Pennsylvania Department of Health
PGC ENDOSCOPY CENTER FOR EXCELLENCE, LLC
Patient Care Inspection Results

Note: If you need to change the font size, click the "View" menu at the top of the page, place the mouse over the "Text Size" menu item, and select the desired font size.

Severity Designations


Minimal Citation - No Harm	Minimal Harm	Actual Harm	Serious Harm

There are 27 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.


PGC ENDOSCOPY CENTER FOR EXCELLENCE, LLC - Inspection Results	Scope of Citation Number of Residents Affected By Deficient Practice

Initial comments:
This report is the result of a full Medicare recertification survey initiated on April 24, 2023, and concluded on May 4, 2023, at PGC Endoscopy Center For Excellence. 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.

It was determined the facility was in compliance with 42 CFR, Title 42, Part 416 - Conditions for Coverage for Ambulatory Surgical Centers at 416.51(c)(1)-(3)(i)-(x) COVID-19 Vaccination of Facility Staff.

Plan of Correction:

Initial comments:

This report is the result of a State licensure survey initiated on April 24, 2023, and concluded on May 4, 2023, at PGC Endoscopy Center For Excellence. 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:

416.41(a) STANDARD CONTRACT SERVICES:

When services are provided through a contract with an outside resource, the ASC must assure that these services are provided in a safe and effective manner.

Observations:
Based on a review of facility documents, medical records (MR) and interview with staff (EMP), it was determined the facility failed to notify the Department of Health (the Department) in writing and receive approval prior to implementing a contracted service for a new electronic medical records system.

Findings include:

A review of facility document "Administrative Services Agreement by and between Physicians Endoscopy, LLC and PGC Endoscopy Center for Excellence, LLC" dated February 1, 2015, revealed "Article III Company's Obligations. ... 3.2 Specific Responsibilities. ... (a) Ongoing responsibility for the statutory and regulatory compliance of the Facility with all state and federal statutes, rules and regulations, and other requirements, including, but not limited to, those laws regarding the establishment and operation of a health care facility in the state in which the Facility is located; ... (c) Adoption and approval of the Facility's operating policies and procedures, and adoption of policies affecting the delivery of health care service;. ... (g) Approval of Facility's contracts for administrative of clinical services; ... Possession and maintenance of all medical records, patient charts, databases and other documentation relating to the Facility..."

A review on April 24, 2023, of facility documents revealed a new contract signed by the facility Administrator July 1, 2022, for [vendor name redacted] Software Inc., electronic medical records software subscription commencing on October 31, 2022.

A review on April 24, 2023, of MR1 through MR10 revealed the medical records were documented in an electronic medical record format by [vendor name redacted] Software Inc. MR3, MR4, MR5, MR6, MR7, MR8, MR9 and MR10 did not include documentation of a discharge order signed by the physician prior to discharge from the facility.

A review on April 24, 2023, of the Department's data base revealed no notification to the Department regarding the facility's intention to begin using [vendor name redacted] Software Inc.

An interview conducted on April 24, 2023, at 3:03 PM with EMP1 confirmed there was no documentation of a discharge order signed by the physician prior to discharge from the facility in MR3, MR4, MR5, MR6, MR7, MR8, MR9 and MR10. EMP1 stated "We used to have discharge orders in the paper charts, but discharge orders do not appear in the new electronic medical record. I don't know how we overlooked that."

A telephone interview conducted on April 27, 2023, at 10:50 AM with EMP1 confirmed the facility began using the new software for electronic documentation on December 1, 2022. EMP1 confirmed the facility did not submit notification and did not receive approval from the Department prior to implementing the new electronic medical records system.

Cross Reference:
416.52(c): Tag 0266: Discharge - Order

Plan of Correction - To be completed: 08/28/2023

On 12/1/22, there was an upgrade to a cloud based EMR system as the current EMR would no longer be supported by the vendor. Since this was not a change in vendors, merely an upgrade, the administrator was not aware that there needed to be a notification to the Department of Health.

