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Based on observations, staff interviews, and review of procedures it was determined that the facility did not comply with requirements for the protection and promotion of patients' rights as required.


Findings Include:


The facility failed to meet the Condition of Participation for Patient Rights due to non-compliance with requirements as follows:

The facility failed to implement an effective surveillance system for the protection of infants and young children on the Pediatric unit, Postpartum/Nursery, and Labor and Delivery unit in order to minimize the potential risk for harm or abduction. In addition, ineffective monitoring of exit from the Pediatric unit, Postpartum/Nursery, and Labor and Delivery unit within the facility was identified.

Cross refer to specific citations noted under Patient Rights, 482.13 (c) (2), TAG # A 144.

Based on staff and patient interviews, review of medical record and facility's policy, it was determined that the hospital failed to:
1) Provide the standardized notice, "An Important Message from Medicare" (IM), within 2 days of admission to Medicare beneficiaries who were inpatients. This was evident in six (6) of ten (10) applicable medical records reviewed (MR #2, #5, #7, #9, #10 & #11).
1) Provide patients at admission information that identifies their rights as hospital patients. This was evident in one of two patients interviewed (MR #6)
Findings include:
During the unit tour {N81- a medical surgical unit}, on 1/21/15 at 11:30 AM, MR #2 was reviewed. It was noted that this 67 year old patient with medical history of large B cell lymphoma was admitted to the facility on 1/15/15. The chief complaint was loose red stools. The record indicted that the patient was to be transferred to another facility today, on 1/21/2015. It was noted a copy of the required standardized notice, An Important Message from Medicare (IM) form was not located in the medical record of this Medicare beneficiary.
This was brought to the attention of staff #8 who was unable to explain why the IM was not located in the medical record.

During the tour of the unit on 1/21/2015 at 11:30 AM, MR #7 was reviewed. It was noted that this 65 year old patient with history of ESRD (End Stage Renal Disease), hypothyroidism, hypertension, was admitted on 1/5/2015. There was also no IM located in the medical record.
Similar circumstances were noted in medical record for the patient in MR # 9 and in closed medical records reviewed for patients in MR #5, #10 & #11, which all lacked IM forms.

During the tour of the unit (Mother & Baby unit), on 1/22/2015 approximately 12:41 PM, the patient in MR #6 was interviewed. This patient reported that she was not provided with any patient rights information.
Staff # 12 was interviewed on 1/22/2015. This staff stated that Patient's Rights information is given, at admission, in the Labor and Delivery unit.
While on the Labor and Delivery unit, on 1/22/2015, a copy of the Patient's Rights information given to a patient was requested from the staff #13 and staff # 14. A folder, with the title Discharge Instructions, was submitted. The documents located in the folder were reviewed. It was noted that there was no Patient's Rights information listed in this folder.
The hospital's policy for notifying all patients of their rights, both inpatient and outpatient, was requested from the facility's staff #15 on 1/22/2015. On 1/29/2015, staff #15 submitted the policy and procedure - Subject: Patient Bill of Rights; effective 1/2015. This policy was reviewed on 1/29/2015. This policy indicated that "a pre-admission package is provided to prospective patients. Included in this package is "Your Rights as a Hospital patient" (DOH) informing the patient of rules and regulations and their rights during their stay at SUNY Downstate Medical Center". The facility failed to consistently implement its patient's rights policy to all patients.

Based on staff interview, review of Patients' Grievance files, Concern of Patient Care Committee (COPC) minutes, Report to the Executive Performance Improvement Committee and hospital's policy, it was determined that the hospital failed to assure that:
- It reviews, investigates, and resolves each patient's grievance within a reasonable time frame.
- It provides written responses to patients/patients' representatives on the outcome of its investigations to all grievances.
This was evident in twenty five (25) of twenty five (25) grievance files reviewed (#1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #17, #18, #19, #20, #21, # 22, #23, #24 & #25).

Findings:
A sample of twenty five (25) complaints made to the hospital, by patients and/or patients' representatives, regarding patient's care, abuse and other issues related to the hospital's compliance with the CMS Hospital Conditions of Participation (CoPs), were reviewed on 1/29/2015. It was noted that twenty five (25) of twenty five (25) grievances files reviewed lacked timely written responses. Of the twenty five (25) grievance files reviewed, seventeen (17) had written responses, but the responses were not within the required 7 days' time frame and eight (8) grievance files lacked written responses on the outcome of the investigations.

The following are a sample of grievance files without responses:

Grievance #1 was reviewed on 1/29/2015. It was noted that the patient filed a complaint with the facility on 6/17/2014 alleging abusive staff. It was noted that the case was discussed in the Concern of Patient Care Committee (COPC) on 6/18/2014. In this committee minutes report, it was indicated that the staff had prior issues and she was referred to Labor Relations. There was no evidence that the complainant was provided with a written response on the outcome of the investigation.

Grievance file #2 was reviewed on 1/29/2015. It was noted that the patient filed a written complaint to the facility on 9/25/2014. The patient alleged inappropriate bodily contact by a staff member. The hospital investigation was not submitted for review. The COPC report indicated that the case was deferred to Risk management. There was no evidence that, as of 1/29/2015, the patient was provided a written response on the outcome of the investigation.

Grievance file # 3 was reviewed on 1/29/2015. It was noted that the patient's spouse filed a complaint with the facility on 6/4/2014 alleging that a computer input error on inputting information regarding a prescription resulted in patient's readmission to the hospital. It was noted that the issue was discussed in Concern of Patient Care Committee meetings. It was documented, in the COPC meeting report that the physician spoke to the patient on 7/1/2014. However, there was no evidence that the complainant was provided with a written response on the outcome of the investigation.

Similar findings were noted in lack of responses in grievances #4, #5, #6, #7 & #8.

The following are a sample of grievance responses not timely:

Grievance file #9 was reviewed on 1/29/2015. The Complaint Form was dated 1/8/2014. It was noted that the patient alleged that he felt mistreated by the nursing staff on the unit. The patient filed the complaint on the day of discharge, on 1/8/2014. The final response to the complainant on the outcome of the investigation was dated 2/25/2014, over 45 days after the complaint was received.

Grievance file #10 was reviewed on 1/29/2015. It was noted that the patient filed a grievance with the facility on 3/18/2014. The patient stated, in the complaint, that she had open heart surgery in the facility on 1/8/2014. During the hospitalization (1/9/2014 to 1/10/2014), she sustained a wound from IV (intravenous) infiltration which was difficult to heal. Located in the file was a copy of the acknowledgement sent to the complainant which indicated that the facility had received the complaint, which was dated 3/18/2014. However, a copy of the final investigation on the outcome of the investigation was not submitted for review.

Grievance file #11 was reviewed on 1/29/2015. It was noted that the facility received a written complaint, dated 7/25/2014, from a patient concerning several patient care issues such as: surgeon cancelling surgery and coercing patient, issues with the anesthesia and/or anesthesiologist and unnecessary pain in the operation. The file indicated the facility received the complaint on 7/25/2014. It was noted that the final response to the complaint on the outcome of the investigation was dated 9/30/2014 over two months after it was received.

Similar findings were noted for grievance files with responses that were not timely for #12, #13, #14, #15, #16, #17, #18, #19, #20, #21, #22, #23, #24 & #25.

Policy subject: Patient Complaint Mechanism No. PTBR-3 effective 7/2013 was reviewed on 1/29/2015. This policy indicated if the facility was unable to resolve, or if the investigation is or will not be completed within 7 days, the Patient Relations Department will inform the patient or the patient's representative in writing that the hospital is still working to resolve the complaint and that the hospital would provide a written response within 30 days. The hospital was not consistently implementing this policy.

Staff #15 was interviewed on 1/29/2015 regarding the timeliness of responses to grievances. This staff stated that Concern of Patient Care Committee meets, to discuss and make determinations on responses to patients' grievances, before the final responses can be mailed to the complainants. She stated that this committee meets weekly.

Based on observation, staff interviews, and review of procedures it was determined that the facility failed to have an effective surveillance system in place for protection of infants and children in the Postpartum/Nursery, Labor & Delivery and Pediatric units.

Findings include:

1. During the tour of the Postpartum/Nursery Unit on the 3rd Floor on 01/21/15 at 11:55 AM, it was revealed that the facility used an electronic tag system manufactured by "McRoberts (Ex-Prosec)" to augment safety and tracking of infants and pediatric patients in the Postpartum/Nursery, Labor & Delivery and Pediatric units.

This system operates by connecting an electronic transponder tag to a plastic band, and this device is then attached around the ankle/wrist of the pediatric patient. This device is linked electronically to a computer tracking system which locks the door of the unit and stairwell when the device worn by an infant/child approaches the proximity of the exit or stairwell doors of the unit. The device also elicits a visual and audible electronic alarm if the exit door or stairwell is kept ajar when an infant/child wearing the device approaches within the proximity of these areas.

