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Based on the review of documents, observations, tests and interviews from 10/30/12 through 11/2/12 from 9:00 am till 4:00 pm, it was determined that the Governing Body failed to carry out its responsibility for the operation and management of the hospital. The Governing Body failed to provide the necessary oversight and leadership as evidenced by the lack of compliance with: Governing Body (42 CFR 482.12), Physical Environment (42 CFR 482.41) and Infection Control (42 CFR 482.42).

Based on the review of documents and the admission packet, it was determined that the facility failed to ensure that patient's rights are promoted regarding complete disclosure in the admission packet related to whom they have to contact to file a grievance.

Findings include:

During the admission process the patient receives an admission packet that was reviewed on 11/2/12 at 2:50 pm with the admission supervisor (employee #9) and it failed to include
updated information of the phone number and address for lodging a grievance with the State agency and the Medicare hot line.

Based on the review of policies and procedures, facility in-service activities and personnel credential files it was determined that the facility failed to operationalize policies and procedures for screening employees aspiring to provide care at the facility.

Findings include:

1. Review of policies and procedures related to Abuse and Neglect protocols on 11/2/12 at 2:40 pm provided the following evidence:

a. According with policies and procedures provided by the facility, all personnel who offer direct care at the facility must be screen in order to identify persons with a record of abuse or neglect. Persons with a record of abuse or neglect should not be hired or retained as employees. However, the only question asked when persons are inquiring about employment is if they were convicted of any crime other than traffic violations.

Based on the review of documents with the quality assurance officer (employee #10), it was determined that the facility failed to ensure that aspects of performance assess processes of care and hospital services and operations are measured and quality indicators are tracked by the quality assurance program.

Findings include:

1. The following information was identified during the review of the quality assurance performance improvement program activities with the quality assurance officer (employee #10) on 11/2/12 at 10:54 am:
a. Discharge Planning services are not complying with the complete quality assurance indicator for the 2012 annual plan. Quality indicators to assess the appropriateness of discharge planning assessment of needs, development of plans, implementation of plans and evaluation of outcomes were not performed or followed from January 2012 through October 2012. The facility failed to determine through the hospital quality assurance performance improvement program if the discharge planning process effectively identified patients who need discharge planning, if the discharge planning process was adequate and whether the plans are effectively executed.

Based on the review of fifty-five staff credential files, it was determined that the facility failed to examine credential files (C.F) to ensure that medical staff have updated Health Certificates, Cardio-pulmonary Resuscitation Certificates (CPR) and Professional College for twenty-nine out of fifty-five credential files reviewed (C.Fs #1, #5, #6, #7, #8, #10, #11, #13, #18, #24, #26, #27, #28, #29, #30, #31, #32, #38, #41, #42, #44, #46, #49, #50, #51, #52, #53, #54 and #55).

Findings include:

1. During the review of fifty-five medical staff credential files on 11/2/12 from 2:00 pm till 3:30 pm, the following was found:

a. Twenty-three out of fifty-five medical staff credential files provided evidence of expired Health Certificates for C.Fs #1, #5, #13, #18, #26, #27, #28 ,#29, #30, #31, #32, #33, #35, #38, #41, #45, #47, #49, #51, #52, #53, #54 and #55.

b. Ten out of fifty-five medical staff credential files provided evidence of expired cardio- respiratory certificates for C.Fs #7, #8, #10, #11, #18, #24, #29, #37, #41 and #55.

c. Three out of fifty-five medical staff credential files provided evidence of expired Professional College certificates for C.F's #7, #42 and #49.

Based on the review of the policies and procedure manual, the manual of abbreviations and personnel signature registry provided by the medical record assistant administrator (employee
#11), it was determined that the facility failed to maintain an updated and approved by the Governing Body abbreviations and signature registry and are reviewed and revised as needed.

Findings include:

1. No evidence was found on 11/2/12 at 2:30 pm of an abbreviation manual that was approved by the Governing Body and includes the pharmacy supervisor's signature of participation. The last revision of the abbreviation manual was in 2007.

2. The signature registry of physicians and other disciplines (nursing, dietitian, respiratory therapist) were reviewed with the medical record assistant administrator (employee #11) on 11/2/12 at 2:30 pm. The signature registry was not updated, did not have the last revision date nor was it approved by the Governing Body.

Based on the observational tour of the medical records department through the central file area with the medical record assistant administrator (employee #11), it was determined that the facility failed to properly secure the central file of the medical record department, it is completely full to capacity and incomplete clinical records within 30 days following discharge.

Findings include:

1. The central file of active records was visited on 11/2/12 from 1:30 pm till 3:45 pm and was found completely full to capacity. The physical area does not have extra space available for new records to be filed. Approximately 200 emergency room clinical records were observed over the counter near the entrance of the medical record room without being filed.

2. The incomplete medical record report reviewed on 11/2/12 at 3:30 pm revealed that there are 1,442 incomplete records over 30 days by the physician, nursing staff and other disciplines. There is an average of 876 monthly discharges.

Based on the review of fifty-three closed and active clinical records with nursing personnel and the Medical Record Administrator assistant (employee #11), it was determined that the facility failed to ensure that medical staff, nursing personnel and other disciplines maintain legible entries for fifty-three out of fifty-three records reviewed (R.R #1 through #53).

Findings include:

Fifty-three clinical records reviewed from 10/30/12 through 11/2/12 from 9:00 am till 3:30 pm contained portions that are not legible. Most notable were the physician's progress notes, nurse's notes, signatures (physicians and nurses), consults, diagnosis, operative reports, informed consent forms, anesthesia reports, discharge summary and physician's orders.

Based on the review of pharmacy reports of inspections of the controlled drug areas with the Pharmacy Supervisor (employee #16) and interview, it was determined that the facility failed to comply with policies and procedures which govern pharmaceutical services, three medication carts had a bag of normal saline on the top of the carts without labels, medication storage room located at the off-site emergency room at "Aguas Buenas" was warm, normal saline was found on a medication cart with a preparation of gentamycin but it did not have the hour when it was prepared on and a syringe was found with a liquid but the syringe was not labeled.

Findings include:

1. During the review of pharmaceutical services administrative duties and responsibilities with the Pharmacy Supervisor (employee #16) on 11/2/12 from 1:00 pm through 3:01 pm the following was found:

a. In August 2012 and October of 2012 the Operating Room, Ambulatory Surgery Area and Endoscope Area controlled medication stocks were not inspected by pharmacy personnel.

b. In August 2012 and October of 2012 the Operating Room, Ambulatory Surgery Area and Endoscope Area general medication stocks were not inspected by pharmacy personnel.


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2. During the observational tour of the second floor on 11/2/12 at 11:45 am with the Pharmacy Supervisor (employee #16), it was found that three medication carts had a bag of normal saline on the top of the carts without labels.

3. The medication storage room located at the off-site emergency room at "Aguas Buenas" was visited on 11/1/12 at 1:15 pm and provided evidence that this room was warm. This room has a small bathroom that has a broken window which stayed in the open position and it did not have a screen, and may be the reason why this room is warm. Also, the broken window is a risk for unauthorized entry to this room if it is not fixed properly.

