QA Investigation Results

Pennsylvania Department of Health
CROZER-KEYSTONE SURGERY CENTER AT BRINTON LAKE (A DEPARTMEN
Health Inspection Results
CROZER-KEYSTONE SURGERY CENTER AT BRINTON LAKE (A DEPARTMEN
Health Inspection Results For:


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Initial Comments:

This report is the result of a State licensure survey conducted on October 29, 2018, and completed on November 13, 2018, at Crozer-Keystone Surgery Center at Brinton Lake. 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:




553.3 (1) LICENSURE
Governing Body Responsibilities

Name - Component - 00
553.3
Governing Body responsibilities include:

(1) Conforming to all applicable Federal, State, and local laws.


Observations:

Based on a review of facility policies, documents and interview with staff (EMP), it was determined the facility failed to conform to all applicable State Laws.

Crozer-Keystone Surgery Center at Brinton Lake was not in compliance with the following State Law related to Act 13 of 2002, Medical Care Availability and Reduction of Error (MCARE) Act 40 PS. 1303.310(a) Patient Safety Committee.

Section 310 Patient Safety Committee

(a) Composition

An ambulatory surgical facility's or birth center's patient safety committee shall be composed of the medical facility's patient safety officer and at least one health care worker of the medical facility and one resident of the community served by the ambulatory surgical facility or birth center who is not an agent, employee or contractor of the ambulatory surgical facility or birth center. No more than one member of the patient safety committee shall be a member of the medical facility's board of governance. The committee shall include members of the medical facility's medical and nursing staff.

This is not met as evidenced by:

Based on a review of facility policy, documents and interview with staff (EMP), it was determined the facility failed to ensure a resident of the community was in attendance for all Patient Safety Committee meetings.

Findings include:

A review of the facility's policy "Patient Safety Plan" dated September 6, 2018, revealed "Patient Safety Committee: The Center, through the Crozer Keystone Health System Local advisory Board (CKHSLAB), will establish a Patient Safety Committee. The Committee will be chaired by the AVP, Ambulatory Services and composed of the Center's Administrator or the Center's Clinical Director, the CK System Director for Patient Safety, a Center health care worker, member of the medical staff and a member of the community served by the Center. The Committee will meet at least quarterly.

Review of the facility's Patient Safety Committee Meeting Minutes revealed meetings were held on February 27, 2018, May 22, 2018, and September 6, 2018. Further review of the committee meeting minutes revealed the community member was not in attendance.

An interview conducted on October 29, 2018, at 1:40 PM with EMP2 and EMP7 confirmed the facility did not have a community member in attendance at the Patient Safety Committee Meetings conducted on February 27, 2018, May 22, 2018, and September 6, 2018. EMP2 and EMP7 confirmed that the facility had failed to follow the facility's Patient Safety Plan.












Plan of Correction:

The Patient Safety Committee met on November 29, 2018. An appropriate community resident member for the Patient Safety Committee was identified and in attendance for the meeting. The Patient Safety Committee will be restructured to ensure all required parties are identified and in attendance at every meeting.
Attendees of the Patient Safety Committee meeting will be recorded within the meeting minutes and reviewed on a quarterly basis by Administrator of the Crozer Keystone Surgery Center at Brinton Lake. The Administrator of the Surgery Center will ensure that 100% compliance has been achieved by all attendees. An audit will be performed quarterly by the Administrator of the Surgery Center.

The Administrator of the Crozer Keystone Surgery Center at Brinton Lake will report the audit results to the Accreditation & Regulatory Department, Medical Director of the Surgery Center and the Assistant Vice President of Ambulatory Services on a quarterly basis. Results will also be reported to the Ambulatory Services Patient Safety and Quality Committee quarterly.

The Administrator of the Crozer Keystone Surgery Center at Brinton Lake is ultimately responsible for this plan of correction and will address any areas of non-compliance.



