The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

FALMOUTH HOSPITAL 67 & 100 TER HEUN DRIVE FALMOUTH, MA 02540 Sept. 22, 2017
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observations, records reviewed and interviews the Governing Body failed to ensure that Hospital A, with its own CMS Certification Number (CCN), was one single entity (hospital) independent (separate) of the Hospital System (Common Ownership of Hospitals A & B) and Hospital B.

Findings included:

1.) Based on records reviewed and interviews Hospital A's Governing Body failed to ensure the Medical Staff was accountable to Hospital A's Governing Body for the quality of care provided to patients.

Refer to TAG: A-0049

2.) The Governing Body failed to appoint one Chief Executive Officer (CEO) who was responsible for managing only Hospital A in its entirety.

Refer to TAG: A-0057

3.) The Governing Body failed to ensure that the Contracted Services were specific and only for Hospital A, as a single entity.

Refer to TAG: A-0083

4.) The Governing Body failed to ensure that the Emergency Department medical staff was responsible for compliance with Hospital policies and procedures.

Refer to TAG: A-0092
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
Based on records reviewed and interviews Hospital A's Governing Body failed to ensure the Medical Staff was accountable to Hospital A's Governing Body for the quality of care provided to patients.

Findings Included:

The document titled, Performance Improvement Plan, 2017, indicated a quality plan for the Hospital System that maintained quality data, developed improvement goals, approved the format of quality data information presented to the Hospital System Board of Trustees, maintained the quality plan, the Health Care System's Infection Prevention Program Plan and monitored outcomes.

The Performance Improvement Plan indicated:

A.) The annual review of the Performance Improvement Plan was submitted to the Hospital System.
B.) The Patient Care Assessment Committee had the responsibility to insure that effective Peer Review, Quality Assurance and Risk Management occurred at Hospital B and
C.) Signatures of Health System Administrators indicating approval of the Performance Improvement Plan for Hospital A.

The Performance Improvement Plan did not indicate a clear quality improvement plan developed, monitored and approved by Hospital A as a single and separate entity. The Performance Improvement Plan did not indicate approval by Hospital A's Governing Body and the Performance Improvement Plan did not indicate the signature of an Administrator of Hospital A.

The Performance Improvement Plan did not indicate Hospital A as a separately certified hospital in the Hospital System and did not indicate a Quality Assessment Performance Improvement Program that was specific to only Hospital A.
VIOLATION: CHIEF EXECUTIVE OFFICER Tag No: A0057
Based on records reviewed and interviews the Governing Body failed for one (Patient #5) of ten medical records sampled to appoint one Chief Executive Officer (CEO) who was responsible for managing only Hospital A in its entirety as a single and separate hospital.

Findings included:

The document titled, Health Care System Organizational Chart, dated 8/2017, indicated a corporate (company) level organization chart. The Health Care System Organizational Chart indicated the Health Care System Governing Body included Hospital A and Hospital B with a President & Chief Executive Officer (CEO, the highest-ranking administrator) of the Health Care System (Hospitals A & B) responsible to the Health Care System Governing Body and responsible as the President and Chief Executive Officer of both Hospitals A and B. The Health Care System Organizational Chart indicated the Chief Executive Officer of the Health Care System shared the responsibilities as a Chief Executive Officer for both Hospital A and Hospital B.

The Health Care System Organizational Chart indicated a Chief Operating Officer (COO, administrator responsible for day-to-day operations) for Hospital A individually and Hospital B individually. The Health Care System Chart did not indicate the Chief Operation Officer as responsible to and reporting to a Chief Executive Officer appointed to only Hospital A.

The Health Care System Organizational Chart did not indicate a separate and individual Governing Body for Hospitals A and B. The Health Care System Chart did not indicate a Chief Executive Officer responsible only for managing Hospital A in its entirety and did not indicate a Chief Executive Officer responsible only for managing Hospital B in its entirety.

Hospital A's web site (https://www.capecodhealth.org/locations/falmouth-hospital/) indicated the Chief Executive Officer as the Chief Executive Officer of the Health Care System.

The Surveyor interviewed the Chief Executive Officer of the Health Care System at 1:30 P.M. on 9/21/17. The Chief Executive Officer of the Health Care System said that he was the Chief Executive Officer, President for both Hospital A and Hospital B.

The documents titled, Health Care System Organizational Chart, dated 8/2017 and Hospital A's Organizational Chart, dated 9/2017, indicated charts with the Chief Medical Officer (physician) responsible to the Chief Executive Officer of the Health Care System. The Organizational Charts did not indicate the Chief Medical Officer responsible for the care of patients at Hospital A to a Chief Executive Officer at Hospital A.

The document titled, Organizational Chart, dated 9/2017, indicated a chart of Hospital A. The Organizational Chart indicated Ancillary Service Directors & Managers were responsible to the Chief Operating Officer of Hospital A and the Chief Executive Officer of the Health Care System. The Organizational Chart indicated the Chief Operating Officer as also responsible for an Assisted Living Facility and a Nursing Home (not a Hospital A department or service). The Organizational Chart did not indicate that the chain of responsibility flowed from the Governing Body of Hospital A to a Chief Executive Officer appointed to only Hospital A and through all capacities, departments, functions, and positions of Hospital A. The Organizational Chart did not indicate a Chief Executive Officer with the responsibility for managing Hospital A in its entirety and as a single and separate entity (Hospital).