In addition, when an infant/child wearing the attached transponder tag is present in the elevator cab on the 3rd and 4th Floor, the specific elevator will fail to operate.

The Deputy Chief of University Police (DCUP) and the nursing staff were interviewed on 01/21/15 at 11:55 AM regarding the effect on the security system when a device band is cut.

The DCUP stated that the facility is utilizing skin sensing device which means that once the tag is cut or becomes loose, the alarm will go off. The nursing staff on the unit stated that if the transponder tag is cut or becomes loose and falls off the child's wrist/ankle, the system will not trigger any alarm, provide other notification, or result in locking of doors from the unit. They presented the transponder, which was not the skin sensing device type and had a regular plastic band.

During the tour of the Postpartum/Nursery unit on 01/21/15 at 12:15 PM it was observed that employees must swipe an identification card at the entrance doors to gain access to the unit, but that no identification card is needed to exit through these portals. Therefore, the main egress door 'exits' were unrestricted, and it was also noted at this time that exits were not continuously monitored by camera and/or staff.

There were rooms near the Main Entrance/Exit to the unit and by the internal stairwell #4 that were beyond the direct observation of the nursing staff. Rooms included, but were not limited to #s 301, 302, 303, 304, 307, 309, and 310, and possibility room #306.

At this time, it was concluded a potential risk existed for child/infant abduction because if the security band is removed or cut, the security system would not alert staff of a possible abduction resulting from the tampering or removal of the device. In addition to the failure to alarm upon removal of the device, it was also observed that unrestricted egress from the unlocked unit doors and the lack of consistent monitoring of the activity at entrances/egress points by unit staff using the existing cameras represented a continuing high risk for elopement.

Inspection of the electronic infant protection system on 01/21/15 found it did not properly operate during system testing conducted on the Postpartum/Nursery unit between 11:55 AM to 12:15 PM.

The surveyor requested the nursing staff present on the unit to activate a tag/transponder in order to test the effectiveness of the system. At the time of testing it was observed that the monitoring computer console utilized for viewing the Infant Abduction system, was continuously alarming with beeping sounds. It would silence and then alarm again. As per the nursing staff and the Nurse Manager present on the floor this alarm has been sounding for a long time, most probably more than a month. Surveyor requested to be shown what was alarming. The staff had to put in their username and password to retrieve the information of the alarm. The computer monitor indicated the reason for the alarm as "Elevator #7 (111848) sensor field antenna is disconnected". The Security staff and engineering staff escorting the surveyor and present at the time of this observation indicated that they were not aware of the issue.

A tag #F17BB7 was activated for the test and tied around the wrist of a nursing staff. When this tag entered the field of the stairwell and the main exit/entrance of the unit, no specific alarm was heard and no notification appeared on the computer console. Also, no overhead announcement was made and no phone call from Security to the unit was made to ensure that everyone was safe.

The chronic alarm condition obscured any other "legitimate" alarm generated. There was no distinct notification or blinking pop up window indicating the location of the "legitimate" alarm. The only thing different during the test was that the icon on the computer monitor indicated the presence of a two alarm condition, but to find out exactly where the alarm is occurring, the staff has to put in their username and password to retrieve that information, which takes time and effort.

On 01/21/15 at 12:45 PM, a tour of the 4th floor Pediatric Unit was conducted and similar issues were noted with the transponder test, with the exception that the 4th floor monitoring console did not indicate the presence of any other alarm. During the transponder test of tag #F16E17, no overhead notification was made, no call from the security to confirm the safety of the floor was made, and the alarm notification on the monitoring console was not instantaneous. Also, the staff had to type in a username and password to retrieve information.

Since the Pediatric Unit did not have cameras or other means of surveillance, and was not utilizing the skin sensing type bands, room #s 421, 415, 420, 412, 413 and 415 had a potentially higher risk of infant/child abduction since these rooms were not in direct line of sight with the nursing staff station.

It was explained and confirmed by the nursing staff that upon cutting the infant abduction transponder band no visual or audible notification was generated on the computer monitor or anywhere else.

The existence of the same unsecured Exit was also noted on the Labor & Delivery unit on the 3rd floor.

The Assistant Vice President of Facilities (AVPF) stated on 01/21/15 at 1:30 PM that the facility had discontinued the use of skin sensing transponder bands many years ago.
The DCUP provided the surveyor on 01/21/15 at 11:30 AM with a policy and procedure titled "Prevention of Infant/Pediatric Abduction - No SAF14" dated 04/02, however, this policy did not describe in detail the way the infant abduction system is supposed to work and did not include a policy and procedure to be followed for preventive maintenance of the infant protection system and all its components, including the device tags/transponders.

The surveyor at that time requested the latest preventive maintenance report for the transponders and the software. No report for any of the current or old preventive maintenance of the system was ever provided to the surveyor. Furthermore, the DCUP also did not provide a Code Pink drill record.

As a result of the above findings, an IMMEDIATE JEOPARDY was declared on 01/21/15 at approximately 2:45 PM. The hospital, in their response to this situation, stated that they had decided to assign security officers 24 hours a day, 7 days a week, at the Postpartum, Labor & Delivery, and Pediatric units until a long term solution is established. The assigned officers are responsible for monitoring the entrance/exit to each of the units.

The immediacy of this immediate jeopardy situation was abated at 5:40 PM on 1/21/15 when the hospital provided, in writing, an interim corrective action plan, and policies to ensure the safety of the patients on the units. The interim measures accepted by the Department of Health to abate the immediate jeopardy situation included: (1) Round the clock posting of security officers in the Postpartum, Labor & Delivery, and Pediatric inpatient area that will be responsible for monitoring the entrance and exit from the main entrance and stairwells; (2) Fixing of the pop up alarms issue and the issue with elevator #7 alarm; and (3) Evaluation for the Long term solution in terms of Skin sensing device or secured entrances and exit along with buzzer system for entrance and exit. The implementation of these interventions was evidenced by review of the schedule for assignment of round the clock hospital security staff and direct observation that a security officer was stationed at the pediatric unit entrance/exit on 01/21/15 at 5:40 PM.

On 01/22/15 between 11:00 AM to 12:30 PM, follow-up tours of the Postpartum Nursery, Labor & Delivery and Pediatric unit were conducted to observe the presence of the security staff on the unit. Security staff were on duty at the newly established posts. The Security guard's position did allow for visualization of all fields and points of entry and egress.

On 01/22/15 at 2:30 PM , AVPF provided facility's documentation on facility's progress to resolve the issue identified. The document indicated that pop up alarm issues were fixed by the vendor at approximately 1 PM on 01/22/15 and Elevator #7 was taken out of service until the completion of repair. The plan further indicated the facility's plan to use swipe cards, surveillance camera and buzzer as the long term solution.

On 01/23/15 at 1:00 PM, AVPF provided follow-up documentation of interim short term measures to correct the immediate jeopardy situation. The AVPF presented the assessment from the vendor of the surveillance camera system and the issuance of a purchase requisition for the swipe card installation. All this while facility continued to provide 24/7 security.

From 01/24/15 to 01/30/15 facility kept working on the long term solution and by 1:00 PM on 01/30/15 indicated that all components to abate the immediate Jeopardy situation had been installed and all issues resolved.

A follow up tour was made to all three units (Postpartum Nursery, Labor and Delivery and Pediatric) on 01/30/15 between 2:30 PM to 3:30 PM. It was noted that the pop up alarms on the Pediatric unit was not resolved. The AVPF corrected the issue, which he stated had occurred because someone had changed the date on the computer console which resulted in the system not being able to show today's alarm. The correct date was set and the notification alarms worked.

The following elements (that were provided as the final progress report/plan to the survey team on 01/30/15 at 4:00 PM) were checked during a tour and were found working:
-The alarm in elevator #7 was repaired.
-Software problem of 'pop-ups' was resolved.
-Installation of surveillance cameras at the locked doors to the units.
-Monitors installed at the nursing stations (to observe the entrance and exit from/to the unit). Buzzers were also installed as a part of this project.
-Installation of swipe card units on the interior of the locked doors, requiring swipe card egress. Previously swipe card was only required for entry.
Connectivity on the interior swipe card units to the buzzer system.
-Installation of additional intercoms at the doors.
-Removal of PIN pads, mandating the use of swipe cards only.
-Removal of the door transcom sensor which deactivated the magnetized door locks on detected motion.
-The magnetized locks on stairwell doors on the 3rd and 4th floors are continuously operational and only deactivate when the fire alarm is activated (this was done for the stairwell #4 - the only stairwell that has doors inside these units).
-Signs were posted at the stairwells indicating 'Emergency Only".

Based on the above plan and confirmation IMMEDIATE JEOPARDY was abated on 01/30/15 at 4:00 PM.

These findings were verified with the Director of Environmental Health and Safety, Deputy Nursing, Director Regulatory Affairs and the nursing staff present at the time of the observations.


Based on record review , it was evident that the hospital failed to follow up on an incident in which the parent removed the transponder and wrist band from the infant.

