Attach_2_Quality_Assurance_Surveillance_Plan.pdf

Medical Support Services

Center for Domestic Preparedness (CDP)

Anniston, AL

Attachment 2

Quality Assurance Surveillance Plan (QASP)

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

MEDICAL SUPPORT SERVICES

1. INTRODUCTION

This Quality Assurance Surveillance Plan has been developed to evaluate Contractor performance while implementing the Performance Work Statement (PWS). It is designed to provide an effective surveillance method for monitoring and evaluating the

Contractor’s performance for the requirements listed in the PWS.

The Contractor, and not the Government, is responsible for management and quality control actions to meet the terms of the contract. The role of the Government is quality assurance to ensure contract standards are achieved. In this contract, the quality control program is the driver for service quality. The Contractor is required to develop a comprehensive program of inspections and monitoring actions. The major step to ensuring a “self-correcting” contract is to ensure that the quality control program approved at contract award provides the measures needed to lead the Contractor to success. Once the quality control program is approved, careful application of the process and standards presented in the remainder of this document will ensure a quality program.

2. OBJECTIVE

This plan provides a quality surveillance strategy for medical support services to be performed at the Department of Homeland Security (DHS)/Federal Emergency

Management Agency (FEMA)/Center for Domestic Preparedness (CDP), located at

Anniston, Alabama. The primary intent of the plan is to provide a basis of the

Contracting Officer’s Representative (COR) evaluation of performance quality.

Oversight of Contractor performance will assure quality performance. The plan will also afford the COR and Contracting Officer a productive mechanism to preclude major deficiencies in performance, provide input for annual contractor past performance evaluations, and make the determination of exercising of contract options.

3. PERFORMANCE INDICATORS (MEASURES).

Surveillance of contractor performance will be performed by the appointed Contracting

Officer’s Representative (COR) and the Contracting Officer based on the surveillance methodologies identified in the Performance Requirements Summary (PRS). The following primary task areas of the contract will be the basis from which all surveillance will originate:

7.1 Medical Treatment Surveillance (Non-COBRATF)

7.2 COBRATF Medical Support

7.3 Blood Draws

7.4 Blood Analysis Laboratory Operations

4. EVALUATION METHODS

The COR efforts will primarily be based on verification and monitoring of the

Contractor’s performance. The Government will use a variety of surveillance methodology and techniques to validate the contractor’s compliance. The COR, assisted by other Government representatives, will perform evaluations based on each of the indicators stated in section 3 of this plan. The below listed methods of surveillance shall be used in the administration of this QASP.

5. PERFORMANCE REQUIREMENT SUMMARY

5.1 Lists the specific section in the PWS that the government will evaluate. The absence of any contract requirement from the PRS shall not detract from its enforceability or limit the rights or remedies of the government under any other provision of the contract.

5.2 Lists the service to be performed.

5.3 Lists the standard of performance for each specific service.

5.4 Lists the surveillance methods the government will use to evaluate the contractors performance in meeting the requirements of the contract.

6. SURVEILLANCE METHODS

6.1 The Government’s quality assurance procedures are based in part on attribute sampling of the recurring critical products of the contract using the concepts of MIL STD

105E sampling procedures and ANSI/ASQC Z1.4 sampling procedures and tables for inspection by attributes.

6.2 The Random Sampling method will be used for recurring service output items

(daily, weekly, monthly, quarterly, semiannually, annually or as required) as determined necessary to assure a sufficient evaluation of contractor performance.

6.3 The 100% Inspection Method will be used for those tasks that occur infrequently and cannot be random sampled because the sample size for a small lot may exceed the lot size. Also the tasks may have a stringent performance requirement where safety or health may be a concern.

6.4 Periodic surveillance. Sometimes called sampling, consists of the evaluation of tasks selected on other than 100 percent or random sample basis. It is appropriate for tasks that occur infrequently and where 100 percent inspection is neither required nor practicable. A predetermined plan for inspecting part of the work is established using subjective judgment and analysis of agency resources to decide what work to inspect and how frequently to inspect it. There will be periodic surveillance of output items as determined necessary to assure a sufficient evaluation of contractor’s performance.

6.5 Customer complaints/Input. This is not a primary method, but it is a valuable supplement to more systematic methods. For example, in a case where random sampling indicates unsatisfactory service, customer complaints can be used as substantiating evidence. In certain situations where customers can be relied on to complain consistently when the quality of performance is poor, e.g., dining facilities, building services;

customer surveys and customer complaints may be a primary surveillance method.

"This Quality Assurance Surveillance Plan is not intended to interfere with Contractor's status as an 'independent contractor' under the law, nor is it intended in any way to supplant the Contractor's responsibility for the day-to-day control and management of its own personnel and other resources for which it is ultimately responsible."