During the survey, it was found that there was no discharge order present in the EMR. This was resolved in all charts on 4/26/23, by the EMR vendor at our request, as it was added to the physician discharge order set.

In order to ensure this POC is being followed, we have added to our monthly physician peer review, that there is a discharge order present on the chart.

Staff and physicians are being educated on the necessity to notify the Department of Health of any upgrades, new equipment, or significant changes here at the center.

The Administrator, along with the Board of Managers will be responsible to notify the Department of Health for any changes going forward.

The physicians are monitoring that the discharge order is present during their monthly peer review. The administrator will monitor the results that the physicians submit to ensure that a discharge order is present.

The administrator will be responsible to notify the Department of Health of all new services. New services will be discussed in the quarterly Continuous Quality Improvement Committee which is reported to the Board of Managers.

416.48(a) STANDARD ADMINISTRATION OF DRUGS:

Drugs must be prepared and administered according to established policies and acceptable standards of practice.

Observations:
Based on a review of facility policy, documents, and interview with staff (EMP), it was determined the facility failed to ensure Lorazepam (a controlled substance) was maintained and tracked in accordance with facility policy.

Findings include:

A review of facility policy "Controlled Substance in the Center" dated October 10, 2020, revealed "STATEMENT: To procure, maintain, administer, track and dispose of controlled substances in an accurate manner consistent with DEA (Drug Enforcement Administration) and Board of Pharmacy requirements. PROCEDURE: There is a double locked storage area in the Medication area of the Center that acts as the storage location for Controlled Substances. At the beginning of the day, two (2) authorized persons (two RN's) visually and concurrently count the controlled substances and mark the beginning inventory on the daily count sheet. All medication given will be notated on the patient's Procedure Record and also on the procedural count. At the completion of each case, the CRNA administering Sedation will record on the daily sheet the amount of controlled substance given to the patient. At the end of the day, two (2) authorized persons (two RN's) will do a joint count visually and concurrently and document end of day count in narcotic log book."

A review of facility document "Controlled Substance Log LORAZEPAM" revealed a form with columns to indicate the date, patient medical record number, patient name, amount of medication given, amount wasted, remaining number of medication vials and staff signatures. Further review revealed "10/9/21 Received 25 vials." Further review revealed "25" was written in the "Remaining" column on the top line of the form.

An observation on April 24, 2023, at 9:34 AM with EMP1 in the Pre- Post endoscopy area revealed a locked medication refrigerator. There were 22 Lorazepam vials stored in the refrigerator.

An interview conducted on April 24, 2023, at 9:36 AM with EMP1 confirmed there were 22 Lorazepam vials in the medication refrigerator, not 25 as was documented on the Lorazepam Controlled Substance Log.

An interview conducted on April 24, 2023, at 10:43 AM with EMP1 confirmed the Lorazepam was received by the facility on October 9, 2021. EMP1 confirmed there was no documentation to account for the three missing vials of Lorazepam and further confirmed there was no documentation of daily checks on the Lorazepam Controlled Substance Log after the Lorazepam was received. EMP1 stated "The form has been sitting in the (Controlled Substance Log) book this whole time. We do not normally go in the medication refrigerator so the Lorazepam has been overlooked since it was placed in there."

An interview conducted on April 24, 2023, at 1:43 PM with EMP5, a certified registered nurse anesthetist (CRNA) confirmed EMP5 did not follow facility policy and failed to document the required information on the Lorazepam Controlled Substance Log when taking the medication for patient use. EMP5 stated "The primary care physician requested we use Ativan (Lorazepam) for a patient (in October 2021). We used three Ativan vials for that patient and I guess I never wrote it down."

Plan of Correction - To be completed: 08/11/2023

Lorazepam was discovered during the survey in a locked medication refrigerator. Only the CRNA staff and Nursing administration have the key for this refrigerator. It was not properly documented for administration and daily counts. Immediately following the survey, the Administrator informed our Medication Disposal Company to retrieve and destroy this medication as it was not being used. This was completed and proper documentation completed.

