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BO. MONACILLOS CARR 22 CENTRO MEDICO DE PUERTO RIC

SAN JUAN, PR 00935

No Description Available

Tag No.: A0264

Based on the review of quality assurance activities with employee #6 (this person previously held the position as the Quality Assurance Officer) and interview with the facility's administrator (employee #8), it was identified that the facility failed to ensure that the quality assurance program requirements are met related with the failure to appoint a quality assurance officer.

Findings include:

During the review of the facility's hospital-wide quality assurance program activities it was identified that the Quality Assurance Officer resigned from her position on 3/25/11. The facility's quality assurance program policies were reviewed with employee #6 (this person previously held the position as the Quality Assurance Officer) on 4/8/11 at 11:53 am and provided evidence that a quality assurance officer must be appointed as part of the leaders to be in charge of coordinating and facilitating quality assurance activities among services in order to ensure that services are provided to patients with high quality. The facility's administrator (employee #8) was interviewed on 4/8/11 at 1:57 pm and he stated that the facility has not made and official appointment for the person who is going to be in charge of the quality assurance program coordination responsibilities.

No Description Available

Tag No.: A0267

Based on review of the facility's hospital-wide patient satisfaction survey with the facility's patient education coordinator (employee #3) and interviews, it was identified that the facility failed to maintain on-going quality assurance activities to ensure facility's patient satisfaction status and blood and components adverse reactions process operations are effective.

Findings include:

1. During the review of the facility's hospital-wide patient satisfaction survey on 4/7/11 at 1:43 pm with facility's patient education coordinator (employee #3), it was identified that operating room services and anesthesia are not included as areas to be evaluated by patients on the satisfaction survey of February of 2011 and March of 2011. The facility's patient education coordinator (employee #3) stated during an interview on 4/7/11 at 2:10 pm that the patient's satisfaction survey instrument was revised in January of 2011 in order to include operating room services and anesthesia as areas to be evaluated by patients, however during the administration of the survey to patients in February and March of 2011, the revised instrument was not used.

2. Review of the incident and accident reports for the month of February of 2011 on 4/8/11
at 9:00 am, it was found that blood components that caused patients' reactions to the transfusion were reported on a medication drug adverse event report form. During interview on 4/8/11 at 10:00 am with the laboratory supervisor (employee #7) she stated that blood component reactions must be reported according with a laboratory mechanisms in order to analyze and report it to the blood bank. If the physician in charge of the patient establishes that the reaction reported was caused by the transfusion, the reaction is dealt with and reported with a mechanism established at the laboratory. If the physician determines that the reaction was not related with the transfusion, an adverse incident report is filed indicating the signs that the patient presented during the transfusion. The risk management program requires adverse events related with transfusions to be reported to the program. The Pharmacy Director (employee #9) stated during an interview on 4/8/11 at 10:48 am that the medication drug adverse event report form must be used exclusively to report drug adverse events. The Pharmacy Director also stated that she had no knowledge that the medication drug adverse event report form was being used to report blood and blood component adverse reaction incidents.

RN/LPN STAFFING

Tag No.: A0393

Based on nursing supervisor roster review and interview with the Director of Nursing (DON) (employee #2), it was determined that the facility failed to provide 24-hour registered nursing supervision during night shifts.

Findings include:

1. During nursing supervisor roster review on 4/8/11 at 8:00 am, the following was found from 4/1/11 through 4/10/11:

a. On 4/2/11, 4/3/11, 4/7/11, 4/9/11, 4/10/11 and 4/11/11 the facility did not have a registered nurse covering 7:00 pm till 7:00 am supervisory shift.

b. On 4/6/11 the facility did not have a registered nurse supervising from 4:00 pm till 7:00 am.

During interview with the Director of Nursing (DON) (employee #2) on 4/7/11 at 10:00 am, she stated that they have a nursing supervisor on-site at the hospital from Monday through Sunday from 7:00 am till 7:00 pm, but from 7:00 pm till 7:00 am there is an on-call nursing supervisor available and nursing personnel are oriented to call the on-call nursing supervisor in the event of a situation or an emergency.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on the observational tour with the Supervisor of Nursing (employee #16), it was determined that the facility failed to ensure that drugs and biologicals are administered by, or under the supervision of nursing personnel in accordance with Federal and State laws and regulations from pharmacy state Law #247 from 2004 (article number 1.02 and article number 1.03).

Findings include:

During the observational tour of the surgery ward with the Supervisor of Nursing (employee #16) on 4/7/11 at 10:40 am, a Zantac 150 mgs tablet, to be given orally (PO) twice a day was observed at the bedside table of the patient in room #226-2. During interview with the patient (R.R #16) on 4/7/11 at 10:41 am, the patient stated that the medication is on the bedside table because when the registered nurse came to the patient's room to administer the medication, the patient had nauseas and the registered nurse left the medication on the bedside table to be taken later.

ORGANIZATION AND STAFFING

Tag No.: A0432

Based on the review of the incomplete medical records report provided by the Medical Record Director (employee #14), it was determined that the facility failed to complete clinical records within 30 days following discharge.

Findings include:

The incomplete medical record report reviewed on 4/8/11 at 1:00 pm revealed that there are 560 incomplete records, 73 from 0-30 days and those over 30 days there are 206 incomplete medical records by nursing staff and other disciplines.

