36C24218Q0190-003.docx

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

For: East Orange VAMC Dental Lab Services

Contract Number:

Contract Description: The contractor must be able to provide and maintain services for the Syracuse elevators, per the scope of work, for the period of October 1, 2016 – September 30, 2017, with 4 option years available.

Contractor’s name: (hereafter referred to as the contractor).

1. PURPOSE

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

· What will be monitored.

· How monitoring will take place.

· Who will conduct the monitoring.

· How monitoring efforts and results will be documented.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (CO) - The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned CO: Michael Spivack Organization or Agency: Department of Veterans Affairs, SAO East, NCO 2

b. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COR:Alencia Johnson

c. Other Key Government Personnel -

3. CONTRACTOR REPRESENTATIVES

The following employees of the contractor serve as the contractor’s program manager for this contract.

a. Program Manager - <Enter name.>

b. Other Contractor Personnel - <Enter name(s) or delete these lines if not applicable> Title: <Enter title(s) or delete these lines if not applicable.>

4. PERFORMANCE STANDARDS

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

5. INCENTIVE

The incentive for all tasks will be the exercising of option periods and past performance.

Timeframe - The Contractor must complete denture steps or finish product within the allowed timeframe outlined in the PWS

Flawed Product - The Contractor must rework flawed products within the allowed timeframe outlined in the PWS

QUALITY ASSESSMENT OFDENTAL LABORATORY PROCEDURES

I. Complete Dentures

A. Casts, Diagnostic and Master

1. Base is 10mm thick at the thinnest portion of the cast

2. 4mm wide land area throughout the circumference of the cast

3. Sulcular depth 3mm on buccal, to follow the contour of the buccal vestibule

4. Sulcular depth 3mm on lingual to follow the contour of the vestibule

5. Free of bubbles and defects

6. All anatomic areas of impression included on cast

7. Tongue area, flat across the arch

8. Base is parallel to the plane of occlusion or residual ridge

B. Impression Trays

1. Rigid and fabricated from the appropriate material

2. Covers all indicated anatomy

3. Handles do not interfere with border molding movements, formed as prescribed, so as not to displace facial musculature

4. Impression material retentive features included in the tray as prescribed

C. Record Base

1. Is fabricated from appropriate material and well adapted to the residual ridge

2. Covers all indicated anatomy

3. Is extended to the land area

4. Is adequately thick for rigidity

5. Is smooth and free of sharp area

D. Occlusion Rim, Maxillary

1. Is fabricated from the prescribed base plate wax

2. Is 10mm wide in the posterior section

3. The posterior sections are placed over the crest of the residual ridges

4. Is straight from the buccal aspect of the record base border to the buccal aspect of the occlusion rim

5. Taper in width to 3mm in the anterior section

6. Anterior section angles 5 degrees anteriorly from the horizontal

7. Anterior is 22mm long from the extent of the labial flange

8. Posterior is 18mm long from the extent of the buccal flange

9. All wax is smooth, without voids

10. Adheres well to the record base

11. The occlusal plane is flat, generally parallel to the residual ridge

E. Occlusion Rim, Mandibular

1. Is fabricated from the prescribed baseplate wax

2. Is 10mm wide in the posterior section

3. The posterior sections are placed over the crest of the residual ridges

4. The posterior sections stop at the beginning of the upward incline of the residual ridges

5. Is straight from the buccal aspect of the record base border to the buccal aspect of the occlusion rim

6. Tapers in width to 3mm in the anterior section

7. Anterior section angles 5 degrees anteriorly from the horizontal

8. Anterior is 18mm long from the extent of the labial flange

9. Posterior extends to the top of the retro-molar pad

10. All wax is smooth, without voids

11. Adheres well to the record base

12. The occlusal plane is flat, ideally parallel to residual ridge

F. Wax Trial Dentures, Maxillary

1. The midline of the arranged teeth matches the marked midline of the occlusion rims

2. The facial surfaces of the anterior teeth are placed in the same plane as the contoured facial surface of the occlusion rims

3. The incisal edges of the anterior teeth are placed in the same plane as the incisal surface of the occlusion rim

4. The inter-dental wax fills the embrasures up to the contact points

5. Adequate inter-dental wax fills the embrasures to allow for finishing of the acrylic resin

6. A 4mm band of simulated attached gingiva is present, elevated to simulate buccal bone

7. The palatal area is 2mm thick

8. A 1mm band of wax is palatal to the posterior teeth to allow for finishing of the acrylic resin

9. Wax does not overlap onto the beginning/palatal of the ridge-lap area of the anterior teeth

10. The opposing occlusion contacts into proper interdigitation at the established vertical dimension of occlusion

G. Wax Trial Dentures, Mandibular

1. The midline of the arranged teeth matches the marked midline of the occlusion rims

2. The facial surfaces of the anterior teeth are placed in the same plane as the contoured facial surface of the occlusion rims

