SOW_ISO_v1.pdf

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PERFORMANCE BASED WORK STATEMENT

FSIS Field Service Laboratories and Accredited Laboratory Program

ISO Accreditation United States Department of Agriculture

Food Safety and Inspection Service

TABLE OF CONTENTS

1.1 Scope of Work

1.2 Non Personal Services

1.3 Security Requirements

1.4 Standards of Performance

1.5 Technical Requirements

1.6 Specific Tasks/Responsibilities

1.7 Place/Schedule/Hours of Performance

1.8 Invoices

1.9 Contractor Furnished Services/Supplies

1.10 Government Furnished Supplies

1.11 Quality Control

1.12 Deliverables/Reporting Requirements

1.13 Attachments

1.1 SCOPE OF WORK

1.1.1 The purpose of this effort is to establish a firm fixed-price contract for an accrediting body to conduct audits/assessments of the USDA Food Safety and Inspection Service (FSIS) Field Service Laboratories (FSLs) and the FSIS Accredited Laboratory Program (ALP) to determine that the FSLs and ALP are performing scope work and support activities in accordance with the most current versions of International Organization for Standardization documents and supporting guidelines specified in this Work Statement. The FSLs will be evaluated against the International Organization for Standardization and the International Electrotechnical Commission Standard 17025 (ISO Standard 17025) and AOAC International’s publication, “Guidelines for Laboratories Performing Food Microbiological and Chemical Analyses of Food and Pharmaceuticals Testing” written by the Analytical Laboratory Accreditation Criteria Committee. This publication is hereafter referred to as ALACC. The ALP will be evaluated against ISO Standards 17034 and 17043. The FSLs and ALP shall be audited against their quality management system policies and procedures currently in place and associated records. The period of performance is for one base-year and four one-year option periods.

1.1.2 The FSIS (the Government) FSLs and ALP are both currently accredited as follows. The FSLs are accredited to the ISO Standard 17025 and ALACC. The ALP is accredited to the ISO Standards 17034 and 17043. Hereafter, the ISO standards may be referenced together.

References to ISO 17025 are understood to include ALACC. The FSLs and ALP are under different management systems and are not under the same direct supervision. The FSLs are in three locations. The FSIS Eastern Laboratory (EL) is located in Athens, Georgia; the Midwestern

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Laboratory (ML) is located in St. Louis, Missouri; and the Western Laboratory (WL) is located in Albany, California. The ALP is co-located with the Eastern Laboratory in Athens, Georgia.

1.1.3 Current FSIS accreditations are as follows.

• ALP ISO 17034: Certificate number 4362.01 expires 10/31/19

• ALP ISO 17043: Certificate number AP-1941 expires 4/27/19

• EL ISO 17025: Certificate numbers 1898.02 and 1898.03 expire 4/30/2020

• ML ISO 17025: Certificate number 1898.04 and 1898.05 expire 4/30/2020

• WL ISO 17025: Certificate number 1898.06 and 1898.07 expire 4/30/2020

Under this base year plus four option years contract, tasks need to be completed such that the ALP accreditations for ISO 17034 and 17043 will have the same expiration date. That date will also coincide with the expiration date of the ISO 17025 accreditation for the Field Service Labs (FSLs). All FSLs received an on-site assessment in 2018. The Contractor may synchronize the assessment dates to provide cost savings and increase efficiency. The following table contains a suggested scheme for synchronizing accreditations (Year 1 = the base year of the contract).

AREA YEAR 1 YEAR 2 YEAR 3 YEAR 4 YEAR 5

ISO 17025 Annual Review On-Site Annual Review On-Site Annual Review ISO 17034 Surveillance On-Site Annual Review On-Site Annual Review ISO 17043 Surveillance On-Site Annual Review Annual Review Annual Review

An on-site assessment is a full review at the FSIS locations. It is typically multiple days and involves in-depth examination of systems and documents, and personnel interviews. An annual review is a remote examination of documentation and does not require and on-site visit. A surveillance assessment may be a remote review or an abbreviated on-site assessment.

