QA Investigation Results

Pennsylvania Department of Health
NAZARETH ENDOSCOPY CENTER, LLC
Health Inspection Results
NAZARETH ENDOSCOPY CENTER, LLC
Health Inspection Results For:


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Initial Comments:

This report is the result of a full Medicare recertification survey conducted on March 18, 2024, at Nazareth Endoscopy Center, Llc. It was determined the facility was in compliance with the requirements of 42 CFR, Title 42, Part 416 - Conditions for Coverage for Ambulatory Surgical Centers.







Plan of Correction:




Initial Comments:

This report is the result of a State Relicensure survey conducted on March 18, 2024, at Nazareth Endoscopy Center, Llc. 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:




555.22 (c)(1-5) LICENSURE
Surgical Services - Preoperative Care

Name - Component - 00
555.22 Pre-operative Care

(c) Written instruction for preoperative procedures, which have been approved by the medical
staff, shall be given to the patient or responsible person, and shall include:
(1) Applicable restrictions upon food and drink before surgery
(2) Special preparations to be made by the patient
(3) The required proximity of the patient to the ASF for a specific time following surgery if applicable.
(4) An understanding that the patient may require admission to the hospital in the event of medical need.
(5) The requirement that, upon discharge of a patient who has received sedation or general anesthesia, a responsible person shall be available to escort patient home. With respect to patients who receive local or regional anesthesia, a medical decision shall be made regarding whether such patients require a responsible person to escort them home.


Observations:
Based on a review of medical records (MR), and interview with staff (EMP), it was determined the written instructions provided for preoperative procedures failed to include an understanding that the patient may require admission to the hospital in the event of medical need for twenty of twenty medical records reviewed (MR1, MR2, MR3, MR4,MR5, MR6, MR7, MR8, MR9, MR10, MR11, MR12, MR13, MR14, MR15, MR16, MR17, MR18, MR19 and MR20).

Findings include:

A review on March 18, 2024 of MR1, revealed the patient presented to the surgery center on January 18, 2024, for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR2, revealed the patient presented to the surgery center on May 1, 2023 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR3, revealed the patient presented to the surgery center on December 8, 2023, for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR4, revealed the patient presented to the surgery center on June 2, 2023 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR5, revealed the patient presented to the surgery center on April 21, 2023 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR6, revealed the patient presented to the surgery center on June 1, 2023 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR7, revealed the patient presented to the surgery center on September 18, 2024 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR8, revealed the patient presented to the surgery center on January 8, 2024 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR9, revealed the patient presented to the surgery center on November 8, 2024 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR10, revealed the patient presented to the surgery center on April 21, 2024 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR11, revealed the patient presented to the surgery center on November 15, 2024, for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR12, revealed the patient presented to the surgery center on December 4, 2023 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR13, revealed the patient presented to the surgery center on November 15, 2023, for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR14, revealed the patient presented to the surgery center on March 18, 2024 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR15, revealed the patient presented to the surgery center on March 18, 2024 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR16, revealed the patient presented to the surgery center on March 18, 2024 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR17, revealed the patient presented to the surgery center on March 18, 2024 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR18, revealed the patient presented to the surgery center on March 18, 2024 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR19, revealed the patient presented to the surgery center on March 18, 2024 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.

A review on March 18, 2024 of MR20, revealed the patient presented to the surgery center on March 18, 2024 for a procedure. There was no documented evidence of the patient being provided with preprocedural instructions that included an understanding that the patient may require admission to the hospital in the event of medical need.


An interview conducted on March 18, 2024, at 1:15 PM with EMP1 confirmed the above findings for MR1, MR2, MR3, MR4, MR5, MR6 and MR7, MR8, MR9, MR10 MR11, MR12, MR13, MR14, MR15, MR16 and MR17, MR18, MR19 and MR20.











