+----------------------+-----------------------------------------------+
| ![](media/image1.jpe | Module 13                                     |
| g){width="1.90625in" |                                               |
| height="1.           | **External Quality Assessment --**            |
| 8729166666666666in"} |                                               |
|                      | **On-site Evaluation and Re-testing**         |
+----------------------+-----------------------------------------------+

+------------------+---------------------------------------------------+
| **Purpose**      | To provide you an overview of External Quality    |
|                  | Assessment with focus on on-site evaluation and   |
|                  | re-testing.                                       |
+------------------+---------------------------------------------------+
| *                | Module 5: Assuring the Quality of HIV Rapid       |
| *Pre-requisite** | Testing                                           |
|                  |                                                   |
| **Modules**      |                                                   |
+------------------+---------------------------------------------------+
| **Learning       | At the end of this module, you will be able to:   |
| Objectives**     |                                                   |
|                  | -   Assess operations at test site to determine   |
|                  |     if quality requirements are met               |
|                  |                                                   |
|                  | -   Take corrective actions following External    |
|                  |     Quality Assessment (EQA)                      |
|                  |                                                   |
|                  | -   Keep appropriate records related to EQA       |
|                  |                                                   |
|                  | -   Avoid common problems associated with EQA     |
|                  |     specimen management                           |
+------------------+---------------------------------------------------+
| **Content        | > What is EQA and why is it important?            |
| Outline**        | >                                                 |
|                  | > EQA Responsibilities                            |
|                  | >                                                 |
|                  | > EQA Methods -- Proficiency Testing, On-Site     |
|                  | > Evaluation, Re-testing                          |
|                  | >                                                 |
|                  | > How to implement EQA                            |
+------------------+---------------------------------------------------+
| **Handouts**     | Corrective Action Form                            |
|                  |                                                   |
|                  | On-site Evaluation Checklist                      |
|                  |                                                   |
|                  | Example Specimen Transfer Log for Re-testing      |
+------------------+---------------------------------------------------+
| ![]              | Customize the module according to the             |
| (media/image2.wm | participants' job positions and responsibilities  |
| f){width="0.4916 | (management versus testing personnel). Other      |
| 6666666666664in" | modifications are also required throughout the    |
| height           | module to provide specific information on         |
| ="0.441666666666 | in-country EQA program.                           |
| 66665in"}**Notes |                                                   |
| on               |                                                   |
| Customization**  |                                                   |
+------------------+---------------------------------------------------+