PROTECTING PATIENT RECORDS

Tag No.: A0441

Based on the observational tour of the medical records department with the Medical Record Director (employee #14) and interview, it was determined that the facility failed to ensure that the medical record department allow confidentiality and privacy when the patient is interviewed by medical record personnel.

Findings include

1. During the observational tour of the medical record department located at the basement on 4/8/11 at 1:10 pm, it was observed that the medical record department does not have an area used by facility personnel to interview patients when requesting a copy of their medical record. The medical record department only has and open waiting room and it is in the same area where all persons enter and does not provide confidentiality for all patients (or family representatives) when they need this service.

2. The medical record director (employee #14) was interviewed on 4/8/11 at 1:15 pm and she stated: "The waiting area is used by all patients, families or visitors when they need medical record orientation, interviews or when requesting a copy of a medical record". However, the medical record department does not allow confidentiality and privacy when the persons are interviewed by medical record personnel.

No Description Available

Tag No.: A0442

Based on observations made of the medical records department with the facility's Medical Record Director (employee #14), it was determined that the medical record area failed to provide security for patients clinical records related to the need to protect windows with bars.

Findings include:

The medical record department located on the first floor under the Pavilion was visited on 4/8/11 at 1:00 pm and was found with six aluminium windows that were not protected from illegal access and did not provide security for patient's medical records.

MEDICAL RECORD SERVICES

Tag No.: A0450

Based on the review of twenty-fours close records reviewed (R.R) in the medical records department, it was determined that the facility failed to ensure that six out of twenty-four records contain appropriate documentation related to the completeness and appropriateness of findings by clinical personnel and other staff involved in the care of the patients (R.R #33,
#34, #35, #46, #47 and #48).

Findings include:

1. R.R #33 was reviewed on 4/8/11 at 3:00 pm and failed to provide evidence of documentation of a Nutritional Assessment (patient food dislikes, food allergies, food intolerance, religion, pre-admission diet, previous meal pattern and nutritional plan).

2. R.R #34 was reviewed on 4/8/11 at 3:15 pm and failed to provide evidence of documentation of the physician's discharge summary related to the patient's vital signs. The medication reconciliation form was not performed by the physician. No evidence of the nurse's signature on the physician's order for 11/5/10 at 11:00 am and on 11/7/10 at 5:00 pm. No evidence of the physician's signature, date and hour on the transfusion and components consent form. No evidence was provide that the operation and treatment consent forms were not performed . No provided evidence that the discharge planning ware not performed by the social worker in accordance with policies/procedures and patient's needs.

3. R.R #35 was reviewed on 4/8/11 at 3:07 pm and failed to provide evidence of documentation of nursing progress notes related to Special Operations and Treatment Consent (no evidence was found of the date, hour and physician's license number). No evidence was found of the physician license number on the "Time Out" surgical and invasive procedure form. The operation report form lacks "wound classification". The immuno-deficiency authorization form failed to provide evidence of documentation related to the name of the physician who ordered the blood test and the date when the physician provided the patient's orientation. No provided evidence that the discharge planning ware not performed by the social worker in accordance with policies/procedures and patient's needs.

4. R.R #46 was reviewed on 4/8/11 at 3:20 pm and failed to provide evidence of the patient's signature on the evaluation form of pre-anesthesia on 2/16/11.

5. R.R #47 was reviewed on 4/8/11 at 3:25 pm and failed to provide evidence of the physician's signature on the automatic drug stop order form for 2/11/11. No evidence was found of the nurse's assessment on 2/26/11 for the shifts of 7:00 am to 3:00 pm, on 3/6/11, 3/7/11 and 3/11/11 for the shift of 3:00 pm to 11:00 pm. The medication reconciliation form lacks the date, hour and physician's signature and did provided the medications re-evaluation when the patient was discharged home. Noevidence that nurse's history was not performed on 3/5/11.

6. R.R #48 was reviewed on 4/8/11 at 3:30 pm and failed to provide evidence of the re-evaluation of the patients' plan of care by the staff nurse during the patient's admission and discharged from 1/7/11 through 1/10/11. No evidence was found of the patient's signature on the admission and treatment consent form. No evidence was found of the patient's signature to authorize given information on the consent form. No evidence was found of the re-evaluation of the patient's plan of care. No provided evidence that the discharge planning ware not performed by the social worker in accordance with policies/procedures and patient's needs.

CONTENT OF RECORD: ORDERS DATED & SIGNED

Tag No.: A0454

Based on records reviewed (R.R) with the Medical Records Director (employee #14), it was determined that the facility failed to ensure that telephone orders are signed as soon as possible for one out of twenty-four records reviewed (R.R #33).

Findings include:

1. Evidence was found during records reviewed on 4/8/11 from 1:00 pm till 5:00 pm and of the review of policies and procedures related to the timeliness of countersignatures when telephone orders are used and it states that the physician has 24 hours to countersign the telephone order.

a. R.R #33 provided evidence on 4/8/11 at 1:00 pm, that a telephone order's was placed on 10/31/10 at 6:00 pm and 9:30 pm and no evidence was found that the physician countersigned the ordered.

CONTENT OF RECORD: INFORMED CONSENT

Tag No.: A0466

Based on the review of twenty-four closed clinical records, policies and procedures, it was determined that the facility failed to ensure that informed consent forms for procedures, treatments and surgery intervention by medical staff are properly executed for four out of twenty-four records reviewed (R.R #34, #35, #44 and #48).

