DIVISION OF AIDS (DAIDS) FUNDED STUDY/TRIAL

###### Laboratory self-description Module

**Version 08/01/2005**

###### 

Study/Trial Name:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Grant Number: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Grantee Principal Investigator:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Instructions:** Please answer the questions below as completely as
possible. If an answer is unknown at this time, enter *TBD* for "to be
determined." Answers may be submitted electronically or on paper. If you
need additional space, please use additional pages, noting the
appropriate question number. **Please make additional copies of this
Module as needed, and complete and submit one for each separate
laboratory that will be participating in the research under this
grant**.

Please indicate the total number of laboratories participating in the
research under this grant: \_\_\_\_\_\_\_\_\_

(NOTE: This question to be answered by the Grantee Principal
Investigator.)

+-----------+-----+--------------------------+---------+---+-----+------+
| #####     |     |                          |         |   |     |      |
| #### I. G |     |                          |         |   |     |      |
| ENERAL IN |     |                          |         |   |     |      |
| FORMATION |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 1\.       |     |                          |         |   |     |      |
| Lab       |     |                          |         |   |     |      |
| oratory's |     |                          |         |   |     |      |
| name and  |     |                          |         |   |     |      |
| complete  |     |                          |         |   |     |      |
| address   |     |                          |         |   |     |      |
| (street,  |     |                          |         |   |     |      |
| city,     |     |                          |         |   |     |      |
| state/    |     |                          |         |   |     |      |
| province, |     |                          |         |   |     |      |
| country): |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 2\.       |     |                          |         |   |     |      |
| Shipping  |     |                          |         |   |     |      |
| address   |     |                          |         |   |     |      |
| (if       |     |                          |         |   |     |      |
| different |     |                          |         |   |     |      |
| than      |     |                          |         |   |     |      |
| above)    |     |                          |         |   |     |      |
| and       |     |                          |         |   |     |      |
| telephone |     |                          |         |   |     |      |
| number,   |     |                          |         |   |     |      |
| including |     |                          |         |   |     |      |
| country   |     |                          |         |   |     |      |
| and/or    |     |                          |         |   |     |      |
| area      |     |                          |         |   |     |      |
| code:     |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 3\. Type  |     |                          |         |   |     |      |
| of        |     |                          |         |   |     |      |
| la        |     |                          |         |   |     |      |
| boratory. |     |                          |         |   |     |      |
| Check all |     |                          |         |   |     |      |
| the       |     |                          |         |   |     |      |
| c         |     |                          |         |   |     |      |
| ategories |     |                          |         |   |     |      |
| of tests  |     |                          |         |   |     |      |
| your      |     |                          |         |   |     |      |
| l         |     |                          |         |   |     |      |
| aboratory |     |                          |         |   |     |      |
| performs. |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
| Chemistry |     |                          |         |   |     |      |
| H         |     |                          |         |   |     |      |
| ematology |     |                          |         |   |     |      |
| Serology  |     |                          |         |   |     |      |
|           |     |                          |         |   |     |      |
| Mic       |     |                          |         |   |     |      |
| robiology |     |                          |         |   |     |      |
| Histology |     |                          |         |   |     |      |
| Flow      |     |                          |         |   |     |      |
| cytometry |     |                          |         |   |     |      |
| (CD4)/I   |     |                          |         |   |     |      |
| mmunology |     |                          |         |   |     |      |
|           |     |                          |         |   |     |      |
| Virology  |     |                          |         |   |     |      |
| Pha       |     |                          |         |   |     |      |
| rmacology |     |                          |         |   |     |      |
| T         |     |                          |         |   |     |      |
| oxicology |     |                          |         |   |     |      |
|           |     |                          |         |   |     |      |
| Other     |     |                          |         |   |     |      |
| (e.g.,    |     |                          |         |   |     |      |
| para      |     |                          |         |   |     |      |
| sitology, |     |                          |         |   |     |      |
| genetics) |     |                          |         |   |     |      |
| \_\_      |     |                          |         |   |     |      |
| \_\_\_\_\ |     |                          |         |   |     |      |
| _\_\_\_\_ |     |                          |         |   |     |      |
| \_\_\_\_\ |     |                          |         |   |     |      |
| _\_\_\_\_ |     |                          |         |   |     |      |
| \_\_\_\_\ |     |                          |         |   |     |      |
| _\_\_\_\_ |     |                          |         |   |     |      |
| \_\_\_\_\ |     |                          |         |   |     |      |
| _\_\_\_\_ |     |                          |         |   |     |      |
| \_\_\_\_\ |     |                          |         |   |     |      |
| _\_\_\_\_ |     |                          |         |   |     |      |
| \_\_\_\_\ |     |                          |         |   |     |      |