+-----------------+------------------------------+---------------------+
| **External      | External Quality Assessment  |                     |
| Quality         | (EQA) is the objective       |                     |
| Assessment      | assessment of a test site's  |                     |
| (EQA):          | operations and performance   |                     |
| Definition**    | by an external agency or     |                     |
|                 | personnel.                   |                     |
+-----------------+------------------------------+---------------------+
| **Why EQA?**    | EQA allows comparison of     |                     |
|                 | performance and results      |                     |
|                 | among different test sites   |                     |
|                 | offering not only an         |                     |
|                 | opportunity for performances |                     |
|                 | checks, but an opportunity   |                     |
|                 | to systematically identify   |                     |
|                 | problems with kits or        |                     |
|                 | operations.                  |                     |
|                 |                              |                     |
|                 | Additionally, EQA also       |                     |
|                 | provides objective evidence  |                     |
|                 | of testing quality,          |                     |
|                 | indicates areas that need    |                     |
|                 | improvement, and identifies  |                     |
|                 | training needs.              |                     |
+-----------------+------------------------------+---------------------+
| **EQA:          | EQA should be conducted at   |                     |
| Conducted at    | all levels of testing        |                     |
| Three Levels**  | service. These include       |                     |
|                 | national reference lab,      |                     |
|                 | provincial or intermediate   |                     |
|                 | lab, and test site (point of |                     |
|                 | service).                    |                     |
|                 |                              |                     |
|                 | For EQA program to be        |                     |
|                 | effective, the Ministry of   |                     |
|                 | Health must establish an     |                     |
|                 | organizational structure and |                     |
|                 | assign responsibility to     |                     |
|                 | assure that on-site          |                     |
|                 | monitoring occurs in all     |                     |
|                 | locations. In most           |                     |
|                 | countries, the National      |                     |
|                 | Reference Laboratory (NRL)   |                     |
|                 | has overall oversight        |                     |
|                 | responsibility. However, to  |                     |
|                 | have better reach in meeting |                     |
|                 | the needs of rural test      |                     |
|                 | sites or points of service,  |                     |
|                 | this may be best             |                     |
|                 | accomplished with oversight  |                     |
|                 | by provincial labs.          |                     |
+-----------------+------------------------------+---------------------+
| **Management    | Someone of authority must    |                     |
| Re              | take responsibility for EQA. |                     |
| sponsibilities: | First of all, they must      |                     |
| An Overview**   | determine policies for EQA   |                     |
|                 | (WHO, WHAT, WHEN, HOW) and   |                     |
|                 | designate a staff member     |                     |
|                 | with the responsibility to   |                     |
|                 | establish and implement the  |                     |
|                 | EQA program.                 |                     |
|                 |                              |                     |
|                 | They are also responsible    |                     |
|                 | for establishing and         |                     |
|                 | maintaining a system for     |                     |
|                 | assessment visits -- this    |                     |
|                 | includes scheduling visits   |                     |
|                 | and conducting evaluation.   |                     |
|                 | Ideally the person           |                     |
|                 | conducting the on-site visit |                     |
|                 | should have an understanding |                     |
|                 | of the Quality Management    |                     |
|                 | System, knowledge of testing |                     |
|                 | technologies, ability to     |                     |
|                 | analyze situations and good  |                     |
|                 | communication skills.        |                     |
|                 |                              |                     |
|                 | Furthermore, it is           |                     |
|                 | management's job to receive  |                     |
|                 | EQA results and support      |                     |
|                 | corrective action measures.  |                     |
|                 | Management will determine    |                     |
|                 | how and when they are        |                     |
|                 | advised of the outcomes of   |                     |
|                 | the EQA program. The best    |                     |
|                 | way to ensure EQA reports    |                     |
|                 | are reviewed by management   |                     |
|                 | is by including them as an   |                     |
|                 | agenda item in management    |                     |
|                 | review meetings.             |                     |
|                 |                              |                     |
|                 | Finally, management must     |                     |
|                 | monitor and maintains        |                     |
|                 | records, investigate         |                     |
|                 | deficiencies, manage         |                     |
|                 | corrective action efforts,   |                     |
|                 | and communicate outcomes.    |                     |
+-----------------+------------------------------+---------------------+
| **Testing       | Test providers' EQA          |                     |
| Personnel's     | responsibilities include:    |                     |
| Res             |                              |                     |
| ponsibilities** | -   Participating in the EQA |                     |
|                 |     program                  |                     |
|                 |                              |                     |
|                 | -   Taking corrective        |                     |
|                 |     actions                  |                     |
|                 |                              |                     |
|                 | -   Maintaining EQA records  |                     |
|                 |                              |                     |
|                 | -   Communicating outcomes   |                     |
|                 |     to supervisors           |                     |
+-----------------+------------------------------+---------------------+
| **EQA Methods** | There are three main EQA     |                     |
|                 | methods:                     |                     |
|                 |                              |                     |
|                 | -   Proficiency testing (PT) |                     |
|                 |     -- Proficiency panel may |                     |
|                 |     be used during on-site   |                     |
|                 |     visits.                  |                     |
|                 |                              |                     |
|                 | -   On-site evaluation,      |                     |
|                 |     which is sometimes       |                     |
|                 |     referred to as on-site   |                     |
|                 |     monitoring visits or     |                     |
|                 |     audits                   |                     |
|                 |                              |                     |
|                 | -   Rechecking or retesting  |                     |
|                 |     of specimens             |                     |
+-----------------+------------------------------+---------------------+
| **What is       | In proficiency testing (PT), |                     |
| Proficiency     | a reference laboratory sends |                     |
| Testing?**      | out panels of specimens to   |                     |
|                 | multiple test sites, who in  |                     |
|                 | turn perform tests on these  |                     |
|                 | panels and report results.   |                     |
|                 | The reported results         |                     |
|                 | indicate quality of          |                     |
|                 | personnel performance and    |                     |
|                 | test site operations.        |                     |
|                 | Results are often compared   |                     |
|                 | across several testing       |                     |
|                 | sites.                       |                     |
+-----------------+------------------------------+---------------------+
| **What is       | On-site evaluation is        |                     |
| On-site         | periodic site visits to      |                     |
| Evaluation?**   | systematic assessment of lab |                     |
|                 | practices. These visits      |                     |
|                 | focus on how the lab         |                     |
|                 | monitors its operations and  |                     |
|                 | ensures testing quality.     |                     |
|                 | They provide information for |                     |
|                 | internal process             |                     |
|                 | improvement. On-site         |                     |
|                 | evaluation is also referred  |                     |
|                 | to as audits, assessments,   |                     |
|                 | or supervisory visits.       |                     |
|                 |                              |                     |
|                 | These site visits enable us  |                     |
|                 | to learn "where we are" so   |                     |
|                 | we may measure gaps or       |                     |
|                 | deficiency. From the visits  |                     |
|                 | we can collect information   |                     |
|                 | for planning &               |                     |
|                 | implementation, monitoring,  |                     |
|                 | and continuous improvement.  |                     |
|                 | They are part of every lab   |                     |
|                 | quality system.              |                     |
|                 |                              |                     |
|                 | These visits should be       |                     |
|                 | instructional rather than    |                     |