Findings include:

Review of an incident report dated 5/22/14 on 1/22/15 found that the mother in MR#2 removed the transponder from the 21 month old child on 5/22/14 and refused to have it placed on her child.

There was no facility response or intervention. The system in place at that time did not alarm when a transponder was cut or removed.

Based on observation, interview and other documents, it was determined the hospital did not ensure that the Out-patient Nutrition Services be included in a quality performance improvement program.
Findings include:

A tour was conducted at the hospital ' s Out-patient Clinics on 1/30/15 at approximately 11:00 AM. The surveyor interviewed the Out-Patient Dietitian in the Pediatric Clinic. The surveyor asked the Dietitian if she receives many referrals from the physicians to see children with weight problems. She responded that she does see many children and adults with obesity. When asked if she is involved in a quality improvement program to show the positive outcome achieved due to nutrition intervention; she responded she was not involved in any performance improvement program. The Out-Patient dietitian does not participate in the food and nutrition department quality improvement program nor is she included in the ambulatory clinic performance improvement program.
Her role in pediatric out-patient nutrition intervention is crucial especially with the current up rise of pediatric obesity. The data obtained by the Dietitian can point to the direction that the hospital needs to focus, which would contribute to improving performance had she been involved in a quality improvement program.

Based on record review and interview it was evident that the hospital QA program did not consistently accurately classify incidents that jeopardized patient safety. This was evident for 1 of 5 patients who were listed on the Adverse Drug Reports. (ADR).

Findings include:

Review of MR#1 on 1/30/15 at 1:00 PM found that the patient, who was discharged from an inpatient admission was prescribed an overdose of medication which was filled by an outside pharmacy. Specifically, on 3/21/14 the patient received a prescription ( reviewed actual prescription ) for Warfarin 5 milligram (mg.) tablets to take 5 tablets at bedtime over a 3 day period. The patient took 25 mg Warfarin for 3 days which represents a 75 mg. dose, which is outside the range of dosage for Warfarin. Additionally, the patient continued to take her standing order of coumadin of 7.5 mg daily. The intended dose was for Warfarin 1 -5 mg tablet per day . Review of the medical record found the patient was recalled to the ED for an abnormal lab result related to this overdose. The International Normalized Ratio (INR - a measure used to determine the clotting tendency of blood) was 9. Patient was admitted for "anticoagulant poisoning". The target INR level varies from case to case depending on the clinical indicators, but tends to be 2–3 in most conditions. However, target INR may be 2.5–3.5 or even 3.0–4.5 in patients with one or more mechanical heart valves.


This incident was found during a review of patient complaints on 1/30/15. There was no incident report for a medication error. At interview with Administrative staff 1/30/15, it was acknowledged that there was no medication error report prepared in that it was classified as an ADR (adverse drug reaction) instead. Review of adverse drug reactions (ADR) found the reference to the overdose.

At interview with the Vice-Chair of Medicine on 01/30/15 at 2 PM it was acknowledged that this was a medication error, not an adverse drug reaction, and that it was the result of the resident making a computer error. He intended that there be 5 mg tablets, not 5 - 5 mg tablets. Review of the prescription found that the form was signed by the resident and that the attending's stamp is next to the resident's signature.

Based on observation, staff interview, review of hospital's menus and other documents, it was determined that the hospital food and dietetic services was not organized and directed in such a manner so as to ensure that the nutritional needs of the patients are met in accordance with practitioners' orders and acceptable standard of practice (see Tag A 628). In addition, food prepared for patient consumption should be maintained in a safe and sanitary condition in order to prevent the possibilities of contamination and transfer of infection.
Findings include:
The Condition of Participation for Food and Dietetic Services is not met due to failure of the hospital's food and dietetics services not ensuring that diets prescribed by a practitioner be provided according to diet manual and menu's nutrient analysis. Packaged foods throughout the kitchen were not labeled appropriately. This presents an unsafe and unsanitary condition for meal preparation in the kitchen. Moreover, the Food Service Director responsible did not implement effective oversight of the daily operation of nutrition and food services. (Refer to Tag A 620 and A 628).

Based on observation, staff interview and review of documents, it was determined that the Director of Food and Nutrition was not responsible for the daily management of dietary services. The Food Service Director failed to monitor all areas of the kitchen, safety practices for food handling and food preparation. The Emergency Food Supply Manual was inadequate. The department is managed by a food service contractor.

Findings include:
1- A tour of the kitchen was conducted on 1/20/15 at approximately 10:00 AM. The surveyor was accompanied by the Food Service Director and Food Service Administrator. The following observation were noted:
a) During tour of all the refrigerators, freezers and dry store room in the kitchen, it was observed that some foods had been removed from their original package and re-packaged with a label noting the date it was re-packaged and the date of expiration. The label did not identify the food that was re-packaged. In order to determine the content of the repackaged food, the packaging must be opened and assessed as to what is the food item. This is an unsafe food practice. In addition, the department's policy and procedure manual did not contain a policy on food labeling. Some examples of food items were cold cuts, variety of cheeses, soup, trays of sandwiches and beef roast. Bags of pasta and tortillas were opened and not labeled.
b) Air Vents throughout the kitchen were dirty and full of dust.
c) Three covers, possibly acrylic, that covered florescent lights in the kitchen were cracked and had large holes on them.
d) All plastic garbage receptacles in the kitchen had lids with a large hole in the middle of the lid or were uncovered. All garbage receptacles in the kitchen should be covered with lids that are solid and have no hole. Garbage receptacles are uncovered only when they are in use.

All observations were shared with the Director and Administrator of Food Service.

e) Menus were not posted in the kitchen for the use of all employees. When the Food Service Director was asked for the posting of the menus the Director showed the surveyor a set of laminated "Regular" diet menus hanging on a key ring located in the cook's rack.
II. A tour of the patient unit pantries was conducted on 1/28/15 at approximately 1:00 PM.
The surveyor was accompanied by the Director of Quality. The unit pantries in overall were found to be dirty. The Interior of the wall cabinets has food stains and spillage. These cabinets had roach motels stuck to the wall of the cabinets with no date of expiration. The floor cabinet beneath the sink appeared very dirt. Some cabinets had food stored in them.
- The 8th floor pantry refrigerator gasket was torn. Temperature log was missing the temperature of the refrigerator for the dates 1/26/15, 1/27 and 1/28/15. The floor of the refrigerator had dried milk stains. Two juices were in the bottom cabinet. White electric water kettle was dirty with dirt stains. Surveyor was informed that the water kettle is on 7 days a week for 24 hours. The surveyor inquired when was the kettle cleaned? Response was when they are dirty a nurse assistant is asked to come to the pantry and clean the kettle. There is no policy on the maintenance or sanitation of the electric hot water kettle.
- The 7th floor pantry refrigerator had the Gasket torn- approximately 12 ".
- The 6th floor pantry had a wall cabinet that has shelves dirty to the touch. The refrigerator contained two turkey (?) sandwiches with no labels. The refrigerators gasket was torn approximately 10". The torn gasket had tape holding the gasket to the door. The temperature of this refrigerator was 52 degrees yet the log noted the temperature at 40 degrees. Nurse Manager on the unit was informed of the current refrigerator temperature.


III. A review of multiple documents titled "Patient Tray Assessment" dated 11/4/14 thru 12/15/15 was conducted on 1/21/15 at approximately 11:00 AM. These document notes the temperature of foods on a tray upon arrival to the unit. The result of the review showed that 14 out of 32 hot food items did not meet hot food temperature. Therefore, 44% of hot food item did not meet hot food temperatures. On cold food item, the review showed that 14 of 21 cold food items did not meet the cold food temperature of 41 degree Fahrenheit. Hence, 67% of cold food items did not meet cold temperature. Overall, the review showed that food arriving on the patient units are not meeting standard food temperature for hot and cold foods. These findings were shared with the Food Service Director and Food Service Administrator.

IV. The Emergency Preparedness Food Supply Manual was reviewed by the surveyor on 1/20/15 at approximately 12:00 PM. The Food Service Director and Food Service Administrator was present during the review. The manual was not user friendly and was found to be inadequate. . This manual contained too many pages and references for a non- food service employee to understand should the need be for a non-food service employee be assigned to prepare Breakfast by the Command Center.
a) The menu in the manual was for three days yet it did not state what therapeutic diets would be covered by this menu.
b) The menu was generic- it noted food items such as dry cereal, milk, pears, crackers etc.
Food items did not state if it was a box, carton, canned or individual packet etc. It also did not state if the food required preparation, e.g. instant potatoes.
c) There was no menu for foods that required a modification in texture such as mechanical soft or puree. Instead a list of food was listed as available for puree.
d) The diagram to locate menu food items, paper goods and water was difficult to read since the font was small and did not have arrows to show the direction where food items were located.
e) There was no information on how the food would be distributed to the units or how much.
f) Water distribution states only that patients should receive 1 gallon per person per day, but does not state if the water would be distributed in 8 oz. bottles, liters or gallons.
g) Kosher food was not mentioned nor was there information on what to provide if needed.
h) There was no age specific pediatric menu or liquid menu in this manual.
i) Paper goods was not mentioned nor was the availability of enteral feeding.