| _\_\_\_\_ |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         | * |     | **   |
|           |     |                          |         | * |     | NO** |
|           |     |                          |         | Y |     |      |
|           |     |                          |         | E |     |      |
|           |     |                          |         | S |     |      |
|           |     |                          |         | * |     |      |
|           |     |                          |         | * |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 4\. Is    |     |                          |         |   |     |      |
| the       |     |                          |         |   |     |      |
| l         |     |                          |         |   |     |      |
| aboratory |     |                          |         |   |     |      |
| ce        |     |                          |         |   |     |      |
| rtified/a |     |                          |         |   |     |      |
| ccredited |     |                          |         |   |     |      |
| by a      |     |                          |         |   |     |      |
| local,    |     |                          |         |   |     |      |
| regional, |     |                          |         |   |     |      |
| and/or    |     |                          |         |   |     |      |
| national  |     |                          |         |   |     |      |
| orga      |     |                          |         |   |     |      |
| nization? |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| > a\. If  |     |                          |         |   |     |      |
| > yes,    |     |                          |         |   |     |      |
| > please  |     |                          |         |   |     |      |
| > provide |     |                          |         |   |     |      |
| > the     |     |                          |         |   |     |      |
| > name of |     |                          |         |   |     |      |
| > the     |     |                          |         |   |     |      |
| > orga    |     |                          |         |   |     |      |
| nization, |     |                          |         |   |     |      |
| > the     |     |                          |         |   |     |      |
| > date of |     |                          |         |   |     |      |
| > last    |     |                          |         |   |     |      |
| > c       |     |                          |         |   |     |      |
| ertificat |     |                          |         |   |     |      |
| ion/accre |     |                          |         |   |     |      |
| ditation, |     |                          |         |   |     |      |
| > and a   |     |                          |         |   |     |      |
| > brief   |     |                          |         |   |     |      |
| > de      |     |                          |         |   |     |      |
| scription |     |                          |         |   |     |      |
| > of the  |     |                          |         |   |     |      |
| > cert    |     |                          |         |   |     |      |
| ification |     |                          |         |   |     |      |
| >         |     |                          |         |   |     |      |
|  program. |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 5\. Which |     |                          |         |   |     |      |
| US-funded |     |                          |         |   |     |      |
| studies   |     |                          |         |   |     |      |
| does the  |     |                          |         |   |     |      |
| l         |     |                          |         |   |     |      |
| aboratory |     |                          |         |   |     |      |
| support   |     |                          |         |   |     |      |
| (i.e.,    |     |                          |         |   |     |      |
| NIH CIPRA |     |                          |         |   |     |      |
| grant,    |     |                          |         |   |     |      |
| HPTN,     |     |                          |         |   |     |      |
| HVTN,     |     |                          |         |   |     |      |
| CDC,      |     |                          |         |   |     |      |
| etc.)?    |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| ########  |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| ######    |     |                          |         |   |     |      |
| ## II. LA |     |                          |         |   |     |      |
| BORATORY  |     |                          |         |   |     |      |
| PERSONNEL |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 1\. Name  |     |                          |         |   |     |      |
| of        |     |                          |         |   |     |      |
| L         |     |                          |         |   |     |      |
| aboratory |     |                          |         |   |     |      |
| Director: |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 2\. Phone |     |                          |         |   |     |      |
| Number:   |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 3\. Fax   |     |                          |         |   |     |      |
| Number:   |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 4\. Email |     |                          |         |   |     |      |
| Address:  |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 5\. Other |     |                          |         |   |     |      |
| key       |     |                          |         |   |     |      |
| l         |     |                          |         |   |     |      |
| aboratory |     |                          |         |   |     |      |
| staff,    |     |                          |         |   |     |      |
| including |     |                          |         |   |     |      |
| names,    |     |                          |         |   |     |      |
| titles,   |     |                          |         |   |     |      |
| roles,    |     |                          |         |   |     |      |
| and       |     |                          |         |   |     |      |
| training. |     |                          |         |   |     |      |
| Please    |     |                          |         |   |     |      |
| describe  |     |                          |         |   |     |      |
| the       |     |                          |         |   |     |      |
| technical |     |                          |         |   |     |      |
| hierarchy |     |                          |         |   |     |      |
| (or       |     |                          |         |   |     |      |
| or        |     |                          |         |   |     |      |