Findings include:

1. One out of twenty-four clinical records reviewed (R.R #34) revealed that the consent for transfusion administration of blood and components did not have the date, hour and physician's name and signature.

2. One out of twenty-four clinical records reviewed (R.R #35) revealed that the general admission and treatment informed consent forms were incomplete for the physician's date, hour and license number.

3. One out of twenty-four clinical records reviewed (R.R #44) revealed that the surgery or procedure consent lacks the physician's name and did not specify the risks or complications during the surgery or procedure.

4. One out of twenty-four clinical records reviewed (R.R #48) revealed that the general admission and treatment informed consent forms were incomplete for the patient's signature.

ADEQUACY OF LABORATORY SERVICES

Tag No.: A0582

1. Based on quality control records review and laboratory testing personnel interview at 9:43 AM, it was determined that the laboratory failed to document the laboratory ' room temperature and humidity.

The finding includes:

a. Review of laboratory quality control records showed that the laboratory did not document the histopathology room temperature since March 30, 2011 and humidity since January 2010.

b. The histopathology testing personnel confirmed that the laboratory failed to document the histopathology room temperature and humidity.


2. Based on syphilis serology quality control records review and laboratory testing personnel interview at 9:48 AM, it was determined that the laboratory failed to include a control of graded reactivity and document the reactivity when quantitative RPR tests were performed.

The findings include:

a. The laboratory performed qualitative and quantitative tests for syphilis serology by RPR method (ASI).
b. Review of syphilis serology quality control showed that the laboratory did not document the reactivity in dilutions on :

Date Patient Test Result

12/20/2010 PT # 1 R 1:4

12/20/2011 PT # 3 R 1:8

12/20/2011 PT # 5 R 1:2

c. The laboratory did not include a control of graded reactivity and a negative control when the patient specimens were processed.

3. Based on the review of records and interview with the laboratory director, it was determined that the blood bank did not evaluate a possible platelets transfusion reaction to the patient # 41-41-55.

The findings include:

a. The blood bank used to document possible transfusion reactions the following forms:

i. Blood products release and reactions.
ii. Blood and Products Transfusion.

b. During the evaluation of the quality assurance program two documents were observed:

i. Confidentiality incident/occurrence report.
ii. Adverse reaction - Department of pharmacy.


c. The Confidentiality incident/occurrence report indicated that on September 29, 2010 at 8: 29 pm patient # 41-41-55 had presented respiratory arrest when they transfused the sixth unit of platelets.

d. Adverse reactions - Department of pharmacy form indicated in the severity of the reaction section: " Serious adverse reaction which put at risk the life of the patient".

e. Form sent to the laboratory did not include information about the unit of platelets which was administered at the time of the reaction.

f. The blood bank did not receive the "Transfusion of blood and its components" form.

g. The blood bank not the evaluation to determine whether what happened to the patient was a possible reaction to platelet transfusion.

4. Based on the evaluation of records and interview with the laboratory director, it was determined that the laboratory did not evaluate nor monitor the Quality Assessment Program (General, Preanalytical, Analytical and Postanalytical) according to established procedures since the year 2010.

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on tests performed on equipment and observations made during the survey for the physical environment with the facility's Engineer (employee #5), it was determined that the physical structure and care areas failed to allow staff to provide care in a safe manner ensuring the well being of patients receiving services related to maintenance closets that are not properly maintained, maintenance related to needed paint and repairs at the Intensive Care Unit, patient's room #210 is in need of maintenance, biohazardous closet of the operating suites without an air extractor, front door of the Radiotherapy waiting room was found with regular glass and the Radiotherapy department was found with wall damage and in need of a water fountain.

Findings include:

1. All maintenance closets located throughout the hospital were visited with the facility's Engineer (employee #5) on 4/7/11 from 8:30 am till 4:00 pm. These closets were found without mop hangers or door closers and with missing ceiling acoustic tiles. Also, the maintenance closets of the Intensive Care Unit and at the Pavilion building (top floor) did not have floor sinks.

2. The Intensive Care Unit was visited on 4/7/11 at 9:30 am with the facility's Engineer (employee #5) and provided evidence of the following:
a. The wall behind the bed at cubicle #3 was found with what appears to be water damage and peeling paint.
b. The wall behind the bed at cubicle #4 and the ceiling were found with what appears to be water damage and peeling paint.

3. During the visit to the second floor nursing ward on 4/7/11 at 10:10 am with the facility's Engineer (employee #5) observations were made of patient's room #210 and provided evidence that the plastic window screens were not properly fastened to the window frame which allows cool air conditioner air to condensate on these screens. Also, the shower floor is not sloped toward the drain and when patients take showers the water flows out into the patient's room.

4. The Radiotherapy department was visited on 4/7/11 at 9:15 am with the facility's Engineer (employee #5) and provided evidence of the following:
a. The back wall of the "Linear Accelerator" room was found with what appears to be water damage.
b. The waiting room does not have a water fountain.

5. During observations of the biohazardous closet of the operating room department with the facility's Engineer (employee #5) on 4/7/11 at 10:00 am it was found that this closet does not have an air extractor.

6. During the observational tour of the Radiotherapy department on 4/7/11 at 9:10 am, it was determined that the front door of the Radiotherapy department is composed of small glass rectangles in a wood frame. This glass door poses a potential hazard if broken by accident because they are not tempered, laminated or wire mess to prevent shattering.

