Objective Elements Non-Compliance Observation
1 IMS 6 a, b,c, d, e The structured medical record review using a
representative sample of both active and
discharged patients, based on statistical principles
was not evident hence no RCA and CAPA
2 IMS 5 a,b,c,d The organization did not have an effective process
for document control and retention policy of keeping
& destruction of records
3 IMS 1 a, c, d The manuals, SOPs, work instructions were not
distributed to all areas of SHCO for meeting the
data needs of relevant stakeholders.There is not
enough space for storage of physical data and no
enough safeguard for protection of electronic
data.SHCO is not registered with Hemovigilance
and Pharmacovigilance
4 AAC 5 .a. Imaging services does not comply with legal and
other requirements e.g. dosimeter,Display of
imaging warning signages and RSO
5 HRM. 7 a, b, c, d, There is no process for crentialing and previllging of
HRM. 8 , a, b, c, d, medical professional and nursing professonals and
HRM 9. A, b, c d paraclinical professonals
6 HRM. 6 ,b, c, d Some of the personnel files did not contain staff
qualification, Job description, verification of
crednetials,health status in service training and
education and evaluation and remarks
7 COP.10, b, c, d, e, f The pre-anaesthesia assessment results in the
formulation of an anaesthesia plan was not
documented in file examined. A preinduction
assessment was also not evident.Informed consent
for administration of anaesthesia, did not contain
type of anaesthesia and its complication,
Remarks by Assessor, If any:
Define the periodicity of review of medical
records. Define the representative sample of
active and passive discharged files based on
statistical principles. Few samples of files to be
uploaded to review identified parameters.
There is no evidence the organization has an
effective process for document control
There is no documentation regarding
information needs of the stakeholders, the
storage in MRD is not visualised.
RSO can be a qualified radiologist or a
Radiology technician certified by AERB. Self
declaration is not accepted.
Credentialing of consultants, doctors, nurses
and pharmacist is not done. Their qualification
need to be verified from respective regulatory
bodies.
Verification of credentials not evidenced.
No evidence of Anaesthesia consent. Intraop
monitoring is of interval of 15 to 30 minutes
which is not accepted by the guidelines. Please
give evidence of ETCO2 monitor.
 anaesthetist signature, name date and time in the
file examined.Patients were not being monitored for
ET CO2 while under anaesthesia . Post
anaesthesia monitoring was not documented and
no evidence of transfer criteria to shift patient from
recovery to ward
8 COP 12 . a, b,c, d. e, The organization did not identifies and manages The SHCO has not identified and manage
f patients who were at higher risk of morbidity and patients who need restraint.
mortality.
9 FMS 5 d. e The organisation had not documented and The eire exit plan does not identify the
displayed exit plan in case of ?re and non-?re placement of fire extinguishers . There is no
emergencies. There was no maintenance plan for evidence of maintenance plan for fire related
fire related equipment and infrastructure equipment and infrastructure
10 MOM. 3. b, c The SHCO did not adhere uniformly to the Give evidences of prescription adhering to the
determined minimum requirements of a minimum requirements
prescriptione.g strength, duration and total quantity
of medicine.Name,signature and registration
number of doctor and also written in capital writer.
Drug allergies and previous drug reactions are not
ascertained uniformly before prescribing in OPD
and IPD case sheets.
11 ROM 2 a, b, c The person heading the organization had no HR head is department specific. She needs to
requisite and appropriate administrative be administrative head of the Organisation
Qualification and experience.Adherehce of statutory and needs training when there is change in
requirement was not evidenced in Xray signages the job. The general consent should not have
and informed consent blanket consent for blood transfusion and
photography.
12 ROM.3.a, c, e. The strategic and operational plans and the The strategic and operational plans of the
organisation's annual budget were not evidenced. SHCO is not evidenced.
The functioning of hospital committees was not
reviewed by the management for their
effectiveness. The SHCO had not documented staff
rights and responsibilities.
13 PRE 2, a , h Patients and family rights did not include respecting
values and beliefs, any special preferences, cultural
needs, and responding to requests for spiritual
needs. Information on how to voice a complaint was
not evident
14 HIC.I, e There was no evidence that the management had
made any provision for the infection control
programme.
15 HIC. 5, a, b ,d, e, f There was no evidence that the organisation
performs surveillance to capture and monitor
infection prevention and control data.
16 HIC 6 a, b ,c, d ,e Sterilisation and/or disinfection of instruments,
equipment and devices were not as per standard
guidelines e.g.no proper lay out,no identification of
single use devices which are meant for reuse, no
proper validation tests and recall procedures when
breakdown was identified
17 PSQ 1 a, b, c, d, e, g, There was no evidence that the organisation
h, i implements a patient-safety programme and a
structured quality improvement programme.
18 PSQ 3, a, b, c, d, e There was no established system for clinical audit
and quality improvement programmes.
Information on how to voice a complaint was
not evident but right to voice a complain
There is no evidence to show a separate
budget has been demarcated for infection
control program.
The effectiveness of house keeping services is
not evidenced.There is no evidence of data
being verified by the infection control team.
No redesigning of sterilisation areas is noticed
as the SHCO has shown only the closed doors
with signage.The cycle and batch is not evident
when autoclave is done more than two times a
day. The class indicator is not evident and
biological tests register is not evidenced.
There is no evidence to show that there is an
established process in the HCO to monitor and
improve quality of nursing care.
Clinical audit incomplete