QA Investigation Results

Pennsylvania Department of Health
AZURA VASCULAR CARE NORTHEAST PHILADELPHIA
Health Inspection Results
AZURA VASCULAR CARE NORTHEAST PHILADELPHIA
Health Inspection Results For:


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Initial Comments:
This report is the result of a State licensure survey conducted on October 27, 2021, at Azura Vascular Care Northeast Philadelphia. 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:




51.31 LICENSURE
Exceptions - Principle

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51.31. Principle

The Department may grant exceptions to this part when the policy and objectives contained therein are
otherwise met, or when compliance would create an unreasonable hardship and an exception would not impair or endanger the health, safety or welfare of a patient or resident. No exceptions or departures from this part will be granted if compliance with the requirement is provided for by statute.


Observations:
Based on a review of facility Bylaws, documents and interview with staff (EMP), it was determined the facility failed to adhere to the Division of Acute and Ambulatory Care ("Department") requirements for an "Exception Request" granted for the use of surgical skin preparations that contain combustible agents by failing to ensure that staff and physician staff involved in the use of surgical skin preparations that contain combustible agents/explosive hazards participated in annual mandatory education.

Findings include:

Review of facility document " Governing Body Bylaws, Azura Vascular Care Northeast Philadelphia" dated April 14, 2021, revealed "....Compliance: The Governing Body shall take all reasonable steps to develop policies to ensure that it and the Center comply with all applicable federal, state and local laws and regulations."

A review on October 27, 2021, of a letter from the "Department" dated November 16, 2010, revealed "The Department of Health is in receipt of your request for an exception to 28 Pa. Code 569.35, relating to the requirement that only nonflammable agents may be present in the surgical suite. You have completed the process established by the Department for requesting an exception to this regulation and agree to the following: ...The facility shall institute annual mandatory education provided to all staff, including the physician staff, involved in the use of surgical skin preparations that contain combustible agents... . The content of the education provided and documentation of same will be reviewed by the Department during the survey or investigation activity..."

A request was made by the survey team for the 2020 annual mandatory education for staff including physician staff involved in the use of surgical skin preparations that contain combustible agents. The facility was unable to provide the documentation requested by the survey team.

An interview conducted on October 27, 2021, at 1:30 PM with EMP1 confirmed the required annual mandatory education for the staff and physician staff involved in the use of surgical skin preparations in the Operating Room (OR) that contain combustible agents had not been completed for the year 2020 and 2021.







Plan of Correction:

Deficiency corrected by providing an annual Inservice training, and a competency assessment regarding surgical skin preparations with the use of combustible agents to all clinical staff, Physicians and Allied Healthcare Practitioners (AHP's). Training initiated on October 28th, 2021, and to be completed by December 30th, 2021.
The content of the Inservice Training and Competency Assessment documentation will be able made available for review for by the Department of Health at any time including survey or investigation activity.
The Inservice training and Competency Assessments will be reported to the Quality Assurance Performance Improvement (QAPI) Committee and the Governing Body (GB) by January 20th, 2022.
To ensure center continues to follow exception requirement, this annual Inservice training and competency assessment will be added to the Mandatory Annual education list of training for all clinical staff, Physicians and AHP's requirement.
Monitoring: The review of this training will be part of the Facility Administrator's annual QI audit, will be included to the Annual GB meeting for quarter 0ne (Q1) and no later than April 20th of every year.
Responsible Party: Adherence will be the responsibility of the Director of Nursing, Facility Administrator and Medical Director.
Correction of deficiency: completed by 1/31/2022



553.3 (8)(ii) LICENSURE
Governing Body Responsibilities

Name - Component - 00
553.3 Governing Body responsibilities include:
(8) Establishing personnel policies and practices which adequately support
sound patient care to include, the following:
(ii) Applications for positions requiring a licensed person shall be hired only after obtaining verification of their licenses, records of education, and written references.



Observations:

Based on a review of facility policy, personnel files (PF) and interview with staff (EMP), it was determined that the facility failed to verify the professional licenses and written references of registered nurses prior to hire as required by the "Department" for four of four personnel files reviewed (PF1, PF2, PF3 and PF4).

