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Based on observations, interviews, medical record review, review of contracts and agreements, review of the Radius Specialty Hospital's Patient Care Assessment/Quality Improvement (PCA/QI) data and minutes, Medical Staff Meeting minutes, credential files, code and rapid response reviews, Pharmacy minutes, and Hospital policies and procedures, indicated the Radius Specialty Hospital failed to maintain compliance with the Condition of Governing Body. Findings include:

1. The Governing Body failed to ensure that all physicians who provided care to Radius Specialty Hospital patients were recommended by the Medical staff and approved by the Governing Body.

Please refer to A046.

2. The Governing Body failed to assess the services provided under contract, identify quality issues, implement improvement activities, and ensure monitoring and sustainability of improvement activities.

Please refer to A083.

3. The Governing Body failed to ensure implementation of Radius Specialty Hospital policies and procedures for prompt evaluation, initial treatment and referral of patients for emergency care when appropriate.

Please refer to A093.

4. Patient Rights 482.13. The Governing Body failed to ensure that patients' rights were met related to the use of physical restraints, informed consent and maintaining patients' privacy.

Please refer to A131, A143, A165, A166, A168, A178, and A179.

5. Quality Assurance/Performance Improvement (QAPI) 482.21. The Governing Body failed to ensure that the QAPI program reflected the complexity of the Hospital's organization and services; involved all hospital departments and services (including those services furnished under contract or arrangement); and focused on indicators related to improved health outcomes and the prevention and reduction of medical errors.

Please refer to A263, A273, A283, A297.

6. Pharmacy Services 482.25. The Governing Body failed to ensure that Radius Specialty Hospital : had an organized pharmaceutical service under the direction of a registered pharmacist and a supervised drug storage area at the Radius Specialty Hospital Satellite located at Quincy Medical Center; implemented policies and procedures for minimizing drug errors and managing the pharmacy service; provided for security of controlled drugs; reported all drug-related adverse events; prevented loss of drugs; and provided a formulary system to all Radius Specialty Hospital patient care units.

Please refer to A490, A491, A492, A493, A494, A501, A502, A503, A504, A508, A509, A510, and A511.

7. Utilization Review (UR) 482.30. The Governing Body failed to ensure that the Radius Specialty Hospital conducted utilization reviews of Medicare eligible patients; ensured the members of the UR Committee did not review patients for whom they were professionally involved; ensure the UR Committee reviewed admissions, durations of stays and professional services furnished including drugs and biologicals; and reviewed professional services provided to Medicare patients to determine medical necessity and to promote the most efficient use of available health facilities and services.

Please refer to A652, A653, A654, A655, and A658.

8. Infection Control 482.42. The Governing Body failed to: consistently ensure a sanitary kitchen environment; ensure staff adherence to infection control policies and procedures; and ensure staff utilized adequate protective personnel equipment to prevent transmission of infections and communicable diseases.

Please refer to A747.

Based on observations, record review and staff interviews, the Radius Specialty Hospital at Boston failed to protect and promote patient's rights in the areas of Informed Consent for 4 sampled patients ((#4, #5, #28 and #29): failed to provide personal privacy during care for six patients (#4, #5, #14, #22, #28 and #29) and failed to follow Hospital polices and procedures for the application and use of Restraints for three of five sampled patients ( #6, #7 and #9) in a total sample of 30. Findings include:

1. For Informed Consent: 4 patients in a total sample of 30 were being video monitored without being given the right to refuse.

Please refer to A131 for additional information.

2. For Personal Privacy: Six patients did not have personal privacy in a total sample of 30;

a. Four patients were being video monitored without given the right to refuse;
b. One patient who did not receive personal privacy during a dressing change;
c. One patient who had hand written signage at the head of the bed that violated personal privacy.

Please refer to A143 for additional information.

3. For Restraints: three of 5 sampled restrained patients did not have restraint usage that followed facility policy and procedures.

a. One patient was restrained in an Easy Release Belt (EZRB) without evidence that it was the least restrictive device and without a care plan;

b. One patient was restrained in a Posey Vest without evidence that it was the least restrictive device;

c. One patient received chemical restraints, twice, without a physician visit and written evaluation within one hour of restraint usage.

Please refer to A164, A166, A168, A178, A179 for additional information.

Based on review of meeting minutes and data and interviews, the Radius Specialty Hospital's Governing Body (GB) failed to ensure that the Quality Assessment Performance Improvement (QAPI) program reflected the complexity of the hospital's organization and services; involved all hospital departments and services (including those services furnished under contract or arrangement); and focused on indicators related to improved health outcomes and the prevention and reduction of medical errors. Findings include:

1. On 5/22/13, review of the Hospital's Patient Care Assessment/Quality Improvement (PCA/QI) data and minutes of meetings from 12/2012 to 5/2013, indicated that Contracted Services did not participate in the Hospital's PCA/QI Plan.

During interview on 5/23/13 at 10:00 A.M., the Regional Director of Performance Improvement, Patient Safety and Regulatory Compliance said that the Hospital did not conduct QAPI for the following contracted services:

a. Services not provided at both the Radius Specialty Hospital at Boston and the Radius Specialty Hospital Satellite located at Quincy Medical Center (QMC); Organ Procurement Services; Infectious Waste Removal; Intravenous (IV) Therapy Services; and Food and Dietary services.

b. Services not provided at the Radius Specialty Hospital Satellite at QMC: Biomedical Engineering; Radiology; Environmental and Maintenance Service; Blood Product Usage; Information Technology; and Emergency Response .

Please refer to A273.

2. On 5/22/13, review of Patient Care Assessment/Quality Improvement (PCA/QI) data and minutes of meetings, Pharmacy and Therapeutics Committee minutes, and Medication Safety Meeting minutes, and interview, indicated the Hospital failed to take actions aimed at performance improvement, actions to measure its success, and track performance to ensure that improvements were sustained over time for contracted services.

Please refer to A283.

3. On 5/22/13, review of the Radius Specialty Hospital's Patient Care Assessment Quality Improvement (PCA/QI) data and minutes of meetings from 12/2012 to 5/2013, indicated the Hospital failed to: document what quality improvement projects were being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects for contracted services.

During interview on 5/23/13 at 10:00 A.M. the Regional Director of Performance Improvement, Patient Safety and Regulatory Compliance said that the Hospital did not conduct Quality Assessment Performance Improvement (QAPI) for contracted services.

Please refer to A297.

4. On 5/22/13, review of PCA/QI data and minutes of meetings from 12/2012 to 5/2013, the Hospital's PCA/QI plan, and interviews, the GB failed to ensure that the PCA/QI program reflected the complexity of the Hospital's organization and services and involved all hospital departments and services, including those services furnished under contract or arrangement.

During interview on 5/23/13 at 10:00 A.M., the Regional Director of Performance Improvement, Patient Safety and Regulatory Compliance said that the Hospital did not conduct QAPI for contracted services.

Please refer to A308.

Based on record review and interview, the Condition of Utilization Review is not met as the Radius Specialty Hospital failed to: (a) conduct utilization review (UR) on Medicare eligible patients; (b) ensure the members of the Utilization Review Committee (UR) did not review patients for whom they were professionally involved with in their care by participating in the development or execution of that patient's treatment plan; (c) have the UR Committee review admissions, durations of stays and professional services furnished including drugs and biologicals; and (d) review professional services provided to Medicare patients, to determine medical necessity and to promote the most efficient use of available health facilities and services. Findings include:

1. The Hospital failed to conduct UR on Medicare eligible patients.

During the initial meeting with the facility staff on 5/20/13 at 9:00 at the Radius Specialty Hospital at Boston, the Chief Operating Officer and the Director of Case Management stated that the Hospital had an agreement with a Quality Improvement Organization (QIO) to perform the UR function at the hospital.

A review of the agreement between the QIO and the hospital indicated that the QIO did not perform the UR function for Medicare patients.

See A 653

2. The Hospital failed to ensure the members of the UR did not review patients whose care they were professionally involved with or by participating in the development or execution of that patient's treatment plan.

Review of the UR plan indicated that, by design and execution, the Hospital UR committee members were reviewing patients for UR purposes, for whom they had care planning and treatment responsibilities. This created a conflict of interest in decision making about a patient's eligibility for continued stay at the Hospital.

See A 654

3. The Hospital failed to have the UR Committee review admissions, durations of stays and professional services furnished including drugs and biologicals.

Review of the UR plan indicated that for UR Committee Reports and Records the following is required:
a. The Case Management Department is responsible for maintaining records of individual and aggregate patient data for admission and extended stay reviews, and complete minutes of all Utilization Review Committee meetings.
b. Minutes of all meetings will be available to all members of the Committee and would be distributed to the Medical Executive Committee and the Governing Body.

The Length of Stay (LOS) Committee notes included the Agenda for the meeting but did not have actual minutes.

The Agenda included the Top 10 DRGs (Diagnostic Related Groups) and Outside Appointments.

Each quarterly meeting included statistics on LOS Trending Summaries and DRGs. Also included were brief notes on Outside Appointments. There were no minutes from the LOS meetings held during January 2013 and April 2013.

See A 655

4. The hospital failed to review professional services provided to Medicare patients, to determine medical necessity and to promote the most efficient use of available health facilities and services.

During interview on 5/23/13 at 12:30 P.M., the Chief Operating Officer, who was the Chairperson of the UR Committee, stated that the UR Committee (LOS Committee) did not review patient admissions or length of stay. The CEO stated no review of professional services was done by the UR Committee, but a review was done at team meetings.

Please refer to A 658

Based on observations, review of policies and procedures, and interviews, the Hospital failed to meet the Condition of Infection Control by failing to (a) consistently ensure a sanitary kitchen environment, (b) ensure staff adherence to infection control policies and procedures, and (c) to provide adequate protective personnel equipment (PPE) to prevent transmission of infections and communicable diseases, affecting 6 (#1, #11, #14, #15, #23, #25) of 30 sampled patients and two Nonsampled Patients (NS E and NS G). The failure of staff to adhere to infection control practices involved 13 observed staff; [Hemodialysis Registered Nurse (HDRN) #1, #2, #3, Central Sterile Technician (CST) #1, Phlebotomist (Phleb #1), Physical Therapy Aide (PTA) #1, Speech Therapist (ST #1), Respiratory Therapist (RT#1), Radiology Technologist (RadTech #1 and #2), Nursing Technician (NT) #2 and Registered Nurse (RN) #7 and #12]. Findings include:

A. The Radius Specialty Hospital at Boston failed to ensure that dishes were properly washed and sanitized at the Main Hospital kitchen.

On 5/20/13 the surveyor observed the dish machine operation. On 10 of 10 observations of the dishmachine, the wash water temperature and the final rinse water temperature failed to reach the required temperatures of 160 degrees F and 180 degrees F respectively as per the manufacturer's requirements on the machine's data plate. The wash water temperature registered between 132 to 152 degrees F. The final rinse water temperature registered between 116 to 118 degrees F.

Since the final rinse water temperature was not reaching 180 degrees F., the dishes were not being sanitized. This placed patients at risk for potential food bourne illnesses.

B. The Radius Speciality Hospital failed to ensure staff adherence to infection control policies and procedures,

1. For Patient #1, the Hospital failed to ensure staff performed hand hygiene between glove changes, increasing the chance of cross contamination. Staff failed to clean equipment (stethoscope) after contaminating it during patient care in a contact precaution room.

2.. Phlebotomist #1 failed to don the appropriate PPE when entering a precaution room on the K5 Respiratory/Ventilator Unit, at Radius Speciality Hospital at Boston, on 5/20/13 at 12:05 P.M. Phlebotomist #1 failed to perform hand hygiene or don a cover gown, as required by hospital policy, prior to entry into the precaution room. Phlebotomist #1 left the precaution room without performing hand hygiene.

3. Observation on the K5 Unit, at Radius Specialty Hospital at Boston, on 5/20/13 at 2:30 P.M., indicated Speech Therapist (ST#1) placed communication equipment onto the floor while s/he performed hand hygiene and donned a cover gown to enter a precaution room. The equipment was then brought to the patient and placed on the patient's over-bed table. ST#1 again placed the communication equipment on the floor when removing her PPE upon exiting the room. Any items that have contact with the floor are considered soiled and would need to be disinfected before being brought to or from the room. The communication equipment was not cleaned when entering or exiting the room.


4. On K5 Respiratory/Ventilator Unit, at Radius Specialty Hospital at Boston, on 5/21/13 at 8:55 A.M., Respiratory Therapist (RT#1)was observed caring for a number of ventilator patients. According to the CDC publication "Guidelines for Preventing Health Care Associated Pneumonia, 2003", in the absence of medical contraindication(s), elevate at an angle of 30-45 degrees the head of the bed of a patient at high risk for aspiration (e.g., a person receiving mechanically assisted ventilation and/or who has an enteral tube in place). Documentation of the head of bed at > 30 degrees was consistently entered on the patient's receiving mechanical ventilation by Respiratory Therapy and Nursing staff. However, when interviewed as to how the head of bed was measured, both RT #1 and RN #3 could not locate the measuring device on Patient # 14's bed. According to RT#1, not all beds on the K5 Unit had measuring devices and RT would "estimate" the level of the head of the bed.

Interview with RT #2 on 5/21/13 at 10:15 A.M., indicated that RT #2 believed that not all of the beds had measuring devices and RT would "guesstimate" the head of the bed level.

5. Inhalers were observed stored in the Pyxis MedStation (an automated medication storage cart) in plastic bags that were taken to the bedside of patients, who were on infection control precautions, and then returned to the Pyxis MedStation, on K5 Unit, at Radius Specialty Hospital at Boston, on 5/21/13 at 9:00 A.M. The inhalers were stored in individual zip-lock bags. RT#1 signed out the medications from the secured system and brought the medications to the doorway of Patient #15. RT#1 placed the medication above the chart holder while RT#1 performed hand hygiene and donned appropriate PPE. The medication bags were labeled with the patient name and left outside of the precaution room. However, after using the inhaler on Patient #15, RT #1 used the same gloves that were used to administer the medication to the patient to return the medication to the zip-lock bag thus contaminating the zip-lock bag. The inhaler was then returned to the Pyxis automated medication dispensing system. The inhaler was not placed in the zip-lock bag in a way to prevent contamination to the bag, therefore increasing the risk of cross-contamination of the Pyxis MedStation.