V. A tour was conducted at the hospital's Out-patient Clinics on 1/30/15 at approximately 11:00 AM see Tag #0273). The surveyor interviewed the Out-Patient Dietitian in the Pediatric Clinic. The surveyor asked the Dietitian if she receives many referrals from the physicians to see children with weight problems. She responded that she does see many patient with obesity. When asked if she is involved in quality improvement she responded she was not. The Out-Patient dietitian does not participate in the clinical nutrition quality improvement program nor is she included in the ambulatory clinic performance improvement program.
Her role in pediatric out-patient nutrition intervention is crucial especially with the current up rise of pediatric obesity. The data obtain by the Dietitian can point to the direction that the hospital needs to focus thus improving performance had she been involved in a quality improvement program.

A review of patient menus was conducted on 1/20/15 at approximately 1:00 PM. Present during the review was an assigned staff Registered Dietitian #1. The Clinical Nutrition Manager had resigned and the staff Dietitian was filling in. The hospital has a one week cycle menu. Each menu of the week cycle has 14 plus diet prescriptions on this one only menu. The menu contains only solid foods. The bottom of the menu states "Diet prescription: (Check all that applies)" - it enumerates all physician prescribed diets and each has a small check off box for the Patient Care Associate (PCA) to enter a selection. This menu is not pre-modified to meet these diet restrictions prior to the PCA obtaining patient food choice. The diets listed on this menu are:
Regular Diet, 2 grams (gm) Sodium (Na) Diet, Low Fat/Low Cholesterol Diet, Heart Healthy Diet, Renal Diet, Diabetic Consistent Carbohydrate Diet-High -Moderate-Low, Clear Liquid Diet, Full Liquid Diet, Mechanical Soft Diet, Chopped Diet, Pureed Diet, Thin Liquids, Nectar-Thick Liquids, Honey-thick Liquids and "Other Modifications". All of these diets are listed on this one menu.

1 - The menu is not individually tailored for each diet. The patient receives this menu on his tray with only his diet checked off. The menu is extremely confusing for a patient to understand. If the patient is on a Clear liquid diet he receives a menu that has solid foods - roast chicken, mashed potatoes, bread etc. instead of only clear liquid food items.

2 - The menu and nutrient analysis does not meet the basic food groups for milk for children or adults.

The 2010 USDA My Plate Dairy Group notes the following needs for the different age groups. Adults (Male or Female) 31-51 years should have 3 cups milk a day; Toddler 2-4 years = 2 to 2 1/2 Cups Milk per day; and School Age 4-12 years = 2 ½ to 3 cups of milk; and Adolescent 13-18 years should have 3 cups of milk per day.

The Nutrient Analysis for the Sunday Pediatric menu for toddler contained only 2 cups of milk for the total day. Therefore, it did not meet the recommended 2 1/2 cup per day.
The school age child nutrient analysis for Sunday provides only 4 oz. milk for the day. The milk group for this age group was not met. The milk group was short by 2 cups of milk.
The adolescent pediatric menu for Sunday nutrient analysis provides only 1 ½ cup of milk for the total day. The milk group is not met for this age group. The milk group is short by 1/1/2 cup of milk for that day.
The Adult nutrient analysis for Sunday states the patient is to receive 1 ½ cup of milk for the day. The milk group is short by 1 ½ cup Milk for that day.
In addition, upon reviewing the nutrient analysis for the Diabetic Consistent Carbohydrate Diet, the basic food group for Milk is not met.
Examples:
A) Sunday Nutrient Analysis for "Low" Consistent Carbohydrate Diet- the patient would receive For Breakfast - 4 ounces (oz) 1% Milk; Lunch - No Milk, Dinner - No Milk; and Evening Snack - 8 oz. Diet Gingerale instead of milk. The patient would only receive 4 oz. milk for the day. The Milk Group is not met and the provision of Diet Gingerale instead of milk is not a standard of practice.
B) Sunday Nutrient Analysis for "Moderate" Consistent Carbohydrate Diet - the patient would receive for Breakfast 4 oz 1% Milk, Lunch 4 oz. 1% Milk, Dinner 4 oz 1% Milk for a total of 1 ½ cup of milk for total day. The milk group is not met for this diet. The patient would also receive as part of his evening snack 8 oz. of Diet Gingerale instead of milk which is not a standard of practice.
C) Sunday Nutrient Analysis for the "High" Consistent Carbohydrate Diet - the patient would receive 1 ½ cup of 1% Milk for the total day. This amount does not meet the need of the basic food group for Milk. The patient would receive as part of their evening snack 8 oz. Diet Gingerale instead of milk. The provision of 8 oz. of Diet Gingerale instead of milk as part of a diabetic evening snack is not a standard of practice.

3 - "The Patient Care Associate (PCA) was interviewed in the kitchen by the surveyor on 1/20/15 at approximately 12:30 PM. The Food Service Director and Administrator was present during the interview. The surveyor asked the PCA how he knows what foods selections to offer if a patient has more than one diet restriction. He informed the surveyor he only knows what foods not to give. If a patient wants a different food than what is offered he cannot give it. When this information was shared with the Contractor's Clinical Administrator, her response was the employee needs more training. The surveyor reviewed the PCA training guide titled "Expressly for You Personal Service Dining". The guide / pamphlet, printed using a very small font, had 43 pages of lists with foods to avoid for different diets, a significant amount of information that PCA's would have to learn and commit to memory. For a prescribed therapeutic diet ensuring that the diet restrictions are followed is key, if staff were using a menu tailored to meet those restrictions there would be less potential for error than if a menu was used that relied on staff's understanding and memory of what items are restricted.
4 - The nutrient analysis for the Regular diet on Sunday Lunch states Roast Chicken. The nutrient analysis for the Low Fat - Low Cholesterol Sundays Lunch states Roast Chicken. Both Roast Chicken items have the same amount of cholesterol in the nutrient analysis, therefore, the Roast Chicken for both diets are the same. For the Low Fat- low Cholesterol the Roast Chicken should be Skinless, however, according to the nutrient analysis and menu both diets are receiving the same roast chicken with the skin. Therefore, the diet for Low Fat - Low Cholesterol, as according to the diet manual and training pamphlet for the PCA, is not being followed. This Low Fat-Low Cholesterol diet for Sunday does not meet the physician prescribed diet.
5 -The Pediatric menu was not age specific. Food items and portions were listed for an adolescent and not for a toddler or school age child. An example - Monday Lunch Pediatric entrees are: Macaroni and Cheese served with tomatoes and okra - 8 oz; Dinner Seasoned Roast Beef - 3 oz, with gravy - 2 oz, Served with mashed potatoes - 4 oz, and with French cut green beans - 4 oz
The food portions are too large for the toddler and school age group. When a parent receives this menu with these portions - they may think that these are the appropriate portion size for a toddler, which could contribute to child obesity at home.
6 - The menu lists a diet titled "Chopped". There is no diet in the diet manual titled "Chopped".
The diet manual states that foods requiring to be chopped is titled "Mechanical Soft" . The physician diet formulary does not have a diet titled "Chopped". The menu diet prescription for chopped is erroneous.
7 - The menu lists a number of diets that are incomplete. One menu states Renal, but does not specify the restrictions and amounts for this diet (e.g.., sodium, potassium, phosphorus or fluid); Low Fat- Low Cholesterol does not specify type or amount of fat and amount of cholesterol restriction; Heart Healthy - the restrictions are not specified for this diet.
The diets listed on the menu are incomplete and non-specific. The patient should know from their menu the diet restrictions the physician has prescribed.
8 - The menu notes "Other modifications", The following questions were raised: what does this mean? Is this another diet not included in the physician diet formulary? What does this mean for the patient? A response to these questions was not provided by food service staff.
Based on all of the above findings, it is evident that the mechanism (menu and nutrient analysis) and process used in providing the patient the physician diet prescription was not fully effective and at times not clear or easy for a patient to understand when addressing their diet restrictions.

A review of the physician diet formulary was conducted on 1/20/15 at approximately 12:30 PM. The diet formulary is created by the nutrition division of the Food Service Department for the use of physician in prescribing diet. This formulary is updated when the hospital diet manual has a diet revision.

Present during this review was staff Registered Dietitian #1. The review of the physician diet formulary showed the following deficits that can affect the nutritional care of the patient.
1- Diabetic Consistent Carbohydrate Diet is defined as Low, Moderate and High.
Deficit - This diet does not contain the amount of carbohydrate per day for the different levels.
The physician must be informed of what he/she is prescribing when ordering any of these levels.
2- 2 grams (gm) Sodium (Na) diet is noted as a low salt diet in the physician diet formulary. The low sodium diet is not a low salt diet.
3- Heart Healthy Diet does not delineate the diet restrictions contained in this diet
4- Low Fat - Low Cholesterol Diet does not specify the amount of fat and cholesterol restricted on this diet
5- Renal Diet - does not specify the amount of protein, sodium, potassium, phosphorus and fluid restriction for this diet
6- The Pediatric Diet does not list the age groups for the physician to choose.

