**Division of AIDS**

**LABORATORY ASSESSMENT VISIT REPORT**

Protocol Title:      

Study Number:      

Name & Location of Laboratory:      

Laboratory Director:      

Biosafety Level of Laboratory:      

(as applicable)

Date Last Monitored:      

Grant Principal Investigator:      

Grant Number:      

DAIDS Program Officer:      

DAIDS Medical Officer:      

Date(s) of Visit:      

Conducted by:      

Table of Contents

Summary of Laboratory DEBRIEFING, SIGNIFICANT FINDINGS and
recommendations

STATUS OF PAST FINDINGS

*Delete if this is first pre-trial site visit*

LABORATORY ASSESSMENT

signature Page

**SUMMARY OF LABORATORY DEBRIEFING, SIGNIFICANT FINDINGS, AND
RECOMMENDATIONS**

*Suggested format for standardizing style - document summary of findings
with headings that are ordered and correspond to Table of Contents and
sections of the report.*

*For Pre-trial assessments, use the following format:*

I.  LABORATORY ASSESSMENT

```{=html}
<!-- -->
```
A.  **Major Deficiencies** that must be corrected prior to trial
    initiation.

> 1\.
>
> 2\.
>
> 3\.

B.  **Minor Deficiencies** that can be addressed on an ongoing basis.

> 1\.
>
> 2\.
>
> 3\.

*For all other assessments, use this format:*

I.  LABORATORY ASSESSMENT

> Summarize findings
>
> **Recommendations or Corrective Actions**
>
> Note these individually

**STATUS OF PAST FINDINGS**

*Delete this section if this is the first laboratory assessment*

DIVISION OF AIDS

CLINICAL RESEARCH OPERATIONS AND MONITORING CENTER

LABORATORY ASSESSMENT

[Instructions:]{.underline} Indicate if the tasks and topics listed were
reviewed and assessed and are adequate. Provide detailed comments as
applicable. Indicate items that were not reviewed or assessed by
checking 'No' or by leaving the fields blank; describe in the Comments
sections. Indicate items that are not applicable in the Comments
sections.

+--------------------------------------------------------+------+------+
| **I. GENERAL OVERVIEW**                                | **Y  | **   |
|                                                        | ES** | NO** |
+--------------------------------------------------------+------+------+
| 1.  Introductions (*Please list participants in        |      |      |
|     Section III*)                                      |      |      |
+--------------------------------------------------------+------+------+
| 2.  Sign Site Monitoring Log                           |      |      |
+--------------------------------------------------------+------+------+
| 3.  Overview of Agenda                                 |      |      |
+--------------------------------------------------------+------+------+
| 4.  Has a DAIDS Laboratory Module been completed?      |      |      |
+--------------------------------------------------------+------+------+
| > a\. If "Yes", is the document available for review?  |      |      |
+--------------------------------------------------------+------+------+
| 5.  Describe the proximity of the laboratory to the    | [    |      |
|     clinic or research site.                           | ]{.m |      |
|                                                        | ark} |      |
+--------------------------------------------------------+------+------+
| 6.  Describe the hours of operation (including         |      |      |
|     holidays and weekends).                            |      |      |
+--------------------------------------------------------+------+------+
| 7.  Is there a copy of the approved protocol and       |      |      |
|     amendments (if applicable) on file?                |      |      |
+--------------------------------------------------------+------+------+

+------------------------------+---------------------------------------+
| **II. Laboratory             |                                       |
| ASSAYs/Activities**          |                                       |
+------------------------------+---------------------------------------+
| #### Hematology              | #### Yes No Comments N/A              |
+------------------------------+---------------------------------------+
| #### Flow                    | #### Yes No Comments N/A              |
| Cytometry/ Immunophenotyping |                                       |
+------------------------------+---------------------------------------+
| #### Chemistry               | #### Yes No Comments N/A              |
+------------------------------+---------------------------------------+
| #### Urine Analysis          | #### Yes No Comments N/A              |
+------------------------------+---------------------------------------+
| #### Microbiology            | #### Yes No Comments N/A              |
+------------------------------+---------------------------------------+
| #### Virology                | #### Yes No Comments N/A              |
+------------------------------+---------------------------------------+
| #### PBMC Processing         | #### Yes No Comments N/A              |
+------------------------------+---------------------------------------+
| #### Immunology/Serology     | #### Yes No Comments N/A              |
+------------------------------+---------------------------------------+
| #### Specimen Storage        | #### Yes No Comments N/A              |
+------------------------------+---------------------------------------+
| #### Specimen Shipping       | #### Yes No Comments N/A              |
+------------------------------+---------------------------------------+
| #### Other                   | #### Yes No Comments N/A              |
+------------------------------+---------------------------------------+
| Please list the SPECIFIC     |                                       |
| tests and activities that    |                                       |
| the lab will perform for the |                                       |
| STUDY:                       |                                       |
+------------------------------+---------------------------------------+

  -------------------- ------------------------------- ------------------
  **III. List                                          
  Laboratory Personnel                                 
  Involved with the                                    
  Study:**                                             

  **NAME**             **TITLE**                       **MET WITH MONITOR
                                                       (Y/N)**

                       Laboratory Director             

                       Laboratory Manager              

                       Laboratory Technician           

                       *Revise Titles and add          
                       additional rows, as necessary*  
  -------------------- ------------------------------- ------------------