| ganogram) |     |                          |         |   |     |      |
| of the    |     |                          |         |   |     |      |
| l         |     |                          |         |   |     |      |
| aboratory |     |                          |         |   |     |      |
| staff.    |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| ######    |     |                          |         |   |     |      |
| ## III. F |     |                          |         |   |     |      |
| ACILITIES |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 1\. How   |     |                          |         |   |     |      |
| far is    |     |                          |         |   |     |      |
| the       |     |                          |         |   |     |      |
| l         |     |                          |         |   |     |      |
| aboratory |     |                          |         |   |     |      |
| from the  |     |                          |         |   |     |      |
| clinic?   |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 2\.       |     |                          |         |   |     |      |
| Describe  |     |                          |         |   |     |      |
| the       |     |                          |         |   |     |      |
| general   |     |                          |         |   |     |      |
| layout of |     |                          |         |   |     |      |
| the       |     |                          |         |   |     |      |
| l         |     |                          |         |   |     |      |
| aboratory |     |                          |         |   |     |      |
| (floor    |     |                          |         |   |     |      |
| plan,     |     |                          |         |   |     |      |
| square    |     |                          |         |   |     |      |
| footage), |     |                          |         |   |     |      |
| including |     |                          |         |   |     |      |
| water,    |     |                          |         |   |     |      |
| el        |     |                          |         |   |     |      |
| ectricity |     |                          |         |   |     |      |
| and gas   |     |                          |         |   |     |      |
| outlets,  |     |                          |         |   |     |      |
| bench     |     |                          |         |   |     |      |
| space,    |     |                          |         |   |     |      |
| and       |     |                          |         |   |     |      |
| storage   |     |                          |         |   |     |      |
| capacity  |     |                          |         |   |     |      |
| (for      |     |                          |         |   |     |      |
| g         |     |                          |         |   |     |      |
| lassware, |     |                          |         |   |     |      |
| reagents, |     |                          |         |   |     |      |
| and       |     |                          |         |   |     |      |
| do        |     |                          |         |   |     |      |
| cuments). |     |                          |         |   |     |      |
| Please    |     |                          |         |   |     |      |
| attach a  |     |                          |         |   |     |      |
| floor     |     |                          |         |   |     |      |
| plan      |     |                          |         |   |     |      |
| diagram   |     |                          |         |   |     |      |
| if        |     |                          |         |   |     |      |
| a         |     |                          |         |   |     |      |
| vailable. |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 3\.       |     |                          |         |   |     |      |
| Describe  |     |                          |         |   |     |      |
| the plans |     |                          |         |   |     |      |
| for       |     |                          |         |   |     |      |
| p         |     |                          |         |   |     |      |
| reventing |     |                          |         |   |     |      |
| una       |     |                          |         |   |     |      |
| uthorized |     |                          |         |   |     |      |
| entry     |     |                          |         |   |     |      |
| into the  |     |                          |         |   |     |      |
| l         |     |                          |         |   |     |      |
| aboratory |     |                          |         |   |     |      |
| area.     |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 4\.       |     |                          |         |   |     |      |
| Describe  |     |                          |         |   |     |      |
| the       |     |                          |         |   |     |      |
| methods   |     |                          |         |   |     |      |
| to ensure |     |                          |         |   |     |      |
| the       |     |                          |         |   |     |      |
| cl        |     |                          |         |   |     |      |
| eanliness |     |                          |         |   |     |      |
| of the    |     |                          |         |   |     |      |
| la        |     |                          |         |   |     |      |
| boratory. |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 5\.       |     |                          |         |   |     |      |
| Describe  |     |                          |         |   |     |      |
| the       |     |                          |         |   |     |      |
| ava       |     |                          |         |   |     |      |
| ilability |     |                          |         |   |     |      |
| of clean, |     |                          |         |   |     |      |
| d         |     |                          |         |   |     |      |
| istilled, |     |                          |         |   |     |      |
| or        |     |                          |         |   |     |      |
| sterile   |     |                          |         |   |     |      |
| water.    |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 6\.       |     |                          |         |   |     |      |
| Describe  |     |                          |         |   |     |      |
| the       |     |                          |         |   |     |      |
| ava       |     |                          |         |   |     |      |
| ilability |     |                          |         |   |     |      |
| and       |     |                          |         |   |     |      |
