Malaria Microscopy Quality Assurance Forms by JeffreyVdeGuzman

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									                                                      Annex 6.1

                               Form 1.      Malarial Blood Films for Validation

(1) Quarter: ______________ (2)Year: __________ (3) Province: _______________________________
(4) Municipality: ___________________________ (5) Barangay: ______________________________
(6) Facility Name: ______________________________________________________________________
(7) Type:      BMMC        RHU       Gov t Hosp      Private Hosp      Others (Specify _______________)
(8) Total No. of blood films submitted: /___/___/___/ (9) Total No. of blood films examined for the quarter:
____
(10) Total No. of Positive for the quarter: ______    Pf ___ Pv_____Pm______ Mixed_______

         Slide ID     Date Examined                    Malaria Blood Film Result                         Remarks
           No.         (mm/dd/yyyy)         Species      Parasites/ul       Parasites/ ul                  (16)
           (11)            (12)              (13)         blood (t, s)           blood
                                                              (14)          (gametocytes)
                                                                                  (15)
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Examined by:           _____________________________________
                      (Signature over printed Name of Microscopist)

Date of Submission: _____________________________________
Noted by Head of Facility: _________________________________
(Note: This form must be submitted in a sealed envelope to the designated supervising validator together with the slides.)
                               Instructions in Accomplishing Form 1

   (1) Quarter          :       Specify the quarter when validation is undertaken
                                Example: 1st , 2nd, 3rd, 4th)
   (2) Year              :      Specify the year the validation is undertaken
                                Example: 2009
   (3) Province         :       Write the complete name of the province
                                Example: Agusan del Sur
   (4) Municipality     :       Write the complete name of the municipality
                                Example: Mainit
   (5) Barangay         :       Write the complete name of the barangay
                                Example: Canluran
   (6) Facility Name    :       Write the complete name of the health facility
                                Example: Esperanza RHU
   (7) Facility Type    :       Tick the appropriate description of the facility
                                Example: BMMC  RHU  Govt. Hospital  Private Hospital
   (8) Total number of :        Write the exact number of blood films submitted to the validator
       blood films submitted    Example: /0/3/0/

   (9) Total No. of blood:      Indicate the total of blood films examined, whether positive or
       films for the quarter    negative Example: 065

   (10) Total No. of Positives: Indicate the number of positive blood films, by type of
        For the quarter         species: Pf, Pv, Pm, Mixed

Columns 9-16

(11) Slide ID Number:   Copy from the Logbook the ID assigned to the particular blood film and
                        transfer to Column 9.
(12) Date Examined:     Write the actual date the blood film was examined by the microscopist
(13)Species      :      Write the Plasmodium species seen.
                        For P. falciparum, F (trophozoite only)
                                             Fg ( gametocytes only)
                                             F + g (trophozoites and gametocytes)
                                             F w/ schizont (trophozoites and schizonts)
                                             F + g w/ schozont (trphozoite, gametocytes and schizont)
                        For P. vivax all or any stages seen                              V
                        For P. malariae all or any stages seen                           M
                        For P. ovale all or any stages seen                              O
                        For mixed infections:
                            Any or all stages of Pv and gameticytes of Pf                VFg
                            Any or all stages of Pv and trophozoites only of Pf          VF
                            Any or all stages of Pm and gametocytes of Pf                MFg
                            Any or all stages of Pm and trophozoites only of Pf          MF
                            Any or all stages of Pv and Pm and gametocytes of Pf         MVFg
                        No malaria parasite seen                                         NMPS

(14-15) Parasite Counts: Applicable only for medtech (RHU/hospital/lab. Facility). Transfer the
                        number of counts from the Malaria Registry (Diagnosis Logbook) to Column
                        14 if asexual (t,s) and in Column 15 if sexual

(16) Remarks :          Indicate if slides were referred for reading and specify the source of
                        the blood films
                        Example: BHWs or field assistant workers were the one who took the
                        blood films



                                                                                                   13
                                             Annex 6.2
                         FORM 2. MALARIAL BLOOD FILMS REPORT BY VALIDATOR

   (1) Quarter ___________ (2) Year: __________                (3) Province: _______________________________

   (4) Municipality/City ___________________________                        (5) Barangay: ________________________

   (6) Facility Name: _______________________________________________________________________

   (7) Type:     BMMC         RHU         Gov t Hosp     Private Hosp        Others (Specify ____________________)

   (8) Total No. of blood films received: /___/___/___/        (9) Date blood films Examined: __________________


