samara sri nathella sampathu chetty clinical …iso 15189 : 2012 - management review meeting -21...

SRI NATHELLA SAMPATHU CHETTY CLINICAL LABORATORY (UNIT OF MEDICAL RESEARCH FOUNDATION) Minutes of the

MRM Review Meeting -21

SAMARA NETHRALAYA

Al ,A ISO 15189 : 2012 - MANAGEMENT REVIEW MEETING -21

Management Review Meeting of SNSC performance based on Internal Audit

Audit cycle — 11 (2016), Jul to Dec 2016 : Dated 09.03.2017

Attendance: By list (list enclosed). The representations were from the SN main lab for Haematology and

Clinical Pathology, Clinical Biochemistry, Sp. Biochemistry, Microbiology and Serology, Histopathology,

Cytogenetics and the Support Services, CSFU, HRD, Commercial, Biomedical, Training Dept, IT Dept,

All Internal auditors &NABH - Coordinator

The stipulated agenda points presented by the Duality Manager, Dr. N. Angayarkanni.

a) The periodic review of requests, and suitability of procedures and sample requirements.

b) Assessment of user feedback.

c) Staff suggestions.

d) Internal audits.

e) Risk management.

0 Use of quality indicators.

g) Reviews by external organizations.

10 Results of participation in inter laboratory comparison programmes (PT/EQA).

i) Monitoring and resolution of complaints.

j) Performance of suppliers.

k) Identification and control of nonconformities.

1) Results of continual improvement including current status of corrective actions

and preventive actions.

m) Follow-up actions from previous management reviews.

n) Changes in the volume and scope of work, personnel, and premises that could

affect the quality management system.

o) Recommendations for improvement, including technical requirements.

Issue Date :20.03.2017 of 12

Prepared & Issued by:

Quality Manager ea' Cilt---- A

Approved by: C\c}.---AciL(tycar&e.

Management Representative



SAND" NETHRMM

1I ISO 15189 : 2012 - MANAGEMENT REVIEW MEETING -21

Audit Team Members and Audited labs/Support services : Internal audit conducted based on

new standard ISO 15189 : 2012 for the following departments

• Quality System : : Ms.Saumya.T.S

• Front Office & Pre analytical area : Dr.J.Malathi

• Clinical Pathology and Hematology : Ms.R.Punitham

• Clinical and Special Biochemistry : Dr.S.Sripriya

• Clinical Microbiology and Serology : Dr.S.R.Bharathi Devi

• Histopathology and Cytopathology : Dr.N.Angayarkanni & Dr.T.Spandana

• Human Resource Department : Ms.Rajalakshmi

• Commercial Department : Ms.R.Punitham

• Central Sterilization Facility Unit : Ms.R.Punitham

• Biomedical Department : Ms.R.Punitham

• Information Tech Dept : Ms.Rajalakshmi

SNSC Collection Centre-Pycrofts Road : Ms.B.Hema

Non-NABL

• Genetics : Ms.U.Jayanthi

• SNSC Collection Centre - NSN : Ms.B.Hema

a. The periodic review of requests, and suitability of procedures and sample requirements:

This has been reviewed for the two quarters in the last 6 months, dept wise. Corrective

actions were taken wherever applicable. The key points are :

• MOU for outsourcing laboratory tests between MRF, 21 pycrofts Road and MRF,

41, College road, Chennai-600 006 is renewed valid for 3years, Date: 09/10/2016 to

08/10/2019.

• MOU for outsourcing laboratory tests between MRF & Lister Metropolis is renewed.

MOU valid for two years, Date: 01/12/2016 to 01/12/2018.

Issue Date : 20.03.2017 of 12


Quality Manager

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i I ISO 15189 : 2012 - MANAGEMENT REVIEW MEETING -21

• In cl biochemistry, due to improved version of the kit, creatinine reference range has been

changed since 02.06.2016.

• New Equipment, Dade Dimension RxL clinical chemistry fully automated Analyzer

(Siemens) has been installed in Biochemistry Lab (30.12.2016) and monitored until EQAS

ie until Feb 2017.

