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RESTRICTIONS ON LUNG FUNCTION TESTING DURING COVID-19 PANDEMIC STANDARD OPERATING PROCEDURE

RESTRICTIONS ON LUNG FUNCTION TESTING DURING COVID-19 PANDEMIC STANDARD OPERATING PROCEDURE

 

RESTRICTIONS ON LUNG FUNCTION TESTING DURING COVID-19 PANDEMIC STANDARD OPERATING PROCEDURE

 

Key Points
This SOP covers:

·         How COVID-19 has impacted the lung function service

·         Adapting to testing in high prevalence then low prevalence in the community

·         Additional Infection control measures

 

Version: 1
 

Lead Author:

 

IICMS Faculty of Respiratory

Groups and individuals consulted All HODS from lung function laboratories in Ireland
Approving individual IICMS Faculty of Respiratory chairperson
 

Date Approved

25/08/2020
Target Audience: Clinical Staff working within the Lung function Dept.Clinical Users of the lung function service
Document Control
Previous Version Information:
Changes made from previous version (if applicable) This is a new SOP

 

1       Introduction

  • This SOP is for use in hospital lung function departments in Ireland and outlines how labs can provide a lung function service now that some restrictions are being
  • The document reviews the recommendations from national and international bodies, bearing in mind that nearly all lung function tests can be aerosol generating procedures (AGP).
  • The document provides an assessment of risk from different patient groups, a list of available tests with indication of associated risk, and some further points that are necessary for reducing risk of virus

 

2       Scope

  • This SOP applies to all Respiratory Physiologists based in a Lung Function Laboratory in Irish hospitals.

 

3       Aims

  • The SOP reviews recommendations from national and international bodies
  • Identify how to risk assess different patient groups, and available tests with indication of associated
  • Identify the correct P.E and cleaning measures implemented to reduce risk of virus transmission.

 

4       Definitions

  • PPE – Personal Protective equipment
  • AGP – Aerosol generated procedure

 

5       Duties and Responsibilities

  • Respiratory Consultant/Clinical Lead

 

  • Finalise information provided in SOP, ensure other Respiratory Consultants are aware of the SOP. Provide clinical expertise and support when required to assess the suitability of referrals from other

 

  • Chief Respiratory Physiologist

 

  • Participate in approval of document. Ensure measures outlined in the SOP are being followed and implemented. Chief Physiologists can also assess non- respiratory referrals and make a clinical judgement on urgency of In cases where they are unsure, the referrals should be sent to the lab Clinic lead or Respiratory Consultant for discussion.
  • Senior/Respiratory Physiologists

 

  • Read and follow this procedure. Refer any questions or orders to Chief Physiologist and report any incidents. Ensure measures outlined in the  SOP are being followed and implemented.

 

6       Restrictions on lung function testing during COVID-19 pandemic

  • A number of international and national bodies have published recommendations. These recommendations also provide advice distinguishing between tests according to risk of virus transmission, and quite a lot of detail on testing procedure, PPE etc. These other issues are covered in different sections

 

 

  • Consultant Microbiologist of the The Health Protection Surveillance Centre (HSPC) in conjunction with the Respiratory National Clinical Program issued Guidance on the Infection Prevention and Control measures required for Pulmonary Function Tests in the context of the COVID-19 pandemic on 21st August 2020. The guidelines were produced with limited input from The IICMS Faculty of Respiratory and the Irish Thoracic Society. Although, the IICMS Faculty of Respiratory will continue to comply with the minimum standard of the guidance issued, the Faculty have not endorsed the guidelines as we fundamentally disagree with the guideline’s stance that routine PFTs are not an AGP, on the PPE needed to perform PFTs and the lack of adequate ventilation needed for PFT laboratories to test patients safely.