+------------------------------------------+---------------------------+
| ### IV. Organization and Personnel       |                           |
+------------------------------------------+---------------------------+
| A. Is an Organizational Chart for        | Yes No Comments           |
| laboratory personnel present?            |                           |
+------------------------------------------+---------------------------+
| B. Is the Laboratory Director's CV on    | Yes No Comments           |
| file?                                    |                           |
+------------------------------------------+---------------------------+
| C. Are the Job Description/Delegation of | Yes No Comments           |
| Duties documents present?                |                           |
+------------------------------------------+---------------------------+
| 1\. Are they applicable to the work      | Yes No Comments           |
| performed for the study?                 |                           |
+------------------------------------------+---------------------------+
| D. Are education records maintained for  | Yes No Comments           |
| all laboratory employees?                |                           |
+------------------------------------------+---------------------------+
| E. Are training records for personnel    | Yes No Comments           |
| kept on file?                            |                           |
+------------------------------------------+---------------------------+
| F. Has the laboratory staff had Good     | Yes No Comments           |
| Laboratory Practices (GLP) or Good       |                           |
| Clinical Laboratory Practices (GCLP)     |                           |
| training?                                |                           |
+------------------------------------------+---------------------------+
| G. Have the staff had Good Clinical      | Yes No Comments           |
| Practices (GCP) training?                |                           |
+------------------------------------------+---------------------------+
| H. Is documentation maintained           | Yes No Comments           |
| indicating the laboratory has assessed   |                           |
| the competency of each employee to       |                           |
| perform his or her assigned duties? List |                           |
| the frequency that competency is         |                           |
| assessed.                                |                           |
+------------------------------------------+---------------------------+
| I. Is the Laboratory Signature Sheet on  | Yes No Comments           |
| file and up-to-date?                     |                           |
+------------------------------------------+---------------------------+
| J. Has the laboratory been certified by  | Yes No Comments           |
| any regulatory agency? If yes, please    |                           |
| list the agency, date of certification,  |                           |
| and requirements for certification.      |                           |
+------------------------------------------+---------------------------+
| *Regulatory Agency:*                     |                           |
|                                          |                           |
| *Dates of Certification:*                |                           |
|                                          |                           |
| *Certification Requirements*:            |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

+------------------------------------------+---------------------------+
| ##### **V. FACILITIES and Equipment**    |                           |
+------------------------------------------+---------------------------+
| A. Describe the laboratory space.        |                           |
| (Designated areas for specimen receipt,  |                           |
| accessioning, analysis, administration,  |                           |
| waste disposal, sample storage,          |                           |
| microbiological isolation,               |                           |
| radioactivity, etc. Note square footage  |                           |
| and what work groups adjoin the lab.     |                           |
| Also note cleanliness, presence of A/C,  |                           |
| fire protection, security features,      |                           |
| etc.)                                    |                           |
+------------------------------------------+---------------------------+
| B. Inventory/Location of Laboratory      |                           |
| Equipment                                |                           |
|                                          |                           |
| \*Check 'Yes' if the equipment is        |                           |
| present and suitable for the study.      |                           |
| Check 'N/A' if the equipment is present, |                           |
| but [not]{.underline} used in the study. |                           |
+------------------------------------------+---------------------------+
| 1\. Freezers                             | Yes No Comments N/A       |
+------------------------------------------+---------------------------+
| 2\. Refrigerators                        | Yes No Comments N/A       |
+------------------------------------------+---------------------------+
| 3\. Liquid Nitrogen Freezers             | Yes No Comments N/A       |
+------------------------------------------+---------------------------+
| 4\. Incubators                           | Yes No Comments N/A       |
+------------------------------------------+---------------------------+
| 5\. Water Baths                          | Yes No Comments N/A       |
+------------------------------------------+---------------------------+
| 6\. Centrifuges                          | Yes No Comments N/A       |
+------------------------------------------+---------------------------+
| 7\. Laminar Air Flow Hoods               | Yes No Comments N/A       |
+------------------------------------------+---------------------------+
| 8.  Chemistry Instrumentation            | Yes No Comments N/A       |
|                                          |                           |
| > Manufacturer/Model:                    |                           |
+------------------------------------------+---------------------------+
| 9.  Hematology Instrumentation           | Yes No Comments N/A       |
|                                          |                           |
| > Manufacturer/Model:                    |                           |
+------------------------------------------+---------------------------+
| 10. Flow Cytometer                       | Yes No Comments N/A       |
|                                          |                           |
| Manufacturer/Model:                      |                           |
+------------------------------------------+---------------------------+
| 11. Pipettors                            | Yes No Comments N/A       |
+------------------------------------------+---------------------------+
| 12. Clean water source, such as          | Yes No Comments N/A       |
|     deionized water (DI) equipment.      |                           |
+------------------------------------------+---------------------------+
| 13. Autoclave                            | Yes No Comments N/A       |
+------------------------------------------+---------------------------+
| 14\. Microscopes                         | Yes No Comments N/A       |
+------------------------------------------+---------------------------+
| 15\. Other (additional equipment used    | Yes No Comments N/A       |
| for protocol-related assays)             |                           |
+------------------------------------------+---------------------------+
| 16\. Are operator's manuals available    | Yes No Comments N/A       |
| for all laboratory equipment?            |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

