Bringing transparency to federal inspections
Tag No.: A0043
Based on document review and staff interview, the hospital's Governing Body failed to demonstrate the following:
- Compliance with Federal hospital regulations;
- Admission of patients by the four physicians currently privileged to practice at Heartland Surgical Specialty Hospital;
- Provide evidence of a current data bank query for two of the four physicians privileged by the Governing Body to admit and care for patients;
- Credential and privilege a radiologist to practice at the hospital and provide radiology services to patients, required for hospital Federal certification;
- Demonstrate compliance with infection control standards and quality measures; and
- Maintain a surgical suite separate from the host hospital's (hospital #2) surgical areas with separate scrub sinks and dressing rooms.
Findings include:
- When interviewed on 3/11/13 at 3:00pm, Administrative staff A verified the hospital had not admitted any patients since the hospital relocated on 6/28/12 (a period of approximately 8-1/2 months).
Review of the State Operations Manual, "Appendix A - Survey Prptocol, Regulations and Interpretive Guidelines for Hospitals", last revised 12/22/11, states in the section "Survey Protocol - Introduction", "Hospitals are required to be in compliance with the Federal requirements set forth in the Medicare Conditions of Participation (CoP) in order to receive Medicare/Medicaid payment. The goal of a hospital survey is to determine if the hospital is in compliance with the CoP set forth at 42 CFR [Code of Federal Regulations] Part 482...Certification of hospital compliance with the CoP is accomplished through observations, interviews, and document/record reviews. The survey process focuses on a hospital's performance of patient-focused and organizational functions and processes. The hospital survey is the means used to assess compliance with Federal health, safety, and quality standards that will assure that the beneficiary receives safe, quality care and services."
Without patients, no Federal hospital survey may be conducted to assess the hospital's compliance with regulations. See the regulations at:
A-0115 Patient's Rights
A-0385 Nursing Services
A-0431 Medical Record Services
A-0528 Radiologic Services
A-0618 Food and Dietetic Services
A-0747 Infection Control
A-0799 Discharge Planning
A-0940 Surgical Services
A-1000 Anesthesia Services
- Review of the medical staff credential files found four physician's currently privileged by the Governing Body to practice at the hospital: an anesthesiologist, an emergency room physician who was also privileged to perform wound care, a plastic surgeon, and an orthopedic surgeon.
Review of hospital of Hospital Board Meeting minutes dated 1/31/13 revealed Administrative staff A and Administrative staff E informed the group that the hospital's license was reinstated by the State effective 1/25/13. The Governing Body members present at the 1/31/13 meeting discussed how to move forward with bringing patients to the hospital. However, the minutes included no communication to the four credentialed physicians with admitting privileges regarding the need to admit patients to the hospital.
When interviewed on 3/11/13, Clinical Service Director staff D stated the hospital had not admitted patients for inpatient care or outpatient services since the state reinstated the hospital's license on 1/25/13. Although requested, facility staff were unable to provide information regarding what actions had been taken to encourage privileged physicians to admit patients or give a date when the hospital would begin to admit patients.
- Review of the credential files for the four practitioners currently privileged to practice at the hospital revealed:
a) Credentialing file of staff F, a surgeon, lacked evidence of a current data bank query.
b) Credentialing file of staff G, a physician, lacked evidence of a current data bank query.
The data bank query is to the national database which provides information that includes at least a list of a practitioner's recent lawsuits, a potential indicator of the physician's competence.
Administrative staff A, interviewed on 3/11/13, acknowledged the hospital failed to have evidence of a current data bank query for physicians F and G as required by hospital policy.
- Review of practitioner credential files and Governing Body minutes failed to find a radiologist privileged to practice at the hospital who could provide radiology services to patients. Radiology is a function of the hospital required for Federal certification. See A-0528, the Condition of Participation for Radiologic Services.
- Observation of Heartland Hospital's "Resource" room on 3/11/13 at 1:30pm revealed room did not provide for the separation of "clean" from "dirty"/"soiled" following infection control standards of practice. Se A-0747, the Condition of Participation for Infection Control.