The Contractor must either use this schedule or propose one of its own when bidding on this contract and must base its bid on its chosen schedule. The schedule used must accomplish the required synchronization of accreditations and may include extending expiration dates. The synchronization must be such that all accreditations can be synchronized on any following contract after the completion of option year four of this contract. The bid must also include travel cost estimates. Travel expenses will be reimbursed at actual cost and allowable costs will be based upon the Federal Travel Regulations (FTR). The Contractor is encouraged to become familiar with the FTR to avoid denied reimbursements. All anticipated costs must be included in the bid.

1.1.4 The FSLs conduct analyses to determine the presence of pathogenic organisms, veterinary drug residues, environmental contaminants, microbial toxins and food ingredients.

The FSLs have been accredited to ISO 17025 for more than fifteen years. The accreditations have been routine and without the need for special consideration except for moving the WL to a new location. Future accreditations are expected to be routine.

1.1.5 Under the Accredited Laboratory Program, FSIS accredits and provides administrative program management over participating private and State laboratories that test meat and poultry products for: moisture, protein, fat, and salt (MPFS); and various chemical residues. In order to carry out the responsibility of accrediting laboratories, and to provide interlaboratory quality

4 | P a g e assurance checks for analytical capabilities, the ALP administers proficiency test studies for meat and poultry food products for participating laboratories. The proficiency test studies enable the ALP to objectively assess participating and qualifying laboratories to determine their ability to provide analytical services in accordance with the quality specified by FSIS. The samples from the proficiency test studies are then used as reference materials (RMs), so PTs and RMs are one and the same physical samples. The PT event results are used to characterize the RMs. The processes, materials, and management system are the same for both ISO 17034 and 17043 accreditations for the ALP. The ALP has been accredited as a PT provider since 2015 and as a reference material producer since 2018. The accreditations have been routine and without the need for special consideration. Future accreditations are expected to be routine.

1.2 NON-PERSONAL SERVICES

1.2.1 No personal services shall be performed under this contract. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

1.2.2 The Contractor shall not perform any inherently Government actions under this contract.

No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work.

1.2.3 The Contractor shall ensure that all of its employees working on this contract are informed of the substance of this clause. Nothing in this clause shall limit the Government's rights in any way under any other provision of the contract, including those related to the Government's right to inspect and accept the services to be performed under this contract. The substance of this clause shall be included in all subcontracts at any tier.

1.3 SECURITY REQUIREMENTS

1.3.1 Under Homeland Security Presidential Directive 12 (HSPD-12) and in accordance with FAR 52.204-9, Personal Identity Verification of Contractor Personnel, and AGAR 452.204-71 Personal Identity Verification of Contractor Employees, all Contractor employees requiring routine physical access to Federally-controlled facilities or routine access to Federally-controlled information systems must go through an FSIS identity proofing and registration process, and must have been successfully identity proofed, and have a successfully adjudicated National Agency Check with (Written) Inquiries (NACI) or Office of Personnel Management (OPM)/National Security (NS) Background Investigation (BI) to serve on this contract.

1.3.2 The Contractor shall provide the Contracting Officer Representative (COR) with information on the names of all employees who will require access to the facility in order to

5 | P a g e perform work on equipment, including approximate date and time of arrival. This should be provided at least 24 hours in advance of work being performed or as mutually agreed upon by the Contractor and COR or designee representative. All employees provided by Contractor must have valid driver’s license or state photo identification before being allowed onto the premises.

1.4 STANDARDS OF PERFORMANCE

1.4.1 The Government requires that the Contractor shall provide personnel who are competent.

The Government has the right to test the Contractor the first day of the contract and any time during contract performance to determine whether the Contractor can perform all contract-required skills and stay within the scope of the contract and ISO Standards 17025, 17034, and 17043. If the Contractor cannot perform all those skills and requirements, the Government activity may request that the Contractor be replaced with a Contractor that can perform all the contract-required skills.