| re        |     |                          |         |   |     |      |
| liability |     |                          |         |   |     |      |
| of        |     |                          |         |   |     |      |
| electric  |     |                          |         |   |     |      |
| power,    |     |                          |         |   |     |      |
| and the   |     |                          |         |   |     |      |
| backup    |     |                          |         |   |     |      |
| p         |     |                          |         |   |     |      |
| rocedures |     |                          |         |   |     |      |
| in case   |     |                          |         |   |     |      |
| of power  |     |                          |         |   |     |      |
| failure.  |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 7\. What  |     |                          |         |   |     |      |
| is the    |     |                          |         |   |     |      |
| range of  |     |                          |         |   |     |      |
| room      |     |                          |         |   |     |      |
| tem       |     |                          |         |   |     |      |
| peratures |     |                          |         |   |     |      |
| during    |     |                          |         |   |     |      |
| various   |     |                          |         |   |     |      |
| times of  |     |                          |         |   |     |      |
| the day?  |     |                          |         |   |     |      |
| How is    |     |                          |         |   |     |      |
| the       |     |                          |         |   |     |      |
| te        |     |                          |         |   |     |      |
| mperature |     |                          |         |   |     |      |
| co        |     |                          |         |   |     |      |
| ntrolled? |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 8\.       |     |                          |         |   |     |      |
| Describe  |     |                          |         |   |     |      |
| your      |     |                          |         |   |     |      |
| computer  |     |                          |         |   |     |      |
| cap       |     |                          |         |   |     |      |
| abilities |     |                          |         |   |     |      |
| (hardware |     |                          |         |   |     |      |
| and       |     |                          |         |   |     |      |
| s         |     |                          |         |   |     |      |
| oftware). |     |                          |         |   |     |      |
| Include a |     |                          |         |   |     |      |
| de        |     |                          |         |   |     |      |
| scription |     |                          |         |   |     |      |
| of the    |     |                          |         |   |     |      |
| l         |     |                          |         |   |     |      |
| aboratory |     |                          |         |   |     |      |
| data      |     |                          |         |   |     |      |
| m         |     |                          |         |   |     |      |
| anagement |     |                          |         |   |     |      |
| system,   |     |                          |         |   |     |      |
| access to |     |                          |         |   |     |      |
| the       |     |                          |         |   |     |      |
| Internet, |     |                          |         |   |     |      |
| and email |     |                          |         |   |     |      |
| ca        |     |                          |         |   |     |      |
| pability. |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
|           |     |                          |         | * |     | **   |
|           |     |                          |         | * |     | NO** |
|           |     |                          |         | Y |     |      |
|           |     |                          |         | E |     |      |
|           |     |                          |         | S |     |      |
|           |     |                          |         | * |     |      |
|           |     |                          |         | * |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 9\. Is    |     |                          |         |   |     |      |
| there a   |     |                          |         |   |     |      |
| procedure |     |                          |         |   |     |      |
| manual    |     |                          |         |   |     |      |
| for       |     |                          |         |   |     |      |
| testing   |     |                          |         |   |     |      |
| and       |     |                          |         |   |     |      |
| sample    |     |                          |         |   |     |      |
| handling  |     |                          |         |   |     |      |
| pr        |     |                          |         |   |     |      |
| ocedures? |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 10\. Are  |     |                          |         |   |     |      |
| personnel |     |                          |         |   |     |      |
| education |     |                          |         |   |     |      |
| and       |     |                          |         |   |     |      |
| training  |     |                          |         |   |     |      |
| records   |     |                          |         |   |     |      |
| readily   |     |                          |         |   |     |      |
| available |     |                          |         |   |     |      |
| for       |     |                          |         |   |     |      |
| review?   |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 11\. Does |     |                          |         |   |     |      |
| the       |     |                          |         |   |     |      |
| l         |     |                          |         |   |     |      |
| aboratory |     |                          |         |   |     |      |
| have a    |     |                          |         |   |     |      |
| policy    |     |                          |         |   |     |      |
| manual    |     |                          |         |   |     |      |
| d         |     |                          |         |   |     |      |
| escribing |     |                          |         |   |     |      |
| the       |     |                          |         |   |     |      |
| op        |     |                          |         |   |     |      |