4. On the second floor of the pediatric ward on 11/2/12 at 11:00 am with the pharmacy supervisor (employee #16) a bag of normal saline was found on a medication cart with a preparation of gentamycin prepared on 11/1/12 with an expiration date of 11/2/12, but it did not have the hour when it was prepared on. The pharmacy supervisor (employee #16) stated on 11/2/12 at 11:05 am that facility policies and procedures require these preparations to be discarded after twenty-four hours.

5. A three milliliter syringe was found with a half of milliliter of a liquid but the syringe was not labeled as to what it contained as found on 11/2/12 at 12:10 pm with the pharmacy supervisor (employee #16).

6. In the Emergency Room an I.V bag of 250 .9 normal saline with 1,200 mg of octreotide acetate prepared on 10/22/12 was observed in the refrigerator of the medication room with an expiration date of 10/23/12 as observed on 10/30/12.

Based on record review #49 with the Pharmacy Supervisor (employee #16) and interview, it was determined that the facility failed to ensure that the effects of medications on patients are monitored to assure medication therapy is appropriate to minimize the occurrence of a possible adverse event.

Findings include:

Record review #49 provided evidence on 11/2/12 at 2:30 pm that the patient was admitted on 10/27/12 with a diagnosis of right hand cellulitis. The medication administration record provided evidence that the patient was ordered Xobuxone 8/2, 1 strip sublingual daily which the patient is providing. The patient was interviewed on 11/2/12 at 2:40 pm and he stated that this medication was prescribed for him in the United States and it is to treat his addiction to heroin as of three years ago. He stated that he had this medication with him but on 10/28/12 it finished and the physician ordered Morphine 2 mgs every 4 hours and on 10/31/12 the physician also added Toradol 30 mgs I.V every 6 hours for 12 hours because Xobuxone is not in the facility's drug formulary. The patient stated that he asked the physician if there were other medications that he could use because he was afraid that he could create an addiction with the Morphine and then he stated that his girlfriend got the Xobuxone on 10/30/12 and is now not using the Morphine. The facility failed to ensure that the effects of medications on patients are monitored to assure medication therapy is appropriate to minimize the occurrence of a possible adverse event.

Based on observations of the liquid unit dose machine (wet Cadet) in the pharmacy department with the Pharmacy Supervisor (employee #16) and interview, it was determined that the facility failed to have policies and procedures related to the use, maintenance and cleaning process of this machine.

Findings include:

A liquid unit dose machine (wet Cadet) was found in the pharmacy department on 11/2/12 at 10:30 am with the Pharmacy Supervisor (employee #16) and provided evidence that the hose for the "residual pushing machine" was draining into a garbage container and the hose that dispenses the medication was in a bottle of alcohol used to disinfect the hose. An Auxiliary pharmacist (employee #39) stated on 11/2/12 at 10:40 am that the hose that dispenses the medications is used to dispense other medications after it is cleaned and disinfected with alcohol and is irrigated with sterile water. The facility could not provide evidence of policies and procedures related to the use, maintenance and cleaning process of this machine.

Based on observations of the medication storage room and medication supply carts with the Pharmacy Supervisor (employee #16), it was determined that the facility failed to ensure that all drugs and biologicals are stored in a proper and safe manner accessible only to authorized personnel.

Findings include:

1. During observations of the medication storage rooms of the Emergency room, Intensive Care Unit and Medicine Ward on the second floor on 10/30/12 from 9:00 am till 12:00 noon and on 11/2/12 from 9:00 am till 12:00 noon, it was found that the medication refrigerators in these rooms were found unlocked. These refrigerators contain controlled medications such as Ativan injectable that were in lockable metal containers in the refrigerators. However, at the Emergency Room and Intensive Care units these metal containers could be removed with the rack that it was attached to and the metal container that was in the medicine ward refrigerator was found unlocked. The facility failed to ensure that controlled medications are protected from unauthorized access.

a. Also, the medication storage room of the Intensive Care Unit is not protected or separated by a door which enables all personnel to gain access to this area.

2. Three out of five medication carts from the second floor were observed open in the medication storage room on 11/2/12 at 11:30 am. The Medicine ward Nursing Supervisor (employee #38) stated on 11/2/12 at 11:35 am that they were all open because the batteries did not work.


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3. The medication cart on the third floor used to provide medications to the patients at rooms #303 through #314 was observed on 11/2/12 at 9:45 am with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2). This cart was left unlocked, the medication administration record (MAR) was left open so that the names of the patients could be seen and medications were left on the top of the cart with the name of the patients on the label. The facility failed to safe guard medications from unauthorized access and failed to protect patient identifiable information. The facility must verify all medication carts to ensure that they comply with all minimum requirements to protect medications.

4. The crash cart located in the Nuclear Medicine Department was observed on 11/2/12 at 9:15 am and provided evidence that the cart was unlocked and the package with medications inside did not have a list of expiration dates for these medications. The facility failed to safe guard medications from unauthorized access.

Based on observations of the pharmacy department with the Pharmacy Supervisor (employee #16), it was determined that the facility failed to ensure that controlled medications are stored in a proper and safe manner accessible only to authorized personnel.

Findings include:

The pharmacy department was visited on 11/2/12 at 9:30 am with the Pharmacy Supervisor (employee #16) and provided evidence that the controlled medication cabinet does not have a working combination lock and the cabinet was found unlocked. This combination lock must be fixed. There is a door with a lock on it that limits the access to the controlled medication cabinet, however this door was found opened and on a shelf within this room next to the controlled medication cabinet were two boxes of Morphine. The Pharmacy Supervisor (employee #16) stated on 11/2/12 at 9:35 am that the two boxes of Morphine are not in the cabinet because they did not fit. The facility failed to ensure that unauthorized personnel are limited to gain access to controlled medications.

Based on the review of medication adverse drug reactions reports with the Pharmacy Supervisor (employee #16), it was determined that the facility failed to promote that drug reactions and drug incompatibilities are immediately reported to the attending physician and if appropriate to the hospital-wide quality assurance program and investigate circumstances where medication irregularities occurred.

Findings include:

1. This facility dispatches between 58,449-226,889 medications monthly. During February 2012, March 2012 and May 2012 no adverse reactions were reported. From the period of January 2012 through October 2012 twenty three adverse reactions were reported; this number is low in comparison with the medication dispatch statistics according with information provided by the Pharmacy Supervisor (employee #16) on 11/2/12 at 1:13 pm. The facility failed to promote the immediate reporting of drug reactions and incompatibilities to the pharmacy department as determined on 11/2/12 at 2:00 pm.

2. According with information provided by the Pharmacy Supervisor (employee #16) on 11/2/12 at 1:10 pm, the medication error monthly report (from January 2012 through October 2012) omissions are the highest percent of incidents found, followed by the administration of a medication different from the the original physician prescription order. However a complete investigation of the circumstances where the omissions and the administration of a medication different from the the original physician prescription order occurs were not performed on an ongoing basis, in order to determine reasons for the incidents and implement corrective actions to improve the medication administration process. The facility failed to identify and take actions in response to medication administration irregularities.