6. Observation on the K5 Unit, at Radius Specialty Hospital at Boston, on 5/22/13 at 9:45 A.M., indicated a Radiology Technologist (RadTech #1) in a Precaution Room (Non-Sampled Patient G). RadTech #1 was seen positioning an x-ray plate behind the patient. Moments later, RadTech #1 was observed at the Nurses Station wearing the PPE, asking for clarification of the Radiology order. RadTech #1 failed to remove his/her PPE when exiting the precaution room, increasing the potential of cross contamination of the external environment from the patient's room.

7. On 5/20/13, observations of the Code Cart at 11:00 A.M. on the Radius Specialty Hospital Satellite located at Quincy Medical Center (QMC), indicated that four disinfectant swab sticks had outdates written directly on the packaging in ink. Ink is a liquid and can penetrate the packaging, rendering the items no longer sterile. During an interview on 5/20/13 at approximately 11:00 A.M., the Central Sterile Service Supervisor said the items were now considered unsterile and removed them from the cart.

8. For Patient #23, on the Radius Specialty Hospital Satellite at QMC, observation of a blood sugar test at 2:20 P.M. on 5/21/13, indicated that Nursing Technician (NT) #2, failed to follow Infection Control Standards of Practice, and the glucometer manufacturer's (Accucheck) and disinfectant manufacturer's (Super Sani-Cloth Wipes), directions for use (DFU), as required.

9. For Patient NS E (a patient on infection control precautions for a diagnosis of Clostridium Difficile), observations on 5/21/13 at 10:00 A.M., indicated that RadTech #1 was in the patient's room taking a portable X-ray. The RadTech's covergown was not properly secured and became contaminated. The RadTech did not change the gown.

The RadTech left the room and came out into the corridor still wearing the contaminated gloves and cover gown. The RadTech removed the gown and gloves outside the patient's room and disposed of them in a receptacle located in the corridor. RadTech #1 then used waterless hand sanitizer to disinfect his/her hands. Contact precaution for C diff required a soap and water hand wash. The RadTech failed to follow Hospital policy for wearing PPE and for contact precaution and hand washing. After intervention by this Surveyor, RadTech #1, used soap and water to clean his/her hands.

10. For Patient #25, an inpatient at the Radius Specialty Hospital Satellite located at Qunicy Medical Center (QMC), observation of a two-step dressing change, in the patient's room at 12:30 P.M., on 5/21/13, indicated the following breeches in infection control practices.

a). RN #7 failed to perform hand hygiene before accessing the clean glove box and donning gloves.
b). RN #7 used his/her the nurses' scissors, that were stored in his/her uniform pocket, to remove the leg dressing and left the contaminated old dressing on the patient's bed. (Items carried in staffs' uniform pockets are considered contaminated).
c). The RN then removed the contaminated gloves and donned sterile gloves without first performing hand hygiene.
d). Before placing the new dressing on the patient's leg, the RN partially removed the Xeroform gauze that covered the patient's graft site, saying,"We're not supposed to remove this gauze, only change the sponge."
e). RN #7 then removed the gloves and accessed the clean (now contaminated) glove box without first performing hand hygiene. The RN donned the gloves, without first performing hand hygiene.

See A 749


(C) The Hospital failed to provide adequate protective personnel equipment (PPE) to prevent transmission of infections and communicable diseases

1. Observation on K5 Unit, at Radius Specialty Hospital at Boston, on 5/20/13 at 10:00 A.M., indicated Personal Protective Equipment (PPE) was available at the entrance to each patient room. The PPE consisted of cover gowns, gloves and masks. According to the Occupational Safety and Health Administration (OSHA) requirement, PPE will be considered "appropriate" only if it does not permit blood or other potentially infectious materials to pass through or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or mucous membranes under normal conditions of use, and for the duration of time which the protective equipment will be used. The available PPE (masks and cover gowns) on the K5 unit, where more than a dozen tracheostomy and ventilator patients requiring frequent suctioning were located, did not meet the OSHA requirement as the cover gowns, were only fluid resistant and not impermeable as required by OSHA. The impermeable cover gowns were observed being distributed on the K5 Unit on 5/21/13 at 7:30 A.M. The impermeable gowns were white, a thicker fabric and labeled by the manufacturer as impervious. In addition, there was only one pair of eye protective wear (shields or goggles) on the unit.


2. For Patient #11, observations on the dialysis unit at 11:10 A.M. on 5/20/13, at Radius Specialty Hospital at Boston, indicated that HDRN #2, wore a yellow cover gown when providing care to and disinfecting the dialysis machine after dialysis for Patient #11. The cover gown was not impervious to fluids, as required.

3. For Patient #1, the Radius Specialty Hospital of Boston failed to ensure staff used appropriate personal protective equipment (PPE) when accessing the dialysis blood circuit and when providing personal care. HDRN #1 did not have an cover gown that was impervious to fluids on while changing out a clotted blood circuit on 5/20/13 at approximately 11;00 A.M. and did not have any face shields eye protection, as required


See A749

Based on medical record reviews, staff interviews, review of the Radius Specialty Hospital's physician listing, review of the Radius Specialty Hospital's contracted services listing, and review of the Quincy Medical Center's physician on-call schedules for 2/2013, 3/2013, 4/2013, and 5/2013, indicated that the Radius Hospital's Governing Body (GB) failed to appoint Quincy Medical Center (QMC) physicians to the medical staff of Radius Specialty Hospital. The QMC physicians provided emergency care to 3 non-sampled (NS B, NS C, NS D) Radius Specialty Hospital patients. Findings include:

1. During interview on 5/20/13 at 10:30 A.M., the Nurse Manager (NM) of the Radius Specialty Hospital Satellite located at Quincy Medical Center (QMC), said that the QMC physician staff provided Emergency Services for the Radius Specialty Hospital Satellite located at QMC.

2. On 5/20/13, review of the contract entitled "Facility and Ancillary Services," that the Radius Specialty Hospital maintained with the QMC, that housed the Radius Specialty Hospital Satellite, indicated that the QMC provided emergency response services for the Radius Specialty Hospital Satellite at Quincy Medical Center. The emergency response services included behavioral emergencies, Code 1 (patient's found unresponsive/not breathing), and Rapid Response (patients whose condition suddenly declined).

3. On 5/20/13, while on site at the Radius Specialty Hospital Satellite located at QMC, the NM provided the Surveyor with a physician on-call schedule. The NM said that the physicians on the on-call schedule were QMC physicians who provided emergency care to the Radius Specialty Hospital Satellite at QMC.

4. Review of the Radius Specialty Hospital's physicians listing on 5/21/13, indicated that none of the physicians on the QMC on-call schedules were listed as active physicians on the Radius Specialty Hospital's physician list.

5. A review of credential files on 5/23/13, indicated that two (#4 and #7) of four on-call QMC physicians were not appointed to the medical staff of Radius Specialty Hospital. During interview on 5/23/13 at approximately 10:00 A.M., the Chief Medical Officer (CMO) said physicians #4 and #7 were not approved to provide patient care at the Radius Specialty Hospital. However, the CMO said in 2/2013, Physician #4 was offered a medical staff application and refused. The Radius Specialty Hospital Satellite at QMC was sharing non-credentialed physicians with the QMC.

6. During interview with the Quincy Medical Center's Chief Nursing Officer (CNO), subsequent to survey on 5/28/13 at 10:00 A.M., the CNO said that the physicians listed on the QMC call schedule were the physicians who would respond to medical emergencies in the Radius Specialty Hospital Satellite at QMC. The CNO said that the physicians would respond anytime of day that a code was called.

7. Review of the QMC Code Documentation Forms, requested during the survey, and again on 5/28/13, indicated that on 9/1/12, 12/10/12 and 12/27/12, the Quincy Medical Center's Code Team responded to medical emergencies in the Radius Specialty Hospital Satellite at QMC.

8. For NS B, on 12/27/12, an anesthesiologist intubated the patient undergoing cardio-pulmonary resuscitation. Review of a Radius Specialty Hospital physician listing indicated that no anesthesiologists were appointed by the Governing Body to practice at Radius Specialty Hospital. Additionally, during interview on 5/22/13 at 10:00 A.M., the Vice President of Clinical Services (VPCS) said the Radius Specialty Hospital didn't appoint any anesthesiologists to the medical staff as it did not provide anesthesia services.

For NS C, on 12/10/12, an Emergency Room physician intubated the patient undergoing cardio-pulmonary resuscitation. Review of a Radius Specialty Hospital physician listing indicated that no emergency room physicians were credentialed at the Radius Specialty Hospital. During interview on 5/22/13 at 10:00 A.M., the VPCS said Radius Specialty Hospital didn't credential any of the QMC's emergency room physicians and that Radius Specialty Hospital did not provide emergency services.

For NS D, on 9/1/12, after providing cardio-pulmonary resuscitation, a QMC physician transferred the patient from the Radius Specialty Hospital Satellite at QMC directly to the Quincy Medical Center's Intensive Care Unit. The QMC physician was not credentialed at the Radius Specialty Hospital.

The Radius Specialty Hospital Satellite at Quincy was sharing non-credentialed physicians with the Quincy Medical Center.

Based on review of Radius Specialty Hospital contracts, Patient Care Assessment/Quality Improvement (PCA/QI) minutes, and interviews, the Radius Specialty Hospital failed to ensure the contracted services complied with the Condition of Quality Assessment Performance Improvement (QAPI).

Findings include:

1. According to QAPI 482.21, the governing body must take actions through the Hospital's QAPI program to: assess the services provided under contract to identify quality and performance problems; implement appropriate corrective or improvement activities; and ensure the monitoring and sustainability of those corrective or improvement activities.

2. On 5/22/13, review of PCA/QI minutes for 4/2012 to 4/2013, indicated the following contracted services failed to report their QAPI activities to the PCA/QI Committee regarding services provided at both the Radius Specialty Hospital at Boston and the Radius Specialty Hospital Satellite located at Quincy Medical Center (QMC). Services not reporting were: organ procurement services; infectious waste removal; intravenous (IV) therapy; Food and Dietary services; Radiology and Biomedical Engineering.

3. During interview on 5/23/13 at 10:00 A.M. the Regional Director of Performance Improvement, Patient Safety and Regulatory Compliance said that the Radius Specialty Hospital did not conduct QAPI for the contracted services of: organ procurement services; infectious waste removal; intravenous (IV) therapy; and Food and Dietary services at both the Radius Specialty Hospital at Boston and the Radius Specialty Hospital Satellite at QMC. Additionally, the contracted services of Biomedical Engineering, Environmental and Maintenance Service; Radiology; Information Technology; and Emergency Response Services at the Radius Specialty Hospital Satellite at Quincy, failed to report QAPI activities to the PCA/QI Committee .

4. For Emergency Response Services, although a brief report was sent to Radius Specialty Hospital at Boston from the Quincy Medical Center (QMC), the Quincy Medical Center conducted all the code and rapid response reviews pertaining to the Radius Specialty Hospital Satellite patients located at QMC. The report did not contain any pertinent data (e.g., timeliness of response, appropriateness of treatment), nor did it identify any opportunities for improvement for the Radius Specialty Hospital Satellite at QMC.

Review of Code Blue Committee minutes on 5/23/13 indicated that the reviews only included codes that occurred in the Radius Specialty Hospital at Boston. The Radius Specialty Hospital at Boston did not conduct any reviews of the codes that occurred at the Radius Specialty Hospital Satellite located at QMC.

5. For waste removal services, review of two infectious waste removal contracts (one for the Radius Specialty Hospital at Boston and one for the Radius Specialty Hospital Satellite at Quincy) on 5/22/13, indicated that both contracts only referred to removal of sharps. Further review of both contracts indicated the equipment provided only referred to "sharps containers." Neither contract referred to removal of red bag/biohazardous or regulated waste.

An email received from the Regional Director of Performance Improvement, Patient Safety and Regulatory Compliance subsequent to survey on 5/30/13, read "At Boston (the Radius Specialty Hospital at Boston) they (infectious waste removal contractors) pick up our sharps and regulated waste. At the Radius Specialty Hospital Satellite at Quincy, they ( the infectioous waste contractors) pick up just sharps as (the QMC) picks up our regulated waste."

The Radius Specialty Hospital lacked a contract with infectious waste removal contractors for regulated waste pick up at the Radius Specialty Hospital at Boston and a contract for regulated waste pick-up at the Radius Specialty Hospital Satellite at QMC.

Based on review of Radius Specialty Hospital contracts, interviews, and review of the list of contracts for contracted services provided at the Radius Specialty Hospital Satellite located at Quincy Medical Center (QMC), the Radius Specialty Hospital failed to ensure the contracts and list included the scope and nature of the services provided.
Findings include:

1. Review of contracts on 5/22/13, indicated that the contracted services of Pharmacy; and I.V. (intravenous) therapy services lacked the scope and nature of the services provided.

2. Review of a list of contracted services provided at the Radius Specialty Hospital Satellite at QMC, on 5/22/13, indicated that the following services also lacked the scope and nature of the services provided: biomedical engineering; housekeeping; maintenance and plant engineering; dietary; biohazard trash removal; blood bank; emergency response (including behavioral, rapid response, Code 1, and life safety drills); security and safety; laundry; and physician coverage nights, evenings, weekends and holidays.

3. Additionally, the Radius Specialty Hospital lacked a contract for biohazard trash removal. The contracts with infectious waste removal contractors for the Radius Specialty Hospital at Boston and the Radius Specialty Hospital Satellite located at QMC, provided to the Surveyor on 5/21/13, were only for the removal sharps ( needles, surgical blades, etc). The contract did not include the disposal of biohazardous trash (e.g., dialysis dialyzers and tubing, bloodied dressings).