+------------------------------------------+---------------------------+
| C. Daily Documentation of temperatures   |                           |
| for temperature sensitive equipment:     |                           |
|                                          |                           |
| If documented by use only, please note   |                           |
| in Comments section.                     |                           |
+------------------------------------------+---------------------------+
| 1\. Freezers                             | Yes No Comments N/A       |
+------------------------------------------+---------------------------+
| 2\. Refrigerators                        | Yes No Comments N/A       |
+------------------------------------------+---------------------------+
| 3\. Liquid nitrogen freezer (and/or      | Yes No Comments N/A       |
| level of nitrogen)                       |                           |
+------------------------------------------+---------------------------+
| 4\. Incubators                           | Yes No Comments N/A       |
+------------------------------------------+---------------------------+
| 5\. Waterbaths                           | Yes No Comments N/A       |
+------------------------------------------+---------------------------+
| 6\. Ambient room temperature             | Yes No Comments           |
+------------------------------------------+---------------------------+
| 7.  Is there a written policy/procedure  | Yes No Comments           |
|     in place explaining how temperatures |                           |
|     are monitored, including during the  |                           |
|     absence of laboratory staff?         |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

+------------------------------------------+---------------------------+
| D. Have acceptable ranges been defined   | Yes No Comments           |
| for all temperature dependent equipment? |                           |
+------------------------------------------+---------------------------+
| E. Is there is a procedure to explain    | Yes No Comments           |
| what to do when monitoring results are   |                           |
| found to be out of specification?        |                           |
+------------------------------------------+---------------------------+
| 1.  Is there documentation of corrective | Yes No Comments           |
|     actions taken in response to values  |                           |
|     that are out of specification?       |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

  ------------------------------------------- ---------------------------
  F. Have all non-certified thermometers been Yes No Comments
  checked against an appropriate certified    
  thermometric device?                        

  Comments:                                   
  ------------------------------------------- ---------------------------

  ------------------------------------------- ---------------------------
  G. Are there documented PM                  Yes No Comments
  [plans]{.underline} for the laboratory's    
  equipment?                                  

  I. Are there documented calibration         Yes No Comments
  [plans]{.underline} for the laboratory's    
  equipment?                                  

  Comments:                                   
  ------------------------------------------- ---------------------------

+------------------------------------------+---------------------------+
| H. Check the appropriate box to indicate |                           |
| the presence of Preventative Maintenance |                           |
| (PM), repair and/or calibration records  |                           |
| for laboratory equipment:                |                           |
|                                          |                           |
| \*Check NA if it was not assessed and    |                           |
| explain in the Comments section.         |                           |
+------------------------------------------+---------------------------+
| 1\. Freezers                             | PM Repair Calibration NA  |
+------------------------------------------+---------------------------+
| 2\. Refrigerators                        | PM Repair Calibration NA  |
+------------------------------------------+---------------------------+
| 3\. Incubators                           | PM Repair Calibration NA  |
+------------------------------------------+---------------------------+
| 4\. Balances                             | PM Repair Calibration NA  |
+------------------------------------------+---------------------------+
| 5\. Centrifuges (must have annual        | PM Repair Calibration NA  |
| calibration)                             |                           |
+------------------------------------------+---------------------------+
| 6\. Laminar Flow Hoods (must have annual | PM Repair Calibration NA  |
| certification record)                    |                           |
+------------------------------------------+---------------------------+
| 7\. Pipettors (must have semi-annual     | PM Repair Calibration NA  |
| calibration and quarterly testing)       |                           |
+------------------------------------------+---------------------------+
| 8.  Clinical Chemistry instrumentation   | PM Repair Calibration NA  |
|                                          |                           |
| > a List each instrument and associate   |                           |
| > check boxes                            |                           |
+------------------------------------------+---------------------------+
| 9.  Hematology instrumentation           | PM Repair Calibration NA  |
|                                          |                           |
| a List each instrument and associate     |                           |
| check boxes                              |                           |
+------------------------------------------+---------------------------+
| 10\. Flow Cytometry instrumentation      | PM Repair Calibration NA  |
+------------------------------------------+---------------------------+
| 11\. DI Water equipment                  | PM Repair Calibration NA  |
+------------------------------------------+---------------------------+
| 12\. Autoclave                           | PM Repair Calibration NA  |
+------------------------------------------+---------------------------+
| 13\. Back-up generator                   | PM Repair Calibration NA  |
+------------------------------------------+---------------------------+
| 14\. Other (any other equipment used for | PM Repair Calibration NA  |
| protocol related testing)                |                           |
+------------------------------------------+---------------------------+
| 15\. Supervisor or designee has reviewed | Yes No Comments           |
| and signed maintenance, repair,          |                           |
| calibration records monthly?             |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

  ------------------------------------------- ---------------------------
  J. Are calibration materials stored as      Yes No Comments N/A
  required by the manufacturer?               

  K. Are calibration materials properly       Yes No Comments N/A
  labeled indicating content and calibration  
  value?                                      

  L. Is there a log of calibration materials, Yes No Comments N/A
  lot numbers with expiration and use dates?  

  Comments:                                   
  ------------------------------------------- ---------------------------

  ------------------------------------------- ---------------------------
  M. Are there plans/procedures for use of    Yes No Comments N/A
  the backup generator?                       

  1\. If no backup generator is available, is Yes No Comments N/A
  critical equipment backed up by an          
  uninterrupted power source (UPS) system?    

  N. Are there back-up plans/procedures for   Yes No Comments
  laboratory equipment failure or             
  malfunction?                                

