Download pdf - Laboratory Network Accreditation Pakistan … 5 GLI...Weighing balance 120 Water stills 115 Magnetic stirrers 84 Water bath 84 Standardized pack of lab supplies 115 Motor Bike 132

Laboratory Network

Accreditation Pakistan experience

Dr Sabira Tahseen

Pakistan

1 5th GLImeeting : Laboratory Network -

Accriditation

SETTING AND WORK DONE

Microscopy Network Accreditation – Pakistan experience

5th GLImeeting : Laboratory Network -Accriditation

2

PAKISTAN


3

DEMOGRAPHY

Population 181M

Area Total 796,095 km2

Density pop Avg : 225/sq.km

Provinces 5 +2

District 136

Climate Extreme variation in temp

HEALTH SYSTEMS

WEAK health systems

WEAK laboratory system

Large Unregulated private sector

MOH at Federal level devolved

Health is provincial chapter

PAKISTAN

Growth Rate :


4

Estimates of burden * 2011

# in thousands

Rate/100k

Mortality

(excluding

HIV)

59 33

Prevalence (incl HIV)

620 350

Incidence (incl HIV)

410 231

Incidence

(HIV-

positive)

1.5 (0.66–1.9)

Case

detection, all

forms (%)

64 (54–79)

6703

15446

21033

31557

48220

65711

88747

100103 101887

104263 105733

10435

23605

34550

45936

68337

82707

103629 106213

112948

105623 103824

2867

7940

12401 14862

22789 25797

33986 34386

43416 45443 45537

1335 2386 4923 4968 5087 5713

7398 7949 9200 8400 11407

0

20000

40000

60000

80000

100000

120000

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

New SS+ve New SS-ve

Extra-pulmonary Retreatment cases

TREND CASE NOTIFICATION

Laboratory network

Organization of lab network

National TB Ref lab

Provincial TB Ref Lab

District Intermediate lab

(115)

Microscopy lab

(1401)


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Situation /Activities MILE STONES

2000 >50 microscopy lab /NO NETWORK/NO NRL/NO IDL

2001 NRL/PRL – designated

2005 Microscopic network coverage in entire Public sector

2005-6 EQA piloted in one district

2006-9 EQA implemented to cover >90% of centers ; IDL established

2009 NRL started culture +DST services

2009-13 Expansion of TB culture and DST services

2010-11 TB disease prevalence survey

2011-13 Early implementation and expansion of XPERT

2012-13 Drug Resistance Survey

EQA AFB Microscopy –Process

Monitoring and evaluation

Data management Impact measurement

EQA – Implementation

Blinded rechecking OSE Panel testing

Organization and Strengthening of TB lab network-

Human resource development Networking /Infrastructure Equipment and supplies

Baseline assessment

GAPS in District laboratories GAPS in Microscopy .Lab

National guideline for QA Diagnosis Review district health sys Piloting Consensus building


Accriditation

BLINDED RECHECKING: EQA of Peripheral level

Microscopy Centers SSM, R & R, slide storage

Intermediate District Laboratories

Random slide collection during district level quarterly meeting,

Blinded Rechecking (First Level Controllers)

Provincial Reference Laboratory

Discrepancies Resolved during Provincial level meeting (Second Level Controller)

Feed back

Feed back


Accriditation

PANEL TESTING :EQA of Intermediate level

National Reference laboratory Preparation of Panel (10

stained+10 unstained ), M&E

Provincial Reference Laboratories

PT during OSV , Recheck discordant slides

Intermediate District laboratory

Feed back

Feed back


Accriditation

Laboratory support -2006-2012

Peripheral Laboratories (# -------- )

# %

Microscopes 1200 100%

Std supply of Packs 1200 100%

Intermediate District Laboratories

Weighing balance 120

Water stills 115

Magnetic stirrers 84

Water bath 84

Standardized pack of lab supplies

115

Motor Bike 132


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Laboratory HRD -2006-2012

Human Resource Development

Peripheral lab staff

# %

Initial training 1221 87

Refresher training 900 64

Intermediate lab staff

Initial training 97 84

Refresher training 70 60.8

Non Lab supervisors

training 117 86

Human resource development

National Reference laboratory

M and E officer 1

Lab supervisors 4

Provincial Reference laboratory

M and E officer 5

Lab supervisors 15


10

Laboratory data Management

Diagnostic Centre

District

Provincial reference lab

Monthly Lab report on Standardized format Quarterly report Compiled

Collection of DC Quarterly lab reports in Intra district meeting Validation and x- checking with TB03 Consolidation of District Quarterly lab Report Consolidated lab report submitted to PRL