Based on the kitchen observational tour, review of policies/procedures and interview, it was determined that the facility failed to store, maintain and prepare food in a safe and sanitary manner related to the failure to ensure that relative humidity and temperatures of the dry food storage area are recorded and registered, that food containers are properly labeled with its contain, that bulk food are stored in an approved container, no evidence was found of an emergency supply of food to be used in the event of a natural disaster, that ready to eat food are stored according with the food code chapter 6 requirements, that expiration dates of the product used are included in the storage area, wiping cloths used in the kitchen does not follow appropriate requirements and facility policies, a dented can was not removed from the dry food storage, no evidence was found of the ice maker machine policies and procedures for the maintenance and cleaning, no evidence was found of the license number, areas where the chemicals were applied and the person who supervised the exterminator in the exterminator's record of his visit to the facility, the housekeeping room is unfinished and personnel do not have a place to empty pails with dirty water when mops are cleaned after use, paper rolls and napkins are not stored covered to avoid exposure to the environment, no evidence of policies/procedures related to oil changes, oil type, temperature, amount and cleaning of the deep fryer were operationlized and available and the dilution of the bleach used in the kitchen exceeds the appropriate chemical solution guideline of 1 ounce of bleach diluted per two gallons of water as recommended by the Food code chapter 4 guidelines and requirements.

Findings include:

1. During the kitchen observational tour performed with the dietitian (employee #7) on 10/31/12 from 9:00 am till 11:45 am, the following was observed:

a. In the kitchen's daily dry food storage area, it was identified that the relative humidity of this area was not measured and registered by kitchen personnel. A mechanism to ensure that this procedure is performed on an ongoing basis was not developed related to relative humidity registration of dry food storage to verify that they are within established parameters.

b. Instant mash potato flakes were placed in an empty container of cinnamon sticks. The Dietitian (employee #7) stated during an interview on 10/31/12 at 9:34 am that the potato flakes were placed in the empty container after they were opened from the original container, however the container was not properly labeled.

c. In the kitchen's dry food storage area, it was observed that there was a 4 pound package of sugar that was broken, located over a box with 16 packages of 2 with pound sugar packages. Sugar was observed all over the two pound sugar box. The facility failed to clean the sugar over the two pound box of sugar and to store bulk food in an approved container.

d. During the visit of the dry food storage room on 10/31/12 at 9:55 am with the dietitian (employee #7), it was found that the facility has various dry food and cans used for the current menus. However, no evidence was found of dry food dedicated for use (with a specific menus) in the event of an emergency or natural disaster. The dietitian (employee #7) was interviewed on 10/31/12 at 10:00 am and she stated that currently she does not have a emergency dry food supply.

e. In the kitchen's dry food storage area, it was observed that a plastic container with approximately 12 packages of loaves of bread. The container were observed in need of cleaning. The Dietitian (employee #7) stated during an interview on 10/31/12 at 9:41 am that the bakery delivers the bread to the hospital in this container. She requested from the bakery personnel to deliver the bread in a clean plastic container, however they continue to deliver the bread in this plastic container in need of cleaning. The facility failed to follow food code chapter 6 requirements for the management and storage of ready to eat food.

f. Many packages of powder gelatin were found located on a shelf. The packages did not include expiration dates in order to determine if is safe to use this product. The dietitian (employee #7) was interviewed on 10/31/12 at 10:05 am and she stated that expiration dates of this product is included on the box that the gelatin is delivered in. However this information were not included as part of the label which describes the product in the dry food storage area.

g. According with information given by the facility's administrative dietitian (employee #7) on 10/31/12 at 10:47 am, the facility has a process to sanitize wiping cloths after use. This process includes placing the wiping cloths in a red bucket of water with a chemical sanitize product and then in a green bucket to rinse it. However in the food production area and in the enteral feeding room only the green bucket was observed.

h. An ice maker machine was observed located near the steam table area. Policies and procedures for the maintenance and cleaning of this machine were not available when requested of the dietitian on 10/31/12 at 10:12 am. The dietitian (employee #7) was interviewed on 10/31/12 at 10:21 am and she stated that the ice machine was installed approximately a month ago and she does not have the manufacturer's specifications to prepare the policies and procedures.

i. A dented 6 pound can of beets was observed located in the dry food storage area.

j. Evidence provided related with exterminator visits to the kitchen lacked information related with the chemical use, exterminator license number, areas where chemicals were applied and the person who supervised the exterminator visit.

k. In the housekeeping room, it was observed that there were four mops with the handle against the floor and the mop heads up against the wall. The area where mops are located lacked a floor sink. The dietitian (employee #7) was interviewed on 10/31/12 at 10:29 am and she stated that the housekeeping floor sink area is unfinished, the area does not have a place to catch the dirty water when mops are cleaned after use.

l. Three rolls of paper napkins and four packages of hand napkins were observed located on a shelf near the area where mops and chemicals are used to clean and store. The rolls of paper and napkins were stored uncovered and exposed to the environment.

m. The dietitian (employee #7) was interviewed on 10/31/12 at 10:34 am and she stated that the oil of the fryer is changed once a week regardless of use, oil type or frying temperature. According with the food safety magazine (referenced by the FDA), oil used for deep fryers should be changed after three to six uses and this depends on the type of oil used and the frying temperature. The facility failed to ensure that policies/procedures related to oil changes, oil type, temperature, amount and cleaning of the deep fryer.

n. Two bottles of bleach (sodium hypochlorite-undiluted) were observed in the area where the automatic food tray cleaner is located. The dietitian (employee #7) was interviewed on 10/31/12 at 10:16 am and she stated that bleach is used to spray the trays before the machine washing in order to eliminate stains. The bleach exceeds the appropriate chemical solution guideline of 1 ounce of the product diluted per each two gallons of water as recommended by the Food code chapter 4 guidelines and requirements.