- Observation in Heartland Hospital's PACU (post-anesthesia care unit) on 3/11/13 at 1:25pm revealed the PACU space, beds, and nursing station were co-mingled within hospital #2's PACU. There was no physical or visual separation to distinguish one hospital from another. Staff B, a certified nurse aide, explained the first bay assigned to Heartland Hospital was the post-operative bed, the second bay the pre-operative bed, and the third bay was set up as a nurse's station. A patient bed blocked the entrance to Heartland Hospital's nurse station (located in the third bay) preventing access without moving the bed.
- Observation on the first floor revealed that Heartland patients would access the surgical area by means of an elevator, the same elevator used by hospital #2's patients. When exiting the elevator on the first floor that led into the surgical area of both Heartland Hospital and hospital #2, observation revealed red tape approximately 3 feet from the elevator prior to entering the common space for both Heartland Hospital and hospital #2's surgical suites and PACU. The red-colored tape designated the common hallway past the tape as sub-sterile, meaning staff were required to wear surgical attire to cross the red line into the sub-sterile area. However, Heartland Hospital's changing rooms for staff were located in a "common" area of the building where they were shared with hospital #2's staff rather than in a separate area of Heartland Hospital.
Surgery requires staff to "scrub" hands, wrists, and arms before conducting a surgical procedure. This requires use of a "scrub" sink. However, while Heartland Hospital's surgical area (located in the surgical suite of hospital #2 without visual or physical separation of the two hospitals, but did contain a sign near one operating room door that said "OR Heartland Hospital"), the scrub sink identified by staff as the sink physician and OR staff would use for Heartland Hospital's OR was not located in the space designated for use by Heartland Hospital: it was in hospital #2's space - between Heartland Hospital's OR and a sub-sterile room identified as hospital #2's space.
The Condition of Participation is not met based on the cumulative effect of the hospital's inability to:
- demonstrate the separation of Heartland Surgical Specialty Hospital from that of hospital #2, a separately certified hospital;
- implementation of systems and facility policies and procedures to ensure the provision of quality care in a safe environment when no patients were present; and
- compliance with Federal hospital regulations and Conditions of Participation.
Tag No.: A0115
Based on observation and staff interview, the hospital failed to demonstrate compliance with the Condition of Participation of Patient's Rights when no patients or visitors were present and the hospital had admitted no patient since 6/28/12.
Findings include:
The hospital had no inpatients or outpatients on the survey date of 3/11/13 and, therefore, the hospital could not demonstrate compliance with the Condition of Participation 42 CFR (Code of Federal Regulations) 482.13: Patient's Rights. Surveyors were unable to interview either patients or visitors regarding Patient's Rights regulations or observe staff implement facility policies regarding Patient's Rights. This includes at least the following Patient's Rights:
Exercise of rights
- Participation in the development and implementation of his or her plan of care
- The patient or his or her representative has the right to make informed decisions regarding his or her care and include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment
- The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives. ("Advance directives" are the decisions of the patient or a legal representative that direct the medical treatment the patient wants when he or she is no longer able to indicate his or her wishes.)
Privacy and Safety
- The patient has the right to personal privacy
- The patient has the right to be free from all forms of abuse or harassment
Confidentiality of Patient Records
- The patient has the right to the confidentiality of his or her clinical records
- The patient has the right to access information contained in his or her clinical records within a reasonable time frame and the hospital must not frustrate the legitimate efforts of individuals to gain access to their own medical records
Administrative staff A, interviewed on 3/11/13 at 3:00pm, verified the hospital had not admitted any patients since the hospital relocated. (Since the relocation was effective 6/28/12, the hospital had not admitted any patients for approximately 8-1/2 months.)
The cumulative effect of the hospital's inability to demonstrate the implementation of systems and facility policies and procedures regarding Patient's Rights regulations to ensure the provision of quality health care in a safe environment.
Tag No.: A0385
Based on observation and staff interview, the hospital failed to demonstrate compliance with the Condition of Participation of Nursing Services when no patients or visitors were present and the hospital had admitted no patient since 6/28/12.