LIFE SAFETY FROM FIRE

Tag No.: A0709

Based on tests to equipment, interviews and observations made during the survey for Life Safety from fire with the facility's Engineer (employee #5), it was determined that the facility does not meet some applicable provision of the 2000 edition of Life Safety Code of the NFPA 101.

Findings include:

The Life Safety from Fire survey was performed from 4/7/11 through 4/8/11 from 8:30 am till 4:00 pm; for deficiencies related to Life Safety from fire (form 2786R) please see tags with letter K on the 2567 form (K0046, K0051, K0062, K0064, K0072, K0144 and K0145).

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observations made during the survey for the physical environment with the facility's Engineer (employee #5), it was determined that the structure of this facility is not maintained to protect and safe guard supplies and equipment to ensure safety and quality related to regular and biohazardous trash dumpsters not properly moved throughout the hospital and the Chemotherapy department is not properly maintained.

Findings include:

1. During observations of the facility with the facility's Engineer (employee #5) on 4/7/11 and 4/8/11 from 8:30 am through 4:00 pm, large movable biohazardous waste dumpsters and large movable regular waste dumpsters were found being wheeled throughout the facility until they were taken out of the building. However these dumpsters were piled high with trash that surpassed the rim of the dumpsters and they did not have transport covers as they moved through the hospital.

2. The Chemotherapy department was visited with the facility's Engineer (employee #5) on 4/7/11 at 11:00 am and the following was found (the area is presently under construction to correct these findings):
a. Treatment seats were found within two feet from each other instead of at least four feet between each treatment chair to ensure privacy and to provide emergency care if a patient needs it.
b. The emergency call system and pull cords were not located on the side of the toilet in the male and female bathrooms.
c. The walls behind the treatment seats had the appearance of water damage and with peeling paint.

COMPLEXITY OF FACILITIES

Tag No.: A0725

Based on tests performed on equipment and observations made during the survey for the physical environment with the facility's Engineer (employee #5) and interview, it was determined that this facility's physical structure is not designed in accordance with Federal and State laws to provide protection of patients and staff related to handicapped parking in front of the hospital, protective covering at the entrance, the morgue does not have housekeeping facilities, the operating room department is not properly designed and maintained, central supply department and the medical record department have windows that are not protected from illegal access, an unprotected area along the side of the hospital with a nine foot drop and the facility does not have a water reserve tank that will allow it to provide continuos services to patients in the event of a water shut down.

Findings include:

1. The Main entrance of the hospital was visited on 4/7/11 at 8:30 am with the facility's Engineer (employee #5) and provided evidence that there are four handicapped parking spaces near this entrance of the Hospital. The four assigned handicapped parking spaces are along the curb in front of the hospital (one car parked in front of the other in a curved line). However, there is one access ramp to the curb located about ten feet from the first parked car and another access ramp located fifteen feet behind the last parked car which means that persons in the two middle parking spaces have to travel a greater distance in the street in front of the hospital in order to gain access to the side walk of the hospital. The ramp that is fifteen feet behind the last car is too far for handicapped patients in wheelchairs to go down the slope of the hospital's road entrance to gain access to the sidewalk and another access ramp should be place between the second and third car to ensure that handicapped persons spend as little time as possible in the road shared by cars arriving at the hospital. Also path traveled shall be smooth (no holes and clear of debris). According with the regulations from "Americans with Disabilities Act" (Ley ADA) (Sections 4.6, 4.7 and 4.8) the route traveled shall be marked and be the shortest route of travel.

2. Observations made on 4/7/11 from 8:30 am till 8:50 am with the facility's Engineer (employee #5) of patients being dropped off to receive services and patients being picked up after receiving these services (medical appointments, laboratory tests, ambulatory surgery and X-rays are some of the services provided at this facility) provided evidence that the main entrance of this hospital is not equipped with a covered entrance to protect patients from the sun and rain to allow patients to be dropped off and picked in a safe and comfortable manner. According to the Americans with Disabilities Act (ADA) section 6.2, "At least one accessible entrance shall be protected from the weather by canopy or roof overhang. Such entrances shall incorporate a passenger loading zone". (The facility provided evidence of a work order to install a canopy).

3. The patient's bathroom of the Nuclear Medicine Department was visited on 4/7/11 at 9:25 am with the facility's Engineer (employee #6) and provided evidence that it can be locked from the inside and staff do not have a key to unlock the door if a patient requires help. Also, no evidence was found of an emergency call system that patients can activate in the event that they need help.

4. The waiting room of the "External Clinics" on the third floor was visited on 4/7/11 at 9:50 am with the facility's Engineer (employee #5) and it was found that this area does not have a water fountain.

5. The morgue was visited on 4/7/11 at 9:20 am with the facility's Safety Officer (employee #5) and provided evidence that it does not have housekeeping facilities to ensure that spills can be cleaned appropriately and that the area is cleaned after used.