Based on tests performed on equipment and observations made during the survey for the physical environment with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2) and interview, 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 walls of operating suites #1 through #3 were not monolithic, maintenance closet near the laboratory department found with chemicals and equipment and the door did not have a door closer to ensure that it swings closed and limits access to non-authorized persons, fire hose cabinets with fire extinguishers have glass doors that are a risk for patients and staff if accidentally broken, patient's bathrooms can be locked from the inside and personnel do not have readily accessible keys, emergency nursing call pull cord in the bathroom located in front of cubicle #3 of the emergency room was wrapped around the grab bar and could not be activated, isolation room doors are not maintained properly, metal shelving and cabinets higher than five feet tall were not fastened to the walls, shower and eye wash station in the laboratory department did not have preventive maintenance evidence for the past year and the water fountains in both off-site emergency rooms were broken and did not work, the facility failed to follow established procedures for the storage of biohazardous and regular trash before they are picked up, the structure of this facility is not maintained to protect and safe guard supplies and equipment to ensure safety and quality related to crash carts located at the nursing station in the emergency room and the crash cart located in Trauma room #2 of the emergency room without a type E oxygen, pharmacy department was found with controlled medication cabinet without a working combination lock, electrical circuit breaker panel (RP2-1E) was found unlocked and did not have a legend, Cold Room without policies/procedures for its use, clean linen is not stored properly, dirty linen is not maintained and stored properly, sharp containers are not in their bases, the facility failed to ensure that infection control measures are followed to reduce the risk of cross contamination and failed to ensure the safety of materials and products used by patients, medication storage room located at the off-site emergency room at "Aguas Buenas" had a broken window, hand sink with broken formica, the facility failed to safe guard medications and sharps from unauthorized access and failed to protect patient identifiable information, maintenance carts with accessible cleaning chemicals and no evidence was found of the cisterns' cleaning or periodic bacteriology tests, 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 handicapped bathrooms that do not comply with "Americans with Disabilities Act" (Ley ADA), lack of functional extractors in janitor's closet, handicapped parking near the emergency room, emergency room cubicles with two patients but without two call systems or manner to provide privacy, decontamination room that does not comply completely with the Guidelines for Design and Construction of Health Care facilities, pediatric emergency room provided evidence that it has a large waiting room near the triage rooms and physician treatment rooms but persons can walk between the waiting room and the treatment rooms unimpeded, the facility does not have a portable Hepa filter machine, outside oxygen cylinder storage area were not covered to protect from the sun and rain, containment dikes for the diesel tanks were found open to prevent rain water from accumulating, Enzol and Cidex-OPA used in areas that are not well-ventilated, smoke barrier doors located in front of mechanical room #1 with a space that is greater than half an inch from the bottom of the door to the floor, fire hose cabinet (fire hose cabinet #38) located in the emergency exit staircase of the laboratory department was found without a handle, the ceiling of the isolation room is not properly designed and the door of the triage room at the off-site emergency room at "Aguas Buenas" is an accordion style which does not allow auditory privacy and care areas failed to provide proper ventilation in the emergency rooms' waiting area, triage area and observation areas which are not equipped with an air disinfection system; also it was determined that the facility does not meet some applicable provision of the 2000 edition of Life Safety Code of the NFPA 101, cited tags are K0018, K0022, K0023, K0046, K0051, K0064, K0072, K0075, K0130 and K0144. All of the above findings makes this condition "Not Met".

Based on tests performed on equipment and observations made during the survey for the physical environment with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2), 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 walls of operating suites #1 through #3 were not monolithic, maintenance closet near the laboratory department found with chemicals and equipment and the door did not have a door closer to ensure that it swings closed and limits access to non-authorized persons, fire hose cabinets and fire extinguisher cabinets have glass doors that are a risk for patients and staff if accidentally broken, patient's bathrooms can be locked from the inside and personnel do not have readily accessible keys, emergency nursing call pull cord in the bathroom located in front of cubicle #3 of the emergency room was wrapped around the grab bar and could not be activated, isolation room doors are not maintained properly, metal shelving and cabinets higher than five feet tall were not fastened to the walls, shower and eye wash station in the laboratory department did not have preventive maintenance evidence for the past year and the water fountains in both off-site emergency rooms were broken and did not work.

Findings include:

1. The maintenance closet located on the first floor of the hospital near the laboratory department was observed on 10/31/12 at 2:40 pm. This closet was found with chemicals and equipment to clean the facility and did not have a door closer to ensure that it swings closed and limits access to non-authorized persons.

2. Operating suites in the hospital were visited on 11/1/12 from 3:00 pm through 3:45 pm with the facility's physical plant manager (employee #2) and provided evidence that the walls of operating suites #1 through #3 were not monolithic, tiles were found but the grout lines were not sealed between the wall tiles which can allow dirt to enter and does not allow proper cleaning.

3. During the observational tour of the off-site emergency room in "Cidra" on 11/1/12 from 9:10 am till 11:00 am, it was determined that fire hose cabinets have glass doors. The fire hose cabinets are located in hallways throughout the facility. The fire hose cabinets do not require a key to open or a device to break the glass to gain access to the hoses. The glass doors are approximately three feet by three feet in size and pose a potential hazard if broken by accident. The glass is not tempered, laminated or of wire mess to prevent shattering. The glass panels were removed from these cabinets during the survey on 11/1/12 but the facility needs to replace the glass with another material (as mentioned above) to reduce the accessibility of the fire hose from children and non-authorized persons.

4. The emergency room was visited on 10/30/12 from 9:30 am till 2:30 pm and provided evidence that patient's bathrooms can be locked from the inside. The physical plant manager (employee #2) locked himself in the bathroom and activated the call system, however personnel could not identify the sound emitted from the nursing call of the bathroom and instead went to the orthopedic procedure room because the light above the door was flashing. It was found that the control panel identified the bathroom as the call system activated but because no one went to the control panel to verify it and because the alarm sound was the same as observation cubicles no one went to the bathroom. After two minutes they realized that the nursing call system was from the bathroom and went to find the door closed. It took approximately two more minutes for them to find the key to open this door. Valuable time was lost because the alarm did not emit a different sound which would alert personnel to go directly to the bathroom and because it was crossed with another area, and time was also lost when personnel did not have a key available to open the door immediately. Personnel need to be supplied with a key or device to open these doors in the event of an emergency and in-service training related to the use of these keys or devices for all personnel from all shifts is required along with periodic testing for compliance.

5. The emergency nursing call pull cord in the bathroom located in front of cubicle #3 of the emergency room was found wrapped around the grab bar and could not be activated when pulled on 10/30/12 at 10:00 am.

6. During the observational tour of the Emergency Room on 10/30/12 from 9:30 am till 2:30 pm with the facility's Engineer (employee #1) the following was determined:
a. The front door of trauma room #2 does not close flush to its frame.
b. The first door (anteroom) of isolation room #1 does not latch closed and tape was placed on the bottom of this door to create a seal to provide negative pressure to the interior room.
c. The first door (anteroom) of isolation room #2 does not latch closed and tape was placed on the bottom of this door to create a seal to provide negative pressure to the interior room.
d. The second doors (doors that lead into the patient's rooms) of isolation rooms #1 and #2
did not have sufficient space between the door and the floor to ensure proper negative pressure flow for the anterooms.

7. The general storage department was visited on 10/31/12 at 9:30 am and the medical record department was visited on 9:50 am and provided evidence that metal shelving and cabinets higher than five feet tall were not fastened to the walls to ensure that they do not tip over, which is a possible hazard to personnel in these areas. The facility's Physical Plant Manager (employee #2) instructed physical plant personnel to bolt the shelves and cabinets into the wall and this task was completed on 10/31/12 before 3:00 pm.

8. The shower and eye wash station located in the laboratory department was observed on 10/31/12 at 2:25 pm with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2). Preventive maintenance was requested of this shower and eye wash, however the facility could not provide this evidence for the past year.

9. The off-site emergency rooms in "Cidra" and "Aguas Buenas" were visited on 11/1/12
from 9:30 am through 1:30 pm with the facility's Engineer (employee #1) and provided evidence that the water fountains in both emergency rooms were broken and did not work.

Based on tests to equipment and observations made during the survey for Life Safety from fire with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2), 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 10/30/12 through 11/2/12 from 9:00 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 (K0018, K0022, K0023, K0046, K0051, K0064, K0072, K0075, K0130 and K0144).

Based on observations made during the survey for the physical environment with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2), it was determined that the facility failed to follow established procedures for the storage of biohazardous and regular trash before they are picked up.