Staff and CRNA staff are being educated to follow proper documentation policies for all controlled medications.

A Quality Improvement study was immediately implemented to ensure that all Controlled medications are being properly counted at the beginning and end of the shift by 2 licensed professionals and properly signed out for administration.

The Director of Nursing and the Administrator will be responsible to ensure that this is being followed properly with report to the Board of Managers.

416.50(a) STANDARD NOTICE OF RIGHTS:

An ASC must, prior to the start of the surgical procedure, provide the patient, or the patient's representative, or the patient's surrogate with verbal and written notice of the patient's rights in a language and manner that ensures the patient, the representative, or the surrogate understand all of the patient's rights as set forth in this section. The ASC's notice of rights must include the address and telephone number of the State agency to which patients may report complaints, as well as the Web site for the Office of the Medicare Beneficiary Ombudsman.

Observations:
Based on a review of facility documents and interview with staff (EMP), it was determined the governing body failed to establish a patient's bill of rights that included the address and telephone number of the State agency to which patients may report complaints.

Findings include:

A review of facility document "Administrative Services Agreement by and between Physicians Endoscopy, LLC and PGC Endoscopy Center for Excellence, LLC" dated February 1, 2015, revealed "Article III Company's Obligations. ... 3.2 Specific Responsibilities. ... Company retains all authority and responsibility over the following, in accordance with its Operating Agreement to the extent applicable: (a) Ongoing responsibility for the statutory and regulatory compliance of the Facility with all state and federal statutes, rules and regulations, and other requirements, including, but not limited to, those laws regarding the establishment and operation of a health care facility in the state in which the Facility is located; ... (c) Adoption and approval of the Facility's operating policies and procedures, and adoption of policies affecting the delivery of health care service; ... (g) Approval of Facility's contracts for administrative or clinical services; ... Possession and maintenance of all medical records, patient charts, databases and other documentation relating to the Facility..."

A review on May 4, 2023, of the facility document "PGC Endoscopy Center for Excellence Patient Rights and Responsibilities," undated, revealed "Complaints should be registered by contacting the center and/or patient advocate through the State Department of Health or Medicare. The center will respond in writing with notice of how the grievance has been addressed within 30 days." The document did not include the address and telephone number of the State Agency (the State Department of Health) to which patients may report complaints.

An interview conducted on May 4, 2023, with EMP1 confirmed the facility document "PGC Endoscopy Center for Excellence Patient Rights and Responsibilities," undated, was the document that was distributed to patients during admission for procedures. EMP1 confirmed the document did not include the address and telephone number of the State Agency to which patients may report complaints.

Plan of Correction - To be completed: 08/28/2023

It is documented in the EMR (under the registration section) that the patient has received a copy of the patient rights. Additional copies of the Patient's Bill of Rights are kept at the registration desk. The address and phone number of the PA Department of Health, Division of Acute & Ambulatory Care address, phone and fax numbers, and website was added to the copy of the Patient Bill of Rights as well as our policy 2.03: Patient Rights and Responsibilities.

Staff are being educated about the importance of ensuring that patients are aware of their patient rights and answer any questions that patients ask.

The administrator and Director of Nursing will be responsible to ensure that the correct agencies' addresses and phone numbers are correct on the form. Any concerns will be brought to the Board of Managers.

There will be a Quality monitoring study completed quarterly by the Director of Nursing or administrator to ensure that the address for the Department of Health remains on the revised form for the patients.

416.51(a) STANDARD SANITARY ENVIRONMENT:

The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.

Observations:
Based on a review of facility policies, observation, and interview with staff (EMP), it was determined the facility failed to ensure staff followed established standards for hand hygiene for the provision of services during an endoscopy procedure in accordance with facility policy.

