Laboratory Quality Management System

LABORATORY
SCOPE OF SERVICES

A. TYPES OF SERVICES

The Laboratory Department provides:

• Clinical and anatomic laboratory services to patients and employees primarily
referred by hospital and community medical providers of Washington County,
extending throughout Rhode Island, southern Massachusetts and nearby parts
of Connecticut.
• Quality test results in an effective time frame to support treatment.
• An appropriate and comprehensive test menu to meet the needs of the
population served.
• Clinical laboratory and anatomical pathology specimen processing and
specimen/tissue storage.
• Appropriate and efficient transfusion services in collaboration with Rhode
Island Blood Center and/or New York Blood Center.
• Appropriate selection of reference laboratory services.
• Appropriate waived, non-waived, and point-of-care testing (POCT).
• Consultation for laboratory test interpretation and utilization.
• Continuing education and guidance to students, physicians and hospital staff.
• Laboratory statistics to medical staff, administration, and inter-departmental
committees.

1
This is a CONTROLLED document. Printed copies are considered uncontrolled and should be checked against the on-line (electronic) version
prior to use.
Laboratory Quality Management System

Specific services provided include:

Service Description
Anatomic pathology and Biopsy, PAP test, fine-needle aspirate, endoscopic ultrasound, frozen section
Cytopathology analysis, pathology consultations, histology processing/staining,
immunohistochemical staining, surgical pathology

Blood Bank & Serology Transfusion services, Serology testing

Clinical Laboratory Analytical testing in the following specialties:

Testing Hematology, Urinalysis, Coagulation, Chemistry, Immunochemistry, Toxicology

Microbiology Testing Bacteriology, mycology and molecular testing.

Point-of-Care testing At numerous units and clinics within the hospital- POCT includes waived
(POCT) testing, moderate complex texting and provider-performed testing.

Hospital-based Inpatient Adult patients of all acuity levels, including those requiring the intensive care
Phlebotomy involved in emergency services, cardiac and oncology services. Newborn
patients that are not NICU level of care.

Outpatient and Home Operate outpatient phlebotomy stations throughout Rhode Island. Serve as a
Care Phlebotomy referral laboratory to physician offices within the hospital system and other
community providers including nursing and group homes for patients of all
ages and stages of life.

Pathologist Consultations On-site, telephone or electronic consultations as needed for questions

regarding the ordering of appropriate laboratory tests and interpretation of
laboratory data for both anatomic and clinical pathology. Applies to questions
that arise from laboratory staff and/or hospital medical staff.
While most questions can be answered by the laboratory director or associate
pathologists. Occasionally the laboratory director or associate will seek
external consultations from outside sources, which may include other
pathologists from University Pathologists, LLC and reference laboratories (i.e.
Rhode Island Blood Center, LabCorp, etc.).
Laboratory Quality Management System

Reference Laboratory The department contracts with several reference laboratories to provide
Services laboratory testing which is not performed in-house. The Medical
Director/Pathologist-in-Chief, Laboratory Director, medical staff and hospital
administration work together to assess and select appropriate reference
laboratories.

The Lab Test Menu is linked to the Lab website. The list includes tests performed in-house, and
the most commonly ordered reference lab tests. The list is not comprehensive of all tests that
are available- providers may contact the laboratory at 401-788-1418 to request information
regarding tests that they need to order but are unable to find or do not appear on the list.
The Laboratory Department further:
• Maintains appropriate accreditation
• Responds to information needs of the organization and the community
• Participates on appropriate committees to facilitate communication of service needs,
appropriate utilization management, and performance improvement efforts
• Supports, conducts and participates in clinical research appropriate to furthering
knowledge of pediatric disease and treatment

The services provided occur in various settings appropriate to the defined need, with limited
laboratory testing provided at satellite locations. The laboratory performs testing based on
requests from persons authorized by law to write laboratory test orders (i.e., physicians,
physician assistants, and advanced registered nurse practitioners).

B. BILLABLE TEST VOLUME

• Clinical Laboratory- approximately 725,000 billable clinical laboratory tests
performed per year, of which about 10% are sent to reference laboratories.
• Anatomic Pathology- approximately 7,000 surgical pathology cases and 2,000
cytology cases are signed out annually.

C. COMPLEXITY OF PATIENT CARE NEEDS

The department is expected provide all diagnostic and therapeutic
evaluations needed by the medical staff (includes tests performed on site
and at reference laboratories).
o Most needs are identified in the following ways:
 Medical staff indicate a need to adopt new test procedures or
additional testing considered standard-of-care via written requests or
consultation with the Chief Pathologist
 Pathologists and laboratory staff indicate need for updated
methodologies, to increase specificity and sensitivity, or to improve
turnaround times.
Laboratory Quality Management System

D. TIMELINESS OF SERVICES
The department is expected to be available for Hospital laboratory services at all
times, on all days, to assure continuity of care for inpatients and emergency
services.
Staff are expected adhere to defined turnaround times in both the clinical
laboratory and anatomic pathology.