Based on observation, record review and interview, the Hospital 's Governing Body failed to implement its written polices and procedures for referral of emergencies for further evaluation and treatment, for two of four patients (Code Patient #1 and #2), at the Radius Specialty Hospital Satellite located at Quincy Medical Center (QMC). Findings include:

Review of the Hospital Policies and Procedures, for Appraising, Treating and Referring Patients with Medical Emergencies, indicated that when staff, i.e. Registered Nurse (RN) or Respiratory Therapist (RT), on duty, discover a patient with an acute change in condition, they shall have a clinician paged immediately to notify them of the emergency. While awaiting the arrival the clinician, the RN or RT shall provide emergency treatment to the best of their abilities. The clinician shall respond immediately to the page and assess the patient . If the clinician determine that the patient requires a transfer to an acute care hospital, the clinician will call the emergency room of such a hospital to inquire about transferring the patient and to provide a summary of the patient's medical condition. Transfer forms will be completed to accompany the Patient and an ambulance arranged for transfer.

On 5/20/13, review of the contract entitled "Facility and Ancillary Services," that the Radius Specialty Hospital maintained with QMC, that housed the Radius Specialty Hospital Satellite, indicated that the QMC provided emergency response services for the Radius Specialty Hospital Satellite at Quincy. The emergency response services included behavioral emergencies, Code 1 (patients found unresponsive/not breathing), and Rapid Response (patients whose condition suddenly declined).

Review of Code 1 responses at the Radius Specialty Hospital Satellite at QMC between 9/2012 and 2/2013 (all that were provided), indicated that three (Code Patients #1, #2 and #3) of four of Code 1 cases reviewed, from the Radius Specialty Hospital Satellite at QMC were directly admitted to the QMC's Intensive Care Unit (ICU) from the Radius Specialty Hospital Satellite at QMC. Code Patient #1 died in the Radius Specialty Hospital Satellite at QMC while waiting to be "transferred" to the Quincy Medical Center's progressive care unit (PCU).
For example:

a.) Review of nursing documentation for Code Patient #1, who was a patient at the Radius Specialty Hospital Satellite at QMC indicated that on 9/11/12 at 5:00 P.M., the patient was on a BiPAP to assist with breathing, had oxygen saturations in the 80's (95 to 99% is average), and a heart rate in 120's (80 is average). At 5:15 P.M., the nurse wrote that the patient was being transferred to the PCU, of the QMC. The PCU is a higher level of care that can provide more monitoring. At 6:27 P.M., the nurse wrote the patient was on BiPAP with an O2 sat in the 90's and was given a nebulizer treatment. At 8:20 P.M., the nurse wrote the patient was found unresponsive with no respirations or pulse. CPR (cardiopulmonary resuscitation) was started and the QMC code team was called and responded. The patient received Epinephrine 4 times intravenously (IV) but the IV line was not "effective." The patient was intubated by the Respiratory Therapist (RT) from the QMC. The code ended at 8:38 P.M. per the physician, with the patient expiring.

Review of the physician progress notes, which summarized the event, indicated the patient's condition was worsening over the evening and s/he felt the patient would require intubation. The Radius Speciality Hospital Satellite at QMC physician wrote s/he told the family that s/he wanted to transfer the patient to the ICU (intensive care unit) versus the PCU at the QMC and that s/he had paged the QMC's Hospitalist Service at least four times in an hour and did not get a response until after 7:00 P.M. The QMC's Hospitalist arrived on Radius Specialty Hospital Satellite at QMC, 30 minutes after being called and told the family the patient would be transferred to the PCU. The Radius Specialty Hospital Satellite at QMC physician wrote s/he was not comfortable keeping the Patient in the Radius Specialty Hospital Satellite at QMC. By the time, arrangements for "transfer" were made the patient arrested and died.

The arrangements for "transfer' were in the making since 5:15 P.M. The patient coded and died at 8:38 P.M. The Radius Specialty Hospital failed to follow its policy and transfer the patient to a higher level of care for further evaluation and treatment, when the patient's condition declined. The Hospital's Governing Body failed to enforce Hospital policy.

b.) Review of documentation for Code Patient #2, who was a patient at the Radius Specialty Hospital Satellite at QMC, indicated that on 9/1/12 at 7:40 A.M., the RT found the patient shaking The patient was blue and slumped over in bed and was unresponsive. The RT called for help and placed the patient on BiPAP. Chest compressions and bag ventilation were started. The QMC's rapid response team arrived as the patient's pulse and respirations began to return. The patient was transferred directly to the ICU of the QMC without being discharged from the Radius Specialty Hospital Satellite at QMC or pre-admitted to the Quincy Medical Center.

An Emergent Transfer form was found in the documentation. The form indicated the staff involved in the transfer were the nursing staff and the Quincy Medical Center's code team. It also indicated that the the patient was being transferred to the "ICU of the Quincy Medical Center." No receiving physician was identified. There was no discharge order or summary from the Radius Specialty Hospital Satellite at QMC evident.

c.) Review of nursing documentation for Code Patient #3, who was a patient at the Radius Specialty Hospital Satellite at QMC, indicated that on 12/27/12, the patient was found unresponsive in bed at 2:25 P.M. by the Registered Nurse (RN). A Code 1 was called and CPR was initiated. At 2:30 P.M., the Quincy Medical Center's code team arrived. The patient received five doses of Epinephrine (for heart rate) IV over 23 minutes and was started on a Dopamine drip for blood pressure support. At 3:10 P.M., the patient was directly admitted to the ICU of the QMC. There was no evidence the patient was discharged from the Radius Specialty Hospital Satellite at QMC, nor admitted to the QMC, before being transferred to the ICU.

During an interview on 5/31/13 at 12:00 P.M., the Chief Medical Officer said that the transfers between the Radius Specialty Hospital Satellite at QMC and the Quincy Medical Center did not include an official discharge from the Radius Specialty Hospital Satellite at QMC and an admission to the Quincy Medical Center, before the patient was transferred.

Based on observation, record review and interview, the Radius Specialty Hospital at Boston failed to allow four of four patients reviewed (#4, #5, #28 and #29), in a total sample of 30, the right to refuse to be videotaped 24 hours a day, in the privacy of their room. Findings include:

1. Observation on 5/20/13, at approximately 9:30 A.M., indicated that all the rooms on the M 4 unit had video monitors in them that were monitored at a central panel at the nursing desk. The central panel was visible to anyone walking behind the front desk such as other providers, housekeepers, consultants, therapists or pharmacy personnel.

During an interview on 5/23/13 at 9:00 A.M., Registered Nurse (RN) #8, said the monitors were used to ensure safety on high risk fall patients and all patients were told on admission about their use.

During an interview on 5/23/13 at 10:00 A.M., the Vice President of Clinical Services said the Hospital does not have a policy or procedure for the use of the video cameras on M4.

2. For Patient #29, admitted in the past week, record review indicated the patient was assessed as a 3 for fall risk. A score of 5 or above is high risk. The patient was assessed as alert and oriented to person, place and time. The patient was admitted with metastatic cancer and needed pain management.

Review of the record indicated there was a two page document titled the "Conditions of Admission and Notice of Provider Privacy Practices." This document contained information on HIPAA (Health Insurance Portability and Accountability Act, Privacy and Security Rules), consent to use Medicare lifetime reserve days, acknowledgement of receipt of notice of provider privacy practices and a statement that by "signing below I hereby give consent to have photographs/videotaped images/other images/audio recordings made for treatment purposes only."

The consent did not give the patient the opportunity to refuse this part of the overall consent as it had for use of the life time Medicare days where the patient could select to agree to use or not agree to the use of the Medicare days. The consent also did not specify what the treatment was that required the patient to be monitored by video camera.

During an interview on 5/23/13 at 2:15 P.M., the patient said that s/he was not aware that she/he was being videotaped and did want the camera turned off, especially while she/he was doing personal care.

See A 143.



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3. For Patient #28, the medical record review indicated that Patient #28 had not signed the Notice of Provider Privacy. On 5/22/13 at 3:00 P.M., during an interview, Patient #28 said s/he knew nothing about video or pictures being taken of him/her while a patient at the Hospital.

4. During an interview on 5/23/13 at 2:00 P.M. with Patient #4, admitted on 5/14/13 for metabolic encephalopathy, Patient #4 said he/she thought the video camera in his/her room was a water sprinkler for the fire alarm system. Patient #4 said his/her son told him/her that it was a video camera.

Review of the Conditions of Admission and Notice of Provider Privacy Practices Form indicated Patient #4 was not given the opportunity to refuse to be monitored by video camera.

5. During an interview on 5/22/13 at 9:30 A.M. with Patient #5, admitted on 4/18/13 for an infected left abdominal pseudo-cyst, Patient #5 said that she/he was not told by hospital staff the video camera was videotaping activities in her/his room.

Review of the Conditions of Admission and Notice of Provider Privacy Practices Form indicated that despite Patient #5's signature on the Form, Patient #5 was not given the opportunity to refuse to be monitored by video camera..

Based on observation, record review and interview, the Radius Specialty Care Hospital failed to provide personal privacy for six sampled patients (#4, #5, #14, #22, #28 and #29) in a total sample of 30. Findings include:

1. For four of four patients (#4, #5, #28 and #29) on the M4 unit, located at the Radius Specialty Hospital at Boston, used video cameras 24 hours a day to watch patient activity without full consent or clinical need.

Observation on 5/20/13, during the orientation tour, indicated that all the rooms on the M4 unit had video cameras in them that were monitored at a central panel at the nursing desk. The central panel was visible to anyone walking behind the front desk such as other providers, housekeepers, consultants, therapists or pharmacy personnel.

During an interview on 5/23/13 at 9:00 A.M., with Registered Nurse (RN) #8 said the video cameras were used to ensure safety on high risk fall patients and all patients were told on admission about their use. RN #8 said they did not do any specific assessment for the use of the video cameras, staff just told patients about them during the patient's admission orientation.

During an interview on 5/23/13 at 10:00 A.M., the Vice President of Clinical Services said the Hospital does not have a policy or procedure for the use of the video cameras on M4.

a.. For Patient #29, admitted in the past week, record review indicated the patient was assessed as a 3 for fall risk. A score of 5 or above is high risk. The patient was assessed as alert and oriented to person, place and time. The patient was admitted with metastatic cancer and needed pain management.

Review of the consent indicated the patient was not given the opportunity to refuse to be videotaped.

During an interview on 5/23/13 at 2:15 P.M., the patient said no one told her/him about being videotaped all the time and the patient said s/he did not want the videotape on, especially when bathing and dressing.

b. During an interview on 5/23/13 at 2:00 P.M. with Patient #4, admitted on 5/14/13 for metabolic encephalopathy, Patient #4 said he/she thought the video camera in his/her room was a water sprinkler for the fire alarm system. Patient #4 said his/her son told him/her that it was a video camera.

Review of the Conditions of Admission and Notice of Provider Privacy Practices Form indicated Patient #4 was not given the opportunity to refuse to be monitored by video camera.

c. During an interview on 5/22/13 at 9:30 A.M. with Patient #5, admitted on 4/18/13 for an infected left abdominal pseudo-cyst, Patient #5 said that she/he was not told by hospital staff the video camera was videotaping activities in her/his room.

Review of the Conditions of Admission and Notice of Provider Privacy Practices Form indicated that despite Patient #5's signature on the Form, Patient #5 was not given the opportunity to refuse to be monitored by video camera.

d. For Patient #28, the medical record review indicated that Patient #28 had not signed the Notice of Provider Privacy. On 5/22/13 at 3:00 P.M., during an interview, Patient #28 said s/he was unaware s/he was being videotaped.



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2. For Patient #22, observations at the Radius Specialty Hospital Satellite located at Quincy Medical Center, on 5/21/13 at approximately 12:30 P.M., indicated that while performing a dressing change for the patient, the RN failed to provide privacy for the patient by not closing the door of the patient's room. The dressing change involved a two-step procedure; changing both a thigh and abdominal dressing. The patient's abdomen and right thigh were exposed throughout dressing change procedure.

The patient's room was situated in a busy area of the unit where housekeeping and other staff (e.g. nurses, nursing technicians, respiratory therapists) had opportunity to view the patient's room.



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3. For Patient #14, observation on the K5 Unit, located in the Radius Specialty Hospital at Boston, on 5/21/13 at 9:30 A.M., indicated hand written signage posted at the head of Patient #14's bed. One sign was addressed to staff, stating that the "patient bites." This was private patient information which should be in the patient care plan not displayed for public information.

Based on observations, record review and staff interviews, the Raduis Specialty Hospital at Boston failed to document that the less restrictive interventions were tried and found to be ineffective to protect the patient, a staff member or others from harm for 2 of 5 (#6 and #9) restrained patients out of a total sample of 30 patients.

Findings include:

1. Facility Restraint Management Policy indicated the following:

Restraints are to be used on a progressive short-term basis only, utilizing the least restrictive type of restraint possible....

All orders for restraint must include: .... Less restrictive alternatives attempted/considered.

A review of the pre-printed format for the physician's order sheet for non-behavioral restraints included 2 check off boxes that indicated "Reality Orientation" and "Diversionary Activities." These were the only 2 interventions that could be checked off on the restraint order sheet. The restraint order sheet did not include a place to document individualized approaches attempted prior to the use of restraints.

2. For Patient #9, the facility failed to document that a Posey Vest was the least restrictive intervention.

Patient #9 was cognitively impaired with a diagnosis of behavioral dyscontrol and Alzheimer's disease.

Review of the medical record on 5/20/13 indicated that on 4/12/13, the physician ordered a Posey Vest restraint, on the day of the patient's admission The physician's order sheet included 2 check off boxes that indicated "Reality Orientation" and "Diversionary Activities" had been attempted prior to the use of restraints. Both had been checked. The restraint was ordered for 24 hours a day indicating the patient was restrained day and night.

A review of the nurse's admission note for 4/12/13, indicated that the resident had a history of being physically abusive, combative, impulsive, anxious, restless and paranoid. The note said the resident ambulated with steady gait and needed 1 staff assist. The note indicated, Posey vest applied for poor safety awareness.

The nurse's notes did not contain an assessment of the restraint that included individualized interventions that had been attempted prior to the use of the posey vest.

During interview on 5/22 at 2:00 P.M. Nursing Supervisor #1 said that the nurse's note on 4/12/13 did not indicate that the patient was exhibiting difficult behaviors at the time the restraint was applied. The Supervisor stated that the nursing note did not adequately document that least restrictive interventions were tried prior to the use of the Posey vest.