| erational |     |                          |         |   |     |      |
| p         |     |                          |         |   |     |      |
| rocedures |     |                          |         |   |     |      |
| and       |     |                          |         |   |     |      |
| organ     |     |                          |         |   |     |      |
| izational |     |                          |         |   |     |      |
| st        |     |                          |         |   |     |      |
| ructures? |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| 12\.      |     |                          |         |   |     |      |
| Describe  |     |                          |         |   |     |      |
| the basic |     |                          |         |   |     |      |
| l         |     |                          |         |   |     |      |
| aboratory |     |                          |         |   |     |      |
| equipment |     |                          |         |   |     |      |
| found in  |     |                          |         |   |     |      |
| your      |     |                          |         |   |     |      |
| l         |     |                          |         |   |     |      |
| aboratory |     |                          |         |   |     |      |
| by        |     |                          |         |   |     |      |
| c         |     |                          |         |   |     |      |
| ompleting |     |                          |         |   |     |      |
| the       |     |                          |         |   |     |      |
| in        |     |                          |         |   |     |      |
| formation |     |                          |         |   |     |      |
| below:    |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| ####      | **  | ###### Desc              | **      |   | *   |      |
| ## Basic  | How | ription of the equipment | Service |   | *De |      |
| Equipment | M   |                          | C       |   | scr |      |
|           | any |                          | ontract |   | ibe |      |
|           | ?** |                          | for     |   | bac |      |
|           |     |                          | equi    |   | kup |      |
|           |     |                          | pment?\ |   | pl  |      |
|           |     |                          | (Circle |   | ans |      |
|           |     |                          | yes or  |   | in  |      |
|           |     |                          | no)**   |   | c   |      |
|           |     |                          |         |   | ase |      |
|           |     |                          |         |   | of  |      |
|           |     |                          |         |   | equ |      |
|           |     |                          |         |   | ipm |      |
|           |     |                          |         |   | ent |      |
|           |     |                          |         |   | f   |      |
|           |     |                          |         |   | ail |      |
|           |     |                          |         |   | ure |      |
|           |     |                          |         |   | and |      |
|           |     |                          |         |   | po  |      |
|           |     |                          |         |   | wer |      |
|           |     |                          |         |   | fai |      |
|           |     |                          |         |   | lur |      |
|           |     |                          |         |   | e** |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| a\.       |     | For **each one** provide | YES /   |   |     |      |
| In        |     | the brand, the model and | NO      |   |     |      |
| cubators: |     | the temperature range    |         |   |     |      |
|           |     |                          | YES /   |   |     |      |
| -   Dry   |     |                          | NO      |   |     |      |
|           |     |                          |         |   |     |      |
| -   CO2   |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| b\.       |     | For **each one** provide | YES /   |   |     |      |
| Refr      |     | the storage capacity and | NO      |   |     |      |
| igerators |     | the temperature range    |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| c\.       |     | For **each one** provide | YES /   |   |     |      |
| Freezers: |     | the brand, the model and | NO      |   |     |      |
|           |     | the storage capacity     |         |   |     |      |
| -   -20°C |     |                          | YES /   |   |     |      |
|           |     |                          | NO      |   |     |      |
| -   -70°C |     |                          |         |   |     |      |
|           |     |                          | YES /   |   |     |      |
| -         |     |                          | NO      |   |     |      |
|    Liquid |     |                          |         |   |     |      |
|           |     |                          |         |   |     |      |
|  nitrogen |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| d\. Water |     | For **each one** provide | YES /   |   |     |      |
| baths:    |     | the brand, the model ,   | NO      |   |     |      |
|           |     | the temperature ranges   |         |   |     |      |
| -         |     | and the capacity         | YES /   |   |     |      |
|   Covered |     |                          | NO      |   |     |      |
|           |     |                          |         |   |     |      |
| -         |     |                          |         |   |     |      |
|    Shaker |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| e\.       |     | For **each one** provide | YES /   |   |     |      |
| Mic       |     | the brand and the model  | NO      |   |     |      |
| roscopes: |     |                          |         |   |     |      |
|           |     |                          | YES /   |   |     |      |
| -         |     |                          | NO      |   |     |      |
|  Compound |     |                          |         |   |     |      |
|           |     |                          | YES /   |   |     |      |
| -   Dark  |     |                          | NO      |   |     |      |
|     field |     |                          |         |   |     |      |
|           |     |                          | YES /   |   |     |      |
| -   Fl    |     |                          | NO      |   |     |      |
| uorescent |     |                          |         |   |     |      |
|           |     |                          |         |   |     |      |
| -         |     |                          |         |   |     |      |
|  Electron |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| f\.       |     | For **each one** provide | YES /   |   |     |      |