E. AVAILABILITY OF SERVICES
• South County Health Main Laboratory- 100 Kenyon Avenue, Wakefield, RI
The Main Lab operates twenty-four hours per day, seven days per week for all inpatient
and emergency room services, STAT outpatient newborn bilirubin testing, and other STAT
outpatient testing as deemed necessary by the patients’ providers.
• South County Health Outpatient and Home Care Laboratory Services-
The department operates multiple outpatient lab locations throughout Rhode Island with
operating hours to suit the patient population and volume of each location.
Locations and hours of operation are documented in Policy #83 and kept up-to-date on the
Laboratory Services website, in the event of an unexpected closure/change in hours.
Home Care phlebotomy services are routinely provided to patients who meet criteria for
Homebound as defined by CMS.

F. STAFFING TO MEET DEPARTMENTAL NEEDS

Lab leaders review daily workload requirements and staff to meet needs.
The department staffs all lab areas based on time of day, day of week and season of
the year, and has defined minimum staffing levels accordingly.
The laboratory staff consists of:
• Approximately 60 full-time equivalents (FTEs) in support of the inpatient,
outpatient and referral needs of the organization and the community.
• Staffing plans for the individual laboratory sections, developed to ensure quality of
laboratory testing and predictable turn-around-times
• A clinical pathologist available by phone at all times (Ext 1341 during day or 1418
off hours).
• An organizational laboratory structure that includes laboratory leadership as
follows:
o Chief Pathologist/Lab Medical Director
o Director, Laboratory
o Team Leaders/Technical Specialists
o LIS and POCT Coordinators
o Lead Technologists and Lead Phlebotomists

• The clinical staff includes:

o Pathologists
o Director, Laboratory
o Team Leaders/Technical Specialists
o LIS and POCT Coordinators
o Medical Lab Scientists/Technologists
o Medical Lab Technicians
Laboratory Quality Management System

o Lab Assistants/Phlebotomists
o Histotechnologists
o Cytotechnologists
The laboratory first responds to staffing shortages by utilizing "on call" and per diem staff,
flexing up part time staff, and offering overtime and bonus pay on a volunteer basis. If the
laboratory is unable to reach minimum staffing in the testing departments utilizing
voluntary methods, the assignment list portion(s) of Policy #146- MT/MLT Schedule
Guidelines take effect, to ensure minimum staffing levels are reached in a fair and
standardized manner.
Lab Quality Management System

G. QUALITY OBJECTIVES AND METRICS

Medical Director/Pathologist-in-Chief, Laboratory Director, Team
Leaders/Technical Specialists and Coordinators monitor document
performance of processes within their area(s) of responsibility. Each lab
section establishes measurable operation-level improvement indicators
consistent with the quality policy. Below are a few examples:
Element of Policy Quality Objective Metrics
Service Excellence Timely result reporting 1. Stat turnaround times for
emergency department (ED).
2. STAT result reporting
outliers
3. Specimen Acceptability rates
Meet and exceed customer 1. Press Ganey Patient
satisfaction. Satisfaction Surveys
2. Monitoring and resolution
of complaints.
3. Outpatient Call-backs
Cost effectiveness 1. Blood Product Wastage
2. Repeat collections
3. Outpatient Lab volume
monitoring
Accurate and Timely Maintain or improve scores in Proficiency test result monitoring
Result Reporting Proficiency Testing and tracking
Perform all defined quality 1. Blood Culture
control measures. Contamination Rates
2. Blood Culture Fill
Volumes
3. Corrected Results reports
4. Specimen
Acceptability monitoring
5. Computer calculation
checks
6. Corrected Reports.
7. Data Transmission
8. Amended Reports –
Anatomic Pathology
9. Surgical
Pathology/Cytology
Specimen Labeling

6
This is a CONTROLLED document. Printed copies are considered uncontrolled and should be checked against the on-line (electronic) version
prior to use.
Laboratory Quality Management System

Retain qualified and competent 1. Turnover report

staff monitoring
2. Employee Surveys
3. Annual competency
evaluations and
continuing education

Quality Patient Accurately identify all patients and 1. Lab-collected Patient

Care samples Identification and Specimen
Labeling errors
2. Blood Bank
requisitions-audit for
completion
Report critical values in a timely 1. Critical Value Reporting
manner 2. Critical Value
Documentation
3. Frozen Section TAT
Reduce Nosocomial Infections 1. MRSA/CDIFF
surveillance audits.
2. CAUTI
monitoring
3. Flu and Covid
activity monitoring
Safety Ensure Employee Safety and 1. Occupational Injury reports
Regulatory Safety Requirements are and monitoring
met. 2. Environmental Audits
3. Safety Rounds
4. Staffing Levels

Safety Event Reporting System- 1. Monitor and investigate

S.A.F.E. and QA Variance Reports events entered in S.A.F.E. and
QA Variance forms
2. Identify and investigate non-
conforming events using RCA
when appropriate/necessary.