The Surveyor interviewed the Chief Operating Officer of Hospital A at 8:00 A.M. on 9/22/17. The Chief Operating Officer said that the Ancillary Service Directors and Managers had a working relationship to the Chief Operating Officer. The Chief Operating Officer said the Ancillary Service Directors and Managers did not report directly to her. The Chief Operating Officer said that she provided information for the performance evaluations of the Ancillary Service Directors and Managers. The Chief Operating Officer said that she did not sign-off (make official) the performance evaluations of the Ancillary Service Directors and Managers.

The contract titled, Employment Agreement, dated 6/20/16, indicated an employment agreement between the Health Care System and the Chief Operating Officer at Hospital A. The Employment Agreement did not indicate an agreement between Hospital A and the Chief Operating Officer of Hospital A. The Employment contract indicated the Chief Operating Officer also performed the duties and responsibilities of the Chief Nursing Officer consistent with the duties in the job description.

The document titled, Chief Operating Officer, dated 7/2017, indicated a Chief Operating Officer job description and the job description did not indicate duties and responsibilities of a Chief Nursing Officer.

The job description titled, Hospital A Human Resource Manager, dated 1/11/17, indicated the Human Resource Manager reported to the Director of Employment Services and Organizational Development (a department of the Health Care System and not a department of Hospital A).

The Surveyor interviewed the Human Resource Manager at 11:00 A.M. on 9/21/17. The Human Resource Manager said she reported to the Director of Employment Services and Organizational Development of the Health Care System. The Human Resource Manager said all clinical Hospital A training, orientation and development was offered by the Clinical Education Director of the Health Care System.

The Health Care System Organization Chart and Hospital A's Organization Chart did not indicate a Clinical Education Director, or Clinical Education Department.

The documents titled, Health Care System-Registered Nurse (RN) Residency & Transition Program, indicated a Health Care System Program at two acute care hospitals, Hospital A and Hospital B, organized under the direction of the Clinical Education Director of the Health Care System. The RN Residency Transition Program indicated shared nursing education services between Hospital A (with its own CMS Certification Number, CCN), the Health Care System (not a hospital and without a CCN) and Hospital B (with its own CCN). The Documents did not indicate Hospital A was represented as a single and separate entity.

The document titled, Basic Arrhythmia Exam, dated 7/2009, indicated a letterhead that represented the Health Care System. The Document did not indicate Hospital A was represented as a single and separate entity.

The document titled, RN Medication Examination, dated 5/2015, indicated it was a Health Care System document. The document did not indicate Hospital A was represented as a single and separate entity.

The document titled, Agreement Contracts List, dated 9/22/17, did not indicate a contract between Hospital A and Hospital B for Clinical Education Services.

The policy titled, Patient Event Reporting System, dated 10/2016, indicated the Risk Manager reported significant events to Administration and Corporate Risk. The policy did not indicate that Hospital A reported significant events to Hospital A's Governing Body.

The policies titled, Interpreter Services Verbal Communication, dated 3/28/16 and Patient Visitation, dated 7/9/15, both indicated they were Health Care System policies. The Interpreter Services Verbal Communication, Patient Visitation, and the policy titled, Self-Administered Medications, dated 8/2016, did not indicate they were a Hospital A policy representing a single and separate entity.

The document titled, The Joint Commission, dated 5/12/17, indicated a letter addressed to the Chief Executive Officer of the Health Care System with results of services surveyed. The document did not indicate The Joint Commission addressed the letter to Hospital A with the results of services surveyed at Hospital A.

The Electronic Medical Record (EMR) for Patient #5 indicated an Initial Nursing Assessment with nurse directions for Hospital B staff only. Patient #5's EMR indicated an EMR System (not Patient #5's medical record) was shared between Hospitals A & B.

Records reviewed did not indicate Hospital A was represented as a clear, single, and separate entity of the Health Care System and entirely separate.
VIOLATION: CONTRACTED SERVICES Tag No: A0084
Based on records reviewed the Governing Body failed to ensure that contracted services were specific and only for Hospital A, as a single entity.

Findings included:

The contract titled, Employment Agreement, dated 6/20/16, indicated an employment agreement between the Health Care System and the Chief Operating Officer at Hospital A. The Employment Agreement did not indicate an agreement between Hospital A and the Chief Operating Officer of Hospital A.

The contract titled, Pharmacy Services Agreement, dated 1/1/2012, indicated a service agreement between Hospital A and Hospital B. The contract indicated administrator signatures representing the Health Care System. The contract did not indicate signatures of administrator(s) representing Hospital A as an independent and separate entity and the contract did not indicate signatures of administrator(s) representing Hospital B as an independent and separate entity.