  Comments:                                   
  ------------------------------------------- ---------------------------

+------------------------------------------+---------------------------+
| ##                                       |                           |
| ### **VI. Testing Facilities Operation** |                           |
+------------------------------------------+---------------------------+
| A. Is there a list of all testing        | Yes No Comments           |
| activities to be performed for the       |                           |
| study?                                   |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

+------------------------------------------+---------------------------+
| B. Have any assay validation programs    | Yes No Comments           |
| been implemented?                        |                           |
|                                          |                           |
| If yes, please list the assays in the    |                           |
| Comments section.                        |                           |
+------------------------------------------+---------------------------+
| 1\. If "Yes", are validation data        | Yes No Comments           |
| present?                                 |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

+--------------+-----------------+---------+------+-------------------+
| C. Written   |                 |         |      |                   |
| Laboratory   |                 |         |      |                   |
| Procedures/  |                 |         |      |                   |
| SOPs for all |                 |         |      |                   |
| st           |                 |         |      |                   |
| udy-specific |                 |         |      |                   |
| assays and   |                 |         |      |                   |
| activities   |                 |         |      |                   |
|              |                 |         |      |                   |
| \*Please     |                 |         |      |                   |
| replace the  |                 |         |      |                   |
| text with    |                 |         |      |                   |
| the exact    |                 |         |      |                   |
| titles of    |                 |         |      |                   |
| these        |                 |         |      |                   |
| SOPs,and/or  |                 |         |      |                   |
| obtain a     |                 |         |      |                   |
| copy of the  |                 |         |      |                   |
| Master SOP   |                 |         |      |                   |
| List for the |                 |         |      |                   |
| laboratory.  |                 |         |      |                   |
+--------------+-----------------+---------+------+-------------------+
| Written      | Present         | Annual  |      | Lab               |
| Procedure/   |                 | Review  |      | Director/Designee |
| SOP Name     |                 | C       |      | Signature Present |
|              |                 | omplete |      |                   |
|              |                 | by Lab  |      |                   |
|              |                 | Dir     |      |                   |
|              |                 | ector/D |      |                   |
|              |                 | esignee |      |                   |
+--------------+-----------------+---------+------+-------------------+
| 1\.          | Yes No Comments | Yes No  |      | Yes No Comments   |
| *Biohazard   |                 | C       |      |                   |
| Safety &     |                 | omments |      |                   |
| Containment* |                 |         |      |                   |
+--------------+-----------------+---------+------+-------------------+
| 2\. *Lab     | Yes No Comments | Yes No  |      | Yes No Comments   |
| Data         |                 | C       |      |                   |
| Management & |                 | omments |      |                   |
| Storage*     |                 |         |      |                   |
+--------------+-----------------+---------+------+-------------------+
| 3*.          | Yes No Comments | Yes No  |      | Yes No Comments   |
| Occupational |                 | C       |      |                   |
| Safety*      |                 | omments |      |                   |
+--------------+-----------------+---------+------+-------------------+
| 4\.          | Yes No Comments | Yes No  |      | Yes No Comments   |
| *Specimen    |                 | C       |      |                   |
| Acquisition, |                 | omments |      |                   |
| Processing,  |                 |         |      |                   |
| Labeling,    |                 |         |      |                   |
| Tracking &   |                 |         |      |                   |
| Storage*     |                 |         |      |                   |
+--------------+-----------------+---------+------+-------------------+
| 5*.Specimen  | Yes No Comments | Yes No  |      | Yes No Comments   |
| Transport*   |                 | C       |      |                   |
|              |                 | omments |      |                   |
+--------------+-----------------+---------+------+-------------------+
| 6\.          | Yes No Comments | Yes No  |      | Yes No Comments   |
| *St          |                 | C       |      |                   |
| udy-specific |                 | omments |      |                   |
| tests being  |                 |         |      |                   |
| performed in |                 |         |      |                   |
| the          |                 |         |      |                   |
| laboratory*  |                 |         |      |                   |
+--------------+-----------------+---------+------+-------------------+
| 7\. *add     | Yes No Comments | Yes No  |      | Yes No Comments   |
| extra lines  |                 | C       |      |                   |
| as needed*   |                 | omments |      |                   |
+--------------+-----------------+---------+------+-------------------+
|              |                 |         |      |                   |
+--------------+-----------------+---------+------+-------------------+
| D. Does the  |                 |         | Yes  |                   |
| laboratory   |                 |         | No   |                   |
| have a       |                 |         | Comm |                   |
| system of    |                 |         | ents |                   |
| documenting  |                 |         |      |                   |
| that all     |                 |         |      |                   |
| personnel    |                 |         |      |                   |
| have read    |                 |         |      |                   |
| all the      |                 |         |      |                   |
| laboratory's |                 |         |      |                   |
| SOPs?        |                 |         |      |                   |
+--------------+-----------------+---------+------+-------------------+
| 1\. Is the   |                 |         | Yes  |                   |
| d            |                 |         | No   |                   |
| ocumentation |                 |         | Comm |                   |
| up-to-date?  |                 |         | ents |                   |
+--------------+-----------------+---------+------+-------------------+
| E. Are       |                 |         | Yes  |                   |
| current      |                 |         | No   |                   |
| laboratory   |                 |         | Comm |                   |
| SOPs         |                 |         | ents |                   |
| available in |                 |         |      |                   |
| the work     |                 |         |      |                   |
| area?        |                 |         |      |                   |
+--------------+-----------------+---------+------+-------------------+
| F. Are old   |                 |         | Yes  |                   |
| versions     |                 |         | No   |                   |
| (retired) of |                 |         | Comm |                   |
| SOPs         |                 |         | ents |                   |
| archived in  |                 |         |      |                   |
| the          |                 |         |      |                   |
| laboratory?  |                 |         |      |                   |
+--------------+-----------------+---------+------+-------------------+
| Comments:    |                 |         |      |                   |
+--------------+-----------------+---------+------+-------------------+

