Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for Metrics-
American Society for Microbiology
Request for Approval of New Data Collection
Supporting Statement B
August 10, 2015
Contact:
Elizabeth Weirich, MS, SM(NRCM), CBSP
Division of Laboratory Systems
Center for Surveillance, Epidemiology, and Laboratory Services
Centers for Disease Control and Prevention
1600 Clifton Rd.
MS F-11
Atlanta, Georgia 30333
Phone: 404.498.2282
Email: eweirich@cdc.gov
Table of Contents
Page Number
B. Collections of Information Employing Statistical Methods
B. 1. Respondent Universe and Sampling Methods 5
B. 2. Procedures for the Collection of Information 5
B. 3. Methods to Maximize Response Rates and Deal with No Response 6
B. 4. Tests of Procedures or Methods to Be Undertaken 6
B. 5. Individuals Consulted on Statistical Aspects and Individuals 7
Collecting and/or Analyzing Data
Appendices
A. Authorization Legislation
B. Published 60-Day Federal Register Notice
C1. Initial Email Letter to Laboratory Response Network Reference Laboratory Director (pre-survey)- BCC
C2. Initial Email Letter to Laboratory Response Network Reference Laboratory Director (post-survey)- BCC
C3. Initial Email Letter to Laboratory Response Network Reference Laboratory Director- BSI
C4. Initial Email Letter to Laboratory Response Network Reference Laboratory Director- UT
C5. Initial Email Letter to Laboratory Response Network Reference Laboratory Director- CDI
D1. Reminder Email Letter to Laboratory Response Network Reference Laboratory Director (pre-survey)- BCC
D2. Reminder Email Letter to Laboratory Response Network Reference Laboratory Director (post-survey)- BCC
D3. Reminder Email Letter to Laboratory Response Network Reference Laboratory Director- BSI
D4. Reminder Email Letter to Laboratory Response Network Reference Laboratory Director- UT
D5. Reminder Email Letter to Laboratory Response Network Reference Laboratory Director- CDI
E1. Initial Email Letter to Sentinel Laboratories (pre-survey)- BCC
E2. Initial Email Letter to Sentinel Laboratories (post-survey)- BCC
E3. Initial Email Letter to Sentinel Laboratories- BSI
E4. Initial Email Letter to Sentinel Laboratories- UT
E5. Initial Email Letter to Sentinel Laboratories- CDI
F1. Reminder Email Letter to Sentinel Laboratories (pre-survey)- BCC
F2. Reminder Email Letter to Sentinel Laboratories (post-survey)- BCC
F3. Reminder Email Letter to Sentinel Laboratories- BSI
F4. Reminder Email Letter to Sentinel Laboratories- UT
F5. Reminder Email Letter to Sentinel Laboratories- CDI
G1. American Society for Microbiology Microbe Magazine Promotional (pre- and post-surveys)- BCC
G2. American Society for Microbiology Microbe Magazine Promotional- BSI
G3. American Society for Microbiology Microbe Magazine Promotional- UT
G4. American Society for Microbiology Microbe Magazine Promotional- CDI
H1. Initial Email Letter to ClinMicroNet Listserv (pre-survey)- BCC
H2. Initial Email Letter to ClinMicroNet Listserv (post-survey)- BCC
H3. Initial Email Letter to ClinMicroNet Listserv- BSI
H4. Initial Email Letter to ClinMicroNet Listserv- UT
H5. Initial Email Letter to ClinMicroNet Listserv- CDI
I1. Reminder Email Letter to ClinMicroNet Listserv (pre-survey)- BCC
I2. Reminder Email Letter to ClinMicroNet Listserv (post-survey)- BCC
I3. Reminder Email Letter to ClinMicroNet Listserv- BSI
I4. Reminder Email Letter to ClinMicroNet Listserv- UT
I5. Reminder Email Letter to ClinMicroNet Listserv- CDI
J1. Initial Email Letter to DivC Listserv (pre-survey)- BCC
J2. Initial Email Letter to DivC Listserv (post-survey)- BCC
J3. Initial Email Letter to DivC Listserv- BSI
J4. Initial Email Letter to DivC Listserv- UT
J5. Initial Email Letter to DivC Listserv- CDI
K1. Reminder Email Letter to DivC Listserv (pre-survey)- BCC
K2. Reminder Email Letter to DivC Listserv (post-survey)- BCC
K3. Reminder Email Letter to DivC Listserv- BSI
K4. Reminder Email Letter to DivC Listserv- UT
K5. Reminder Email Letter to DivC Listserv- CDI
L1. American Society for Microbiology Clinical Microbiology Issues Update Newsletter (pre- and post-surveys)- BCC
L2. American Society for Microbiology Clinical Microbiology Issues Update Newsletter- BSI
L3. American Society for Microbiology Clinical Microbiology Issues Update Newsletter- UT
L4. American Society for Microbiology Clinical Microbiology Issues Update Newsletter- CDI
M. Privacy Act Checklist
M1. Survey Instrument (pre-survey)- BCC
M2. Survey Instrument (post-survey)- BCC