Findings include:

1. The facility has two small dumpsters used to place regular trash at the back of the hospital and was visited on 10/30/12 at 2:30 pm with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2) and it was determined that the doors and lids of these dumpsters were found in the open position.

2. On 10/30/12 at 2:35 pm with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2) twelve large containers (approximately 50 gallons each) with lids were found filled with biohazardous waste and were in an open area which is not protected from unauthorized persons. Three of the twelve lids were broken and did not seal shut exposing the biohazardous trash that was in the containers and two containers were found with the lids partially open because there was too much biohazardous trash in the containers. The facility failed to ensure that biohazardous trash is protected from unauthorized access and from vermin.

Based on observations made during the survey for the physical environment with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2) and interview, 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 crash carts located at the nursing station in the emergency room and the crash cart located in Trauma room #2 of the emergency room without a type E oxygen, pharmacy department was found with controlled medication cabinet without a working combination lock, electrical circuit breaker panel (RP2-1E) was found unlocked and did not have a legend, the "Cold Room" was found without policies/procedures for its use, clean linen is not stored properly, dirty linen is not maintained and stored properly, sharp containers are not in their bases, the facility failed to ensure that infection control measures are followed to reduce the risk of cross contamination and failed to ensure the safety of materials and products used by patients, medication storage room located at the off-site emergency room at "Aguas Buenas" had a broken window, hand sink with broken formica, the facility failed to safe guard medications and sharps from unauthorized access and failed to protect patient identifiable information, maintenance carts with accessible cleaning chemicals and no evidence was found of the cisterns' cleaning or periodic bacteriology tests.

Findings include:

1. The crash carts located at the nursing station in the emergency room and the crash cart located in Trauma room #2 of the emergency room were found without a type E oxygen cylinder attached to the carts on 10/30/12 at 9:30 am and 10:00 am with the facility's Engineer (employee #1). To ensure that patients receive immediate care in the event of an emergency the oxygen cylinder shall be attached to the crash cart to ensure that it goes where the cart goes.

2. The pharmacy department was visited on 10/31/12 at 9:00 am with the facility's Engineer (employee #1) and provided evidence that the controlled medication cabinet does not have a working combination lock and the cabinet was found unlocked. This combination lock must be fixed and controlled medication cabinets must have at least two different locking devices (two different keys or a key and a combination). There is a door with a lock on it that limits the access to the controlled medication cabinet, however the key to this door was found in a drawer in front of this door and unauthorized personnel can gain access to this room if they find the key.

3. The electrical circuit breaker panel located in the general storage area was observed on 10/31/12 at 9:35 am with the facility's Engineer (employee #1). The electrical circuit breaker panel (RP2-1E) was found unlocked and did not have a legend with the circuit breakers and area that they served to ensure their proper use in the event of an emergency.

4. The "Cold Room" used by the facility to place corpses until they are removed from the facility was visited on 10/31/12 at 1:00 pm with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2) and the following was determined:
a. The temperature of this room was 51ºF on 10/31/12 at 1:00 pm. The facility does not have policies and procedures related to an established temperature range which is appropriate for this room nor the maximum time that they can keep the corpse in this area.
b. No evidence was found of a dedicate mop and pail for this room and procedures related to the proper cleaning of this room.
c. There is a double door which leads to the exterior of the facility which has approximately a half inch gap under the door which will not keep the cold in this room and can allow pests to enter.
d. Approximately 20 boxes with surgical supplies (surgical trays) were found stored in this room, the facility's Engineer (employee #1) stated on 10/31/12 at 1:15 pm that maintenance personnel placed it there because there was no room in the operating department.

5. The general maintenance department (Janitor Services) used by maintenance personnel to place supplies and receive and store clean linen was visited on 10/31/12 at 1:30 pm with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2) and it was found that this area was not organized in a manner to prevent possible cross contamination of the clean linen. Three large bins with recently received packages of clean linen were found in the main receiving area where the supervisor performs clerical work and maintenance supplies and boxes are kept. The supervisor of the Janitor service (employee #19) stated on 10/31/12 at 1:35 pm that he receives the clean linen and leaves it in the bins until they are distributed to the different wards during the day and he does not have a dedicated separated area for the clean linen. The facility's Engineer (employee #1) identified a proper linen storage area in this department and instructed employee #19 where to put the clean linen. A small room in this department where cleaning chemicals are stored will be removed and this room will be used to place the clean linen and a new room will be built in this department which will have an air extractor, smoke detector and sprinkler heads and the door will have a door closer.

6. In the hallway of the facility in front of the general maintenance department (Janitor Services) on 10/31/12 at 8:45 am, four large bins were found with dirty linen. The supervisor of the Janitor service (employee #19) stated on 10/31/12 at 1:35 pm that they are placed there in the morning after they are collected from the wards and after they weigh and record the weight of each bag they are taken to the outside of the building. The outside dirty linen storage area was visited on 10/31/12 at 1:45 pm and it was found that the bins were placed up against the hospital wall near the biohazardous and regular garbage area. The facility failed to ensure that the dirty linen is stored in an area where it is protected from unauthorized access and protected from vermin.

7. The blood bank room located in the laboratory department was visited on 10/31/12 at 2:10 pm with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2) and provided evidence that two sharp containers were not in their bases and could be removed by unauthorized personnel or could tip over and fall to the ground.

8. The electrical circuit breaker panel located in the laboratory department near the main counter was observed on 10/31/12 at 2:25 pm with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2). The electrical circuit breaker panel was found unlocked and did not have a legend with the circuit breakers and area that they served to ensure their proper use in the event of an emergency. There were also open slots where missing circuit breakers were supposed to be which is a risk for personnel to receive an electrical shock.

9. The room identified on the fourth floor as the "Ice Room" was visited on 10/31/12 at 3:15 pm with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2). This room was found unlocked and had four I.V stands, a broken seat, five enteral nutrition machines, a large bin with clean linen (the plastic wrap around one of the packages was open exposing it to the environment) and a refrigerator was found with the enteral nutrition of the patient in room #405A. The facility failed to ensure that infection control measures are followed to reduce the risk of cross contamination and failed to ensure the safety of materials and products used by patients.

10. During observations at patient room #420 on 10/31/12 at 4:00 pm with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2), it was found that this room had a sign on the front door advising "Contact Precautions". Kitchen personnel (employees #31 and #32) were in the process of handing out dinner food trays. These employees were observed with gloves on and entered patient's room #420 and placed the food tray on the food tray table of the room and moved it close to the patient. When these employees left the room they did not remove their gloves nor wash their hands before going on to the next patient food tray delivery. The facility failed to ensure that infection control measures are followed to reduce the risk of cross contamination from patient to patient.

11. Evaluation room #2 of the off-site emergency room in "Cidra" was visited on 11/1/12 at 9:50 am with the facility's Engineer (employee #1) and was found that the hand sink counter had broken formica and the evaluation/treatment bed had a ripped vinyl cover which will not allow proper cleaning.

12. The medication storage room located at the off-site emergency room at "Aguas Buenas"was visited on 11/1/12 at 1:15 pm and provided evidence that this room was warm. This room has a small bathroom that has a broken window which stayed in the open position nor did it have a screen, and is the reason why this room is warm. Also, this broken window is a risk for unauthorized entry to this room if it is not fixed properly.