District lab data entered on line and hard copy sent by Post

Provincial Data analyzed and feed back to DLS during quarterly meeting

National Lab Data consolidated analyzed Feed back to PRL


Accriditation

ACHIEVEMENT AND CHALLENGES



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ACHIEVEMENT : Microscopy & EQA coverage and Case notification

50

256

453

750

982 1026

1132 1163 1159 1181 1187

1401

12

324 360

940 1005

1106 1097 1088

0

10 14

20

26

41

54

60 59 59 59

0

10

20

30

40

50

60

70

0

200

400

600

800

1000

1200

1400

1600

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 (3Q)

#DC EQA coverage CNR SS+VE


Accriditation

CHALLENGES

• EQA implemented in phased manner, impossible to implement all at same time / loss of focus on earlier started.

• Shift of focus of NRL from smear microscopy after 2007 – too quick succession of recommendations by WHO: culture & DST network; LED FM; LPA;

Xpert. – Disease prevalence survey and drug resistance survey

• High human resource turn over : designation of non competent or willing worker as coordinator /controller by district

• Tendering procedures ,Procurement delay. and Weak logistic and supply system • Implementation and sustainability both are dependent on donor

funding compounded by time needed to plan and obtain budgets from donors • Autonomy of Provinces plus Variation in resources and commitment level ,? • Improving EQA system: involvement / handing-over to provinces; reporting and

monitoring system. • Weak Infrastructure : compounded by Frequent Electricity shut down


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ASSESSMENT RESULTS



Accriditation

PILOT TEST Microscopy network accreditation tool

• When : March-april 2012 • By Whom : • Dr. Armand Van Deun, The

Union and Antwerp SRL • Dr. Marijke Becx-Bleumink,

independent consultant • Where : 3 district of Punjab • Sites visited

– National Reference Laboratory (NRL), Islamabad,

– Provincial Reference Laboratory (PRL) in Lahore, N. Punjab

– 3-Districts Intermediate lab – 3-4 centres in each district


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STANDARD 1

The TB microscopy network structure , its services to the NTP, its management, future expansion and appropriate use (balanced with that of other available TB laboratory methods)are defined in a STRATEGIC PLAN


Accriditation

SITUATION

STRATEGIC PLAN – 2012-16 :

The sputum smear microscopy will continue to remain the method of choice for detecting TB cases among symptomatic persons seeking care at health facilities and monitoring of treatment response in smear positive cases.

countrywide program for blinded rechecking of the slides at regular intervals (EQA) will remain main axis securing the quality microscopy service

improving quality of services and coverage both in public as well as private sector


Accriditation

Standard-1 : Assessment

• Policies are sound and follow recent WHO recommendations (number of samples per suspect series; definition of a positive case; gradual introduction of LED fluorescence microscopy (FM), ...).


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STANDARD 2

• A national AFB-microscopy MANUAL with STANDARD OPERATING PROCEDURES exists, and is accessible in some format at all microscopy laboratories.


Accriditation

SOP :Microscopy laboratories

Sm & Staining

chart

R&R & microscope

Chart Manual


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Guideline /SOP

EQA Guideline

Supervisors training module

Training Module


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Standard-2 : Assessment

• National guidelines for AFB-microscopy as well as its EQA exist, besides training materials.

• Labs usually have an AFB-manual , as well as the global posters on AFB-microscopy or some handouts from training, BUT

• A true SOP or at least a few simple job-aides are lacking;

• The manual is not unequivocal on stain preparation


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STANDARD 3.

There is documented and recent evidence of complete COVERAGE of the population by AFB-microscopy laboratories, organized as a NETWORK.


Accriditation

Microscopy Coverage


25

50

256

453

750

982 1026 1132 1148 1159 1181 1187

1401

0

200

400

600

800

1000

1200

1400

1600

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 (Q3)

#DC

#DC

MICROSCOPY NETWORK Provinc

e /

Region

DHQ THQ RHC BHU TCH Others

NGO

/PVT

hosp

Private

labs Total

Avg.pop

cov/DC

Punjab 32 73 288 6 14 50 26 103 592 166184

Sindh 20 46 97 15 8 38 50 56 330 123833

KPK 24 15 73 8 4 59 21 29 233 102293

B. Tan 24 3 38 26 1 14 2 11 119 74205

FATA 7 2 5 2 0 10 0 0 26 161019

GB 3 0 2 1 0 12 4 0 22 54254

AJK 5 8 31 13 0 10 0 2 69 60911

ICT 2 3 1 1 3 10 100,000

Total 115 147 536 71 30 194 104 204 1401 129545


Accriditation

National Reference Lab (NRL) 181, 493, 127

4 Provinces & 3 Regions

(136 Districts)

PRL –

Punjab 98,380,749

36 Districts

PRL –

Sindh

40, 864, 740

23 Districts

PRL – KPK

23, 834, 242 24 Districts

PRL – Balochistan

8, 830,444 30 Districts

RL – FATA

4, 186, 501

07 Agencies

RL – AJK

4,202,854

10 Districts

RL – GB

1, 193, 597

06 Districts

36/36

27,32,798 Avg. Catch.

