HospitalInspections.org

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Based on document review and staff interview, the Governing Body (GB) failed to maintain responsibility for the oversight of all services including contracted services provided in the facility.

This failure places all patients at risk for receiving poor quality services with the potential for negative outcomes.

Findings:

The Governing Body failed to ensure that the Medical Staff Requirements were met.
See Tag A 044

The Governing Body failed to approve Policies and Procedures for three (3) of ten (10) contracted services reviewed.
See Tag A 048

The Governing Body failed to ensure compliance with the Requirement for Quality Assurance and Performance Improvement for services provided under contract.
See Tag A 083

The Governing Body failed to ensure the development of a contract which included the scope and nature of the services provided under contract.
See Tag A 085
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Based on record review and interview, the facility failed to ensure that all Physicians and Mid-Level Practitioners (MLPs) received: a) Department Specific Orientation in eight (8) of eight (8) Personnel Files reviewed, and b) Annual Education in five (5) of eight (8) Personnel Files reviewed.

This failure places patients at risk for poor quality care provided by staff who lack the required Orientation and Annual Education.

Findings:

a) On 01/26/16, during a review of Staff P's (Psychiatrist) Personnel File who was appointed 10/25/04, the facility was unable to provide evidence of Department Specific Orientation upon hire.

On 01/26/16, during a review of Staff O's (Emergency Department Physician) Personnel File who was appointed on 6/26/06, the facility was unable to provide evidence of Department Specific Orientation upon hire.

On 01/26/16, during a review of Staff I's (Anesthesiologist) Personnel File who was appointed on 2/26/15, the facility was unable to provide evidence of Department Specific Orientation upon hire.

Similar findings were noted in Personnel Files of Medical Staff Members J, M, N, Q and R.

This was confirmed with Staff A (Vice President Performance Improvement Quality Assurance Catholic Health Services) at the time of the Personnel File reviews.

b) On 01/26/16, during a review of Staff O's (Emergency Department Physician) Personnel File who was appointed 6/26/06, the facility was unable to provide evidence of Annual Education.

On 01/26/16, during a review of Staff P's (Psychiatrist) Personnel File who was appointed 10/25/04, the facility was unable to provide evidence of Annual Education.

Similar findings were noted in the Personnel Files of Medical Staff Members J, M and N.

This was confirmed with Staff A (Vice President Performance Improvement Quality Assurance Catholic Health Services) at the time of the Personnel File reviews.
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Based on document review and interview, the Governing Body (GB) failed to approve Policies and Procedures in three (3) of ten (10) Contracted Services reviewed. This was evident for Anesthesia Services, Maternal Fetal Medicine, and the Hyperbaric Oxygen Therapy and Wound Care Center.

This failure places all patients receiving services at risk for potential harm.

Findings:

During interview of Staff F (Chief Medical Officer) and Staff G (Chief Administrative Officer) on 01/20/16 at 11:00AM, the staff members stated that there are no Policies and Procedures for the Anesthesia Services.

During interview of Staff J (Director of Anesthesiology) on 01/20/16 at 11:15AM, the staff member stated that Rockville Anesthesia Group LLP has been providing Anesthesia Services at Mercy Medical Center for at least the last ten (10) years. He stated that "A few months ago I realized we did not have any Policies and Procedures. I did not notify Upper Management that there were no Policies and Procedures for Anesthesia. I have not reviewed any Mercy Medical Center Policies and Procedures."

On 01/20/16 a review of the Meeting of the Board of Trustees Minutes dated 06/09/15 revealed the approval of an "On Call and Clinical Services Agreement for Maternal Fetal Medicine (MFM) with Madonna Physicians Services".

During interview of Staff A (Vice President Performance Improvement Quality Assurance Catholic Health Systems-VPPIQA CHS) on 01/25/16 at 11:45AM, the staff member stated that "MFM started providing services at Mercy on 07/01/15".

A review of the MFM Manual revealed that the Policies and Procedures documented another hospital's name, and the effective, and revised or approval dates were blank.

During interview of Staff G (Chief Administrative Officer) and Staff F (Chief Medical Officer) on 01/20/16 at 11:45AM, the staff members stated that "There is nothing in writing when Policies and Procedures are reviewed, however, the rule is every three (3) years".