        Slid     Microscopist s Results         Blood Films Results by        Reading
                                                                                              Smear Quality Assessment
        e ID             (11)                         Validator               Accuracy
                                                                                                       (14)
        No.                                              (12)
        (10)   Type of      Count   Count     Specie     Parasit   Paras       - no      Smear      Staining     Remarks
               Species     (asexu   (Sexu        s        es/ ul    ites/         error             G- Good
                (11a)      al)        al)      (12a)     blood        ul                  G- good      stained    (Describe
                           (t,s)    (11c)                 ( t, s)  blood      X - with      smear   U- under        smear
                           (11b)                          (12b)    (gam           Error   P-poor       stained   assessment
                                                                   etocyt     (13)         Smear    O - over       results)
                                                                     es)                   (14a)                    (14c)
                                                                   (12c)                            Stained
                                                                                                      (14b)
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Total                                                                             No. %
                                                                              /
                                                                              X




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                                           Instructions in Accomplishing Form 2

(1) Quarter           :           Specify the quarter when blood films were submitted
                                  Example: 1st , 2nd, 3rd, 4th)
(2) Year              :           Specify the year the blood films were submitted
                                  Example: 2009
(3) Province          :           Write the complete name of the province
                                  Example: Agusan del Sur
(4) Municipality/ :               Write the complete name of the municipality or city
    City                           Example: Mainit
(5) Barangay        :             Write the complete name of the barangay
                                  Example: Canluran
(6) Facility Name:                Write the complete name of the health facility
                                  Example: Esperanza RHU
(7) Facility Type :               Tick the appropriate description of the facility
                           Example: BMMC          RHU           
                                                              Govt. Hospital           
                                                                                Private Hospital
(8) Total number of:       Write the exact number of blood films received by the validator
      blood films received Example: /0/2/5/
 (9) Date Examined:        Write the actual date the blood films were examined by the validator

Columns 10-14
(10) Slide ID number:             Write the ID number as it appears on the blood film
                                  Example: ASDS09-1-1001 (Agusan Sur, Year 2009, Microscopist 1, Slide # 1
(11)Microscopist s:               Copy the microscopist s results into Columns 11a Species, 11b Count
    Results                       (asexual) and 11c Count (sexual) from Columns 13-15 in the accomplished Form 1
                                  submitted by the microscopy center
(12a) Validator s Result:         Write the results of validation in terms of the type of Plasmodium species seen
                                  For P. falciparum, F (trophozoite only)
                                                      Fg ( gametocytes only)
                                                      F + g (trophozoites and gametocytes)
                                                      F w/ schizont (trophozoites and schizonts)
                                                      F + g w/ schozont (trphozoite, gametocytes and schizont)
                                  For P. vivax all or any stages seen                              V
                                  For P. malariae all or any stages seen                           M
                                  For P. ovale all or any stages seen                              O
                                  For mixed infections:
                                       Any or all stages of Pv and gameticytes of Pf               VFg
                                       Any or all stages of Pv and trophozoites only of Pf         VF
                                       Any or all stages of Pm and gametocytes of Pf               MFg
                                       Any or all stages of Pm and trophozoites only of Pf         MF
                                       Any or all stages of Pv and Pm and gametocytes of Pf        MVFg
                                  No malaria parasite seen                                         NMPS

(12b) Validator s Result:         Write the results of validation in terms of the parasite counts   asexual

(12c) Validator s Result:         Write the results of validation in terms of the parasite counts   sexual

(13) Reading Accuracy:            Results must be of the same species and counts must be within the range of +/-
                                  20% from the validator s count to be accurate (). If at least one result not
                                  consistent, mark the reading accuracy with X.

(14a) Smear Quality           :   Put a G if the smear is good; and P if the smear is poor.

(14b) Staining Quality :          Put a G if the staining is good, U if it is under-stained and O if over-stained

(14c) Remarks             :       Write down relevant comments or observations regarding the smear, e.g. smear
                                  too thick or too small, blood film not fit for diagnosis. Validator s remarks or
                                                             general 3
                                  comments may include aAnnex assessment on the quality of smears and
                                  staining and suggestions on how to improve them if necessary.


                                                                                                                     15
                                          Annex 6.3
                            Form 2a. VALIDATION SUMMARY REPORT

Report prepared by:

For CHD/PHTO/PHO:

for the attention of:
(name of microscopist
and head of laboratory/
facility)
Date report prepared:

SUMMARY OF RESULTS:
No. of blood films
received:
Date received:
Date of Validation:
Correct Diagnosis:            No. of blood films correctly   Total No. of blood films    % accuracy
                                      diagnosed                     validated

Wrong Diagnosis:              No. of blood films wrongly     Total No. of blood films     % error
                                      diagnosed                     validated


Interpretation of Results




Validator s Comments
and Recommendation



Schedule and slide
selection scheme for
next validation:
Schedule of on-site visit
(if applicable):
                                   Name                                      Signature
Validator:
Supervisor:
Date:
Copies of Report to:   Microscopists, MHO, PHO
                       Head of Laboratory/Facility
(Note: Hard and electronic copies to be retained by the validator.)