• Inter Laboratory Comparison (ILC) for Antibodies to Aquaporin-4/NMO has been made

twice a year

•Dr.T.Spandana joined as Assistant Professor in Clinical Biochemistry Lab on 19.08.16.

• Dr.T.Spandana was trained in ISO 15189: 2012 and subsequently got authorized

signatory ship in clinical biochemistry as on 18.01.17 in the field of Clinical

Biochemistry.

b. Assessment of user feedback:

This analysis is done in SN-Main lab (CI.Haematology, CI,Pathology, CI.Biochemistry &

SNSC Collection Centre — Pycrofts Road), Microbiology and Histopathology labs.

Internal customer feedback: The observed measures (Jul - Dec'16) are above the

objectives stipulated , in all the laboratories.

• Histopathology & Cytopathology (Jul - Dec'16) : 92% (Objective - 80%)

• Microbiology & Serology (Jul - Dec'16) :91% (Objective - 80%)

• Main lab (Hematology, CI.Pathology and CI.Biochemistry and

SNSC Collection Centre - Pycrofts Road) (Jul - Dec'16) :85% (Objective - 80%)

External customer feedback:

• SN Main lab: Collection, CI.Haematology, CI.Pathology, CI.Biochemistry

(Jul - Dec'16) : 91% (Objective - 85%)

• SNSC Collection Centre - Pycrofts Road (Jul - Dec'16) :90% (Objective - 80%)

Issue Date :20.03.2017 of 12


Quality Manager N. 0

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Approved by:


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SANWA NEW DAIWA

I s ISO 15189 : 2012 - MANAGEMENT REVIEW MEETING -21

• Staff suggestions: 7 (Jul - Dec'16)

Approved- 5;

• Mantoux reading on the particular date can be mentioned in the notice board in the

collection area by the technicians. After taking the reading the names can be removed

from the notice board

• Provide sterile swab tissue paper for the swab collection area

• Provide backrest revolving stools / chairs for Microscopy & Verification in computer

REH Blood Collection timing to be revised to: 11.00am -2.00pm, to enable

transportation on time so that the time period between time of collection and analysis

of the samples can be reduced as well as the lysis of RBCs can be prevented.

Name board for Pediatric Collection area

Not Approved — 2 (Name board for HOD room and Swab collection area; to

allow breakfast time for 7.30am duty)

d. Internal audits:

• Internal audit - 11 (2016) conducted by Internal Assessors based on New Standard

ISO 15189 : 2012: all the NCs have been closed. (Minor NC-31, Major NC-19).

e. Risk management : (Based on CAPA)

• Clinical Hematology : Mantoux Injection given to the wrong patient (pre-analytical error:

patients identity), Wrong updating of report and verification of Platelet count, Hb value

remarks not included (Post analytical).

• Clinical Biochemistry: Critical Alert updated with mistaken patients identity, Blood sugar,

Globulin values was wrongly updated (Post analytical error).

• Microbiology & Serology: RPR report was wrongly uploaded. The Identification of Gram

Positive cocci isolated from urine was wrongly updated, The sensitivity of Acinetobacter

calcoaceticus isolated in culture to colistin was reported as resistant. (Post analytical error).

Issue Date : 20.03.2017 I of 12


Quality Manager N . 3%-\---

Approved by: cmcLadocadtm..,

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SANWA NETHRMAYA

Al Ile. ISO 15189 : 2012 - MANAGEMENT REVIEW MEETING -21

• Histopathology: Due to shortage of Manpower, Increase in workload especially number of

Frozen and Permanent sections, time taken for completion of processing, embedding,

sectioning, staining took 3 working days due to which turn around time (TAT) has exceeded 4

working days. (Analytical/Post analytical error).

Recollection / Amendment of reports / CAPA were done as warranted in the above cases.

