Rapid Influenza Diagnostic Testing Practices in Laborato

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Rapid Influenza Diagnostic Testing Practices in Laboratories

The following questions are about rapid influenza diagnostic testing (RIDT) practices and procedures in your laboratory. These questions should be completed by the Laboratory Director or Laboratory Supervisor.

Section A: Background and Demographic Information

1. Which of the following best describes your title?

a. Laboratory medical director

b. Laboratory director

c. Laboratory manager - administrative

d. Technical consultant

e. General supervisor

f. Specialty supervisor

g. Non-supervisory testing personnel

h. Other (Specify): ________________________________

1a. Which of the following best describes your laboratory?

a. Independent

b. Reference laboratory

c. Laboratory inside a hospital

d. Other (Specify): ________________________________

 

1b. Which of the following best describes the facility in which you work? (Please select one.)

a. Community (City or County) non-profit hospital                                      

b. Community for-profit hospital  

c. Laboratory for a hospital and/or clinic (i.e. centralized laboratory) network

d. University/Medical school/Teaching Hospital 

e. Veterans Administration Hospital  

f. Commercial/Independent laboratory, Single location 

g. Commercial/Independent laboratory, Multiple locations 

h. Outpatient clinic

i. Other (Specify):__________________________________

1c. If you answered “hospital” above, what is the size of your hospital?

 

       a. Greater than 500 beds

       b. 200-499 beds

       c. 100- 199 beds

d. Less than 100 beds

1d.What type(s) of Clinical Laboratory Improvement Amendment (CLIA) certificate(s) does your laboratory hold? (Select all that apply)

a. Certificate of Waiver

b. Certificate for Provider-Performed Microscopy Procedures (PPMP)

c. Certificate of Registration

d. Certificate of Compliance

e. Certificate of Accreditation

1e. What are the qualifications of your microbiology laboratory director?

 a. Clinical microbiologist PhD

b. Clinical microbiologist and Pathologist MD

c. Clinical microbiologist MD 

d. Pathologist director (AP only)

e. Pathologist director (AP/CP)

f. Physician director, type_____________________________

 g. Other (Specify)___________________________________

1f. Does your microbiology laboratory director have any of the following certifications?

 a. American Board of Medical Microbiology (ABMM)

 b. American Board of Pathology, Medical Microbiology

 c. Neither of the above

 d. Other (Specify) __________________________________

Section B: Testing Practices

2. Have RIDTs ever been performed in your laboratory?

 a. Yes  Continue with Question 2a

 b. No  Explain below and then Skip to Question 28-28d and then end survey)

If No, why are rapid influenza diagnostic tests not performed in your laboratory?(Select all that apply)

 1. Rapid test kits are too costly

 2. Tests are not sensitive enough to detect influenza

 3. Tests are not specific enough to detect influenza

 4. Diagnosis of influenza is based on clinical judgment of a practitioner, not a rapid test result

 5. Treatment is the same regardless of rapid test result

 6. We perform rapid test method(s) other than RIDTs Enzyme Immuno Assay (EIA) method

Please check if applicable:

 Direct Fluorescent Antibody (DFA)

 Nucleic acid amplification/RT-PCR

 7. Other (Specify) __________________________________________________

2a. In which of the following time frames have RIDTs been performed in your laboratory?

(Select all that apply)

 a. Prior to April 15, 2009 (before the emergence of H1N1)

 b. After April 15, 2009 (since the emergence of HIN1)

 c. RIDTs are currently performed

NOTE: If RIDTs are not currently performed in your laboratory, please answer the following questions according to procedures followed when they were in use.

3. When is RIDT available? (Select only one)

a. Throughout the year for all patients

b. Throughout the year for select patients

c. Only during influenza season for all patients      

d. Only during influenza season for select patients

e. Other (Specify)________________________________________________

3a. When RIDTs are available, please indicate your laboratories testing frequency.

a. One shift a day

b. Two shifts a day

c. All three shifts a day

d. Other

4. Approximately how many rapid influenza tests were performed in your laboratory between?

August 1, 2009 and July 31, 2010? _________

August 1, 2010 and July 31, 2011? _________

5. Since the emergence of 2009 H1N1 (after April 15, 2009), have rapid influenza diagnostic testing practices in your laboratory changed?