|                 | punitive. The main purpose   |                     |
|                 | of on-site visits is to      |                     |
|                 | observe the testing site     |                     |
|                 | under routine conditions in  |                     |
|                 | order to check that it is    |                     |
|                 | meeting quality              |                     |
|                 | requirements.                |                     |
+-----------------+------------------------------+---------------------+
| **What is       | Re-testing is the process by |                     |
| Re-testing?**   | which a random selection of  |                     |
|                 | specimens are collected from |                     |
|                 | the routine workload at the  |                     |
|                 | test site and sent to the    |                     |
|                 | reference laboratory for     |                     |
|                 | validation. It is used to    |                     |
|                 | detect errors.               |                     |
+-----------------+------------------------------+---------------------+
| **EQA Should    |                              |                     |
| Lead to         |                              |                     |
| Corrective      |                              |                     |
| Actions**       |                              |                     |
+-----------------+------------------------------+---------------------+
|                 | A Corrective action is an    |                     |
|                 | action taken to correct a    |                     |
|                 | problem or non-conformance / |                     |
|                 | deficiency within the        |                     |
|                 | Quality Management System.   |                     |
|                 | Examples of a                |                     |
|                 | non-conformance include:     |                     |
|                 |                              |                     |
|                 | -   Production of an         |                     |
|                 |     incorrect result         |                     |
|                 |                              |                     |
|                 | -   Any step within a        |                     |
|                 |     process which            |                     |
|                 |     contributed to an        |                     |
|                 |     incorrect result         |                     |
|                 |                              |                     |
|                 | -   When the documented      |                     |
|                 |     quality system is not    |                     |
|                 |     followed exactly as      |                     |
|                 |     intended                 |                     |
|                 |                              |                     |
|                 | -   When the quality system  |                     |
|                 |     does not meet the        |                     |
|                 |     requirements of quality  |                     |
|                 |     standards or             |                     |
|                 |     requirements             |                     |
+-----------------+------------------------------+---------------------+
| **Problems May  | Problems may lie anywhere in |                     |
| Occur           | the testing process:         |                     |
| Throughout the  | pre-testing, testing, and    |                     |
| Testing         | post-testing. Most problems  |                     |
| Process**       | occur in the pre and post    |                     |
|                 | analytic phase of testing.   |                     |
|                 | The integrity of the         |                     |
|                 | specimen may have been       |                     |
|                 | compromised during           |                     |
|                 | preparation, shipping or     |                     |
|                 | after receipt by improper    |                     |
|                 | storage or handling          |                     |
|                 |                              |                     |
|                 | Problems such as with        |                     |
|                 | reagents, test methods,      |                     |
|                 | quality control, or          |                     |
|                 | competency of staff may      |                     |
|                 | occur during testing. Due to |                     |
|                 | the numbers of specimens     |                     |
|                 | collected and transported by |                     |
|                 | various test sites, care     |                     |
|                 | must be taken to ensure      |                     |
|                 | proper transcription of data |                     |
|                 | throughout the testing       |                     |
|                 | process                      |                     |
+-----------------+------------------------------+---------------------+
| **Take          | Whenever problems are        |                     |
| Corrective      | detected, corrective actions |                     |
| Actions**       | must be taken.               |                     |
|                 |                              |                     |
|                 | -   Use problem-solving team |                     |
|                 |                              |                     |
|                 | -   Investigate root causes  |                     |
|                 |     and develop appropriate  |                     |
|                 |     corrective actions       |                     |
|                 |                              |                     |
|                 | -   Implement corrective     |                     |
|                 |     actions                  |                     |
|                 |                              |                     |
|                 | -   Examine effectiveness    |                     |
|                 |                              |                     |
|                 | -   Record all actions and   |                     |
|                 |     findings                 |                     |
+-----------------+------------------------------+---------------------+
| **On-Site       | As a tester, you should      |                     |
| Evaluation      | understand the process for   |                     |
| Process**       | how the visits will be       |                     |
|                 | conducted. This will assist  |                     |
|                 | you in preparing for a       |                     |
|                 | productive visit. Refer to   |                     |
|                 | handout "On-site Evaluation  |                     |
|                 | Checklist" at the end of     |                     |
|                 | this module.                 |                     |
|                 |                              |                     |
|                 | The on-site evaluation       |                     |
|                 | process includes the         |                     |
|                 | following steps:             |                     |
|                 |                              |                     |
|                 | 1.  Pre-Evaluation           |                     |
|                 |     Preparation              |                     |
|                 |                              |                     |
|                 | 2.  Entrance Interview       |                     |
|                 |                              |                     |
|                 | 3.  Information Gathering    |                     |
|                 |                              |                     |
|                 | 4.  Outcome Assessment       |                     |
|                 |                              |                     |
|                 | 5.  Exit Conference          |                     |
|                 |                              |                     |
|                 | 6.  Reporting                |                     |
+-----------------+------------------------------+---------------------+
| **Tester        | You as a tester play an      |                     |
| Re              | important role in ensuring a |                     |
| sponsibilities: | productive site visit.       |                     |
| Ensuring a      | Review the table below for   |                     |
| Productive Site | tasks that should be         |                     |
| Visit**         | performed before, during,    |                     |
|                 | and after a site visit.      |                     |
|                 |                              |                     |
|                 | +-----+------------------+   |                     |
|                 | | **  | Record keeping   |   |                     |
|                 | | Bef | is essential.    |   |                     |
|                 | | ore | Get organized    |   |                     |
|                 | | V   |                  |   |                     |
|                 | | isi | Confirm date of  |   |                     |
|                 | | t** | visit            |   |                     |
|                 | |     |                  |   |                     |
|                 | |     | Review written   |   |                     |
|                 | |     | policies and     |   |                     |
|                 | |     | procedures       |   |                     |
|                 | |     |                  |   |                     |
|                 | |     | Conduct internal |   |                     |
|                 | |     | assessment in    |   |                     |
|                 | |     | preparation of   |   |                     |
|                 | |     | site visit       |   |                     |
|                 | +-----+------------------+   |                     |
|                 | | **  | Participate in   |   |                     |
|                 | | Dur | visits --        |   |                     |
|                 | | ing | cooperate        |   |                     |
|                 | | V   |                  |   |                     |
|                 | | isi | Ask questions of |   |                     |
|                 | | t** | site assessors   |   |                     |
|                 | +-----+------------------+   |                     |
|                 | | *   | Take corrective  |   |                     |
|                 | | *Af | actions, where   |   |                     |
|                 | | ter | necessary. These |   |                     |
|                 | | V   | corrective       |   |                     |
|                 | | isi | actions should   |   |                     |
|                 | | t** | be taken         |   |                     |
|                 | |     | immediately to   |   |                     |
|                 | |     | help ensure the  |   |                     |
|                 | |     | continued        |   |                     |
|                 | |     | quality of       |   |                     |
|                 | |     | testing.         |   |                     |
|                 | +-----+------------------+   |                     |
+-----------------+------------------------------+---------------------+
| **On-site       | Someone should take          |                     |
| Evaluation:**   | responsibility for preparing |                     |
| *               | for on-site visits. A team   |                     |
| *Pre-Evaluation | consisting of both program   |                     |
| Preparation**   | and laboratory staff should  |                     |