Findings include:

A review of facility policy "Infection Control Plan" dated April 20, 2020, revealed "POLICY The Center has established an Infection Control Plan that includes the recommendations of the Centers for Disease Control (CDC), Society of Gastroenterology Nurses and Associates (SGNA), American Society of Gastrointestinal Endoscopy (ASGE) and Occupational Safety and Health Administration (OSHA) considered and selected by the Board of Managers. The Plan addresses the identification, reduction, and prevention of health care related infections and communicable diseases within the scope of operations of the Center."

A review of facility policy "Gown, Glove and Hand Washing Policy" dated April 20, 2020, revealed "HAND HYGIENE ... If hands are not visibly soiled, healthcare personnel may use the Center-approved alcohol-based hand rub (ABHR) for routine decontamination of hands. ... Decontaminate hands before having direct contact with patients. Decontaminate hands after contact with a patient's intact skin (i.e. when taking pulse, BP, or lifting patient. Decontaminate hands after contact with body fluids, excretions, mucous membranes, non-intact skin if hands are not visibly soiled. Decontaminate hands if moving from a contaminated body site to clean body site. Decontaminate hands after contact with inanimate objects (including medical equipment) in immediate vicinity of the patient. Decontaminate hands after removing gloves."

An observation on May 4, 2023, at 10:27 AM to 10:50 AM in OR2 of an upper endoscopy procedure for MR11, revealed the following:

1. At approximately 10:39 AM, EMP4, a certified registered nurse anesthetist (CRNA) assisted with the "time out" procedure by holding MR11's wrist and reading MR11's identification band. At approximately 10:40 AM EMP4 was observed donning gloves and inserting an intravenous (IV) catheter. EMP4 did not perform hand hygiene prior to donning the gloves.

2. At approximately 10:41 AM, EMP4 was observed removing gloves after inserting the IV catheter, adjusting the oxygen flowmeter, adjusting the cardiac monitor, documenting in the computer and injecting medication into MR11's IV without first performing hand hygiene.

3. At approximately 10:43 AM, EMP4 was observed discarding the medication syringe in the sharps container and opening the trash can with an un-gloved hand to discard trash. Further observation revealed EMP4 donned a gown and gloves in preparation for the endoscopy procedure without first performing hand hygiene.

4. At approximately 10:46 AM, EMP4 was observed adjusting the oxygen flowmeter and positioning MR11's head and mouth guard prior to removing the glove from EMP4's right hand. Further observation revealed EMP4 was handling the computer mouse before reapplying a glove to EMP4's right hand without first performing hand hygiene.

An interview conducted on May 4, 2023, at 12:00 PM with EMP1 and EMP2 confirmed EMP4 failed to follow the facility's policy for hand hygiene during the endoscopy procedure.

Plan of Correction - To be completed: 08/11/2023

Staff, physicians and CRNAs are attending an in-service and policy review on Gown, Glove and Handwashing Policy (8.23). Question and answer period is being provided.

An additional handwashing QA study will be performed each month strictly in the procedure room, during a procedure. Staff or Providers who don't follow the policy will be counselled.

The Infection Control Nurse/Director of Nursing and Administrator will be responsible to ensure proper handwashing policy is followed by staff, physicians and CRNA staff. This will be reported to the Board of Managers quarterly.

416.52(c)(2) STANDARD DISCHARGE - ORDER:

[The ASC must -]
Ensure each patient has a discharge order, signed by the physician who performed the surgery or procedure in accordance with applicable State health and safety laws, standards of practice, and ASC policy.

Plan of Correction - To be completed: 08/11/2023

On 12/1/22, there was an upgrade to a cloud based EMR system as the current EMR would no longer be supported by the vendor.

During the survey, it was found that there was no discharge order present in the EMR. This was resolved in all charts on 4/26/23, by the EMR vendor at our request, as it was added to the procedural physician discharge order set.

Staff and physicians have been educated that there needs to be a discharge or transfer order for each patient.

In order to ensure this POC is being followed, we have added to our monthly peer review, that there is a discharge order present on the chart.

The Administrator will be responsible to ensure that this POC is sustained with reporting to the Board of Managers.