Findings include:

Review of facility policy "Human Resources Policy" dated May 27, 2021, revealed "...hiring and employment reporting practices adhere to all applicable federal, state and local regulations and guidelines.... All new hires..and employees returning to employment ..., regardless of the reason or duration of separation are subject to the following background checks and verifications...credential/licensure check (if required based on the job description)... Note: Some states or positions may require additional background checks and verifications prior to an employee starting work...All offers of employment are contingent upon review and approval of verification results by Human Resources."

Review on October 27, 2021, of PF1, a registered nurse hired on June 14, 2021, revealed the license of the professional registered nurse was not verified until June 28, 2021.

Review on October 27, 2021, of PF2, a registered nurse hired on August 26, 2020, revealed the license of the professional registered nurse was not verified until November 10, 2020.

An interview conducted on October 27, 2021, at 11:08 AM with EMP 1 confirmed the facility had not verified the professional registered nurse license of PF1, hired June 14, 2021, professional license verified on June 28, 2021, and PF2 hired on August 26, 2020, professional license verified on November 10, 2020. EMP1 stated "The professional license verification for both of the registered nurses (PF1 and PF2) did not occur until after the date of hire."
___________________

Review on October 27, 2021, of PF1, a registered nurse hired on June 14, 2021, revealed no evidence of documentation that two written references were verified prior to hire.

Review on October 27, 2021, of PF2, a registered nurse hired on August 26, 2020, revealed no evidence of documentation that two written references were verified prior to hire.

Review on October 27, 2021, of PF4, a registered nurse hired on June 28, 2021, revealed no evidence of documentation that two written references were verified prior to hire.

An interview conducted on October 27, 2021, at 11:35 AM with EMP1 confirmed that the facility had not verified a minimum of two written references for PF1, PF2 and PF4, professional registered licensed nurses prior to hire. EMP1 confirmed the facility was not in compliance with the "Department" regulation for verification of written references for professional licensed staff prior to hire.













Plan of Correction:

Deficiency will be corrected by education of the Facility Administrator (FA) and changing the hiring process. FA orientated and reinforced on adherence to Human Resources Policy for hiring and employment reporting practices to all applicable federal, state and local regulations and guidelines. Human Resource, HR Policy 101A which give guidance to the hiring process in adhering to all regulations including State, Pennsylvania Department of Health.
The education will also be provided to HR Business Partners and HR Resources who coordinates reference checks for new employees.
Hiring Process:
The following Hiring process put in place to ensure adherence to policy and regulation:
- Recruiter sends new hire name and email address to HR once offer has been accepted
- An HR signature verification Software will be used to send new hire professional references via email. The reference forms will automatically be sent to the two references that the new hire enters in the system.
- HR then saves the completed PDF forms in the employee's electronic file
- Manager will have a checkbox item on their new hire checklist that says "References completed and saved". This will prompt the manager to check the employee's electronic file to ensure there are 2 saved references prior to their start date. It is the manager's responsibility to check on this prior to the start date, and alert HR and Talent Acquisition Team if references are not completed, in order not to delay the start date until references are fully completed.

No new employee can start work without ensuring References have been reviewed, signed, and validated.
All new clinical staff hired; their license must be validated at their respectively Professional credentialing board/State by the FA/DON prior to start date.
Sign sheet documentation of education training will be kept in file for review as needed.
Compliance: The FA will report to the QAPI and GB every quarter list of newly hired staff, and present updates on written reference verification and License verification compliance.

Responsibility of the FA to ensure this deficiency corrections are adhered to
Completed date: 1/31/2022



567.1 Principle LICENSURE
CHAPTER 567 - ENVIRONMENTAL SERVICES

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567.1 Principle

The ASF shall have a sanitary environment, properly constructed,
equipped and maintained to protect surgical patients and ASF personnel from
cross-infection and to protect the health and safety of patients.


Observations:
Based on review of facility policies, observation, and interview with staff (EMP), it was determined the facility failed to maintain the operating room table in a safe and sanitary manner and failed to dispose of expired medications and supplies.

Findings include:

A review of facility policy "Environmental Cleaning" dated February 6, 2021, revealed "Purpose: To maintain a clean and safe environment for patients, staff, and visitors. Policy: The patient care environment throughout the facility will be maintained in a state of cleanliness that meets professional standards in order to protect patients and healthcare personnel from potentially infectious microorganisms. ...Guidelines 5. Supply and Equipment Management a. The integrity of clean equipment and supplies shall be assessed prior to use."

An observation conducted on October 27, 2021, at 11:07 AM in Operating Room (OR) 2 with EMP2 revealed several large areas where the silver coating had worn away on the OR table wheel base, revealing a dark brownish red material that appeared to be rust.