H. ROLES AND RESPONSIBILITIES

Laboratory Quality Management System

Overall responsibilities for ensuring compliance with the QMS, are described
below:

Position Responsibility
Chief Nursing/Operating Responsible for nursing and operations at the senior executive
Officer level.

Director of Allied Health Responsible for executive sponsorship of laboratory

Services management and laboratory quality providing oversight and
alignment within the System.

Laboratory Medical Responsible for the clinical aspects of laboratory testing, which
Director/Chief includes approval of the new tests, test procedures, reference
Pathologist ranges, report format, clinical interpretation, and consultation.
Responsible for the approval of overall QMS activities.

Director, Laboratory Responsible for the business management and strategic

direction of the laboratory in support of overall quality
management. Ensures that QMS is established, implemented,
monitored, documented and quality is continuously improving.
Responsible for periodic reviews by organizational committees
and Senior Management for effectiveness and continuing
suitability. Provides guidance for staff to develop and
document appropriate operational procedures and monitoring
metrics, aligned with the QMS.
Responsible for activities involved in daily laboratory
operation such as testing, reporting, and logistics.

Team Responsible for planning and controlling QMS processes within

Leaders/Technical their area of responsibility, including the implementation of
Specialists Quality Management objectives and the provision of resources
needed to implement and improve these processes. Team
Leaders/Technical Specialists are responsible for corrective
action related to quality variances. Maintain control of lab costs
within budget. Evaluate quality control and quality assurance
statistics and maintains policies and procedures

Lead Technologists and Responsible for supervising the activities of the QMS on the
Lead Phlebotomists frontline and creating an environment of trust and
accountability. Ensure performance of standard biological,
microbiological, and chemical tests to assure their delivery in
an accurate and timely fashion using proper safety precautions.
Participate in root cause analyses for the management of
quality variances and safety events.
Laboratory Quality Management System

Staff Responsible for the quality of individual work and the

development and implementation of the policy and procedures
applicable to the processes performed. Identifying and
reporting of quality variances.

I. ETHICAL CONDUCT

1. The hospital system has a Corporate Compliance Program, which requires all
dealings be conducted in a lawful and ethical manner.

2. Through adherence to Professional Conduct and Responsibility

standards, all staff members conduct themselves in a professional and ethical
manner, to protect and promote organization-wide integrity

J. LEADERSHIP COMMITMENT

Laboratory leaders provide evidence of commitment to the development and

implementation of the quality management system and continually improve its
effectiveness utilizing the following activities:

• Establish the quality management system and review annually.

• Communicate the policy to employees during laboratory training/orientation and
annual competency.
• Leaders ensure that employees at all levels understand, implement and maintain
the quality management system. Document through training procedures, competency
assessment and the employee performance review. The internal audit and the
leadership review processes demonstrate compliance.
• Testing personnel understand and implement section policies and procedures.
Leaders document through training/competency and maintain documentation in
the employee file.
• Communicate information related to the quality management system through
daily huddles, emails, text application messages, Lab Leadership meetings, Lab Staff
meetings, document read & signs, stay interviews, text application messages and via
email.

K. QUALITY SYSTEM SUMMARY

1. The laboratory defines policies for each applicable standard.

Laboratory policies will be maintained in a document control system approved by the
Medical Director. Members of the Lab Leadership Team develop and maintain
documented procedures that further describe how the specific policy objectives and
goals are implemented within the department.
Laboratory Quality Management System

2 . Technical procedures are maintained in each section’s manuals.

Technical procedures specify the equipment and resources needed to produce
quality results in accordance with the applicable standards and policies. Section
policies and procedures are maintained in the document control system and are
approved by the Team Leaders/Technical Specialists and Medical Director.