1. Use of quality indicators: Quarterly reports from all the labs monitored by QM.

• Pre Analytical : Sample collection, Transport time, Repeat & Rework : All are within the

objectives (Jul - Dec'16)

• Analytical : (Internal & External QC, Equipment down time) All are within the objective

from Jul - Dec'16; except : Clinical Haematology — EQAS & IQC, Clinical Biochemistry —

EQAS & IQC, Microbiology & Serology - Equipment Down Time (Autoclave) : CAPA

documented

• Post Analytical : (Turnaround time, Amendment test reports) All are within the objective

From Jul - Dec'16; except : Clinical Biochemistry, Histopathology, Microbiology &

Serology - Turn around time : CAPA documented.

• Feedback forms (Internal & External) have been reviewed. Corrective actions were taken

wherever applicable.

g. Reviews by external organizations:

• Tamil Nadu Pollution control Board certificate for disposal of waste (Air, Water &

Biomedical waste) Renewal of Certificate was done on March 2016 (Validity till 31.03.2018)

for SNSC Collection Centre at Pycrofts road (JKCN Centre), Chennai.

• Absolute Alcohol Renewal of license done on April'16. Valid up to Mar-2017.

• GJ Multiclave (For Biomedical waste) renewal has been done on May 2015 for SN Main,

SNSC Collection centre — Pycrofts road (Valid upto May 2018)

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of 12


Quality Manager

Approved by: A6219kailM

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SRNKARA NETHRALAYA

Al 1. ISO 15189 : 2012 - MANAGEMENT REVIEW MEETING -21

• Biomedical Department : Renewal of Calibration Certificate done from Jul - Dec'16

• Digital Multimeter — 16.09.2016— 16.09.2017

• Digital Tachometer - 19.09.2016 — 19.09.2017

• Weight box — 27.12.2016 — 27.12.2017

• Indicator with Sensor - 20.04.2016 — 20.04.2017

• Digital stopwatch -28.12.2016-28.12.2017

• BP Apparatus - 19.12.2016 — 19.12.2017

• Glass Thermometer -21.12.2016-24.12.2017

• Maintenance Department: Renewal of Calibration Certificate done From Jul — Dec'16

• Temperature Indicator with Sensor -25.11.2016-25.11.2017

• Hygrometer - 23.11.2016 — 23.11.2017

h. Results of participation in inter laboratory comparison programmes (PT/EOM):

• This has been reviewed for the two quarters in the last 6 months, From Jul - Dec'16

dept wise : Satisfactory Results except : Clinical Biochemistry — ILQC.

• MOU with Lister lab for Inter Lab Comparison : Renewal has been made and is valid till

July 2017.

i. Monitoring and resolution of complaints:

• Based on Internal & External feedback forms (Jul - Dec'16) actions were taken and the issues

settled (as in point b)

j. Performance of suppliers:

• Vendor evaluation completed for the period of (Jul - Dec'16) is given by commercial dept.

• Vendor Complaint for the period of (Jul - Dec'16) : 3 Complaints (Settled)

Issue Date : 20.03.2017 1 of 12


Quality Manager e) .

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Approved by:

Management Representati

SANKARK NETHRAIAYA

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MRM Review Meeting -21 ISO 15189 : 2012 - MANAGEMENT REVIEW MEETING -21

k. Identification and control of nonconformities :

• Daily non conformances are documented in all the laboratories and discussed in the

respective departmental lab meetings for corrective action. CAPA are documented as

warranted

• As requested by QM, all technical and non-technical staff including secretaries are

encouraged to independently state the daily NC in a timely manner in the records followed

by supervisors' attestation.

I. Results of continual improvement including current status of corrective actions and

preventive actions :

Continual Improvement: (Jul to Dec 2016)

Quality System :

Procedure for Disenabling computer login/ HMS/ EMR/email id access for specified roles once notified by HR department on resignation/ separation of services has been updated

• Guidelines for Vaccination procedure has been updated

• Flow chart for arrival of material has been updated.

Floor cleaning procedure has been updated.