 

  • The Irish Thoracic Society (ITS), in conjunction with the IICMS Faculty of Respiratory, published guidance on the 24th March 2020, with updates on the 30th March and May 19th 2. The different versions of the guidance referred to what lung function testing is appropriate as the transmission of the virus changes. Version 3 of the guidance states that patients should only be referred for testing where it is absolutely essential for clinical management. It advises that if testing is needed for other patients, this decision will be made following discussion between the consultant respiratory physician and the physiologist. Where this is agreed upon, spirometry, bronchodilator response, diffusing capacity/DLCO and lung volumes (by body plethysmography only) can be performed. It advises that no other aerosol generating procedures such as bronchial challenge testing or CPET should be performed at this time.

 

 

 

 

 

6.1.3         ERS guidance1 is the most detailed of those currently available. It divides recommendations into those that should be applied during high community prevalence, low community prevalence, and controlled (near normal). These prevalence states are not defined, and there is no category for medium community prevalence. We should assume high community prevalence during periods of lock-down in your region. During high community prevalence, testing should be restricted “to patients requiring urgent / essential tests only for immediate diagnostics of current illness”. During low community prevalence all other tests can be reintroduced, but “exercise testing, nebulisation, bronchial challenge tests, and other aerosol generating procedures should be limited to specific equipment and testing rooms”. The ERS expert group are expected to publish a more detailed document on individual test safety precautions.

 

 

 

6.1.4      The ARTP in the UK published guidance on 18th March 2020 3, with an update on 9th April and 26th May. This guidance refers to what lung function testing is appropriate during delay phase and during crisis phase of the pandemic. During crisis phase, blood gases and saturation checks are permitted, and spirometry should only be performed in exceptional circumstances. No other tests should be performed. During the delay phase all tests need to still be carefully clinically justified, but spirometry, diffusing capacity, lung volumes, FeNO, blood gases, and CPET, can be performed, and other urgent procedures in exceptional cases. On 24th August, the ARTP published updated guidelines for recommencing physiological services. The guidelines present a risk mitigation approach to restarting services using a patient, procedure, plant methodology. The higher the risk associated with the patient group and the test being performed, the higher the ventilation requirement needed in the laboratory.

 

 

6.1.5      ATS statement on website Advice regarding COVID 19 for Pulmonary Function Laboratories 4 states that ‘pulmonary function testing be limited to tests that are only essential for immediate treatment decisions, that the type of pulmonary function testing be limited to the most essential tests when possible, and that measures to protect both the staff and individuals being tested should be put in place.”

 

 

6.1.6      Other thoracic societies have published statements raising concerns for safety of patients attending for, and staff performing, lung function tests. These include the Chinese Thoracic Society (CTS)7,9, Canadian Thoracic Society, The Thoracic Society of Australia and New Zealand (TSAZRS/ANZRS)8, French society of respiratory medicine12, Turkish Thoracic Society13, Spanish Thoracic Society SEPAR11 and Italian Respiratory Society10.

 

 

 

6.2         Distinguishing between patient groups

 

6.2.1. The general guidance listed above does not distinguish between different patient groups. However, we know that some of the patients are more likely to generate an aerosol even when the physiologist follows careful procedures.

  • Patients with COPD or Bronchitis e.g. sputum induced by force manoeuvres.
  • Patients with chronic cough, g. those with CF or non CF bronchiectasis, as many lung function manoeuvres will trigger a bout of coughing
  • Spirometry naïve patients: Younger patients and very elderly patients, who are have a high probability of requiring several practice blows/efforts in preparation for spirometry or have a poor mouthpiece seal when performing a

 

  • Patients with tracheostomies

 

  • Patients on NIV/supplementary oxygen

 

 

 

  • Distinguishing between lung function tests

 

Test Classify as AGP Rationale PPE (consideration) Full- FIT tested mask, gloves, visor, apron
Spirometry (plus BDR) High risk for AGP High risk of patient coughing induced by test

BDR (by MDI/Spacer use only)