3. The incisal edges of the anterior teeth are placed to develop the horizontal and vertical overlap necessary for the individual clinical requirements

4. The occlusal plane of the mandibular posterior teeth is at the appropriately indicated height of the retro-molar pads (1/2 – 2/3 up the RMP 2mm inferior to the highest portion of the RMP)

5. The central groove line of the mandibular posterior teeth is placed over the crest of the residual ridge

6. The number of posterior teeth is in harmony with space available from the distal of canine to the beginning of the ascending ramus

7. The inter-dental wax fills the embrasures up to the contact points

8. Adequate inter-dental wax fills the embrasures to allow for finishing of the acrylic resin

9. A 4mm band of simulated attached gingiva is present, elevated to simulate buccal bone

10. A 1mm band of wax is lingual to the posterior teeth to allow for finishing of the acrylic resin

11. Wax does not overlap onto the beginning/lingual of the ridge-lap of the anterior teeth

12. The buccal shelf area is concave, of adequate thickness

H. Processed and Polished Prosthesis

1. The acrylic resin free of pits, fissures, and porosity

2. The acrylic resin is polished on all non-tissue bearing areas

3. The denture borders are anatomically complete

4. No evidence of flash remains on the denture borders

5. The denture bases remain adequately thick for rigidity

I. Remount Casts

1. The denture borders are well supported around the buccal periphery

2. Base is 10mm thick at the thinnest portion of the cast

3. 4rnm wide land area throughout the circumference of the cast

II. Removable Partial Dentures

A. Custom Impression Trays

1. Rigid and fabricated from the appropriate material

2. Covers all indicated anatomy

3. Handles do not interfere with border molding movements, formed as prescribed

4. Impression material retentive features included in the tray as prescribed

B. Rests

1. Follow the dimensions and location of the design

2. Fill the prepared rest seats completely

3. Are minimally 1.5mm thick

4. Are no greater in contour than the original marginal ridge/buccal cusp ridge/fossae area

C. Minor Connectors

1. Follow the dimensions and location of the design

2. Are broad and fan shaped at the junction with the major connecter

3. Are minimally 1.5mm thick

4. Crosses the gingival margin at 90 degrees

D. Guide Plates

1. Follow the dimensions and location of the design

2. Are thinned and tapered only at the marginal ridge areas, when no rest is present

E. Major Connectors

1. Follow the dimensions and location of the design

2. Have definitive external finish lines

3. Have definitive internal finish lines

F. Denture Base Retention

1. Follow the dimensions and location of the design

2. Show a broad connection to the major connector

3. Are not extended more than 2mm buccal to the crest of the residual ridge

4. Contains a tissue-stop that contacts the residual ridge of the master cast

G. Retainers, Indirect

1. Follow the dimensions and location of the design

2. Are broad and fan shaped at the junction with the major connector

3. Are minimally 1.5mm thick

4. Crosses the gingival margin at 90 degrees

H. Retainers, Direct

1. Follow the dimensions and location of the design

2. Are uniformly tapered to the retentive tip

3. Are minimally 1.5mm wide

I. Wax Trial Removable Partial Dentures, Maxillary

1. The midline of the arranged teeth matches the market midline of the occlusion rim

2. The facial surfaces of the anterior teeth are placed in the same plane as the contoured facial surface of the occlusion rims

3. The incisal edges of the anterior teeth are placed in the same plane as the incisal surface of the occlusion rim

4. The inter-dental wax fills the embrasures up to the contact points

5. Adequate inter-dental wax fills the embrasures to allow for finishing of the acrylic resin

6. A 4mm band of simulated attached gingiva is present, elevated to simulate buccal bone

7. A 1mm band of wax is palatal to the posterior teeth to allow for finishing of the acrylic resin

J. Denture Base Retention

1. Follow the dimensions and location of the design

2. Show a broad connection to the major connector

3. Are not extended more than 2mm buccal to the crest of the residual ridge

4. Contains a tissue-stop that contacts the residual ridge of the master cast K. Retainers, Indirect

1. Follow the dimensions and location of the design

2. Are broad and fan shaped at the junction with the major connector

3. Are minimally 1.5mm thick

4. Crosses the gingival margin at 90 degrees

L. Retainers, Direct

1. Follow the dimensions and location of the design

2. Are uniformly tapered to the retentive tip

3. Are minimally 1.5mm wide

M. Wax Trial Removable Partial Dentures, Maxillary

1. The midline of the arranged teeth matches the marked midline of the occlusion rim

2. The facial surfaces of the anterior teeth are placed in the same plane as the contoured facial surface of the occlusion rims