1.4.2 Performance reports may be provided by the COR annually to the Contracting Officer (CO) to ensure acceptable performance of the contract. Any annual reports provided by COR to Contracting Officer after completion of each performance period will be reported to the Government’s hard copy folder.

1.5 TECHNICAL REQUIREMENTS

1.5.1 The Contractor shall perform assessments of the programs’ quality management systems along with related documents and procedures to identify nonconformances to the requirements found in ISO/IEC 17025, 17034, and 17043. Assessors provided by the Contractor must be qualified as auditors and U.S. citizens. The assessment shall be ongoing over the period of the contract and may be conducted in stages according to the industry’s commonly accepted practices. Activities may include, but are not limited to, on-site visits with entry and exit briefings, desk audits, review of quality documentation and sample handling, interviews of technical and management staff, and examination of records.

1.5.2 The Contractor shall be recognized by an official accrediting organization as qualified to assess and certify that the FSLs and ALP meet, or do not meet, the requirements of the ISO 17025, ALACC, ISO 17034, and ISO 17043 Standards. The Contractor shall have Mutual Recognition Agreements (MRAs) indicating that national and international accrediting bodies recognize the Contractor’s accreditations for the same fields of accreditation included in this contract. The Contractor shall be a full member or signatory of international cooperative arrangements. The Contractor shall also be recognized by an official accrediting organization as qualified to perform accreditation services under the current ISO/IEC Standard 17011.

1.5.3 The Contractor shall have:

• A minimum of 10 years of in-depth experience assessing regulatory food testing labs to both the ISO 17025 and ALACC requirements.

• In-depth experience assessing PT Providers and RM Producers to ISO Guides and Standards to include ISO 17034 and ISO 17043.

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• A record of past performances that are mostly Exceptional and at least Very Good (see Performance Ratings at the end of this Work Statement) or equivalent ratings.

• No additional fees for follow-up accreditation services (e.g., scope expansion within the same technology, report reviews, corrective action reviews).

Contractors with past performance ratings of Marginal or Unsatisfactory, or equivalent ratings, will not be considered for the award of this contract.

1.5.4 The assessment cycles shall be scheduled by consensus between the Contractor and the COR. The Contractor may contact the FSLs directly to schedule activities (assessment dates, document transfer, etc.). The COR will provide the contact information for the FSLs. As of the starting date of this contract, the COR is the contact for the ALP. Although the Contractor may contact the FSLs directly, all deliverables must include the COR as the main contact so that the deliverables may be tracked and accounted for.

1.5.4.1 While the Contractor may contact the FSLs directly, only the CO may obligate FSIS. If the Contractor experiences any issues that may increase costs beyond those agreed upon in this contract, the Contractor must contact the CO or COR before incurring additional costs. Depending on the circumstances, the CO may accept or deny the extra work.

However, if the situation is such that any accreditation is in jeopardy, the Contractor may revoke accreditations if the extra work is not allowed.

1.6 SPECIFIC TASKS/RESPONSIBILITIES

1.6.1 The Contractor’s documented routine accreditation activities for a five-year cycle of accreditation will be used if applicable. This information must be known by the COR before awarding the contract as described in section 1.1.3 of this work statement. After the contract award, any significant changes in the Contractor’s routine accreditation requirements or activities must be communicated to the COR in a timely manner. The Contractor’s work plan and assessment activities must meet timelines for maintaining uninterrupted accreditation and must not obstruct this requirement.

1.6.2 The Contractor shall submit a general work plan outlining the proposed assessment start and completions dates at each site for the base year and following option year one. The work plan will include, at a minimum, the proposed assessment schedules and types of communications/reports that are part of the assessment process and estimated certification dates.