Yes (Full)
Diffusing Capacity Medium risk High risk of patient coughing induced by test Yes (Full)
Plethysmography Medium risk High risk of patient coughing induced by test Yes (Full)
Wash-in/Wash-out FRC tests Medium risk Contamination of circuits and analysers, O2 at high pressure causes room contamination. High costs Yes (full)
FeNO Low risk if maximal expiration not used Lower risk of coughing, patient is not required to perform maximal

expiration

Standard PPE
nNO Low risk if maximal expiration is not used Lower risk of coughing, patient is not required to perform maximal

expiration

Standard PPE
6MWT Medium risk Low risk patient not performing maximal exercise, easier to perform test with social distancing using Bluetooth monitor.

Patient wears mask.

Standard PPE
SPT No Standard PPE
Hypoxic Challenge Test

 

High risk

 

 

 

High flow O2 and high flow N2

 

 

Yes (Full)
Bronchial challenge

Methacholine/Mannitol

 

 

EVH

High risk

 

 

 

Ultra-High risk

No filter at mouthpiece.

Cough and sputum inducing off mouthpiece

 

High ventilation rates using gas, excessive droplet production-uncontrollable

Yes (Full) FFP3

 

 

 

 

Full and special room

CPET High risk Maximal ventilation rates of > 100L/min. No way of using filters. High ACH essential otherwise settling time> 3 hours Yes (Full) FFP3
Exercise induced asthma test High risk High risk of patient coughing induced by test Yes (Full) FFP3
Respiratory Muscle (MIP, MEP, PCF) High risk High risk of patient coughing induced by test Yes (Full)

 

      6.3      Home spirometry

 

6.3.1. The pandemic has encouraged dramatically increased utilisation of telemedicine. The NICE COVID-19 rapid guideline: Cystic Fibrosis6 recommends providing home spirometry where appropriate. A large amount of research is beingperformedinthisareaatpresent,anditiscertainthathomemonitoring isgoingtobemorewidespreadinfuture.

 

 

6.3.2    A TeleSpirometry subgroup has been set up among the IICMS Faculty of Respiratory to look into setting up pilot studies in telespirometry. As well as providing testing to patients who are too unwell to attend hospital, telespirometry may help provide direct access for primary care referrals especially as testing in the community may be too risky in the future.

Patients performing home spirometry will need to be trained by our physiology team, and ideally should have at least some of their manoeuvres remotely monitored during performance.

 

6.3.3    Please note that the purpose of home spirometry during this time is to reduce the risk of infection transmission and therefore such monitoring needs to be performed by video link. It is not appropriate for healthcare staff to be visiting patients’ homes to administer and supervise this spirometry.

6.3.4    Drive-through spirometry has been attempted and is potentially a novel opportunity to conduct spirometry in both the hospital and community setting. A pilot study was conducted in Sligo General Hospital. 2 patients attending the clinic were asked to return to their car and to park in a designated car park. Height, weight sex, age and symptoms were ascertained on attending the clinic and were entered into a portable spirometer. The portable spirometer with bacterial/viral filter attached was given to the patient and the technique for testing was described, the window of the car was then raised nearly fully and the spirometry manoeuvres were then completed under instruction from the Respiratory Physiologist. Once completed the patient was asked to once again park their car and to return to clinic. The results were then reported and printed and made available to the ongoing clinic.

            Unfortunately it was not sustainable as the weather deteriorated. A purpose built car-park with weather protection would likely be needed for this initiative to be successful in the future.

             6.4     Which patients should currently be tested?

 

6.4.1    According to the ERS Group 9.1-Lung Function testing during COVID-19 pandemic and beyond, when there is a low prevalence in the community then recommendations for the Post Peak Phase or Level 2 safety can be implemented. They state that although the risk of infection transmission is lower than during the peak of the pandemic, significant safety measures are still required.