During interview of Staff A (Vice President Performance Improvement Quality Assurance Catholic Health Systems-VPPIQA CHS) on 01/26/16 at 10:00AM, the staff member stated that the "Hyperbaric Oxygen Therapy and Wound Care Center started to provide services 03/15".

On 01/26/16 at 11:00AM during a review of the Governing Body Minutes with Staff G (Chief Administrative Officer), the staff member could not provide evidence that the Governing Body was reviewing and adopting any Policies and Procedures.

Although the Hyperbaric Oxygen Therapy and Wound Care Center started to provide services in 03/15, the staff member could not provide any evidence that the Policies and Procedures were adopted by the Governing Body.

Staff G (Chief Administrative Officer) was asked the following questions: How do we know that the Governing Body is aware when Contracts need renewal? When Policies and Procedures need to be renewed? When new Contracted Services need the Policies and Procedures adopted? Staff G (Chief Administrative Officer) replied "I will try to find the answer".

Review of the Bylaws and Rules and Regulations of the Medical Staff revealed that "The duties of the Executive Committee shall be to coordinate the activities and general Policies of the various Departments".
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Based on document review and interview, the facility did not ensure that the Quality Assurance Performance Improvement Evaluations for the Contracted Services were reviewed by the Governing Body in five (5) of ten (10) Contracts reviewed.

This failure places patients at risk for poor quality care.

Findings:

On 01/26/16 at 10:30AM review of the Meeting of the Board of Trustees Minutes with Staff G (Chief Administrative Officer) revealed that the Quality Assurance Performance Improvement Evaluations for the following Contracted Services: Hyperbaric Oxygen Therapy and Wound Care, New York Organ Donor Network, New York Blood Bank, Maternal Fetal Monitoring and Anesthesia were not reviewed.

On 01/26/16 at 11:00AM Staff G (Chief Administrative Officer) confirmed this finding.
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Based on document review and interview, the facility failed to ensure that there was a Contract in place with the Anesthesia Group that provides Anesthesia Services.

This failure places patients at potential risk for poor quality care.

Findings:

During interview of Staff J (Director of Anesthesiology) on 01/20/16 at 11:15AM, the staff member stated that "Rockville Anesthesia Group LLP has contracted with Mercy Medical Center to provide the Anesthesia Service for at least the last ten (10) years".

Interview of Staff F (Chief Medical Officer) and Staff G (Chief Administrative Officer) on 01/20/16 at 11:00AM revealed that Rockville Anesthesia is a Contracted Service that provides the Anesthesia Services.

During interview of Staff K (Vice President Performance Improvement) on 01/20/16 at 1:35PM, the staff member stated that "There is no Contact for Anesthesia Services."
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Based on document review and interview, the Hospital Quality Assurance Program failed to provide evidence of tracking and trending for issues related to Anesthesia Services.

This failure places all patients receiving Anesthesia Services at risk for potential negative outcomes.

Findings:

In the afternoon of 01/22/16, a review of the Quality Assurance (QA) data related to Anesthesia revealed that the QA Department uses an Ongoing Professional Practice Evaluation (OPPE) Program to evaluate each individual Anesthesiologist's performance.

Review of the undated facility Overview of OPPE Reports & Report Guidelines revealed that "Due to constraints with Administrative data, some Practitioners may have understated volumes" and states "Examples of Practitioners with challenges related to reporting volume through Administrative data include: Anesthesiologists".

A review of ten (10) Patient Medical Records revealed that the Anesthesiologist is not identified as a Provider.

Since Anesthesiologists are not classified as Attending Physicians in the Medical Record, the volumes and quality measures which include: CVA (Cerebral Vascular Accident) within twenty-four (24) hours of Anesthesia and MI (Myocardial Infarction) within twenty-four (24) hours of Anesthesia are not reflective of the actual number of services provided, the results, or outcomes.

A review of the Anesthesia Departmental OPPE, indicated zero (0) cases for Ambulatory Discharges (Ambulatory Surgery, Catheterization Lab, and Endoscopy) for all four (4) quarters.

Further review revealed the first and second quarters for the total number of surgical cases were listed as one (1) for the first quarter and four (4) for the second quarter.

In the afternoon of 01/22/16, during an interview with Staff H (Assistant Vice President Quality for Catholic Health Services), at the time of the Anesthesia Department Quality Assessment review, when asked if QA reviews all cases involving Anesthesia, the staff member stated "We don't track the Department, we look at each individual Physician".