It was facility policy for the physician to include on the restraint order sheet whether Reality Orientation and Diversionary Activities had been tried for every patient placed in restraint. Otherwise it was up to the nurse to document that least restrictive interventions were tried prior to the use of restraints.

3. For Patient #6, the facility failed to document that an Easy Release Belt (EZRB) was the least restrictive intervention.

Patient #6 was cognitively impaired with a diagnosis of dementia with behavioral disturbance.

During tour of the facility on 5/20/13 at 10:30 A.M., the patient was observed wearing an EZRB. The patient was unable to release the belt on command.

Review of the medical record on 5/22/13 indicated that on 5/15/13, the physician ordered an EZRB. The physician's order sheet included 2 check off boxes that indicated "Reality Orientation" and "Diversionary Activities" had been attempted prior to the use of restraints. Both had been checked. The restraint was ordered for 24 hours a day indicating the patient was restrained day and night. The restraint order sheet did not include the patient's response to the least restrictive device tried and for how long they were tried.

A review of the nurse's notes for 5/15/13, indicated that the resident was screaming on and off and was difficult to redirect. The note said that the resident was compliant with taking medications and cooperative with care. The note then said that the resident was in an EZRB.

The medical record did not contain an assessment of the restraint that included individualized interventions that had been attempted prior to the use of restraints.

On 5/22/13 at 11:30 A.M., the patient was observed wearing an EZRB. The patient was unable to release the belt on command. (The medical record revealed that the Posey Vest was reduced to the EZRB on 5/1/13. The physician's order for the restraint on 5/1/13 indicated the patient was restrained in the belt 24 hours a day.)

During interview on 5/22/13, at 2:00 P.M., the Nursing Supervisor #1 stated that it was facility policy for the physician to include on the restraint order sheet whether Reality Orientation and Diversionary Activities had been tried. Otherwise it was up to the nurse to document that least restrictive interventions were tried prior to the use of restraints.

Based on observation, record review and staff interview, the Radius Specialty Hospital at Boston failed to update the plan of care following the implementation of restraint for 1 patient (#6) in a sample of 5 restrained patients, in a total sample of 30 patients.

Patient #6 was cognitively impaired with a diagnosis of dementia with behavioral disturbance.

During tour of the facility on 5/20/13 at 10:30 A.M., the patient was observed wearing an Easy Release Belt (EZRB.) The patient was unable to release the belt on command.

Review of the medical record on 5/22/13, indicated that on 5/15/13, the physician ordered an EZRB.

A review of the patient's care plan dated 5/21/13, did not include the restraint usage.

During interview on 5/22/13, at 2:00 P.M., the Nursing Supervisor #1 stated that it was facility policy for the patient's care plan to be updated following the implementation of a restraint.

Based on record review and staff interview, the Radius Specialty Hospital at Boston failed to obtain a physician's order for a physical hold (restraint) for 1 patient (#7) in a sample of 5 restrained patients, in a total sample of 30 patients.

Findings include:

Patient #7 was cognitively impaired with diagnoses of dementia with behavioral disturbance, anxiety and major depression.

A review of the medical record indicated that on 5/9/13, an incident occurred where the patient was attempting to release restraints of another patient and pushing the other patient's wheelchair. When staff attempted to separate the patients, Patient #7 became aggressive and combative with staff: punching, kicking and spitting. Staff were unable to de-escalate Patient #7 and a "code safe" was called. Nursing notes indicated the patient was physically restrained by staff holding the patient down and an intramuscular (IM) antipsychotic was administered.

During interview on 5/23/13 at 3:00 P.M., Nursing Supervisor #1 stated that a "code safe" was an alert that was put on the loud speaker and a large group of staff usually came to the unit to try and manage the patient. She said that a physical hold was usually part of a "code safe" but that it was not facility policy to obtain a physician's order for the physical hold. The Nursing Supervisor indicated that hosptial policy would be updated to include a physician's order for a physical hold.

Based on record review and staff interview, the Radius Specialty Hospital of Boston failed to have each patient seen by a physician or licensed independent practitioner within one hour of a restraint being utilized for the management of violent or self destructive behavior, for one patient (#7) in a sample of 5 restrained patients, in a total sample of 30 patients.

Findings include:

Patient #7 was cognitively impaired with diagnoses of dementia with behavioral disturbance, anxiety and major depression.

Review of medical record indicated that the resident received a chemical restraint (medication used to control behavior) of Zyprexa (antipsychotic) 2.5 milligram (mg.) on 5/11/13, for agitation and 5/15/13, for extreme agitation.

On 5/11/13, the nurse on duty obtained a telephone order for the chemical restraint at 8:15 P.M. The physician did not sign the telephone order until 7:00 A.M. on 5/12/13.

On 5/15/13, the nurse on duty obtained a telephone order for the chemical restraint at 7:40 P.M. The physician did not sign the telephone order until 6:30 A.M., on 5/16/13.

During interview on 5/23/13 at 11:30 A.M., Nursing Supervisor #1 stated that the patient should have been seen by a physician within one hour of initiating the chemical restraint .

Hospital policy for behavioral restraints indicated:

"The MD/LIP is notified immediately after the restraint is applied and must conduct an in-person evaluation within 1 hour, and sign the restraint order, even if the restraint has been discontinued in the interim period."

Based on record review and staff interview, the Radius Specialty Hospital of Boston failed to have each patient receive an evaluation by a physician or licensed independent practioner following the use of restraint for management of violent or self destructive behavior, for one patient (#7), in a sample of 5 restrained patients, in a total sample of 30 patients. Findings include:

Patient #7 was cognitively impaired with diagnoses of dementia with behavioral disturbance, anxiety and major depression.

Review of medical record indicated that the resident received a chemical restraint of Zyprexa (antipsychotic) 2.5 milligram (mg.) on 5/11/13, for agitation and 5/15/13, for extreme agitation.

There were no notes for either incident, by a physician or a licensed independent practitioner that evaluated the patient's immediate situation, the patient's reaction to the intervention, the patient's medical and behavioral condition and the need to continue or terminate the restraint.

During interview on 5/23/13 at 11:30 A.M., Nursing Supervisor #1 stated that the patient should have an evaluative note documented by a physician for each incident.

Hospital policy for behavioral restraints indicated:

"The MD/LIP is notified immediately after the restraint is applied and must conduct an in-person evaluation within 1 hour, and sign the restraint order, even if the restraint has been discontinued in the interim period."

Based on review of the Hospital's Patient Care Assessment Quality Improvement (PCA/QI) data and minutes of meetings from 12/2012 to 5/2013, staff interview, the Hospital failed to:
1. Integrate contracted services into the hospital-wide PCA/QI;
2. Ensure that the Governing Body (GB) specified the frequency and detail of data collection.
Findings include:

1. On 5/22/13, review of the Hospital's PCA/QI data and minutes of meetings from 12/2012 to 5/2013, indicated they lacked any information that Contracted Services submitted data to the hospital's PCA/QI Organization.

During interview on 5/23/13 at 10:00 A.M., the Regional Director of Performance Improvement, Patient Safety and Regulatory Compliance said that the Hospital did not conduct QAPI for the contracted services of: Organ Procurement Services; Infectious Waste Removal; Intravenous (IV) Therapy Services; Food and Dietary services (at both the Hospital and the Hospital Satellite); and b). Biomedical Engineering; Environmental and Maintenance Service; Radiology; Blood Product Usage; Information Technology; and Emergency Response Services at the Hospital Satellite..

2. Review of the Hospital's PCA/QI Plan on 5/22/13, indicated that use of blood and blood components and restraint use were quality indicators to be monitored on an ongoing basis. Review of the PCA/QI minutes indicated the minutes lacked documentation of ongoing monitoring of these indicators. Additionally, review of the PCA/QI Committee's reporting schedule also lacked documentation that these two indicators were scheduled to be reviewed.

Review of the PCA/QI Plan indicated it also lacked evidence that the GB specified the frequency and detail of data collection.

Based on review of Patient Care Assessment Quality Improvement (PCA/QI) data and minutes of meetings, Pharmacy and Therapeutics Committee minutes, and Medication Safety Meeting minutes, and interview, the Hospital failed to take actions aimed at performance improvement, measure its success, and track performance to ensure that improvements were sustained over time. Findings include:

1. Review of PCA/QI data and minutes on 5/22/13, indicated that the Hospital failed to conduct any quality assessment performance improvement (QAPI) for the following contracted services:
a). At both the Radius Specialty Hospital at Boston and the Radius Specialty Hospital Satellite located at Qunicy Medical Center (QMC)t: Organ Procurement; Infectious Waste Removal; Intravenous (IV) Therapy Services; Food and Dietary Services; and
b). Biomedical Engineering; Environmental and Maintenance Service; Blood Product Usage; Information Technology; and Emergency Response Services at the Hospital Satellite.

2. During interview on 5/23/13 at 10:00 A.M., the Regional Director of Performance Improvement, Patient Safety and Regulatory Compliance said that the Hospital did not conduct any QAPI on the above contracted services.

3. On 5/22/13, review of Pharmacy and Therapeutics Committee minutes from 8/2012 to 3/2013 and Medication Safety Meeting minutes from 7/2012 to 3/2013, the Hospital's Patient Care Assessment/Quality Improvement (PCA/QI) data and minutes of meetings from 12/2012 to 5/2013, indicated that although the Hospital took actions aimed at performance improvements for Pharmacy Services, the Hospital did not measure its success, and track performance improvement to ensure that improvements were sustained over time. For example:

a). On 5/22/13, review of Medication Safety Meeting quarterly minutes indicated that for each quarter the data showed that most of the errors were conducted by Medicine, Respiratory Therapy, and the Pharmacy.

b). For 7/2012 to 9/2012: Pharmacy had 23 of 32 errors and Medicine had 17 of 32 errors.
For 10/2012 to 12/2012: Pharmacy had 18 of 36 errors and Medicine had 15 of 36 errors.
For 1/2013 to 3/2013: Pharmacy had 22 of 53 errors, Respiratory had 12 of 53 errors, and Medicine had 27 of 53 errors.

c). Each quarter (10/2012 to 12/2012, 1/2013 to 3/2013) the plan read the same:
"i). Continue to monitor;
ii). Continue monthly review at Medication Safety Meetings;
iii). Education effort is necessary to encourage reporting of medication errors; and
iv). Education effort is needed to encourage staff to self report and other disciplines to report."

The quarter from 7/2012 to 9/2012 read similar: "Continue to monitor, continue review of potential medication errors at morning meeting, continue review of monthly medication error review for both Boston and Quincy at Medication Safety committee meeting, and continue use of posters to convey message of preventing medication errors on the nursing units."

d). The Pharmacy and Therapeutic Committee 'minutes' were only an 'agenda.' For example:
i). Minutes (agenda) for 11/12/12 read, "New Business; 1. Methadone use/Suboxone use; 2. Darbopoetin dosing protocol; 3. Adverse drug reaction Vancomycin or Furosemide; 4. Other Business; 5. Adjourn."

ii). Minutes (agenda) for 1/15/13 read, "New Business; 1. Medication reconciliation policy; 2. Therapeutic substitution-statins; 3.Aminoglycoside extended dosing protocol; 4.Pharmacy interventions 10/2012 to 12/2012; 5.Other business- FDA Ambien new dosing recommendations, Code Cart Additions. "

4. None of the Pharmacy and Therapeutics Committee minutes or Medication Safety Meeting minutes contained changes that would lead to improvement, measurable indicators to measure success, and tracking of performance to ensure that improvements were sustained.

Based on review of the Radius Specialty Hospital's Patient Care Assessment/Quality Improvement (PCA/QI) data and minutes of meetings from 12/2012 to 5/2013, the Hospital failed to: document what quality improvement projects were being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects. Findings include:

1. On 5/22/13, review of a listing of contracted services and contractual agreements, indicated the following services were provided under contract: Organ Procurement Services; Infectious Waste Removal; Intravenous (IV) Therapy Services; Radiology; Food and Dietary Services at both the Radius Specialty Hospital and the Radius Specialty Hospital Satellite located at Quincy Medical Center (QMC), and Biomedical Engineering; Environmental and Maintenance Service; blood product usage; Information Technology; and Emergency Response Services at the Hospital Satellite.

2. Review of PCA/QI data and minutes on 5/22/13, indicated the following: a). the minutes lacked documentation of the quality improvement that the above services conducted; b). the minutes lacked documentation of the reasons the projects were conducted; and the minutes lacked documentation of measurable progress achieved by the above services. The Hospital did not included these contracted services in the Hospital's PCA/QI.

During interview on 5/23/13 at 10:00 A.M. the Regional Director of Performance Improvement, Patient Safety and Regulatory Compliance said that the Hospital did not conduct QAPI for the above contracted services.

Based on review of the Hospital's Patient Care Assessment Quality Improvement (PCA/QI) data and minutes of meetings from 12/2012 to 5/2013, the Hospital's PCA/QI plan, and interviews, the Governing Body (GB) failed to ensure that the PCA/QI program reflected the complexity of the Hospital's organization and services and involved all hospital departments and services, including those services furnished under contract or arrangement. Findings include:

1. On 5/22/13, review of a listing of contracted services and contractual agreements, indicated the following services were provided under contract: Organ Procurement Services Infectious Waste Removal; Intravenous (IV) Therapy Services; Radiology; Food and Dietary Services at both the Radius Specialty Hospital and the Radius Specialty Hospital Satellite located at Quincy Medical Center (QMC) and Biomedical Engineering; Environmental and Maintenance Service; blood product usage; Information Technology; and Emergency Response Services at the the Radius Specialty Hospital Satellite.

2. Review of PCA/QI data and minutes, and the PCA/QI Plan on 5/22/13, indicated that the above contracted services were not included in the Hospital's PCA/QI plan nor did these services participate in the Hospital's PCA/QI.

3. During interview on 5/23/13 at 10:00 A.M. the Regional Director of Performance Improvement, Patient Safety and Regulatory Compliance said that the Hospital did not conduct QAPI for the above contracted services.