553.3 (13)(i-iv) LICENSURE
Govern Body Responsibilities

Name - Component - 00
Governing Body responsibilities include:
(13) Approving major contracts or arrangements affecting the medical care provided under its auspices, including, those concerning;
(i) The employment for contractual arrangements with practitioners and others providing direct patient care.
(ii) The provision of all treatment related services including, radiology, medical laboratory, pathology , anesthesia and pharmaceutical services.
(iii) The provision of care by other health care organizations.
(iv) The provision of education to students and post graduate trainees.



Observations:

Based on review of facility documents and interview with staff (EMP), it was determined the Board of Managers and/or Local Advisory Board failed to establish written contracts and/or written agreements for pharmacy and laboratory services at Crozer-Keystone Surgery Center at Brinton Lake.

Findings include:

Review on October 29, 2018, of facility document "AMENDED AND RESTATED OPERATING AGREEMENT OF PROSPECT CCMC, LLC dated January 1, 2017, revealed "(c) The Board of Managers shall: ... .Take all reasonable steps to conform to all applicable Federal, State, and local laws and regulations... 11.7 Advisory Law. This Agreement shall be governed by and interpreted in accordance with the laws of the Commonwealth of Pennsylvania. ...11.1 Execution of Contracts. The Member, except as otherwise provided in this Agreement, may authorize any officer or officers, agent or agents, to enter into any contract or execute any instrument in the name of and on behalf of the Company, and such authority may be general or confined to specific instances; and, unless so authorized or ratified by the Board of Managers, no officer, employee or other agent shall have any power or authority to bind the Company by any contract or engagement or to pledge its credit or to render it liable for any purpose or to any amount."

Review on October 29, 2018, of facility document "Contract Agreements" revealed no documented evidence that the Board of Managers and/or the Local Advisory Board had established written contracts and/or written agreements for pharmacy and laboratory services at Crozer-Keystone Surgery Center at Brinton Lake. The facility was unable to produce a contract or a written agreement for these services.

An interview conducted on October 29, 2018, at 1:07 PM with EMP2 and EMP7 confirmed the facility's Board of Managers and/or the Local Advisory Board had not established contracts nor written agreements for pharmacy and laboratory services at Crozer-Keystone Surgery Center at Brinton Lake.









Plan of Correction:

A contract with Crozer Chester Medical Center has been established for Laboratory Services, Pathology Services, Anesthesia Services, Radiological and Pharmaceutical Services (Ancillary Services) for the Crozer Keystone Surgery Center at Brinton Lake. The contracts will be reviewed and approved by the Local Advisory Board meeting on January 18, 2019 and reflected in the committee meeting minutes.

The contract established with Crozer Chester Medical Center auto-renews to ensure there is no lapse in contractual agreement. The contracts will be added to the annual review process of contracted services and will be reviewed by the Assistant Vice President of Ambulatory Services on an annual basis to ensure sustained compliance.

The Assistant Vice President of Ambulatory Services is ultimately responsible for this plan of correction and will address any areas of non-compliance.



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

Name - Component - 00
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 review of facility policy, documents and interview with staff (EMP), it was determined that the Governing Body failed to establish a patient's bill of rights not less in substance and coverage than the minimal patient's bill of rights required by the "Department" for an Ambulatory Surgical Facility (ASF).

Findings include:

Review of the facility's policy "Patient Rights and Responsibilities" last revised April 2018 revealed "POLICY STATEMENT: Crozer-Keystone Health System (CHS) is committed to notifying and educating our patients about their rights and responsibilities in order to deliver the highest quality of care in a transparent, collaborative setting. CKHS will display these rights and responsibilities in appropriate patient access and care areas and provide them to patients routinely. CKHS will also make its staff aware of these rights and responsibilities by listing them in this policy, as set forth below: II. PATIENT RIGHTS AND RESPONSIBILITIES Your Rights and Responsibilities as a patient of this hospital, or as a family member or guardian of a patient at this hospital, we want you to know the rights you have under Federal and Pennsylvania state law as soon as possible in your hospital stay. We are committed to honoring your rights, and want you to know that by taking an active role in your health care, you can help your hospital caregivers ADM-2E 2 meet your needs as a patient or family member. That is why we ask that you and your family share with us certain responsibilities. Your Rights As a patient, you or your legally responsible party, have the right to care without discrimination due to age, AIDS or HIV status, ancestry, color, culture, disability, education, gender identity, income, language, marital status, national origin, race religious creed, sex, sexual orientation, union membership, or who will pay your bill. As our patient, you have the right to safe, respectful, and dignified care at all times. You will receive services and care that are medically suggested and within the hospital ' s services, its stated mission, and required law and regulation. Communication You have the right to:
1. Have a family member, another person that you choose, or your doctor notified when you are admitted to the hospital. 2. Receive information in a way that you understand. This includes interpretation and translation, free of charge, in the language you prefer for talking about your health care. This also includes providing you with needed help if you have vision, speech, hearing, or cognitive impairments. 3. Designate a support person, if needed, to act on your behalf to assert and protect your patient rights. 4. Designate a lay caregiver for information sharing, and discharge notification, planning and instruction. Informed Decisions
You have the right to: 1. Receive information about your current health, care, outcomes, recovery, ongoing healthcare needs, and future health status in terms that you understand.
2. Be informed about proposed care options including the risks and benefits, other care options, what could happen without care, and the outcome(s) of any medical care provided, including any outcomes that were not expected. You may need to sign your name before the start of any procedure and/or care. "Informed consent " is not required in the case of an emergency. 3. Be involved in all aspects of your care and to take part in decisions about your care. ADM-2E 3 4. Make choices about your care based on your own spiritual and personal values. 5. Request care. This right does not mean you can demand care or services that are not medically needed. 6. Refuse any care, therapy, drug, or procedure against the medical advice of a doctor. There may be times that care must be provided based on the law.
7. Expect the hospital to get your permission before taking photos, recording, or filming you, if the purpose is for something other than patient identification, care, diagnosis, or therapy.
8. Decide to take part or not take part in research or clinical trials for your condition, or donor programs that may be suggested by your doctor. Your participation in such care is voluntary, and written permission must be obtained from you or your legal representative before you participate. A decision to not take part in research or clinical trials will not affect your right to receive care. ..."

1. Review on November 13, 2018, of MR4 admitted on October 23, 2018, for a "Right Subclavian Infuse-A-Port surgical procedure" revealed a signed consent form as an attestation to receiving the hospital's patient rights and responsibilities. Further review revealed MR4 did not contain a signed patient rights and responsibilities form nor a signed consent form containing the minimal patient rights and responsibilities statements as required by the "Department" for an ASF.

2. Review on November 13, 2018, of MR5 admitted on October 25, 2018, for an "Open Reduction Internal Fixation Left Clavicle surgical procedure" revealed a signed consent form as an attestation to receiving the hospital's patient rights and responsibilities. Further review revealed MR5 did not contain a signed patient rights and responsibilities form nor a signed consent form containing the minimal patient rights and responsibilities statements as required by the "Department" for an ASF.

3. Review on November 13, 2018, of MR6 admitted on October 25, 2018, for a "Medial and Lateral Meniscal Tears, left knee surgical procedure" revealed a signed consent form as an attestation to receiving the hospital's patient rights and responsibilities. Further review revealed MR6 did not contain a signed patient rights and responsibilities form nor a signed consent form containing the minimal patient rights and responsibilities statements as required by the "Department" for an ASF.

A telephone interview conducted on November 13, 2018, at 10:45AM with EMP5 confirmed that the signed consent forms in MR4, MR5 and MR6 did not contain the minimal patient rights and responsibilities statements as required by the "Department". Futher interview with EMP5 confirmed the patient rights and responsibilities statements in MR4, MR5 and MR6 were representative of Crozer Chester Medical Center (hospital) and did not include the patient rights and responsibilities statements as required by the "Department" for an ASF.
.