|                 | collectively plan for and    |                     |
|                 | conduct the on-site visit.   |                     |
|                 | Doing so will provide a      |                     |
|                 | comprehensive view of the    |                     |
|                 | testing site, and will       |                     |
|                 | prevent vertical             |                     |
|                 | assessments. Appropriate     |                     |
|                 | training should be provided  |                     |
|                 | for those who will serve as  |                     |
|                 | assessors.                   |                     |
|                 |                              |                     |
|                 | A schedule of when the       |                     |
|                 | visits will occur should be  |                     |
|                 | developed and communicated   |                     |
|                 | to the test site. The        |                     |
|                 | frequency of the visit may   |                     |
|                 | be determined by a number of |                     |
|                 | factors:                     |                     |
|                 |                              |                     |
|                 | -   Previous results where   |                     |
|                 |     problems or deficiencies |                     |
|                 |     have been noted, due to  |                     |
|                 |     complaint or follow-up   |                     |
|                 |                              |                     |
|                 | -   Number of trained        |                     |
|                 |     assessors                |                     |
|                 |                              |                     |
|                 | -   Minimum frequency 2x     |                     |
|                 |     year for established     |                     |
|                 |     sites                    |                     |
|                 |                              |                     |
|                 | -   Quarterly for new sites  |                     |
+-----------------+------------------------------+---------------------+
|                 | There are both advantages    |                     |
|                 | and disadvantages for        |                     |
|                 | unannounced visits.          |                     |
|                 |                              |                     |
|                 | -   Announcing the date of   |                     |
|                 |     the visit will ensure    |                     |
|                 |     that relevant staff will |                     |
|                 |     be present during the    |                     |
|                 |     visit.                   |                     |
|                 |                              |                     |
|                 | ```{=html}                   |                     |
|                 | <!-- -->                     |                     |
|                 | ```                          |                     |
|                 | -   Unannounced visits will  |                     |
|                 |     most likely give you a   |                     |
|                 |     true picture of routine  |                     |
|                 |     practice. These          |                     |
|                 |     unscheduled visits aim   |                     |
|                 |     to fix the problem and   |                     |
|                 |     improve the system to    |                     |
|                 |     prevent recurrence.      |                     |
|                 |                              |                     |
|                 | Evaluation visits may also   |                     |
|                 | be conducted in response to  |                     |
|                 | a problem within the system. |                     |
|                 | Schedule evaluation visits   |                     |
|                 | during a time that will      |                     |
|                 | minimize disruption of       |                     |
|                 | services.                    |                     |
+-----------------+------------------------------+---------------------+
| **On-site       | The entrance interview sets  |                     |
| Evaluation:**   | the tone for the entire      |                     |
| **Entrance      | visit. Individuals           |                     |
| Interview**     | conducting the visit should  |                     |
|                 | be prepared, positive and    |                     |
|                 | courteous. They should first |                     |
|                 | introduce the evaluation     |                     |
|                 | team and show identification |                     |
|                 | before entering the          |                     |
|                 | facility. Part of this       |                     |
|                 | entrance interview also      |                     |
|                 | includes an overview of the  |                     |
|                 | process in terms of what     |                     |
|                 | will be done. This may       |                     |
|                 | include review of facility,  |                     |
|                 | record review, observation,  |                     |
|                 | interview with testing       |                     |
|                 | staff, use of proficiency    |                     |
|                 | panel, and exit interview.   |                     |
+-----------------+------------------------------+---------------------+
| **On-site       | Individuals conducting the   |                     |
| Evaluation:**   | onsite visit will need to    |                     |
| **Information   | gather information in an     |                     |
| Gathering**     | organized, consistent manner |                     |
|                 | to make decisions about the  |                     |
|                 | site's quality system. They  |                     |
|                 | should try to minimize       |                     |
|                 | disruption to the work flow  |                     |
|                 | of testing site during the   |                     |
|                 | information gathering        |                     |
|                 | effort.                      |                     |
|                 |                              |                     |
|                 | Observation of test          |                     |
|                 | performance may be           |                     |
|                 | accomplished by observing    |                     |
|                 | staff performing actual      |                     |
|                 | patient/client testing, or   |                     |
|                 | by use of proficiency panel  |                     |
|                 | comprised of 5-10 specimens. |                     |
|                 | Site assessors should plan   |                     |
|                 | in advance to arrive at site |                     |
|                 | with proficiency panel.      |                     |
|                 | Provision of proficiency     |                     |
|                 | panel is the responsibility  |                     |
|                 | of reference labs. At all    |                     |
|                 | times, respect patient       |                     |
|                 | privacy and confidentiality  |                     |
+-----------------+------------------------------+---------------------+
| **On-site       |                              |                     |
| Evaluation:**   |                              |                     |
| **Outcome**     |                              |                     |
| **Assessment**  |                              |                     |
+-----------------+------------------------------+---------------------+
|                 | If problems are detected,    |                     |
|                 | the assessor should          |                     |
|                 | determine the impact of the  |                     |
|                 | problem in relation to       |                     |
|                 | patient test outcome. Ask    |                     |
|                 | the following questions:     |                     |
|                 |                              |                     |
|                 | -   Does the problem result  |                     |
|                 |     in inaccurate test       |                     |
|                 |     results?                 |                     |
|                 |                              |                     |
|                 | -   Does the problem result  |                     |
|                 |     in a high probability of |                     |
|                 |     inaccurate test results? |                     |
|                 |                              |                     |
|                 | ```{=html}                   |                     |
|                 | <!-- -->                     |                     |
|                 | ```                          |                     |
|                 | -   Is immediate corrective  |                     |
|                 |     action necessary?        |                     |
+-----------------+------------------------------+---------------------+
| **On-Site       | Findings from the on-site    |                     |
| Evaluation:     | visit should be reviewed     |                     |
| Exit            | with supervisory and testing |                     |
| Conference**    | staff. When reviewing        |                     |
|                 | findings, try to make        |                     |
|                 | positive statements first    |                     |
|                 | and acknowledge staff        |                     |
|                 | cooperation and support.     |                     |
|                 | When addressing negative     |                     |
|                 | findings, allow test site to |                     |
|                 | discuss findings and provide |                     |
|                 | additional information.      |                     |
|                 | Provide instructions and     |                     |
|                 | timeframe for the test sites |                     |
|                 | to submit plans for          |                     |
|                 | correcting problems.         |                     |
+-----------------+------------------------------+---------------------+
| **On-site       | An on-site evaluation report |                     |
| Evaluation:     | should include the following |                     |
| Reporting**     | information:                 |                     |
|                 |                              |                     |
|                 | -   Site Name & Location     |                     |
|                 |                              |                     |
|                 | -   Date of Visit            |                     |
|                 |                              |                     |
|                 | -   Assessment Team Members  |                     |
|                 |                              |                     |
|                 | -   Major Findings           |                     |
|                 |                              |                     |
|                 | -   Recommendations for      |                     |
|                 |     corrective actions       |                     |
|                 |                              |                     |
