Pennsylvania Department of Health
KEYSTONE KIDNEY CENTER
Patient Care Inspection Results

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Severity Designations


Minimal Citation - No Harm	Minimal Harm	Actual Harm	Serious Harm

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KEYSTONE KIDNEY CENTER - Inspection Results	Scope of Citation Number of Residents Affected By Deficient Practice

Initial comments:

This report is the result of a State licensure survey conducted onsite July 6, 2023 and completed offsite on July 19,2023, at Keystone Kidney Center. It was determined the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Ambulatory Care Facilities, Annex A, Title 28, Part IV, Subparts A and F, Chapters 551-573, November 1999.

Plan of Correction:

51.4 (c) LICENSURE Change on Ownership/Management:

51.4. Change in ownership; change in management.

(c) A health care facility shall notify the Department in writing at least 30 days after a change of management of a health care facility. A change in management occurs when the person responsible for the day to day operation of the health care facility changes.

Observations:

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to notify the Department of Health (Department) in writing at least 30 days after a change of management for the person who was responsible for the day to day operation of the ambulatory surgery facility.

Findings include:

Review of facility documents on July 6, 2023, revealed EMP1 became the Senior Director of Quality and Fixed Site Operations on March 17, 2023. There was no documented evidence the Department was notified by the facility of the change in day to day operational management of the facility.
Review of electronic mail from EMP1 on May 23, 2023, revealed " ...As of yesterday, there has been an administrative change and I will now be the point of contact for Keystone... " On May 24, 2023, EMP1 was instructed via electronic mail to notify Department about administration change for the password agreement.
Interview on July 6, 2023, at approximately 12:37 PM with EMP1 confirmed they did not notify the Department in writing after a change of Administration that occurred at the end of May 2023.

Plan of Correction - To be completed: 08/01/2023

EMP1 became the Sr. Director of Quality and Fixed Site Operations on March 24, 2023. At that time, there was still an administrator at the facility that reported to EMP1. On May 23, 2023, the administrator resigned (stayed on as a consultant). EMP1 became the administrator for the facility effective that day.

To meet the standard (late), the Department of Health was notified in writing of the change on July 6, 2023.

A checklist of necessary reporting requirements, was created on August 1, 2023 to have in place for any/all changes in management. This form will be forwarded to the Quality committee for completeness.

Each month, at Quality review, a place holder will be on the agenda to report on changes and required reporting. All checklist forms will be reviewed for completeness and compliance with reporting requirements.

The medical director, the administrator and the quality committee will be responsible to monitor compliance with plan of correction. In addition, an audit will be done by an office employee to be sure the forms are completed and reporting took place within the required timeframes to all entities.

All changes were put in place on August 1, 2023.

551.53 (1)(2)(3) LICENSURE Presurvey preparation:

551.53 Presurvey Preparation

Prior to an annual survey site visit of an ASF by the Department, the Department may request from the ASF documents or records of the ASF, or other information necessary for the Department to prepare for the site visit. The ASF shall provide the information requested including a declarative statement that sets forth the information requested in 551.31 (relating to licensure) as follows:
(1) A list of operative procedures proposed to be performed at the facility.
(2) The highest level of anesthetic proposed to be used for each proposed operative procedure.
(3) The highest PS patient level proposed to receive outpatient surgical treatments at the facility.

Observations:

Based on review of Department of Health (Department) documents and staff interview (EMP), it was determined the facility failed to send the requested Ambulatory Surgery Center (ASC) documents necessary for the Department to prepare for the state licensure survey.

Findings include:

On May 24, 2023, the Department sent a letter to EMP1 at the Keystone Kidney Center, that requested materials required for the state licensure survey to be provided one week prior to survey date. A second letter was sent by Department to ASC three days prior to the scheduled onsite survey.

The requested documents were not received prior to the onsite survey on July 6, 2023.

Interview on July 6, 2023, at approximately 9:45 AM with EMP1 confirmed the requested materials were not provided prior to onsite survey as requested by the Department.

Plan of Correction - To be completed: 07/06/2023

The center's new administrator was working with the previous administrator (working as a consultant) and failed to be sure that all materials were sent as required.

All the requested materials were provided to the surveyor on the day of the survey. Some materials were emailed to the surveyor post survey as requested.

For future surveys, the administrator will work with a nurse on the needs for the survey. Once a date for the survey is set, the list of requirements will be printed. The due date for the documents will be written prominently on the list. As the documents are gathered, they will be checked off on the list. Once all documents are collected, the administrator and the nurse will review to be sure all are in place. They will be emailed as required and the date of email will be written on the list. The due date for the documents to be sent will also be placed on the work calendar for the administrator and the nurse with alerts put in place as reminders.

This POC was printed, highlighted and placed in the DOH binder for reference with next survey on August 1, 2023.

The administrator is responsible to monitor compliance with the plan of correction. The nurse will also check to be sure that the POC remains in the DOH binder, that once a date is given for the next survey, the due date for materials is prominently written on the list. No further deficiency should be found for this standard on future surveys.

553.3 (1) LICENSURE Governing Body Responsibilities:

553.3
Governing Body responsibilities include:

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

Observations:

Based on review of facility documents and staff interview (EMP), it was determined the facility failed to conform to applicable state laws.