a. No

b. Yes (Please explain): _______________________________________________________

6. Who provides technical oversight of influenza testing in your laboratory?

       a. Doctoral specialist on site

       b. Doctoral specialist off site

       c. Non-doctoral specialist on site

       d. Non-doctoral specialist off site

6a. What kind of procedures/instructions are provided to clinicians ordering RIDTs by the laboratory?) (Select all that apply)

a. No specified procedures exist?  Skip to Question 7

b. Written procedures for contacting laboratory when ordering RIDTs

c. Written procedures for when it is appropriate to order a RIDT (for example, not in summer, not on an asymptomatic person etc.)     

 d. Written instructions explaining how well the test works to diagnose influenza disease (sensitivity, specificity, in what population, etc.)

e. Contract or memo

f. Other (Specify) _______________________________________________

6b. Who approved the procedures/instructions that are provided to the clinicians ordering RIDT?

 a. Lab Director

 b. Emergency Department Director

 c. Infection Control Director or staff

 d. Other (Specify) _____________________________________________

 g. Do not know

6c. Does the procedure of ordering RIDTs vary by shift (e.g. day, evening, night shift)?

a. No

b. Yes (Explain) _______________________________________________

7. Does your lab consider the impact of currently circulating influenza subtypes on the performance of the RIDT?

 a. Yes  b. No

8. What is the initial screening test for influenza in your facility?

 a. RIDT

 b. Direct Fluorescent Antibody DFA

 c. Viral Culture

 d. Nucleic acid amplification/RT-PCR

 e. Other (Specify)_______________________________

8a. In addition to RIDT, what other tests are used to diagnose influenza in your laboratory?

 a. Viral culture

 b. Immunofluorescence [Direct Fluorescent Antibody (DFA)]

 c. Nucleic acid amplification/ RT-PCR

 d. Serology

 e. None

 f. Other (Specify)_____________________________________

Section B1: Pre-Analytic Phase

9. What is the source of RIDT specimens received by your laboratory? (Select all that apply)

a. Inpatients within our hospital/facility

b. Inpatients from other hospital/facility

b. Hospital based ambulatory patients

c. Doctor’s office patients

d. Emergency Department patients within our hospital(s)

e. Emergency Department patients for other hospitals

f. Patients from long term care facilities

g. Other (Specify)______________________________________

10. How are the RIDT specimens transported to your laboratory? (Select all that apply)

       a. Hand delivered

       b. Translogic tubing system

       c. Local courier

       d. Air Mail

       e. Other (Specify) ______________________________________

10a. Is the respiratory specimen transported in any of the following media? (Select all that apply)

 a. Phosphate buffered saline

 b. M4RT viral transport media

 c. Hanks Balanced Salt solution

 d. UTM viral transport media

 e. Normal Saline

 f. No transport media is used

 g. Other (Specify)________________________________________

11. What type of specimen do you most often receive for rapid influenza testing? (Select only one)

 a. Throat swab

 b. Nasopharyngeal wash

 c. Nasophayngeal aspirate

 d. Nasophayngeal swab

 e. Nasal wash

 f. Midturbinate swab

 g. Other (Specify)_______________________________________________

11a. What other type(s) of specimen(s) do you accept? (Select all that apply)

 a. Throat swab

 b. Nasopharyngeal wash

 c. Nasophayngeal aspirate

 d. Nasophayngeal swab

 e. Nasal wash

 f. Midturbinate swab

 g. Other (Specify)_______________________________________________

11b. Do you accept specimens other than the type specified by the test manufacturer?

 a. Yes  b. No

12. Who collects the RIDT specimens in your facility (Select all that apply)?

 a. Laboratory Staff

 b Emergency Department Staff

 c. Respiratory therapist

 d. Physicians/Residents

 e. Other (Specify)_______________________________________________________

12a. Does the staff collecting specimens change due to…. (Select all that apply)

 a. Shift

 b. Holidays or weekends

 c. Patient volume

 d. Available staff

 e. Other (Specify)____________________________________________________________

13. Is there an algorithm or triage system in place for collecting and testing specimens from critical or high risk patients?

a. Yes b. No c. Don’t know

13a. Is there an algorithm or triage system in place for collecting and testing specimens from high volume outpatient areas such as Emergency Department?

a. Yes b. No c. Don’t know

14. Did your laboratory perform a validation/verification study on the sensitivity and specificity of the RIDT used most frequently in your laboratory?