|                 | Completed checklist and      |                     |
|                 | report should be submitted   |                     |
|                 | to relevant authorities,     |                     |
|                 | e.g., Quality Manager, Site  |                     |
|                 | Manager, Program Manger, or  |                     |
|                 | MOH.                         |                     |
+-----------------+------------------------------+---------------------+
| **Issues to     | Implementation of a          |                     |
| Consider Prior  | re-testing program requires  |                     |
| to Implementing | consideration of the         |                     |
| a Re-testing    | following issues:            |                     |
| Program**       |                              |                     |
|                 | -   What is the purpose of   |                     |
|                 |     re-testing?              |                     |
|                 |                              |                     |
|                 | -   Is re-testing feasible?  |                     |
|                 |                              |                     |
|                 | -   Does technical capacity  |                     |
|                 |     exist at reference lab?  |                     |
|                 |                              |                     |
|                 | -   Can turnaround of        |                     |
|                 |     re-testing be            |                     |
|                 |     accomplished in a timely |                     |
|                 |     manner allowing for      |                     |
|                 |     immediate corrective     |                     |
|                 |     actions?                 |                     |
|                 |                              |                     |
|                 | -   What type of specimen    |                     |
|                 |     should be collected for  |                     |
|                 |     re-testing?              |                     |
|                 |                              |                     |
|                 | -   How should EQA specimens |                     |
|                 |     be labeled and recorded? |                     |
|                 |                              |                     |
|                 | -   When should specimens be |                     |
|                 |     shipped / transported to |                     |
|                 |     reference laboratory?    |                     |
|                 |                              |                     |
|                 | -   Which laboratory should  |                     |
|                 |     re-test specimens        |                     |
|                 |     submitted by test sites? |                     |
+-----------------+------------------------------+---------------------+
| **Statistical   | If re-testing is to be one   |                     |
| Basis for       | of the EQA methods, it must  |                     |
| Re-testing:     | be based upon statistical    |                     |
| Error           | considerations. Specimens    |                     |
| Detection**     | MUST be collected randomly.  |                     |
|                 | Every effort should be made  |                     |
|                 | to avoid systematic sampling |                     |
|                 | bias. Outcome of re-testing  |                     |
|                 | must be analyzed for         |                     |
|                 | effective and timely         |                     |
|                 | feedback.                    |                     |
+-----------------+------------------------------+---------------------+
| **Re-testing    | The process for re-testing   |                     |
| Process**       | includes the following       |                     |
|                 | steps:                       |                     |
|                 |                              |                     |
|                 | 1.  Determine specimen type  |                     |
|                 |                              |                     |
|                 | 2.  Determine sampling plan  |                     |
|                 |     and time interval        |                     |
|                 |                              |                     |
|                 | 3.  Collect specimens        |                     |
|                 |                              |                     |
|                 | 4.  Store specimens until    |                     |
|                 |     transport                |                     |
|                 |                              |                     |
|                 | 5.  Package and transport    |                     |
|                 |     specimens along with     |                     |
|                 |     paperwork to designated  |                     |
|                 |     laboratory               |                     |
|                 |                              |                     |
|                 | 6.  Compare re-test results  |                     |
|                 |     with site results        |                     |
|                 |                              |                     |
|                 | 7.  Take Corrective actions, |                     |
|                 |     if needed                |                     |
+-----------------+------------------------------+---------------------+
| **Tester        | Your responsibilities in a   |                     |
| Re              | re-testing program is to:    |                     |
| sponsibilities: |                              |                     |
| Re-Testing**    | -   Follow written policies  |                     |
|                 |     and procedures           |                     |
|                 |                              |                     |
|                 | -   Collect appropriate      |                     |
|                 |     specimen                 |                     |
|                 |                              |                     |
|                 | -   Record keeping is        |                     |
|                 |     essential                |                     |
|                 |                              |                     |
|                 | -   Take necessary           |                     |
|                 |     precautions to avoid     |                     |
|                 |     transcription errors     |                     |
|                 |                              |                     |
|                 | -   Package and transport    |                     |
|                 |     EQA specimens to         |                     |
|                 |     designated reference     |                     |
|                 |     laboratory               |                     |
|                 |                              |                     |
|                 | -   Take necessary           |                     |
|                 |     corrective actions       |                     |
+-----------------+------------------------------+---------------------+
| **Specimen      | Specimens for re-testing can |                     |
| Requirements**  | be either Dried Blood Spots  |                     |
|                 | (DBS) or serum/plasma.       |                     |
|                 |                              |                     |
|                 | -   If using Dried Blood     |                     |
|                 |     Spots (DBS), collect 100 |                     |
|                 |     µl on labeled filter     |                     |
|                 |     paper and store the      |                     |
|                 |     samples refrigerated in  |                     |
|                 |     appropriately packaged   |                     |
|                 |     re-sealable plastic bag. |                     |
|                 |                              |                     |
|                 | -   If using serum or        |                     |
|                 |     plasma, collect 0.5 ml   |                     |
|                 |     aliquot in labeled       |                     |
|                 |     cryovial, and store at   |                     |
|                 |     2-8ºC for up to 1 week   |                     |
|                 |     or at -20ºC or below if  |                     |
|                 |     longer than 1 week.      |                     |
|                 |                              |                     |
|                 | All specimens should be      |                     |
|                 | properly labeled. At a       |                     |
|                 | minimum, include specimen    |                     |
|                 | identification number and    |                     |
|                 | date of collection. This     |                     |
|                 | information needs to be      |                     |
|                 | captured on a form that is   |                     |
|                 | submitted along with         |                     |
|                 | specimen to a reference      |                     |
|                 | laboratory.                  |                     |
|                 |                              |                     |
|                 | Refer to Module 14 for       |                     |
|                 | details on the use of Dried  |                     |
|                 | Blood Spots for re-testing.  |                     |
+-----------------+------------------------------+---------------------+
| **EQA Specimen  | You can find an example of   |                     |
| Transfer Log**  | EQA specimen transfer log at |                     |
|                 | the end of this module.      |                     |
+-----------------+------------------------------+---------------------+
| **Specimen      | Given the volume of          |                     |
| Management :    | specimens that may be        |                     |
| Common          | required for re-testing,     |                     |
| Problems**      | care must be taken to avoid  |                     |
|                 | errors that may occur in the |                     |
|                 | pre-analytic and             |                     |
|                 | post-analytic phase of       |                     |
|                 | testing.                     |                     |
|                 |                              |                     |
|                 | Common problems include:     |                     |
|                 |                              |                     |
|                 | -   Transcription errors,    |                     |
|                 |     such as mislabeling      |                     |
|                 |     cryovial or DBS card,    |                     |
|                 |     from Lab register to     |                     |
|                 |     specimen transfer log,   |                     |
|                 |     and from reference lab   |                     |
|                 |     to testing site          |                     |
|                 |                              |                     |
|                 | ```{=html}                   |                     |
|                 | <!-- -->                     |                     |
|                 | ```                          |                     |
|                 | -   Inadequate specimens     |                     |
|                 |                              |                     |
|                 | Remember -- a test result is |                     |
|                 | only as good as the specimen |                     |
|                 | received for testing.        |                     |
+-----------------+------------------------------+---------------------+