51.3 (a) LICENSURE Notification:

51.3 Notification

(a) A health care facility shall notify the Department in writing at least 60 days prior to the intended
commencement of a health care service which has not been previously provided at that facility.

Observations:

Based on a review of facility documents, medical records (MR) and interview with staff (EMP), it was determined the facility failed to notify the Department of Health (the Department) in writing and receive approval prior to implementing a contracted service for a new electronic medical records system.

Findings include:

A review of facility document "Administrative Services Agreement by and between Physicians Endoscopy, LLC and PGC Endoscopy Center for Excellence, LLC" dated February 1, 2015, revealed "Article III Company's Obligations. ... 3.2 Specific Responsibilities. ... (a) Ongoing responsibility for the statutory and regulatory compliance of the Facility with all state and federal statutes, rules and regulations, and other requirements, including, but not limited to, those laws regarding the establishment and operation of a health care facility in the state in which the Facility is located; ... (c) Adoption and approval of the Facility's operating policies and procedures, and adoption of policies affecting the delivery of health care service;. ... (g) Approval of Facility's contracts for administrative of clinical services; ... Possession and maintenance of all medical records, patient charts, databases and other documentation relating to the Facility..."

A review on April 24, 2023, of facility documents revealed a new contract signed by the facility Administrator July 1, 2022, for [vendor name redacted] Software Inc., electronic medical records software subscription commencing on October 31, 2022.

A review on April 24, 2023, of MR1 through MR10 revealed the medical records were documented in an electronic medical record format by [vendor name redacted] Software Inc. MR3, MR4, MR5, MR6, MR7, MR8, MR9 and MR10 did not include documentation of a discharge order signed by the physician prior to discharge from the facility.

A review on April 24, 2023, of the Department's data base revealed no notification to the Department regarding the facility's intention to begin using [vendor name redacted] Software Inc.

An interview conducted on April 24, 2023, at 3:03 PM with EMP1 confirmed there was no documentation of a discharge order signed by the physician prior to discharge from the facility in MR3, MR4, MR5, MR6, MR7, MR8, MR9 and MR10. EMP1 stated "We used to have discharge orders in the paper charts, but discharge orders do not appear in the new electronic medical record. I don't know how we overlooked that."

A telephone interview conducted on April 27, 2023, at 10:50 AM with EMP1 confirmed the facility began using the new software for electronic documentation on December 1, 2022. EMP1 confirmed the facility did not submit notification and did not receive approval from the Department prior to implementing the new electronic medical records system.

Cross Reference:
555.24(g): Surgical Services - Postoperative Care

Plan of Correction - To be completed: 08/28/2023

On 12/1/22, there was an upgrade to a cloud based EMR system as the current EMR would no longer be supported by the vendor. Since this was not a change in vendors, merely an upgrade, the administrator was not aware that there needed to be a notification to the Department of Health.
During the survey, it was found that there was no discharge order present in the EMR. This was resolved in all charts on 4/26/23, by the EMR vendor at our request, as it was added to the procedural physician discharge order set.

In order to ensure this POC is being followed, we have added to our monthly physician peer review, that there is a discharge order present on the chart.

Staff and physicians are being educated on the necessity to notify the Department of Health of any upgrades, new equipment, or significant changes here at the center.

The Administrator will be responsible to notify the Department of Health for any changes going forward. The Board of Managers will be notified of this notification to the Department of Health.

The physicians are monitoring that the discharge order is present during their monthly peer review. The administrator will monitor the results that the physicians submit to ensure that a discharge order is present.

The administrator will be responsible to notify the Department of Health of all new services. New services will be discussed in the quarterly Continuous Quality Improvement Committee which is reported to the Board of Managers.

553.12 (a) LICENSURE Patient's Bill of Rights - Implementation:

553.12 PATIENT'S BILL OF RIGHTS -
IMPLEMENTATION

(a) The ASF governing body shall establish a patient's bill of rights not less in substance and coverage than the minimal patient's bill of rights provided by subsection (b).

