SOH_Medical Surveillance_QASP_Sole Clinic_FY2021_FINAL.pdf

QUALITY ASSURANCE SURVEILLANCE PLAN

For

Maryland Army National Guard Occupational Health Medical Surveillance Sole Clinic

Issued 11 March 2021

TABLE OF CONTENTS

1. INTRODUCTION

2. ROLES AND RESPONSIBILITIES

3. IDENTIFICATION OF REQUIRED PERFORMANCE STANDARDS/QUALITY

LEVELS

4. METHODOLOGIES TO MONITOR PERFORMANCE

5. QUALITY ASSURANCE DOCUMENTATION

6. ANALYSIS OF QUALITY ASSURANCE ASSESSMENT

ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY

ATTACHMENT 2: SAMPLE QUALITY ASSURANCE MONITORING FORM

ATTACHMENT 3: QUALITY ASSURANCE WORKSHEET

1. INTRODUCTION

This quality assurance surveillance plan (QASP) is pursuant to the requirements listed in the performance work statement (PWS) entitled Maryland Army National Guard (MDARNG) Occupational Health (OH) Medical Surveillance Sole Clinic. This plan sets forth the procedures and guidelines the Safety and Occupational Health (SOH) office will use, ensuring the required performance standards or services levels are achieved by the contractor.

1.1. Purpose

1.1.1. The purpose of the QASP is to describe the systematic methods used to monitor performance and to identify the required documentation and the resources to be employed. The QASP provides a means for evaluating whether the contractor is meeting the performance standards/quality levels identified in the PWS and the contractor’s quality control plan (QCP), and to ensure that the government pays only for the level of services received.

1.1.2. This QASP defines the roles and responsibilities of all members of the integrated project team (IPT), identifies the performance objectives, defines the methodologies used to monitor and evaluate the contractor’s performance, describes quality assurance documentation requirements, and describes the analysis of quality assurance monitoring results.

1.2. Performance Management Approach

1.2.1 The PWS structures the acquisition around “what” service or quality level is required, as opposed to “how” the contractor should perform the work (i.e., results, not compliance). This QASP will define the performance management approach taken by the SOH office to monitor and manage the contractor’s performance to ensure the expected outcomes or performance objectives communicated in the PWS are achieved.

Performance management rests on developing a capability to review and analyze information generated through performance assessment. The ability to make decisions based on the analysis of performance data is the cornerstone of performance management; this analysis yields information that indicates whether expected outcomes for the project are being achieved by the contractor.

1.2.2 Performance management represents a significant shift from the more traditional quality assurance (QA) concepts in several ways. Performance management focuses on assessing whether outcomes are being achieved and to what extent. This approach migrates away from scrutiny of compliance with the processes and practices used to achieve the outcome. A performance-based approach enables the contractor to play a large role in how the work is performed, as long as the proposed processes are within the stated constraints. The only exceptions to process reviews are those required by law (federal, state, and local) and compelling business situations, such as safety and health. A “results” focus provides the contractor flexibility to continuously improve and innovate over the course of the contract as long as the critical outcomes expected are being achieved and/or the desired performance levels are being met.

1.3. Performance Management Strategy

1.3.1 The contractor is responsible for the quality of all work performed. The contractor measures that quality through the contractor’s own quality control (QC) program. QC is work output, not workers, and therefore includes all work performed under this contract regardless of whether the work is performed by contractor employees or by subcontractors. The contractor’s QCP will set forth the staffing and procedures for self-inspecting the quality, timeliness, responsiveness, customer satisfaction, and other performance requirements in the PWS. The contractor will develop and implement a performance management system with processes to assess and report its performance to the designated government representative. The contractor’s QCP will set forth the staffing and procedures for self-inspecting the quality, timeliness, responsiveness, customer satisfaction, and other performance requirements in the PWS. This QASP enables the government to take advantage of the contractor’s QC program.