+------------------------------------------+---------------------------+
| G. Normal Values or Reference            |                           |
| Intervals/Ranges                         |                           |
+------------------------------------------+---------------------------+
| 1\. Is there a list of reference         | Yes No Comments           |
| intervals for all analytes tested in the |                           |
| laboratory? If "Yes" please list how     |                           |
| they were established/obtained in the    |                           |
| Comments section.                        |                           |
+------------------------------------------+---------------------------+
| 2\. Is there a list of critical/panic or | Yes No Comments N/A       |
| life-threatening values for safety       |                           |
| tests?                                   |                           |
+------------------------------------------+---------------------------+
| 3\. Are there protocol-specific tests    | Yes No Comments           |
| that do not have normal (reference       |                           |
| intervals) values?                       |                           |
|                                          |                           |
| If 'Yes', please list in the Comments    |                           |
| section.                                 |                           |
+------------------------------------------+---------------------------+
| 4\. Do the reportable ranges for all     | Yes No Comments N/A       |
| required safety tests span those listed  |                           |
| in the DAIDS table for grading severity  |                           |
| of adverse experiences?                  |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

+-------------------------------+----------+---------------------------+
| ##### **VII                   |          |                           |
| . Test and Control Articles** |          |                           |
+-------------------------------+----------+---------------------------+
| A. Qualitative/Quantitative   |          |                           |
| Tests                         |          |                           |
+-------------------------------+----------+---------------------------+
| Name of assay                 | QC       |                           |
|                               | F        |                           |
|                               | requency |                           |
+-------------------------------+----------+---------------------------+
| Complete Blood Count          |          |                           |
| (CBC)/Full Blood Count (FBC)  |          |                           |
+-------------------------------+----------+---------------------------+
| Clinical Chemistry Analytes   |          |                           |
|                               |          |                           |
| (Group by instrument and      |          |                           |
| control type used)            |          |                           |
+-------------------------------+----------+---------------------------+
| Urinalysis                    |          |                           |
+-------------------------------+----------+---------------------------+
| Pregnancy tests (urine and/or |          |                           |
| serum)                        |          |                           |
+-------------------------------+----------+---------------------------+
| *Please list all              |          |                           |
| study-specific tests being    |          |                           |
| performed*                    |          |                           |
+-------------------------------+----------+---------------------------+
| 1\. Are logs present          |          | Yes No Comments           |
| documenting control results   |          |                           |
| assayed with each test as     |          |                           |
| described in the specific     |          |                           |
| assay procedure?              |          |                           |
+-------------------------------+----------+---------------------------+
| 2\. Does the technologist     |          | Yes No Comments           |
| performing the QC initial the |          |                           |
| logs?                         |          |                           |
+-------------------------------+----------+---------------------------+
| 3\. Are Levy Jennings charts  |          | Yes No Comments           |
| utilized to document QC data? |          |                           |
+-------------------------------+----------+---------------------------+
| 4\. Has a supervisor/designee |          | Yes No Comments N/A       |
| reviewed and signed Levy      |          |                           |
| Jennings charts?              |          |                           |
+-------------------------------+----------+---------------------------+
| 5\. Has a supervisor/designee |          | Yes No Comments           |
| reviewed and signed all QC    |          |                           |
| logs?                         |          |                           |
+-------------------------------+----------+---------------------------+
| 6\. Are all QC documents      |          | Yes No Comments           |
| available for the past two    |          |                           |
| years?                        |          |                           |
+-------------------------------+----------+---------------------------+
| Comments:                     |          |                           |
+-------------------------------+----------+---------------------------+

  ------------------------------------------- ---------------------------
  B. Is there an approved QA Plan on file? If Yes No Comments
  "yes", who is it approved by?               

  ------------------------------------------- ---------------------------

  ------------------------------------------- ---------------------------
  C. Quality Control Failure/Corrective       
  Action                                      

  1\. Is there a written Corrective Action    Yes No Comments
  Plan?                                       

  2\. Is there a Corrective Action log        Yes No Comments
  present for QC failures?                    

  3\. Has a supervisor/designee reviewed and  Yes No Comments
  signed the Corrective Action log?           

  4\. What is the follow-up plan to           
  Corrective Actions? How are future errors   
  prevented?                                  

  Comments:                                   
  ------------------------------------------- ---------------------------

  ------------------------------------------- ---------------------------
  D. QC materials                             

  1\. Are there inventory records of QC       Yes No Comments
  materials with lot numbers, use dates and   
  expiration dates?                           

  2\. If the lab makes its own QC materials,  Yes No Comments N/A
  are they properly labeled with the          
  ingredients, date prepared, and expiration  
  date?                                       

  a\. If yes, is there an SOP for the         Yes No Comments N/A
  preparation, source, description, storage   
  and record keeping for laboratory prepared  
  QC material?                                

  3\. Are all quality control materials       Yes No Comments
  currently in use dated within the           
  manufacturers assigned expiration dates?    

  4\. Are all quality control materials       Yes No Comments
  currently in use properly stored as         
  required by the manufacturer (or the lab if 
  homemade)?                                  

  Comments:                                   
  ------------------------------------------- ---------------------------

  ------------------------------------------- ---------------------------
  E. Reagent/Testing Kits                     

  1\. Are all reagents/testing kits currently Yes No Comments
  in use within the manufacturers assigned    
  expiration dates?                           

  2\. Are all reagents/testing kits currently Yes No Comments
  in use properly stored as described by the  
  manufacturer?                               

  3\. Are all reagents/solutions properly     Yes No Comments
  labeled to indicate identity, lot number,   
  storage requirement, date                   
  prepared/reconstituted and exp. date?       