+-----------------+----------------------------------------------------+
| ![](m           | -   EQA provides early warning for systematic      |
| edia/image7.wmf |     problems associated with kits or operations    |
| ){width="1.1701 |                                                    |
| 388888888888in" | -   Problems may occur throughout the testing      |
| height="0.83194 |     process                                        |
| 44444444445in"} |                                                    |
|                 | -   On-site visits are designed to be instructive, |
| **Key message** |     not punitive                                   |
|                 |                                                    |
|                 | -   Corrective actions should be implemented and   |
|                 |     recorded for any problems identified.          |
|                 |                                                    |
|                 | -   A test result is only as good as the specimen  |
|                 |     received for testing.                          |
+-----------------+----------------------------------------------------+

+-----------------+----------------------------------------------------+
| ![](m           | On-Site Evaluation Visit Role Play                 |
| edia/image8.png |                                                    |
| ){width="0.8916 |                                                    |
| 666666666667in" |                                                    |
| height="0.67847 |                                                    |
| 22222222223in"} |                                                    |
+-----------------+----------------------------------------------------+
| Observe the     |                                                    |
| scenario of a   |                                                    |
| on-site         |                                                    |
| evaluation      |                                                    |
| visit. Answer   |                                                    |
| the following   |                                                    |
| questions..     |                                                    |
+-----------------+----------------------------------------------------+
| **What did you  |                                                    |
| observe?**      |                                                    |
|                 |                                                    |
| \_\             |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
|                 |                                                    |
| \_\_\_\_\_\_    |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
|                 |                                                    |
| \_\_\_\_\       |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
+-----------------+----------------------------------------------------+
| What did you    |                                                    |
| learn?          |                                                    |
| \_\_\_          |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
|                 |                                                    |
| \_\_\_\_\       |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
|                 |                                                    |
| \_\_\_\_\       |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
+-----------------+----------------------------------------------------+