1.3.2 The government representative(s) will monitor performance and review performance reports furnished by the contractor to determine how the contractor is performing against communicated performance objectives. The government will make determination regarding incentives based on performance measurement metric data and notify the contractor of those decisions. The contractor will be responsible for making required changes in processes and practices to ensure performance is managed effectively.

2. ROLES AND RESPONSIBILITIES

2.1. The Contracting Officer

The contracting officer (CO) is responsible for monitoring contract compliance, contract administration, and cost control and for resolving any differences between the observations documented by the SOH Contracting Officer’s Representative (COR) and the contractor. The CO will designate one full-time COR as the government authority for performance management. The number of additional representatives serving as technical inspectors depends on the complexity of the services measured, as well as the contractor’s performance, and must be identified and designated by the CO.

2.2. The Contracting Officer’s Technical Representative

The contracting officer’s technical representative (COTR) is designated in writing by the CO to act as his or her authorized representative to assist in administering a contract.

COTR limitations are contained in the written appointment letter. The COTR is responsible for technical administration of the project and ensures proper government surveillance of the contractor’s performance. The COTR is not empowered to make any contractual commitments or to authorize any contractual changes on the government’s behalf. Any changes that the contractor deems may affect contract price, terms, or conditions shall be referred to the CO for action. The COTR will have the responsibility for completing QA monitoring forms used to document the inspection and evaluation of the contractor’s work performance. Government surveillance may occur under the inspection of services clause for any service relating to the contract.

3. IDENTIFICATION OF REQUIRED PERFORMANCE STANDARDS/QUALITY

LEVELS

The required performance standards and/or quality levels are included in the PWS. If the contractor meets the required service or performance level, it will be paid the amount agreed on in the contract. Failure to meet the required service or performance level will result in a deduction from the monthly amount.

4. METHODOLOGIES TO MONITOR PERFORMANCE

4.1. Surveillance Techniques

In an effort to minimize the performance management burden, simplified surveillance methods shall be used by the government to evaluate contractor performance when appropriate. The primary methods of surveillance are:

• Random monitoring, which shall be performed by the COTR/COR designated inspector.

• 100% Inspection – each month, the COTR/COR, shall review the generated documentation

• Periodic Inspection – COTR/COR typically performs the periodic inspection

4.2. Customer Feedback

The contractor is expected to establish and maintain professional communication between its employees and customers. The primary objective of this communication is customer satisfaction. Customer satisfaction is the most significant external indicator of the success and effectiveness of all services provided and can be measured through customer complaints.

Performance management drives the contractor to be customer focused through initially and internally addressing customer complaints and investigating the issues and/or problems but the customer always has the option to communicate complaints to the COR, as opposed to the contractor.

Customer complaints, to be considered valid, must set forth clearly and in writing the detailed nature of the complaint, must be signed, and must be forwarded to the COTR/COR. The COTR/COR will accept those customer complaints and investigate using the Quality Assurance Monitoring Form – Customer Complaint Investigation, identified in Attachment 2.

Customer feedback may also be obtained either from the results of formal customer satisfaction surveys or from random customer complaints.

4.3. Acceptable Quality Levels

The acceptable quality levels (AQLs) included in Attachment 1, Performance Requirements Summary Table, for contractor performance are structured to allow the contractor to manage how the work is performed while providing negative incentives for performance shortfalls. For certain critical activities such as those involving the performance of facility inspection, the desired performance level is established at 100 percent. Other levels of performance are keyed to the relative importance of the task to the overall mission performance for the MDARNG SOH office.

5. QUALITY ASSURANCE DOCUMENTATION

5.1. The Performance Management Feedback Loop

The performance management feedback loop begins with the communication of expected outcomes. Performance standards are expressed in the PWS and are assessed using the performance monitoring techniques shown in Attachment 1.

5.2. Monitoring Forms

The government’s QA surveillance, accomplished by the SOH COR will be reported using the monitoring forms in Attachments 2 and 3. The forms, when completed, will document the government’s assessment of the contractor’s performance under the contract to ensure that the required results for quality facility inspections are being achieved.