  4\. Is there a reagent log to document      Yes No Comments
  receipt, preparation, and expiration dates? 

  5\. Are aliquotted reagents (if applicable) Yes No Comments N/A
  prepared properly and labeled correctly?    

  6\. Is there documentation showing that all Yes No Comments
  reagents/kits are lot-to-lot tested prior   
  to use?                                     

  Comments:                                   
  ------------------------------------------- ---------------------------

+------------------------------------------+---------------------------+
| F. Parallel Testing (Check N/A for tests |                           |
| not performed in this laboratory.)       |                           |
+------------------------------------------+---------------------------+
| 1\. [HIV EIA Assay]{.underline} -- Is    | Yes No Comments N/A       |
| there documentation that three known     |                           |
| control samples are tested with each new |                           |
| lot of reagents with reproducible        |                           |
| results?                                 |                           |
+------------------------------------------+---------------------------+
| 2\. [HIV RNA PCR]{.underline} -- Is      | Yes No Comments N/A       |
| there documentation that three known     |                           |
| samples (negative, low-positive, and     |                           |
| high positive) are tested with each new  |                           |
| lot? Are results within a prescribed     |                           |
| range of the results obtained with the   |                           |
| previous lot number?                     |                           |
+------------------------------------------+---------------------------+
| 3\. [Qualitative PCR Assays]{.underline} | Yes No Comments N/A       |
| -- Documentation that appropriate        |                           |
| controls are tested with each new lot of |                           |
| reagents with reproducible results?      |                           |
+------------------------------------------+---------------------------+
| 4\. [CBC/ FBC]{.underline} -- Are new    | Yes No Comments N/A       |
| lot controls run in parallel with the    |                           |
| previous lot before being put into use?  |                           |
+------------------------------------------+---------------------------+
| 5\. [Chemistry Controls]{.underline} --  | Yes No Comments N/A       |
| Are new lots of controls run in parallel |                           |
| with the previous lot of controls to     |                           |
| establish a mean and acceptable standard |                           |
| deviation?                               |                           |
+------------------------------------------+---------------------------+
| 6\. [CD4/CD8]{.underline} -- Are at      | Yes No Comments N/A       |
| least two known control specimens        |                           |
| (CD4:CD8 ratio \<1.0 and \>1.0) run in   |                           |
| parallel with reproducible results?      |                           |
+------------------------------------------+---------------------------+
| 7.  Does a Supervisor or Director sign   | Yes No Comments N/A       |
|     validity checks for each parallel    |                           |
|     test?                                |                           |
|                                          |                           |
| Please describe how parallel test        |                           |
| records are stored in the Comments       |                           |
| section.                                 |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

  ------------------------------------------- ---------------------------
  G. Culture Media N/A (not used in this lab  
  for the study)                              

  1\. Is a media QC log present?              Yes No Comments

  2\. Does a technologist initial the media   Yes No Comments
  QC log?                                     

  3\. Is a QC Failure/Corrective Action log   Yes No Comments
  present for media?                          

  4\. Are both logs (QC and QC                Yes No Comments
  Failure/Corrective Action) reviewed and     
  signed by supervisor/designee monthly?      
  Please describe the follow-up procedure in  
  the Comments section.                       

  5\. Is the media in use within the          Yes No Comments
  expiration date?                            

  Comments:                                   
  ------------------------------------------- ---------------------------

+------------------------------------------+---------------------------+
| H. Microscopy Staining Procedures N/A    |                           |
| (not used in this lab for the study)     |                           |
|                                          |                           |
| (prepare a checklist for each direct     |                           |
| staining technique used for the study    |                           |
| (AFB, Gram, KOH etc)                     |                           |
+------------------------------------------+---------------------------+
| 1\. Is a control slide stained each day  | Yes No Comments           |
| with documented observations initialed   |                           |
| by a technologist?                       |                           |
+------------------------------------------+---------------------------+
| 2\. Is a corrective action log present   | Yes No Comments           |
| for stain QC?                            |                           |
+------------------------------------------+---------------------------+
| 3\. Are logs reviewed and signed by      | Yes No Comments           |
| supervisor/designee monthly? Please      |                           |
| describe the follow-up procedure in the  |                           |
| Comments section.                        |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

+------------------------------------------+---------------------------+
| ### VIII. Records and Reports            |                           |
+------------------------------------------+---------------------------+
| A. Are copies of Project-specific lab    | Yes No Comments N/A       |
| manuals, Study Specific Procedures,      |                           |
| Protocols and Appendices available to    |                           |
| laboratory personnel?                    |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

  ------------------------------------------- ---------------------------
  B. Specimen Tracking Forms/Requisitions     

  Walk through the specimen tracking process  
  and describe in detail. (Include whether a  
  manual or electronic system, logs and forms 
  used, etc.)                                 

  1\. Does the SOP or Manual of Procedures    Yes No Comments
  correctly reflect the process?              

  2\. Are sample tracking forms retrievable   Yes No Comments
  for the entire protocol?                    

  3\. Are the forms archived following the    Yes No Comments
  study? If so, for how long?                 

  Comments:                                   
  ------------------------------------------- ---------------------------

  ------------------------------------------- ---------------------------
  C. Result Modifications                     

  1\. What process is used to ensure that     
  there are no errors in recording or         
  reporting of test results?                  

  2\. How will errors detected/reported by    
  the data center be corrected? (Response to  
  queries? In study data and in source        
  documents)                                  

  3\. Is there a log kept for result          Yes No Comments
  modifications/corrective actions?           