 

 

6.4.2           During the high prevalence of the pandemic we should only be performing spirometry that is essential for clinical management. The phases are dynamic and will likely cycle between high to low in localised areas of Ireland.  The prospect of the phases ending but more likely to be a transitioning pattern. This phase is now relatively low, but may need to be reintroduced if we have a second peak of infection.

 

6.4.3           From June 8th 2020 the Irish government gave permission for the country to move to Phase 2 of their re-opening. This signalled we had moved to a low prevalence phase. In this phase we suggest it would be appropriate to offer testing in the following patients2:

 

  • Rapid Access Lung Clinic outpatients
  • CF inpatients
  • Pre-operative assessment for urgent surgery
  • Immunocompromised
  • Patients with severe airway disease where testing is essential for clinical management.

 

 

  • Due to a reduced testing capacity in laboratories during the pandemic, it may not be possible to offer tests for routine clinic review or annual assessment in stable patients. Even during this phase all tests will still need to be requested and justified by a Consultant and all will need to be checked by a senior physiologist prior to booking. If the transmission of the virus becomes stable/controlled, it may be possible for us to extend testing further, but the risks will need to be assessed by a respiratory consultant and senior physiologist. Decision making should consider the patient’s risk group and the type of test being requested, as well as the clinical

 

  • Lung function testing that is being performed as part of a research investigation should be assessed on an individual If it is an ongoing study or trial of an intervention, and lung function is a primary outcome or an essential part of safety monitoring, then ongoing testing may be appropriate. In all cases the study sponsor should explore the possibility of home testing rather than laboratory testing.

 

6.5           Pre-test screening

Current guidance is that all patients referred for lung function testing should undertake a pre-test questionnaire for COVID-19 symptoms within 3 days of their scheduled test and then again on the day of the test, prior to the test being performed. Any patient presenting with new symptoms consistent with COVID-19 such as cough, fever, loss of sense of taste or smell etc should be postponed until they are symptom free. Patients may undergo a COVID swab test prior to their test if this is in-line with local hospital policy. Patients who test positive should not have their lung function test performed. Patients who test negative will still be treated as potentially infectious as current screening has a false negative rate.

 

 

6.5.1   Inpatients: All inpatients should have a pre-test questionnaire for COVID symptoms prior to testing. Patients admitted to hospital may have a COVID swab in line with local policies. It is best to wait until receiving a result before proceeding with lung function testing. Patients who have a positive result should not proceed with testing, and should wait a minimum of 30 days post positive screen (ERS).

 

  • Outpatients: If the local protocol allows for widespread swabbing, the referring team may arrange for the patient to have a swab prior to their outpatient visit. This will need to be taken within a maximum of 72 hours prior to testing, Infectivity is highest around time of onset and for first few days, very low in most after day 7.

 

6.6      Pre-Test Symptom Questionnaire

A Pre-test symptom questionnaire should be conducted prior to lung function testing in all outpatients and inpatients, even if they have a negative COVID Swab test. Before the patient is tested, a phone call should be made within 3 days prior to testing to check they don’t have the symptoms listed below8 and this must be assessed again on the day of procedure.

  • Cough
  • Shortness of breath or difficulty breathing
  • Fever
  • Chills
  • Muscle pain
  • Sore throat
  • New loss of taste or smell

Symptoms may appear 2-14 days after exposure to the virus. People with these symptoms may have COVID-19: This list is not all possible symptoms. Other less common symptoms have been reported, including gastrointestinal symptoms like nausea, vomiting, or diarrhoea.

Please be aware negative COVID-19 samples may be falsely negative for a variety of reasons even though the patient is presenting with symptoms. If a patient has symptoms of COVID-19 or this is suspected, DO NOT TEST (ERS group 9.1 recommendations)3.

(Appendix 1 – ERS triage question before appointment)

 

  • List of screening questions

 

  Yes No
Have you been unwell recently with fever >37.8C    
Do you have a new or current cough?    
Have you recently loss your sense of taste or smell?    
Have you had a recent sore throat?    
Have you recently been suffering from extreme fatigue?    
Have you recently been complaining of headache?    
Have you been admitted to hospital recently?    
Did you have a recent COVID screen? If yes, please record result either positive/negative/pending    
Do you have diarrhoea? Or Vomiting?    
Do you have any other infections?    