a. Yes,  Continue

b. No,  Skip to Question 15

c. Don’t know,  Skip to Question 15

14a. What specimens were used to perform the validation/verification study? (Select all that apply)

 a. Split fresh patient specimens

 b. Split stocked frozen patient samples

 c. Frozen stock influenza virus

 d. Company provided panels

 e. Public Health lab provided panels

 f. Sample exchange or donation from outside laboratory

 g. Purchased panels

 h. Multiple specimen sources

 i. Don’t know

 j. Other__________________

14b. Where was the comparison (“gold standard” ) testing for the RIDT validation/verification performed?

 a. In-house

 b. A reference laboratory (could be a clinical, commercial or public health laboratory)

14c. What was the comparison (“gold standard”) method used for the RIDT validation/verification study?

 a. Virus culture

 b. RT-PCR

 c. DFA

 d. Another RIDT

 e. Other

 f. Don’t know

14d. How often does your lab perform verification studies to select a RIDT?

 a. Every season

 b. Once in every two-three years

 c. Have not changed the kit in last 3 years

 d. Not applicable

Section B2: Analytic Phase

15. Please indicate which RIDT is currently used most frequently in your laboratory. (Select only one)

 a. 3M™ Rapid Detection Flu  f. (Quidel) – Moderate Complexity

A+B Test (3M)  g. QuickVue® Influenza A+B Test (Quidel)

 b. Directigen™ EZ Flu  h.TRU FLU® (Bioscience)

A+B (Becton-Dickinson)  i. XPECT™ Flu A&B (Remel/Thermofisher)

 c. BinaxNOW® Influenza  j. Other: _____________________________

A&B (Alere) - CLIA Waived _____________________________

 d. BinaxNOW® Influenza

A&B (Alere) - Moderate Complexity

 e. Clearview Exact® II Influenza A &B

 f. QuickVue® Influenza Test

15a. Why was this RIDT selected? (Select all that apply)

 a. Low cost

 b. Ease of use

 c. Turn-around time

 d. Type of specimen required

 e. Perceived sensitivity (the test correctly identifies patients with influenza)

 f. Perceived specificity (the test correctly identifies patients without influenza)

 g. Sales representative gave them to us to try

 h. Clinical Laboratory Improvement Amendment (CLIA) waived status

 j. In -house verification studies

 k. Published findings

 l. Other (Specify) __________________

_______________________________

 m. Don’t know

15b. What is the estimated sensitivity (ability to identify patients with influenza) of the RIDT

that is most frequently used in your laboratory? ____________%

15c. From what source did you learn about the estimated sensitivity of this RIDT test?

 a. Package insert

 b. Ongoing monitoring/Pre-implementation verification study

 d. Published studies

 e. Physician input

 f. Other (Specify) __________________________________________________

16. Are you planning to change methodologies from RIDT to one of the newer rapid technologies?

 a. No

 b. Yes, we have decided to change to a rapid molecular method , FDA Approved (Cepheid Xpert® Flu)

 c. Yes, we have decided to change to a new film array technology, FDA Approved (Idaho Technology Film Array RP System®/Film Array Respiratory Panel®)

 d. We are considering changing to a rapid molecular technology, FDA Approved (Cepheid Xpert® Flu)

 e. We are considering changing to a film array technology, FDA Approved (Idaho Technology Film Array RP System®/Film Array Respiratory Panel®)

 f. Other (Specify) _____________________________________________________________

17. Who tests the RIDT specimens in your facility? (Select all that apply)

 a. Laboratory Staff

 b. Emergency Department/Medical Staff

 c. Respiratory therapist

 d. Other (Specify) _______________________________________________________

Section B3: Post-Analytic Phase

18. What is the average turn-around time to report results of an RIDT specimen once it is received in your laboratory for the day, evening, and night shift?