| Cen       |     | the brand, the model and | NO      |   |     |      |
| trifuges: |     | the temperature ranges   |         |   |     |      |
|           |     |                          | YES /   |   |     |      |
| -   Room  |     |                          | NO      |   |     |      |
|     temp. |     |                          |         |   |     |      |
|           |     |                          | YES /   |   |     |      |
| -   Ref   |     |                          | NO      |   |     |      |
| rigerated |     |                          |         |   |     |      |
|           |     |                          | YES /   |   |     |      |
| `         |     |                          | NO      |   |     |      |
| ``{=html} |     |                          |         |   |     |      |
| <!-- -->  |     |                          |         |   |     |      |
| ```       |     |                          |         |   |     |      |
| -   Ul    |     |                          |         |   |     |      |
| tra-speed |     |                          |         |   |     |      |
|           |     |                          |         |   |     |      |
| -         |     |                          |         |   |     |      |
| Microtube |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| g\.       |     | For **each one** provide | YES /   |   |     |      |
| Pipetting |     | the brand, the model and | NO      |   |     |      |
| devices:  |     | the range of liquid      |         |   |     |      |
|           |     | volumes                  | YES /   |   |     |      |
| -         |     |                          | NO      |   |     |      |
|    Single |     |                          |         |   |     |      |
|           |     |                          | YES /   |   |     |      |
|   channel |     |                          | NO      |   |     |      |
|           |     |                          |         |   |     |      |
| -   Mult  |     |                          |         |   |     |      |
| i-channel |     |                          |         |   |     |      |
|           |     |                          |         |   |     |      |
| -         |     |                          |         |   |     |      |
|  Repeater |     |                          |         |   |     |      |
|           |     |                          |         |   |     |      |
|   pipette |     |                          |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+
| h\.       |     | For **each one** provide | YES /   |   |     |      |
| Laminar   |     | the size, the level of   | NO      |   |     |      |
| flow      |     | safety (e.g. BL2) and    |         |   |     |      |
| hoods     |     | note if includes UV      |         |   |     |      |
+-----------+-----+--------------------------+---------+---+-----+------+

<table>
<colgroup>
<col style="width: 17%" />
<col style="width: 8%" />
<col style="width: 36%" />
<col style="width: 3%" />
<col style="width: 10%" />
<col style="width: 1%" />
<col style="width: 1%" />
<col style="width: 6%" />
<col style="width: 3%" />
<col style="width: 10%" />
</colgroup>
<tbody>
<tr class="odd">
<td>i. Mixers, shakers and rockers</td>
<td></td>
<td>For <strong>each one</strong> provide the capacity (tubes and/or
plates), and note if speed adjustment exists</td>
<td colspan="3">YES / NO</td>
<td colspan="4"></td>
</tr>
<tr class="even">
<td>j. Hematology instrument – brand, model</td>
<td></td>
<td>For each one note the brand, the model and how the Part
Differential</td>
<td colspan="3">YES / NO</td>
<td colspan="4"></td>
</tr>
<tr class="odd">
<td>k. Chemistry Analyzers –</td>
<td></td>
<td>For <strong>each one</strong> provide the brand, the model and the
capacity (number of tests)</td>
<td colspan="3">YES / NO</td>
<td colspan="4"></td>
</tr>
<tr class="even">
<td><blockquote>
<p>l. Flow Cytometer – brand, model</p>
</blockquote></td>
<td></td>
<td>For each one provide the brand and the model</td>
<td colspan="3">YES / NO</td>
<td colspan="4"></td>
</tr>
<tr class="odd">
<td>m. Other:</td>
<td></td>
<td></td>
<td colspan="3">YES / NO</td>
<td colspan="4"></td>
</tr>
<tr class="even">
<td>n. Other:</td>
<td></td>
<td></td>
<td colspan="3">YES / NO</td>
<td colspan="4"></td>
</tr>
<tr class="odd">
<td colspan="10">13. Describe the process and resources for establishing
regular equipment maintenance schedules.</td>
</tr>
<tr class="even">
<td colspan="10"></td>
</tr>
<tr class="odd">
<td colspan="10">14. Which Standard Operating Procedures (SOPs) are
there related to equipment maintenance and calibration, backup plans in
case of equipment failure, and other equipment-related issues?</td>
</tr>
<tr class="even">
<td colspan="10"></td>
</tr>
<tr class="odd">
<td colspan="10"><p id="iv.-safety" class="heading">IV. SAFETY</p></td>
</tr>
<tr class="even">
<td colspan="10">1. Describe your procedures to protect staff from blood
borne pathogens and other hazardous materials (e.g. staff vaccination,
personal protective equipment, shower facilities, routine disinfection
of the work area, labeling of biohazardous waste, disposal of sharps in
an appropriate sharps container, etc.).</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10">2. Describe the laboratory’s plan for addressing an
accidental exposure to blood borne pathogens.</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="7"></td>
<td colspan="2"><strong>YES</strong></td>
<td><strong>NO</strong></td>
</tr>
<tr class="odd">
<td colspan="7"><blockquote>
<p>a. Does a National policy exist?</p>
</blockquote></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="10">3. How are biohazardous materials stored prior to
shipment or disposal?</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10">4. Describe how the laboratory disposes of hazardous
materials.</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10">5. Describe the laboratory procedures in case of
fire.</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10">6. Describe the training that the staff receives
related to laboratory safety.</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10">7. Which of the following safety equipment do you have
available:</td>
</tr>
<tr class="odd">
<td colspan="10"><p> spill kit sharps container</p>
<p> eye-wash kit radioactive waste container</p>
<p> fire extinguisher radioactive shields</p>
<p> biohazard waste container safety shower<br />
other __________________________</p></td>
</tr>
<tr class="even">
<td colspan="7">8. Do you have a safety manual?</td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="10">9. Which SOPs do you have related to safety?</td>
</tr>
<tr class="even">
<td colspan="10"></td>
</tr>
<tr class="odd">
<td colspan="10"><p id="v.-samples" class="heading">V. SAMPLES</p></td>
</tr>
<tr class="even">