An interview conducted on October 27, 2021, at 11:08 AM with EMP2 confirmed the OR table wheel base in OR2 had several large areas where the silver coating had worn away, revealing a dark brownish red material that appeared to be rust.
____________

A review of facility policy "Medication Expiration Management" dated February 7, 2021, revealed "Purpose To establish a safe and consistent approach for managing the expiration of medications in the center. ... Procedure ...2. Expired, discontinued, and contaminated medications are removed from stock and disposed according to policy. ...6. Multiple Dose Vials (MDV) - Injectable products (contain preservative) a. Opened or accessed MDV should immediately be assigned a label with a 'beyond-use' date and initials. i. The beyond-use date for opened or entered MDV with antimicrobial preservatives is 28 days from the date it was opened or entered unless manufacturer specifies shorter."

An observation on October 27, 2021, at 11:55 AM with EMP2 revealed an open vial of tuberculin solution in the medication refrigerator. Further observation revealed the vial was labeled with an open date of August 5, 2021. No beyond-use date was found on the vial.

An interview on October 27, 2021, at 11:56 AM with EMP2 confirmed the vial had been opened August 5, 2021, and there was no beyond-use date on the vial. EMP2 stated "I think open vials expire within 30 days."
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An observation on October 27, 2021, at 11:44 AM with EMP2 and EMP7 in the "Nursing Storage" room (nursing supplies available for patient use) revealed a box containing six angiocatheters (IV catheters). Further observation revealed the expiration date on the angiocatheters was September 30, 2021.

An interview on October 27, 2021, at 11:45 AM with EMP2 and EMP7 confirmed the six angiocatheters found in the "Nursing Storage" room had an expiration date of September 30, 2021.



















Plan of Correction:

The table in Operating Room (OR) 2 revealed several large areas where the silver coating worn away on the wheelbase, showing a dark brownish red material that appeared to be rust.

Correction: Table base was re-surfaced, coated and painted to remove rust.
Prevention from occurrence: Lead Tech will include inspection of all units in the procedure rooms during Monthly inventory check and report any issue to FA for immediate address. Monthly inventory report will be shared with the Medical Director and Regional Director. Report will be saved on the shared Center Drive for easy as needed.
Compliance and Auditing: Inventory/equipment Monthly report will be reviewed by FA and report to the QAPI and GB quarterly meetings.
Responsibility: It is the responsibility of the Lead Technologist and FA to ensure adherence and compliance.
Completion: It will be completed January 31st,2022.
Medication expiration. The MDV Multidose Vail, with injectable product was disposed of immediately on 10/27/2021.
Six angiocatheters were disposed of immediately on 10/27/2021
To Prevent any future occurrences; the Director of Nursing, DON will perform monthly Medication and expired items review and oversight of all medication and Nursing supplies in both storage rooms and Refrigerator. This monthly review will be conducted for at least six months with 100% compliance. DON conducted a sign-in in-service training on Medication Storage, policy MM121 for all clinical staff. In-service documentation is kept on file for access as needed. In-service training completed 11/30/2021.
Any month with noncompliance/any expired vials, the review will be extended for another six months until there is 100% compliance for six consecutive months.
Documentation review and In-service training will be presented to QAPI and GB for oversight.
Monitoring: The FA and DON will monitor process for compliance.
Completion: January 31st, 2022, 2021 Q4 reporting. Additional data collection and reporting will continue as needed.
Responsible Party: The DON will be responsible for compliance



567.41 LICENSURE
MAINTENANCE SERVICE - Principle

Name - Component - 00
567.41 Principle

The ASF shall be equipped, operated and maintained to sustain its
safe and sanitary characteristics and to minimize health hazards in the ASF
for the protection of patients and employes.


Observations:
Based on a review of facility policy, documents, and interview with staff (EMP), it was determined the facility failed to maintain eyewash stations within the recommended temperature range for the safety of employee use.

Findings include:

A review of facility policy "Eyewash" dated February 6, 2021, revealed "Purpose To minimize the risk of serious eye injury by establishing a formal procedure for selecting, installing, testing, and maintaining emergency eyewash stations. Policy Where the eyes or body of any person may be exposed to injurious corrosive material, suitable facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use. ...Process See current Eye Wash Log."