The proposed work plan shall be submitted to the COR within 30 calendar days of the award of this contract electronically in Microsoft Office™ or Adobe™ format. The Contractor will identify individuals who may perform the assessment and provide documentation declaring that the individuals are U.S. citizens and are qualified to perform the assessment. This information will be provided to the COR within 30 calendar days of the award of this contract. The plan and assessor(s) must be acceptable to the FSIS ALP and FSLs management. Before the assessment begins, the Contractor shall identify a qualified person, or group of people, who will coordinate the process for resolution of disagreements that arise in the case that FSIS does not agree with findings that indicate a deficiency/nonconformance its management system or operation. The Contractor will indicate to the COR that this is done prior to commencing the assessment.

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1.6.3 The Contractor will supply the COR with all requirements for successful assessments.

This includes any checklists of auditing criteria or any other normal expectations related to the ISO standards. This is due within 14 calendar days of the award of this contract and anytime when there is a change in requirements during the contracting period. This deliverable may be actual documents or links to the specific requirements. This does not include providing FSIS with the ISO and ACLASS Standards. FSIS is responsible for acquiring these Standards.

1.6.4 Work plans as specified in section 1.6.1 of this Work Statement will be created and submitted by the Contractor to the COR when/if option years two and four are exercised. The work plans are due within 30 calendar days of exercising the option years two and four.

1.6.5 The Contractor shall perform ISO 17025 conformance assessments of the FSLs, and ISO 17034 and 17043 conformances assessments of the ALP during the base-year of the contract by the schedule agreed upon between the Contractor and FSIS as discussed in section 1.1.3 of this Work Statement. The process presented here, is the minimum required to achieve the objectives of this contract. The date for the initial evaluation will be mutually agreed upon and within the Contractor’s normal scheduling practices. Upon scheduling any on-site assessments throughout the duration of this contract, the Contractor will provide a proposed agenda/schedule for entry and exit briefings, initial report times, and final report. This schedule is to be provided to the COR prior to the on-site assessment. The Contractor shall provide a written draft report listing deficiencies and recommendations to be provided to the FSL and ALP management immediately upon completion of the assessment at the facility, during the exit briefing. The purpose of this draft is for discussions to clarify any misunderstandings. The Contractor will then provide the final electronic deficiency report to the COR, by a date determined by the Contractor’s documented routine procedures for scheduling. The final deficiency report shall contain enough detail to identify the corresponding ISO requirement for each deficiency and for the FSIS staff to craft an appropriate response. The FSIS response to the deficiency report will be submitted to the Contractor within the time period determined by the Contractor’s documented routine procedures for scheduling and will be submitted after the COR receives the final report. The Contractor will determine if the corrective actions proposed in the responses are appropriate and if deficiencies have been addressed and communicate this back to the COR within the time period determined by the Contractor’s documented routine procedures for scheduling. When FSIS and the Contractor agree that all deficiencies have been properly addressed, the initial cycle of the process is completed. Electronic deliverables will be in a format mutually agreed upon by both parties.

1.6.5.1 FSIS does not allow its government employees to access non-government file sharing websites. Reports and communications must be in a format agreed upon between the Contractor and FSIS.

1.6.6 Upon completion of a satisfactory assessment, the Contractor shall provide a letter and certificate to the FSLs and ALP management stating that the FSLs and ALP are in compliance with the pertinent ISO/IEC and ALACC Standards. Any other regulatory and technical requirements involved that are outside the scope of ISO 17025, ALACC, ISO 17034, or ISO 17043 must be mutually agreed upon. FSIS reserves the right to refuse to follow accreditation requirements that are not found in the ISO Standards. Accrediting Body interpretations of the

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ISO Standards are acceptable if they are the industry norm and do not constitute a requirement created and imposed solely by the Accrediting Body.

1.6.7 Information concerning the assessment shall be considered confidential, and shared only with FSIS personnel. The Contractor may include listing the FSLs and ALP as successful accredited entities and may communicate this to the public. However, the Contractor may not imply that FSIS preferentially endorses their services.