Plan of Correction:

The Crozer Keystone Surgery Center at Brinton Lake's policy ADM 201 will be revised to include the requirements of regulation 553.12 for the Ambulatory Surgical Facility ("ASF"). Patients will be provided a copy of the patient's bill of rights upon registration on the day of arrival to the ASF. A signed attestation by the patient stating that they have received a copy of the bill of rights will be placed in the patient's medical record. Bill of rights forms will be printed along with the attestation form. The Administrator of the Surgery Center will update the policy by January 4, 2019.

100% of Registration staff at the Surgery Center will be educated by January 18, 2019. The education will be completed by the Administrator of the Surgery Center or designee.

Beginning January 2019, monthly audits will be conducted by the Business Office Manager, or designee to ensure the patient's bill of rights is placed in the patient's medical record. Thirty charts per month will be audited to assure compliance with this corrective action at the Surgery Center. Audits will continue until 100% compliance is achieved for three consecutive months.

The Administrator of the Crozer Keystone Surgery Center at Brinton Lake will report the audit results to the Accreditation & Regulatory Department, Medical Director of the Surgery Center and the Assistant Vice President of Ambulatory Services on a quarterly basis. Results will also be reported to the Ambulatory Services Patient Safety and Quality Committee quarterly

The Assistant Vice President of Ambulatory Services is responsible to present the revised policy and associate forms to the Local Advisory Board for approval by January 18, 2019. Approval will be reflected in the January Local Advisory Board committee meeting minutes.

The revised forms and associated policies will be implemented by January 18, 2019.

The Administrator of the Surgery Center is ultimately responsible for this plan of correction and to ensure sustained compliance.



555.2 LICENSURE
Medical staff membership

Name - Component - 00
555.2 Medical Staff Membership

A member of the medical staff shall be qualified for membership and the exercise of clinical privileges granted to him. The governing body of the ASF, after considering the recommendations of the medical staff, may grant clinical privileges to qualified, licensed practitioners in accordance with their training, experience and demonstrated competence and judgement. Members of the medicals staff and others granted clinical privileges shall currently hold licenses to practice in this Commonwealth.


Observations:

Based on review of facility Bylaws, documents, credential files (CF), and interview with staff (EMP), it was determined the facility failed to comply with granting privileges to the medical staff in accordance with the facilty's Bylaws for one of one credential file reviewed (CF1).

Findings include:

A review of facility Bylaws "Article VI Procedures For Appointment and Reappointment" last revised February 3, 2018, revealed "General Procedures. The Medical Staff, through its designated committees and Departments, shall investigate and consider each application for appointment or reappointment to the Staff and each request for modification of Staff membership status and shall adopt and transmit recommendations thereon to the Operations Committee. The Operations Committee shall be responsible for the final decision as to Medical Staff appointments and the final authority on granting, extending, terminating or reducing Medical Staff privileges. A separate, confidential record shall be maintained for each applicant requesting Medical Staff membership or Clinical Privledges."

A review of facility document "Certified Registered Nurse Anesthetists Delineation of Privileges" no date on the form revealed "**If you would like to opt out of any of the core privileges, please mark through the privileges and provide an explanation as to why you have opted out of the core privilege.**" Further review revealed no evidence of documentation on the form instructing the applicant to how to respond when requesting privileges.

A review on October 29, 2018, of CF1 revealed a signed and approved delineation of privilege form. Further review of the form revealed partial downward lines and or arrows drawn in the requested privilege column of the form. Futher review revealed a signed and dated statement by the department chair and CF1, a certified registered nurse anesthetist revealed "I have requested only those privileges for which by education, training, current experience, or demonstrated performance I am qualified to perform, and that I wish to exercise at Taylor Hospital." In addition, the form was signed and dated on November 29, 2016, by CF1 and the department chair's recommendation was signed and dated on December 1, 2016.