4. Review of the PCA/QI Plan on 5/22/13, indicated that use of blood and blood products and restraint use were identified as two of the Hospital's quality indicators. Review of the Hospital's PCA/QI data and minutes indicated that the minutes lacked documentation of data review and ongoing monitoring of these indicators. There was no reference to these indicators in the PCA/QI minutes.

Based on review of a listing of Radius Specialty Hospital physicians, physicians credentialed at the Hospital, review of credential files, and interviews, the Hospital failed to assure that all physicians who provided care to Hospital patients were recommended by the medical staff to the Governing Body (GB) for medical staff membership. Findings include:

1. On 5/20/13 the Nurse Manager (NM) of the Radius Specialty Hospital Satellite located at Quincy Medical Center (QMC) provided the Surveyor with an on-call schedule of Quincy Medical Center (QMC) physicians. At approximately 12:00 P.M. on 5/20/13, the NM said that the physicians on the schedule covered the Hospital Satellite for emergencies and other patient care needs.

2. On 5/22/13, the Surveyor selected four QMC physicians' credential files from the list. Review of the credential files on 5/23/13, indicated that two (#4 and #7) of the four QMC physicians had not been were not credentialed by the Radius Specialty Hospital medical staff.

3. During interview on 5/23/13 at approximately 11:00 A.M., the Chief medical Officer (CMO) said Physician #4 was asked to apply to the Radius Specialty Hospital medical staff but declined and Physician #7 was not credentialed by the Radius Specialty Hospital and did not cover emergencies at the Hospital Satellite. The CMO said that only QMC physicians scheduled on-call from 7:00 P.M. to 7:00 A.M., weekends and holidays, were credentialed at the Radius Speciality Hospital.

4. During interview with the QMC Chief Nursing Officer (CNO), subsequent to survey on 5/28/13 at 10:00 A.M., the CNO said that the physicians listed on the QMC call schedule were the physicians who would respond to medical emergencies on the Radius Specialty Hospital Satellite at QMC. The CNO said that the physicians would respond anytime of day that a code was called.

Based on observation, record review and interview, the Radius Specialty Hospital at Boston failed to administer medications to two patients (#1 and #11), in accordance with physician orders and/or in accordance with approved medical staff policies and procedures. Findings include:

1. Review of the Radius Specialty Hospital at Boston medication administration policy on 5/22/13, read, "Medications must be given within 60 minutes before or after the scheduled administration time."

2. For Patient #1, staff failed to administer Aranesp (stimulates red blood cell development) 40 micrograms (mcg) subcutaneously (sc) every Tuesday, as ordered by the physician, on 4/30/13.

Patient #1 had end stage renal disease (ESRD) with anemia and was on hemodialysis. Record review indicated the patient's hemoglobin was low at 9.5 on 5/7/13 (for ESRD patients goal is 11-12)

Review of the physician orders, dated 4/30/13, indicated the physician discontinued the previous order for Aranesp 25 mcg sc and ordered the patient to receive Aranesp 40 mcg sc every Tuesday.

Review of the medication administration record (MAR) indicated the patient received Aranesp 25 mcg sc on May 7th and May 14, 2013. Review of the MAR indicated the order had not been changed from 25 mcg to 40 mcg of Aranesp.

During an interview on 5/20/13, at approximately 2:30 P.M., the unit charge nurse, R.N. #11 said the error occurred due to a transcription omission and would be corrected.



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3. For Patient #11, observations on 5/20/13, at approximately 11:00 A.M. at Radius Specialty Hospital Satellite at Quincy Medical Center (QMC), indicated that the patient had completed a hemodialysis treatment. During the observation, RN #6 said that the patient was dialyzed three times a week, on Mondays, Wednesdays, and Fridays.

Medical record review on 5/20/13, indicated that three medications were not documented as being administered to the patient. The medications were as follows:

Colace (stool softener) 100 milligrams (mg) PO (by mouth ) BID (twice a day);
Nephrovite (a vitamin) one tablet daily;
Effexor (anti-depressant) 37.5 mg PO daily.

During interview at 1:45 P.M. on 5/21/13, RN #6 said that facility policy identified daily as 10:00 A.M. and BID as 10:00 A.M. and 10:00 P.M. The RN also said that the patient had a physician's order to hold administering the above medications on dialysis days, until the completion of the dialysis treatment.

Review of physician's orders from the date of the patient's admission (5/14/13) through 5/20/13, indicated that there was no order to hold any of the patient's medications on dialysis days.

Review of the patient's medication administration record (MAR) on 5/21/13, indicated that the medications were administered on 5/20/13 as follows: Colace was administered at 12:53 P.M, approximately three hours late; Nephrovite was administered at 12:53 P.M., approximately three hours late; and Effexor was administered at 12:00 P.M., two hours late.

Hospital staff failed to adhere to the Radius Specialty Hospital's policy for medication administration.

Based on medical record review and staff interview, the Radius Specialty Hospital failed to ensure that medical records were accurately written for 2 (#20 and #24) of 30 sampled patients. Findings include:

1. During interview on 5/21/13 at 10:20 A.M. at Radius Specialty Hospital Satellite located at Quincy Medical Center , Registered Nurse (RN) #16 said that when an error is made in a medical record entry, one line is drawn through the incorrect entry, the word error written, and the writers name documented.

During an interview, subsequent to survey on 6/3/13, at 11:00 A.M., the Vice President of Clinical Services (VPCS) said the same as RN #16, regarding medical record entry errors.

2. For Patient #20, medical record review on 5/21/13 at the Radius Specialty Hospital Satellite at QMC, indicated that the record had multiple entries with items crossed out with multiple lines. Some entries had so many lines crossing them out, that they were almost illegible. The entries were as follows:

a). A physician's order dated 5/11/13 at 10:05 A.M. read: "D/C Met." This entry had approximately five crossout lines over the letters D/C and three cross out lines over the word Met. The entry had more than one line crossed through it, the word error was not written, nor did it include the name of the person writing the entry.

b). A physician's order, dated 5/3/13 at 4:15 P.M, had two entries crossed out. The first read: "Tylenol (for pain) 650 mg (milligrams) PO (by mouth), TID (three times a day)." This entry had four cross out lines through it. The second crossed out entry read: " Tylenol". This entry had three cross out lines over the word Tylenol. The entry had more than one line crossed through it, the word error was not written, nor did it include the name of the person writing the entry, as required by facility policy.

c). A physician's order,dated 5/3/13 at 4:16 P.M., had multiple entries crossed out. The first error was under Diagnosis. The physician had entered the word "fall." This was crossed out approximately six times. Under Allergies, the entry read: "Right humeral Fx (fracture), pain, HTN (hypertension), CAD (coronary heart disease)." This entry had approximately 12 total crossouts.

The above entries had more than one line crossed through them, the word error was not written, nor did it include the name of the person writing the entry, as required by facility policy.

3. For Patient #24, review of a blood bank form, on 5/21/13 at Radius Specialty Hospital Satellite at QMC, indicated that the pre-transfusion time/start time had been documented 1510 (3:10 P.M.). This entry was crossed out and the time 1520 (3:20 P.M.) written in. The word error was not written above the cross-out, nor was the name of the person crossing out the entry documented, as required.

RNs (#8 and #17), who performed the blood transfusion, failed to adhere to hospital policy for correcting incorrect medical entry errors.

Based on record review and staff interview, the Radius Specialty Hospital failed to have all orders dated, timed and authenticated by the ordering practitioner promptly, for 3 patients (#8, #11 and #30) in a total sample of 30 patients. Findings include:

1. For Patient #8, at the Radius Specialty Hospital at Boston, medical record review indicated the patient was cognitively impaired with diagnosis of dementia with paranoid type psychosis.

A review of the medical record on 5/21/13, indicated the physician ordered a restraint on 5/9/13 and 5/10/13. Documentation indicated that neither order was timed, as required.


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2. For Patient #30, at the Radius Specialty Hospital Satellite located at Quincy Medical Center (QMC), medical record review on 5/21/13, indicated that Physician #12 gave the following telephone order on 4/5/13 at 11:06 P.M to Registered Nurse (RN) #10: "D/C (discontinue) peripherally inserted central catheter (PICC) line placement and chest X-ray, instead have Intravenous (IV) Solutions (the contracted IV company) nurse insert two peripheral IVs."

As of 5/21/13, the order was still not signed by Physician #12, over 45 days since the order was given. Additionally, RN #6 said that Physician #12 was in the Quincy Medical Center at the time the telephone order was given.

3. For Patient #11, at the Radius Specialty Hospital Satellite at QMC, medical record review on 5/20/13, indicated that the Patient's Nephrologist dictated hemodialysis telephone orders to RN #11 on 5/15/13 at 7:45 A.M. The Nephrologist signed the telephone orders but failed to date and time the orders, although required.

Based on observation, record review and interview, the Radius Specialty Hospital failed to meet the Condition of Participation (CoP) to have an organized pharmaceutical service, directed by a registered pharmacist at the Radius Specialty Hospital Satellite located at Quincy Medical Center (QMC) and failed to implement policies and procedures, developed by the Hospital's medical staff, for minimizing drug errors and managing the pharmacy service. Findings include:

1. Review of the contract titled "Facility and Ancillary Services Agreement" indicated the Radius Specialty Hospital contracted for provision of pharmacy services from the Quincy Medical Center (QMC) for the the Radius Specialty Hospital Satellite located at Quincy Medical Center.

The Pharmacy staff serving the Radius Specialty Hospital Satellite at QMC were contracted through the Quincy Medical Center. Although the Radius Specialty Hospital had a full service Pharmacy, the Hospital failed to provide pharmacy services at the Radius Specialty Hospital Satellite.

See A491, A493

2. The Radius Specialty Hospital Pharmacy failed to participate in decisions about emergency medication kits in the emergency code cart, located on the Radius Specialty Hospital Satellite at QMC, that was provided by the QMC.

See A500

3. The Radius Specialty Hospital failed to have their policies and procedures, developed by the Radius Specialty Hospital's medical staff, for minimizing drug errors and managing the pharmacy service, implemented for the Radius Specialty Hospital Satellite at QMC patients.

Review of the pharmacy polices and procedures at the Radius Specialty Hospital Satellite at QMC indicated they were the polices and procedures of the Quincy Medical Center and not polices and procedures of Radius Specialty Hospital. In addition, the Radius Specialty Hospital Satellite at QMC used the Quincy Medical Center's formulary, not Radius Specialty Hospital pharmacy's formulary.

See A500

4. The Radius Specialty Hospital at Boston failed to provide one patient (#3), with access to antibiotics needed to treat a blood infection for 15 hours, by failing to follow the Radius Specialty Hospital's Medication Access policy.

See A506.

Based on observation, record review and interview, the Radius Specialty Hospital pharmacy failed to procure, distribute and control all medication products (including medication-related devices) for inpatient use at the Radius Specialty Hospital Satellite located at Quincy Medical Center (QMC), as required.
Findings include:

Review of the contract titled "Facility and Ancillary Services Agreement" indicated Radius Specialty Hospital contracted for provision of pharmacy services from the Quincy Medical Center for the Radius Specialty Hospital Satellite at QMC, even though the Radius Specialty Hospital at Boston had a full Pharmacy Service.

Observation and interview on 5/21/13 at approximately 1:00 P.M., indicated that pharmacy services for the Radius Specialty Hospital Satellite at QMC were provided under the direction of the Quincy Medical Center's Director of Pharmacy and from Quincy Medical Center pharmacy personnel.

The medications for the Radius Specialty Hospital Satellite at QMC were supplied by the Quincy Medical Center and were not supplied by Radius Specialty Hospital pharmacy staff, although Radius Specialty Hospital at Boston had a pharmacy and pharmacy staff.

Observation on 5/21/13 at approximately 1:00 P.M., indicated that pharmacy services, including the storage of drugs and biologicals used for the Radius Specialty Hospital Satellite at QMC, were stored in the same area as the drugs and biologicals that were provided for the Quincy Medical Center.

During an interview on 5/21/13 at approximately 2:00 P.M., the Director of Pharmacy from the Quincy Medical Center said a single supply of drugs and biologicals was used for both the Quincy Medical Center and the Radius Specialty Hospital Satellite at QMC.

Based on record review and interview, the Radius Specialty Hospital failed to provide Pharmacy services through its own Pharmacy and staff at the the Radius Specialty Hospital Satellite located at Quincy Medical Center (QMC). Findings include:

The the Radius Specialty Hospital at Boston had its own fully functioning pharmacy.

Review of the "Facility and Ancillary Services Agreement" indicated that all the pharmacy services, including all personnel, were provided, by contract, by the Quincy Medical Center, for the Radius Specialty Hospital Satellite at QMC.

Observation and interview on 5/21/13 at approximately 1:00 P.M., indicated that pharmacy services for the Radius Specialty Hospital Satellite at QMC were provided under the direction and supervision of the Quincy Medical Center's Director of Pharmacy. The pharmacy was staffed by Quincy Medical Center pharmacy personnel. Quincy Medical Center pharmacy personnel were observed to enter the Radius Specialty Hospital Satellite at QMC patients' physician medication orders into the Quincy Medical Center's Meditech pharmacy module and electronically checked for dosage, interactions and therapeutic duplications.

During an interview on 5/21/13 at approximately 1:00 P.M., the Quincy Medical Center's Director of Pharmacy said s/he or his/her designee participated in the Radius Specialty Hospital Satellite at Quincy's biweekly multidisciplinary patient care rounds and sent a monthly report of adverse drug reactions and medication errors to the Radius Specialty Hospital's Director of Pharmacy.

Based on record review and interview, the Radius Specialty Hospital at Boston's Pharmacy failed to participate in decisions about emergency medication kits in the emergency code cart located at the Radius Specialty Hospital Satellite located at Quincy Medical Center (QMC) that was provided by the Quincy Medical Center's pharmacy. Findings include:

1. Review of the contract titled "Facility and Ancillary Services Agreement" between the Radius Specialty Hospital Satellite at QMC and the Quincy Medical Center (QMC) indicated "the QMC shall make available a fully stocked Emergency Cart (the Code Cart) which shall be located on the LTCH (Long Term Acute Care Hospital) unit for use in responding to LTCH patient code situations. The QMC shall stock and restock the Code Cart in accordance with the QMC polices and procedures regarding the maintenance and stocking of Code Carts."