Plan of Correction:

1. As noted per the survey on March 18,2024: Nazareth Endoscopy Center was deficient in 555.22(c) (1-5) Licensure Surgical-Services- Preoperative Care.
2. The Nazareth Endoscopy Center follows Nursing Policy and Procedure, Policy 101.1 which states the following.
A. The pre-operative procedure instructions are to be approved by the Medical Staff at EPGI/office setting.
B. The approved pre-operative procedure instructions are given to the patient when the patient visits the office and schedules a procedure at the Center, e.g. colonoscopy procedure instructions.
C. A copy of the pre-operative procedure instructions is sent to the Center along with additional patient information (history and physical, etc.).
D. A copy of the pre-operative procedure instructions is placed on the Center's chart by the person/s assigned to chart preparation.
E. The pre-operative procedure instructions are to be a permanent part of the patient's medical record. It is not to be discarded.
F. If there is not a copy on the patient's chart the receptionist or an assigned staff member is to notify the office/EPGI and obtain a copy of the patient's pre-operative procedure instructions and add it to the Center's chart.
G. The copy of the pre-operative procedure instructions can be used as a reference for the nursing staff if the patients should call with questions concerning their pre-operative procedure instructions or when the nurses make the pre-assessment/pre-procedure phone call to the patient.
H. The pre-operative procedure written instructions are required to include the following information:
- Applicable restrictions in regard to food and drink prior to surgery/procedure.
- Special preparations to be made by the patient.
- An understanding that the patient may require admission to the hospital in the event of medical need.
- Upon discharge of a patient who has received MAC sedation, a responsible person shall be available to escort the patient home.
3. Nazareth Endoscopy is responsible for ensuring that the patient received the pre-procedure instructions and documentation of such is on the patient records. The Administrator had a clinical staff meeting with the nursing following the DOH report on 4/9/24. It was reinforced that during the pre-assessment phone call the patient would be asked if received instructions and a review would be completed. The nurse would ensure that a copy was sent from the office to the center, if not the nurse will reach out to the office and obtain a copy to be placed in the patient medical record.
4. The Patient Safety Officer for Nazareth Endoscopy Center has been assigned to randomly monitor 20 charts per month starting 4/22/2024 to ensure this is being completed per 555.22. The PSO will report this to the DON, Administrator and QA committee quarterly.



557.3 (b) LICENSURE
QA & Improvement Program

Name - Component - 00
557.3 The Quality Assurance and Improvement Program

(b) The quality assurance program shall provide for the identification of problems and actions taken - through the monitoring and evaluation process - which improve the quality of patient care.


Observations:

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to follow their quality assurance plan for the identification of problems and actions taken - through the monitoring and evaluation process - which improve the quality of patient care.

Findings include:

Review of the facility's quality assurance plan, on March 18, 2024 review date July 2022, revealed, "Purpose" The Quality Assessment Plan (the Plan) as delineated below proves guidelines for the conduct on an ongoing quality management program designed to monitor and evaluate objectively and systematically the quality and appropriateness of Patient care, pursue opportunities to improve patient care and resolve identified problems..."

The facility was unable to provide documentation that monitoring and evaluation was being completed for the identification of problems and actions taken - through the monitoring and evaluation process - which improve the quality of patient care.

Interview with EMP1 on March 18, 2024, at 2:30 PM with confirmed that the above findings.











Plan of Correction:

1. As noted per the survey on March 18,2024: Nazareth Endoscopy Center was deficient with identifying problems through a monitoring and evaluation process and then taking corrective actions to improve the quality of patient care (573B).
2. As stated in our quality management plan on a monthly basis data is monitored and compiled, then reported quarterly to the Quality Management Committee, for the following indicators: patient satisfaction, types of procedures performed, infection control, serious complications and deaths, adverse situations in the pre-post procedure area, hospital admissions and ER visits, patient event reporting, medical record chart review, patient post-procedure phone call, and ASA-3 patients.
3. It has been acknowledged that Nazareth Endoscopy Center needs to perform a quality assessment plan on a quarterly basis. As our QA study for 2024, we have chosen to do timeouts in the procedure room, before the induction of anesthesia, by all staff in the procedure room.
4. This data will be collected intermittently and randomly, by direct observation, by the DON and reported to the center administrator.
5. The data will be observed, recorded and compiled during the 2nd quarter of 2024, then revisited until the goal of 95% is achieved.
6. The data will be reviewed monthly with the QA committee and reported quarterly to the governing board.