An interview conducted on October 29, 2018, at 2:19 PM with EMP10 confirmed that the approved privileges in CF1 was not requested and approved based on the facility's bylaws and that the form lacked direction on how to request and approve the privileges. Further interview confirmed the privileges for CF1 should have been approved for the Crozer-Keystone Surgery Center at Brinton Lake and not solely approved for Taylor Hospital. In addition, EMP2 and EMP10 confirmed CF1 currently performs procedures at the ASF and the statement referencing Taylor Hospital does not align with the facility's bylaws for approving privileges at the ASF.







Plan of Correction:

The Director of Medical Affairs will ensure that the Delineation of Privileges documentation for Certified Registered Nurse Anesthetists ("CRNA") at the Crozer Keystone Surgery Center at Brinton Lake will be changed to include the following elements:

1. Requesting that all reviewing providers that initial the approval do not draw a line with arrows across multiple check boxes.
2. Ensure that all dates & signature lines are completed.
3. Supporting documentation for requested privileges is present.
4. Additional verbiage regarding instructions for an opting out clause.
5. Appropriate heading on Delineation of Privileges will reflect all facilities where privileges are granted.

The Director of Medical Affairs will ensure that the Delineation of Privileges documentation for CRNA's is revised to include these elements by January 22, 2019.

New Delineation of Privileges will be sent to the Credentials Committee on January 22, 2019 for approval. The Director of Medical Affairs will ensure this is presented.

Education of 100% of the Credentialing Coordinators will be completed by January 25, 2019. This is the ultimate responsibly of the Director of Medical Affairs.

Audits will be conducted by the Director of Medical Affairs or designee for all CRNA's processed beginning January 28, 2019 and will continue until 100% compliance is achieved for three consecutive months. Audit results will be reported monthly to the Medical Executive Committee by the Director of Medical Affairs until 100% compliance has been achieved.

The Director of Medical Affairs is ultimately responsible for this plan of correction and to ensure sustained compliance.



555.22 (b) LICENSURE
Surgical Services - Preoperative Care

Name - Component - 00
555.22 Pre-operative Care

(b) A written statement indicating informed consent, obtained by the practitioner, and signed by the patient, or responsible person, for the performance of the specific procedures shall be procured and made part of patient's clinical record. It shall contain a statement which evidences the appropriateness of the proposed surgery, as well as any alternative treatments discussed with the patient. It shall also identify any practitioner who shall participate in the surgery.


Observations:

Based on review of facility policy, documents, medical records (MR) and interview with staff (EMP), it was determined the facility failed to ensure an executed surgical consent form was in compliance with ambulatory surgical facility (ASF) regulations for three of three medical records reviewed (MR4 and MR5).

Findings include:

Review of facility document "Consent To Operation, Diagnostic Procedures Medical Treatment and Blood Transfusions" last revised May 2016 revealed "...11. Transfusion Of Blood Or Blood Products. If I need a transfusion of blood or blood products, I understand the blood will be supplied by sources available to the hospital and tested in accordance with state and federal laws. I understand no guarantees have been made regarding blood or blood products. I understand there are risks to transfusion, which include allergy symptoms, infections, jaundice, fever, and hemolytic reactions (when transfused red blood cells are destroyed by antibodies in the circulation). Although the risk is extremely low, transmission of infectious disease such as hepatitis and HIV (the AIDS virus) is possible. The risks and alternatives, including directed and autologous (self) donations have been explained to me and I consent to the transfusion of blood and blood products if my doctor believes it is needed medically. I understand this consent will remain in effect during my entire hospital stay."

Review of facility document "Informed Consent and Authorization For Anesthesia" last revised August 2018 revealed "...6. Should the need arise during my Procedure or the immediate postoperative period, I also consent to the administration of blood and/or blood products. Further, I understand that in spite of careful testing and screening of blood and blood products by collecting agencies, I may still be subject to ill effects as a result of receiving a blood transfusion and/or blood products. I have been told that the potential risks include fever and allergic reactions, hemolytic reactions, transmission of disease such as hepatitis, AIDS, and cytomegalovirus, and fluid overload."