Findings include:
The hospital had no inpatients or outpatients on the survey date of 3/11/13 and, therefore, the hospital could not demonstrate compliance with the Condition of Participation 42 CFR (Code of Federal Regulations) 482.23: Nursing Services. Surveyors were unable to interview patients, visitors, or nursing staff regarding Nursing Services regulations or observe staff implement facility policies regarding Nursing Services regulations. This includes at least the following Nursing Services regulations:
Staffing and Delivery of Care
- A registered nurse must supervise and evaluate the nursing care for each patient.
- The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient.
- A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient's needs and the specialized qualifications and competence of the nursing staff available.
- Non-emplyee licensed nurses who are working in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of the clinical activities of non-employee nursing personnel which occur within the responsibility of the nursing services.
Preparation and Administration of Drugs
- Drugs and biologicals must be prepared and administered in accorance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient's care and accepted standards of practice.
- All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures.
- Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. If blood transfusions and intravenous medications are administered by personnel other than doctors or medicine or osteopathy, the personnel must have special training for this duty.
("Biological" is a class of medications derived from a wide array of living sources - including blood, viruses, antibodies, and vaccines - for the purpose of fighting various diseases.)
Administrative staff A, interviewed on 3/11/13 at 3:00pm, verified the hospital had not admitted any patients since the hospital relocated. (Since the relocation was effective 6/28/12, the hospital had not admitted any patients for approximately 8-1/2 months.)
The cumulative effect of the hospital's inability to demonstrate the implementation of systems and facility policies and procedures regarding Nursing Services regulations to ensure the provision of quality health care in a safe environment.
Tag No.: A0431
Based on staff interview and review of records, the hospital failed to demonstrate compliance with the Condition of Participation of Medical Record Services when no patients were present and the hospital had admitted no patient since 6/28/12.
Findings include:
Administrative staff A, interviewed on 3/11/13 at 3:00pm, verified the hospital had not admitted any patients since the hospital relocated. (Since the relocation was effective 6/28/12, the hospital had not admitted any patients for approximately 8-1/2 months.)
Therefore, the hospital could not demonstrate compliance with the Condition of Participation 42 CFR (Code of Federal Regulations) 482.24: Medical Record Services. Surveyors were unable to review medical records to determine the facility's compliance with these regulations.
The cumulative effectof the hospital's inability to demonstrate the implementation of systems and facility policies and procedures regarding Medical Record Services regulations.
Tag No.: A0528
Based on observation and staff interview, the hospital failed to demonstrate compliance with the Condition of Participation of Radiologic Services when it had no practitioner privileged and qualified to provide radiology services at the hospital and had no patients since 6/28/12.
Findings include:
- The hospital had no inpatients or outpatients on the survey date of 3/11/13.
- The Hospital Radiology Services Coverage Agreement, reviewed on 3/11/13, found it stated, "(d) Medical Staff. Any physician providing radiology interpretive services will be credentialed through Heartland Surgical Specialty Hospital's (HSSH) medical staff as set forth in the Medical Staff Bylaws...."
However, the list of medical staff provided by hospital staff and reviewed on 3/11/13 included the names of four physicians privileged and credentialed at the hospital, but none of the four credentialed physicians was a qualified radiologist.
Administrative staff A interviewed on 3/11/13 acknowledged the hospital failed to credential a radiologist.
- The hospital could not demonstrate compliance with the Condition of Participation at 42 CFR (Code of Federal Regulations) 482.26: Radiologic Services. Surveyors were unable to interview patients or visitors regarding Radiologic Services or observe staff implement facility policies and procedures regarding radiologic procedures, including those that may be conducted at the time of surgery. This includes at least the following Radiologic Services regulations:
Safety for Patients and Personnel
- The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel.
- Proper safety precautions must be maintained against radiation hazards. This includes adequate shielding for patients, personnel, and facilities, as well as appropriate storage, use and disposal of radioactive materials.
- Radiation workers must be checked periodically, by the use of exposure meters or badge tests, for amount of radiation exposure.
- Only personnel designated as qualifed by the medical staff may use the radiologic equipment and administer procedures.