Based on observations and staff interview, the facility did not ensure that supplies and equipment were maintained to ensure an acceptable level of safety and quality.

Findings include:

1. On 01/23/15 at 12:00 PM, during survey of the Dialysis unit it was noted that a patient was receiving treatment on station #11. The conductivity of the machine was reading 14.1. The nursing staff was asked to show the theoretical conductivity (TCD) of the machine, which indicates the parameters of the actual conductivity to be given to the patient. The TCD for the dialysate prescription of 2 Potassium (K) 2.5 Calcium (Ca) and 138 Sodium /35 Bicarbonate, was reading as 13.8 and the alarm range for the high and low conductivity was set at 13.8 to 14.8.

The staff operating the dialysis machine was not aware of the relationship of TCD and the actual conductivity value.

As per the Fresenius manual the alarm range for the conductivity of the dialysate being given to the patient is set by default, +/- 0.5 of the TCD. With this manufacture's requirement the alarm range should have been 13.3 to 14.3. Thus for this particular machine the conductivity of the dialysate would have go to 14.8 before it would alarm, instead of an alarm at 14.3 which is a default high level of conductivity based on TCD.

The Nephrology Doctor in charge of the Dialysis unit at that time, provided a policy and procedure titled "Conductivity Check/Acute Dialysis Opening Procedures". This policy indicated that the TCD should be 13.7, and using that number the limit should be 13.2 to 14.2.

The policy did not address different baths the unit utilizes which may affect the TCD and hence the alarm range.

No in-service information was provided for the staff regarding the TCD.

2. The Bio-Med technician was asked to provide information for the change of the deaeration brush at 8000 hours (hrs) as required by the manufacturer. The Bio-Med Tech acknowledged that there was no tracking done to ensure the brushes are changed at every 8000 hrs and stated that it is the vendor's responsibility.

Surveyor requested information for the brush change on machine #10 (serial number 22765) which is currently clocking 24581 hours and had its annual preventive maintenance on 11/14/14. The documents provided from the vendor dated 11/15/14 did not indicate information of change of the brush or use of the brush as part of the preventive maintenance.

It is to be noted that vendor does specify use/change of 'Motor Brush , Hard 12 millimeter (mm)) in their documentation if deaeration brush is used such as they documented it for machine #2 (serial number 28330) which is currently clocking 9628 hours and had its annual preventive maintenance on 11-10-14.

Similar issue of no information and documentation for deaeration brush change for machines clocking more than 8000 hrs was noted for other dialysis machines in the unit. Thirteen machines out of 15 machines present in the unit are clocking hours between 14180 to 26651.

Findings were verified with Bio-Med technician and Director of Regulatory Affairs.

Based on interview it was evident that the infection control officer did not ensure that the infection control program was integrated into both medical records and the lab.

Findings include:

At interview with the infection control director on 1/22/15 it was reported that the infection control department has not established a satisfactory method of co-coordinating reporting with the medical records department to obtain a list of the targeted International Classification of Diseases - Ninth Revision (ICD-9) codes procedures for reporting. This resulted in the facility having to remove 19 surgical procedure denominators from National Healthcare Safety Network (NHSN) for procedures that were not reportable. This would result in higher infection rates as the denominator is decreased and the numerators (infections) is increased. Such incorrect information renders the reporting of actual infections to be inaccurate.

It was acknowledged that the infection control department acted in reliance of an incorrect blood culture report. This was not a patient error, but rather a statistical error.

The lab supplied an instrument generated (Micro-scan) list of blood cultures, not a report (an LSI report), that would have included all positive bloods, with or without susceptibilities.

A. Based on record review, interview and observation it was evident that the hospital did not formulate a system to ensure that any projects are subject to a risk assessment for possible exposure of patients to infectious waste.

Findings include:

On 1/25/15 at approximately 2:00 PM on unit Room # A8-401, it was observed that both doors to the soiled utility room (401) were wide open to both nursing units. The soiled utility room has 2 doors opening to 2 separate nursing units. The room contained soiled items, an unused bedpan hopper and an industrial size sink.

Two contracted maintenance workers were found in the room performing a repair of the damper system. This type of work required opening a portion of the ceiling. No partition was found in the room to minimize the spread of matter. The facility had partitions for the purpose of sealing off work areas to minimize patient and staff contact with infectious waste.

During an immediate interview with the workers, they stated that they were working on the dampers. Their supervisor was asked if anyone in the facility was aware that the doors were open. He stated that did not know.

The facility was unable to provide any risk assessment for this project

At interview with the Infection Control Director 1/25/15 at 2:15 PM , it was stated that he was not aware of this project.

No risk assessment for this project was furnished during the survey.


B. Based on observation and interview, it was evident that the facility failed to ensure that isolation notices posted next to the doors of rooms of patients who are on contact precautions are visible and readable.

On tour of the facility, on 1/22/15 several contact isolation signs were noted posted outside rooms. The last portion of the sign was not visible or readable and contained vital information regarding instructions for visitors. The background of the signs is deep red to maroon and the lettering is black which fades into the deepening maroon at the bottom third of the sign. At interview with nursing staff (Nursing supervisors) on the units, it was found that they acknowledged that the instructions were not legible.







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C. Based on observations, staff interviews and document reviews, it was determined the infection control officer was not effective in her role to ensure that patients receive care in a sanitary and clean environment to prevent and minimize the risks of infections and cross contamination.

Findings include:
(1) During the tour of the facility from 01/20/15 to 01/30/15 between 11:00 AM to 3:45 PM, the grills, perimeters and floors in various areas of the facility were noted to be dusty and dirty.

The examples included, but were not limited to:
i. On 2nd floor near Operating Room suite, a lot of dirt and dust was noted in the corners and behind the fire/smoke double doors.
ii. The sterile supplies room in the Operating room suite had dusty and dirty perimeters. Also the wall in the room was noted in disrepair, specifically, there was a hole in one area.
iii. Around the Operating room doors, accumulation of dust and dirt was observed. (such as OR #8, OR #11 and others).
iv. The mechanical ventilation grills were noted laden with dust in the operating rooms.
v. The track of Isolation room A1-531 in the Emergency Department had a broken door track and lot of dust and dirt was observed accumulated around it.
vi. The Quiet room in the Emergency Department was noted having dirty exhaust grill and the perimeters were dusty and dirty.
vii. The data and electrical closets in the facility, especially in areas such as the Transplant Unit on 8th floor was noted having very dusty and dirty floors. As soon as the doors were open for such rooms/closets, dust started spreading in the air and spilled outside the rooms/closets.
viii. The ceiling tiles in the Step-Down unit of Neurology-7th floor were observed very dirty and dusty.
ix. In the Neonatal Intensive Care 3rd floor, the mechanical vents by bed/bassinet #1 and #4 were noted dusty and dirty. Dirt was accumulated behind the head boards that are open to the surrounding area.

(2) During the tour of the Operating room suite-2nd floor on 01/20/15 at 12:15 PM, it was noted that almost all operating room floors had numerous patches resulting from repairs. The patches appeared of different material than the floor material. Furthermore there were still areas in some ORs that exhibited gaps and were in disrepair (such as OR #11 and OR #2)

As per American Institute of Architects (AIA) 1996-97 section 7.28.B4 "Floor materials shall be easily cleanable and appropriately wear-resistant for the location". The code further states "In all areas subject to frequent wet-cleaning methods, floor material shall not be affected by germicidal cleaning solutions."

The facility was requested at the time of observation to provide information on the material used for patching.

On 01/21/15 at 11:00 AM, Director of Facilities/Engineering (DOFE) provided the surveyor with the information that the Operating Room has "Resin mix" floor and the patch used is "Rockite" which is a Portland cement. The DOFE acknowledged that the way to fix disrepair in a resin mix floor is to patch it or repair it with the same material and not use any other product.

As per the manufacturer information available on company website, Rockite should not be used on wet locations and also that it is not waterproof. Therefore, this indicates that if body fluid spills occur, then there cannot be thorough and effective cleaning to ensure no cross contamination occurs.