Observations:

Based on a review of facility documents and interview with staff (EMP), it was determined the governing body failed to establish a patient's bill of rights that included the address and telephone number of the State agency to which patients may report complaints.

Findings include:

A review of facility document "Administrative Services Agreement by and between Physicians Endoscopy, LLC and PGC Endoscopy Center for Excellence, LLC" dated February 1, 2015, revealed "Article III Company's Obligations. ... 3.2 Specific Responsibilities. ... Company retains all authority and responsibility over the following, in accordance with its Operating Agreement to the extent applicable: (a) Ongoing responsibility for the statutory and regulatory compliance of the Facility with all state and federal statutes, rules and regulations, and other requirements, including, but not limited to, those laws regarding the establishment and operation of a health care facility in the state in which the Facility is located; ... (c) Adoption and approval of the Facility's operating policies and procedures, and adoption of policies affecting the delivery of health care service; ... (g) Approval of Facility's contracts for administrative or clinical services; ... Possession and maintenance of all medical records, patient charts, databases and other documentation relating to the Facility..."

A review on May 4, 2023, of the facility document "PGC Endoscopy Center for Excellence Patient Rights and Responsibilities," undated, revealed "Complaints should be registered by contacting the center and/or patient advocate through the State Department of Health or Medicare. The center will respond in writing with notice of how the grievance has been addressed within 30 days." The document did not include the address and telephone number of the State Agency (the State Department of Health) to which patients may report complaints.

An interview conducted on May 4, 2023, with EMP1 confirmed the facility document "PGC Endoscopy Center for Excellence Patient Rights and Responsibilities," undated, was the document that was distributed to patients during admission for procedures. EMP1 confirmed the document did not include the address and telephone number of the State Agency to which patients may report complaints.

Plan of Correction - To be completed: 08/28/2023

It is documented in the EMR (under the registration section) that the patient has received a copy of the patient rights. Additional copies of the Patient's Bill of Rights are kept at the registration desk. The address and phone number of the PA Department of Health, Division of Acute & Ambulatory Care address, phone and fax numbers, and website was added to the copy of the Patient Bill of Rights as well as our policy 2.03: Patient Rights and Responsibilities.
Staff are being educated about the importance of ensuring that patients are aware of their patient rights and answer any questions that patients ask.

The administrator and Director of Nursing will be responsible to ensure that the correct agencies' addresses and phone numbers are correct on the form. Any concerns will be brought to the Board of Managers.

The administrator and Director of Nursing will be responsible to ensure that the correct agencies' addresses and phone numbers are correct on the form. Any concerns will be brought to the Board of Managers.

There will be a Quality monitoring study completed quarterly by the Director of Nursing or administrator to ensure that the address for the Department of Health remains on the revised form for the patients.

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

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.

Plan of Correction - To be completed: 08/11/2023

Written instructions are provided to the patients by the practice staff.
The center staff RNs call patients prior to their procedures to complete pre-calls. During the pre-call, the patient is asked if they have any questions to the written instructions that they have received from the practice staff and the nurse provides the clarification. It is documented in the EMR that the patient has received instructions for: "preparation for the procedure, center location, must have a driver, NPO, no smoking or vaping after midnight, bring inhalers and list of updated medications, insurance cards, photo ID and any special instructions are documented (such as hold blood thinners, diabetic medication, etc.).

Staff are being educated to ensure this section is completed for each patient. The monthly nursing Peer Review includes that this section is completed for each patient that is reviewed. The Director of Nursing and administrator will be responsible to ensure this is documented. Any concerns will be communicated to the Board of Managers.

555.24 (g) LICENSURE Surgical Services - Postoperative:

555.24 Post Operative Care

(g) Patients shall be discharged only upon the written signed order of a practitioner.

Plan of Correction - To be completed: 08/11/2023

On 12/1/22, there was an upgrade to a cloud based EMR system as the current EMR would no longer be supported by the vendor.
During the survey, it was found that there was no discharge order present in the EMR. This was resolved in all charts on 4/26/23, by the EMR vendor at our request, as it was added to the procedural physician discharge order set.