Administrative staff A, interviewed on 3/11/13 at 3:00pm, verified the hospital had not admitted any patients since the hospital relocated. (Since the relocation was effective 6/28/12, the hospital had not admitted any patients for approximately 8-1/2 months.)
The cumulative effect of the hospital's inability to demonstrate the implementation of systems and facility policies and procedures regarding Radiologic Services regulations to ensure the provision of quality health care in a safe environment.
Tag No.: A0618
Based on observation and staff interview, the hospital failed to demonstrate compliance with the Condition of Participation of Food and Dietetic Services when no patients or visitors were present and the hospital had admitted no patient since 6/28/12.
Findings include:
The hospital had no inpatients or outpatients on the survey date of 3/11/13 and, therefore, the hospital could not demonstrate compliance with the Condition of Participation 42 CFR (Code of Federal Regulations) 482.28: Food and Dietetic Services. Surveyors were unable to interview either patients or visitors regarding Food and Dietetic Services regulations or observe staff implement facility policies and procedures regarding these regulations. This includes at least the following Food and Dietetic Services regulations:
- Menus must meet the needs of the patients, and
- Nutritional needs must be met in accordance with recognized dietary practices and in accordance with orders of the practitioner or practitioners responsible for the care of the patients.
Administrative staff A, interviewed on 3/11/13 at 3:00pm, verified the hospital had not admitted any patients since the hospital relocated. (Since the relocation was effective 6/28/12, the hospital had not admitted any patients for approximately 8-1/2 months.)
The cumulative effect of the hospital's inability to demonstrate the implementation of systems and facility policies and procedures regarding Food and Dietetic Services regulations to ensure the provision of quality nutritional care for patients.
Tag No.: A0747
Based on observation and staff interview, the hospital failed to demonstrate compliance with the Condition of Participation of Infection Control when no patients or visitors were present and the hospital had admitted no patient since 6/28/12.
Findings include:
- The hospital had no inpatients or outpatients on the survey date of 3/11/13 and, therefore, the hospital could not demonstrate compliance with the Condition of Participation at 42 CFR (Code of Federal Regulations) 482.42: Infection Control. Surveyors were unable to interview patients, visitors, or staff regarding Infection Control regulations and hospital practices, policies or procedures, or observe staff implement facility policies and procedures regarding infection control. This includes at least the following Infection Control regulation:
--The infection control officer or officers must devleop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel.
Observation of Heartland Hospital's "Resource" room on 3/11/13 at 1:30pm revealed the following:
a) The standard of practice for nursing and infection control is that "clean" medical supplies and equipment is to be kep separate from "soiled" or "dirty" (potentially contaminated with microorganismas that may spread infection) medical supplies and equipment. This separation is done to minimize the potential of contamination of "clean" supplies/equipment by debris, residue, and potentially infectious microorganisms from "dirty" supplies/equipment.
b) Heartland Hospital converted a patient room this room's bathroom into a "clean" utility room and a "soiled" utility room called the "Resource" room. The "Resource" room had an eight-foot by eight-foot anteroom. Heartland Hospital had divided the anteroom in half with red tape on the floor: the area on the left side of the red tape was the "soiled" side while the area on the right side of the red tape one was the "clean" side.
c) The unlocked room designated "soiled" utility room contained a hopper (used to discard/flush biological waste) in place of the toilet in the patient bathroom. However, the hospital failed to provide PPE (Personal Protective Equipment) near the hopper for staff use or a flushing rim to prevent unintentional splatter. The Occupational Safety and Health Administration (OSHA), a nationally accepted reference for safety, requires protective equipment, including personal protective equipment for eyes, face, head, and extremities, protective clothing, respiratory devices, and protective shields and barriers to be provided, used, and maintained in a sanitary and reliable condition wherever it is necessary by reason of hazards of processes or environment, chemical hazards, radiological hazards, or mechanical irritants encountered in a manner capable of causing injury or impairment in the function of any part of the body through absorption, inhalation or physical contact (29 CFR 1910.132(a)).d) Observation in the soiled/dirty utility room (the "bathroom" section of the converted patient room) revealed a sink and faucet placed in the middle of the countertop. The countertop had a red piece of tape along the right side of the sink to designate a "clean" space for the hospital's eyewash kit, but this designated "clean space" for the eyewash station was between two "dirty spaces" - the sink and the hopper. The lack of separation through the use of space between clean and dirty areas increases the potential of contamination of clean items.