2. During an interview on 5/23/13 at approximately 10:00 A.M., the Chief Executive Officer (CEO) said the Radius Specialty Hospital did not have any input into the contents of the code cart as it belonged to the QMC and was provided to the Radius Specialty Hospital Satellite at QMC under agreement.

The Hospital pharmacy should participate in hospital decisions about emergency medication kits. The supply and provision of emergency medications stored in the kits must be consistent with standards of practice and should be appropriate for the Hospital's patient demographics.

3. Review of the pharmacy policies and procedures at the Radius Specialty Hospital Satellite at QMC indicated they were the policies and procedures of the QMC and not policies and procedures of the Radius Specialty Hospital. In addition, the Radius Specialty Hospital Satellite at QMC used the QMC's formulary, not the Radius Specialty Hospital pharmacy's formulary.

4. During an interview on 5/21/13 at approximately 2:00 P.M, the Nurse Manager of the Radius Specialty Hospital Satellite at QMC said therapeutic substitutions for drugs not on the QMC's formulary were individually approved by the prescriber and subsequently dispensed to the Radius Specialty Hospital Satellite at QMC patients.

5. Interview on the K5 Unit, at the Radius Specialty Hospital at Boston, on 5/22/13 at approximately 10:00 A.M., with both RN#1 and RN#3, indicated that eye medications for patients on precautions are brought into the patient rooms and left in the bedside table.

According to interviews with the the Education Coordinator and the Chief of Pharmacy Services on 5/22/13 at approximately 2:00 P.M., no medications are to be left at the patients' bedside without a specific physician order to do so. The Chief of Pharmacy said that this is a patient safety and drug storage issue covered by hospital policy and procedures.

Based on record review and interview, the Radius Specialty Hospital at Boston failed to provide one patient (#3), with access to antibiotics needed to treat a blood infection for 15 hours, by failing to follow the Radius Specialty Hospital's Medication Access policy. Findings include:

1. Patient #3 was admitted to the the Radius Specialty Hospital at Boston on 5/12/13 at 5:00 P.M. with a diagnosis of bacterial endocarditis, congestive heart failure, acute kidney injury, depression, hypertension and Hepatitis C. The admission orders included an order for Nafcillin 2 grams (gms) every four hours, intravenously (IV). The first dose was provided from the Night Pharmacy Pyxis MedStation (medication dispensing system) at 6:38 P.M. The pharmacy closed at 5:00 P.M.

Further review of the MAR indicated no other doses of Nafcillin were given until 9:00 A.M. on 5/13/13. The patient missed three doses of Nafcillin, due at 9:00 P. M. on 5/12/13, 1:00 A.M. on 5/13/13 and 5:00 A.M. on 5/13/13

Review of the record indicated that nursing staff called the Physician Assistant (PA) on call at 10:00 P.M. on 5/12/13, who ordered the 9:00 P.M. dose of Nafcillin to be held due to Nafcillin not being available. At 1:00 A.M., nursing again called the PA who ordered the patient to receive Ampicillin 2 grams intravenously, one time until Nafcillin was available. The Ampicillin was given at 1:15 A.M.

Per the Radius Specialty Hospital Medication Access Policy, if the medication is not available in the Night Pharmacy or Pyxis MedStation, the Pharmacist on call must be contacted to determine if the medication is available in the Pharmacy. If deemed appropriate to enter the Main Pharmacy (drug cannot be held or substituted for) the Main Pharmacy may be entered.

When the Surveyor inquired why there was a delay in obtaining the Nafcillin for this patient, the pharmacy department provided a report that stated the Registered Nurse (RN) removed the only dose of 2 gm Nafcillin from the Night Pharmacy Pyxis. No one called the on-call Pharmacist to get more Nafcillin, per Radius Specialty Hospital policy. The Hospital Director of Pharmacy was involved in investigating the medication error.

Based on record review and interview, the Hospital failed to conduct Utilization Review (UR) on Medicare eligible patients. Findings include:

During the initial meeting with the facility staff, on 5/20/13 at 9:00, the Chief Operating Officer and the Director of Case Management stated that the hospital had an agreement with a Quality Improvement Organization (QIO) to perform the UR function at the hospital.

A review of the agreement between the QIO and the hospital indicated that the QIO did not perform the UR function for Medicare patients.

The Hospital did have a UR plan that stated the scope of the UR Committee was to review all admissions to the hospital for medical necessity, review all Medicare cases where the mean length of stay (LOS) was exceeded and these cases would also be reviewed for medical necessity. Medicare cases that exceed the Centers for Medicare and Medicaid Services (CMS) threshold for cost outliers would be reviewed for medical necessity and appropriateness of the professional services provided, including drugs and biologicals.

The Plan stated that all admission reviews and extended stay reviews would be reviewed by the UR committee as a whole or a subgroup of the UR committee or a Hospital case manager or other qualified person designated by the UR committee.

During interview on 5/23/13, at 11:00 A.M., the Director of Case Management provided notes from the Length of Stay committee which s/he said performed the same function as a UR Committee. S/he stated that the UR Committee function for reviewing new admissions and length of stay were not reviewed at the UR Committee meetings but that function was delegated to the case managers.

The Length of Stay (LOS) committee notes included the Agenda for the meeting but did not have actual minutes. The Agenda included a Review of Discharges for the following:

Trending Summary
Trending Summary by Unit
Over Length of Stay by Unit.

The Agenda included the Top 10 DRGs (Diagnostic Related Group) and Outside Appointments.

Each quarterly meeting included statistics on Length of Stay Trending Summaries and DRGs. Also included were brief notes on Outside Appointments. There were no minutes from the LOS meetings held during January 2013 and April 2013.

During interview on 5/23/13 at 12:30 P.M., the Chief Operating Officer (CEO), stated that the UR Committee (LOS Committee) did not review patient admissions or length of stay. S/he stated that the patient length of stay reviews were done at the weekly Team Meetings on the different units with the case manager, physician and other disciplines present.

Based on record review and interview, the Hospital failed to ensure the members of the Utilization Review Committee (UR) did not review patients for whom they were professionally involved in the patient's care by participating in the development or execution of that patient's treatment plan. Findings include:

Review of the UR plan indicated that, by design and execution, the Hospital UR committee members were reviewing patients for UR purposes, for whom they had care planning and treatment responsibilities. This created a conflict of interest in decision making about a patients' eligibility for continued stay at the Hospital.

The UR Plan stated that all admission reviews and extended stay reviews would be reviewed by the UR committee as a whole or a subgroup of the UR committee or a Hospital Case Manager or other qualified person designated by the UR committee.

Cases reviewed for medical necessity and use of professional services, drugs and biologicals, are assigned a score according to the following criteria:
a. medical care provided appears appropriate and necessary with no issue
b. medical care unusual but no clear mandate regarding variance
c. medical care overall necessary and appropriate but with minor opportunity for improvement.
d. medical care provided does not meet standards of care for appropriateness and for necessity.

Cases scored C or D were forwarded to the Medical Staff Peer Review Committee or the the Chief Medical Officer for review and if needed, action.

The plan did not define who makes the initial review and assignment of scoring of medical necessity. The plan did not identify who the UR committe was.

The function of the UR committee is to have the physicians on the UR committee evaluate the medical necessity.

During interview on 5/23/13, at 11:00 A.M., the Director of Case Management provided notes from the Length of Stay (LOS) committee which s/he said performed the same function as a UR Committee. S/he stated that the UR Committee function for reviewing new admissions and length of stay were not reviewed at the Committee meetings but that function was delegated to the case managers.

During interview on 5/23/13 at 12:30 P.M., the Chief Operating Officer (COO), stated that the UR Committee (LOS Committee) did not review patient admissions or length of stay. He stated that the patient length of stay reviews were done at the weekly Team Meetings on the different units with the case manager, physician and other disciplines present.

The Hospital did not have a identifiable UR committee.

This also presents a conflict of interest as team meetings cannot be used in place of UR since all members of the team are involved in the patient's treatment and care.

Based on review of the Utilization Review (UR) Committee minutes and staff interview, the hospital failed to have the UR Committee review admissions, durations of stays and professional services furnished including drugs and biologicals.

Finding include:

The UR plan also states all new admissions would be reviewed within 3 business days of admission.

During interview on 5/23/13, at 11:00 A.M., the Director of Case Management provided notes from the Length of Stay (LOS) committee which s/he said performed the same function as a UR Committee. S/he stated that the UR Committee function for reviewing new admissions and length of stay were not reviewed at the Committee meetings but that function was delegated to the case managers.

Case managers are involved in the care and treatment of patients and should not be reviewing cases for UR purposes.

The Length of Stay (LOS) committee notes included the Agenda for the meeting but did not have actual minutes. The Agenda included a Review of Discharges for the following:

Trending Summary
Trending Summary by Unit
Over Length of Stay by Unit.

Each quarterly meeting included statistics on Length of Stay Trending Summaries and DRGs. Also included were brief notes on Outside Appointments. There were no minutes from the LOS meetings held during January 2013 and April 2013.

During interview on 5/23/13 at 12:30 P.M., the Chief Operating Officer stated that the UR Committee (LOS Committee) did not review new patient admissions, required to be done within three business days of admission, or length of stay. He stated that the patient length of stay reviews were done at the weekly Team Meetings on the different units with the case manager, physician and other disciplines present.

The hospital's UR Plan indicated that reviews of admissions and length of stays would be reviewed by:

- the Utilization Review Committee as a whole, or
- a subgroup of the UR Committee, or
- a Case Manager, or other qualified person designated by the UR Committee.

Review by the Case Manager was contraindicated due to the fact that the CM was involved in the care and treatment of the patient.

Although the UR Committee/LOS Committee met quarterly and had appropriate membership, there were no committee minutes and the UR Committee's regulatory function of providing case reviews for extended length of stay patients was not conducted by the UR Committee/LOS Committee.

Based on record review and interview, the Hospital 's Utilization Review (UR) Committee failed to review professional services provided to Medicare patients, to determine medical necessity and to promote the most efficient use of available health facilities and services. Findings include:

The Hospital's UR plan that stated the scope of the defined UR Committee was to review all admissions to the hospital for medical necessity, review all Medicare cases where the mean length of stay (LOS) was exceeded and these cases would also be reviewed for medical necessity. Medicare cases that exceed the Centers for Medicare and Medicaid Services (CMS) threshold for cost outliers would be reviewed for medical necessity and appropriateness of the professional services provided, including drugs and biologicals.

The Plan stated that all admission reviews and extended stay reviews would be reviewed by the UR committee as a whole or a subgroup of the UR committee or a Hospital case manager or other qualified person designated by the UR committee.

Cases reviewed for medical necessity and use of professional services, drugs and biologicals, are assigned a score according to the following criteria:
a. medical care provided appears appropriate and necessary with no issue
b. medical care unusual but no clear mandate regarding variance
c. medical care overall necessary and appropriate but with minor opportunity for improvement.
d. medical care provided does not meet standards of care for appropriateness and for necessity.

Cases scored C or D are forwarded to the medical Staff Peer Review Committee or the Chief Medical Officer for review and if needed, action.

The plan did not define who makes the initial review and assignment of scoring of medical necessity. The Ur committee was not identifiable in the UR plan.

The plan did state that no member of the Committee should review a particular case if he/she has served as attending physician for the patient at any point during the patient's stay.

During interview on 5/23/13 at 12:30 P.M., the Chief Operating Officer, who was the Chairperson of the UR Committee, stated that the UR Committee (LOS Committee) did not review patient admissions or length of stay. He stated that the patient length of stay reviews were done at the Weekly Team Meetings on the different units, with the case manager, physician and other disciplines present. The CEO stated no review of professional services was done by the UR Committee, but a review was done at team meetings.

The team cannot act in lieu of the UR Committee since the team is involved in the care and treatment of the patient.

Based on observation, staff interview, the Hospital failed to consistently maintain the facility or supplies, i.e. Personal Protective Equipment, to acceptable levels of safety and quality.
Findings include:

1. Observations on the K5 Respiratory/Ventilator Unit, on 5/20/13 at 9:10 A.M., at the Radius Specialty Hospital at Boston, indicated evidence of water intrusion on ceiling tiles located in the medication room (1 tile), soiled utility room (2 tiles), janitor closet (2 tiles) and the patient shower room (1 tile).


2. Observation on the K5 Unit on 5/20/13, in patient room 503 and the solarium revealed windows that could be manually opened. The windows in room #503 and the solarium either lacked screens or the screens in these windows were in disrepair with breaks in the screening. According to the CDC "Guidelines for Environmental Infection Control in Health-Care Facilities" 2003, Sealing windows in modern health-care facilities helps to minimize insect intrusion. When windows need to be opened for ventilation, ensuring that screens are in good repair and closing doors to the outside can help with pest control. Insects should be kept out of all areas of the health-care facility, especially ORs and any area where immunosuppressed patients are located.

According to the staff and the Infection Control Preventionist, the windows on the K5 unit were not "usually" opened. However, review of Patient # 16's medical record, a case management note on April 1, 2013 indicated an open window in Patient #16 room. Patient #16 had a tracheostomy tube and was on total ventilator support ( a tube that is surgically implanted in the neck to attach the patient to a breathing machine).

3. Observation, on the K5 Unit on 5/20/13 at 9:10 A.M. indicated a box of cartridges for the point of care machine (I-stat) in the Medication Refrigerator. Medication refrigerators are dedicated to medications only.



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4. The Hospital failed to maintain dietary equipment and supplies to ensure acceptable levels of safety and quality.

At the Radius Specialty Hospital at Boston, a tour of the Main Kitchen and Nourishment Kitchens was conducted with Food Service Director (FSD) #1 on 5/20/13 at approximately 10:15 A.M. with a follow-up visit at 2:20 P.M.

The cook's walk-in refrigerator floor had visible signs of wear and tear with peeling paint previously cited by the City of Boston Inspectional Services on 12/12/12. FSD #1 stated that the Hospital had hired a painter but the painter is doing other things.

The reach-in refrigerator by the tray line used for holding salads and sliced meats had duct tape applied to one corner of the cover. The produce walk-in refrigerator door was not in good repair with insulation visible on the inside of the door by the handle.

