QA Investigation Results

Pennsylvania Department of Health
CHILDREN'S DENTAL SURGERY OF MALVERN
Health Inspection Results
CHILDREN'S DENTAL SURGERY OF MALVERN
Health Inspection Results For:


There are  22 surveys for this facility. Please select a date to view the survey results.

Surveys don't appear on this website until at least 41 days have elapsed since the exit date of the survey.



Initial Comments:

This report is the result of a full Medicare recertification survey conducted on October 5, 2022, at Children's Dental Surgery of Malvern. It was determined the facility was not in compliance with the requirements of 42 CFR, Title 42, Part 416 - Conditions for Coverage for Ambulatory Surgical Centers.




Plan of Correction:




416.44(a)(1) STANDARD
PHYSICIAL ENVIRONMENT

Name - Component - 00
The ASC must provide a functional and sanitary environment for the provision of surgical services.
Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area.


Observations:

Based on facility observation and employee interview (EMP), it was determined Children's Dental Surgery of Malvern failed to ensure that humidity was being monitored daily in the sterilization room.

Findings Include:

Review of facility policy titled Refrigerator and Room Temperature Control with a revision date of 6/30/22 revealed "Temperature and humidity are to be monitored every day of facility opening and should be within ranges designated ..."

Tour of facility on October 5, 2022, at approximately 2:00 PM revealed the humidity equipment was not operational as the equipment required a new battery. Humidity Log for October 3, 2022, and October 4, 2022, was not completed per policy.

Interview with EMP 1 on October 5, 2022, at approximately 2:50 PM confirmed the humidity equipment was not operational and the humidity log had not been completed.







Plan of Correction:

Patient care technicians will be responsible for checking temperature and humidity equipment is functional and the appropriate logs are completed every day the facility is open, and ensure the temperature and humidity is within ranges designated in Policy 219: Refrigerator and Room Temperature Control.

All staff members working in the Sterilization room will be required to attend in-service to be held the week of 10/31/22. DON will be responsible for conducting in-service. Staff will be required to sign documentation of attendance and understanding of Policy 219: Refrigerator and Room Temperature Control.

Staff will be required to sign off daily that temperature and humidity levels in Sterilization have been checked and equipment is operational. The DON will be notified immediately of any equipment malfunction, or temperature/humidity levels that are out of range.

The DON will be responsible for checking that documentation is completed on a weekly basis and will be required to sign off that audit has been completed.

This corrective action will be complete on 12/27/22.



416.48(a) STANDARD
ADMINISTRATION OF DRUGS

Name - Component - 00
Drugs must be prepared and administered according to established policies and acceptable standards of practice.





Observations:

Based on facility observation and employee interview (EMP), it was determined Children's Dental Surgery of Malvern failed to ensure outdated medications were removed from their crash carts.
Findings include:
1. The crash cart located in the Post Anesthesia Care Unit area contained two doses of Atropine 1MG which expired September 2022. Sodium Bicarbonate 4.2% expired July 1, 2022. The crash cart located in the Operating Room area contained Dextrose 25g/50 ML (2) doses expiring May 1, 2022.
2. The facility was unable to provide a policy for expired medications.
3. Interview with EMP 1 on October 5, 2022, at approximately 3:00 PM confirmed the medications were expired.






Plan of Correction:

Assigned RN will complete an audit of all crash carts located in the facility at the beginning of each month to ensure no expired medications remain in the carts. If a critical medication is found to be approaching expiration within the next 30 days, the RN will notify the DON immediately. Per Policy 424: Drug Shortages/Critical Drug Shortage Policy the "DON will take the following steps: 1) Check the FDA's website for extending the expiration date of the specific critical medication. 2) Administrators from the other surgery centers will be contacted to see if they have any overage to be shared. 3) Additional suppliers will be contacted to check availability." If alternate medication is found that is not currently on the formulary, pharmacy consultant will be notified so medication can be added, MAB will be notified for approval. If the critical medication is unobtainable the DON will ensure that a Critical Drug Shortage/Expired Emergency Medication form is completed and placed in the medication management binder located in the administration office. All expired medication will have a "Manufacturer Backorder" sticker placed to prevent accidental exposure and alert staff the medication is approved for use.

Policy 424: Drug Shortage/Critical Drug Shortage Policy will be reviewed with DON and applicable staff nurses the week of 10/31/22 by the administrator. Staff will be required to sign documentation of attendance and understanding of this policy.

The staff member completing the audit at the beginning of each month will be required to sign off that all medication expiration dates have been checked and DON has been notified of any critical medications approaching expiration. The DON will be responsible for completing a separate cart audit in the middle of each month to ensure all expiration dates have been checked. The DON will be required to sign off that this audit has been completed. After the audit is complete if any medication is found to be reaching expiration DON will complete the following steps per Policy 424: "1) Check the FDA's website for extending the expiration date of the specific critical medication. 2) Administrators from the other surgery centers will be contacted to see if they have any overage to be shared. 3) Additional suppliers will be contacted to check availability."

The DON will be responsible for making sure all audits have been completed.

This corrective action will be complete on 12/27/22.