When asked if the facility only had five (5) surgical cases involving Anesthesia from January to June 2015, Staff H (Assistant Vice President Quality for Catholic Health Services) replied "No, but this is all the data that the OPPE pulled over".

When asked for the Data Analysis to evaluate trends for Anesthesia, Staff H (Assistant Vice President Quality for Catholic Health Services) stated "This is all we have".

Staff H (Assistant Vice President Quality for Catholic Health Services) also stated that "QA is only done by case referral. If something happens during a procedure that involves Anesthesia, and a Nurse or Doctor in the OR feels it needs to be reviewed, they can refer it to QA."

The facility's Quality Assurance Department was unable to provide evidence of collecting data. Therefore, they could not accurately track and trend issues related to Anesthesia Services.
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Based on observation, document review and interview, the OR staff did not implement the Operating Room Policies and Procedures for protecting OR attire when entering or exiting the Restricted / Semi-Restricted Areas.

This failure places all patients at risk for potential infections.

Findings:

Review of the Policy titled "Infection Control Policy for the Anesthesiology Department" dated 04/2003, revealed in the Section Dress Code: "All personnel leaving the OR / LDR (Labor and Delivery Room) Area with scrubs will don a cover gown that is closed in the back or a lab coat that is buttoned down the front, and must remove their masks, caps [hats], and shoe covers."

Review of the Policy titled "Operating Room Attire" dated 08/2015, revealed in #19: "All scrubs should be changed when returning to the Restricted / Semi-Restricted Area if they have not been protected by a cover up."

Review of the Policy titled "Operating Room" undated, revealed in the Section Dress Code: "When leaving the OR Suite, personnel will wear a cover gown. Scrub uniforms worn outside the OR Suite must be changed before returning to the Restricted Area. Shoe covers, head covers and masks are removed upon leaving the Suite."

All three (3) Policies require the covering of OR attire when leaving the Restricted Areas. Two (2) Policies require scrub uniforms worn outside the OR Suite to be changed before returning to the Restricted Areas.

On 01/21/16 at 9:45AM, staff were observed donning OR attire (scrubs, hair covers and shoe covers) in the Women's Locker Room. Staff then exited the Locker Room and entered the OR Semi-Restricted and Restricted Areas through the OR Break Room without following the above Policies and Procedures.

On 01/21/16 at 10:00AM observations in the OR Break Room revealed five (5) OR staff members eating with their gowns, shoe covers, and head covers on. The staff did not have lab coats or gown covers over their OR attire.

This was confirmed in the presence of Staff C (OR Nurse Manager) and Staff E (OR Nursing Educator) at the time of observation.

Staff S (Circulating Nurse) on 01/21/16 at 10:35AM was observed entering the OR Break Room from the Semi-Restricted Area wearing scrubs, a head cover, and shoe covers. On interview the staff member stated that he came from the OR Area. He does not wear a lab coat, or remove his head cover or shoe covers to enter the OR Break Room. After he eats, he returns to the Semi-Restricted / Restricted Areas without changing. He stated that he would only change his clothes before returning to the Semi-Restricted / Restricted Areas if he soiled his clothes when eating.

At 10:45AM Staff C (OR Nurse Manager) confirmed that OR staff enter the Locker Rooms through the Break Room to use the bathrooms without covering their scrubs. Staff returned to the OR through the OR Break Room without changing their attire.

During an interview with Staff L (Infection Control Nurse) on 01/21/16 at 10:50AM, the staff member stated that "The staff should remove the hats and booties [shoe covers] and cover the scrubs with a buttoned lab coat" before entering the OR Break Room. She also stated that she was not comfortable with staff eating in their OR attire.
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Based on document review and interview, the facility failed to: a) maintain responsibility for the provision of the Anesthesia Services provided to all patients, and b) ensure that the Anesthesia Quality Assurance Program implemented corrective actions and monitoring when patient care issues were identified.

These failures placed all patients receiving Anesthesia Services at risk for poor quality care and poor outcomes.