e) The "clean" portion of the patient/"utility" room contained patient supplies (such as vital sign machines, IV [intravenous] solutions and pumps), the covered clean linen cart, wound dressing supplies and other patient care supplies - all typically considered "clean". However, hospital staff stored containers of liquid disinfectants and disinfectant wipes in the window ledge of the clean utility room next to patient supplies, items considered "dirty" or "soiled" and, therefore, not appropriate for storage with "clean" patient supplies.
f) Corporate Clinical Director, staff D, interviewed on 3/11/13 at 3:50pm, stated Heartland Hospital contracted with its co-located hospital, hospital #2, for housekeeping services. Hospital #2's housekeeping staff cleaned the hallways and emptied trash for both hospitals. Corporate Clinical Director staff D explained Heartland had a different contract for cleaning the patient room and the operating room. Staff D explained hospital #2's housekeeping staff swept both hospitals with the same equipment (potentially bringing infectious waste from hospital #2 into the leased Heartland Hospital space).
In addition, Staff D explained hospital staff cleaned the operating room and post-operative area located on the first floor with a housekeeping cart brought down from Heartland's second floor soiled utility room. Since the operating room is considered a "sterile" area, bringing a housekeeping cart from the second floor's soiled utility room to the first floor, the location of operating rooms, would contaminate the sterile operating room, increasing the potential for patients who had a surgical procedure to acquire an infection.
Administrative staff A, interviewed on 3/11/13 at 3:00pm, verified the hospital had not admitted any patients since the hospital relocated. (Since the relocation was effective 6/28/12, the hospital had not admitted any patients for approximately 8-1/2 months.)
The cumulative effect of the hospital's inability to demonstrate the implementation of systems and facility policies and procedures regarding Infection Control regulations to ensure the provision of quality health care in a safe environment.
Tag No.: A0799
Based on observation and staff interview, the hospital failed to demonstrate compliance with the Condition of Participation of Discharge Planning when no patients or visitors were present and the hospital had admitted no patient since 6/28/12.
Findings include:
The hospital had no inpatients or outpatients on the survey date of 3/11/13 and, therefore, the hospital could not demonstrate compliance with the Condition of Participation at 42 CFR (Code of Federal Regulations) 482.43: Discharge Planning. Surveyors were unable to interview either patients or visitors regarding Discharge Planning regulations and hospital practices, policies or procedures, or observe staff implement of facility policies and procedures regarding Discharge Planning. This includes at least the following Discharge Planning regulations:
Identification of patients in Need of Discharge Planning
- The hospital must identify at an early stage of hospitalization all patients who are likely to suffer adverse health consequences upon discharge if there is no adequate discharge planning.
Discharge Planning Evaluation
- The hospital must provide a discharge planning evaluation to the patients identified in the regulation listed above and to other patients upon the patient's request, the request of a person acting on the patient's behalf, or the request of the physician.
- The discharge planning evaluation must include an evaluation of the likelihood of a patient needing post-hospital services and of the availability of the services.
- The discharge planning evaluation must include an evaluation of the likelihood of a patient's capacity for self-care or of the possibility of the patient being cared for in the environment from which he or she entered the hospital.
- The hospital personnel must complete the evaluation of a timely basis so that appropriate arrangements for post-hospital care are made before discharge, and to avoid unnecessary delays in discharge.
- The hospital must include the discharge planning evaluation in the patient's medical record for use in establishing an appropriate discharge plan and must discuss the results of the evaluation with the patient or individual acting on his or her behalf.
Discharge Plan
- The hospital must arrange for the initial implementation of the patient's discharge plan.
- The hospital must reassess the patient's discharge plan if there are factors that may affect continuing care needs or the appropriateness of the discharge plan.