• Vendor evaluation procedure has been updated

Master List of Forms and Records has been segregated department wise

• Duties of Assistant Professor has been updated

• Room temperature & Refrigerator Temperature procedure has been updated.

• Contingency plan during disasters has been framed and this needs further improvement after discussion with DPS/HR and the management.

Issue Date : 20.03.2017 of 12


Quality Manager 34'



SAMARA NETHRKLAYA

i. I ISO 15189 : 2012 - MANAGEMENT REVIEW MEETING -21

Haematology & Clinical Pathology:

• Started using Blood transfer device for all the vacutainer tubes (Mar'16)

Vesmatic 20 (Sr. No:2329) ESR Analyzer installed on 2/8/16

Coulter Act 5diff AL (Sr.No:AY I8085)-Hematology Analyzer installed on 19/9/16

• Doom centrifuge installed on 4/10/16 at clinical pathology dept

• New Water bath installed on 21/10/16

• Pre analytical area -Measures for registration errors implemented from Dec'16 onwards

• Blood collection-Started using tube holder for ESR tubes (Dec'16)

Clinical & Special Biochemistry

• The Dade Equipment budgeted was approved by the management which was installed on

30th Dec'16.

• As per schedule the training programme were implemented.

• Ms.Logeswari lab technician joined on 14th July 2016, she has been trained for routine work

and operation of automated equipments (Dade Behring, Cobas CI I I & AVL Analyzer).

• Ms.R.Punitham, Dr.T.Spandana & Ms.Gayathri attended CME Programme.

• Dr.T.Spandana attended ISO 15189 : 2012 Internal Audit & Quality Management System

Training at Cancer Institute, Chennai and got signing authorityship from 18.01.17 onwards

• Dr.T.Spandana participated & presented the poster in the "1SIEM 2017" Conference & Lab

Workshop on 10th & Il th Feb 2017 & Dr.S.R.Bharathi Devi participated in the Lab

Workshop on 10th Feb 2017.

• Sodium fluoride vacutainer tube changed from powder form to coated form. (BD company to

Grainer company).

Issue Date :20.03.2017 of 12


Quality Manager & . dri-

Approved by: -tot 0




SANWA NETHRALOYA

.i. I ISO 15189 :2012 - MANAGEMENT REVIEW MEETING -21

Histopathologv lab:

Proficient testing is in place. New technicians (BSMLT) were trained in histopathology

techniques.

Microbiology lab:

• All authorized final reports of positive serology test results was uploaded in HMS within 60 minutes from the time of completion irrespective of turn around time.

Corrective action & Preventive action :

• Quality Control Programme: Internal and External QC, 1LQC, PT programme in each of

the lab has been verified. The labs have taken appropriate corrective actions as required

• Measure on QC is verified quarterly by QM as part of Quality Indicator.

m. Follow-up actions from previous management reviews:

• ISO 15189 : 2012 Internal Audit & Quality Management System Training attended by

Dr.S.R.Bharathi Devi, Dr.S.Sripriya, Dr.T.Spandana & Ms.B.Hema.

• SNSC Staff members attended CME Programme organized by SN Academy

• Requisition form to be made in HMS- shall be followed up

n. Changes in the volume and scope of work, personnel, and premises that affect QMS :

List of NABL Accreditation tests at SNSC Clinical laboratory approved in the

recertification audit (validity)

• Clinical Haematology : 20 and Clinical Pathology : 19

• Clinical and Special Biochemistry: 19

• Clinical Microbiology and Serology : 27

• Histopathology : 7 and Cytopathology - 4

Total: 96 Tests

Issue Date :20.03.2017 _

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Quality Manager . &A../

Approved by:

-"CaCciLts. ,___—_ Management Representativ



SAMARA NETHOLLAYA

i I

- ISO 15189 : 2012 - MANAGEMENT REVIEW MEETING -21

Staff adequacy:

One Lab Technician is proposed for Clinical Biochemistry in 2017

One Lab Technician is proposed for main lab collection in 2017

All the vacancy created due to resignations have been filled up.