 

Family member health checklist:

Has anybody else in the family been unwell recently with any of the following?

  • Fever
  • Cough
  • Shortness of breath
  • Diarrhoea
  • Muscle pains
  • Persistent or new cough
  • Loss of taste or smell
  • Is anybody suffering from extreme fatigue
  • Sore throat
  • Headaches

Since your/the last visit to hospital, has anyone in the family had a COVID-19 test?

If yes, please record the result either, POSITIVE/NEGATIVE/STILL PENDING Has anyone in the family had contact with someone known to be positive for COVID-19?

 

6.8           Risk assessment

A risk assessment should be conducted for every test and every patient before testing. The following questions should be considered:

Is the test essential for clinical management?

Is the patient likely to be coughing during the procedure?

Do they have a tracheostomy?

What PPE is necessary?

Patients should wear a surgical mask on arrival if they don’t already have one on.

Throughout testing, patients should be seated on the allocated seats 2m away (stickers on the floor can provide a guide).

Patients should be asked to wash their hands/hand gel before entering the lab. If the patient is touching equipment this will help try to eliminate contamination.

Patients who need to cough should be provided with tissues and encouraged to cough into the tissue, which should be disposed of in the clinical waste bins.

 

6.9           Organisational

6.9.1     Testing room: It is recommended by the ERS that AGPs should ideally be performed in negative pressure rooms. However, they do acknowledge that this is only available in specialist centres. The Centre for Disease Control’s guidelines on ventilation in health-care facilities14 state that the peak efficiency for particle removal in the air space occurs between 12 -15 air changes per hour (ACH). The table in the Appendix from the CDC document shows that for an ACH of 12-15, air-borne contaminates will be removed in approximately 20 minutes. Therefore, a wait time of >20 minutes post AGP is sufficient.

 

 

  • The air change per hour (ACH) of a room used for AGP has a direct impact on the duration of time it should be vacated following the test before cleaning4. For rooms with ACH of 12, the room should be left for at least 20 minutes before cleaning. A sign should be placed on thedoorwhentestingtoalertpeoplenottoThesignmustbeupdated once the AGP is finished, stating the time the procedure was finished. For performance of AGP, full PPE must be worn. Any items, that are not required for the test,should be removed from the testing room. Other staff members should not enter a room when an AGP is takingplace.

 

  • Working areas: Staff should try to maintain physical distancing of 2 metres wherever possible. In line with HSE guidelines, staff members are required to wear a surgical masks in all areas where a physical distance of 2 metres cannot be maintained.

 

6.9.4    Waiting rooms: Waiting rooms should be reconfigured so that patients waiting can maintain a distance of 2 metres. HSE guidelines recommends that patients should wear masks when attending for hospital appointments. Bookings should be spaced out throughout the day to minimise interactions between patients.

 

6.9.5    Test time: Additional time needs to be allowed while booking a test to ensure donning and doffing is performed appropriately as well as to allow sufficient time for decontamination of equipment and recalibration of measurement devices.

 

 

6.10        Personal Protective Equipment

 

6.10.1 The laboratory should follow the guidance of their local Infection Control team as guidelines may change over time.

 

  • When performing a Pulmonary Function Test (AGP) on any patient, the respiratory physiologist should wear the following PPE:
  • FFP3 mask
  • Eye protection-either googles or face shield
  • Gown
  • Gloves

 

7       Summary

This SOP hopes to give laboratories guidance in how they can safely re-open their services in the post peak phase of the pandemic. The IICMS Faculty of Respiratory recommends that labs use this a template to refine their own SOPs in accordance with their local Infection Control team’s guidelines. The Faculty will continue to work with the Irish Thoracic Society to update guidelines when it is necessary.

