risk audit overview - srl gurukulsrlgurukul.com/pdf/operations lab head train the trainer.pdf ·...

STRICTLY PRIVATE AND CONFIDENTIAL

Risk Audit Overview

Dr. Simi Bhatia

Lab Head Induction Program

29th / 30th November 2018

Risk Audit Checklist

● Operations

● Finance



S. No. Particulars Impact Rating Things to check/review

1 Valid agreement is available with the Waste management vendor High 3 Check for the vendor agreement copy and see if its valid.

2

Waste is segregated and disposed as per biomedical waste management rules

Colour coding is followed for waste bins as per the biomedical waste management rulesYellow: Human tissues, organs,body parts, animal tissues and body parts, Items contaminated with blood, body fluids like dressings, plaster casts, cotton swabs and bags containing residualor discarded blood and blood components, Expired medicines, soiled Linen & bedding, blood bagsRed: Tubing, bottles, catheters, urine bags, syringes, glovesWhite(Puncture proof containers): Needles, Syringes, Sharp objectsBlue: Glassware, broken glass, vials, mettalic body parts

High 3

Waste is to be segragated and disposed daily/once in 2 days. Check for state rule applicable on the labs.

Identify cases where disposal was not done as per defined frequency and ascertain reasons.

3 Waste bins are cover with lidMediu

m2 Observation based

4BMW waste bags are bar coded at the time of handing over to BMW agency as per the BMW guidelines High 3

The timeline for bar coding has been extended to 27th March 2019. In case the lab has not implemented, record it as "Not Applicable"Wherever implemented, check if the bar code is generated every time the waste is handed over to the vendor and compare the quantity as per bar code with the register.

5 Biomedical waste management chart is displayed at the labMediu

m2 Observation based. The chart must be displayed in all departments of the lab.

6Waste record is updated in the register on the day of handing over to BMW vendor

Medium

2 Check if the register/ records are available and daily entry is done.

7

Records of any major accidents including accidents caused by fire hazards, blasts during handling of biomedicalwaste and the remedial action taken and the records relevant thereto, (including nil report)in Form I to the prescribed authority and also along with the annual report;

High 3Check if Form I (accident reporting) has been submitted to the state pollution control board separately. In case there were no accidents during the year, nil reporting is compulsory.

WASTE MANAGEMENT

4

8Training to be imparted to its health workers involved in handling of bio medical waste at the time of induction and once a year. Training records to be maintained

High 3 Check the training records for all health workers.

9 All health workers are hepatitis B and tetanus vaccinated High 3Check for certificates available confirming the vaccination for Hepatits B and records available for Tetanus. Also check the TITRE reports for all health workers.

10Maintain all record for operation of autoclaving for a period of five years;

Medium

2 Check for records of autoclaving

11 Annual return filed with State Pollution control board High 3

Annual return copy filed with the State board before 30th June of every year.

3-way match:Quantity of waste to be generated as per annual return vs Quantity of waste generated as per daily waste record register vs Quantity of waste generation mentioned in annual report

12Availability of authorization from state pollution control board for waste generation and disposal

High 3 Check for authorization document

WASTE MANAGEMENT


1List of equipment's (with categorisation of critical and/or non critical) lying at lab is available

High 3 Check if the list of equipment is available with categorization.

2 AMC is available for all critical equipment's at the lab Medium 2Against the list of equipment, check which are tagged as critical/non-critical. For all owned critical equipments, AMC should be available and valid/renewed.

3Preventive maintenance schedule is available and maintennance is conducted as per schdule

High 2

Preventive Maintenance schedule should be in line with the above list. Date of last preventive maintenance, current/due date shoule be mentioned in the schedule. Also check if there are equipments which are present in lab but not on the list. PM is done for all equipments critical/non-critical.Blue cards must be maintained and updated with the PM details. Check if PM is carried as per frequency mentioned on the blue cards.

4All the equipment's are labeled with the preventive maintenance details

Medium 2Date of last PM done should be mentioned on the machine. Check on sample basis if the same is mentioned on the machine. This detail must match the PM schedule and blue cards of the particular equipment.

5Availability of maintenance and breakdown records for all equipment's

Medium 2Check Machine breakdown records and whether they are updated.Check whether written\typed records are available. Also check if the breakdown details are mentioned in the blue cards.