5.2.1 The SOH COR will retain a copy of all completed QA surveillance forms.

6. ANALYSIS OF QUALITY ASSURANCE ASSESSMENT

6.1. Determining Performance

6.1.1. Government shall use the monitoring methods cited to determine whether the performance standards/service levels/AQLs have been met. If the contractor has not met the minimum requirements, it may be asked to develop a corrective action plan to show how and by what date it intends to bring performance up to the required levels.

Failure to meet the AQL may result in a deduction from agreed upon payment.

6.2 Reporting

6.2.1. At the end of each quarter, the SOH COR will prepare a written report for the SOH Manager (SOHM) summarizing the overall results of the quality assurance surveillance of the contractor’s performance. This written report, which includes the completed quality assurance monitoring forms (attachment 2 and attachment 3), will become part of the QA documentation. It will enable the government to demonstrate whether the contractor has met the stated objectives and/or performance standards, including cost/technical/scheduling objectives.

6.3. Reviews and Resolution

6.3.1. The SOHM may require the contractor’s project manager, or a designated alternate, to meet with the COR and other government IPT personnel as deemed necessary to discuss performance evaluation. The COR will define a frequency of in-depth reviews with the contractor, including appropriate self-assessments by the contractor; however, if the need arises, the contractor will meet with the COR as often as required or per the contractor’s request. The agenda of the reviews may include:

• Quarterly performance assessment data and trend analysis

• Issues and concerns of both parties

• Recommendations for improved efficiency and/or effectiveness

6.3.2 The QAR must coordinate and communicate with the contractor to resolve issues and concerns regarding marginal or unacceptable performance.

6.3.3 The COR and contractor should jointly formulate tactical and long-term courses of action. Decisions regarding changes to metrics, thresholds, or service levels should be clearly documented. Changes to service levels, procedures, and metrics will be incorporated as a contract modification at the convenience of the KO.

Attachment 1: Performance Requirements Summary

PWS

Paragraph

Task

Performance Standard

Acceptable Quality Level (AQL)

Surveillance Method Used / Frequency

1.6.1 Quality Control The contractor shall

develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services.

The contractor developed and maintained an effective QC Plan (QCP) to ensure services are performed in compliance with contract.

Employee Feedback

1.7. Place of Services OH services

geographically located within 55 miles from MDARNG duty stations.

Contractor provided services within the geographical range. Survey (geographical)

1.7.2. Performance of

Services

The contractor shall provide outlined services without deficiencies.

Contractor offered services and delivered results without error.

Documentation

1.7.7. Services and

Reports

The contractor shall abide by the privacy of the employee.

The contractor provided confidential areas at the time of examination for all services as well protected health information records.

Employee Feedback;

Documentation

1.7.8. Testing The contractor will

conduct testing based upon the list provided to them by the MDARNG Occupational Health Nurse (OHN).

Testing requirements were conducted according to the spreadsheet provided by

MDARNG OHN.

Documentation

1.7.14. Health Information The contractor shall

protect all health information.

The contractor protected health information IAW with

HIPAA.

Observation; Documentation

1.7.15 Protected Health

Information

Complete training Contractor provided completion documentation for employees expected to be on site prior to start of work

Receipt of documentation

1.7.17 Special

Qualifications

It is the responsibility of the contractor to ensure the health care team are current and appropriately licensed, trained, boarded and certified to perform medical surveillance screening and

Contractor provided licensing and certifications, to include calibration, prescribed in

PWS.

Receipt of documentation testing.

1.7.18 Conferences Contractor will

attend post award conference and periodic progress meetings

Contractor attended all post award meetings and conference.

Observation

1.7.19 Contract

Communication

Contractor is to designate a POC in writing to the KO for contracting actions.

The contractor designated a contracting manager who is fully working with the KO and COR on contracting actions.