Pop/lab

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

26/23 (Inter. Labs)

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

15, 71,720 Avg. Catch.

Pop/lab

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

24/24 (Inter. Labs)

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

9,93,093 Avg. Catch.

Pop/lab

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

10/30 (#IDL/#district)

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

8, 83,044 Avg. Catch.

Pop/lab

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


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

5,98,071

Avg. Catch.

Pop/lab

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


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


Pop/lab

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


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


Pop/lab

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

592 (Total # DCs)

14 (Avg. #

DCs/Dist)

06 – 30 (Range #

DCs/Dist)

1,66,184 (Avg. Catch.

Pop. /DC)

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

- )

330 (Total # DCs)

12 (Avg. #

DCs/Dist)

06 – 56 (Range #

DCs/Dist)

1,23,833 (Avg. Catch.

Pop. /DC)

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

-

233 (Total # DCs)

08 (Avg. #

DCs/Dist)

05 – 17 (Range #

DCs/Dist)

1,02,293 (Avg. Catch.

Pop. /DC)

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

-

119 (Total # DCs)

3 (Avg. # DCs/Dist)

01 – 06 (Range # DCs/Dist)

74,205 (Avg. Catch. Pop.

/DC)

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

26 (Total # DCs)

04 (Avg. #

DCs/Dist)

03 – 05 (Range # DCs/Dist)

1, 61,019 (Avg. Catch.

Pop. /DC)

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

-

69 (Total # DCs)

7 (Avg. #

DCs/Dist)

03 – 07 (Range #

DCs/Dist)

60, 911 (Avg. Catch.

Pop. /DC)

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

-

22 (Total # DCs)

4 (Avg. #

DCs/Dist)

01 – 04 (Range #

DCs/Dist)

54,254 (Avg. Catch.

Pop. /DC)

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

-

01 NRL

04 PRL

03 RL

115 Intermediate Labs 1190 Diagnostic Centers


Accriditation

Standard 3 : Assessment

• Overall the NETWORK has been very well developed over the last 10 years, where it hardly existed before that time.

• With few exceptions, coverage is complete and efficient at one lab for about 150,000 population.

• The intermediate level is well developed with impressive numbers of dedicated and generally highly motivated, hard-working staff at districts and provinces


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STANDARD 4

Qualifications and number of staff required for performing AFB-microscopy and its EQA are appropriate and complemented by job descriptions and training curricula with sufficient emphasis on competence.


Accriditation

HR FOR MICROSCOPY SERVICES

Central level

• New induction

• M& E officer

• SLS

Intermediate

• Additional task to Designated staff

• EQA coordinator

• DLS

• X-checker

Peripheral

• Regular staff

• Micro-scopist


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Standard-4: Assessment

• impressive numbers of dedicated and generally highly motivated, hard-working staff at districts and provinces

• Training has been intensive and continues to be organised regularly at the PRL; however – there is a HIGH TURNOVER OF MICROSCOPISTS and

TOO LONG WAITING for formal training courses at the province;

– District supervisors try to train newly appointed staff during frequent visits, but also due to inadequate supervision support at this level this system seems unreliable

5th GLImeeting : Laboratory Network -

Accriditation 31

STANDARD- 5

External quality assessment targets all laboratories and includes regular supervision visits.


Accriditation

EQA coverage


1026 1131 1148 1159

1181 1187

1401

324 360

940 1005

1106 1097 1088

95 188

570 640

749 827 807

0

200

400

600

800

1000

1200

1400

1600

2006 2007 2008 2009 2010 2011 2012 (3Q)

# DC # DC under EQA # acceptable performance

52.2%

60.6%

67.7%

63.8%

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29.3%

75.3% 74.2%

Supervision visit 2012

Q1 Q2 Q3 Q4

National Reference Lab 42 24 47 15 128

Provincial Reference lab Punjab (North)

44 94 100 63 301

Provincial Reference lab Punjab (South)

122 99 96 94 411

Provincial Reference lab Sindh

46 75 19 60 200

Provincial Reference lab KPK

69 40 59 82 250

Provincial Reference lab Balochistan

55 37 50 75 217

Total 378 369 371 389 1507 5th GLImeeting : Laboratory Network -Accriditation

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Standard-5:Assessment

External quality Assessment

Rechecking EQA, on-site supervision and panel testing (for the intermediate level only) are regular and achieve almost complete coverage.