  4\. Does the Laboratory Director/Designee   Yes No Comments
  review and sign the log monthly?            

  5\. How does the Laboratory Director        
  address consistent corrective actions?      

  Comments:                                   
  ------------------------------------------- ---------------------------

  ------------------------------------------- ---------------------------
  D. Reporting                                

  1\. Is there a list of places to which      Yes No Comments
  laboratory results are reported?            

  2\. Where appropriate, are analyte results  Yes No Comments
  reported with accompanying reference        
  intervals?                                  

  3\. Do the laboratory reports identify the  Yes No Comments
  laboratory performing the testing, and the  
  time & date the test was performed?         

  4\. How are test results reported to        
  clinicians?                                 

  5\. How are critical/panic or               
  life-threatening values reported to         
  clinicians?                                 

  6\. How is communication of test results    
  and panic values recorded?                  

  Comments:                                   
  ------------------------------------------- ---------------------------

  ------------------------------------------- ---------------------------
  E. Archiving Data                           

  1\. Does the laboratory archive result data Yes No Comments
  (instrument printouts, etc.)? If "Yes",     
  please explain in the Comments section how  
  archiving is accomplished, and how long     
  data is archived.                           

  2\. Are the archived records accessible     Yes No Comments N/A
  only to authorized personnel?               

  3\. Are archived records stored in a        Yes No Comments N/A
  secured location?                           

  Comments:                                   
  ------------------------------------------- ---------------------------

  ----------------------- ----------------------- -----------------------
  F. Record Review                                
  Performed Not                                   
  performed/ Not                                  
  applicable                                      

  Records Reviewed        From Visit:             To visit (inclusive):

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  

                                                  
  ----------------------- ----------------------- -----------------------

+----------------------------------------+-----------------------------+
| ### IX. Transportation of Samples      |                             |
+----------------------------------------+-----------------------------+
| A. Specimen Transport                  |                             |
+----------------------------------------+-----------------------------+
| 1\. Is there an SOP to address         | Yes No Comments             |
| transport of specimens from the        |                             |
| clinic(s) to the lab, between off-site |                             |
| clinics, and within the lab?           |                             |
+----------------------------------------+-----------------------------+
| 2\. Are the containers used for sample | Yes No Comments             |
| transport sturdy non-breakable         |                             |
| closable containers labeled            |                             |
| "biohazard"?                           |                             |
+----------------------------------------+-----------------------------+
| a\. Are the containers IATA-certified? | Yes No Comments             |
+----------------------------------------+-----------------------------+
| 3\. How does the lab confirm that      |                             |
| specimens were received at their       |                             |
| destination?                           |                             |
+----------------------------------------+-----------------------------+
| 4\. How does the lab address           |                             |
| monitoring of temperature conditions   |                             |
| during transportation of specimens?    |                             |
+----------------------------------------+-----------------------------+
| Comments:                              |                             |
+----------------------------------------+-----------------------------+

  ---------------------------------------- ------------------------------
  B. Does the SOP on receiving specimens   Yes No Comments
  explain sample identification and        
  assessing the quality of specimens?      

  C. Are wet specimens (blood, urine, body Yes No Comments
  fluids etc.) retained for potential      
  re-evaluation? If "Yes" explain in the   
  Comments section.                        

  1\. Is there an SOP explaining this?     Yes No Comments

  Comments:                                
  ---------------------------------------- ------------------------------

+----------------------------------------+-----------------------------+
| D. Shipping Certification/Training N/A |                             |
| (The lab does not ship samples.)       |                             |
+----------------------------------------+-----------------------------+
| 1\. Is there a training plan in place  | Yes No Comments             |
| for shipping certification?            |                             |
+----------------------------------------+-----------------------------+
| 2\. Is there documentation of persons  | Yes No Comments             |
| trained for shipping?                  |                             |
|                                        |                             |
| \*In the Comments section, please list |                             |
| all personnel with IATA- certification |                             |
| and the dates of certification.        |                             |
+----------------------------------------+-----------------------------+
| 3\. Are shipping certifications        | Yes No Comments             |
| renewed as required?                   |                             |
+----------------------------------------+-----------------------------+
| 4\. Is there a policy in place for     | Yes No Comments             |
| shipping samples internationally?      |                             |
+----------------------------------------+-----------------------------+
| Comments:                              |                             |
+----------------------------------------+-----------------------------+

+------------------------------------------+---------------------------+
| ### X. Personnel Safety                  |                           |
+------------------------------------------+---------------------------+
| A. Is there a written safety program?    | Yes No Comments           |
+------------------------------------------+---------------------------+
| B. Does the lab maintain a log of all    | Yes No Comments           |
| safety-related incidents?                |                           |
+------------------------------------------+---------------------------+
| 1\. Does the Lab Director or designee    | Yes No Comments           |
| review and sign this log?                |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

  ------------------------------------------- ---------------------------
  C. Material Safety Data Sheets (MSDS) or    
  equivalent                                  

  1\. Are MSDS or equivalent on file?         Yes No Comments

  2\. Are MSDS or equivalent readily          Yes No Comments
  available to all laboratory personnel?      

  3\. Is there documentation that laboratory  Yes No Comments
  personnel have reviewed the MSDS or         
  equivalent?                                 