A review on October 27, 2021, of facility documents "Eye Wash Station" Logs dated January through September 2021 revealed "Inspection Details. Monthly: Take the temperature of the water. Record the temperature. Water must be tepid (60-100 degrees F)." A review of the "Post-op Hall" log revealed a temperature reading of 103 degrees recorded August 26, 2021. A review of the "Pre-Op (Board Hall)" log revealed a Temperature reading of 101 degrees recorded June 22, 2021, and 103 degrees recorded September 29, 2021. A review of the "Tech Hall" log revealed temperatures of 101 degrees recorded on February 16, 2021, and August 26, 2021. A review of the "Dirty Closet" log revealed temperatures of 101 degrees recorded on March 31, 2021, and September 29, 2021.

An interview conducted on October 27, 2021, at 10:50 AM with EMP2 confirmed the eyewash temperatures recorded on the logs had exceeded 100 degrees for each of the eye wash stations within the past year. EMP2 stated "The staff do not know the process to correct the eyewash temperatures out of range."

__________
Based on a review of facility policy, observation, and interview with staff (EMP), it was determined the facility failed to ensure thermometer/hygrometer devices were calibrated to accurately monitor temperature and humidity ranges within the facility.

Findings include:

A review of facility policy "HVAC: Temperature, Humidity, and Air Pressures" dated February 6, 2021, revealed "Purpose ...To provide a consistent process for the monitoring of temperature, humidity, and proper pressure relationships, where required. To comply with codes, regulations, standards, and/or nationally accepted guidelines, as applicable, for maintaining air flow, temperature and humidity. To ensure compliance with the manufacturers' instructions for use (IFU's) for surgical supplies and equipment."

An observation on October 27, 2021, at 10:46 AM in the Pre-Operative Area with EMP2 revealed a thermometer/hygrometer. Further observation of the thermometer/hygrometer revealed the Quality Calibration (QC) was dated to expire April 13, 2021.

An observation on October 27, 2021, at 11:35 AM in Operating Room (OR) 2 with EMP2 revealed a thermometer/hygrometer. Further observation of the thermometer/hygrometer revealed the Quality Calibration (QC) was dated to expire May 18, 2021.

An observation on October 27, 2021, at 11:37 AM in OR1 with EMP2 revealed a thermometer/hygrometer. Further observation of the thermometer/hygrometer revealed the Quality Calibration (QC) was dated to expire June 7, 2021.

An observation on October 27, 2021, at 11:44 AM in the "Nursing" storage and equipment room with EMP2 revealed a thermometer/hygrometer. Further observation of the thermometer/hygrometer revealed the Quality Calibration (QC) was dated to expire June 7, 2021.

An observation on October 27, 2021, at 11:45 AM in the "RT" (Radiologic Technologist) storage and equipment room with EMP2 revealed a thermometer/hygrometer. Further observation of the thermometer/hygrometer revealed the Quality Calibration (QC) was dated to expire June 7, 2021.

An interview conducted on October 27, 2021, at 11:36 AM with EMP2 confirmed medical equipment and supplies in the Pre-Operative Area, OR2, OR1, Nursing Storage and "RT" storage areas was sensitive to temperature and humidity conditions and that the quality calibration dates on the temperature/hygrometers units used to monitor temperature and humidity was not calibrated prior to the quality control expiration dates labeled on the devices.
___________

Based on a review of facility documents, observation, and interview with staff (EMP), it was determined the facility failed to ensure preventive maintenance was performed on patient equipment in accordance with the recommended preventative maintenance schedule.

Findings include:

1) An observation on October 27, 2021, at 11:45 AM in the "RT" (Radiologic Technologist) storage and equipment room with EMP7 revealed an infiltration pump used to inject air during procedures. Further observation revealed a preventive maintenance sticker that indicated preventive maintenance was due August 2021.

An interview conducted on October 27, 2021, at 11:46 AM with EMP7 confirmed the infiltration pump was used for patient care and the preventive maintenance was due in August 2021. EMP7 stated "This equipment is not used daily but the preventive maintenance should have been done."

A request was made by the survey team on October 29, 2021, for the preventive maintenance report for the infiltration pump. A review of the preventive maintenance report provided by the facility to the survey team revealed preventive maintenance was last performed on the infiltration pump February 22, 2021, and the next recommended date was August 23, 2021.