The document titled, Management Agreement, dated 10/1/2014, indicated a contracted service between the Hospital System and a Food Service Company. The Management Agreement indicated the Food Service Company provided services to both the Hospital A and Hospital B. The Management Agreement indicated the Food Service Company communicated only with the President and Chief Executive Officer of the Hospital System. The Management Agreement indicated by signature that the President and Chief Executive Officer of the Hospital System was responsible for the Management Agreement. The Management Agreement did not indicated a signature of a Chief Executive Officer appointed to only Hospital A. The Management Agreement did not clearly indicate the Food Service Company responsible for food services specifically for Hospital A.
VIOLATION: EMERGENCY SERVICES Tag No: A0092
Based on observations, records reviewed and interviews, the Governing Body failed to ensure that the Emergency Department Medical Staff was responsible for compliance with Hospital policies and procedures.

Findings included:

The Hospital A policy titled, Medial Screening Examination, indicated that Hospital A screened all individuals who came to the Hospital requesting an examination or treatment for an emergency medical condition.

The Surveyor observed, at 9:15 A.M. on 9/21/17, a half piece of "White Paper" (a paper form without a title) with the letterhead that indicated the Hospital System, and a line for a date, time, name, date of birth, age, and reason for visit on the greeter desk in the Emergency Department. The piece of "White Paper" indicated that a patient presented to the Emergency Department for an examination or treatment.

The Surveyor interviewed Volunteer #1 at 9:15 A.M. on 9/21/17. Volunteer #1 said she remembered only one (1) patient leaving without being-seen (registered and examined), after completing the "White Paper" because of a long wait time.

The Surveyor interviewed the Emergency Department Nurse Director at 9:45 A.M. on 9/21/17. The emergency room Nurse Director said the Hospital shredded the " White Paper" (completed by a patient) if the patient left the Emergency Department without being seen.

The Emergency Department Nurse Director's description of the Hospital shredding the "White Paper' indicated the Hospital did not maintain an accurate log of all patients that presented to the Emergency Department for care.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on records reviewed and interviews, Hospital A's Quality Assessment Performance Improvement activities failed for one (Patient #9) of ten medical records sampled to implement preventive actions and mechanisms that include feedback and learning throughout the hospital after Patient #9's adverse patient event.

Findings included:

The policy titled, Patient Event Reporting System, dated 10/2016, indicated that Hospital A used the information gathered from investigations of significant events to identify opportunities for improvement.

The document titled, Report, indicated Patient #9's adverse patient event, a Vancomycin (a powerful life-saving antibiotic) medication error occurred on 8/7/17.

The Laboratory Report, dated 8/8/17, indicated Patient #9's Vancomycin level was 24.3, (high level and potentially harmful).

The Document titled, Hospital A Pharmacy Adult Vancomycin Dosing and Monitoring Protocol, dated 12/2016, indicated a random drug level goal was 15-20.

The meeting minutes titled, Hospital A Medication Safety Committee, dated 9/26/17, indicated Hospital A investigated the medication error of Patient #9 that occurred on 8/7/17. The meeting minutes identified that pharmacy staff and registered nurses needed education regarding verification of Vancomycin orders. The meeting minutes indicated the Hospital would implement education through staff meetings, huddles and rounding. The meeting minutes indicated that nurse managers would conduct audits.

The Surveyor interviewed the Clinical Risk Manager at 9:30 A.M. on 9/22/17. The Clinical Risk Manager said she did not recall if Hospital A implemented corrective actions identified by the Medication Safety Committee.

Hospital A provided no clear documentation or information to indicate that Hospital A implemented the corrective actions regarding Patient #9's Vancomycin medication error of 8/7/17, as recommended by Hospital A's Medication Safety Committee, by the time of the Survey on 9/22/17, more than one (1) month after the medication error. Hospital A provided no documentation to indicate that Nurse Managers conducted audits as identified in the Medication Safety Committee Meeting Minutes dated 9/26/17.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on records reviewed and interviews the Nursing Services failed to appropriately define the scope of practice for Diagnostic Technicians working within the Emergency Department Nursing Service and define that starting an intravenous (IV) was within the scope of Nursing Practice in accordance with the Board of Registration in Nursing.

Findings included:

The Board of Registration in Nursing, as authorized by Generals Law of the State, limit the practice of infusion therapy to include the insertion and removal of short and midline peripheral intravenous devices to registered nurses and to licensed practical nurses consistent with organization policy and procedure. Administration of IV medications (Normal Saline was considered a medication) was not within the scope of practice of a Diagnostic Technician and only a licensed nurse or physician/physician assistant may administer IV medications (http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/dhpl/nursing/nursing-practice/advisory-rulings/iv-therapy.html).

Hospital A policy titled, Medication and IV Therapy Practice Guidelines, dated 9/21/17, indicated Diagnostic Technicians may perform venipuncture. The policy did not indicate that Hospital A approved Diagnostic Technicians to start IVs.

The Job Description titled Diagnostic Technician, undated, indicated starting an intravenous (IV) was an essential duty and responsibility.

The Surveyor interviewed Registered Nurse #1 at 10:15 A.M. on 9/21/17. Registered Nurse #1 said that Diagnostic Technicians started intravenous (IVs).