3. All employees are responsible for the quality system.

Individual policies and procedures further define specific employee responsibilities.
The quality system includes a formal system of planned activities. The quality manual
is maintained current, to reflect changes to the system.
4. Lab Leadership members assess and monitor quality on an ongoing basis.
Processes are observed and monitored to assess whether the quality management
system is implemented as planned, is effective and is consistently in use in all
laboratory sections and sites. This information is shared with staff on a regular basis.
5. As need is identified, the department takes corrective action and makes
changes to improve.
When leaders identify trends in errors and/or opportunities to improve, they modify
processes and procedures with the goal of preventing errors and improving for the
future.
Non-conforming events are identified and investigated in accordance with hospital
policy for root cause analysis.

QUALITY ASSURANCE, ASSESSMENT AND IMPROVEMENT

A. GENERAL LABORATORY
Essential components in the quality assurance, assessment and improvement
process include:
• Identify aspects of service to be monitored and evaluated
• Identify indicators
• Establish criteria
• Collect data
• Analyze data and identify problems (if any)
• Develop a plan for corrective action and future prevention
• Document actions taken
• Monitor and evaluate effectiveness of actions taken

1. On-site Inspections
• Accrediting agencies provide standards of compliance in all aspects of safety,
quality control and proficiency.
• College of American Pathologists (CAP), The Joint Commission (TJC), American
Association for Blood Banks (AABB), Rhode Island Department of Health
(RIDOH) and Health Care Financing Administration (HCFA)

2. Proficiency Survey and Q-Track results and intradepartmental monitors are

reviewed individually.
Laboratory Quality Management System

• Medical Director/Pathologist-in-Chief, Laboratory Director, and Team

Leaders/Technical Specialists to identify trends and opportunities to improve

3. Quality Assurance Variance Reports

• Refer to Policy #95- Quality Assurance Variance Reports
• Reviewed by the Lab leadership to identify trends and opportunities to improve,
and to document follow-up with staff members as appropriate.

4. Safety Event Reporting System- Events and Feedback

• Refer to Policy #113- Handling and Resolution of Complaints
• Members of Lab leadership review and investigate reports, and follow up as
needed with staff members and/or to develop process improvement plans and
policy/procedure updates.

B. CLINICAL LABORATORY

1. Internal Quality Control Activities-

• Each section of the clinical laboratory maintains section-specific quality

assurance programs, which include a written policy and documentation thereof.
Process Category Metric
Core Pre-analytic -Patient and specimen identification
-Specimen integrity
Analytic -Materials
-Equipment
-Quality Control
-Calibration
Post-analytic -Manual result entry review
-Turnaround Time Monitoring
-Calculation checks

Support -Procedures
-Training and Competency

2. External Proficiency Program

• CAP Proficiency Survey Programs- received two to three times per year
depending on the survey. Results are compared to national peer-groups.
• For full list of enrolled proficiency surveys, see reference guide- CAP Proficiency
and Q-tracks Monitors

3. Q-track Quality Monitors

Laboratory Quality Management System

• For full list of enrolled Q-tracks, see attached reference guide- CAP Proficiency
and Q-tracks Monitors

C. ANATOMIC PATHOLOGY (SURGICAL AND AUTOPSY PATHOLOGY)

1. Internal Quality Control Activities-

• Anatomic pathology maintains a section-specific quality assurance program,

which includes a written policy and documentation thereof.
Process Category Metric
Core Pre-analytic -Patient and specimen identification
-Specimen integrity
Analytic -Intra-departmental Case Review- Prospective
review prior to issuance of final reports
(Consultation)
-Intraoperative Consultations
Post-analytic -Extra-Departmental Case Review
-Retrospective audit of completed cases after
issuance of final reports (Peer review)
-Turnaround Time Monitoring- frozen sections
and surgical pathology cases
-Synoptic report review
-Annual audit of receptor studies for breast
cancer cases
-Tissue/Transfusion Review Committee

Support -Procedures
-Training and Competency

REFERENCES
1. Clinical and Laboratory Standards Institute (CLSI). A Quality Management System Model for
Laboratory Services. 5th ed. CLSI guideline QMS01. Clinical and Laboratory Standards Institute,
Wayne, PA; 2019.

2. Valenstein P. Quality Management In Clinical Laboratories. Chicago, IL: CAP Press, 2005.
Laboratory Quality Management System

3. Jhai Q, Siegal GP. Quality Management in Anatomic Pathology. Northfield, IL: CAP Press,
2017

4. ISO Standards compendium: ISO 9001:2015, Quality management systems -- Requirements.

Geneva, Switzerland: International Organization for Standardization, 2015.

5. ISO 15189:2012 Medical laboratories -- Requirements for quality and competence. Geneva,
Switzerland: International Organization for Standardization, 2012.

6. Informational graphic. QMS Core and Support Processes Graphic, College of American
Pathologists.
https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/WebApplic
ations/pdf/QMS_Core_and_Support_Processes.pdf