1.7 PLACE/SCHEDULE/HOURS OF PERFORMANCE

1.7.1 PLACE: The Contractor will perform the on-site assessments of the FSIS Field Service Laboratories at their locations in Athens, Georgia; St. Louis, Missouri; and Albany, California.

The Contractor will perform the on-site assessment of the ALP at the Russell Research Center (co-located with the Eastern Laboratory) in Athens, Georgia.

1.7.2 SCHEDULE: The Contractor shall perform the following tasks listed and shall adhere to the following schedule and deliverable requirements.

Task Number

Deliverable Completion Date # of Copies

Format To Be Delivered To

1 Work plan 30 calendar days after the contract award and option years two and four.

1 MS Office™ or Adobe™ product.

Otherwise negotiable.

COR

2 Qualification/citizen-ship declaration of potential assessors

30 calendar days after the contract award and prior to each time a different assessor is assigned to perform work on this contract

1 Email and/or MS Office™ and/or Adobe™ product.

Otherwise negotiable.

COR

3 Notification that person to coordinate disputes has been assigned

TBD, but prior to start of assessment

1 Contractor’s choice

COR

4 Assessment requirements

14 calendar days after the award of the contract

1 Contractor’s choice. Not verbally.

COR

5 On-site assessment TBD in the base year and option years two and four

NA NA COR, FSLs, and the ALP

6 On-site assessment Agenda/Schedule

Prior to the on-site assessment

1 Contractor’s choice

COR

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Task Number

Deliverable Completion Date # of Copies

Format To Be Delivered To

7 Draft Deficiency Report

TBD as scheduled for exit briefing

1 Contractor’s choice, but in a format compatible for ALP viewing (both physical and electronic copies preferred)

FSLs and

ALP

Management.

Inform the

COR.

8 Final Deficiency Report

To be determined by the Contractor’s documented routine procedures for scheduling

1 MS Office™ or Adobe™ product

COR

9 FSIS response to the Final Deficiency Report

To be determined by the Contractor’s documented routine procedures for scheduling

1 MS Office™ or Adobe™ product

Contractor

10 Final Report To be determined by the Contractor’s documented routine procedures for scheduling

1 MS Office™ or Adobe™ product

COR

11 Certification letter and certificate

TBD at FSLs and ALP’s successful resolution of addressing deficiencies

1 Contractor’s choice of visual media; hard copy of the certificate required

FSLs and

ALP

Management.

Inform the

COR.

1.7.3 HOURS OF PERFORMANCE:

1.7.3.1 Services shall be provided on an as needed basis and on a schedule mutually agreed upon, Monday through Friday, excluding holidays.

1.7.3.2 HOLIDAYS: The following is a list of legal holidays that the Federal Government observes. Contract providers shall perform services on a schedule established by the COR.

New Year’s Day January 1st* Martin Luther King’s Birthday Third Monday in January Presidents’ Day Third Monday in February Memorial Day Last Monday in May Independence Day July 4th* Labor Day First Monday in September

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Columbus Day Second Monday in October Veterans’ Day November 11th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th*

NOTE: *Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday, will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above. If the area in which a contract employee is scheduled to work is closed due to the holiday and the employee is not required to report in, payment will not be made for those hours. Closures of the agency due to inclement weather or other such acts of God shall be handled in the same manner.

In addition to the days designated above as holidays, the Government may observe additional days in accordance with 5 USC 6103.

1.8 INVOICES The Contractor must submit payment request through the Invoice Processing Platform (IPP) at www.IPP.gov. Invoices are submitted after work is performed and services received by FSIS. Costs must not exceed the prices agreed upon in this contract.

1.8.1 The Contractor will provide itemized invoices and enough detail to determine legitimate costs. The costs for assessing each of the FSLs and the ALP will be differentiated in the invoices such that separate lines of accounting/funding may be employed.