Staff and physicians have been educated that there needs to be a discharge or transfer order for each patient.

In order to ensure this POC is being followed, we have added to our monthly physician peer review, that there is a discharge order present on the chart.

The Administrator will be responsible to ensure that this POC is sustained with reporting to the Board of Managers.

561.23 LICENSURE Controlled substances and other drugs:

There shall be policies and procedures developed and approved by the medical staff which establish controls governing the use of controlled substances and other drugs, including sedatives, anticoagulants, antibiotics, oxytoxics and corticosteroids. Policies shall be established regarding written orders for appropriate dosage of all drugs.

Observations:

Based on a review of facility policy, documents, and interview with staff (EMP), it was determined the facility failed to ensure Lorazepam (a controlled substance) was maintained and tracked in accordance with facility policy.

Findings include:

A review of facility policy "Controlled Substance in the Center" dated October 10, 2020, revealed "STATEMENT: To procure, maintain, administer, track and dispose of controlled substances in an accurate manner consistent with DEA (Drug Enforcement Administration) and Board of Pharmacy requirements. PROCEDURE: There is a double locked storage area in the Medication area of the Center that acts as the storage location for Controlled Substances. At the beginning of the day, two (2) authorized persons (two RN's) visually and concurrently count the controlled substances and mark the beginning inventory on the daily count sheet. All medication given will be notated on the patient's Procedure Record and also on the procedural count. At the completion of each case, the CRNA administering Sedation will record on the daily sheet the amount of controlled substance given to the patient. At the end of the day, two (2) authorized persons (two RN's) will do a joint count visually and concurrently and document end of day count in narcotic log book."

A review of facility document "Controlled Substance Log LORAZEPAM" revealed a form with columns to indicate the date, patient medical record number, patient name, amount of medication given, amount wasted, remaining number of medication vials and staff signatures. Further review revealed "10/9/21 Received 25 vials." Further review revealed "25" was written in the "Remaining" column on the top line of the form.

An observation on April 24, 2023, at 9:34 AM with EMP1 in the Pre- Post endoscopy area revealed a locked medication refrigerator. There were 22 Lorazepam vials stored in the refrigerator.

An interview conducted on April 24, 2023, at 9:36 AM with EMP1 confirmed there were 22 Lorazepam vials in the medication refrigerator, not 25 as was documented on the Lorazepam Controlled Substance Log.

An interview conducted on April 24, 2023, at 10:43 AM with EMP1 confirmed the Lorazepam was received by the facility on October 9, 2021. EMP1 confirmed there was no documentation to account for the three missing vials of Lorazepam and further confirmed there was no documentation of daily checks on the Lorazepam Controlled Substance Log after the Lorazepam was received. EMP1 stated "The form has been sitting in the (Controlled Substance Log) book this whole time. We do not normally go in the medication refrigerator so the Lorazepam has been overlooked since it was placed in there."

An interview conducted on April 24, 2023, at 1:43 PM with EMP5, a certified registered nurse anesthetist (CRNA) confirmed EMP5 did not follow facility policy and failed to document the required information on the Lorazepam Controlled Substance Log when taking the medication for patient use. EMP5 stated "The primary care physician requested we use Ativan (Lorazepam) for a patient (in October 2021). We used three Ativan vials for that patient and I guess I never wrote it down."

Plan of Correction - To be completed: 08/11/2023

Lorazepam was discovered during the survey in a locked medication refrigerator. Only the CRNA staff and Nursing administration have the key for this refrigerator. It was not properly documented for administration and daily counts. Immediately following the survey, the Administrator informed our Medication Disposal Company to retrieve and destroy this medication as it was not being used. This was completed and proper documentation completed.
Staff and CRNA staff are being educated to follow proper documentation policies for all controlled medications.

A Quality Improvement study was immediately implemented to ensure that all Controlled medications are being properly counted at the beginning and end of the shift by 2 licensed professionals and properly signed out for administration.