Findings:

a) The facility failed to develop an Organizational Chart for the Anesthesia Department.
See Tag A1001

The facility failed to implement Policies and Procedures that define the Anesthesia Department's scope of practice.
See Tag A1001

The facility failed to develop and implement current Policies on the role and supervision of the Certified Registered Nurse Anesthetist.
See Tag A1001

The facility failed to ensure that Policies and Procedures were developed and updated for all Anesthesia Services provided.
See Tag A1002

The facility failed to ensure that the Policy and Procedure for the Pre-Anesthesia Evaluation met the required Guidelines.
See Tag A1003

The facility failed to ensure that a Policy and Procedure was in place for the Intraoperative Anesthesia Record.
See Tag A1004

The facility failed to ensure that a Policy and Procedure was in place for the Post-Operative Anesthesia Evaluation.
See Tag A1005



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b) The Anesthesia Department did not accurately track issues identified by the Anesthesia Quality Assurance Program or Implement recommendations by the Peer Review Committee.

On 01/21/16, a review of the "Anesthesia Quarterly Peer Review Meetings" Committee Minutes for April 15, 2015 revealed Peer Reviews of Medical Records #11 and #14.

A Peer Review for Patient #11 revealed an opportunity for improvement in documentation regarding interventions. However, no further "Action and Follow-Up" was noted in the Follow-Up Meeting Minutes.

A Peer Review for Patient #14 revealed that "An opportunity for improvement with documentation was recommended". However, no further "Action and Follow-Up" were noted in the Follow-Up Meeting Minutes.

Review of the Anesthesia Department OPPE (Ongoing Professional Practice Evaluation) on 01/22/16 revealed a zero (0) in "Documentation Issues" for three (3) quarters in 2015 (April-June, July-September, and October-December) despite the Peer Reviews identifying the above two (2) documentation issues in April 2015.

A review of the June 24, 2015 Meeting Minutes documented a Peer Review of Patient #13's care and recommended the development of Pre-Op Insulin Protocols. However, no Protocol was developed or implemented as of 01/21/16, seven (7) months later.

This was confirmed on 01/21/16 by Staff K (Vice President Performance Improvement).
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Based on document review and staff interview, the facility failed to: a) develop an Organizational Chart for the Anesthesia Department, b) implement Policies and Procedures that define the Anesthesia Department's scope of practice, and c) develop and implement current Policies on the role and supervision of the Certified Registered Nurse Anesthetist (CRNA).

These failures place all patients receiving anesthesia at risk for negative outcomes.

Findings:

a) On 01/20/16 during the Entrance Conference, a copy of the Anesthesia Services Organizational Chart was requested.

On 01/25/16 at 12:00 Noon, Staff A (Vice President Performance Improvement Quality Assurance Catholic Health Systems-VPPIQA CHS) stated "You didn't get one (Anesthesia Services Organizational Chart)?"

On 01/26/16 at 1:25PM Staff A (VPPIQA CHS) provided the Surveyor a List titled Department of Anesthesia 2016 with the names and titles of four (4) Physicians and one (1) CRNA (Certified Registered Nurse Anesthetist).

During interview of Staff A (VPPIQA CHS) on 01/25/16 at 1:25PM, the staff member agreed that this was not an Organizational Chart.

b) Review of the Anesthesia Manual revealed that the facility lacked a Policy or Procedure for the delineation of the qualifications of Practitioners, the types of anesthesia, the locations anesthesia may be provided, and the administration of anesthesia.

Furthermore, the "Anesthesia Department-Delivery Room" Policy was four (4) paged document. However, only Page 1 was present, Pages 2, 3 and 4 were missing.

On 01/20/16 at 11:15PM Staff F (Chief Medical Officer), Staff G (Chief Administrative Officer) and Staff J (Director of Anesthesiology) acknowledged the findings.

c) During interview of Staff J (Director of Anesthesiology) on 01/20/16 at 11:15AM, the staff member was asked for current Policies on the role and supervision of the Certified Registered Nurse Anesthetist (CRNA). He stated that they follow the AANA (American Association for Nurse Anesthetist) Guidelines. He pointed to the Guidelines in the book. When Staff J was asked the date of the Guidelines, he stated "They don't change much".

Review of the AANA Guidelines in the Manual revealed that the document became effective October 1992, and has not been updated in twenty-three (23) years.

Further review of the Anesthesia Manual revealed under Adjunct Staff: "The CRNA employed by Rockville Anesthesia Group [who presently provides service] and Long Island Obstetrical Anesthesiology" [who do not provide service].