	Average Turn-Around Time – Receipt to Reporting
Shift	Less than 30 minutes	30 minutes to less than one hour	1-2 hours	greater than 2 hours	Not Available during shift
Day Shift (Select one) 					
Evening Shift (Select one) 					
Night Shift (Select one) 					

18a. Are there special procedures for faster turn-around time for handling RIDT specimens from critical or high risk patients

a. Yes b. No c. Don’t know

19. Who usually communicates the RIDT results from your laboratory? (Select only one)

a. Laboratory Director

b. Laboratory Supervisor

c. Laboratory Technician who performed the test

d. It varies, there isn’t one specific person who is responsible for conveying the results

e. Other (Specify)_______________________________________________________________

19a. How are RIDT results most often communicated? (Select only one)

		For Routine Patients (Select Only One)	For High Risk/Critical Patients (Select Only One)
a.	By phone		
b.	Computer/electronic		
c.	Fax		
d.	Paper record		
e.	By smartphone		
f.	Other (Please describe)___________________________		

19b. To whom are the RIDT results from your laboratory most often communicated? ((Select only one)

a. The ordering provider

b. The nurse

c. The clerk on the floor

d. It varies, there isn’t one specific person who results are typically communicated to

e. Other (Specify)__________________________________________________

19c. Does your RIDT report include any disclaimer on the impact of test performance due to influenza prevalence?

a. Yes b. No c. Don’t know

20. To which of the following did your facility report positive influenza test results? (Select all that apply)

		Prior to H1N1 emergence (before April 15, 2009)		Since H1N1 emergence (after April 15, 2009)
a.	The local health department		
b.	The state health department		
c.	Other organization/agency		
	Specify________________________
d.	None – We do not report influenza results		
e.	Don’t know		

20a. Which department within your facility reports positive influenza test results to health departments? (Select all that apply)

		Prior to H1N1 emergence (before April 15, 2009)		Since H1N1 emergence (after April 15, 2009)
a.	The emergency department		
b.	Laboratory		
c.	Infection control		
d.	Other entity within the hospital (specify		
	Specify________________________
e.	The doctor’s office		
f.	None		
g.	Don’t know		

21. Does your laboratory conduct confirmatory testing of RIDT results internally? (Select all that apply)

 a. Yes, on specimens from patients who tested positive for influenza

 b. Yes, on specimens from patients who tested negative for influenza

 c. Yes, on specimens from patients in outbreak settings (e.g. congregate facilities and schools)

 d. No  Skip to Question 21c

21a. On which types of specimen(s) is confirmatory testing performed internally? (Select all that apply)

		Beginning of the influenza season	Middle of the influenza season	End of the influenza season	Off season
a.	Positive RIDT specimens				
b.	Negative RIDT specimens				

21b. What type of confirmatory testing is done internally? (Select all that apply)

 a. Culture

 b. RT-PCR/ Nucleic acid amplification (FDA approved)

 c. RT-PCR/ Nucleic acid amplification (In-house developed)

 d. DFA

 e. Repeat RIDT, same type

 f. Another RIDT, different type

 g. Other (Specify)_____________________________________________________

 h. None

21c. Does your laboratory send specimens out for confirmatory testing of rapid influenza diagnostic test results?

(Select all that apply)

 a. Yes, we send specimens from patients who tested positive for influenza

 b. Yes, we send specimens from patients who tested negative for influenza

 c. Yes, we send specimens from patients in outbreak settings (e.g. congregate facilities and schools)

 d. No -> Skip to Question 22

21d. Which type of specimen(s) does your laboratory send out for confirmatory testing? (Select all that apply)

		Beginning of the influenza season	Middle of the influenza season	End of the influenza season	Off season
a.	Positive RIDT specimens				
b	Negative RIDT specimens				

21e. What type of confirmatory testing is done externally? (Select all that apply)

 a. Culture

 b. RT-PCR/ Nucleic acid amplification (FDA approved)

 c. RT-PCR/ Nucleic acid amplification (In-house developed)

 d. DFA

 e. Repeat RIDT, same type

 f. Another RIDT, different type

 g. Other (Specify)________________________

 h. None

Section C: Quality Assurance

22. What is done to ensure good laboratory practices are followed in performing RIDTs within the laboratory?

(Select all that apply by completing the following sentence) Our laboratory . . .

 a. Has no formal processes

 b. Has a written procedures manual

 c. Has standard operating procedures for performing RIDTs

 d. Has a system in place for monitoring and evaluating the procedures for Patient Test Management

 e. Ensures those who perform RIDTs follow the manufacturer’s instruction/package inserts or our written procedures that include the manufacturer’s instructions.