ENGINEERING AND MAINTAINANCE

OPERATIONSS.

No.Particulars Impact Rating Things to check/review

III Customer Care

1 Patient feedback forms are available at the reception Medium 2 Check if feedback forms are available at the labs

2 Patient feedback are analysed on monthly basis Medium 2

Check availability on monthy analysis report and action taken, if any

Also check if any other means is available for recording complaints and its subsequent resolution (may be register)

3 Problem sample records are available and analysed High 3Check is the records of Problem sample are available and analysis has been documented

4TAT for report generation is defined in system for all the tests

High 3

Obtain the report generation TAT report from Lab and check the delays in genration of the report against TAT definedThe compliance requirement of atleast 85% to be metAlso check on sample basis , the TAT updated in ERP by the Lab ( take the SOP of test where TAT is defined , cross check TAT as per SOP and as per ERP )

IV Other

1Attendence records are regularly maintianed

Medium 2 Bio metric machine/Attendance Register availability

2

CPO/ Director HR / HR Spoke/ Centre Head approval is available on the free medical tests availed by employees

Medium 2

Employees working in SRL are eligible for free medical tests after approval of HR Head. Check if HR Head's approval was available for sample casesEnsure pre approval was taken for the test. Also , if more than prescribe limit test has been done by same person in 1 month ( check sop guideline for this )

CUSTOMER CARE AND OTHERS

FINANCES.


1Updated price list approved by corporate is available at the lab

Medium

2Check if the latest rate list is available.

2 Approved price list is updated in the system High 3 Take the dump of price master and compare with the price list

3

Single test rate is appearing against one test code - if no, are patients has been billed on both the rates

High 3

Take the price master and check if the duplicate code exist.

Ascertain reason of duplicate codes. Contact central team\lab management for the same.

Compare the sales register with duplicate codes and check if the patients are billed on both the codes( Consider Plant Code + Price group from price list while doing the testing)

4Only system is used for billing and no manual receipts are given to patients

Low 1Observation based. Check the sales master and discuss with lab head if any manual billing is done.If yes, document the reason and check for approvals.

5Test rates cannot be edited at the time of billing

High 3Do a system walkthrough and check one case to see if rates can be edited at the time of billing.

6Updated test rates are updated in the system on timely basis

Medium

2Rates are updated periodically as a process. Check when was the last time rates were updated

7Accessioning is done on the same day of invoice generation

Medium

2Compare dates in accessioning report and invoice report against same patient ID/Test ID. There must be 98% compliance in accessioning.

BILLING AND COLLECTION



BILLING AND COLLECTION

8

11Home visit charges charged as predefined policy

Low 1Check on the home visit slips if charges are mentioned. Visit rates can also vary depending on the distance.

12Valid agreements are available of all consultant doctors Mediu

m2

Take the list of consultant doctors at lab and check the agreements for validity

13Payments are made to consultant doctors on the basis of agreement

Medium

2Check the invoices against agreed rates. If expired agreements are available, check if payment is done as per old rates agreed

8

Discount provided to patients are approved as per the policy and adequate documents are available for the same

High 3

Review the sales dump and check for cases where discounts were given. Select a sample of 30 and check for approval email\hard copy from Lab Head..

Check for cases where discounts were given beyond 20%, identify reasons. For corporate check agreement copies and for walk in check approvals on sample basis and identify reasons

9Outstanding cash is lying only against 'credit patients' and not 'walk in patients'.

Medium

2Take the outstanding report and check for cases where outstanding cash is lying against walk-in patients for more than 3 days. Identify reasons for the same.

10Home visit slips are available for home visits done

Low 1Check if home visit slips are available at lab for home visits done during audit period on a sample basis

FINANCES.


1 Entire cash is deposited in bank on the next day of billing in its entirety.

High 3Check against the bank deposit slips aavailable. Also take the dump of ledger to see the date of entry for deposit

2 Segregation of duties for cash management (front desk cashier and accountant) is ensured

High 3Check if reconciliaion is prepared and reviewed by different individuals.

3 Sales data is reconciled with the billing software and accounting software ( i.e SAP and CLIMS matching )

High 3Check whether same is being performed on a weekly basis and report is shared with corporate. There must be 98% compliance in reconciliation.