+-----------------+----------------------------------------------------+
| ![](m           | Module Review                                      |
| edia/image9.wmf |                                                    |
| ){width="1.0in" |                                                    |
| height="0.96041 |                                                    |
| 66666666667in"} |                                                    |
+-----------------+----------------------------------------------------+
| Find out how    |                                                    |
| much you have   |                                                    |
| learned by      |                                                    |
| answering these |                                                    |
| questions.      |                                                    |
+-----------------+----------------------------------------------------+
| Describe your   |                                                    |
| r               |                                                    |
| esponsibilities |                                                    |
| in EQA.         |                                                    |
|                 |                                                    |
| \_\_\_          |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
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| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
+-----------------+----------------------------------------------------+
| What is         |                                                    |
| proficiency     |                                                    |
| testing?        |                                                    |
|                 |                                                    |
| \_\_\_          |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
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| _\_\_\_\_\_\_\_ |                                                    |
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| _\_\_\_\_\_\_\_ |                                                    |
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| \_\_\_\_\_\_\_\ |                                                    |
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| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
+-----------------+----------------------------------------------------+
| What is On-site |                                                    |
| evaluation?     |                                                    |
| \_\_\_          |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
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| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
+-----------------+----------------------------------------------------+
| What is         |                                                    |
| Re-testing?     |                                                    |
| \_\_\_\_\_\_    |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
|                 |                                                    |
| \_\_\_\_\_\_    |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
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| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
|                 |                                                    |
| \_\_\_\_\_\_    |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
+-----------------+----------------------------------------------------+
| ![](m           | Module Review                                      |
| edia/image9.wmf |                                                    |
| ){width="1.0in" |                                                    |
| height="0.96041 |                                                    |
| 66666666667in"} |                                                    |
+-----------------+----------------------------------------------------+
| Find out how    |                                                    |
| much you have   |                                                    |
| learned by      |                                                    |
| answering these |                                                    |
| questions.      |                                                    |
+-----------------+----------------------------------------------------+
| Explain the     |                                                    |
| process for     |                                                    |
| on-site         |                                                    |
| evaluation.     |                                                    |
|                 |                                                    |
| \_\_\_          |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
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| _\_\_\_\_\_\_\_ |                                                    |
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| _\_\_\_\_\_\_\_ |                                                    |
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| _\_\_\_\_\_\_\_ |                                                    |
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| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
+-----------------+----------------------------------------------------+
| What are some   |                                                    |
| issues that are |                                                    |
| considered      |                                                    |
| prior to        |                                                    |
| implementing a  |                                                    |
| re-testing      |                                                    |
| program?        |                                                    |
|                 |                                                    |
| \_\_\_          |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
+-----------------+----------------------------------------------------+
| -   Explain the |                                                    |
|     process for |                                                    |
|     re-testing. |                                                    |
|                 |                                                    |
|     \_\_\_      |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
+-----------------+----------------------------------------------------+
| -   What are    |                                                    |
|     some common |                                                    |
|     problems    |                                                    |
|     associated  |                                                    |
|     with        |                                                    |
|     specimen    |                                                    |
|     management? |                                                    |
|                 |                                                    |
| -   \_\         |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
| \_\_\_\_\_\_\_\ |                                                    |
| _\_\_\_\_\_\_\_ |                                                    |
+-----------------+----------------------------------------------------+