FEMA CENTER FOR DOMESTIC PREPAREDNESS (CDP) MEDICAL SUPPORT SERVICES

PERFORMANCE REQUIREMENTS SUMMARY (PRS)

PERFORMANCE WORK

STATEMENT (PWS) TASKS

METRIC

TYPE

PERFORMANCE STANDARD/

ACCEPTABLE QUALITY LEVELS (AQL) MONITORING METHOD

1.4.5 The contractor shall report to the COR

in writing within 24 hours all accident/incidents occurring while performing work under this contract in accordance with CDP Accident/Incident

Reporting Policy

Timeliness No more than two contract discrepancies per quarter for all of the requirements of this section

100% Inspection

COR records the date/time each report is received.

1.4.5 The contractor shall report to the COR

in writing within 24 hours all accident/incidents occurring while performing work under this contract in accordance with CDP Accident/Incident

Reporting Policy

Quality Reports are complete and accurate 95% of the time wih 5% or less requiring rework.

100% Inspection

COR reviews reports for completion and accuracy.

1.4.5.3 The contractor shall perform a

written risk assessment document for all employee related operations and work assignments under the scope of this contract.

The risk assessment shall include a Job

Hazard Analysis (JHA) for each titled position. Each JHA shall be reviewed in a timely manner not to exceed twenty-four

(24) months to ensure changes limited to the following information: job title, job location, task description, hazard description, hazard to task description, hazard controls and training requirements have not occurred.

Quality Reports are complete and accurate 95% of the time wih 5% or less requiring rework.

100% Inspection

COR reviews reports for completion and accuracy.

1.5.1.7.2 Each employee shall complete

required training as mandated by regulatory agency standards (i.e. respiratory protection, blood borne pathogens, hazard communications, and fall protection). The contractor shall maintain a record of all training completed by contract personnel and will facilitate access to these records for inspection purposes by government

Quality No more than two contract discrepancies per quarter for all of the requirements of this section

100% Inspection

COR reviews records for completion and accuracy.

PERFORMANCE WORK

STATEMENT (PWS) TASKS

METRIC

TYPE

PERFORMANCE STANDARD/

ACCEPTABLE QUALITY LEVELS (AQL) MONITORING METHOD

employees designated by the CO and/or inspections by outside regulatory agencies.

1.8.1 Technical Progress Report due NLT

the 10 th day of each month.

Quality

Reports received are complete and accurate 95% of the time with 5% or less requiring rework.

100% Inspection

COR reviews reports for completion and accuracy.

1.8.1 Technical Progress Report due NLT

the 10 th day of each month.

Timeliness

No more than two contract discrepancies per quarter for all of the requirements of this section

100% Inspection

COR records the date/time each report is received.

1.8.2 Financial Reports due NLT the 10

th of each month.

Quality

Reports received are complete and accurate 95% of the time with 5% or less requiring rework.

100% Inspection

COR reviews reports for completion and accuracy.

1.8.2 Financial Reports due NLT the 10

th of each month.

Timeliness

No more than two contract discrepancies per quarter for all of the requirements of this section

100% Inspection

COR records the date/time each report is received.

4.1 Government Furnished

Property/Equipment 100% Annual Report Quality

91-95 % of the reports received are complete and accurate with 5% or less requiring rework.

100% Inspection

COR reviews reports for completion and accuracy.

4.1 Government Furnished

Property/Equipment 100% Annual Report Timeliness

95% on time and inclusive of all required information.

100% Inspection

COR records the date/time each report is received.

4.3.8 Equipment Warranties. The contractor

shall inventory, maintain warranty documentation and track such inventories, as well as the warranties on future equipment/systems purchased and installed throughout the life of the contract.

Quality

Equipment warranty maintained on a warranty log, and appropriate warranty information documented for each piece of component or part installed are 95% accurate.

Periodic Inspection

COR reviews warranty log for completion and accuracy.

STATEMENT (PWS) TASKS

METRIC

TYPE

PERFORMANCE STANDARD/

ACCEPTABLE QUALITY LEVELS (AQL) MONITORING METHOD

6.1 A written notification of any non-

compliance shall be provided by the contractor by email to the COR within 24 hours of discovery

Timeliness

No more than two contract discrepancies per quarter for all of the requirements of this section

100% Inspection

COR records the date/time each report is received.

6.1 A written notification of any non-

compliance shall be provided by the contractor by email to the COR within 24 hours of discovery.

Quality Reports received are complete and accurate 95% of the time with 5% or less requiring rework.

100% Inspection

COR reviews reports for completion and accuracy.