4 Discounts for corporate patients are automatically updated in the system and there is no manual intervention.

High 3

Check if rates are updated on the system as agreed with the companies.

Check if any manual billing is being done by labs. Ascertain reasons and approval for the same

Do a system walkthrough and check if discounts for corporate patients can be edited in the system.

5 Cash collected from sales is not utilized for petty expenses

High 3

Check if petty cash is maintained separately and cash collected from patients is not used by the lab for petty expenses.

Take the petty cash expense ledger and check the entries. Also check if petty cash reconciliation is done and review is perfromed

6 Average cash balance details is shared with HO as per the defined frequency ( Daily basis)

High 3Check emails shared with HO for cash balances

7 Cash insurance is adequate for the average cash lying at lab.

Medium

2Check for average cash available at lab on any given day and compare with the insurance policy

CASH MANAGEMENT




1Purchase requisitions for stock items are approved by lab heads

Medium 2Take samples of PR raised during audit period and check if the same were approved by lab head

2 GRN is prepared on the same day of receipt of material Medium 2

Take the purchase dump and check against the gate register if the GRN was done on the same day.

Also, check if system does not allow GRN before the delivery date mentioned in PO

3Batch number and expiry date is appearing in GRN report (wherever applicable)

High 3Filter out cases in Purchase dump where expiry date is required but not mentioned. Ascertain reason for the same

4 GRN is received against approved PO High 3Check for purchases without PO references

5Lab Head approvals are available in case of emergency purchase

Medium 2Check for approval against emergency purchases on a sample basis. Identify the reasons for the same

6Expired/near expiry items are segregated from the normal items

High 3Check if expired/near expiry items are available at lab. Stacking of the items and segragation from new stock. Take photograph if expired/near expiry stock is not segragated and labeled.

7 Expired stock details are shared with HO on monthly basis Medium 2Check for emails shared with HO for expired stock

8Consumption of items is booked in the system on a weekly basis

High 3Obtain consumption report and check the booking dates. Identify cases where weekly consumption was not done. Check consumption department-wise.

9Stock transfer is done in the system for items transferred to/ from other labs

High 3Check if any stock transfer was done to other labs or received from labs. See the documentation and recording in books

10Inventory holding is within defined limits as per the policy (Inventory holding of 45 days)

Medium 2

Ascertain average daily consumption from consumption report. Compare with the inventory value and see if stock holding is above 45 days.

Also check if the consumption of expired stock is booked in the consumption report. Ascertain reasons for the same. Ask from lab head if any expired but useable analysis is conducted on a monthly basis. Obtain copies if the same is conducted.

PROCUREMENT AND INVENTORY

FINANCE

S. No.

Particulars Impact Rating Things to check/review

IV Other

1 Fixed assets are tagged with FAR codes Low 1Obtain FAR from Lab and check the asset availability in lab. Check if the assets are tagged properly. Asset code on the machines should be same as asset code on the equipment.

V SOPs

Approved standard operating procedure documents are available for the following functions:

1 Engineering & Maintenance High 3 Check Availability, note down the last updated date of SOP and by whom

2 Billing & Collection High 3 Check Availability, note down the last updated date of SOP and by whom

3 Procurement & Inventory High 3 Check Availability, note down the last updated date of SOP and by whom

4 Customer Care High 3 Check Availability, note down the last updated date of SOP and by whom

5 Quality High 3 Check Availability, note down the last updated date of SOP and by whom

6 Safety High 3 Check Availability, note down the last updated date of SOP and by whom

OTHER AND SOP’S



OPERATIONS CHECKLIST COMPARISON

WASTE MANAGEMENTS. No. Particulars

SRL OWNED LABS

FRANCHISEE LABSFORTIS LABS

OTHER HOSPITAL LABS

1 Valid agreement is available with the Waste management vendor × ×

2

Waste is segregated and disposed as per biomedical waste management rules

Colour coding is followed for waste bins as per the biomedical waste management rulesYellow: Human tissues, organs,body parts, animal tissues and body parts, Items contaminated with blood, body fluids like dressings, plaster casts, cotton swabs and bags containing residualor discarded blood and blood components, Expired medicines, soiled Linen & bedding, blood bagsRed: Tubing, bottles, catheters, urine bags, syringes, glovesWhite(Puncture proof containers): Needles, Syringes, Sharp objectsBlue: Glassware, broken glass, vials, mettalic body parts