  Comments:                                   
  ------------------------------------------- ---------------------------

+------------------------------------------+---------------------------+
| D. Is there documentation of             | Yes No Comments           |
| participation in safety training?        |                           |
|                                          |                           |
| > If yes, list the training provider.    |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

+------------------------------------------+---------------------------+
| E. Safety Precautions                    |                           |
+------------------------------------------+---------------------------+
| 1\. Is a written Standard/Universal      | Yes No Comments           |
| Precautions Policy available?            |                           |
+------------------------------------------+---------------------------+
| 2\. Are laboratory personnel vaccinated  | Yes No Comments           |
| for Hepatitis B?                         |                           |
+------------------------------------------+---------------------------+
| 3\. Is there safety equipment such as    | Yes No Comments           |
| eyewashes, safety showers, fire          |                           |
| extinguishers, fire blankets and sharps  |                           |
| containers present in the lab? Please    |                           |
| describe in the Comments section.        |                           |
+------------------------------------------+---------------------------+
| a\. Is the safety equipment maintained?  | Yes No Comments           |
+------------------------------------------+---------------------------+
| 4\. Is Personal Protective Equipment     | Yes No Comments           |
| (PPE) utilized by laboratory staff?      |                           |
|                                          |                           |
| If "No" explain in Comments section.     |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

  ------------------------------------------- ---------------------------
  F. Is there a written policy for the        Yes No Comments
  disposal of biohazardous materials and      
  "sharps"? (If "No", explain in Comments.)   
  Please describe how biohazardous waste is   
  disposed of in the Comments section.        

  1\. If the lab autoclaves its own waste, is Yes No Comments N/A
  a biological autoclave indicator used to    
  assure proper autoclave function and        
  complete sterilization of material with     
  each run, or at least weekly?               

  Comments:                                   
  ------------------------------------------- ---------------------------

+------------------------------------------+---------------------------+
| ### XI. External Qual                    |                           |
| ity Assurance (EQA)/ Proficiency testing |                           |
+------------------------------------------+---------------------------+
| A. Does the laboratory participate in    | Yes No Comments           |
| any external proficiency testing?        |                           |
|                                          |                           |
| > (If yes, list the each test involved,  |                           |
| > frequency, proficiency program         |                           |
| > provider and where the results are     |                           |
| > reported.)                             |                           |
+------------------------------------------+---------------------------+
| B. Describe the remedial action plans    |                           |
| for poor EQA performance.                |                           |
+------------------------------------------+---------------------------+
| C. Describe the back-up testing plans    |                           |
| available in case of persistent poor EQA |                           |
| performance.                             |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

+------------------------------------------+---------------------------+
| ### X                                    |                           |
| II. Laboratory Information Systems (LIS) |                           |
+------------------------------------------+---------------------------+
| A. Is a LIS utilized in this laboratory  | Yes No Comments           |
| (if "No" the rest of section IX is N/A)? |                           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

  ------------------------------------------ ----------------------------
  B. LIS                                     

  1\. Is documented validation data present? Yes No Comments

  2\. Can accurate and complete copies be    Yes No Comments
  generated by the LIS?                      

  3\. Are computer time-stamped audit trails Yes No Comments
  used by the LIS?                           

  4\. Is system access limited to authorized Yes No Comments
  individuals?                               

  5\. Is system access updated to account    Yes No Comments
  for staffing changes?                      

  6\. Is there a written SOP for the         Yes No Comments
  operation of the LIS present?              

  Comments:                                  
  ------------------------------------------ ----------------------------

### 

+------------------------------------------+---------------------------+
| ### XIII. L                              |                           |
| aboratory DATA Management Systems (LdmS) |                           |
+------------------------------------------+---------------------------+
| A.  Does this laboratory facility use a  | Yes No Comments           |
|     LDMS?                                |                           |
|                                          |                           |
| If "No" disregard the rest of section IX |                           |
| and explain how specimen                 |                           |
| storage/shipping data is maintained in   |                           |
| the Comments section.                    |                           |
+------------------------------------------+---------------------------+
| B. LDMS reports obtained by the monitor: |                           |
+------------------------------------------+---------------------------+
| 1\. Primary Specimens Received Report    | Yes No Comments           |
+------------------------------------------+---------------------------+
| 2\. Storage Detail Report                | Yes No Comments           |
+------------------------------------------+---------------------------+
| 3\. Shipping Report                      | Yes No Comments           |
+------------------------------------------+---------------------------+
| Comments:                                |                           |
+------------------------------------------+---------------------------+

  ------------------------------------------ ----------------------------
  C. Specimen Verification                   

  1\. Can the PID, date, protocol,           Yes No Comments
  derivative and additive for specimens be   
  verified with the LDMS?                    

  2\. Is the laboratory staff able to        Yes No Comments
  demonstrate specimen storage locations in  
  LDMS?                                      

  3\. Does the LDMS report accurately        Yes No Comments
  reflect the number, type, and volume of    
  all specimen aliquots as well as their     
  storage location and shipping record?      

  4\. Can the physical presence of specimens Yes No Comments
  be verified with the LDMS Storage Detail   
  Report?                                    

  Comments:                                  
  ------------------------------------------ ----------------------------

  ------------------------------------------ ----------------------------
  D. LDMS manual available in laboratory?    Yes No Comments

  Comments:                                  
  ------------------------------------------ ----------------------------

  ------------------------------------------ ----------------------------
  E. LDMS Back Up                            

  1\. Is the LDMS backed up weekly?          Yes No Comments

  2\. Is the LDMS backup disk stored in      Yes No Comments
  different location than LDMS computer?     

  3\. Are storage media properly labeled,    Yes No Comments
  stored, and protected from damage or       
  unauthorized use?                          

  Comments:                                  
  ------------------------------------------ ----------------------------

**SIGNATURE PAGE**

Prepared by: Date:

Reviewed by: Date:

(Signature DAIDS Representative)