6.1.1.2.4 Develops and maintains SOPs for

all general and specific tasks in the contract

Performance Work Statement, to include required reviews, updates/changes, and new procedures (as required).

Quality SOPs are complete and accurate 95% of the time with 5% or less requiring rework.

100% Inspection

COR reviews calendars for completion and accuracy.

7.1.2 The contractor shall ensure all medical

staff meet and maintain, at the contractor’s expense, all the required qualifications, certifications and licenses in the performance of this contract.

Timeliness

All requirements met without any contract discrepancies.

100% Inspection

COR reviews medical licensing for currency.

7.1.2.2 Alabama Emergency Medical

Technician (EMT) licenses are required for the level of service identified by the contractor and approved by the COR.

Timeliness All requirements met without any contract discrepancies.

100% Inspection

COR validates licensing for appropriate level of service identified.

7.1.2.3 Ambulance drivers shall have a

current State of Alabama driver’s license and current State of Alabama ambulance license.

Timeliness

All requirements met without any contract discrepancies.

100% Inspection

COR validates licensing for currency.

7.1.5 The contractor shall conduct pre-

training and post-training medical screening and student vitals as scheduled in the specified training course requirements.

Timeliness

No more than three contract discrepancies per quarter for all of the requirements of this section Periodic Inspection

STATEMENT (PWS) TASKS

METRIC

TYPE

PERFORMANCE STANDARD/

ACCEPTABLE QUALITY LEVELS (AQL) MONITORING METHOD

7.1.6 The contractor shall maintain the

required DEA license and provide expendable medical supplies, emergency medical supplies and all required drugs.

Timeliness

All requirements met without any contract discrepancies.

Periodic Inspection

7.1.7 The contractor shall provide

maintenance and calibration of all medical equipment assigned under this contract.

Quality

No more than one contract discrepancies per quarter for all of the functional requirements of these sections, combined.

Periodic Inspection

7.2.1 The contractor shall provide

COBRATF medical support personnel that are fully qualified as described within the

COBRATF Standards Document.

Quality

Medical support personnel training and certifications are documented and in accordance with the

COBRATF Standards Document.

Periodic Inspection

7.2.6.1 Medically clears students to train at

the COBRATF when the decision cannot be determined by the on-site Government’s

Occupational Health Nurse (OHN), RN.

Quality No more than one contract discrepancies per quarter for all of the requirements of this section. Periodic Inspection

7.2.6.3 Purchase drug supplies for utilization

by contractor’s on-site medical support personnel. The contractor shall ensure required drugs and supplies do not exceed expiration dates, and proper disposal of expired items.

Timeliness Inventory logs and documentation for disposal of expired drugs are accurate 95% of the time with 5% or less requiring rework.

100% Inspection

7.3.3.1 Pre-training Blood Draws. The

contractor shall deliver all blood drawn specimens, per the student roster, to the blood lab for testing within 30 minutes of completion.

Timeliness

No more than two contract discrepancies per quarter for all of the requirements of this section. Periodic Inspection

7.3.3.2 Post Training Blood Draws. The

contractor shall deliver all blood drawn specimens, per the student roster, to the blood lab for testing within 30 minutes of completion.

Timeliness No more than two contract discrepancies per quarter for all of the requirements of this section. Periodic Inspection

7.3.5 The contractor shall establish and

maintain all records for blood draws and the required documents to be delivered to the blood lab for positive control and

Quality All requirements met without any contract discrepancies. Periodic Inspection

STATEMENT (PWS) TASKS

METRIC

TYPE

PERFORMANCE STANDARD/

ACCEPTABLE QUALITY LEVELS (AQL) MONITORING METHOD

accountability of blood drawn specimens.

7.3.6 The contractor shall develop and

maintain disposal procedures of any and all biohazardous waste resulting in blood draw operations.

Quality Disposal procedures are followed 100% of the time. Periodic Inspection

7.4.2 Medical Laboratory Technicians

(MLTs) will be required to complete yearly certifications in accordance with U.S. Army

Public Health Command (USAPHC), training certification and biannual certification from the State of Alabama

Clinical Laboratory Improvement

Amendment (CLIA).

Timeliness Maintain currency of required yearly certifications and biannual certifications for all MLTs 100% of the time.

Biannual/Annual Inspection

7.4.3 MLTs must undergo a 40 hour training

program at USAPHC in order to perform assay. Certificate documentation will be provided to the COR upon Receipt.

Timeliness All requirements met without any contract discrepancies. Periodic Inspection

7.4.6.1 Calibrate, standardize, adjust and

operate all equipment used to perform RBC-

ChE testing.

Quality Calibration logs, maintenance logs, and set-up logs will be 95% complete and accurate 5% or less requiring rework.

Periodic Inspection