13. The medication cart on the third floor used to provide medications to the patients at rooms #303 through #314 was observed on 11/2/12 at 9:45 am with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2). This cart was left unlocked, the medication administration record (MAR) was left open so that the names of the patients could be seen and medications were left on the top of the cart with the name of the patients on the label. Also, the sharp container on this cart was not fixed in place to avoid unauthorized removal or the container from tipping over. The facility failed to safe guard medications and sharps from unauthorized access and failed to protect patient identifiable information. The facility must verify all medication carts to ensure that they comply with all minimum requirements to protect medications.

14. Maintenance carts were observed from 10/30/12 through 11/2/12 from 9:00 am till 4:00 pm with cleaning chemicals on top and in the middle of the carts and did not have a cabinet on these carts where personnel can lock these cleaning solutions to limit its accessibility to non authorized persons.

15. The crash cart located in the Nuclear Medicine Department was observed on 11/2/12 at 9:15 am and provided evidence that the cart was unlocked and the package with medications inside did not have a list of expiration dates for these medications. The facility failed to safe guard medications from unauthorized access.

16. Written evidence about bacteriological tests and cleaning of the water cistern for the two off-site emergency rooms at "Cidra"and "Aguas Buenas" was requested on 11/2/12 at 1:00 pm. No evidence was provided that bacteriology tests were performed consistently on a monthly basis to the water used at the facility and no evidence was provided of the annual cleaning of these cisterns according with state law requirements (Chapter XXV, Article #1, from November 7, 1999).

Based on tests performed on equipment and observations made during the survey for the physical environment with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2) and interview, 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 handicapped bathrooms that do not comply with "Americans with Disabilities Act" (Ley ADA), lack of functional extractors in janitor's closet, handicapped parking near the emergency room, emergency room cubicles with two patients but without two call systems or manner to provide privacy, decontamination room that does not comply completely with the Guidelines for Design and Construction of Health Care facilities, pediatric emergency room provided evidence that it has a large waiting room near the triage rooms and physician treatment rooms but persons can walk between the waiting room and the treatment rooms unimpeded, the facility does not have a portable Hepa filter machine, outside oxygen cylinder storage area were not covered to protect from the sun and rain, containment dikes for the diesel tanks were found open to prevent rain water from accumulating, Enzol and Cidex-OPA used in areas that are not well-ventilated, smoke barrier doors located in front of mechanical room #1 with a space that is greater than half an inch from the bottom of the door to the floor, fire hose cabinet (fire hose cabinet #38) located in the emergency exit staircase of the laboratory department was found without a handle, the ceiling of the isolation room is not properly designed and the door of the triage room at the off-site emergency room at "Aguas Buenas" is an accordion style which does not allow auditory privacy.

Findings include:

1. The two handicapped toilets (male and female) located within the emergency room (E.R) waiting area were visited on 10/30/12 at 9:30 am with the facility's Engineer (employee #1) and physical plant manager (employee #2). It was found that the drainage tubes under the hand sinks extended out to nine inches from the wall. In order for persons in wheelchairs to access these sinks without hurting their legs the drainage tube can not extend beyond six inches as required by the "Americans with Disabilities Act" (Ley ADA).

2. The main janitors' closet of the emergency room was visited on 10/30/12 at 10:00 am with the facility's Engineer (employee #1) and it was found that this closet did not have a functional air extractor.
a. Also, the janitors' closet of the off-site emergency room at "Aguas Buenas" was visited on 11/1/12 at 11:30 am with the facility's Engineer (employee #1) and it was found that this closet did not have an air extractor.

3. The two handicapped toilets (male and female) located on the first floor near the laboratory department were visited on 10/31/12 at 3:10 pm with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2) and provided evidence that they do not have the universal sign identifying them as handicapped accessible.

4. The facility does not have handicapped parking spaces in front of the emergency room as determined on 10/30/12 at 9:30 am. Handicapped parking spaces need to be near the front of the emergency room for those patients who are handicapped and arrive by car by themselves. These handicapped parking spaces must have handicapped signs and one of these signs must indicate "Van Accessible" and have the appropriate space requirements.

5. The emergency room was visited on 10/30/12 from 9:30 am through 2:30 pm with the facility's Engineer (employee #1) and it provided evidence that fourteen out of fourteen observation cubicles contained two patients each. Within these cubicles (which measures 120 square feet) there is only one nursing call system for both patients and no ceiling mounted curtains to provide patients with privacy in these cubicles. If these cubicles are to be used for two patients, then the facility must ensure the patient's safety by having a call system accessible to both patients when lying on their stretchers and the facility must ensure each patients' privacy when receiving treatment in the cubicles.

6. The emergency room was visited on 10/30/12 at 11:30 am and provided evidence that the facility has a decontamination room that does not comply completely with the Guidelines for Design and Construction of Health Care facilities (GDCHCF) for the 2006 edition in chapter 2.1, section 5.1.3.7, number 5 and appendix A5.1.3.7 (4) on page 72 "Decontamination room within the facility"). This decontamination room does not have two hand held shower heads with temperature controls, a portable suction machine for this room and two hospital telephones. The anteroom of the decontamination room from the hospital side needs a work counter, a hand washing station with hands free control and storage area for supplies and for equipment for the decontamination process. Also the outside door does not have a sign identifying the room from the outside and the floor is not mark where the door swings open.
a. Also, the decontamination room of the off-site emergency room in "Cidra" was visited on 11/1/12 at 10:00 am and provided evidence that it does not have two hand held shower heads with temperature controls or a portable suction machine.

7. The pediatric emergency room was visited on 10/30/12 from 1:15 pm till 2:30 pm with the facility's Engineer (employee #1) and provided evidence that it has a large waiting room near the triage rooms and physician treatment rooms. Patients and family members were observed walking between the waiting room and the treatment rooms unimpeded. The facility failed to have a structural division between these areas where they can control the traffic of patients and family members to ensure patient safety and privacy.
a. Also, the doors of the physician treatment rooms were found opened and there were patients inside. The facility placed door closers on these doors on 10/31/12 but they must ensure through follow up monitoring to ensure that patients privacy is upheld.

8. The facility has various isolation rooms throughout the hospital including the emergency rooms as determined from 10/30/12 through 11/2/12 from 9:00 am till 4:00 pm. However, the facility does not have a portable Hepa filter machine which can be used if isolation room Hepa filters fail. The facility's Engineer (employee #1) stated on 10/30/12 at 12:00 noon that the facility has a company that they can call to rent these machines but they do not have any on site.

9. During observations of the outside oxygen cylinder storage area on 10/30/12 at 2:45 pm
with the facility's Engineer (employee #1) it was found that this area also has the in-line systems for oxygen and other operating room gases. Four different areas within this storage area were found with in-line connections with different gases, however they were not covered to protect from the sun and rain.