A review on November 13, 2018, of MR4, revealed a signed Consent to Operation, Diagnostic Procedures Medical Treatment and Blood Transfusions consent form dated September 19, 2018,which contained consent for the Transfusion of Blood Or Blood Products. Further review revealed an Informed Consent and Authorization for Anesthesia form dated October 23, 2018, contained consent for administration of blood and/or blood products during the procedure or the immediate postoperative period.

A review on November 13, 2018, of MR5, revealed a signed Consent to Operation, Diagnostic Procedures Medical Treatment and Blood Transfusions consent form dated September 19, 2018, which contained consent for the Transfusion of Blood Or Blood Products. Further review revealed an Informed Consent and Authorization for Anesthesia form dated October 25, 2018, contained consent for the administration of blood and/or blood products during the procedure or the immediate postoperative period.

A telephone interview conducted on November 13, 2018, at 11:00 AM with EMP5 confirmed MR4 and MR5 contained signed consents for the transfusion of blood and/or blood products. EMP5 stated "We do not transfuse blood and blood products at the ASF at any time during the patient's admission."





























Plan of Correction:

The form "Informed Consent and Authorization for Anesthesia," and form "Consent to Operation, Diagnostic Procedures Medical Treatment and Blood Transfusions," will be updated by the Director of Risk Management to reflect the appropriate information is provided to patients and that no patients will receive blood transfusions or blood products at the Crozer Keystone Surgery Center at Brinton Lake. The updated consent forms will be reviewed by January 16, 2019 b the Forms Committee. Once approved, the updated consent forms will be uploaded and immediately available for use by staff at the Crozer Keystone Surgery Center at Brinton Lake.

The Assistant Vice President of Ambulatory Services is responsible to present the revised consent forms to the Local Advisory Board for approval by January 18, 2019. Approval will be reflected in the January Local Advisory Board committee meeting minutes.

Thirty chart audits will be conducted on a monthly basis by the Administrator of the Surgery Center or designee to ensure that the appropriate surgical and anesthesia consent forms were utilized. The audits will begin on February 1, 2019 and will continue until 100% compliance is achieved for three consecutive months.

The Administrator of the Crozer Keystone Surgery Center at Brinton Lake will report the audit results to the Accreditation & Regulatory Department, Medical Director of the Surgery Center and the Assistant Vice President of Ambulatory Services on a quarterly basis. Results will also be reported to the Ambulatory Services Patient Safety and Quality Committee quarterly.

The Director of Risk Management is ultimately responsible for this plan of correction and to ensure sustained compliance.



555.23 (e) LICENSURE
Surgical Services - Operative Care

Name - Component - 00
555.23 Operative Care

(e) The ASF shall have a written transfer agreement with a hospital which has emergency and surgical services available or physicians performing surgery in the ASF shall have admitting privileges at a hospital in close proximity tot he ASF, to which patients may be transferred.

Observations:

Based on a review of facility documents and interview with staff (EMP), it was determined the facility failed to ensure a written transfer agreement with a local hospital in close proximity to the ambulatory surgical facility (ASF), to which patients may be transferred.

Findings include:

Review on October 29, 2018, of the facility document "AMENDED AND RESTATED OPERATING AGREEMENT OF PROSPECT CCMC, LLC dated January 1, 2017, revealed "(c) The Board of Managers shall: ... .Take all reasonable steps to conform to all applicable Federal, State, and local laws and regulations... 11.7 Advisory Law. This Agreement shall be governed by and interpreted in accordance with the laws of the Commonwealth of Pennsylvania."

Review on October 29, 2018, of facility document "Contract Log" failed to reveal the facility had a written transfer agreement with the closest acute care hospital in proximity to Crozer-Keystone Surgery Center at Brinton Lake.

An interview conducted on October 29, 2018, at 2:00PM with EMP2 and EMP7 confirmed that the facility did not have a transfer agreement with the closest hospital in proximity to the ASF. Further interview confirmed that the providers at Crozer-Keystone Surgery Center at Brinton Lake were not required to have admitting privileges at the closest acute care hospital in proximity to the ASF.

