M3. Survey Instrument- BSI
M4. Survey Instrument- UT
M5. Survey Instrument- CDI
MM1. Pilot Test Results- BCC
MM2. Pilot Test Results- BSI
MM3. Pilot Test Results- UT
MM4. Pilot Test Results- CDI
N. PRA Part I Worksheet
O1a. PRA Part II Worksheet- BCC microbiology supervisor baseline survey
O1b. PRA Part II Worksheet- BCC microbiology supervisor post-survey
O2a. PRA Part II Worksheet- BCC laboratory director baseline survey
O2b. PRA Part II Worksheet- BCC laboratory director post-survey
O3a. PRA Part II Worksheet- BCC laboratory manager baseline survey
O3b. PRA Part II Worksheet- BCC laboratory manager post-survey
O4a. PRA Part II Worksheet- BCC medical technologist baseline survey
O4b. PRA Part II Worksheet- BCC medical technologists post-survey
P1. PRA Part II Worksheet- BSI microbiology supervisor
P2. PRA Part II Worksheet- BSI laboratory director
P3. PRA Part II Worksheet- BSI laboratory manager
P4. PRA Part II Worksheet- BSI medical technologist
Q1. PRA Part II Worksheet- UT microbiology supervisor
Q2. PRA Part II Worksheet- UT laboratory director
Q3. PRA Part II Worksheet- UT laboratory manager
Q4. PRA Part II Worksheet- UT medical technologist
R1. PRA Part II Worksheet- CDI microbiology supervisor
R2. PRA Part II Worksheet- CDI laboratory director
R3. PRA Part II Worksheet- CDI laboratory manager
R4. PRA Part II Worksheet- CDI medical technologist
RR1. PRA Part II Worksheet- LRN Reference Lab Director BCC-baseline sentinel laboratory letter
RR2. PRA Part II Worksheet- LRN Reference Lab Director BCC-post sentinel laboratory letter
RR3. PRA Part II Worksheet- LRN Reference Lab Director BSI-baseline sentinel laboratory letter
RR4. PRA Part II Worksheet- LRN Reference Lab Director UT-baseline sentinel laboratory letter
RR5. PRA Part II Worksheet- LRN Reference Lab Director CDI-baseline sentinel laboratory letter
RR6. PRA Part II Worksheet- LRN Reference Lab Director BCC-baseline sentinel laboratory reminder letter
RR7. PRA Part II Worksheet- LRN Reference Lab Director BCC-post sentinel laboratory reminder letter
RR8. PRA Part II Worksheet- LRN Reference Lab Director BSI-baseline sentinel laboratory reminder letter
RR9. PRA Part II Worksheet- LRN Reference Lab Director UT-baseline sentinel laboratory reminder letter
RR10. PRA Part II Worksheet- LRN Reference Lab Director CDI-baseline sentinel laboratory reminder letter
S1. Internal Division Human Subjects Research Determination Form
S2. Human Subjects Tracking Form
B. Collections of Information Employing Statistical Methods
Respondent Universe and Sampling Methods
The American Society for Microbiology will not perform any sampling for their BCC, BSI, UT, and CDI surveys.
Procedures for the Collection of Information
Overview of the Data Collection System
On behalf of the ASM and the CDC, the Laboratory Response Network (LRN), which was founded by the CDC, will recruit laboratories that perform the kinds of testing affected by these LPGs to take the surveys. The LRN message system routinely alerts LRN laboratories concerning various important clinical and public health topics. Messages regarding ASM surveys will be worded as an invitation, not as a coercive request. Some states may opt not to recruit LRN laboratory participation, but because the issues are important to clinical and public health, we expect good participation by most states.
The CDC LRN Coordinator will email a letter, addressed from the ASM Project Manager, to the Laboratory Directors of the LRN Reference Laboratories (Attachment C1-C5/D1-D5 reminders). These ~55 LRN Reference Laboratory Directors will be asked to then email the sentinel laboratories (Attachment E1-E5/F1-F5 reminders), which include hospital and independent laboratories, in their states, and provide a hyperlink to access the survey tool online. SurveyMonkey® will be used as the data collection instrument and responses will be collected and maintained by ASM.
We anticipate that approximately 4200 sentinel laboratories will be contacted and asked to complete the survey on-line. The email request will specify that the respondent should be a microbiology supervisor, and in the case where a microbiology supervisor is not employed, then either the laboratory director or laboratory manager will be asked to participate in each of the five unique surveys: BCC baseline (Attachment M1), BCC post-dissemination (Attachment M2), BSI baseline (Attachment M3), UT baseline (Attachment M4), and CDI baseline (Attachment M5).
