ClinicalLaboratories Colorado,USA

Clinical Laboratories

Colorado, USA

117809.78 Scope of Service

Copy of version 6.0 (approved and current)

Last Approval orPeriodic Review Completed 7/26/2021

Periodic review not required

Effective Date 7/26/2021

Controlled Copy ID 182651

Location Test Catalog upload

Organization Highlands Ranch

Comments for version 6.0Updated for FY22

Approval and Periodic Review Signatures

Type Description Date Version Performed By Notes

Approval Lab Director 7/26/2021 6.0 Carol Dittmann

Approval Lab Manager 7/16/2021 6.0 Sarah Miller







Approval Lab Director 4/11/2019 2.0

Edward Ashwood


Approval Lab Director 12/14/2018 1.0

Edward Ashwood


Version History

Version Status Type Date Added Date Effective Date Retired

6.0 Approved and Current Major revision 7/16/2021 7/26/2021 Indefinite

5.0 Retired Major revision 7/22/2020 7/22/2020 7/26/2021




1.0 Retired Initial version 12/2/2018 12/14/2018 4/11/2019

117809.78.Scope of Service, Version 6.0.

Highlands Ranch Hospital

Laboratory Clinical and Anatomical Pathology

FY22

University of Colorado Health. Approved and current. Effective starting 7/26/2021. 117809.78 (version 6.0) Scope of Service

Controlled copy ID 182651. Printed on 8/13/2021 11:16 AM (EDT). Page 1 of 3

Laboratory Services - Clinical and Anatomical Pathology Scope of Services 2021-2022 (FY22) Scope of Services Transfusion

Services

Care Team/Staffing Model Department

Standards/

Practice

Guidelines

QUALITY

Metrics

Laboratory Services

Clinical Laboratory testing

Inpatient and outpatient

phlebotomy/specimen

collection services

Surgical/Anatomic Pathology

Services

Clinic Support services

Clinical Pathology (CP)

departments

Transfusion Services Phlebotomy Specimen Processing Send-out reference lab testing Blood gas analysis Chemistry Hematology Urinalysis Microbiology (limited service) Molecular diagnostics (limited

services) Therapeutic drug monitoring Toxicology Clinical pathology consultation Point of Care Testing (POCT)

oversight Anatomic Pathology (AP)

departments

Surgical Pathology Frozen Sections Cytology Histology/Immunohistochemistry Send-out reference lab testing

Products available

from Transfusion

Services:

Leukoreduced Red Blood Cells (AS-3)

Fresh Frozen Plasma – 24 hour outdate

Platelets, apheresis, pre-storage leukocyte reduced

Cryoprecipitate, Pooled

Pediatric aliquots (red cell, FFP, Cryoprecipitate, Platelets)

Rh Immune Globulin Irradiated cellular

products Convalescent

Plasma* Services provided by Transfusion Services

ABO/Rh typing Screening for

unexpected antibodies Compatibility testing Antibody identification Direct Antiglobulin

Test Antigen typing* Fetal Maternal

Hemorrhage Screen Test

Kleihauer-Betke

(Fetal Maternal

Hemorrhage Study)

– performed at

Care Team

Lab Medical Director (CU

Medicine)

AP Department Director (CU

Medicine)

Pathologists’ (CU Medicine)

Pathologists’ Assistants

Lab Leadership (Manager,

Supervisors, Leads)

Lab Quality Coordinator

Medical Laboratory Scientists

(MLS)

Cytotechnologist

Histotechnologists

Gross Technicians

Lab Processing Specialists (LPS)

Clinical Lab Technicians (CLT)

Lab Processing Technicians (LPT)

Phlebotomists (PBT)

Registered Nurses

Medical Assistants

Patient Access Specialists

Staffing Model

A Pathologist is on site at minimum

8am-4pm M-F

A Pathologist is on call 24/7 when

not onsite.

Inpatient Clinical Laboratory follows

a 24/7 patient care delivery model.

Minimum staffing:

2 MLS (3 MLS dayshift M-F); 1

MLS designated as Charge Tech

when no leadership is onsite.

1 LPT (2 LPT dayshift M-F)

Regulatory

The laboratories operate within the regulatory requirements and/or accreditation standards of the following organizations:

CMS, Clinical Laboratory Improvement Act (CLIA)

College of American Pathologist (CAP)

The Joint Commission

Food and Drug Administration (FDA)

Departmental policies,

processes and

procedures are

developed based on

needs revealed by

patient demographics,

advances in the industry,

changes in regulations,

inspection reports, and

deficiencies or

inadequacies identified in

current processes.

Audits and systems

checks are in place or

are being developed as a

means to evaluate and

modify current

processes. A

standardized process is

in place for

implementation of new

policies and procedures.

Metrics

Include but not

limited to:

Patient Experience

Critical call turnaround time

Stat testing turnaround time

Blood culture contamination

Frozen Section turnaround time

Non-concordant Surgical Pathology discrepancies

Transfusion reactions

FDA reportable Transfusion Service events

Workload metrics



Patient population

The laboratory serves all patient populations seen by Highlands Ranch Hospital, UCHealth Cancer Center, and surrounding outpatient clinics.

o Test result reference ranges are age/sex appropriate when applicable.

Hours of Operation:

Inpatient Lab

24 hours a day 7 days a week

Outpatient Lab

0700-1700

Monday-Friday

Closed on weekends &

observed holidays

COVID Drive Thru

Refer to the UCHealth

website for current hours of

operation.

Pathology/Histology/Cytology

0800-1600 Monday – Friday Pathologist on call 24/7

Security

Badge access for staff

UCHealth UCH

hematology

section*

Antibody Titer* * Not immediately available at HRH

Outpatient Laboratory

Minimum staffing of 1 LPT or PBT

Drive Thru minimum staffing 2

MA/RN or MA/RN with PAR

Anatomic Pathology

Minimum: 2 Histotechnologist

M-F 8am-4pm.

Pathology Support

M-F 8-4pm.

Minimum: At least 1 of the following

titles:

Cytotechnologist Pathologists’

Assistant

CLT

LPT Specialist

Embedded Clinic Phlebotomy –

hours based on clinic.

Assignments are based on

anticipated workload, and

experience level of those on duty.

Staffing needs are assessed

throughout each shift.



ClinicalLaboratories Colorado,USA

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