6. The operating suite department was visited with the facility's Engineer (employee #5) as part of the complaint investigation (performed from 1/25/11 through 1/27/11) and on 4/7/11 at 11:30 am the facility's Engineer (employee #5) was interviewed and she stated that the previous deficiencies cited have not been corrected due to the high volume of cases that they see in the operating suites; the following was cited and not corrected:
a. The male and female dressing rooms are not constructed to provide one-way traffic. Staff enter through a door located in a non restricted hallway near the biohazardous closet, into the dressing room where they change from their street clothes into their scrubs and then access the same non restricted hallway in their scrubs and then pass through a door that opens into the operating suite area (semi-restricted).
b. The hospital's operating suite department does not have a designated phase II area. It does not have lounge chairs to place patients after they change back into their street clothes to continue with their stabilization process (lounge chairs should be separated by at least four feet from one another, should have curtains between the chairs). The phase II area needs a hand washing station, should have designated storage space or space for family members, the lounge chairs should be set up so that patients have privacy from one another, but are in the direct line of sight of the nurse. The phase II area also needs a patient's bathroom that complies with "Americans with Disabilities Act" (Ley ADA) related to door width (a minimum of 32 inches is needed), toilet seat height (height should be between 17 and 19 inches) and grab bars (should be located behind and on the side of the toilet).
c. Rust was found on I.V stands and other metal tables in operating suites #1, #3 and #4.
d. Sharp containers were found in operating room suites #1, #3 and #4 placed directly on the floor.
e. The room used to process equipment with Cidex OPA was visited and it did not have an exhaust hood: Manufacturers' recommendations suggests that the solution is used in a well-ventilated area and stored in closed containers with tight fitting lids, and the user must use gloves, eye protection and fluid-resistant gowns. The use of Cidex OPA should be in an area that is ventilated with a local exhaust hood which contains a filter media.
f. Operating suite doors #1 through #6 were found with locks that can lock the doors from the inside, which could impede emergency assistance if needed.
g. Operating suites #1 through #6 were observed equipped with central air conditioner system with returns, however split unit air conditioner were also observed. The split unit air conditioners were cooling the operating suites because the central air condition unit is not working as stated by the facility's Engineer (employee #6) on 1/26/11 at 11:25 am. She stated that the split units are only used if the central air conditioner system is not working. Split unit air conditioners are not recommended in suites because they blow and push air and particles around the suite where as central air conditioning is a constant, even flow. According with "Guidelines for Design and Construction of Health Care Facilities" (GDCHCF) chapter 2.1, Appendix A10.2.2.4, the system should have a single directional flow regime, with both high and low exhaust locations, 20 to 25 air changes per hour and turbulence and air movement shall be considered to minimize the fall of particulates on sterile surfaces.
h. The air "returns" in operating suites #1 and #3 did not work.
i. Operating suites #1 through #6 were observed with exposed oxygen tubing and suction tubing throughout the suites, these tubes shall be concealed behind the walls.
j. The ceiling above the anesthesia cart in operating suite #1 was found with a part that was opened allowing air movement from behind the ceiling into the suite and the floor near the anesthesia cart was repaired in cement which will not allow for proper cleaning.
k. The glass door of the storage cabinet in operating suite #3 did not close which does not protect the material from cross contamination from patient to patient.
l. Operating suites #1 through #6 do not have hands free intercom systems within the suites connected to the nursing station and recovery room.

7. During the outside observational tour of the hospital with the facility's Engineer (employee #5) on 4/7/11 at 8:35 am, it was determined that the entrance of the hospital has a small garden where people can sit on a small wall along the walk way before entering into the lobby of the hospital. Behind the garden of this area is another small wall that is before the hospitals outside wall, from the small wall to the hospital's outside wall there is a space of approximately five to six feet and between this space is a nine foot drop off to a cement floor where the hospital has air conditioner units (and water accumulation in some areas). The small wall is not protected with a fence or other structure to prevent someone from falling into this space (nine foot drop). The height of this small wall is one foot and the unprotected span covers approximately fifteen to twenty feet. (The facility implemented a contingency plan related to frequent rounds and the guard in charge of the parking area in front of the hospital will monitor to ensure that persons do not approach the unprotected area until the fence is repaired).

8. The Central Supply department located at the basement was visited on 4/7/11 at 9:05 am and was found with windows that were not protected from illegal access.

9. A visit to the facility's cistern or water reserve tank was requested of the facility's Engineer (employee #5) on 4/7/11 at 3:00 pm. She stated during an interview on 4/7/11 at 3:05 pm that the facility is supplied by the same water reserve as the entire Medical Center (approximately eight hospitals, medical school, nursing school among other facilities) and she did not know the capacity of the reserve. She also stated that if there is a scheduled water shut off by the local water authority they have a small plastic household water tank that they fill on the second floor so that they can flush toilets and clean the hospital but it is not connected to the hospitals' water pipes. In the event of an unscheduled water shut down or problems with the large water reserve, water shortage or of a natural disaster (hurricane, earth quake) a small plastic household water tank will not be capable to provide enough water to give services to patients. A formal study shall be performed, taken into account the number of floors in the hospital, inpatient area, services provided and estimated potable water used to ensure that a water reserve tank for this hospital is of sufficient capacity.

10. The medical record department located on the first floor under the Pavilion was visited on 4/7/11 at 8:55 am and was found with windows that were not protected from illegal access.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on the observational tour with the Infection Control Officer (employee #12), review of policies and procedures, it was determined that the facility failed to provide standards for infection control for the Intensive Care Unit, housekeeping room and Chemotherapy department.