Further review of the Manual revealed the effective, revision and administrative approval dates and signatures were missing for the following Policies: "Controlled Drug Anesthesia Agents For CRNAs," "CRNA On Duty In Delivery Room" and "Anesthesia Department-Delivery Room".

Staff F (Chief Medical Officer), Staff G (Chief Administrative Officer), and Staff J (Director of Anesthesiology) agreed that many of the Policies and Procedures did not include effective, revised or approval dates making it impossible to determine the validity of the Policy and Procedure. They acknowledged that the Manual was not up to date.
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Based on interview and document review, the facility failed to ensure that Policies and Procedures were developed and updated for all Anesthesia Services provided.

This failure placed all patients at risk for potential harm while receiving anesthesia.

Findings:

During interview of Staff F (Chief Medical Officer) and Staff G (Chief Administrative Officer) on 01/20/16 at 11:00AM, the staff members stated that there are no Policies and Procedures for the Anesthesia Services.

During interview of Staff J (Director of Anesthesiology) on 01/20/16 at 11:15AM, the staff member stated that Rockville Anesthesia Group LLP has been providing Anesthesia Services at Mercy Medical Center for at least the last ten (10) years. He stated that "A few months ago I realized we did not have any Policies and Procedures. I did not notify upper Management that there were no Policies and Procedures for Anesthesia. I have not reviewed any Mercy Medical Center Policies and Procedures."

During the above interview Staff F (Chief Medical Officer) and Staff G (Chief Administrative Officer) provided the Surveyors with a black binder and told the Surveyors that they found the Policies and Procedures. A review revealed that the Anesthesia Policies and Procedures dated back to 1992. Many of the Policies and Procedures did not include effective, revised, and approved dates.

Review of the "Infection Control Policy" for the Anesthesiology Department documented the Policy was instituted in 1986 but has not been reviewed and updated since the last revision in 2003, thirteen (13) years ago.

Review of the "Equipment Maintained" and "Routine Equipment Checks / Safety" revealed that the Policies have not been reviewed or updated since 1998, eighteen (18) years ago.

The Manual lacked evidence of the following Policies and Procedures: Safety practices in all Anesthetizing Areas; Protocol for Supportive Life Functions, Reporting Requirements, Documentation Requirements and Post-Anesthesia Staff Responsibilities.
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Based on document review and interview, the facility failed to ensure that the Policy and Procedure for the Pre-Anesthesia Evaluation met the required Guidelines.

This failure places all patients that require anesthesia at risk for complications.

Findings:

Review of the "Pre-Anesthesia Assessment Interview" revealed that the Policy has not been reviewed or updated since 2001, fifteen (15) years ago.

The Policy also allows the Registered Nurse to order laboratory, diagnostic studies, and pre-anesthesia medications, and perform a Pre-Anesthesia Assessment which is not within the Registered Nurses' scope of practice.

The Pre-Anesthesia Evaluation Policy does not define the required Assessment elements and the timeframe including: medical history; anesthesia, drug and allergy history; patient interview and examination.

The Policy also does not include anesthesia risk, identification of potential problems, or the development of a plan for the patient's anesthesia care.

On 01/20/16 at 11:15PM Staff F (Chief Medical Officer), Staff G (Chief Administrative Officer), and Staff J (Director of Anesthesiology) acknowledged the findings.
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Based on document review and interview, the facility failed to ensure that a Policy and Procedure was in place for the Intraoperative Anesthesia Record.

This failure places all patients that require anesthesia at risk for complications.

Findings:

There is no Policy or Procedure for the Intraoperative Anesthesia Record for each patient who receives anesthesia.

On 01/20/16 at 11:15AM Staff F (Chief Medical Officer), Staff G (Chief Administrative Officer), and Staff J (Director of Anesthesiology) acknowledged the findings.
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Based on document review and interview, the facility failed to ensure that a Policy and Procedure was in place for the Post-Operative Anesthesia Evaluation.

This failure places all patients that require anesthesia at risk for complications.

Findings:

There is no Policy or Procedure for the Post-Operative Anesthesia Evaluation for each patient who receives anesthesia.

On 01/20/16 at 11:15AM Staff F (Chief Medical Officer), Staff G (Chief Administrative Officer), and Staff J (Director of Anesthesiology) acknowledged the findings.