(3) During the tour of the facility from 01/20/15 to 01/30/15 between 10:30 AM and 4:00 PM, following areas were observed exhibiting wrong air flow/pressure:

i. The Clean utility room across in the Emergency Department exhibited negative air pressure instead of the required positive air pressure. The door of the room also lacked self-closure.

ii. The Sterilized supply room (A2-515) in the Operating Room suite exhibited neutral air pressure instead of the required positive air pressure.

iii. The Soiled Utility room # A1-541 in the Emergency Department exhibited neutral air pressure instead of the required negative air pressure.

iv. The Soiled Utility room # 8-SC04 in the Transplant Unit-8th Floor exhibited neutral air pressure instead of the required negative air pressure.

v. The Soiled Utility room # A7-404A on the Med/Surge unit 7th floor, exhibited positive air pressure instead of the required negative air pressure.

vi. The Medication room on the Med/Surge unit 7th floor exhibited negative air pressure instead of the required positive air pressure.

vii. The Housekeeping closet room # A7-338, exhibited neutral air pressure instead of the required negative air pressure.

viii. The Decontamination room of the Endoscopy reprocessing room exhibited neutral air pressure instead of required negative air pressure.

ix. In the afternoon of 01/20/15 at about 02:00 PM, it was observed that the Clean Central Sterile Supplying/processing area was strongly negative to the adjacent area. Therefore the air from the dirty area was flowing into the clean sterile area.

During the observation of wrong air flow/pressures in the above examples from between 10:30 AM and 4:00 PM, no explanation or reason was provided for the rooms not being in compliance.

(4) On 01/20/15 at 2:15 PM the temperature of the Central Sterile Processing Room was noted to be 80*Fahrenheit (F). Similar temperature was noted in the Decontamination room. In reviewing the log of January 2015 it was observed that the temperature for this area was continuously between 80*F to 78*F. As per Central Sterile Processing Room staff , the Engineering Department was notified of the high temperature issue. No documentation or follow up was provided regarding the communication of the issue and resolution.

(5) During the tour of the the sterilizer work area/Clean Sterile Processing room on 01/20/15, no audible and visual alarm was noted for exhaust system which is intended to alert the staff to the loss of air-flow as required by AIA 1996 7.31.D19 and thus ensure appropriate infection control is maintained.

(6). During the tour of the Central Clean Sterile Processing room on at 01/20/15 at 2:00 PM, the document review for sterilization records revealed that the facility is not performing the 48 hour Biological Indicator test.

The Director of Sterilization Services stated that the facility is utilizing "3 M Attest (Trademark) Super Rapid 5 steam-plus challenge pack 41482V" and thus are not required to perform 48 hour Biological Indicator test.

Centers for Disease Control in their "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" states that:
"A rapid-readout biological indicator detects the presence of enzymes of G. stearothermophilus by reading a fluorescent product produced by the enzymatic breakdown of a nonfluorescent substrate.
The rapid-readout biological indicator is a dual indicator system as it also detects acid metabolites produced during growth of the G. stearothermophilus spores. This system is different from the indicator system consisting of an enzyme system of bacterial origin without spores."
As per the manufacturer, 'in the use of rapid-readout biological indicators the studies and data collected indicates that most growth visual positives were detected by fluorescence within 3 hours of incubation and by the visual pH color within 48 hours of incubation. (pH is a measure of the acidity or basicity of an aqueous solution. Solutions with a pH less than 7 are said to be acidic and solutions with a pH greater than 7 are alkaline.)


Therefore, by not having a 48 hour reading for pH (which is acid metabolites) the Biological Indicator results are not comprehensive.
The manufacture recommends to incubate the positive control and sterilized Biological Indicators for 3 hours. The final fluorescent negative biological indicator reading is to be made at 3 hours.
Furthermore, the processed biological indicator and the positive control may also be further incubated at 60°Centigrade (C) for a visual pH color change. The biological indicators are examined for early detection of positive results (media turns yellow) at convenient time intervals such as 12, 18 and 24 hours. The final negative reading (media remains purple) for a visual pH color change is made at 48 hours. The positive control should show a yellow color change of the growth media within 48 hours.
The appearance of a yellow color in the processed indicator demonstrates bacterial growth and a sterilization process failure. No color change (i.e. media remains purple) indicates an adequate sterilization process. A final negative result is made after 48 hours of incubation. The positive control indicator should show a color change from purple to yellow for the processed indicator results to be valid.

Above findings were verified with Director of Sterilization Services and Director of Infection Control.


(7)(a). On 01/20/15 at 1:00 PM, the Operating room staff were interviewed regarding how the humidity and temperature in the Operating Rooms are maintained. The nursing staff and Director of Environmental Health and Safety (DEHS) stated that the humidity and temperature is monitored through a computerized system and the staff also notes the value on the monitoring console installed in each room. The staff also stated that the computer readings are displayed on a master readout console by the nurse's station.

During the tour of the Operating room suite it was noted that OR #11 did not have a temperature/humidity monitoring console in the room. When the main display from the computer system was observed near the nurse's station, the humidity in OR #11 was observed to be 11.2%.

Following were the other humidity ranges of the OR rooms that were out of range in the display of the master readout console :
a. OR #4 = 15.8% where as the OR room console was reading 20%
b. OR #5 = 18.7% where as the OR room console was reading 19%
c. OR #8 = 19.8% where as the OR room console was reading 19%
d. OR #9 = 16.9% where as the OR room console was reading 20%

The DEHS was asked regarding the discrepancy and which reading was correct. The DEHS did not have an answer for why the computer display readout was so much out of range. Furthermore, DEHS and other engineering staff were requested to provide information or trending of humidity for past months and it was not provided.

On 01/21/14 at 11:00 AM, DEHS stated that the computer system readout console is experiencing calibration issues. Surveyor was not told how long the issue was going on and if the staff were aware of the issue before the survey.

(7)(b). The humidity in the Sterile Supplies room in the Operating Room suite was noted to be 18% on the wall's monitoring console. This was noted to be below the facility's policy of having minimum 20% humidity.

(8). During the observation of the Triage room in the Emergency Department on 01/20/15 at 3:00 PM, it was observed that the triage room does not have negative air pressure, which is needed to ensure that the patients and staff are safe from a possible air-borne infection.

American Institute of Architects (AIA) 1996-97 section 7.9.D3 states that:

"The triage area requires special consideration. As the point of entry and assessment for patients with undiagnosed diseases."

Above findings were verified with Director of of Environmental Health and Safety and Director of Infection Control during the times of observations.


(9)(a). As per AIA 7.9.D22, at least one airborne infection isolation room should be provided complying with the requirements of Section 7.2 in the emergency department. Section 7.2.C4 states that "air borne infection isolation room shall have self-closing devices on all room exit doors." During the survey of the Emergency Department on 01/20/15 at 2:30 PM, it was noted that the facility has two rooms designated to be isolation rooms. Isolation room #A1-531 did not comply with all requirements of Section 7.2. The isolation room did not have self-closure or self-closure mechanism installed at the room exit sliding door.


(b). The isolation rooms in the Emergency Department including, but not limited to isolation room #A1-529 did not comply by requirement of AIA 1996-97 section 7.28.B8. The ceiling tiles were porous and were of such material that they would not minimize the retention of dirt as required and would not be thoroughly washable/cleanable.

Similar issue of porous ceiling tiles in the isolation room was noted in other isolation rooms of the facility such as the isolation room on Med/Surge Unit-7th floor and isolation room in Neonatal Intensive Care unit-3rd floor.

10. During the tour of the Clean Linen room/Laundry in the basement conducted on 01/22/15 at 3:30 PM, following issues were noted:
i. The room was very dirty and dusty. There was thick layer of dust accumulation on pipes, ducts, vents and all around the perimeter of the room.

ii. The clean linens were stored in such a way that they were directly under the dust laden ducts and vents. Some linens were leaning against dusty pipes. These linen are used by patients in all patient care areas in the facility.

iii. The room did not have any drop ceiling to prevent cross contamination from the dust to the clean linen. As per AIA 1996-97 section 7.28.B7 "In dietary areas and in other areas where dust fallout may present a problem, provide suspended ceiling".


11. During the tour of the facility from 01/20/15 to 01/30/15 between 10:30 AM to 4:00 PM, following infection control/cross contamination issues were observed in the facility:

i. The gasket of the refrigerator in the Medical Intensive care unit was noted broken and dirty with thick black accumulation.
ii. The gasket of the refrigerator for the breast milk in the Neonatal Intensive Care Unit (NICU) was noted broken and dirty.
iii. In the Medical Intensive Care unit it was noted that the wall of Bay #8 had brownish stains by the bedside.


12. On 01/23/15 at 3:30 PM, during the tour of the Endoscopy Suite area it was noted that the decontamination room did not contain any handwash sink.

As per AIA 1996-97 section 9.9.B2 a freestanding handwashing fixture is required.

13. During the tour of the facility's Outpatient Clinic at Lefferts Avenue on 01/30/15 between 12:00 PM to 1:30 PM, following issues were noted:
a. The floor and corners of the waiting room were noted dusty and dirty.
b. The Clean Utility room exhibited neutral air-pressure instead of required positive air-pressure.
c. The Soiled Utility room exhibited neutral air-pressure instead of required negative air-pressure.
d. The upholstery of the exam table in room #119 was noted torn.
e. The vaccine refrigerator was noted having dirty gasket with black accumulation in cervices.

All above findings were verified with the Director of Environmental Health and Safety, Deputy Director of Nursing, Interim Assistant Vice President Design & Construction and all other staff accompanying the surveyor during tour / observation.