In addition, the ASM will also recruit laboratory directors as well as medical technologists to take each of the five SurveyMonkey® surveys. The ASM will email a letter containing the SurveyMonkey® hyperlinks for the five surveys, to each of their ClinMicroNet (Attachment H1-H5/I1-I5 reminders) and DivCNet (Attachment J1-J5/K1-K5 reminders) listservs inviting ~828 and ~1470 subscribers, respectively, to participate. Moreover, the ASM will email the same letter containing the SurveyMonkey® hyperlinks for the 5 surveys to invite the ASM Clinical Microbiology Issues Update newsletter subscribers (~1453 total) (Attachment L1-L4), which include microbiology supervisors, laboratory directors, laboratory managers, and medical technologists in a 25%:25%:25%:25% ratio, to participate. The ASM Clinical Microbiology Issues Update newsletter provides monthly updates on policy matters of concern to clinical microbiologists and is provided by ASM’s Office of Public Affairs. These listservs are used by ASM as a method for open communication among clinical microbiology laboratories to improve patient care.
Methods to Maximize Response Rates and Deal with No Response
The CDC LRN Coordinator will email a letter (Attachment C1-C5/D1-D5 reminders), addressed from the ASM Project Manager, to the Laboratory Directors of the LRN Reference Laboratories in each state or jurisdiction asking them to forward a separate, attached survey invitation letter to all LRN sentinel laboratories (Attachment E1-E5/F1-F5 reminders) in their state or jurisdiction inviting them to participate in each of the five surveys. Two weeks following the distribution of these cover letters, the ASM will ask APHL to email a reminder cover letter (Attachment D1-D5) to all LRN Reference Laboratory Directors, who will then forward reminder survey invitation letters to the sentinel laboratories (Attachment F1-F5) asking them to complete the BCC, BSI, and UT baseline surveys during a specified date in 2015 (and the CDI baseline survey in 2016). Following the dissemination of the initial BCC baseline survey (Attachment M1), ASM will launch a promotional campaign strategy to raise awareness of the existence of the BCC LPG. Six months later, the BCC post-survey (Attachment M2) will be distributed in the same manner to the same laboratories in order to determine if there were any changes in laboratory practices due to the recommendations made in the BCC LPG.
To maximize response rates for their BCC (Attachment M1 & M2), BSI (Attachment M3), UT (Attachment M4), and CDI (Attachment M5) surveys that will be disseminated to each of their ClinMicroNet, DivCNet, and Clinical Microbiology Issues Update newsletter listservs, the American Society for Microbiology will employ a campaign strategy that differs from that which will be used to target LRN sentinel laboratories. The ASM will publicize the surveys and encourage participation by advertising the surveys in ASM’s Microbe (Attachment G1-G4), a monthly news magazine freely accessible to the public http://www.microbemagazine.org. Moreover, the ASM Project Manager on this cooperative agreement project will email four separate letters (Attachment H1-H5 & J1-J5) for each of the surveys containing the SurveyMonkey® hyperlinks, to each of their ClinMicroNet and DivCNet listservs; two weeks after these letters are sent, ASM’s Project Manager will send a reminder email (Attachment I1-I5 & K1-K5) to their ClinMicroNet and DivCNet listserv subscribers asking them to respond to the surveys if they have not already done so. In the event the response rate for either listserv is less than 20%, a reminder email displaying the same content as the first reminder (Attachment I1-I5 & K1-K5), will be distributed four weeks after the initial email is sent. Unlike with the ClinMicroNet and DivCNet campaign strategies that will be employed, the ASM will send out a Clinical Microbiology Issues Update newsletter to their subscribers for each of the surveys, which will contain the respective SurveyMonkey® hyperlink (Attachment L1-L4).
The total length of time to respond to each of the baseline surveys will be limited to one month.
Tests of Procedures or Methods to be Undertaken
The BCC, BSI, UT, and CDI surveys were pilot tested (Attachment MM1, MM2, MM3, and MM4) with 9 laboratory professionals representing a diverse spectrum of the kinds of microbiology supervisors, laboratory directors, laboratory managers, and medical technologists who work in the types of laboratories that collect blood for culturing; perform rapid diagnostic tests to promote more accurate and timely administration of targeted antibiotic therapy for patients with bloodstream infections; collect, store and preserve urine for microbiological culture that improve the diagnosis and management of patients with urinary tract infections; and diagnose and manage patients with C. difficile infection (CDI), including sentinel laboratories, which include hospital and independent laboratories. The ASM were able to use the CDC LRN Coordinator’s help to identify representatives from this cohort. The ASM identified volunteers to take the survey and then, collected impressions concerning any ambiguities or other concerns and finally followed up with phone calls when necessary. The ASM attempted to include a variety of geographical areas, including laboratories in smaller metropolitan areas, when possible.
Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data
The following provided consultation on survey design:
Karen Wooten, MA
Mathematical Statistician
Carter Consulting, Inc.
2310 Parklake Drive, NE, Suite 535
Atlanta, GA 30345
Phone: 770-939-2601
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Terri Phan |
| File Modified | 0000-00-00 |
| File Created | 2021-01-24 |