3 Waste bins are cover with lid

4BMW waste bags are bar coded at the time of handing over to BMW agency as per the BMW guidelines × ×

5 Biomedical waste management chart is displayed at the lab

6 Waste record is updated in the register on the day of handing over to BMW vendor × ×

7

Records of any major accidents including accidents caused by fire hazards, blasts during handling of biomedicalwaste and the remedial action taken and the records relevant thereto, (including nil report)in Form I to the prescribed authority and also along with the annual report;

× ×

8Training to be imparted to its health workers involved in handling of bio medical waste at the time of induction and once a year. Training records to be maintained

×

9 All health workers are hepatitis B and tetanus vaccinated

10 Maintain all record for operation of autoclaving for a period of five years;

11 Annual return filed with State Pollution control board × ×

12Availability of authorization from state pollution control board for waste generation and

disposal × ×

OPERATIONS CHECKLIST

COMPARISON

S. No. ParticularsSRL

OWNED LABS

FRANCHISEE LABS

FORTIS LABS

OTHER HOSPITAL

LABS

1List of equipment's (with categorisation of critical and/or non critical) lying at lab is available

2 AMC is available for all critical equipment's at the lab

3Preventive maintenance schedule is available and maintennance is conducted as per schdule

4 All the equipment's are labeled with the preventive maintenance details

5 Availability of maintenance and breakdown records for all equipment's

ENGINEERING AND MAINTAINENCE



OPERATIONS CHECKLIST

COMPARISON

S. No. ParticularsSRL OWNED

LABSFRANCHISEE

LABSFORTIS LABS

OTHER HOSPITAL LABS

III Customer Care

1 Patient feedback forms are available at the reception × ×

2 Patient feedback are analysed on monthly basis × ×

3 Problem sample records are available and analysed × ×

4 TAT for report generation is defined in system for all the tests

IV Other

1Attendence records are regularly maintianed

2CPO/ Director HR / HR Spoke/ Centre Head approval is available on the free medical tests availed by employees

× × ×



CUSTOMER CARE AND OTHER


OWNED LABS

FRANCHISEE LABS

FORTIS LABS

OTHER HOSPITAL

LABS

1 Updated price list approved by corporate is available at the lab × × ×

2 Approved price list is updated in the system × × ×

3Single test rate is appearing against one test code - if no, are patients has been billed on both the rates

× × ×

4 Only system is used for billing and no manual receipts are given to patients × × ×

5 Test rates cannot be edited at the time of billing × × ×

6 Updated test rates are updated in the system on timely basis × × ×

7 Accessioning is done on the same day of invoice generation × × ×

8Discount provided to patients are approved as per the policy and adequate documents are available for the same

× × ×

9 Outstanding cash is lying only against 'credit patients' and not 'walk in patients'. × × ×

10 Home visit slips are available for home visits done × × ×

11 Home visit charges charged as predefined policy × × ×

12 Valid agreements are available of all consultant doctors

13 Payments are made to consultant doctors on the basis of agreement

FINANCE CHECKLIST

COMPARISONBILLING AND COLLECTION




OWNED LABS

FRANCHISEE LABS

FORTIS LABS

OTHER HOSPITAL

LABS

1 Entire cash is deposited in bank on the next day of billing in its entirety. × × ×

2Segregation of duties for cash management (front desk cashier and accountant) is ensured

× × ×

3Sales data is reconciled with the billing software and accounting software ( i.e SAP and CLIMS matching )

× × ×

4Discounts for corporate patients are automatically updated in the system and there is no manual intervention.

× × ×

5 Cash collected from sales is not utilized for petty expenses × × ×

6Average cash balance details is shared with HO as per the defined frequency ( Daily basis)