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                                         Annex 6.4
                            Form 3. On-Site Supervisory Checklist


I. General Information
(1) Name of laboratory/facility:                      (2) Date of Visit (mm/dd/yyyy)
                                                           /__/__/-/__/__/-/__/__/__/__/
(3) Type of facility:      BMMC        RHU           Gov t Hosp            Private Hosp
Address of the laboratory: _________________________________________________________
                             No./St.       (4) Municipality               (5) Province
Telephone/Mobile/Fax: _____________________     E-mail: ______________________________
Name of head of laboratory:
Name of facility head/director:


Name of Microscopist: __________________________________________________________
Date of last training: /__/__/-/__/__/-/__/__/__/__/ No. of MTs in the Laboratory:
 (on Malaria)            mm      dd        yyyy
II. Procedures
A. Archiving of blood films
    Average number of blood films read/month
    No. of blood films read/ day*:
    No. of blood films archived/assessed by validator:
    (* For highly endemic areas) maximum of 10blood
films
B. Smear Preparation
    No. of blood films reviewed (maximum of 10 blood                         Quality (%)
films)                                                 YES         NO         Good     Poor
                                                                             _____ _____
     Thick and Thin blood film prepared?                                     _____ _____
     Staining Technique used: Giemsa                               If NO, specify__________

C. Performance (Review of slides)                             Q1        Q2
   1. Cross-checking or Validation
      No. of blood films cross-checked by validator
      Sensitivity (%)
      Specificity (%)
      Accuracy (%)
   2. Reference blood films (EQAS)
      No. of blood films read
      Sensitivity (%)
      Specificity (%)
      Accuracy (%)
III. Microscopy Set-up                                     Good    Poor         REMARKS
1.   Bench space
2.   Sink / washing area/staining area
3.   Power source
4.   Ventilation (airconditioned/fan/exhaust/windows)
5.   Table/space for (storage) of supplies and materials
6.   General condition of microscope (with spare bulb)



                                                                                          17
IV. Laboratory Supplies                                     Yes   No   REMARKS
1. Slides*
2. Lancets*
3. Giemsa stain (If other than Giemsa stain is used,
   specify under remarks.)*
4. Buffer salts*
5. Staining jar
6. Drying rack
7. Graduated cylinder
8. Methanol*
9. Immersion oil (brand)*
10. Tally counter
11. Lens paper*
12. Slide boxes for storage
13. Alcohol/cotton*
V. Documentation
1. Log book/record book                                     Yes   No   REMARKS
1.1. Log book / record book located in the lab?
1.2 Name/age/address/sex/date/travel history of
     patients recorded neatly and legibly?
1.3 Date blood film collected/received recorded?
1.4 Species identification performed?
1.5 Parasite counting performed? (If yes, specify method
    used under remarks column, i.e., plus system/semi-
    quantitative or quantitative)
2. Forms
2.1 Request forms used?
2.2 Result/Report forms accomplished?
2.3 Referral forms used?
3. Manuals
3. 1 Technical Manual (SOP for Malaria)/ Bench Aids
    located in the lab?
3.2 Microscope manufacturer s operating manual
    available?
4. Logbook for Maintenance Records available?
VI. Biosafety
1.   Wearing of protective gowns?
2.   Wearing of gloves?
3.   Containers for dry waste/trash?
4.   Containers for infectious materials?
5.   Puncture resistant container for sharps and needles?
VII. Type of Waste Disposal
 1. burying or deep pit
 2. cemented septic vault
 3. Others (specify)



                                                                             18
VIII. Results of Staining and Smearing
Demonstration (if needed)




Key Findings, Actions Taken and Recommendations
        Findings                   Actions Taken   Recommendations




                                                                 19
                                                               Annex 6.5

                                                 Form 4. Consolidated Validation Report
                                                          Quarter: __________


I. Summary of Findings, Actions Taken and Recommendations

                Key Findings                                 Actions Taken                Recommendations and Follow-up
II. Results of Validation by Facility (Blinded Re-checking of Sample Blood Films)
  Health           Area      Microco    # of blood     Date        Date       Type                Validation Result                  Quality of      Quality of     Remarks
  Facility                    spist        films       blood    blood films    of                                                    Smear (%)      Staining (%)
                                        submitted      films     validated    Error   Accuracy     Sensitivity        Specificity   Good     Poor   G     O     U
                                                     received




III. Results of On-Site Validation
      Facility                     Procedures                           Microscopy       Laboratory          Documentation          Biosafety   Type of       Observed
                                                                          Set-up          Supplies             (Logbook,                         Waste       Performance
                                                                                                             Record Book ,                      Disposal       (if done)
                                                                                                              Manual and
                      Archiving of     Blood Film    Review of                                                   Forms)
                      Blood FIlms      Preparation   Blood Films




Prepared by    :          ___________________________                                  Noted by          :        ____________________________
                                                                                                                     Malaria Validator Supervisor


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