10. The diesel tank located at the back of the facility used to fuel the water pump of the sprinkler system was visited on 10/30/12 at 3:05 pm with the facility's Engineer (employee #1) and provided evidence that it has a containment dike, however the drain of this dike was found open to prevent rain water from accumulating. No evidence was found that the drain has the capability to be closed to retain the diesel in the event that the tank leaks.
a. The diesel tank located at the back of the off-site emergency room at "Cidra" used to fuel the electrical generator was visited on 11/1/12 at 11:00 am with the facility's Engineer (employee #1) and provided evidence that it has a containment dike, however the drain of this dike was found open to prevent rain water from accumulating. No evidence was found that the drain has the capability to be closed to retain the diesel in the event that the tank leaks.

11. The sterile supply department used by the operating department to clean and sterilize equipment was visited on 10/31/12 at 11:20 am with the facility's Engineer (employee #1) and it was found that Enzol is used in the main receiving area. Enzol is an enzymatic solution used to clean surgical equipment and the Manufacturers' recommendations suggests that the solution is to be used in a well-ventilated area. The area where personnel use Enzol did not have an air extractor and the facility could not provide evidence of how many times per hour the air exchanged in this location to ensure that they meet the criteria for well ventilated.

12. The door of mechanical room #1 was visited on 10/31/12 at 11:50 am with the facility's Engineer (employee #1) and provided evidence that it does not have a door closer.

13. The smoke barrier doors located in front of mechanical room #1 was visited on 10/31/12 at 11:45 am with the facility's Engineer (employee #1) and provided evidence that there is a space that is greater than half an inch from the bottom of the door to the floor.

14. The fire hose cabinet (fire hose cabinet #38) located in the emergency exit staircase of the laboratory department was found without a handle to open the door of this cabinet on 10/31/12 at 2:00 pm with the facility's (Engineer #1) and Physical Plant Manager (employee #2).

15. The facility has an isolation room in the Intensive Care Unit of the hospital as determined on 10/31/12 at 3:00 pm. However, the ceiling is an acoustic tile ceiling and does not provide the protective measures needed related to the containment and extraction of air in isolation rooms in accordance with the Centers for Disease Control (CDC).

16. The two handicapped toilets (male and female) located at the off-site emergency room in "Cidra" and the two handicapped toilets at the off-site emergency room in "Aguas Buenas" were visited on 11/1/12 at 9:30 am and 1:30 pm with the facility's Engineer (employee #1) and provided evidence that they do not have the universal sign identifying them as handicapped accessible.

17. The two off-site emergency rooms in "Cidra" and in "Aguas Buenas" were visited on 11/1/12 from 9:30 am and 1:30 pm with the facility's Engineer (employee #1) and it was found that each E.R has a room dedicated for the use of Cidex OPA. According with the Manufacturers' recommendations, they suggest that the solution is used in a well-ventilated area. The use of Cidex OPA should be in an area that is ventilated with a local exhaust.

18. The male handicapped bathroom at the "Aguas Buenas" off-site emergency room was visited on 11/1/12 at 11:30 am and provided evidence that the door handle and the faucet operators of the hand sink are not ADA approved. The handle and faucet need to be operated by pushing or pulling, not by grasping.

19. The door of the triage room was observed at the off-site emergency room at "Aguas Buenas" on 11/1/12 at 11:45 am. The door is an accordion style and that when closed does not afford patients in this room with auditory privacy nor can the nurse look out into the waiting room to verify patients' status when waiting.

20. The two handicapped toilets (male and female) located on the Nuclear Medicine department were visited on 11/2/12 at 9:30 am and provided evidence that the toilets do not have at least two grab bars and the toilet seat height is not at least 17 inches high from the floor as required by ADA.

Based on observations made during the survey for the physical environment with the facility's Engineer (employee #1), it was determined that the physical structure and care areas failed to provide proper ventilation in the emergency rooms' waiting area, triage area and observation areas are not equipped with an air disinfection system.

Findings include:

The emergency rooms (adult, pediatric and the two off-site emergency rooms in "Cidra" and "Aguas Buenas") were visited on 10/30/12 from 9:30 am till 2:30 pm and on 11/1/12 from 9:30 am till 1:30 pm and provided evidence that the waiting room area, triage area and the observation area of the adult, pediatric and the two off-site emergency rooms are not equipped with an air disinfection system (for example: Ultraviolet lights). According with the "Guidelines for Design and Construction of Health Care Facilities" (GDCHCF) the triage area is the point of entry of undiagnosed and untreated airborne infections and should be designed and ventilated to reduce exposure of staff, patients and families to airborne infectious diseases. Through the facility's infection control program, determinations must be made related to general ventilation and air disinfection similar to inpatient requirements for airborne infection isolation rooms according to the CDC "Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health Care Facilities". The waiting area and observation area are other areas to provide protection with an air disinfection system.

Based observational tour of the entire facility for infection control standards of practice and interview from 10/31/12 through 11/2/12 from 9:00 am till 4:00 pm with the Infection Control Officer (ICO) (employee #14), it was determined that the facility failed to promote sanitary and safe care through its infection control program in the emergency room, decontamination room, nursing personnel did not use a mask when intervening with a patient on airborne droplet precautions, clean curtains and sheets are stored in areas with dirty equipment, medications are not maintained appropriately related with expiration dates, Cidex OPA is used in an area that does not have proper ventilation, laundry room is not arranged to prevent cross contamination between clean and dirty linen, central supply department does not maintain proper temperature, biohazardous and regular trash are not maintained to prevent cross contamination and unauthorized access, the Cold Room does not have policies/procedures to ensure temperature, body holding time frame and cleaning and the temperature of the freezer in the cold room was not recorded, ice machines are and the dialysis unit are not properly maintained, the Medicine Intensive Care Unit and Neonatal Intensive Care Unit are not maintained to reduce the risk of cross contamination, maintenance employees and kitchen personnel are not following infection control standard precautions when intervening with patients on "contact precautions" and two irrigation syringes were observed in patient's rooms #302 A, #320 B which did not have a label with the date when started and it was determined that the facility failed to maintain a log of all incidents related to infections to promote sanitary and safe care through its infection control program in the emergency room, laundry room, central supply department, operating room department, medicine intensive care unit and pediatric care unit related to improper infection control procedures and failed to follow infection control standards of practice, all of which makes this condition of participation "Not Met".

Based on the observational tour with the Infection Control Officer (ICO) (employee #14), interviews and review of policies/procedures (P&P), it was determined that the facility failed to promote sanitary and safe care through its infection control program in the emergency room, decontamination room, nursing personnel did not use a mask when intervening with a patient on airborne droplet precautions, clean curtains and sheets are stored in areas with dirty equipment, medications are not maintained appropriately related with expiration dates,
Cidex OPA is used in an area that does not have proper ventilation, laundry room is not arranged to prevent cross contamination between clean and dirty linen, central supply department does not maintain proper temperature, biohazardous and regular trash are not maintained to prevent cross contamination and unauthorized access, the Cold Room does not have policies/procedures to ensure temperature, body holding time frame and cleaning and the temperature of the freezer in the cold room was not recorded, ice machines are and the dialysis unit are not properly maintained, the Medicine Intensive Care Unit and Neonatal Intensive Care Unit are not maintained to reduce the risk of cross contamination, maintenance employees and kitchen personnel are not following infection control standard precautions when intervening with patients on "contact precautions" and two irrigation syringes were observed in patient's rooms #302 A, #320 B which did not have a label with the date when started.