Based on review of policies and procedures, interviews and observation it was determined that the infection control department failed to formulate and implement policies and procedures regarding the proper cleaning of ventilators between use. The policy was authored by the Respiratory Therapy Department.

Findings include:

Review of facility policy titled "Cleaning of Mechanical Ventilators" (originally issued 3/87, last approved 1/15) prepared by the Director of Respiratory and approved by the Infection Control Director, and Vice President of Facilities, on 1/22/15 at 11:00 AM identified several unsafe practices.

Specifically, no reference is made as to where the cleaning of vents takes place. Section (2) of the above policy describes the need of personnel cleaning the vents to wear personal protective equipment and in fact using eye protection if the circuit is wet or there is any chance of a splash. There was no reference in the policy as to what barriers, if any should be set up if the cleaning takes place in an area proximal to other patients.

At interview with the Assistant Director of Respiratory Therapy on 1/ 22 /15 at approximately 12:00 PM, it was stated that the ventilators are cleaned in a room on the 4th floor. At interview with the Director of Respiratory on 01/22 /15 at 11:00 AM it was stated this room is not used that the vents are cleaned at the patient's bedside and that the disposable parts of the vent are discarded in the regular garbage can in the patient's room. If the devices are visibly soiled they are placed in a red bag in the patient's room. The Director further stated the vents (cleaned and ready for use and dirty) are stored in the Intensive Care Unit (ICU) and that used vents are cleaned in the ICU. The distance between patients' equipment is very short. It was observed that a vent for a patient can be 1 foot from the head of the patient in an adjacent cubicle. This was observed on 1/22 /15 at 12:00 PM in the Medical Intensive Care Unit (MICU). The Director of Respiratory Services was present for this observation.

The policy for cleaning of vents after use was promulgated by Respiratory therapy and approved by Infection Control.

Based on staff and patient interviews, review of medical record and hospital policy, it was determined that the facility failed to consistently ensure that it identified all patients who needed discharge planning evaluations at an early stage of hospitalization. This was evident in four (4) of thirteen (13) medical records reviewed (MRs: #2, #4, #5 & #6).

Findings include:
During the tour of the unit (N81- a medical/ surgical unit), on 1/21/2015 at 11:30 AM, staff #8 stated that the patient in MR #2 was to be transferred to another hospital today.

MR #2 was reviewed on 1/21/2015 at 11:30 AM. It was noted that the patient, a 67 year old male, with history of large B cell lymphoma, hypertension, heart disease a fib (atrial fibrillation), prostate cancer & Hodgkin's disease, presented to the facility's ED (Emergency Department) from home, on 1/15/2015. The presenting symptoms were syncope episode and dark red loose stools. The nursing admission assessment (Admission Profile), dated 1/16/2015 at 11:41 AM, was reviewed on 1/21/2015 at approximately 11:30 AM. It was noted that there was a discharge assessment note from either the social service or nursing staff. The physician's Discharge Instructions, dated 1/21/2015 (updated on 1/21/2015 13:45), indicated that the patient was transferred to another hospital, at the patient's request.

MR# 4 was reviewed on 1/21/2015. It was noted that the patient, a 73 year-old with history of hypertension, diabetes, chronic heart failure and asthma, was admitted with diagnosis of endometrial hyperplasia. It was noted that this patient was admitted for surgical management on 1/21/2015. The patient was discharged on 1/22/15. It was noted that this patient did not have a discharge planning assessment; this patient was not referred to social work, as per the facility's discharge planning policy.

MR #5 was reviewed on 1/26/2015. It was noted that the patient, a 52 year old female patient with medical history of Crohn's disease, chronic pancreatitis and alcohol abuse, presented with abdominal pain. The patient was admitted, on 9/7/2014, with diagnosis of severe sepsis, and she was discharged on 9/10/2014. It was noted that the patient was evaluated by a psychiatrist who recommended outpatient alcoholic abuse program. This patient did not have a discharge planning assessment and/or evaluation for an appropriate discharge plan.

Similar findings noted for the patient in MR #6 who did not have a discharge planning assessment or complete discharge planning evaluation.

Policy and Procedure No: DP-1; subject: Discharge Planning was reviewed on 1/21/2015.
This policy indicated that "On Admission: Nursing completes the nursing assessment data based within 24 hours of admission. If patient meets hi-risk criteria, refers to social worker for potential psychosocial assessment and/or intervention as appropriate. Social Worker- for cases that are referred by nursing due to hi-risk diagnosis, the social worker documents in the medical record within 24 hours after the referral " . It was noted that the nursing staff was not consistently referring all patients meeting high- risk criteria to the Social Work for discharge planning evaluations. This policy did not specify who is responsible for screening the patient for discharge assessment and discharge planning.
It was noted that the facility's discharge planning policies and procedures did not address all of the requirements of 42 CFR 482.43(a) - 482.43(e).

The discharge planning policy and procedure was discussed with staff #16 and staff #17 on 1/21/2015. The staff stated that the facility has formed a Discharge Planning sub-committee with the focus on undertaking the task of reviewing the hospital's discharge planning process. They also stated that the facility is working on a new discharge planning policy.

Based on staff interviews and review of medical records, it was determined that the hospital failed to ensure that each patient who needed discharge planning has a discharge planning evaluation which entails, individual post-discharge needs, in order to identify the specific areas that must be addressed in the discharge plan. This was evident in five (5) of thirteen (13) applicable records reviewed.

Findings include:
During the touring of the unit N81, on 1/21/2015, staff #2 reported that the patient in MR #3 was to be discharged today, 1/21/2015.
The patient in MR #3 (housed in 801-A) was interviewed at bedside, on 1/21/2015 at approximately 10:40 AM. The patient stated that he was leaving today; he was waiting for his wife to pick him up.

MR #3 was reviewed on 1/21/2015. It was noted, this 75 year old, with history of ESRD ( End Stage Renal Disease) on HD (hemodialysis) , CAD ( coronary artery disease), HTN ( hypertension), CVA ( cerebrovascular accident), dementia and Hepatitis B, presented in the facility's Emergency Department (ED) on 1/19/2015. The chief complaint was chest tightness. The patient was admitted with diagnosis a typical chest pain. The record indicated that prior to admission the patient had home care services. The nursing admission profile, dated 1/20/2015 3:37, indicated that the patient was referred to social work on 1/20/2015. It was noted that there was no discharge planning assessment and/ or evaluation located in the record.

MR #3 was re-reviewed on 1/23/2015 at 1:15 PM after the patient was discharged. The discharge planning evaluation, dated 1/21/2015 12:00 PM, was reviewed. It was noted that the discharge evaluation was completed by a social work intern (SWI). SWI noted patient requested that SWI speak with his wife concerning home care services. The SWI noted patient's wife confirmed that they both received joint services, 7 days a week, Monday - Sunday from 8:00 - 8:00 PM. It's unclear if both patient and the patient's wife received care from the same care provider. The allotted time for each spouse was not documented. The discharge evaluation did not include if the current home care services were adequate for this patient. The Discharge instruction, dated 1/21/2014 at 4:45 PM, indicated that the patient's home care services were to be reinstated. The date and time the home care services were to be initiated was not documented.

MR #7 was reviewed, while on the unit NS61, on 1/22/2015 at 2:25 PM. It was noted that the patient , a 65 year old female with medical history of ESRD (end stage renal disease) on HD (hemodialysis), DM (diabetes), CAD (coronary artery disease), hypothyroidism, and HTN (ypertension), was brought to the Emergency Department (ED) by ambulance, after she was found unresponsive and in complete heart block. The patient was admitted to MICU (medical intensive care unit) on 1/5/2015. It was documented that the patient's condition improved; she was transferred to a regular unit where she was waiting short term rehabilitation placement. There was no discharge planning evaluation found in the record during this review.

MR #7 was re-reviewed on 1/23/2015 at approximately 3:30 PM. The Social Work notes which was documented in the General Discharge Summary, last updated dated 1/23/2015 13:34 (1:34 PM), was reviewed. The social work noted that the patient is being discharge on 1/23/2015. Patient was accepted to ---- Nursing Home. The discharge evaluation did not include the care that the patient will need after discharge. The reasons why the patient could not return to the same setting where she was living prior to admission was not included in the discharge evaluation.

During the unit tour on 1/22/2015 at 3:30 PM, the physician caring for the patient in MR #8 was interviewed. This staff stated that the patient was scheduled for discharged today.
The patient in MR #8 housed in 606 A was interviewed at bedside on 1/22/2015 at approximately 3:40 PM. The patient stated that she was not going to be discharged today because "she was still feeling dizzy". The patient stated that the reason for admission was because she was feeling dizzy at home and she fell. The patient also stated that she had prior home care services, but she was requesting additional services. The patient stated that she needs additional assistance at home especially during the nights. It was observed that the patient had visual bruises on her face. The patient stated that the bruises was as a result of the fall.