1.9 CONTRACTOR FURNISHED SERVICES/ SUPPLIES

1.9.1 SERVICES:

1.9.1.1 The Contractor shall provide the personnel, services, supervision, etc., necessary to conduct the assessment as described herein except where specifically identified as government-furnished supplies and services (section 1.10).

1.9.2 SUPPLIES:

1.9.2.1 The Contractor shall provide the materials and supplies necessary to conduct the assessment as described herein except where specifically identified as government-furnished supplies and services (section 1.10).

1.9.2.2 The Contractor will make all requirements for successful accreditation known to FSIS.

1.10 GOVERNMENT FURNISHED SERVICES/SUPPLIES

1.10.1 SERVICES:

http://www.ipp.gov/

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1.10.1.1 The FSLs and ALP will provide access to all necessary documents, records, corrective action responses and personnel. The COR will provide technical direction and clarification as needed or as requested by the Contractor.

1.10.1.2 FSIS will ensure appropriate management personnel attend the entry and exit briefings.

1.10.1.3 When documentation is in electronic format, FSIS will provide information to the Contractor in a mutually agreed upon format.

1.10.1.4 During on-site assessments, FSIS will provide temporary office/working space at the facility during working hours.

1.10.1.5 FSIS will respond to any requests for supplemental information, records, or documentation within the specified period after receiving the request.

1.10.2 SUPPLIES:

1.10.2.1 Not Applicable

1.11 QUALITY CONTROL

1.11.1 Government Quality Assessment and Improvement (QA&I): The Government will monitor the Contractor’s performance under this contract using the quality improvement/ assessment procedures in accordance with Attachments 1 and 2, Performance Quality Level Matrix.

1.12 DELIVERABLES/REPORTING REQUIREMENTS

1.12.1 The Contractor electronic reports will be in a format compatible with MS™ Office or Adobe™ products. If the Contractor wishes to use another format, it must be negotiated with

FSIS.

1.12.2 The Contractor shall submit work products as detailed in the Specific Tasks and Responsibilities section 1.6 and within the timelines specified in the Schedule at paragraph 1.7.2.

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1.13 ATTACHMENTS

ATTACHMENT 1

PERFORMANCE REQUIREMENT SUMMARY

The Government will measure services under the performance objectives listed in the following table by applying the corresponding performance standards and acceptable performance quality levels.

Performance Outcomes

PBWS

Paragraph

Acceptable Performance Level

Monitoring Method

Deficiency report to the COR

1.6.5 100 % of the time Government review and written feedback

Final report to the COR

1.6.5 100 % of the time Government review and written feedback

ATTACHMENT 2

QUALITY ASSURANCE SURVEILLANCE PLAN

Performance Standards. The Performance Requirements Summary Matrix, Attachment 1 and Attachment 2 in the Performance Work Statement include performance standards. The Government shall use these standards to determine Contractor performance and shall compare Contractor performance to the Acceptable Quality Level (AQL).

Performance Outcomes

PBWS

Paragraph

Acceptable Performance Level

Monitoring Method

Remedies

Final deficiency report to the

COR

1.6.5 100 % of the time

Government review and written feedback

1)Option of CO to terminate contract for non-performance 2)Document performance in Government’s hard copy folder

Final report to the COR

1.6.5 100 % of the time

Government review and written feedback

1)Option of CO to terminate contract for non-performance 2)Document performance in Government’s hard copy folder

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PERFORMANCE RATINGS.

The Government will rate past performance using the following performance standards.

Exceptional: Performance significantly exceeds contract requirements to the Government’s benefit.

Very good: Performance exceeds contract requirement to the Government’s benefit.

Satisfactory: Performance meets contractual requirements.

Marginal: Performance does not meet some of the contractual requirements.

Unsatisfactory: Performance does not meet contractual requirements.

Below are other performance evaluation factors that may be monitored and documented in the Contractor’s performance records, but cannot be quantified by numerical measurements:

• Contractor providing personnel exceeding the minimum qualification standards;

Performance above or below the standard, for above factors, may be documented in the Government’s hard copy folder.