Initial Comments:

This report is the result of a State licensure survey conducted on October 5, 2022, at Children's Dental Surgery Of Malvern. It was determined the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Ambulatory Care Facilities, Annex A, Title 28, Part IV, Subparts A and F, Chapters 551-573, November 1999.












Plan of Correction:




561.25 LICENSURE
Distressed drugs, devices and cosmetics

Name - Component - 00
561.25 Distressed drugs, devices and cosmetics

Drugs, devices and cosmetics which are outdated, visibly deteriorated, unlabeled or inadequately labeled, recalled, discontinued or obsolete shall be identified by the licensed pharmacist or responsible practitioner and shall be disposed of in compliance with applicable Commonwealth and Federal regulations.


Observations:

Based on facility observation and employee interview (EMP), it was determined Children's Dental Surgery of Malvern failed to ensure outdated medications were removed from their stock.
Findings include:
1. The crash cart located in the Post Anesthesia Care Unit area contained two doses of Atropine 1MG which expired September 2022. Sodium Bicarbonate 4.2% expired July 1, 2022. The crash cart located in the Operating Room area contained Dextrose 25g/50 ML (2) doses expiring May 1, 2022.
2. The facility was unable to provide a policy for expired medications.
3. Interview with EMP 1 on October 5, 2022, at approximately 3:00 PM confirmed the medications were expired.





Plan of Correction:

Assigned RN will complete an audit of all crash carts located in the facility at the beginning of each month to ensure no expired medications remain in the carts. If a critical medication is found to be approaching expiration within the next 30 days, the RN will notify the DON immediately. Per Policy 424: Drug Shortages/Critical Drug Shortage Policy the "DON will take the following steps: 1) Check the FDA's website for extending the expiration date of the specific critical medication. 2) Administrators from the other surgery centers will be contacted to see if they have any overage to be shared. 3) Additional suppliers will be contacted to check availability." If alternate medication is found that is not currently on the formulary, pharmacy consultant will be notified so medication can be added, MAB will be notified for approval. If the critical medication is unobtainable the DON will ensure that a Critical Drug Shortage/Expired Emergency Medication form is completed and placed in the medication management binder located in the administration office. All expired medication will have a "Manufacturer Backorder" sticker placed to prevent accidental exposure and alert staff the medication is approved for use.

Policy 424: Drug Shortage/Critical Drug Shortage Policy will be reviewed with DON and applicable staff nurses the week of 10/31/22 by the administrator. Staff will be required to sign documentation of attendance and understanding of this policy.

The staff member completing the audit at the beginning of each month will be required to sign off that all medication expiration dates have been checked and DON has been notified of any critical medications approaching expiration. The DON will be responsible for completing a separate cart audit in the middle of each month to ensure all expiration dates have been checked. The DON will be required to sign off that this audit has been completed. After the audit is complete if any medication is found to be reaching expiration DON will complete the following steps per Policy 424: "1) Check the FDA's website for extending the expiration date of the specific critical medication. 2) Administrators from the other surgery centers will be contacted to see if they have any overage to be shared. 3) Additional suppliers will be contacted to check availability."

The DON will be responsible for making sure all audits have been completed.

This corrective action will be complete on 12/27/22.


567.43 LICENSURE
Ventilation System

Name - Component - 00
The ventilation system shall be inspected and maintained in accordance with the written maintenance schedule to ensure that a properly conditioned air supply meeting minimum filtration, humidity and temperature requirements is provided in critical areas such as the surgical and recovery suites under
Chapter 571 (relating to construction standards).


Observations:

Based on facility observation and employee interview (EMP), it was determined Children's Dental Surgery of Malvern failed to ensure that humidity was being monitored daily in the sterilization room.

Findings Include:

Review of facility policy titled Refrigerator and Room Temperature Control with a revision date of 6/30/22 revealed "Temperature and humidity are to be monitored every day of facility opening and should be within ranges designated ..."

Tour of facility on October 5, 2022, at approximately 2:00 PM revealed the humidity equipment was not operational as the equipment required a new battery. Humidity Log for October 3, 2022, and October 4, 2022, was not completed per policy.

Interview with EMP 1 on October 5, 2022, at approximately 2:50 PM confirmed the humidity equipment was not operational and the humidity log had not been completed.









Plan of Correction:

Patient care technicians will be responsible for checking temperature and humidity equipment is functional and the appropriate logs are completed every day the facility is open, and ensure the temperature and humidity is within ranges designated in Policy 219: Refrigerator and Room Temperature Control.

All staff members working in the Sterilization room will be required to attend in-service to be held the week of 10/31/22. DON will be responsible for conducting in-service. Staff will be required to sign documentation of attendance and understanding of Policy 219: Refrigerator and Room Temperature Control.

Staff will be required to sign off daily that temperature and humidity levels in Sterilization have been checked and equipment is operational. The DON will be notified immediately of any equipment malfunction, or temperature/humidity levels that are out of range.

The DON will be responsible for checking that documentation is completed on a weekly basis and will be required to sign off that audit has been completed.

This corrective action will be complete on 12/27/22.