Findings include:

During the observational tour with the Infection Control Officer (employee #12) on 4/8/11 from 8:30 am till 11:55 am of patient's rooms, waste storage area, housekeeping rooms, supply areas, clean utility room, Intensive Care Unit, Operating room department and Chemotherapy department, the following was found:

1. During a visit to the housekeeping closet located outside of the intensive care unit on 4/8/11 at 9:30 am, a mop was observed on top of the faucet, two full carton boxes were observed directly on the floor near the draining water area. The housekeeping closet lacks hand soap and a dispenser, hand paper and dispenser, holders for mops and duster, hand washing sink, trash can and hand sanitizer.

2. During a visit on 4/8/11 at 10:30 am to the Chemotherapy department area located on the first floor, the walls behind the treatment seats had the appearance of water damage and with peeling paint.

3. The Intensive Unit Care was observed with the following on 4/8/11 at 10:00 am: the wall behind the bed at cubicle #3 was found with what appears to be water damage and peeling paint. The wall behind the bed at cubicle #4 and the ceiling were found with what appears to be water damage and peeling paint.

4. The housekeeping department located at the basement was visited on 4/8/11 at 10:45 am and was observed with very dusty window screens.

5. The last revision of the Procedure Manual of the Central Laundry was performed in February of 2009, no evidence was found of the revision for February of 2011.

DISCHARGE PLANNING - EARLY IDENTIFICATION

Tag No.: A0800

Based on the review of clinical records, policies/procedures and interview with the Social Worker Director (employee #1), it was found that the facility failed to establish the criteria to identify at an early stage of hospitalization all patients who are likely to suffer adverse health consequences upon discharge.

Findings include:

1. During interview with the social worker director (employee #1) on 4/7/11 at 9:30 am related to the discharge planning process she stated that she checks the census every day for new admissions then she performs the initial discharge planning evaluation for all patients during a 24 hour period from the admission or she evaluates them when a consult is placed by a physician. After the first evaluation she performs a discharge plan with the multi-disciplinary group and every three days she re-evaluates the discharge plan. The reassessment is to be performed every three days with the plan or as needed. Related to the quality program she stated that the last quality was performed in December of 2010 and was related to when the discharge date was written, if discharge plans were answered in 24 hours and Transportation services.

2. The facility's policies and procedures related to Discharge Planning reviewed on 4/7/11 at 9:45 am states that Discharge Planning should begin as soon as they determine the patient's needs to facilitate high acute medical care when necessary. However the facility failed to establish a time frame for the initial discharge planning assessment and re-assessment after admission. The facility failed to establish psychosocial risk criteria for identifying patients who are likely to suffer adverse health consequences upon discharge without adequate discharge planning.

3. The facility failed to establish a mechanism of screening according to risk criteria as reviewed on 4/7/11 at 10:45 am. The Discharge planning services failed to perform surveillance of issues which need to be assess to ensure the quality of care offered to patients. The data was not presented as indicators or information obtained in order to present facility approach of quality improvement and patient health outcomes as the result of the care provided by the service.

DISCHARGE PLANNING EVALUATION

Tag No.: A0806

Based on the review of policies and procedures related to the Discharge Planning Program with the Social Worker Director (employee #1), it was determined that the facility failed to ensure that discharge planning has policies/procedures related to a defined time frame to assess patients after the screening.

Findings include:

1. During review of policies and procedures on 4/7/11 at 9:45 am with the social worker director (employee #1) who performs discharge planning, the following was identified:

a. Discharge planning evaluations are performed for patients based on needs identified by screening during admission to the facility. Other patients have to be referred by the physician or nurse to be evaluated by the discharge planning program. However, no evidence was found of policies and procedures related to a defined time frame to perform assessments after the referral or screening.

REASSESSMENT OF A DISCHARGE PLAN

Tag No.: A0821

Based on the review of policies and procedures and six medical records with the social worker director (employee #1), it was determined that the facility failed to ensure that ongoing reassessments are performed for patient's needs for factors that may affect continuing of care.

Findings include:

Policies and procedures were reviewed on 4/7/11 at 9:45 am and provided evidence that they do not address the time frame that reassessments are to be performed.

REASSESSMENT OF DISCHARGE PLANNING PROCESS

Tag No.: A0843

Based on the review of documents and policies/procedures with the Social Worker Director (employee #1), it was determined that the facility failed to ensure that its discharge planning process is reassessed on an on-going basis.

Findings include:

1. Discharge planning services is collecting and reporting to the Quality Assurance Program Statistical Reports instead of reports that include the surveillance of issues related to the discharge date, consults were performed within the first 24 hours of admission and Transportation Services as reviewed on 4/7/11 at 10:15 am. The reports was submitted until December of 2010. No evidence was provided related to the Discharge Planning Quality for the year of 2011. The data was not presented as indicators or information obtained in order to present facility approach of quality improvement and patient health outcomes as the result of the care provided by the service.

2. No evidence was found on 4/7/11 at 10:25 am of an ongoing mechanism to reassess its discharge planning process.

WRITTEN POLICIES AND PROCEDURES

Tag No.: A0885

Based on the review of the policies and procedures, six closed medical records with the Nursing Director (employee #2), it was determined that the facility failed to address and implement written protocols to ensure that the notification to the Organ Procurement Organization (OPO) was documented in the patient's medical records for six out of six medical records (R.R #6, #7, #8, #9, #10, #11).

Findings include:

1. The facility's policies and procedures reviewed on 4/7/11 at 3:30 pm states that nursing professional must be noted on the referral sheet to Lifelink with the time of death and time that the death is reported to LifeLink. The nurse should note in the medical record the reference number that Lifelink provides and the name of the person who took the information.