Plan of Correction:

The Assistant Vice President of Ambulatory Services has obtained a transfer agreement between the Crozer Keystone Surgery Center at Brinton Lake and Crozer Chester Medical Center and is responsible to obtain another transfer agreement from the hospital within the closest proximity to the Crozer Keystone Surgery Center at Brinton Lake. All new transfer agreements for the Crozer Keystone Surgery Center at Brinton Lake will be obtained by January 18, 2019.

The transfer agreements will be reviewed and approved by the Local Advisory Board and will be reflected in the committee meeting minutes by January 18, 2019. The Assistant Vice President is responsible to ensure that the transfer agreements are presented at the Local Advisory Board meeting.

The transfer agreements established for the Crozer Keystone Surgery Center at Brinton Lake will auto-renew to sustain compliance with having a transfer agreement in place. The agreements will be added to the annual review process of contracted services and will be reviewed by the Assistant Vice President of Ambulatory Services on an annual basis to ensure sustained compliance.

The Assistant Vice President of Ambulatory Services is ultimately responsible for this plan of correction and will address any areas of non-compliance.



567.1 Principle LICENSURE
CHAPTER 567 - ENVIRONMENTAL SERVICES

Name - Component - 00
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 observation, review of facility policy, documents and interview with staff (EMP), it was determined the facility failed to adhere to professionally acceptable standards and guidelines for processing, packaging and maintaining sterilized instruments.


Findings include:

Observation on October 29, 2018, at 1:45PM in the sterilization room with EMP2, EMP8 and EMP9 revealed autoclaved sterilized peel packages containing sterilized instruments labeled with the date of sterilization and the load number on each package. Further observation revealed the sterilized peel packages were not labled with the sterilizer identification number, package contents and expiration date.

A review of the facility's policy "Assembling and Wrapping SPD-801" no date revealed " Policy: Assembling and wrapping procedures will ensure sterilant penetration, provided a barrier to microorganisms and allow sterile presentation of the package contents. ... PURPOSE: To ensure proper sterilization techniques and recommended wrapping and assembling of surgical instruments. C. All trays are then wrapped, square fashion in the hospital approved disposable wrap. Appropriate indicator tape applied on the outside along with the load number date, name of set and initials of personnel. D. All manufacture instructions for maintenance, use and sterilization are available on the website one Source... The website provide immediate 24/7 access to all information necessary for properly disassemble, decontaminate, package and reprocessing of any items in the department. ... Preoperative Standards and Recommended Practices. AORN (2015). Denver :AORN, Inc. Sterilization in Healthcare Facilities, Association Advancement of Medical Instrumentation (AAMI) 2012."


Review of the Center Of Disease and Control "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 last revised February 15, 2017, revealed "18. Storage of Sterile Items...c. Label sterilized items with a load number that indicates the sterilizer used, the cycle or load number, the date of sterilization, and, if applicable, the expiration date. Category IB. 811, 812, 814, 816, 819 d. The shelf life of a packaged sterile item depends on the quality of the wrapper, the storage conditions, the conditions during transport, the amount of handling, and other events (moisture) that compromise the integrity of the package. If event-related storage of sterile items is used, then packaged sterile items can be used indefinitely unless the packaging is compromised..."


An interview conducted on October 29, 2018, at 1:50 PM with EMP8 and EMP9 confirmed that the sterilized peel packages in the sterilizer room was not labeled with the sterilizer identification number, package contents and expiration date.

______________________

Based on review of the 2006 edition of the Association of Perioperative Registered Nurses (AORN) Standards, Recommended Practices, and Guidelines, observation and interview with staff (EMP), it was determined the facility failed to adhere to an acceptable standard of practice for wrapping of instruments for sterilization.

Findings include:

Observation tour conducted on October 29, 2018, at 2:00 PM with EMP2, EMP5, EMP8 and EMP9 revealed an anesthesia workroom with autoclaved sterilized peel packaged instruments dated August 29, 2018, Further observation revealed the room was not monitored for temperature and humidity.