3. The incisal edges of the anterior teeth are placed in the same plane as the incisal surface of the occlusion rim

4. The inter-dental wax fills the embrasures up to the contact points

5. Adequate inter-dental wax fills the embrasures to allow for finishing of the acrylic

6. A 4mm band of simulated attached gingiva is present to simulate buccal bone

7. A 1mm band of wax is palatal to the posterior teeth to allow for finishing of the acrylic resin

8. Wax does not overlap onto the beginning/palatal of the ridge-lap area of the anterior teeth

9. The opposing occlusion contacts into proper interdigitation at the established vertical dimension of occlusion

N. Wax Trial Removable Partial Dentures, Mandibular

1. The midline of the a teeth matches the marked midline of the occlusion rims

2. The facial surfaces of the a teeth are placed in the same plane as the contoured facial surfaces of the occlusion rims

3. The incisal edges of the anterior teeth are placed in the same plane as the incisal surface of the occlusion rim

4. The occlusal plane of the mandibular posterior teeth is at the appropriately indicated height of the retro-molar pads (1/2 – 2/3 up the up the RMP, 2mm inferior to the highest portion of the RMP)

5. The central groove line of the mandibular posterior teeth is placed over the crest of the residual ridge

6. The number of posterior teeth is in harmony with space available from the distal of the canine to the beginning of the ascending ramus

7. The inter-dental wax fills the embrasures up to the contact points

8. Adequate inter-dental wax fills the embrasures to allow for finishing of the acrylic resin

9. A 4mm band of simulated attached gingiva is present, elevated to simulate buccal bone

10. A 1mm band of wax is lingual to the posterior teeth to allow for finishing of the acrylic resin

11. Wax does not overlap onto the beginning of the ridge-lap area of the anterior teeth

12. The buccal shelf area is concave, of adequate thickness

1. Processed and Polished Prosthesis

0. The acrylic resin is free of pits, fissures, and porosity

0. A smooth junction exists between the acrylic resin and external finish lines

0. The acrylic resin is polished an all non tissue bearing areas

0. The denture borders are anatomically complete

0. No evidence of flash remains on the denture borders

0. The denture bases remain adequately thick for rigidity

6. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

a. DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)

b. PERIODIC INSPECTION. (Evaluates outcomes on a periodic basis. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.)

c. USER SURVEY. (Combines elements of validated user complaints and random sampling. Random survey is conducted to solicit user satisfaction. May also generate inspections and sampling.)

d. VALIDATED USER/CUSTOMER COMPLAINTS. (Relies on the patient to identify deficiencies. Complaints are then investigated and validated.)

e. 100% INSPECTION. (Evaluates all outcomes.)

f. PERIODIC SAMPLING. (Variation of random sampling. However, sample is only taken when a problem/deficiency is suspected. Sample results are applicable only for the specific work inspected. Since sample is not entirely random, it cannot be applied to total activity performance.)

g. RANDOM SAMPLING. (Designed to evaluate performance by randomly selecting and inspecting a sample of cases.

h. Progress or status meetings.

i. Analysis of contractor's progress reports. (Evaluate cost, schedule, etc.)

7. RATINGS

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

PASS – Met the standard FAIL – Did not meet the standard

8. DOCUMENTING PERFORMANCE

a. ACCEPTABLE PERFORMANCE

The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action.

b. UNACCEPTABLE PERFORMANCE

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COTR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's program manager.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

9. FREQUENCY OF MEASUREMENT

a. Frequency of Measurement.

During contract performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.

<After award, both the contractor’s Program Manager and the COR shall sign this document.>

Signature – Contractor Program Manager

Signature – Contracting Officer’s Technical Representative

SAMPLE QUALITY ASSURANCE MONITORING FORM

SERVICE or STANDARD:

SURVEY PERIOD:

SURVEILLANCE METHOD (Check):

LEVEL OF SURVEILLANCE (Check):

ANALYSIS OF RESULTS:

Observed Service Provider Performance Measurement Rate: ______%

Narrative of Performance During Survey Period:

PREPARED BY: ___________________________________ DATE: _________________