Selection of the sample of slides for rechecking is routinely done during the quarterly district meetings

Process of random selection of slides was properly done.


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EQA by Blinded rechecking

• Staining problem identified seems to have corrupted the rechecking EQA.

– Rechecking detects almost no errors in most districts of Punjab

– ? Blinding not done

• First controller performance on the rechecking series is not evaluated


36


EQA by Blinded rechecking

• Sufficient staff for EQA at district level, but have multiple tasks besides TB lab EQA,

• Sample size is on the high side (around 80 smears per year/lab, with some 25 labs per district). On the other hand

• Time for rechecking may be short.


Accriditation 37

Standard-5 :Assessment

EQA by panel testing

• The NRL prepares excellent sets of panel smears, (for controllers assessment)

• High-quality panel testing had revealed numerous and serious errors on the intermediate level (controllers)

• confirming that some controllers are unsuitable.

• Corrective action seems to lag behind


Accriditation 38

Standard-5 :Assessment

Supervision :

• Supervision has been intensive, but little effective

– Staining solutions has not been discovered

• insufficient guidance from National, aiming at building up a cadre of expert supervisors at intermediary level during joint site visits.


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STANDARD- 6

Globally standardized RECORDING AND REPORTING FORMATS for AFB-microscopy and its quality assurance are used at all levels of the network:

Workload , quality indicators and onsite observations all suggest good quality AFB microscopy for at least 75% of the labs


Accriditation

Standard -6 : Quality indicators laboratory Performance

Positivity rate Follow up examination

0,9% 1,1%

1,4% 1,7%

2,2%

2,6%

3,7%

4,6%

5,6%

6,1%

5,8%

5,2%

0,0%

1,0%

2,0%

3,0%

4,0%

5,0%

6,0%

7,0%

2006 2007 2008 2009 2010 2011

P-1 P-2 P-3 P-4 R-1 R-2

Positivity rate Suspect examination

12,8% 13,6%

14,5% 15,3%

14,6% 14,6% 14,2%

18,8% 18,1%

21,2% 21,1% 21,0%

16,5% 16,2%

18,6% 17,8%

15,4%

18,0%

31,4%

22,9%

17,5%

7,5%

12,5%

17,5%

22,5%

27,5%

2005 2006 2007 2008 2009 2010 2011

P-1 P-2 P-3 P-4 R-1 R-2


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Standard -6 : Assessment

• Staining problem identified ( quality of stain and stain preparation staining technique).

• Workload ideal in small but excessive in the larger hospitals,

• Work load left to only one of the many staff present; • this makes high quality work impossible, even if stains

and microscopes were good. • Data on the network are exceptionally complete, both

for rechecking and routine performance figures, and seem to indicate very good quality

Internal quality control has been set up, mainly for the staining solutions.


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STANDARD 7

The NRL manager or laboratory specialist of the NTP ensures excellent control over microscopy network supplies and equipment


Accriditation

Standard -7: Assessment

• Many new microscopes have been procured and distributed, as well as equipment for stains preparation at intermediate level


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Standard -7: Assessment

• Good new microscopes (Olympus CX21) by the NTP are not in use by the TB microscopists

• Stock outs of essential supplies, mainly sputum cups , H2SO4 acids and sometimes slides

• Regulations for tenders and use of funds are such that many procurement turns out to be local, with little or no guarantee of uniform quality.

• Buffer stocks are now totally inexistent and very few stocks are left at these levels.

• In principle sound supply system has been set up, largely decentralised to the provinces but there is no good system for control of supplies (inventory taking & reporting largely lacking)


45

STANDARD: 8-11

STANDARD ASSESSMENT RESULTS

Standard -8 Private sector

Satisfactory but difficult to sustain

Standard -9 Dedicated Budget

Yes ( Government + Donor funding)

Standard-10 Safety Satisfactory

Standard -11 Referral mechanism

Weak


46

CONCLUSION

• on-site visits uncovered serious deficiencies.

• Since the visits could reach only districts of the N. Punjab province, it is possible that these do not exist in other parts of the country.

• However, at this point “AFB-microscopy services in Pakistan may not reach the level of performance required for accreditation of the network”


Accriditation 47

Conclusion

• Setting up / maintaining good network very demanding:

• Accreditation assessment forces to recognize the problems clearly and useful to correct, even if it doesn't lead to accreditation.


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