× × ×

7 Cash insurance is adequate for the average cash lying at lab. × × ×

FINANCE CHECKLIST

COMPARISONCASH MANAGEMENT



FINANCE CHECKLIST

COMPARISON


OWNED LABS

FRANCHISEE LABS

FORTIS LABS

OTHER HOSPITAL

LABS1 Purchase requisitions for stock items are approved by lab heads

2 GRN is prepared on the same day of receipt of material × × ×

3 Batch number and expiry date is appearing in GRN report (wherever applicable)

4 GRN is received against approved PO

5 Lab Head approvals are available in case of emergency purchase

6 Expired/near expiry items are segregated from the normal items

7 Expired stock details are shared with HO on monthly basis

8 Consumption of items is booked in the system on a weekly basis

9 Stock transfer is done in the system for items transferred to/ from other labs ×

10 Inventory holding is within defined limits as per the policy (Inventory holding of 45 days) ×

PROCUREMENT AND INVENTORY



FINANCE CHECKLIST

COMPARISON


OWNED LABS

FRANCHISEE LABS

FORTIS LABS

OTHER HOSPITAL

LABS

IV Other

1 Fixed assets are tagged with FAR codes

V SOPs

Approved standard operating procedure documents are available for the following functions:

1 Engineering & Maintenance

2 Billing & Collection × ×

3 Procurement & Inventory

4 Customer Care

5 Quality

6 Safety

OTHER AND SOP’s



THANK YOU !!


INTERLAB CODES

21

TYPES OF CODES

Interlab codes are used when samples are accessioned at an SRL Lab and sent to another SRL

Lab for testing.

There are 4 interlab codes which exist in SRL:

a. Result verification code

b. Kit down

c. Panel parameter

d. Quality surveillance

22

USES OF INTERLAB CODES

Result verification code is used in case of recheck/discrepancy of test results.

Kit down code is used when there are no reagents / kits left in the lab and samples are sent to another

lab

Panel parameter code is used when one test in a particular panel is not being performed in the lab

Quality surveillance code is used when lab receives samples from external agencies for testing such

as AIIMS and CMC Vellore as per NABL policy

23

SAMPLE ACCESSIONING AND REPORTING

Primary Accessioning of samples sent in interlab codes is performed in the lab sending the sample

Secondary accessioning is done in lab receiving the sample and test results are released which are

then noted down by the lab sending the samples and entered in CLIMS

24

PANEL PARAMETER

25

RESULT VERIFICATION

26

KIT DOWN

27

QUALITY SURVELLIANCE

THANK YOU


Monthly Lab Review & Self Audit

30/11/18

Workload & Quality Indicators

Category Data Source/ Target

Accessions

# of Accessions CLIMS

# of Acceptance

Total

TestsTotal # of Tests CLIMS

Test / Accession Ratio

Consumption

Consumption (From P&L

sheet)P&L

Consumption %

TAT % TAT achieved (from 1-Key) 1 Key/ >95%

PSNPSN Number CLIMS/ <0.8%

PSN %

RassaysRe-assays (Numbers) Manual entry/ <1.0%

Re-assays %

TNPTNP (Numbers) CLIMS/ <0.4%

TNP %

31

Quality Indicators

Reporting Errors Numbers

# of Critical alerts missed Numbers

# of Trainings* Numbers

# of New Tests / Instruments added* Numbers

Kit down Hours* Hrs of kit down

Equipment down Hours* (To be

entered in CLIMS)Hrs of equipment down

EQAS (% Achieved)* BioRad/ Randox

32

Clinician Connect

CategoryData Target

Clinian

Connect

Telephonic Doctor interactions (number)

E mail / WA interaction: Sharing of articles /

publications / updates etc

Publications / Conference Participation-poster/oral

paper

Round table meetings

Clinician Lab Tour (in coordination with sales team)

Nursing homes/Small hospital tie ups - Clinician

/RMO /Intern & support staff interaction with lab

doctors

Hospital rounds(Microbiologists)

Reference lab Doctor-Fortis clinician interactions

33

Self Audit

BMW Management

(Y/N)

Agreement with vendor

Authorization from pollution control board

BMW Barcoding being used

Monthly report uploaded in SRL world

Vaccination for Hep B + Anti HBs titres

Vaccination for Tetanus

Equipments (Y/N)

AMC for critical equipments

PM of all equipments timely done

Fixed assets tagging available

All discounts approved as per policy (Y/N)

Procurement &

Inventory (Y/N)

Expired/ near expiry stock segregated

GRN entries done daily

Consumption entered weekly

Reagent used after expiry date

Physical verification of stock done

SOP available (Y/N)

Billing & Collection

Materials

Engineering & Maintenance

Logistics

Customer Care

Quality

Safety

Thank You

risk audit overview - srl gurukulsrlgurukul.com/pdf/operations lab head train the trainer.pdf ·...

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