Observation

1.7.22.1 Handling/Access to

Classified Information

Complete training Contractor provided completion documentation for employees expected to be on site prior to start of work

Receipt of documentation

1.7.22.2 OPSEC Training Complete training Contractor provided completion documentation for employees expected to be on site prior to start of work

Receipt of documentation

1.7.22.3 Threat Awareness

Reporting Program

Complete training Contractor provided completion documentation for employees expected to be on site prior to start of work

Receipt of documentation

4.0 Contractor

furnished property, materials, and equipment

Contractor is to furnish the facilities, equipment, labor and services as prescribed by the

PWS

Contractor furnished required materials and equipment to perform services.

Documentation

5.0 Examination

reports/invoices

Contractor shall ensure two copies of the employee’s examination findings are furnished. One copy shall be sent to the MDARNG OHN as designated in section 5.2, and one copy shall be mailed directly to the individual employee’s home of record within fifteen

(15) working days

Contractor provided medical reports/documentation for all procedures/testing annotated on the exam requirements form per employee. Results were legible and included the employee’s full name, last four digits of social security number, DOB, job code and date of service on each form.

Receipt of documentation upon completion of testing services.

If abnormal findings are identified that may be a serious health concern, the contractor shall notify the employee and the MDARNG OHN immediately to be referred accordingly IAW section 1.7.9. of this

PWS.

Examination results/reports, invoices, and any other correspondence will be addressed to

MDARNG OHN.

Abnormal findings, if any, were communicated immediately to the employee and MDANG OHN.

Examination results/reports were provided to OHN and employee within 30 working days upon completion of testing services. An itemized invoice was provided to the MDARNG OHN within 15 days of employee examination.

Documentation;

Communication

Documentation

5.3 Conduct Contractor will

present themselves with the utmost professionalism.

Contractors were highly professional. They carried themselves with confidence and made sure to use each moment as a teaching moment for the staff

Observation; Employee Feedback

5.11. Safety Facilities will be in

compliance with applicable OSHA requirements.

Contractors maintains a safe establishment at all times.

Observation; Employee Feedback

ATTACHMENT 2: SAMPLE QUALITY ASSURANCE MONITORING FORM

SERVICE OR STANDARD:

SURVEY PERIOD:

SURVEILLANCE METHOD (Check):

� Random Sampling � 100% Inspection � Periodic Inspection � Customer Complaint

LEVEL OF SURVEILLANCE (Check):

� Monthly � Quarterly � As needed

PERCENTAGE OF ITEMS SAMPLED DURING SURVEY PERIOD: ______ %

ANALYSIS OF RESULTS:

Observed Service Provider Performance Measurement Rate: ______%

Service Provider’s Performance (Check): � Meets Standards

� Does Not Meet Standards

Narrative of Performance During Survey Period:

PREPARED BY: _______________________________ DATE: _________________

ATTACHMENT 3: QUALITY ASSURANCE WORKSHEET

QUALITY ASSURANCE WORKSHEET

Performance Rating

Deliverable/Service

Quality Rating Causative Factors Effect on Mission

Action Required /

Date

All services available within 55 miles from each MDARNG duty station.

Green Comments Unnecessary for “Green” QA Rating.

Yellow

Red

Quality of employee examinations

Green Comments Unnecessary for “Green” QA Rating.

Yellow

Red

Completes and forwards reports within 30 days of completion

Green Comments Unnecessary for “Green” QA Rating.

Yellow

Red

Communicates effectively with OHN and MDARNG Technicians while providing a safe and secure location upon services.

Green Comments Unnecessary for “Green” QA Rating.

Yellow

Red

Rating Description

Green Yes performance and technical specifications are being met at AQL.

Yellow

Yes, performance and technical specifications are currently being met at the minimum AQL, but the following service / deliverable needs contractor attention.

The Customer must identify what component of the deliverable and/or service requires attention.

Red

No, performance and technical specifications are not being met at AQL and the following service / deliverable needs immediate contractor resolution.

The Customer must identify what component of the deliverable and/or service is below the minimum AQL.