Review of the AORN "Recommended Practices for Selection and Use of Packaging Systems ... Recommended Practice II ... Packaging system should be compatible with the sterilization process. 1. Packaging systems for steam sterilization should ... provide adequate air removal, permit steam penetration and direct contact with item(s) surfaces, permit adequate drying, permit use of material compatible (i.e., non-degradable) with the sterilizing process and maintain the integrity. The purpose of packaging systems is to permit sterilization of the package contents, maintain sterility of the contents until the package is opened, and permit delivery of contents without contamination... .Storage at room temperature and humidity permits adequate steam penetration and prevention of superheating. 4. Room temperature and humidity should be monitored and recorded on a daily basis. The recommended temperature and humidity are 20C to 23C (68F to 73F); 30% to 60%humidity."

An interview conducted on October 29, 2018, at 2:15 PM with EMP2, EMP5, EMP8 and EMP9 confirmed the anesthesia workroom contained autoclaved sterilized peel packaged instruments dated August 29, 2019. Further interview confirmed that the temperature and humidity readings were not monitored. EMP8 and EMP9 further stated that autoclaved instruments are stored in the drawers in the anesthesia workroom. EMP2 stated "I can understand why it would be important to take temperature and humidity readings for maintaining the sterilized instruments in this area."





Plan of Correction:

The Director of Clinical Services at the Crozer Keystone Surgery Center at Brinton Lake will educate the Sterile Processing Department Employees to ensure that the appropriate labels are applied to the sterile peel packs. The labels will include, date of sterilization, load number, the sterilizer (employee) identification number and expiration dates if applicable. No expiration date will be routinely assigned as per event related shelf life policy. Peel packs will be labelled to identify contents. The Director of Clinical Services will perform a weekly audit to ensure staff compliance. The Administrator is ultimately responsible for this plan of correction, and will address any areas of non-compliance.

The Administrator of the Crozer Keystone Surgery Center at Brinton Lake will report the audit results to the Accreditation & Regulatory Department, Medical Director of the Surgery Center and the Assistant Vice President of Ambulatory Services on a quarterly basis. Results will also be reported to the Ambulatory Services Patient Safety and Quality Committee quarterly.


Anesthesia Work Room: A thermometer/hygrometer was placed in the Anesthesia Work room by the Administrator of the Crozer Keystone Surgery Center at Brinton Lake to monitor the temperature and humidity daily to comply with the recommended temperature of 20C to 23C (68F to 73F) and humidity of 30% to 60%. The Administrator of the Crozer Keystone Surgery Center at Brinton Lake will update the temperature and humidity log sheet which to include the Anesthesia Work Room. The temperature and humidity of the Anesthesia Work Room will be recorded daily (Monday Friday) on the temperature and humidity log by the OR shift manager.

The Administrator of the Crozer Keystone Surgery Center or designee will conduct weekly audits of the temperature and humidity log to ensure proper completion and compliance. The audits will begin on in January of 2019 and will continue until 100% compliance is achieved for three consecutive months.

The Administrator of the Crozer Keystone Surgery Center at Brinton Lake will report the audit results to the Accreditation & Regulatory Department, Medical Director of the Surgery Center and the Assistant Vice President of Ambulatory Services on a quarterly basis. Results will also be reported to the Ambulatory Services Patient Safety and Quality Committee quarterly.

Policy ADM-228 will be updated to reflect the addition of the Anesthesia Work Room temperature and humidity monitoring. The Administrator of the Crozer Keystone Surgery Center at Brinton Lake is ultimately responsible for ensuring this plan of correction and sustained compliance.

The Assistant Vice President of Ambulatory Services is responsible to present the revised policy to the Local Advisory Board for approval by January 18, 2019. Approval will be reflected in the January, 2019 Local Advisory Board committee meeting minutes.

The Administrator of the Crozer Keystone Surgery Center at Brinton Lake is ultimately responsible for this plan of correction and will address any areas of non-compliance.