. The following table contains a list of Significant Test Results.

SIGNIFICANT TESTS

Results Called During Business Hours / *** Inpatient & Outpatient results called 1st shift (7 days/wk)

****Inpatient and Emergency Room patients call 24/7(7 days/wk)/Outpatient results called 1st shift (7

days/wk) ┼ called only once per admission. Call Responsibility = RED-Customer Service ; Green-

Referrals ; Blue- Technologist.

Hepatitis Testing - HAV IgM- Positive, HBc IgM -Positive, HCV -Positive, HBSAG

RPR -Reactive

Lyme Screen - Positive & Equivocal

HIV - Positive performed on-site***

AFB Smear, Positive- performed on and off-site***

Carbapenem Resistant Enterobacteraciae (KPC/CRM)***┼

Chlamydia trachomatis (Probe or PCR) Positive***

Clostridium difficile toxin, Positive****┼

Cryptosporidium antigen, Positive- performed on and off-site

Extended Spectrum Beta-Lactamase Producers (ESBL)***┼

Fungal culture, Positive (except Candida )

Giardia antigen, Positive- performed on and off-site

Influenzae A and/or B rapid test, Positive ****

Legionella Urine Antigen, Positive****

Listeria monocytogenes, any site***

Methicillin Resistant Staphylococcus aureus (MRSA)****┼

Mycobacteria culture or probe, Positive- performed off-site***

Neisseria gonorrhoeae (Probe or PCR ) culture, Positive***

Comprehensive Ova and Parasites, Positive - performed off-site

Pertussis (PCR or culture), Positive- performed off-site***

Rapid Strep Group A, Positive ****

RSV rapid test, Positive ****

Shiga- toxin, Positive***

Streptococcus Group A culture- all sites, Positive***

Streptococcus pneumoniae Urine Antigen****

Stool pathogens (Salmonella, Shigella, Campylobacter,Yersinia, Vibrio, Aeromonas and Plesiomonas) Positive-

performed on & off-site***

Vancomycin Resistant/Intermediate Enterococcus (excluding E. casseliflavus, E, gallinarum)***┼

Vancomycin Resistant/Intermediate Staphylococcus sp.***┼

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Catholic Medical Center Laboratory 100 McGregor Street, Manchester, NH 03102

CONFIDENTIALITY AND DISCLOSURE OF RESULTS

CONFIDENTIALITY OF RESULTS

Lab “result access’ is limited to those who may need to access the reports at the request

of a patient or physician practice.

Testing results are routinely released to the ordering provider. Results may also be

released to a provider who is “covering” for the ordering provider and to a “copy to”

physician at the request of the ordering provider. Most results are transmitted

electronically to providers. A signed confirmation fax is completed by the provider when

a new fax set up is generated.

Routinely critical results are given over the phone to a provider with an electronic report

to follow. Every effort is made to fax a report to the physician to eliminate a verbal result.

Mailed reports are sealed in an envelope marked “lab reports” and noted to be

“confidential”. Routinely, staff in the customer service department are the only staff

handling printed lab results. All hard copies of reports are placed in a secure shred bin

for destruction.

Results may also be released to the patient with a signed release. All requests for results

are directed to be mailed to the patient or picked up by the patient. The lab discourages

the use of personal fax machines.

Results are provided to the National Tumor registry and state, local, or federal agency as

directed by NH law.

Requests for lab work may be supplied to a billing service for processing professional

fees. Ideally these files are sent electronically.

All hard copies of reports are placed in a secure shred bin for destruction.

DISCLOSURE OF RESULTS

The possibility of an incidental disclosure of results exits.

Faxing to the wrong provider, wrong number or the incorrect patient would require the

initiation of a “CMC DISCLOSURE FORM” The form would be completed by the

laboratory, scanned into the lab order and a copy sent to medical records.

A disclosure of a larger scale would be reported to the appropriate agencies and the

patients. CMC Laboratory complies with all Disclosure policies and procedures.