# CORRECTIVE ACTION FORM

**This Corrective Action is a result of:**

\_\_\_\_\_\_Occurrence Date\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Time:
\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_Internal Assessment Date\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Time:
\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_External Assessment: Date\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Time:
\_\_\_\_\_\_\_\_\_\_

**Description of Problem or Finding:** *(What happened and Why)*

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Reported by: (Staff Name)
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Corrective Action Taken:** *(What was done to prevent re-occurrence?)*

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Staff Name: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Reviewed by: (Test Site Manager / Quality Officer)
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Date Reviewed:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**On-site Evaluation Checklist -- Assessment of Quality System**

+------------+-------------------------------+----+----+--------------+
| **Quality  |                               | *  | ** | **Assessor's |
| System     |                               | *Y | No | comments**   |
| E          |                               | es | ** |              |
| ssential** |                               | ** |    |              |
+============+===============================+====+====+==============+
| **Orga     | -   Is there a quality policy |    |    |              |
| nization** |     manual present and        |    |    |              |
|            |     accessible?               |    |    |              |
|            |                               |    |    |              |
|            |     -   Does the policy       |    |    |              |
|            |         manual address all    |    |    |              |
|            |         elements of the       |    |    |              |
|            |         quality system?       |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Does the site have a      |    |    |              |
|            |     designated quality        |    |    |              |
|            |     officer?                  |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Is the site manager aware |    |    |              |
|            |     of all quality system     |    |    |              |
|            |     components?               |    |    |              |
+------------+-------------------------------+----+----+--------------+
| **P        | -   Does testing staff        |    |    |              |
| ersonnel** |     possess certificate       |    |    |              |
|            |     indicating successful     |    |    |              |
|            |     participation in HIV      |    |    |              |
|            |     rapid test training?      |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Has the staff been        |    |    |              |
|            |     oriented to the           |    |    |              |
|            |     patient/client flow at    |    |    |              |
|            |     the test site?            |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Does staff demonstrate    |    |    |              |
|            |     professionalism?          |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Is number of staff        |    |    |              |
|            |     adequate for the site     |    |    |              |
|            |     workload?                 |    |    |              |
|            |                               |    |    |              |
|            |     -   Approximately how     |    |    |              |
|            |         many tests does each  |    |    |              |
|            |         staff member perform  |    |    |              |
|            |         per month?            |    |    |              |
+------------+-------------------------------+----+----+--------------+
| *          | -   Are standard operating    |    |    |              |
| *Documents |     procedures for all        |    |    |              |
| and        |     aspects of the testing    |    |    |              |
| Records**  |     process written,          |    |    |              |
|            |     up-to-date, and           |    |    |              |
|            |     accessible to staff?      |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Is the handwriting        |    |    |              |
|            |     legible?                  |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Do worksheets include     |    |    |              |
|            |     appropriate information?  |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are external quality      |    |    |              |
|            |     control records           |    |    |              |
|            |     up-to-date, easily        |    |    |              |
|            |     reviewed?                 |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are corrective actions    |    |    |              |
|            |     recorded?                 |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are results interpreted   |    |    |              |
|            |     and recorded according to |    |    |              |
|            |     the SOP and site          |    |    |              |
|            |     protocol?                 |    |    |              |
+------------+-------------------------------+----+----+--------------+
| **         | -   Are kits and reagents     |    |    |              |
| Purchasing |     stored properly?          |    |    |              |
| and        |                               |    |    |              |
| I          |                               |    |    |              |
| nventory** |                               |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Is staff following "first |    |    |              |
|            |     in, first out" method     |    |    |              |
|            |     when managing inventory   |    |    |              |
|            |     stock?                    |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Is there a policy for     |    |    |              |
|            |     re-ordering kits and      |    |    |              |
|            |     supplies?                 |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Is minimum stock on hand? |    |    |              |
|            |     (Look at re-order levels) |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Is the site ever unable   |    |    |              |
|            |     to perform testing        |    |    |              |
|            |     because there are no kits |    |    |              |
|            |     or supplies on hand?      |    |    |              |
|            |                               |    |    |              |
|            |     -   How frequently does   |    |    |              |
|            |         this occur?           |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   If unable to test, how is |    |    |              |
|            |     this information provided |    |    |              |
|            |     to clients?               |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Does testing site have    |    |    |              |
|            |     adequate space for        |    |    |              |
|            |     storage of specimens?     |    |    |              |
+------------+-------------------------------+----+----+--------------+
| **E        | -   Is refrigerator clean and |    |    |              |
| quipment** |     organized?                |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are refrigerator          |    |    |              |
|            |     temperatures monitored    |    |    |              |
|            |     and recorded?             |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are freezer temps         |    |    |              |
|            |     monitored and recorded,   |    |    |              |
|            |     if present?               |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   If centrifuge is used,    |    |    |              |
|            |     are function checks       |    |    |              |
|            |     routinely performed?      |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   If non-disposable         |    |    |              |
|            |     pipettes are used, are    |    |    |              |
|            |     calibration records       |    |    |              |
|            |     available?                |    |    |              |
+------------+-------------------------------+----+----+--------------+
| **Process  | -   Is there a written        |    |    |              |
| Control**  |     procedure for collecting, |    |    |              |
|            |     processing and storing    |    |    |              |
| *Specimen  |     specimens?                |    |    |              |
| M          |                               |    |    |              |
| anagement* |                               |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are specimens             |    |    |              |
|            |     appropriately labeled and |    |    |              |
|            |     packaged for transport to |    |    |              |
|            |     reference laboratory?     |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Does staff follow         |    |    |              |
|            |     universal or standard     |    |    |              |
|            |     precautions when          |    |    |              |
|            |     collecting or handling    |    |    |              |
|            |     patient/client specimens? |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Do DBS or other collected |    |    |              |
|            |     specimens meet acceptance |    |    |              |
|            |     criteria?                 |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Observe staff perform     |    |    |              |
|            |     rapid test using client   |    |    |              |
|            |     specimen. All steps       |    |    |              |
|            |     should follow SOP.        |    |    |              |
+------------+-------------------------------+----+----+--------------+
| *Quality   | -   Are both internal and     |    |    |              |
| Control*   |     external quality control  |    |    |              |
|            |     samples analyzed?         |    |    |              |
|            |                               |    |    |              |
|            |     -   How often?            |    |    |              |
|            |                               |    |    |              |
|            |     -   What is the source of |    |    |              |
|            |         QC material?          |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are external quality      |    |    |              |
|            |     control results recorded  |    |    |              |
|            |     and reviewed?             |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are appropriate           |    |    |              |
|            |     corrective actions taken  |    |    |              |
|            |     when controls results do  |    |    |              |
|            |     not produce expected      |    |    |              |
|            |     results?                  |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Is HIV status reported    |    |    |              |
|            |     only when internal and    |    |    |              |
|            |     external control is       |    |    |              |
|            |     acceptable?               |    |    |              |
+------------+-------------------------------+----+----+--------------+
| **I        | -   Are test results properly |    |    |              |
| nformation |     maintained and            |    |    |              |
| Ma         |     accessible?               |    |    |              |
| nagement** |                               |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Is a computer used in     |    |    |              |
|            |     recording information and |    |    |              |
|            |     data? If yes, are there   |    |    |              |
|            |     procedures to assure      |    |    |              |
|            |     accuracy?                 |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Is patient/client         |    |    |              |
|            |     confidentiality           |    |    |              |
|            |     maintained?               |    |    |              |
|            |                               |    |    |              |
|            |     -   If yes, is there      |    |    |              |
|            |         adequate back-up to   |    |    |              |
|            |         assure integrity of   |    |    |              |
|            |         data in case of       |    |    |              |
|            |         equipment (computer)  |    |    |              |
|            |         failure?              |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Is the testing site       |    |    |              |
|            |     meeting program reporting |    |    |              |
|            |     requirements?             |    |    |              |
+------------+-------------------------------+----+----+--------------+
| **         | -   Is there a written policy |    |    |              |
| Occurrence |     for investigating errors? |    |    |              |
| Ma         |                               |    |    |              |
| nagement** |                               |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   How is communication with |    |    |              |
|            |     affected customers        |    |    |              |
|            |     handled?                  |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are all errors, with any  |    |    |              |
|            |     corrective action and     |    |    |              |
|            |     communication, recorded?  |    |    |              |
+------------+-------------------------------+----+----+--------------+
| **As       | -   What EQA method(s) is     |    |    |              |
| sessment** |     used?                     |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are results of re-testing |    |    |              |
|            |     submitted to testing site |    |    |              |
|            |     in timely manner?         |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are appropriate actions   |    |    |              |
|            |     taken when re-testing     |    |    |              |
|            |     results differ from       |    |    |              |
|            |     initial results?          |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Has the testing site been |    |    |              |
|            |     monitored within last 6   |    |    |              |
|            |     month?                    |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Have corrective actions   |    |    |              |
|            |     been taken for previously |    |    |              |
|            |     identified problems?      |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are corrective actions    |    |    |              |
|            |     taken and recorded?       |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are the results of        |    |    |              |
|            |     on-site monitoring        |    |    |              |
|            |     communicated to staff?    |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            |                               |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Observe staff perform     |    |    |              |
|            |     rapid tests using         |    |    |              |
|            |     proficiency panel.        |    |    |              |
|            |     (record results for each  |    |    |              |
|            |     individual). All steps    |    |    |              |
|            |     should follow SOP.        |    |    |              |
+------------+-------------------------------+----+----+--------------+
| **Process  | -   Have any projects been    |    |    |              |
| Imp        |     undertaken for process    |    |    |              |
| rovement** |     improvement?              |    |    |              |
+------------+-------------------------------+----+----+--------------+
| **Service  | -   Is staff courteous to     |    |    |              |
| and        |     clients?                  |    |    |              |
| Sati       |                               |    |    |              |
| sfaction** |                               |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are there efforts to      |    |    |              |
|            |     reassure client and/or    |    |    |              |
|            |     alleviate client's fear   |    |    |              |
|            |     of needle or sight of     |    |    |              |
|            |     blood?                    |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   When reporting to outside |    |    |              |
|            |     providers, is turnaround  |    |    |              |
|            |     time appropriate?         |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Does the site solicit     |    |    |              |
|            |     input and advice from     |    |    |              |
|            |     clients?                  |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are program needs and     |    |    |              |
|            |     expectations being met?   |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Is the testing space      |    |    |              |
|            |     adequate in size; clean   |    |    |              |
|            |     and well organized?       |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Is the environment        |    |    |              |
|            |     suitable for patient      |    |    |              |
|            |     testing (e.g.             |    |    |              |
|            |     temperature, electrical   |    |    |              |
|            |     supply)?                  |    |    |              |
+------------+-------------------------------+----+----+--------------+
| **         | -   Is storage space          |    |    |              |
| Facilities |     adequate, clean and       |    |    |              |
| and        |     maintained?               |    |    |              |
| Safety**   |                               |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are gloves available and  |    |    |              |
|            |     used routinely?           |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are hand washing supplies |    |    |              |
|            |     and facilities available  |    |    |              |
|            |     in a convenient area?     |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are work areas            |    |    |              |
|            |     disinfected?              |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Is biohazard waste        |    |    |              |
|            |     disposed of safely?       |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Does the laboratory have  |    |    |              |
|            |     policy and procedure for  |    |    |              |
|            |     addressing accidental     |    |    |              |
|            |     exposure to infectious    |    |    |              |
|            |     material?                 |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Are emergency contacts    |    |    |              |
|            |     located in visible area   |    |    |              |
|            |     at test site?             |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            | -   Is staff aware of policy  |    |    |              |
|            |     for post exposure         |    |    |              |
|            |     prophylaxis?              |    |    |              |
+------------+-------------------------------+----+----+--------------+
|            |                               |    |    |              |
+------------+-------------------------------+----+----+--------------+

**Example Specimen Transfer Log for Re-testing**

**\[Insert Name of Referring Testing Site,**

**Contact Name**

**Address and Phone Number\]**

**Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Referring Testing
Site
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

<table>
<colgroup>
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 10%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
</colgroup>
<tbody>
<tr class="odd">
<td><strong>Specimen Tracking Number</strong></td>
<td><strong>Test Subject ID*</strong></td>
<td><strong>Final Result (Testing Site)</strong></td>
<td><strong>Date Specimen Collected</strong></td>
<td><p><strong>Specimen Type</strong></p>
<p><strong>(DBS or Serum)</strong></p></td>
<td><strong>Collected by</strong></td>
<td><strong>Referral Lab Req<sup>†</sup> Completed ()</strong></td>
<td><strong>Date to referral lab</strong></td>
<td><strong>Date Conf Result Received</strong></td>
<td><strong>Result of Re-test</strong></td>
</tr>
<tr class="even">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
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</tr>
<tr class="even">
<td></td>
<td></td>
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<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
</tbody>
</table>

\*ID = Identification

^†^Lab Req = Laboratory Requisition