2. Six out of six closed medical records reviewed on 4/8/11 at 8:45 am for organ procurement organization (OPO) failed to document in the medical record the date, hour, referral number and person to whom it was notified when the referral to Life Link was made (R.R. #6, #7, #8, #9, #10, #11). The facility reports all information needed in the Life Link referral Sheet, however this sheet is not part of the medical record. The Life Link referral Sheet is used to perform OPO Quality and not part of the medical record.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observations made of the surgical department, interview and review of policies/procedures with the Director of Nursing (DON) (employee #2) and Operating Room Manager (employee #15), it was determined that the facility failed to ensure that surgical services maintains a high standard of medical practice and patients' care.

Findings include:

1. Observations made of the surgical department on 4/8/11 from 9:30 am till 12:00 noon provided the following evidence:

a. It is required by local law to comply with the guidelines for Design and Construction of Hospital and Health Care Facilities. These guidelines on table 7.2 (ventilation requirements for areas affecting patient care in hospitals and outpatient facilities) requires that the relative humidity must be kept between 30-60 % and temperature of 68-73?F in the operating suites, the following relative humidity were measured on 4/8/11: in suite #6 the temperature registered 65?F and relative humidity registered 82% at 9:00 am, in suite #5 the temperature registered 66?F and relative humidity registered 76% at 9:15 am, in suite #3 the temperature registered 65.8?F and relative humidity registered 62% at 9:35 am, in suite #2 the temperature registered 64.1?F and relative humidity registered 79% at 9:45 am, suite #1 the temperature registered 65.7?F and relative humidity registered 85% at 10:10 am.

b. The phase I area lacks a sharp container at each cubicle, personnel have to go to the counter area to discard all sharp objects in the sharp container.

c. A large sharp container was found in operating room suites #1, #2, #3, #4, #5 and #6 on the floor without a security rack.
d. The sterile storage room located near the autoclave room at the operating suite department was visited on 4/8/11 at 10:30 am and it was found that the room was warm due to its location near the autoclave room, the temperature was measured to be 77 ?F. The air conditioning was full of dust and the storage cabinet of the sterile material were observed without a door which does not protect the material from cross contamination from patient to patient.
e. The male and female dressing rooms are not constructed to provide one-way traffic. (Please cross refer tag #725, #10a).
f. The hospital's operating suite department does not have a designated phase II area (Please cross refer tag #725, #6b).
g. Rust was found on I.V stands and other metal tables in operating suites #1, #3 and #4.

h. Sharp containers were found in operating room suites #1, #3 and #4 placed directly on the floor.

i. The room used to process equipment with Cidex OPA was visited and it did not have an exhaust hood: Manufacturers' recommendations suggests that the solution is used in a well-ventilated area and stored in closed containers with tight fitting lids, and the user must use gloves, eye protection and fluid-resistant gowns. The use of Cidex OPA should be in an area that is ventilated with a local exhaust hood which contains a filter media.

j. Operating suites #1 through #6 were observed with exposed oxygen tubing and suction tubing throughout the suites, these tubes shall be concealed behind the walls.

k. The glass door of the storage cabinet in operating suite #3 did not close which does not protect the material from cross contamination from patient to patient.

l. Operating suites #1 through #6 do not have hands free intercom systems within the suites connected to the nursing station and recovery room.

m. Two medicine residents were observed on 4/8/11 at 10:40 am using cellular phones in the restrictive area. Policies and procedures states that personal calls must be done during periods of rest.

n. Two anesthetist employee were observed on 4/8/11 at 11:05 am in the restrictive area with a sweater or coat over their surgical scrubs.

o. On 4/8/11 at 10:50 am the anesthesia room was found with the door to access the medication room opened and unlocked and the medication cabinet was found unlocked with medications unattended.

p. The recovery room area was visited on 4/8/11 at 12:00 noon and provided evidence of the following: Twelve IV bags of 5% Dextrose and .9 Sodium Chloride expired since March of 2011. The crash cart was found with three Vacutainer expired since August of 2010.

q. On 4/8/11 from 9:00 am till 11:00 am, it was observed that in the restrictive area an anesthesiologist personnel was using crocs shoes without shoe covers.

r. The housekeeping maintenance room was observed on 4/8/11 at 10:50 am with six mops and six pails with identification labels and one pail and mop for contaminated cases. During interview with the housekeeping personnel (employee #17) he stated that he does not have a mop and pail to clean the area of recovery and hallway, he uses a mop and pail from any suite. This procedures does not protect the facility's patients from possible cross contamination from one suite to the another.

s. The operating department cleaning log book was reviewed on 4/8/11 at 11:40 am and failed to include which chemical products are used to clean the operating rooms.

t. The hallway was observed on 4/8/11 at 9:40 am with the supply cabinet without doors which will not protect its contents from possible cross contamination.

HISTORY AND PHYSICAL

Tag No.: A0952

Based on the review of seven records and policies/procedures of the operating room with the Director of Nursing (DON) (employee #2) and Operating Room Manager (employee #15), it was determined that the facility failed to have complete history and physical work-ups for three out of seven records reviewed (R.R #19, #25 and #26) related to the patient's name, age, sex, record number, physician's name, weight, height, high blood pressure, heart rate, temperature, past history, social history and family history.