The floor drains throughout the kitchen including in the hot food preparation equipment area, by the two preparation sinks, in the dishmachine area and behind the cafeteria serving line were dirty and in need of cleaning. The FSD stated that the drains are cleaned monthly and were last cleaned in April 2013.

The floor tiles by the 3 bay sink were not in good repair with worn/missing grout with moisture accumulating between the tiles. There were also approximately 8 floor tiles missing. The surveyor followed up with a member of the hospital's environment services staff on 5/23/13 who said that no one had been in yet to evaluate the floor tiles.

Throughout the main kitchen, the ceilings were noted to be dirty with grease and grime. The ceiling above the clean end of the dishmachine and above the clean pot/pan storage rack was dusty.

The wall behind the hand wash sink was in poor repair with broken discolored caulking between the sink and the wall.

Throughout the main kitchen, floor edges were not maintained in a clean manner with food and other debris visible. Equipment such as the two can opener blades and the knife rack were observed to be dirty on 5/20/13 in the A.M. tour and also during the follow up visit in the afternoon.

A tour of the nourishment kitchens on 5/20/13 between 11:55 A.M. and 12:25 P.M. indicated the following:
refrigerator gaskets on the M - 5 Unit and the K - 2 Unit were torn and/or cracked. The interior of the microwave ovens on the M - 4 Unit and the M - 5 Unit had worn discolored surfaces. The hand wash sink on the M - 5 Unit had cracked discolored caulking between the sink and the wall.


B. The Radius Specialty Hospital Satellite, located at Quincy Medical Center (QMC), was provided food services under contract by QMC. A tour of the Main Kitchen at QMC was conducted with FSD #2 on 5/22/13 at 9:30 A.M.

Observation of the cook's preparation area indicated there were a number of broken pieces of equipment including three conventional ovens, the tilt skillet and the small grill. FSD #2 stated that staff use the 2 convection ovens, the stacked steamers, the 2 kettles and the large grill to prepare approximately 400 meals per day (including the cafeteria meals).

The base of the steam table was observed to be in poor condition. The lower edge of the unit had a broken surface which prevented adequate cleaning. A hose from the ceiling was observed in close proximity to the steam table. FSD #2 stated that at times a bucket is placed beneath the hose/tubing to collect the water that leaks. A member of the environmental services staff said that the hose is in place due to a roof leak which is in the process of being repaired.

The milk chest lid was in poor condition with a broken inside surface with insulation showing. The 2 door reach-in refrigerator had cracks on the inside of each door. The 2 door reach-in refrigerator in the cold food preparation room was out of service for approximately 3 months. The walk-in refrigerators had dirty fan covers. The basement walk-in freezer had a section of approximately 10 missing floor tiles which prevented adequate cleaning of the freezer floor.

In the pot/pan washing area, the 3rd bay of the 3 bay sink was not in use for approximately one week due to a problem with the drain and grease trap. Staff had to immerse food preparation equipment which could not be placed through the dishmachine, such as the blender, into a large pan or pot with the sanitizing solution. Staff also had to bail water from the other 2 sink bays due to the drain problem.

Ceramic wall tiles in the pot/pan area were not in good repair. A piece of wood was observed in place of the ceramic tile on the lower wall behind the pot/pan rack. Ceiling panels in the dishmachine room were discolored and approximately 4 panels did not appear secure.

In the nourishment kitchen of Radius Specialty Hospital Satellite at QMC, the ice machine was not working. The RN manager stated that the ice machine had been out of service for approximately 2 days. A container of ice sent by the kitchen lacked drainage holes. The ice had partially melted and any remaining ice cubes were floating in water.

Based on observation and staff interview, the Hospital did not ensure proper lighting in food preparation areas.
Findings include:

The Radius Specilaity Hospital Satellite located at Quincy Medical Center (QMC). QMC's kitchen provided food services to the Radius Specialty Hospital Satellite.

A tour of the Main Kitchen at the QMC was conducted with Food Service Director (FSD) #2 on 5/22/13 at 9:30 A.M.

During observation of the cook's preparation area, the surveyor requested that staff turn on the lights in the hood above the stoves and other food preparation equipment to check for proper hot food holding temperatures and preparation techniques.

Food service staff said that the hood lights had not worked for approximately 30 years.

Based on observations, interviews, and review of the Hospital's policies/procedures, and infection control logs, the Hospital failed to consistently ensure an acceptable level of infection prevention practices for 6 of 30 sampled patients (#1, #11, #14, #15, #23, #25) of 30 sampled patients and two Nonsampled Patients (NS E and NS G). The failure of staff to adhere to infection control practices involved 13 observed staff; [Hemodialysis Registered Nurse (HDRN) #1, #2, #3, Central Sterile Technician (CST) #1, Phlebotomist (Phleb #1), Physical Therapy Aide (PTA) #1, Speech Therapist (ST #1), Respiratory Therapist (RT#1), Radiology Technologist (RadTech #1 and #2), Nursing Technician (NT) #2 and Registered Nurse (RN) #7 and #12]. Findings include:

1. For Patient #1, the Radius Specialty Hospital at Boston failed to ensure staff used appropriate personal protective equipment (PPE) when accessing the dialysis blood circuit and when providing personal care. Staff also failed to perform hand hygiene between glove changes, increasing the chance of cross contamination.

Patient #1 has diagnoses of end stage renal disease with hemodialysis, closed tracheostomy, anoxic brain injury with coma, diabetes type II, Stage IV sacral decubitus, and a gastrostomy tube (GT) for feedings. The patient is on special contact precautions for clostridium difficile bowel infection (C. diff) and for Methicillin Staphylococcus Aureus (MRSA) and Vancomycin Resistant Enterococcus (VRE) .

On 5/20/13 at 11:00 A.M., the Vice President of Clinical Services (VPCS) accompanied the Surveyor to the dialysis unit at the Radius Specialty Hospital at Boston and observed the patient in the hemodialysis suite while on dialysis. The patient had a left chest wall tunneled catheter in place used for dialysis. Hemodialysis Registered Nurse (HDRN) #1 was observed to be wearing a sheer yellow isolation gown. The Surveyor asked and was provided the same gown to put on to make observations while in the dialysis unit. The manufacturer's label on the bag containing the isolation gowns indicated the gowns were "fluid resistant" not impermeable to fluid.

Per Occupational Safety and Health Administration (OSHA), Personal Protective Equipment (PPE) will be considered "appropriate" only if it does not permit blood or other potentially infectious materials to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used.

According to standards, full barrier protection (gloves, impervious gown, and face shield) is used during initiation and discontinuation of a dialysis treatment as well as when accessing the extracorporeal (blood) circuit such as during intravenous medication administration or changing of the blood circuit because of the high risk of a blood exposure

At approximately 11:10 A.M. the venous lines of the dialysis machine circuit clotted for Patient #1. HDRN #1, placed the machine on bypass and stated s/he needed to change out the entire system. HDRN #1 put on a mask and gloves and placed a mask loosely over the patient's face. The mask fell off and the nurse did not replace it. The nurse began to change over the lines, disconnecting them from the catheter without putting on a face shield. Failing to replace the patient's mask, increased the patient's risk of contaminating his/her open and exposed blood lines to the patient's own respiratory bacteria, increasing potential for central line acquired blood infection. HDRN #1's failure to wear a full face shield placed the nurse at risk for bloodborne infections from cross contamination from blood splatter during line access.

HDRN#1 changed gloves five times without performing hand hygiene between glove changes. After HDRN #1 finished changing the blood lines, s/he walked over to the sink which was by the exit door and washed her/his hands.

On 5/20/13 at 11:30 A.M., HDRN #1 said s/he is supposed to do hand hygiene with each glove removal but it was "more important to change the lines quickly." The Surveyor inquired if there was any alcohol based hand gel in the hemodialysis unit s/he could have used and the nurse said no but s/he could get some.

The Surveyor then asked HDRN #1 about using a face shield. The nurse said a face shield should be used whenever accessing the blood lines such as when changing the circuit or giving medications. HDRN#1 said s/he did not have any face shields in the unit.

On 5/20/13 at 2:30 P.M., the Surveyor observed a special contact precaution sign outside the door of Patient #1 at the Radius Speciality Hospital at Boston . The sign directed anyone entering the room to don an isolation gown and gloves if contact with patient or any items in the patient's environment was anticipated, and to perform hand washing with soap and water prior to entering and leaving the patient's room.

The Surveyor donned PPE to include gown and gloves and entered to patient's room to make observations. The patient was in bed with the head of the bed elevated. The patient was alert but not responsive. The Surveyor observed a bag in the corner with the patient's hand splints in it. At 2:45 P.M., Physical Therapy Aide (PTA) #1 entered the room without any PPE on. PTA #1 said s/he was there to do range of motion to the patient's upper extremities and put the arm splints on. PTA #1 was observed to retrieve the splints from the corner of the room and place them on the patient's bed. When the Surveyor introduced her/himself, the PTA then stopped, left the room and donned PPE. The PTA failed to follow the contact precautions by donning the appropriate PPE before entering the room and initiating contact with the patient.

On 5/22/13 at 12:00 P.M., RN #11 was observed donning PPE to include a gown and gloves when entering the patient's room at Radius Speciality Hospital at Boston. RN #11 brought her/his own stethoscope into the room which (s)he wore underneath the isolation gown.

Prior to administering the medications via the GT, RN #11 checked the placement of the GT by listening to the air introduced via syringe into the stomach using her/his stethoscope which was covered with a glove. RN #11 then hung the stethoscope over her/his shoulders on top of the isolation gown. This contaminated the stethoscope, requiring it be disinfected upon leaving the room.

RN #11 administered the medications appropriately. Upon leaving the room, RN #11 removed the PPE, washed her/his hands but failed to disinfect the stethoscope, as required.



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2. The Hospital failed to ensure that dishes were properly washed and sanitized.

On 5/20/13, in the Radius Specialty Hospital at Boston's kitchen, the surveyor observed the dishmachine in operation. On 10 of 10 observations of the dishmachine, from approximately 9:30 A.M. 10:30 A.M., the wash water temperature and the final rinse water temperature failed to reach the required temperatures of 160 degrees Fahrenheit (F) and 180 degrees F respectively, as per the manufacturer's requirements on the machine's data plate. The wash water temperature registered between 132 to 152 degrees F. The final rinse water temperature registered between 116 to 118 degrees F.

The surveyor then reviewed the "Dishwashing/Warewashing Machine Temperature Log". The log indicated that the dishmachine failed to reach the required wash water temperature on 3 of the previous 4 days: 5/16, 5/17 and 5/19/13. The dishmachine failed to reach the required final rinse water temperature on 4 of the previous 4 days: 5/16, 5/17, 5/18 and 5/19/13. There was no documentation of temperature checks done on 5/20/13.

During interview on 5/20/13 at 2:30 P.M., Food Service Director (FSD) #1 said that the contracted service company was called at 7:30 A.M. on 5/20/13 regarding the dishmachine temperatures but still had not responded as of 2:30 P.M. on 5/20/13. At that time, FSD #1 called another service company about the dishmachine.

In the interim, FSD #1 called a staff member from the Facility Maintenance Department to check the dishmachine. The staff member was not able to correct the dishmachine temperature problem.

Since the final rinse water temperature was not reaching 180 degrees F., the dishes were not being sanitized. Upon surveyor inquiry, FSD #1 stated that the Hospital would use disposable dishes for supper.



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3. On 5/20/13, observations of the Code Cart at 11:00 A.M. on the Radius Specialty Hospital Satellite located at Quincy Medical Center (QMC), indicated that four disinfectant swab sticks had outdates written directly on the packaging in ink, by the Central Sterile Staff. On 5/20/2013 at approximately 11:05 A.M., during an interview, the Central Sterile Supervisor (CSS) said that the staff should not have documented on the swab sticks in ink, as ink is a liquid and can penetrate the packaging, rendering the items no longer sterile. The CSS said the items were now considered unsterile and removed them from the cart.

4. For Patient #11, observations at 11:10 A.M. on 5/20/13 at the Radius Specialty Hospital Satellite at QMC, indicated that HDRN #2, wore a yellow cover gown when providing care to and disinfecting the dialysis machine after dialysis for Patient #11. The cover gown was not impervious to fluids, as Surveyor #1 had tested the sleeve of the same type of cover gown with water. The water penetrated the gown sleeve.

5. For Patient NS E (a patient on infection control precautions for a diagnosis of Clostridium Difficile), observations on 5/21/13 at 10:00 A.M. at the Radius Specialty Hospital Satellite at QMC, indicated that RadTech #1 was in the patient's room taking a portable X-ray. The RadTech's covergown was unsecured at the neck and the waist. The gown was observed to have fallen off the upper torso and was bunched up at the waist of the RadTech. As (s)he removed the X-ray cassette from under the patient, RadTech #1's scrubs became contaminated as they came in contact with the patient's bed. The RadTech said (s)he would change his/her scrubs.

The RadTech left the room and came out into the corridor still wearing the contaminated gloves and cover gown. The RadTech removed the gown and gloves and disposed of them in a receptacle located in the corridor. RadTech #1 then used waterless hand sanitizer to disinfect his/her hands. After intervention by this Surveyor, RadTech #1, used soap and water to clean his/her hands, as required by Hospital policy and Infection Control Standards of practice. However, RadTech #1 went into another patient's room and used that patient's sink to wash his/her hands.

6. For Patient #25, observation of a two-step dressing change, in the patient's room at 12:30 P.M. on 5/21/13 at the Radius Specialty Hospital Satellite at QMC, indicated the following breeches in infection control practices and failure to follow the physician's order.