Resignations /Appointments:

• Haematology: Junior Executive - I (Ms.Priya)

Lab Assistant - 1 (Ms.Vineetha)

Lab Secretary - 3 ( Ms. Revathi, Ms.Dhanalalkshmi & Ms.Amsabai)

• Biochemistry Lab : Junior Executive - 1 (Ms.Brindha)

Lab Technician - 1 (Ms.Roja).

• Histopathology Lab : Senior Lab Technician - 1 (Mr.Purushothaman)

Lab Technician - 1 (Ms.Thenmozhi)

• Microbiology: Senior Scientist - 1 (Dr.M.K.Janani)

Junior Scientist - 1 (Ms.Vimalin Jeyalatha)

Executive - 2 (Ms.Revathi & Ms.Vaidegi)

• Cytogenetics (Non NABL) : Head of Department - 1 (Dr.A.J.Pandian)

Lab Secretary - 1 (Ms.Rekha)

Appointments :Refilling of the post:

• Haematology: Junior Executive - 1 (Ms.Hema)

Lab Technician - I (Ms.Sumathi)

Lab Secretary - 2 (Ms.Saranya & Ms.Divya Bharathi)

Issue Date :20.03.2017 of 12


Quality Manager

Approved by: ,-- ay:a.




SAND" NETHRKLPYP,

At. I ISO 15189 : 2012 - MANAGEMENT REVIEW MEETING -21

• Biochemistry : Assistant Professor - 1 (Dr.T.Spandana)

Lab Technician - I (Ms.Logeswari)

• Histopathology : Lab Technician - 2 (Ms.Bhuvana & Ms.Anitha)

• Microbiology : Assistant Professor - 1 (Dr.Premalatha)

Junior Executive - 3 (Ms.Janaki, Ms.Gayathri, Ms.lmaya Kumari)

Lab Technician / Trainee - 2 (Ms.Nathiya & Mr.Divakar)

• Cytogenetics (Non NABL) : Head of Department - 1 (Dr.S.Mathavan)

Lab Secretary - 1 (Ms.Jeevajothi)

Promotions: Nil

Document control: Version numbers of documents revised in 2016 (Jul - Dec'16) :

Quality System:

• Corrective & Preventive Action Report: SNSC/C&P/2017/Version-1.5

• Amendment Request Form: SNSC/ARF/2017/Version-1.5

• Referral Laboratory Evaluation Form: SNSC/REF/2017Ner-1.5

• SNSC Collection Quarterly Reporting to Quality Manager on Continual Improvement:

SNSC/QR-CC/2016Ner-1.2

• Quarterly reporting of the Dy.Technical Manager to the QM on Continual

Improvement: SNSC/QR/2016/Ver-1.8

• Checklist for Medical Laboratories Collection Centre: SNSC/CC-CL/2016Ner-1.1

• Lab Requisition Form: F/SNSC/ML/LRF/1.19

Issue Date: 20.03.2017 of 12


Quality Manager & . d1/4 -AT

Approved by:

•c_ Management Representative



ANKARA NETHRALAYA

i )Ik ISO 15189 : 2012 - MANAGEMENT REVIEW MEETING -21

0. Recommendations for improvement, including technical requirements : QM

• Communications on new joiners in SNSC along with designation and outline of

scope of work needs to be snet to QM.

• Manual awareness: fix the protocol for new joinees will be fixed as per HOD

decision of each lab and this shall be communicated to QM

• Review of labs involved in MOU and ILQC should have documented evidences on

Complaints/ feedback/ instructions etc (use formats).

Thank You

DA )4. Ang;Akanni,

Forwarded by:

Quality Manager, Medical Research Foundation SNSC Clinical Laboratory Chennai —600 006.

Dr.HN.Madhavan Dy. Management Representative Medical Research Foundation SNSC Clinical Laboratory Chennai — 600 006.

Date: 20.03.2017

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samara sri nathella sampathu chetty clinical …iso 15189 : 2012 - management review meeting -21...

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