Regent Street Clinic

On this page

• Overview
• Learning culture
• Safe systems, pathways and transitions
• Safeguarding
• Involving people to manage risks
• Safe environments
• Safe and effective staffing
• Infection prevention and control
• Medicines optimisation

Our assessment focused on one quality statement, Medicines Optimisation, under the key question of safe. We only assessed one quality statement which means we have not rated the service on this occasion. We will carry out future assessments to cover other parts of the assessment framework at a later date and update our website with our findings.

We reviewed the storage and stock control of medicines, processes to record consent, recording of medicines and vaccines administered to patients, along with the general oversight of medicines management. We found the provider failed to demonstrate safe processes for the storage, administration and recording of medicines.

We reviewed safe recruitment systems and staff training. The provider failed to demonstrate safe recruitment and training systems for their staff.

We identified breaches in the Health and Social Care Act 2008, Regulation 12, Safe Care and Treatment and Regulation 17, Good Governance. We issued the provider with a warning notice to make improvements.

This service scored 3 (out of 100) for this area. Find out what we look at when we assess this area and How we calculate these scores.

We did not look at Learning culture during this assessment. There is no previous rating for the Safe key question so we cannot yet publish a score for this area.

We did not look at Safe systems, pathways and transitions during this assessment. There is no previous rating for the Safe key question so we cannot yet publish a score for this area.

We did not look at Safeguarding during this assessment. There is no previous rating for the Safe key question so we cannot yet publish a score for this area.

We did not look at Involving people to manage risks during this assessment. There is no previous rating for the Safe key question so we cannot yet publish a score for this area.

We did not look at Safe environments during this assessment. There is no previous rating for the Safe key question so we cannot yet publish a score for this area.

We did not look at Safe and effective staffing during this assessment. There is no previous rating for the Safe key question so we cannot yet publish a score for this area.

We did not look at Infection prevention and control during this assessment. There is no previous rating for the Safe key question so we cannot yet publish a score for this area.

We received concerns from patients who had used the service prior to the assessment, regarding how travel vaccines were being administered to patients, including vaccines being administered without appropriate authorisation and outside of their shelf-life; patients not receiving adequate doses of rabies vaccines and a lack of staff training.

During our assessments, staff informed us that there was no process in place to report, record and learn from errors or near misses. This meant that patients could be exposed to further errors or near misses due to lessons not being learnt and changes made to safeguard people. The registered manager did tell us that they had not had any errors occur.

We found that there was a lack of an appropriate training matrix that would ensure staff had received training appropriate for their role. The training policy did not contain information on role specific training and what would be considered as mandatory training. For example, we reviewed training records of four staff members.

We found that one staff member had not received training to identify the difference between the administration of intradermal and intra-muscular injections; two staff members had not received appropriate life support training or sepsis awareness training; three staff members had not completed mandatory safeguarding training or infection prevention and control training; all four staff members had not received fire awareness training or equality and diversity training.

We found there was a lack of oversight for prescribing at the service, and prescribing policies and procedures were not always being followed. For example, at both the Nottingham and Bristol locations the provider was unable to provide a stock control record of vaccines detailing batch numbers and expiry dates received into stock or administered to patients. Some medicines such as antibiotics were not securely stored and were accessible to administrative staff. This is contrary to their medicines management policy. The providers medicines management policy stated that they do not prescribe controlled medicines such as hypnotics or sleeping tablets, however, during the assessment at the Bristol location, evidence was seen of two patients being prescribed these medicines.

We found out of date vaccines and medicines in the vaccine’s fridge. Two fridges were overstocked and refrigeration temperature monitoring checks were not being effectively recorded. This put patients at risk of receiving a medicine or vaccine with reduced efficacy or contamination due to inappropriate storage and lack of adequate monitoring. Our findings of medicines storage also contravened the providers medicines management policy.

Vaccines were being administered to patients ‘off-label’ meaning that the provider was not using the vaccines according to the manufacturers instructions. We were concerned that the use of off-label vaccines was not explained to patients and explicit consent was not obtained prior to the vaccines being administered. The use of off-label vaccines was not recorded within the patient record. For example, we saw four records of people who had received rabies vaccines administered off-label at the Bristol location, and ten patient records at the Nottingham location, whose records did not show that consent had been obtained or that an explanation had been provided to the patient regarding the vaccine being used off-label.

At the Nottingham location our specialist nurse adviser saw that staff were administering Rabipur (rabies vaccine) intradermally, which is off-label. To do this staff were drawing up multiple doses of Rabipur from a single use vial, into multiple unlabelled syringes, and storing these in the fridge. This meant there was a risk these vaccines could be mistaken for another product or used beyond their shelf-life. The providers guidance stated that after being drawn up the vaccine should be administered within 6 hours. The specialist nurse adviser reviewed 10 sets of patients notes who were administered the Rabipur vaccine and observed that five patients were administered the vaccination outside of the providers stated 6-hour time frame. This meant that the vaccine may be ineffective in protecting the patient from rabies.

We found that appropriate legal authority was not always in place for staff to administer vaccines. This meant that nurses administered vaccines without legal authority, the required information and permission to support them to do this in a safe way. At the Nottingham location we saw three Patient Group Directives (PGDs) documents which were not signed by an authorised prescriber and by nurses who administered the vaccinations. We also noted that two PGDs were missing. At the Bristol location, the provider was unable to produce any PGDs to evidence nurses had the legal authority to administer vaccines or medicines.

We found that the service was unable to evidence that Patient Safety Alerts and recalls issued by the Medicines and Healthcare products Regulatory Agency, (MHRA), were being received and actioned in a safe manner. The staff told us it would be very difficult for them to track and trace patients in a timely way if an MHRA alert related to a vaccine or medicine which had been administered to a patient. This was due to the provider not having an effective stock control system which included batch numbers and expiry dates, and not appropriately recording the administration of vaccines and medicines within the patient record which included batch numbers. The omission of this data meant that if urgent action was required, the provider would be unable to identify or contact affected patients in a timely manner, putting patients at risk of harm.

The provider was unable to demonstrate that safe recruitment practices were being followed in line with the health and social care act 2008 requirements. For example, there were gaps in the staff files of four employees we reviewed. There was no evidence that their identity had been checked or that references had been requested for all four staff members. We were informed after the onsite visit that the records were in place and could be provided upon request, however, we have not witnessed this evidence.