The Director of Nursing and the Administrator will be responsible to ensure that this is being followed properly with report to the Board of Managers.

567.1 LICENSURE Principle:

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 a review of facility policies, observation, and interview with staff (EMP), it was determined the facility failed to ensure staff followed established standards for hand hygiene for the provision of services during an endoscopy procedure in accordance with facility policy.

Findings include:

A review of facility policy "Infection Control Plan" dated April 20, 2020, revealed "POLICY The Center has established an Infection Control Plan that includes the recommendations of the Centers for Disease Control (CDC), Society of Gastroenterology Nurses and Associates (SGNA), American Society of Gastrointestinal Endoscopy (ASGE) and Occupational Safety and Health Administration (OSHA) considered and selected by the Board of Managers. The Plan addresses the identification, reduction, and prevention of health care related infections and communicable diseases within the scope of operations of the Center."

A review of facility policy "Gown, Glove and Hand Washing Policy" dated April 20, 2020, revealed "HAND HYGIENE ... If hands are not visibly soiled, healthcare personnel may use the Center-approved alcohol-based hand rub (ABHR) for routine decontamination of hands. ... Decontaminate hands before having direct contact with patients. Decontaminate hands after contact with a patient's intact skin (i.e. when taking pulse, BP, or lifting patient. Decontaminate hands after contact with body fluids, excretions, mucous membranes, non-intact skin if hands are not visibly soiled. Decontaminate hands if moving from a contaminated body site to clean body site. Decontaminate hands after contact with inanimate objects (including medical equipment) in immediate vicinity of the patient. Decontaminate hands after removing gloves."

An observation on May 4, 2023, at 10:27 AM to 10:50 AM in OR2 of an upper endoscopy procedure for MR11, revealed the following:

1. At approximately 10:39 AM, EMP4, a certified registered nurse anesthetist (CRNA) assisted with the "time out" procedure by holding MR11's wrist and reading MR11's identification band. At approximately 10:40 AM EMP4 was observed donning gloves and inserting an intravenous (IV) catheter. EMP4 did not perform hand hygiene prior to donning the gloves.

2. At approximately 10:41 AM, EMP4 was observed removing gloves after inserting the IV catheter, adjusting the oxygen flowmeter, adjusting the cardiac monitor, documenting in the computer and injecting medication into MR11's IV without first performing hand hygiene.

3. At approximately 10:43 AM, EMP4 was observed discarding the medication syringe in the sharps container and opening the trash can with an un-gloved hand to discard trash. Further observation revealed EMP4 donned a gown and gloves in preparation for the endoscopy procedure without first performing hand hygiene.

4. At approximately 10:46 AM, EMP4 was observed adjusting the oxygen flowmeter and positioning MR11's head and mouth guard prior to removing the glove from EMP4's right hand. Further observation revealed EMP4 was handling the computer mouse before reapplying a glove to EMP4's right hand without first performing hand hygiene.

An interview conducted on May 4, 2023, at 12:00 PM with EMP1 and EMP2 confirmed EMP4 failed to follow the facility's policy for hand hygiene during the endoscopy procedure.

Plan of Correction - To be completed: 08/11/2023

Staff, physicians and CRNAs are attending an in-service and policy review on Gown, Glove and Handwashing Policy (8.23). Question and answer period is being provided.
An additional handwashing QA study will be performed each month strictly in the procedure room, during a procedure. Staff or Providers who don't follow the policy will be counselled.

The Infection Control Nurse/Director of Nursing and Administrator will be responsible to ensure proper handwashing policy is followed by staff, physicians and CRNA staff. This will be reported to the Board of Managers quarterly.

Back to County Map

Home : Press Releases : Administration
Health Planning and Assessment : Office of the Secretary
Health Promotion and Disease Prevention : Quality Assurance

Copyright � 2001 Commonwealth of Pennsylvania. All Rights Reserved.
Commonwealth of PA Privacy Statement