<td colspan="10">1. Which of the following specimens does your
laboratory or clinic collect and/or handle? (Check all that apply.)</td>
</tr>
<tr class="odd">
<td colspan="10"><p> Blood Respiratory secretions</p>
<p> Urine Sputum</p>
<p> Stool Tissue</p>
<p> Genital secretions Other ________________________________</p></td>
</tr>
<tr class="even">
<td colspan="7"></td>
<td colspan="2">YES</td>
<td><strong>NO</strong></td>
</tr>
<tr class="odd">
<td colspan="7">2. Has your laboratory ever isolated peripheral blood
mononuclear cells (PBMC) from whole blood before?</td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="10"><blockquote>
<p>a. If yes, how do you count PBMC?</p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="10"> Manual Automated</td>
</tr>
<tr class="even">
<td colspan="7">3. Has your laboratory ever frozen <u>viable</u> PBMC
(-80°C, LN2)?</td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="10"><blockquote>
<p>a. If yes, what method do you use to control the rate of freezing
PBMC?</p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="10"></td>
</tr>
<tr class="odd">
<td colspan="10">4. What mode of transportation is used to get specimens
from the study/trial site to the laboratory?</td>
</tr>
<tr class="even">
<td colspan="10"></td>
</tr>
<tr class="odd">
<td colspan="10">5. How long does it take for specimens to reach the
laboratory from the time of specimen collection?</td>
</tr>
<tr class="even">
<td colspan="10"></td>
</tr>
<tr class="odd">
<td colspan="7">6. Is dry ice available?</td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="7">7. Is liquid nitrogen available?</td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="10">8. Which courier would you use for international
shipments of infectious/non-infectious specimens to and from your
laboratory?</td>
</tr>
<tr class="even">
<td colspan="10"></td>
</tr>
<tr class="odd">
<td colspan="4"></td>
<td><strong>YES</strong></td>
<td colspan="3"><strong>NO</strong></td>
<td colspan="2"><strong>NOT REQUIRED</strong></td>
</tr>
<tr class="even">
<td colspan="4">9. Do you have export permits for shipping
infectious/non-infectious samples outside the country?</td>
<td></td>
<td colspan="3"></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="10"><blockquote>
<p>a. If yes, from which organization?</p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="10"></td>
</tr>
<tr class="odd">
<td colspan="7"></td>
<td colspan="2"><strong>YES</strong></td>
<td><strong>NO</strong></td>
</tr>
<tr class="even">
<td colspan="7">10. Are permits required for importing specimens into
your country?</td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="10"><blockquote>
<p>a. If yes, from which organization?</p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="10"></td>
</tr>
<tr class="odd">
<td colspan="10">11. Describe the shipping containers you use to
transport samples, and whether or not the containers are International
Air Transport Association (IATA) certified.</td>
</tr>
<tr class="even">
<td colspan="10"></td>
</tr>
<tr class="odd">
<td colspan="7"></td>
<td colspan="2">YES</td>
<td><strong>NO</strong></td>
</tr>
<tr class="even">
<td colspan="7">12. Are any staff members certified to ship dangerous
goods (e.g., IATA certification)?</td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="10">13. Describe the training received by staff for
shipping dangerous goods.</td>
</tr>
<tr class="even">
<td colspan="10"></td>
</tr>
<tr class="odd">
<td colspan="10">14. Describe how samples are tracked from collection
through transport to the laboratory, processing, testing, storage, and
shipping from the laboratory (including how specimens are
logged/recorded at each step).</td>
</tr>
<tr class="even">
<td colspan="10"></td>
</tr>
<tr class="odd">
<td colspan="10">15. Which SOPs do you have related to items V.1 – V.14
above?</td>
</tr>
<tr class="even">
<td colspan="10"></td>
</tr>
<tr class="odd">
<td colspan="10"><p id="vi.-laboratory-data-management"
class="heading">VI. LABORATORY DATA MANAGEMENT</p></td>
</tr>
<tr class="even">
<td colspan="10">1. How and where are test results recorded?</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10">2. Describe the procedure for reporting “out of range”
and life-threatening/panic values.</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10">3. How do you ensure that there are no errors in the
recording and reporting of test results?</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10">4. Describe how test reports are maintained (include a
description of how reports are stored to ensure ready identification and
timely accessibility, and for how long the reports are maintained).</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10">5. Describe the training which staff receive related to
laboratory data management.</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10">6. Describe your procedure for changing data on a
laboratory report and for tracking the changes.</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10">7. Which SOPs do you have related to recording and
reporting results and to laboratory data management?</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10">8. If data is stored electronically, describe backup
and electronic storage methods.</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10"><p id="vii.-tests" class="heading">VII. TESTS</p></td>
</tr>
<tr class="odd">
<td colspan="10"><p id="a.-quality-controlquality-assurance"
class="heading">A. Quality Control/Quality Assurance</p></td>
</tr>
<tr class="even">
<td colspan="7"></td>
<td colspan="2"><strong>YES</strong></td>
<td><strong>NO</strong></td>
</tr>
<tr class="odd">
<td colspan="7">1. Does the laboratory participate in an external
proficiency testing program (or external quality assessment
program)?</td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="10"><blockquote>
<p>a. If yes, describe the programs, testing agencies, which tests or
analytical results are evaluated, frequency of testing, and remedial
action plan when failing a proficiency testing round.</p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="7"></td>
<td colspan="2">YES</td>
<td><strong>NO</strong></td>
</tr>
<tr class="odd">
<td colspan="7">2. Are there written guidelines for ensuring the quality
of laboratory tests (including criteria for rejecting test
results)?</td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="10">3. Who is responsible for implementing a quality
assurance plan in the laboratory and for follow-up actions?</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10">4. For which tests do you have normal range values?
(Laboratory printouts may be attached to this Module that provide this
information - check if laboratory printouts are attached.)</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10">5. What sources do you use as reagent suppliers?