- As needed, the patient and family members or interested persons must be counseled to prepare them for post-hospital care.
- The hospital, as part of the discharge planning process, must inform the patient or the patient's family of their freedom to choose among participating Medicare providers of post-hospital care services and must, when possible, respect patient and family preferences when they are expressed.
- The hospital must not specify or otherwise limit the qualified providers that are available to the patient.
Administrative staff A, interviewed on 3/11/13 at 3:00pm, verified the hospital had not admitted any patients since the hospital relocated. (Since the relocation was effective 6/28/12, the hospital had not admitted any patients for approximately 8-1/2 months.)
The cumulative effect of the hospital's inability to demonstrate the implementation of systems and facility policies and procedures regarding Discharge Planning regulations to ensure the provision of the care needs of each patient were met after hospitalization.
Tag No.: A0940
Based on observation and staff interview, the hospital failed to demonstrate compliance with the Condition of Participation for Surgical Services when this hospital that planned to provide surgical services had no patients present and the hospital had admitted no patient since 6/28/12.
Findings include:
The hospital had no inpatients or outpatients on the survey date of 3/11/13 and, therefore, the hospital could not demonstrate compliance with the Condition of Participation 42 CFR (Code of Federal Regulations) 482.51: Surgical Services. Surveyors were unable to interview staff or observe them implement facility policies and procedures regarding Surgical Services. This includes at least the following Surgical Services regulations:
- The operating rooms must be supervised by an experienced registered nurse or a doctor of medicine or osteopathy.
- Licensed practical nurses (LPNs) and surgical technologists (operating room technicians) may serve as "scrub nurses" under the supervision of a registered nurse.
- Qualified registered nurses may perform circulating duties in the operation room. In accordance with applicable State laws and approved medical staff policies and procedures, LPNs and surgical technologists may assist in circulatory duties under the supervision of a qualified registered nurse who is immediately available to respond to emergencies.
- A properly executed informed consent form for the operation must be in the patient's chart before surgery, except in emergencies.
Administrative staff A, interviewed on 3/11/13 at 3:00pm, verified the hospital had not admitted any patients since the hospital relocated. (Since the relocation was effective 6/28/12, the hospital had not admitted any patients for approximately 8-1/2 months.)
The cumulative effect of the hospital's inability to demonstrate the implementation of systems and facility policies and procedures regarding Surgical Services regulations to ensure the provision of quality health care in a safe environment.
Tag No.: A1000
Based on observation and staff interview, the hospital failed to demonstrate compliance with the Condition of Participation of Anesthesia Services when this hospital that planned to provide surgical services (which usually requires anesthesia services) had no patients present and the hospital had admitted no patient since 6/28/12.
Findings include:
The hospital had no inpatients or outpatients on the survey date of 3/11/13 and, therefore, the hospital could not demonstrate compliance with the Condition of Participation 42 CFR (Code of Federal Regulations) 482.52: Anesthesia Services. Surveyors were unable to interview staff or observe staff implement facility policies and procedures regarding Anesthesia Services. This includes at least the following Anesthesia Services' regulations:
- The organization of anesthesia services must be appropriate to the scope of the services offered. Anesthesia must be administered only by a qualified anesthesiologist; a doctor of medicine or osteopathy (other than an anesthesiologist); a dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law; a certified registered nurse anesthetist (CRNA) who unless exempted by a State exemption is under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed; or an anesthesiologist's assistant who is under the supervision of an anesthesiologist who is immediately available if needed.
- A pre-anesthesia evaluation completed and documented by an individual qualified to administer anesthesia, performed within 48 hours prior to surgery or a procedure requiring anesthesia services.
Administrative staff A, interviewed on 3/11/13 at 3:00pm, verified the hospital had not admitted any patients since the hospital relocated. (Since the relocation was effective 6/28/12, the hospital had not admitted any patients for approximately 8-1/2 months.)
The cumulative effect of the hospital's inability to demonstrate the implementation of systems and facility policies and procedures regarding Anesthesia Services regulations to ensure the provision of quality health care in a safe environment.