Review of the Physician's Orders on 5/21/13, indicated the order read: "Discontinue vaseline to right (R) temple, R thigh. Discontinue wound care to temple. R temple Xeroform and DCD (dry clean dressing) and Kerlix wrap around head daily. (On the ) R thigh leave Xeroform to skin, change ABD pad and Kerlix wrap daily."

a). RN #7 failed to perform hand hygiene before accessing the clean glove box and donning gloves.
b). RN #7 used his/her contaminated nurses' scissors that she removed from his/her uniform pocket, to remove the leg dressing and left the contaminated old dressing on the patient's bed next to the leg wound. (Items carried in staff's pockets are considered contaminated).
c). The RN then removed the now-contaminated gloves and donned sterile gloves without first performing hand hygiene.
d). Before placing the new sponges on the patient's leg, the RN partially lifted the Xeroform gauze from the patient's graft site, saying,"We're not supposed to remove this gauze, only change the sponge." (The physician's order indicated to leave the Xeroform to skin).
e). RN #7 then removed the gloves and accessed the clean (now contaminated) glove box without first performing hand hygiene. The RN donned the gloves, without first performing hand hygiene, although required.
f). RN #7 then noticed there wasn't a bottle of saline for irrigation in the patient's room. The RN removed the gloves and left the room with the patient's temple wound exposed. The RN did not perform hand hygiene after glove removal and before leaving the patient's room, as required by Hospital policy.
g). The RN returned with the bottle of saline, removed the cover from the saline, donned clean gloves (again without first performing hand hygiene), ripped the paper covering off a sterile sponge, poured some saline on the sterile sponge while holding it in his/her hands, and wiped the R temple wound with the saline moist sponge (this step was not ordered by the physician).
h). The RN then removed a sterile Xeroform gauze from its packaging, and cut it into wound sized pieces, using his/her same contaminated scissors (s)he used to remove the leg dressing. The RN then placed the now contaminated Xeroform gauze on the patient's temple wound. RN #7 did not first disinfect the scissors before using them to cut the sterile Xeroform gauze.
i). RN #7 then opened two sterile sponges, while wearing the same now-contaminated gloves used to handle the contaminated scissors, used to cut the Xeroform gauze, and placed the now-contaminated sponges on the patient's R temple wound.

During interview with the the Radius Specialty Hospital Satellite at QMC Nurse Manager, on 5/21/13 at approximately 1:30 P.M., the NM said RN #7 should have used a sterile dressing kit to perform the dressing change and sterile scissors to cut the Xeroform gauze.

Additionally, all the patient's sterile dressing supplies were stored on the counter, located immediately next to the handwashing sink, providing a risk of cross-contamination of the supplies from splashing water.

7. For Patient #23, observation of a blood sugar test at 2:20 P.M. on 5/21/13 at the Radius Specialty Hospital Satellite at QMC, indicated that Nursing Technician (NT) #2, failed to follow Infection control Standards of Practice, and the glucometer manufacturer's (Accucheck) and disinfectant manufacturer's (Super Sani-Cloth Wipes), directions for use (DFU), as follows:

a). Review of the Accucheck manufacturer's DFU on 5/21/13, read:

"If using commercially available pre-moistened disinfecting cloths, squeeze off excess disinfecting solution. Wipe the meter thoroughly, while avoiding the strip port, code key slot, and connector. Lay the meter on a flat surface while wiping over the strip port area. Allow the meter to air dry for the recommended contact time according to the disinfecting solution product labeling."

b). Review of the Super Sani-Cloth Wipes DFU on 5/21/13, read:

"Cleaning Procedure: All blood and other body fluids must be thoroughly cleaned from surfaces before disinfection by the germicidal wipe."

"Disinfecting: Unfold a clean wipe and thoroughly wet the surface (glucometer). Treated surface must remain visibly wet for a full two minutes. Use additional wipes if needed to assure a continuous two minute wet time."

c). NT #2 removed the container of test strips from the blood glucose testing kit carrying case, located outside the patient's room, and brought the container into the patient's room. NT #2 then placed the container of test strips on the patient's over-riding table.

d). After obtaining the patient's blood sugar, NT #2 picked up the container of test strips from the over-riding table and took them from the patient's room, while wearing the same now-contaminated gloves, used to obtain the patient's blood sample. NT #2 failed to remove the contaminated gloves and perform hand hygiene before handling the test strip container. NT #2 then placed the now-contaminated container of test strips into the clean carrying case, creating a risk for cross-contamination of the entire carrying case.

e). NT #2 failed to disinfect the carrying case and its contents, after placing the contaminated test strip container in the case, as required by Infection Control Standards of Practice.

f). NT #2 was observed wiping off the glucometer, used to obtain Patient #23's blood sugar, with the same contaminated gloves used to obtain Patient #23's blood sample. NT #2 did not adhere to Hospital policy, which required the glucometer to be disinfected according to the Accucheck and Super Sani-Cloth Wipes DFU.

g). NT #2 did not lay the glucometer on a flat surface while wiping over the strip port area nor ensure the glucometer was visibly wet for two minutes and allow the glucometer to air dry for a full two minutes, before replacing the glucometer back into the carrying case.



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8. On the K5 Respiratory/Ventilator Unit on 5/20/13 at 12:05 P.M. at the Radius Specialty Hospital at Boston, Phlebotomist #1 (Phleb #1), was observed to enter a contact precaution room. The phlebotomist was using a rolling cart stocked with phlebotomy supplies which was rolled to the bedside. Phleb #1 failed to perform hand hygiene or don a cover gown, as required by hospital policy, prior to entry into the precaution room. After handling the patient, Phleb #1 retrieved supplies from the cart, potentially contaminating the clean supplies held in the cart. Phleb #1 left the precaution room without performing hand hygiene.

9. Observation on the K5 Unit, at the Radius Specialty Hospital at Boston, on 5/20/13 at 2:30 P.M., indicated Speech Therapist (ST #1) carried a piece of equipment, used for optical communication, to a precaution room. ST #1 paused at the entrance to the room to read the precaution sign. ST #1 then placed the communication equipment onto the floor while (s)he performed hand hygiene and donned the cover gown. The equipment was then brought to the patient and placed on the patient's over-bed table. ST #1 again placed the communication equipment on the floor when removing her PPE upon exiting the room. Any items that have contact with the floor are considered soiled and would need to be disinfected before being brought to or from the room. The communication equipment was not cleaned when entering or exiting the room.

10. Observation on K5 Respiratory/Ventilator Unit, at the Radius Specialty Hospital at Boston, on 5/21/13 at 8:55 A.M. Respiratory Therapist (RT#1) was observed caring for a number of ventilator patients. According to the CDC publication "Guidelines for Preventing Health Care Associated Pneumonia, 2003", in the absence of medical contraindication(s), elevate at an angle of 30-45 degrees the head of the bed of a patient at high risk for aspiration (e.g., a person receiving mechanically assisted ventilation and/or who has an enteral tube in place). Documentation of the head of bed at > 30 degrees was consistently entered on the patient's receiving mechanical ventilation by Respiratory Therapy and Nursing staff. However, when interviewed as to how the head of bed was measured, both RT #1 and RN #3 could not locate the measuring device on Patient # 14's bed. According to RT#1, not all beds on the K5 Unit had measuring devices and RT would "estimate" the level of the head of the bed.

Interview with RT #2 on 5/21/13 at 10:15 A.M., indicated that RT #2 believed that not all of the beds had measuring devices and RT#2 would "guesstimate" the head of the bed level. Therefore, the documentation of the head of the bed level was not consistently based on observation of an appropriate head of bed measurement device.

11. Inhalers were observed stored in the Pyxis MedStation (an automated medication dispensing system) in plastic bags that were taken to the bedside of patients, who were on infection control precautions, and then returned to the Pyxis MedStation, on K5 Unit, at the Radius Specialty Hospital at Boston, on 5/21/13 at 9:00 A.M. The inhalers were stored in individual zip-lock bags. RT#1 signed out the medications from the secured system and brought the medications to the doorway of Patient #15. RT#1 placed the medication above the chart holder while RT#1 performed hand hygiene and donned appropriate PPE. The medication bags were labeled with the patient name and left outside of the precaution room. However, after using the inhaler on Patient #15, RT #1 used the same gloves that were used to administer the medication to the patient to return the medication to the zip-lock bag thus contaminating the zip-lock bag. The inhaler was then returned to the Pyxis MedStation. The inhaler was not placed in the zip-lock bag in a way to prevent contamination to the bag, therefore increasing the risk of cross-contamination of the Pyxis MedStation.

12. Observation on the K5 Unit, at the Radius Specialty Hospital at Boston, on 5/22/13 at 9:45 A.M., indicated a Radiology Technologist (RadTech #1) in a Precaution Room (Non-Sampled Patient G). RadTech #1 was seen positioning an x-ray plate behind the patient. Moments later, RadTech #1 was observed at the Nurses Station wearing the PPE, asking for clarification of the Radiology order. RadTech #1 failed to remove his/her PPE when exiting the precaution room, increasing the potential of cross contamination of the external environment from the patient's room.

13. Observation on K5 Unit, at the Radius Specialty Hospital, on 5/20/13 at 10:00 A.M., indicated Personal Protective Equipment (PPE) was available at the entrance to each patient room. The PPE consisted of cover gowns, gloves and masks. According to the Occupational Safety and Health Administration (OSHA) requirement, PPE will be considered "appropriate" only if it does not permit blood or other potentially infectious materials to pass through or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or mucous membranes under normal conditions of use, and for the duration of time which the protective equipment will be used. The available PPE (masks and cover gowns) on the K5 unit, where more than a dozen tracheostomy and ventilator patients requiring frequent suctioning were located, did not meet the OSHA requirement as the cover gowns, were only fluid resistant and not impermeable as required by OSHA. In addition, there was only one pair of eye protective wear (shields or goggles) on the unit.

The impermeable cover gowns were observed being distributed on the K5 Unit on 5/21/13 at 7:30 A.M. The impermeable gowns were white, a thicker fabric and labeled by the manufacturer as impervious.

Based on record review and interview the Hospital failed to follow their agreement with an Organ Procurement Organization (OPO) for notifying the OPO in a timely manner,of patients who have died in the hospital for 5 of 5 death record review patients (#1, #2, #3, #4 and #5) Findings include:

1. According to the Organ and Tissue Donation Policy and Procedure, revised on 8/2012, when a death occurs the Hospital must make a referral to the OPO within a timely manner. A timely manner is interpreted as one hour from the time the patient is identified asystolic (without a beating heart). In all cases, upon referral of the patient for consideration of organ and tissue donation, the physician or nurse must make a notation in the medical records. The notation will include the date, time of referral and the OPO staff accepting the referral.

2. Record review indicated DPR Patient #4 (deceased record review patient) expired on 3/28/13 at 9:00 A.M. The physician completed a form titled "Notification of Death and Opportunity for Anatomical Gift" on which the physician documented that the OPO was notified of the patient's death at 11:40 A.M., 2 hours and 40 minutes after the patient had expired. This did not meet the timely death notification requirement of one hour.

3. Record review indicated DPR Patient #5 ( deceased patient record) expired on 3/4/13 at 11:40 A.M. The physician completed a form titled "Notification of Death and Opportunity for Anatomical Gift" on which the physician documented that the OPO was notified of the patient's death at 13:40 (1:40 P.M.), 2 hours after the patient had expired. This did not meet the timely death notification requirement of one hour.

4. For death record reviews Patients #1, #2 and #3, the notation in the medical record did not include the time that staff notified the OPO of the patients death as per the Hospital policy.

Based on record review and review of the pol;icy and procedure of Organ and Tissure Donation , the Hospital failed to identify areas for performance improvement in timely notification of the Organ Procurement Organization (OPO), based on feedback provided by the OPO. Findings include:

The Hospital has policies and procedures for timely notification of the OPO of one hour if the patient is asystolic (without heartbeat).

Review of the feedback on referral data and timely notification data from the OPO from January 2011 through December 2012 indicated that timely notification was less than 75% for 7 out of 12 months. Five of 12 months were at 100%. The overall average for timely notification for the 12 months of 2012 was less than 70%. The average timely notification rate for 2011 was 80%.

During an interview on 5/23/13 at approximately 10:00 A.M., the Regional Director of Performance Improvement, Patient Safety and Regulatory Compliance said Organ Procurement and timely notification were not reviewed in Quality Assurance and there was no Performance Improvement plan to increase the rate of timely notifications.

Based on record review and staff interview, the hospital failed to provide menus which were designed to meet the needs of the patients for 2 patients (#17 and #18), out of a sample of 30 patients. Findings include:

1. Patient #17 was admitted to the hospital on 4/24/13 with diagnoses including malnutrition who was on total parenteral nutrition (TPN) for nutritional support.

Review of the physician's orders, dated 5/12/13, indicated that the patient's diet was to be advanced to a low fiber diet. Review of the current diet manual did not include a low fiber diet. Review of the Week 3, 2013 menu cycle indicated there was no menu planned for a low fiber diet. In lieu of a planned menu, Dietitians #1 and #2 said that individual diets are updated on the computer.

Observation of lunch on 5/20/13, indicated that the meal ticket on the patient's lunch tray read: "low residue" diet. The patient was served baked fish, baked potato with skin, sour cream and a dinner roll. The surveyor inquired about a baked potato with skin being allowed on a low fiber or low residue diet. Dietitians #1 and #2 said that the patient should not have been served a baked potato with skin.


2. Patient #18 was admitted to the hospital on 5/13/13 with diagnoses including nephritic syndrome, hypertension and dysphagia.

Review of the physician orders dated 5/13/13 indicated that the patient was to receive a "renal diet with no concentrated sweets". The physician also ordered a Speech Language Therapy (SLT) evaluation. As a result of the SLT evaluation, on 5/14/13, the physician ordered that a "chopped solids, thin liquids" texture be added to the therapeutic diet.

Review of the current diet manual under "altered textured diets and liquids" indicated that on a chopped diet, most meats are cubed and raw vegetables and hard fruits are finely diced. Review of the Week 3, 2013 menu cycle indicated there was no menu planned for a chopped diet. In lieu of a planned menu for the chopped texture, Food Service Director #1 said that the Dietitians correct/update the diet consistency on the computer as per the Speech Therapy recommendations.

Observation of lunch on 5/20/13 indicated that the meal ticket on the patient's lunch tray read: "Renal Diet Chopped No Concentrated Sweets." The patient was served a green salad, a hamburg patty on a roll, fruit cocktail and ginger ale. The surveyor inquired about the salad not being diced/chopped and the hamburg patty being served whole. Dietitians #1 and #2 said that the patient should have been served a chopped salad and chopped meat.