 f. Has knowledgeable personnel who teach/mentor new staff

 g. Evaluates the competency/performance of staff periodically

 h. Participates in a proficiency testing program

 i. Documents problems arising in using RIDTs and takes corrective action

 j. Evaluates the effectiveness of corrective actions taken in regard to the quality issues related to RIDT

 k. Ensures CDC guidelines are followed

 l. Ensures other external guidelines are followed

22a. If you have a system in place for monitoring and evaluating the procedures for Patient Test Management within the laboratory, please specify what it includes below. (Select all that apply)

 a. Specimen collection

 b. Specimen labeling

 c. Preservation and transportation

 d. Test requisition completeness

 e. Test report completeness

 f. Timely reporting of results

 g. Accuracy and reliability of test reporting systems

 h. Storage and retrieval of results

 i. No system in place

 j. Other (Specify):___________________________

 k. Not applicable

23. What is done to ensure that RIDT guidelines and good laboratory practices are followed outside of the laboratory? (Select all that apply by completing the following sentence) Our laboratory . . .

 a. Does not evaluate quality assurance practices for other areas performing RIDTs

 b.Designates someone responsible for overseeing testing quality assurance outside of the laboratory

 c. Reviews or participates in updating a written procedures manual

 d. Reviews or participates in updating standard operating procedures for performing RIDTs

 e. Reviews or participates in evaluating procedures for patient test management

 f. Ensures those who perform RIDTs follow the manufacturer’s instructions/package inserts or our written procedures that include the manufacturer’s instructions

 g. Has knowledgeable personnel who teach/mentor new staff outside of the laboratory.

 h. Evaluates the competency/performance of staff periodically outside of the laboratory

 i. Ensures those who perform RIDTs follow CDC guidelines

 j. Ensures those who perform RIDTs follow other external guidelines

 k. Provides or participates in a proficiency testing program for testing performed externally

 l. Other (Specify) __________________________________________________________

23a.If you have a system in place for monitoring and evaluating the procedures for Patient Test Management that occur outside the laboratory, please specify what it includes below. (Select all that apply)

 a. Specimen collection

 b. Specimen labeling

 c. Preservation and transportation

 d. Test requisition completeness

 e. Test report completeness

 f. Timely reporting of results

 g. Accuracy and reliability of test reporting systems

 h. Storage and retrieval of results

 i. No system in place

 j. Other (Specify) _________________________________________

 k. Not applicable

24. Does your laboratory have a mechanism to monitor ongoing RIDT performance?

 a. Yes (Briefly describe)________________________________________________________________

 b. No

25. What quality controls samples are used for the RIDT?

 a. Positive and negative control from the kit

 b. Previously positive and negative patient specimens

 c. Both of the above

 d. None of the above

 e. Other (Specify)_____________________________________________________________________

25a. How often are the quality control samples run?

 a. Every time a new box of RIDT is opened

 b. Once with every new lot or shipment

 c. Performed every 30 days

 d. Performed on weekly basis

 e. No quality control samples are run

26. What bio-safety procedures are in place for RIDT testing?

 a. Routine BSL-2 protective equipment (e.g. gloves, lab coat, eye protection)is employed

 b. Testing is performed in a Class II bio-safety cabinet

 c. Testing is performed behind a bench shield

 d. Additional Personal Protective Equipment (e.g. mask, N-95 respirator, etc.)is employed

 e. RIDT testing is performed in a isolated/sequestered area

 f. RIDT testing is performed on an open bench area

 g. Other (Specify)__________________________________________________________

Section D: Training

27. How is staff trained to do RIDT testing? (Select all that apply)

 a. Informal on-the-job training

 b. Formal in-service education

 c. Provided with manual/directions to read and review

 d. Rely on educational program skills obtained prior to employment

 e. Other (specify)____________________________________________________________

 f. Don’t know

27a. Who is responsible for training staff to collect RIDT specimens?

 a. Laboratory

 b. Respiratory Therapy Staff

 c. Emergency Department Staff

 d. Nursing Staff

 e. Other (Specify)___________________________________________________________

27b. What types of educational information is provided by laboratories to those ordering RIDTs?

 a. Educational comments on lab reports regarding sensitivity and specificity of tests

 b. Educational comments on test interpretation

 c. Educational information regarding specimen collection

 d. Educational memos or posters

 e. Other (Specify)__________________________________________________________

27c. What is the frequency of training of laboratory testing personnel?