Findings include:

1. R.R #19 is a 52 years old female admitted on 3/26/11 with a diagnosis of Left Hip Infection and there is a surgical date of 3/31/11. The record review was performed on 4/8/11 at 11:07 am and evidence was found of an incomplete physician's history and physical work-up related to the patient's name, age, sex, record number, physician's name, weight, height, high blood pressure, heart rate, temperature, social history and family history.

2. R.R #25 is a 42 years old female admitted on 4/7/11 with a diagnosis of Hernia. The record review was performed on 4/8/11 at 11:18 am and provide evidence of an incomplete physician's history and physical work-up related to the patient's name, record number, weight, height, high blood pressure, heart rate and temperature.

3. R.R #26 is a 52 years old female admitted on 4/7/11 with a diagnosis of Failed Left Knee and there is a surgical date of 4/7/11. The record review was performed on 4/8/11 at 11:30 am and evidence was found of an incomplete physician's history and physical work-up related to the patient's name, record number, physician's name, weight, height, past history, social history and family history.

INFORMED CONSENT

Tag No.: A0955

Based on the review of seven medical records and policies/procedures of the operating room with the Director of Nursing (DON) (employee #2) and Operating Room Manager (employee #15), it was determined that the facility failed to execute complete surgery informed consents that includes date, hour and name of patient, name of the anesthesiologist for four out of seven records reviewed (R.R #15, #19, #26 and #28).

Findings include:

1. During the review of seven records on 4/7/11 through 4/8/11 from 1:30 pm till 3:00 pm, the following was determined:

a. R.R #15 provided evidence that the surgical procedure consent form did not include the name of patient.
b. R.R #19 provided evidence that the surgical procedure consent form did not include the name of the anesthesiologist and lacks the date and hour that the consent was taken .
c. R.R #26 provided evidence that the surgical procedure consent form did not include the name of the patient.
d. R.R #28 provided evidence that the surgical procedure consent form did not include the name of the anesthesiologist and lacks the hour that the consent was taken.

REQUIRED OPERATING ROOM EQUIPMENT

Tag No.: A0956

Based on the observational tour of the operating rooms with the Director of Nursing (DON) (employee #2) and Operating Room Manager (employee #15), it was determined that the facility failed to ensure the availability of a call-in system for suite #6.

Findings include:

1. The operating room department was visited on 4/8/11 from 9:30 am till 12:00 noon with the Director of Nursing (DON) (employee #2) and Operating Room Manager (employee #15) and provided evidence of the following:

a. Suites #6 did not have a working hands free intercom systems within the suites connected to the nursing station.

OPERATING ROOM REGISTER

Tag No.: A0958

Based on documents reviewed with the Director of Nursing (DON) (employee #2) and Operating Room Manager (employee #15) and interview, it was determined that the facility failed to ensure that the operating room log registry is complete and up dated.

Findings include:

1. A surgery registration log book was observed on 4/7/11 at 3:00 pm and did not include the following: the total amount of the operation procedure, name of the assistant of the surgeon, name of nursing personnel (scrub and circulating nurses), type of anesthesia used, pre and post-op diagnosis and age of patient.
2. The recovery registry logbook was not updated since 12/17/10. During interview on 4/7/11 at 2:40 pm with the Operating Room Manager she stated that it is not update because the information is listed in a notebook and then they pass it to the registry.

OPERATIVE REPORT

Tag No.: A0959

Based on the review of seven medical records and policies/procedures of the operating room with the the Director of Nursing (DON) (employee #2) and Operating Room Manager (employee #15), it was determined that the facility failed to have complete operative reports that include tissue collected (yes or no), signature of the surgeon, license number, date and hour for one out of seven records reviewed (R.R #28).

Findings include:

1. During the review of seven closed records on 4/7/11 and 4/8/11 from 1:30 pm till 3:00 pm, the following was determined:

a. R.R #28 provided evidence that the operative report did not include tissue collected (yes or no), signature of the surgeon, license number, date and hour.

DELIVERY OF ANESTHESIA SERVICES

Tag No.: A1002

Based on the review of seven medical records to evaluate anesthesia services with the Director of Nursing (DON) (employee #2) and Operating Room Manager (employee #15), it was determined that the facility failed to ensure that informed consent forms are properly executed for one out of seven records reviewed (R.R #25).

Findings include:

1. During the review of seven medical records on 4/7/10 from 11:30 am till 1:30 pm the pre-anesthesia assessment form did not provide space to write the hour that the patient sign.
2. During the review of seven medical records on 4/7/10 from 11:30 am till 1:30 pm the pre-anesthesia assessment form was incomplete due to the lack of the signature of the patient for R.R #25.

POST-ANESTHESIA EVALUATION

Tag No.: A1005

Based on the observational tour through the operating rooms (O.R) and review of policies and procedures of anesthesia services with the Director of Nursing (DON) (employee #2) and Operating Room Manager (employee #15), it was determined that the facility failed to ensure a proper post-anesthesia recovery follow up.

Findings include:

1. The facility's policies and procedures of post-operative calls was reviewed on 4/8/11 at 1:15 pm, it states that patients are evaluated by telephone calls to their homes between 24 to 48 hours after surgery. If they do not make contact within this time they shall extend the time to 72 hours and the files remain in this area.
a. The facility failed to establish the number of phone call during the 24 to 48 hours to estimate the post anesthesia recovery and failed to attach this form to the medical record as reviewed on 4/8/11 at 1:25 pm.