MR# 8 was reviewed, on 1/22/2015, at approximately 3:45 PM. It was noted that the patient, 77 year old female with history of diabetes, hypertension and pulmonary embolism, presented to the facility's ED (Emergency Department) due to an episode of syncope. The record indicated that home aid found her on the floor, with bruises on her face. The patient was admitted on 1/20/2015. The Social worker (SW) discharge planning notes dated "1/21/2015 at 9:30 AM" was reviewed. The SW noted that the patient lived alone. Patient received seven days a week four hours per day (7 x 4) of home care through --- (a home care provider). The SW noted that the home care services will be reinstated when the patient was medical ready for discharge. It was noted there was no discussion with the patient in order to determine if the patient had any issue with the home care agency or if this agency was addressing all of her home care needs. The SW noted "patient asked for an increase in services; this will be discussed with --- and they will assess her for an increase following discharge". The discharge planning evaluation did not include if the patient would benefit from an increase in home care services. This patient fell at home resulting in hospitalization. The discharge planning evaluation did not include if the current home care services was an important factor or if the patient would required more supervision at home. It was noted that the discharge planning did not include if an alternative plan was discussed with the patient in the event that the increase in home care the services was denied.

MR #8 was re-reviewed on 1/23/2015 at 3: 26 PM. The General Discharge Information dated 1/23/2015 was reviewed. The Social Work discharge notes, dated 1/23/2015 15:31 (3:31 PM), indicated "patient to be discharged with home care services reinstated through ---. Services will start in patient's home tomorrow 1/24/15; patient will go home with her son tonight". It was noted that discharge planning did not included the home care agency's response to the patient's request for increase in home care services. The discharge evaluation did not include if the patient's son would be able to assist the patient so that she may remain in her home if the increase in home care services is not approved.

Similar finding of lack of complete discharge planning evaluations were noted for the patients in MR #9 & #10.

Based on staff interview and medical record review, it was determined that the facility failed to consistently include the discharge planning evaluation in the patient's medical record, where it would be available to guide the development of the patient's discharge plan. This was evident in three (3) of thirteen (13) medical records reviewed.

Findings include:

MR #7 was reviewed on 1/22/2015 at 2:25 PM. It was noted that the patient , a 65 year old female with medical history of ESRD (end stage renal disease) on HD ( hemodialysis), DM (diabetes), CAD (coronary artery disease), hypothyroidism, HTN hypertension, was brought to the Emergency Department (ED) by ambulance, after she was found unresponsive and in complete heart block. The patient was admitted on 1/5/2015. It was noted that there was no discharge planning evaluation notes located in the record.
An attempt was made to interview the patient who was housed in 610A. The patient appeared confused as she was unable to discuss her discharge plan. She was unable or unaware that the discharge plan involved placement in a short term rehabilitation facility.
The discharge planner assigned to this patient was interviewed on the unit on 1/22/2015 at approximately 3:00 PM. The staff #11 stated that she completed her discharge planning evaluation notes the night before, but she was unable to locate the pages which contained her evaluation in the medical records.

MR #10 was reviewed on 1/26/2015. It was noted the patient, a 78 year-old male history of progressive supranuclear palsy was admitted on 8/15/2014. The record indicated that he was admitted for syncope due to orthostatic hypotension with a component of Parkinson ataxia and vascular dementia. On 8/20/2014, the physician progress notes indicated that "the disposition was SAR (short term rehabilitation), SW on the case". Social work discharge note, dated 8/21/2014 15:48 (3:38 PM), "patient is being discharge to ------ nursing home. Patient's family is aware of the discharge. At this time no further services needing". It was noted that the documentation regarding the development of the discharge plan could not be found in this medical record.

Similar findings noted for patient in MR #5 who lacked the documentation in the record on the development of the discharge planning evaluation.

Based on review of medical records and hospital's policy, it was determined that the facility failed to present to patients for whom home health care services are indicated in the discharge planning evaluation, list of home care agency (HHA). This was evident in two (2) of thirteen (13) medical records reviewed (MR #s #9, #10)

Findings include:
MR #9 was reviewed, in the unit N71 on 1/22/2015 at approximately 3:55 PM. It was noted that the patient, 80 year old male, with history including Multiple Myeloma on chemotherapy, Diabetes, ESRD (end stage renal disease) on HD (hemodialysis) was brought to the facility's ED (Emergency Department) by emergency services from the dialysis center after the patient was noted to be having chills and shaking, on 1/19/2015. The patient was admitted with fever.
The discharge planning evaluation was reviewed. It was noted that on 1/21/2015 at 4:00 PM, the SW noted "patient does have home care but short term; patient expressed wanting long term home care". It was noted that the discharge planning assessment did not include date the short term home care services will end. The SW noted "patient stated he has MSHS (name of home care agency) in the home now; referral made to the home care agency ". There was no discussion that there was a discussion with the patient about making referrals to other home care agencies or exploring with the patient other home care agencies which may meet the patient's home care needs. The patient was not given a list of home care choice.
SW noted received message from the patient's home care agency stating that "the patient would benefit from long term but has not make the necessary call to have this put in place. Patient is scheduled for 1/22/15. SW will follow". The patient was discharged on 1/22/2015. There was no other SW progress notes.
The General Discharge Summary updated by social worker 1/22/2015 13:03 (1:30 PM) was reviewed. Social Work notes: "referral made to MJHS (name of home care agency) nursing services, social work, physical therapy and assess PT (physical therapy) with long term home care. As patient has expressed a need for this service". It was noted that the patient was discharged before the required services was put in place.


MR #10 was reviewed on 1/26/2015. It was noted that this patient was recently discharged from this facility to a skilled nursing facility on 8/21/2015. The patient was readmitted to this facility on 8/22/2014. It was noted that the physician documented in the record "patient, 78 year old know to be hypertensive and vascular dementia was discharged from this facility on 8/21/2015 the patient was sent back from the nursing home due to reported aggressive behavior. The patient was evaluated and found to be medically stable but the nursing home refused to take the patient back. The patient was readmitted to the medical floor for placement". The physician noted that it was difficult to find placement as no nursing home wanted to take the patient with history of agitation. The physician noted that the family agreed to take the patient home and arranging private care. The patient was discharged to home on 8/29/2014.
Social work note updated dated 8/29/2014 indicated that a "referral was made to VNS for nursing services, physical and occupational therapy plus asses PT for home care services". There was no documentation that the home care services was approved. The family was not given choice of home care services.

Policy No: DP-1 was reviewed. This policy indicated that if the patient requires skilled nursing home care services, social worker is to present the patient or family a list of Certified Home Care Agencies. The hospital failed to steps to assure that its discharge planning policies and procedures are consistently implemented.

Based on interview it was determined that the hospital did not ensure that all personnel who are assigned to the Emergency Department (ED) on a regular basis, but are not ED staff are adequately trained in the rights of all persons in the access of services.

Findings include:

At interview with the University Hospital Police Officer at the fixed post in the ED EMS (Emergency Medical Services) access ramp on 1/ 20/15 at 10:00 AM, this officer was asked what he would do if a person came in walking up that ramp who was not brought in by EMS, but who had a medical complaint. He replied that he would direct the patient to walk around the corner and go to "walk in triage".

Interview with the Hospital Police Director on 1/20 /15 at 11:00 AM, acknowledged that this officer was not correct and that that all officers are trained that all patients are to be allowed into ED triage and never to direct a patient out of or away from the ED or the hospital.

Review of officers' files found that they receive training in EMTALA rights. However, there is no specific training that would address an issue where the patient is not being "turned away", but instead is directed to another entrance to the hospital.

Based on record review, review of policies and procedures, employee files and job descriptions, interview and observation it was evident that the emergency department (ED) did not formulate and implement a policy to ensure the safe triage for patients.

Findings include:

During the tour of the ED on 1/ 20 /15 at approximately 11:00 AM, a staff member in a nursing uniform was observed taking vital signs and interviewing patients in the corner of the ED waiting room. She had her own desk, a computer terminal, and electronic vital signs machines, Her location in the ED waiting room was proximal to the Registration clerks and the nursing triage booth.

At interview with this employee (#1) on 1/20/15 at 11:15 AM, it was stated that she reviews the blue card that is filled out by the patient which includes an area titled "Reason for visit" and that she enters this information and any other assessments into the ED computer. She asks the patient for any other complaints and she stated that if the patient "looks sick" she relates this assessment to the triage nurse and ensures that this type of patient would be seen immediately by the triage nurse. She stated that she received no formal training for patient assessments related to her role in the triage process in the ED. Further interview indicated that she was a Nursing Assistant.

Review of ED triage policies and procedures titled "Triage of Patient" effective date 4/12 on 1 / 20 /15 found no references to this practice and the use of a Nursing Assistant for triage activities . Review of patient ED records found that this assessment was documented by this employee and past ED records found that Nursing Assistants regularly performed these tasks.

Review of the personnel record of the interviewed employee found no evidence of this practice in her job description and no training specific to the role of assessment or triage of ED patients.