 a. Initial training only

 b. Annual Training

 c. Only when test kit is changed

 d. No training is conducted

27d. What is the frequency of training of clinicians for respiratory specimen collection?

 a. Initial training only

 b. Annual training

 c. No training

 d. Don’t Know

Section E: Influenza Information and Resources

28. How do you obtain information regarding influenza activity in your area? (Select all that apply)

 a. Media

 b. Journal publications

 c. Local Health Department

 d. State Health Department

 e. Local hospitals

 f. CDC guidance at www.CDC.gov

or www.cdc.gov/flu

 g. Guidance at www.WHO.int

 h. Our hospital infection control staff or infections disease consult service

 i. Professional Organizations (e.g. Websites, newsletters)

 j. Other internet sites (Specify)

 k. Other (Specify)

28a. How do you prefer to receive influenza-related information? (Select up to two responses)

 a. Direct email (e.g. GovDelivery, CDC newsletter/update)

(Please specify type of email communication you prefer) __________________________

_________________________________________________________________________

 b. CDC social media (e.g. Twitter, RSS Feed, Facebook)

 c. CDC publications and articles (e.g. MMWR, EID)

 d. Audio/visual broadcasts (e.g. podcasts, Webinars, conference calls)

 e. Clinician Outreach and Communication Activities (COCA)

 f. Professional organization resources (e.g. newsletters, announcements)

 g. Other (Specify) _____________________________________________________________

28b. Did your state or local public health system provide information related to influenza testing?

 a. Yes  b. No  c. Don’t know

28c. What kind of information did your state and local public health systems provide regarding influenza?

(Select all that apply under each time period)

Prior to H1N1 emergence Since H1N1 emergence

(before April 15, 2009) (after April 15, 2009)

a. Recommendations for rapid influenza

diagnostic test use  

b. Guidelines for interpretation of rapid influenza

diagnostic test results……………………………….  

c. Guidelines for diagnosing influenza  

d. Treatment guidelines  

e. Surveillance data (prevalence and

location of confirmed cases)  

f. Training resources  

g. Unaware of the information provided by

my state and local public health systems  

h. Other (Specify)____________________________  

28d. Do state and local public health systems provide influenza information in a timely manner?

 a. Yes

 b. No

 c. Information not provided

 d. Don’t know

Section F: Advantages and Disadvantages

29. What are the top three problems that your laboratory has encountered with RIDTs or the testing process? (Select up to three responses)

 a. Differing opinions on which RIDT kit the laboratory should use

 b. Shortage of RIDT kits

 c. Rapid tests are not very good at correctly identifying those with influenza (poor sensitivity)

 d. Rapid tests are not very good at correctly identifying those without influenza (poor specificity)

 e. Poor performance with certain circulating influenza subtypes

 f. Difficulty interpreting test results/ambiguous test results

 g. Expense of RIDT kits

 h. Staff availability

 i. Inadequate/improperly collected specimen

 j. Other (Specify) ___________________________________________________________

 k. None (have not experienced any problems with RIDT)

29a. What do you perceive are the advantages of RIDT to your laboratory? (Select all that apply)

 a. Inexpensive

 b. Rapid

 c. Useful for “stat” testing

 d. Useful for third shift

 e. None

 f. Other: (Specify)____________________________________________________________

29b. What do you perceive are the advantages of RIDT to your facility? (Select all that apply)

 a. Don’t know

 b. It enhances the ability to make

accurate diagnoses

 c. It reduces unnecessary antibiotic prescriptions

 d. It helps inform decision about antiviral prescriptions

 e. It is useful during an influenza outbreak

 f. It helps physicians decide if a patient can return to work or school

 g. None

29c. What do you perceive are the disadvantages of RIDT? (Select all that apply)

 a. Lacks specificity

 b. Lacks sensitivity

 c. Too costly

 d. Not very useful during periods of low influenza activity

because there is a higher probability of false positives

 e. During peak influenza activity, clinical judgment is more predictive

of influenza than rapid influenza diagnostic test results

 f. Tests are difficult to perform

 g. Results are difficult to interpret

 h. For patients with flu-like symptoms, treatment (with antiviral medication) is the same regardless of

the rapid influenza diagnostic test result

 i. None

 j. Other (Specify)_______________________________________________________________

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