2) An observation on October 27, 2021, at 12:05 PM in the post operative recovery area with EMP2 revealed an ultrasound machine stored in Bay1. Further observation revealed a preventive maintenance sticker that indicated preventive maintenance was due February 2021.

A request was made by the survey team on October 29, 2021, for the preventive maintenance history for the ultrasound machine stored in Bay1. A review of the preventive maintenance report provided by the facility to the survey team revealed the annual preventive maintenance check was last performed on the ultrasound machine May 13, 2020.

An interview conducted on October 27, 2021, at 12:05 PM with EMP2 confirmed the ultrasound machine stored in Bay1 was used for patient care and an annual maintenance check was performed on May 13, 2020. EMP2 confirmed that the facility had not performed the annual maintenance check for 2021.
























Plan of Correction:

Deficiency: eyewash temperatures exceeded 100 degrees
Eyewash stations; All eyewash stations have Temperature regulators, were inspected and confirmed to be operational. On 10/28/2021, The FA adjusted all temperature regulators to maintain water temperature between 72- 90 degrees.
FA In-service and demonstrated to the staff on how to adjust and confirm the temperature regulator are working. In-service documentation saved on the center shared drive for easy access as needed.
Monitoring: FA and DON will monitor the eyewash temperature for the three months of weekly inspection and testing to ensure units stay with range. Data for the review period will be made available upon request.
Compliance: Weekly data will be reported to the QAPI 2021 fourth quarterly report, under equipment status, with report updated to the GB for review and approval for full compliance of deficiency.
Responsibility: FA, DON and Lead Tech will be responsible for adherence to corrective action.
Completion date: 01/31/2022.

Thermometers for: Pre-Operative Area, Operating Room (OR) 2, OR1, Nursing" storage and equipment room, and RT" (Radiologic Technologist) storage and equipment room were replaced on 11/9/2021, with active current Calibrated units; S/N # 210466415, Expiration 6/7/2023, S/N # 210844925, Expiration 10/4/2023, S/N # 210845231, Expiration 10/4/2023, S/N # 210845222, Expiration 10/4/2023, and S/N # 210845204, Expiration 10/4/2023 respectively
Monitoring and Auditing: The DON will perform quarterly inspection of units, include thermometer calibrated status on the QAPI quarter reports under equipment status. This will remain a mandatory requirement for quarterly equipment status reporting. This report will be reported to the GB quarterly report.
Compliance Responsibly: The DON of will be responsible for ensuring all units are up to date with calibration status as part Environmental Infection center review
Completion: January 31st, 2022

Infiltration Pump Biomedical expiration sticker dated 06/2021.
Corrective action: The Vendor acknowledge in a written memo (memo will be made available upon request and made part of the Equipment record) that the sticker was placed in error.
The unit is scheduled for routine PM annually, the next scheduled PM is 02/2022. Wrong sticker removed.
Monitoring: Moving forward the FA will review, inspect and document, Biomedical report and equipment data correlates with equipment stickers quarterly.
FA reviewed documentation will be included on QAPI reporting under Equipment and reported to the GB
Responsibility: FA will be responsible for adherence to this corrective action
Completion: January 31st, 2022.

Ultrasound machine; Siemens Acuson X150 preventive maintenance PM sticker dated due February 2021.
Corrective action:
Sticker was placed on unit was by Biomedical Vendor in error (documentation provided). PM is routinely performed by Manufacturer, Siemens, as recommended. Center has a service agreement with Vendor; document made available.
Ultrasound Machine: Siemens the manufacturer performed the unit PM, 5/13/2020 documentation provided and will be available upon request. Manufacturer recommended PM interval is every 24 months. Next PM will be scheduled next year, on or before May 2022.
To eliminate the duplicative services with Biomedical and Siemens, Biomedical was advise not to perform safety check, hence why the Biomedical sticker dated February 2020 was still on unit. (Written Memo from Biomedical Vendor is available for review).
Monitoring and Auditing: Moving forward the FA will be generated list of Biomedical equipment and manufacturer Vendor equipment. Quarterly, FA report will inspect and document, Manufacturer equipment list for PM check, making sure PM was competed with stickers on unit. Report will be included on the QAPI quarterly meeting, under Equipment status, and forwarded to the GB quarterly meeting for review and approval.
Compliance and Responsibility: The FA will be responsible for ensuring all Vendor Manufacturer units have been PM and sticker dated on the respective units; and compliance with deficiency.
Completion: January 31st, 2022.