 

8             References

 

1.      Guidance on the Infection Prevention and Control measures required for Pulmonary Function Tests in the context of the COVID-19 pandemic

https://www.hpsc.ie/a-z/respiratory/coronavirus/novelcoronavirus/guidance/guidanceforhealthcareworkers/acutehospitalsguidance/IPC%20Measures%20for%20pulmonary%20function%20tests%20V1.0.pdf

 

 

  1. ITS/IICMS Guidance on Lung Function Testing: SARS COVID-19 Infection Version 3 19th May 2020

 

  1. Recommendation from ERS Group 9.1 (Respiratory function technologists

/Scientists) Lung function testing during COVID-19 pandemic and beyond

 

  1. COVID19 INFECTION CONTROL ISSUES FOR LUNG FUNCTION : Prepared by ARTP COVID19 Group Version 1.4: 21st May 2020

 

  1. ARTP Guidelines for recommencing physiological services during the COVID-19 endemic phase: August 2020

https://www.artp.org.uk/write/MediaUploads/Standards/COVID19/ARTP_COVID-19_endemic__guidance_Vers_5.6_final.pdf

 

  1. ATS: Pulmonary Function Laboratories: Advice Regarding COVID-19 Advice Regarding COVID-19 For Pulmonary Function Laboratories

https://www.thoracic.org/professionals/clinical-resources/disease-related- resources/pulmonary-function-laboratories.php Meredith C. McCormack, MD MHS David A. Kaminsky, MD

 

 

  1. Chinese Medical Association Respiratory Branch (2020). Expert consensus on lung function tests during epidemic prevention and control of new coronavirus pneumonia. Chinese Journal of Tuberculosis and Respiratory Diseases, 2020, 43. DOI: 10.3760 / cma.j.cn112147-20200225-00175. http://rs.yiigle.com/yufabiao/1183736.htm (Accessed March 31, 2020).

 

  1. Peak Respiratory Bodies recommend suspension of lung function testing (The Thoracic society of Australia and New Zealand) https://www.thoracic.org.au/documents/item/1864

 

  1. Task Force of Pulmonary Function Testing and Clinical Respiratory Physiology, Chinese Association of Chest Physicians; Pulmonary Function Testing Group, Respiratory Therapeutics Group, Chinese Thoracic Society. Zhonghua Jie He He Hu Xi Za Zhi. 2020;43(4):302-307. doi:10.3760/cma.j.cn112147-20200225-00175

 

  1. Bignamini, E., Cazzato, S., Cutrera, R. et al.Italian pediatric respiratory society recommendations on pediatric pulmonary function testing during COVID-19 pandemic. Ital J Pediatr46, 68 (2020). https://doi.org/10.1186/s13052-020-00829-0

 

  1. Rethinking Respiratory Function Test Lab in the Era of COVID-19 :

considerations about the “today” and the “day after”.SEPAR Spanish recommendation for prevention of infection in lung function https://www.aeped.es/sites/default/files/recomendaciones-de-prevencion-de-infeccion-por-coronavirus-en-las-unidades-de-funcion-pulmonar-de-los-diferentes-ambitos-asistenciales-20-mayo-2020-v2.pdf

 

  1. Recommendations of Group “Pulmonary Function” of the French Society of Respiratory Medicine (SPLF). http://splf.fr/centre-de-documentation-covid-19/

 

  1. Gemicioğlu B, Börekçi Ş, Dilektaşlı AG, Ulubay G, Azap Ö, Saryal S.

Turkish Thoracic Society Experts Consensus Report: Recommendations for Pulmonary Function Tests During and After COVID 19 Pandemic. Turk Thorac J. 2020;21(3):193-200. doi:10.5152/TurkThoracJ.2020.20

 

  1. Guidelines for Environmental Infection Control in Health-Care Facilities updates July 2019 CDC https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html

 

 

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