Keystone Kidney Center was not in compliance with the following State Law:

"Medical Care Availability and Reduction of Error (MCARE) Act - Reduction and Prevention of Health Care -ACT of July. 20, 2007, P.L. 331, No. 52, Chapter 4, Health Care-Associated Infections... Section, 403. Infection control plan. (a) Development and compliance.--Within 120 days of the effective date of this section, a health care facility and an ambulatory surgical facility shall develop and implement an internal infection control plan that shall be established for the purpose of improving the health and safety of patients and health care workers and shall include: (1) A multidisciplinary committee including representatives from each of the following if applicable to that specific health care facility: (i) Medical staff that could include the chief medical officer...(ii) Administration representatives that could include the chief executive officer, the chief financial officer...(iii) Laboratory personnel. (iv) Nursing staff that could include a director of nursing or a nursing supervisor. (v) Pharmacy staff that could include the chief of pharmacy. (vi) Physical plant personnel.
(vii) A patient safety officer. (viii) Members from the infection control team, which could include an epidemiologist. (ix) The community, except that these representatives may not be an agent, employee or contractor of the health care facility or ambulatory surgical facility ... (8) The procedure for distribution of advisories issued under section 405(b)(4) so as to ensure easy access in each health care facility for all administrative staff, medical personnel and health care workers ..."

This is not met as evidenced by:

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to include a community member on their infection control committee.

Review on July 6, 2023, of facility document "Keystone Kidney Center Infection Control Committee List," reviewed March 29, 2023, revealed no community member on the list.

Interview with EMP1 on July 6, 2023 at 6:50 PM via electronic mail revealed, "I was told that the pharmacy consultant serves as the community member."

Plan of Correction - To be completed: 08/01/2023

The previous administrator (no longer an employee of Keystone Kidney) will serve on the Infection control committee as the community member. She will be included with all committee meetings moving forward. This will begin with the next meeting.

The structure of the Infection Control committee was modified August 1, 2023 to include one of the previous administrators (she also serves on another committee as a community member).

Policy was updated on August 1, 2023 to include the community member.

Quarterly meetings will be monitored by the administrator to be sure that all required participants attend the meetings.

The administrator will monitor the standards annually to be sure that all elements of the Infection Control plan are followed or are updated if needed.

553.31 (a) LICENSURE Administrative responsibilities:

A full time person in charge shall be appointed who has authority and responsibility for the operation of the ASF at all times. Qualifications, authority, responsibilities and duties of the person in charge shall be defined in a written statement adopted by the governing body.

Observations:

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to ensure that a full-time administrator was appointed to have authority and responsibility for Keystone Kidney Center at all times.

Findings include:

Review on July 6, 2023, of the facility document "Position Description: Senior Director of Quality and Fixed Site Operations," revealed " ...This role manages
Fixed Site operations and overseeing of Office Based Lithotripsy, ambulatory surgery
centers and stone centers operations.... " Continued review revealed the job description was signed and dated on March 17, 2023 by the Administrator (EMP1).

During an interview with EMP1 on July 6, 2023, at approximately 2:45PM, EMP1 confirmed they are not onsite at the facility full time.

Plan of Correction - To be completed: 07/07/2023

The center's administrator is responsible for everything at the facility on a full time basis. The administrator is on site on all patient care days and always when anyone is on site in the facility. A presence will be maintained to keep the facility compliant with all testing, quality and infection control standards. All required testing and checks are performed.

The administrator is responsible full time for the facility. The facility is available to treat patients every day, however, based on physician preference, cases are done periodically during the month. The administrator works remotely on days there are no patients scheduled at the facility. The administrator is always at the facility on patient care days and at least once a week. On days that there are no patients, there are no other staff in the facility. The administrator is always available by phone to patients, physicians or any other needs. Should volume increase for treatment days, the administrator will remain on site full time.
While working off site, all requirements, i.e. meetings, policy reviews, quality initiatives, etc are done by the administrator.

Each month at quality review, case volume will be reviewed as well on site time of the administrator as well as completeness of all administrator duties.

559.2 (1) LICENSURE Director of Nursing:

559.2 Director of Nursing

The director of nursing shall be an currently licensed as a registered nurse in this Commonwealth
and be responsible and accountable to the person in charge of the ASF for:
(1) Delivery of nursing service to the patients,

Observations:

Based on review of facility documents and interview with staff (EMP) it was determined the facility failed to ensure a Director of Nursing (DON) was responsible for the delivery of nursing care to patients.

Findings include:

Review on July 6, 2023, of facility document, "Keystone Mobile Partners," revealed no designated DON listed as facility staff.

Personnel file for DON was requested on July 7, 2023. No personnel file was provided.

Interview on July 6, 2023 at approximately 2:30 PM with EMP1, revealed a registered nurse from the fixed site facility in Chicago, Illinois would float to Keystone Kidney Center in Pennsylvania if patients were scheduled.

Plan of Correction - To be completed: 08/18/2023

We are currently working on having a nurse licensed in Pennsylvania. Once licensure comes through, the nurse will be appointed as the Director of Nursing and personnel file will contain current state licensure and job description. The goal is to have this complete by September 30, 2023.

This plan has been altered to comply with the requirement for licensure that a Director of Nursing be in place upon licensure.
The administrator, effective August 18, 2023, had been named the interim Director of Nursing.
As the licensure comes through for the registered nurse, the Board of Directors will be notified and the Director of Nursing will be changed to the registered nurse. Once that takes place, the DOH will be notified of the change as required. Anticipation is by the September 30, 2023.

At the monthly quality reviews, the status of the licensure of the nurse and appointment to Director of Nursing will be discussed.
Annually, positions of importance will be reviewed and approved by the Board of Directors to be sure that positions of importance (Director of Nursing, administrator, medical director, safety officer, Infection control coordinator, etc) are fulfilled. Documentation will be made in the meeting minutes.

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