Describe the decision making and criteria for choosing suppliers.</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10">6. Explain the system used to maintain the inventory of
supplies (i.e., reagents, stock, equipment, etc.).</td>
</tr>
<tr class="odd">
<td colspan="10"></td>
</tr>
<tr class="even">
<td colspan="10"><p id="b.-types-of-tests" class="heading">B. Types of
Tests</p></td>
</tr>
<tr class="odd">
<td colspan="10"><strong>1. Diagnosis, study eligibility, and study
endpoints</strong></td>
</tr>
<tr class="even">
<td colspan="10">Please check all tests that your laboratory is able to
perform:</td>
</tr>
<tr class="odd">
<td colspan="10"><p> HIV rapid test (Specify: _______________) Hepatitis
C</p>
<p> HIV ELISA Toxoplasmosis</p>
<p> HIV Western Blot CD4 + cell enumeration</p>
<p> HIV Indirect fluorescence antibody Method (e.g., flow
cytometry;<br />
test (IFA) Dynabeads)______________________</p>
<p> TB HIV viral load quantitation</p>
<p> Malaria Method (e.g., RNA PCR,</p>
<p> Pregnancy test heat-denatured p24)________________</p>
<p> Syphilis (Specify: __________________) Other
______________________________</p>
<p> Hepatitis B</p></td>
</tr>
<tr class="even">
<td colspan="10"><strong>2. Subject safety monitoring</strong></td>
</tr>
<tr class="odd">
<td colspan="10">Please check all the tests that your laboratory is able
to perform:</td>
</tr>
<tr class="even">
<td colspan="10"><blockquote>
<p>a. Blood Chemistry:</p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="10"><p> Sodium Lactate</p>
<p> Potassium Triglycerides</p>
<p> Chloride Lipase</p>
<p> Phosphorus Creatinine phosphokinase</p>
<p> Bicarbonate Calcium</p>
<p> Creatinine Glucose</p>
<p> Albumin Other ______________________________</p></td>
</tr>
<tr class="even">
<td colspan="10"><blockquote>
<p>b. Hematology:</p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="10"><p> Hemoglobin Differential WBC</p>
<p> Hematocrit Platelets</p>
<p> Mean corpuscular volume Other _______________________________</p>
<p> White blood count</p></td>
</tr>
<tr class="even">
<td colspan="10"><blockquote>
<p>c. Liver function</p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="10"><p> Total bilirubin Alkaline phosphatase</p>
<p> AST (SGOT) Other _______________________________</p>
<p> ALT (SGPT)</p></td>
</tr>
<tr class="even">
<td colspan="10"><blockquote>
<p>d. Urine Analysis</p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="10"> Urine Analysis</td>
</tr>
<tr class="even">
<td colspan="10"><strong>3. Microbiology</strong></td>
</tr>
<tr class="odd">
<td colspan="10">Please check all the tests that your laboratory is able
to perform:</td>
</tr>
<tr class="even">
<td colspan="10"><blockquote>
<p>a. Smears, staining, and microscopic exams</p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="10"><p> AFB India Ink</p>
<p> Gram stain Stool Ova and Parasites</p>
<p> KOH prep Other _______________________________</p>
<p> Malaria smears</p></td>
</tr>
</tbody>
</table>

<table style="width:100%;">
<colgroup>
<col style="width: 18%" />
<col style="width: 1%" />
<col style="width: 17%" />
<col style="width: 3%" />
<col style="width: 16%" />
<col style="width: 4%" />
<col style="width: 17%" />
<col style="width: 1%" />
<col style="width: 8%" />
<col style="width: 10%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="10"><blockquote>
<p>b. Culturing specimens:</p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td colspan="2"><h6 id="bacterial">Bacterial</h6></td>
<td colspan="2"><strong>Fungal</strong></td>
<td colspan="2"><strong>Mycobacterial</strong></td>
<td colspan="2"><strong>Other</strong></td>
</tr>
<tr class="odd">
<td colspan="2"><p id="blood" class="heading">Blood</p></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2"><strong>Tissue</strong></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2"><strong>Sputum</strong></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2"><strong>Urine</strong></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2"><strong>CSF</strong></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2"><strong>Stool</strong></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2"><strong>Other</strong></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2"><strong>Other</strong></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="10"><blockquote>
<p>c. Cryptococcal antigen titer Bacterial antigen detection</p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="10"><strong>5. Histology</strong></td>
</tr>
<tr class="odd">
<td colspan="10"><blockquote>
<p>a. Tissue processing and staining Other
__________________________</p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="10"><strong>6. Drug resistance/susceptibility
testing</strong></td>
</tr>
<tr class="odd">
<td colspan="7"></td>
<td colspan="2"><strong>YES</strong></td>
<td><strong>NO</strong></td>
</tr>
<tr class="even">
<td colspan="7"><blockquote>
<p>a. Does the laboratory perform anti-microbial susceptibility
testing?</p>
</blockquote></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="10"><blockquote>
<p>If yes, please mark: bacteria fungi</p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="7"><blockquote>
<p>b. Can your laboratory perform genotypic or phenotypic anti-viral
susceptibility testing?</p>
</blockquote></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="10"><blockquote>
<p>If yes, please list the organisms and describe the methods you use to
detect emergence of resistance to drugs.</p>
</blockquote></td>
</tr>
<tr class="even">
<td></td>
<td colspan="2"><strong>Genotypic</strong></td>
<td colspan="2"><strong>Phenotypic</strong></td>
<td colspan="5"><strong>Specify Method</strong></td>
</tr>
<tr class="odd">
<td>HIV</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="5"></td>
</tr>
<tr class="even">
<td>Other</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="5"></td>
</tr>
<tr class="odd">
<td>Other</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="5"></td>
</tr>
</tbody>
</table>

######## Laboratory Module Completed By:

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