Findings include:

1. The following was observed related to the review of the policies/procedures manual and observations of the emergency department with the E.R Supervisor (employee #13) and Emergency Room Administrator (employee #12) on 10/30/12 from 9:30 am till 3:00 pm, the offsite ERs on 11/1/12 from 9:00 am till 1:00 pm and 11/2/12 from 8:00 am till 10:00 am:

a. The decontamination room used for the management of patients who become contaminated was visited on 10/30/12 at 12:20 pm and was found without a sign on the door identifying it as such and no material or equipment was found to deal with patients who need the use of this room.

b. In cubicle #3 used for critical ER patients was found with a patient (patient #39) with a diagnosis of Septic Shock and R/O Leptospirosis and was on airborne droplet precautions as found on 10/30/12 at 11:30 am. Nursing personnel (employee #30) was observed entering and intervening with the patient, however she did not have a mask on as part of the required isolation precaution barrier.

c. The clean utility room was visited on 10/30/12 at 10:30 am and was found with a large open cabinet with clean bed sheets for patients' use. Also, the room was observed with other equipment (I.V stand, privacy curtain, I.V pump and maintenance cart) and no evidence was found if this equipment was clean or dirty.

d. Approximately 30 bags with clean curtains were observed in the janitor's closet near the observation area on 10/30/12 at 10:55 am, however the room was observed with dust and was used to store dirty maintenance equipment.

e. The isolation cart was observed in the clean utility room on 10/30/12 at 2:00 pm with 10 boxes of open gloves. The facility failed to prevent cross contamination related to the use of 10 open boxes of gloves and placed this cart which is used for isolation room patients in the clean utility room.

f. Ear and nose speculums were found loose on the adult/pediatric physician's desk in the evaluation room in a plastic container, but it could not be determined which were clean and which were used and they were exposed to the environment.

g. Two boxes with isolation room material were observed on 10/30/12 at 1:30 pm in the supply room directly on the floor.

h. One I.V bag of 250 .9 normal saline with 1,200 mg of octreotide acetate prepared on 10/22/12 was observed in the refrigerator of the medication room with an expiration date of 10/23/12 as observed on 10/30/12.

i. One multi-use vial of Xylocaine 2% (20 ml) used for local anesthesia was observed in the minor surgery room without a label indicating the date when it was opened as reviewed on 10/30/12 at 11:15 am which is not in accordance with CDC guidelines to label and discard after 28 days from opened.

j. Two bottles of .9% normal saline and sterile water (single use) for irrigation was observed on 10/30/12 at 2:30 pm in the medication room and triage area without labels indicating the date when they were opened.

k. Nineteen tubes of 2.5 ml PT/PTT were observed in the pediatric tray area and treatment area with an expiration date of March 2012 and September 2012. Also, three tubes with green caps were observed in the pediatric area with an expiration date of March 2011.

2. The offsite ER in "Cidra" was visited on 11/1/12 at 9:00 am with the E.R Supervisor (employee #17) and the following was observed:

a. Ear and nose speculum were found loose on the physician's desk and in a plastic container, but it could not be determined if they were clean and which were used.

b. Two sterile sheets were observed in the minor surgery room on 11/1/12 at 9:45 am with the expiration date of May 2011.

3. The offsite ER in "Aguas Buenas" was visited on 11/1/12 at 11:30 am with the ER Supervisor (employee #18) and the following was observed:

a. The medication and material storage room was visited on 11/1/12 at 12:00 noon and was found that the temperature was 21ºC and humidity on 80%. The storage room has bathroom and it was observed that the window of the bathroom was open and did not have a screen. The facility failed to ensure that the material and medications in this storage room is maintained at the appropriate temperature and humidity.

b. The utility room was visited on 11/1/12 at 12:10 pm and was found with one container of Cidex OPA. The tray with Cidex OPA solution was found with the date prepared of 10/18/12, however the test strips used to validate its concentration and effectiveness expired in August 2012.

4. The following was observed in the central supply department (CSD) on 10/31/12 at 9:20 am related to infection control procedures:

a. The sterile material room in the CSD was visited on 10/31/12 at 9:20 am with the central supply supervisor (employee #33) and was found that the registration log to record temperature and humidity for the room used to maintain sterile materials was observed with temperature of 75ºF on 10/20/12, 10/22/12, 10/24/12, 10/29/12 and 10/31/12. The CSD supervisor (employee #33) stated during interview on 10/31/12 at 9:30 am that the temperature did not meet the parameters established of 68ºF to 73ºF, since the start of the construction to make the CSD larger and the integrity of the sterile material is being evaluated.

5. One box of 24 cans (24 ounces) was observed on 10/31/12 at 10:30 am in the general storage supply area with an expiration date of August 2012.

6. The following was observed in the environmental services (ES) area on 10/31/12 from 10:40 am till 11:00 am related to infection control procedures:

a. On 10/31/12 at 10:45 am the clean linen storage room was visited with the ICO (employee #14) and the Maintenance Director (employee #19) to evaluate the storage process and the receiving and processing of dirty linen. The area was observed with maintenance equipment (dusters, mops, pails, floor polishers, vacuum cleaners and other materials) near two bins with approximately 1,000 clean sheet, fitted sheets, baby clothes for the nursery and operating room scrubs without protective covers. In this area was observed three empty bins which are used to transport clean linen which contained a large amount of dirt and dust inside of it. The environmental services employee (employee #15) stated during interview on 10/31/12 at 10:50 am that these bins are in this area because they are used to place the dirty linen that is collected from the wards and then collected by the contracted linen service to be cleaned and returned. He also stated that the clean linen are delivered with the same truck that carries dirty linen. No evidence was found that the facility is evaluating possible cross contamination between clean and dirty linen.

b. Four bins used to place dirty linen in were found at the back of the hospital in an open area against a wall as observed on 10/31/12 at 10:55 am with the facility's ICO (employee #14) and the Maintenance Director (employee #19) and they were found without a protective roof exposing them to the environment and vermin.

c. Two small dumpsters used to place regular trash at the back of the hospital was visited on 10/31/12 at 11:00 am with the facility's ICO (employee #14) and the Maintenance Director (employee #19) and it was determined that the doors and lids of these dumpsters were found in the open position.

d. Twelve large containers (approximately 50 gallons each) with lids were found at the back of the hospital as visited on 10/31/12 at 10:55 am with the facility's ICO (employee #14) and the Maintenance Director (employee #19) filled with biohazardous waste and were in an open area which is not protected from unauthorized persons. Three of the twelve lids were broken and did not seal shut exposing the biohazardous trash that was in the containers. The facility failed to ensure that biohazardous trash is protected from unauthorized access and from vermin.

7. The cold room (body holding unit to place corpse) was visited on 10/31/12 at 11:10 am
with the facility's ICO (employee #14) and the Maintenance Director (employee #19) and the following was observed:

a. The room temperature was 40ºF and humidity was at 90% on 10/31/12 at 11:00 am. The ICO (employee #14) stated during an interview on 10/31/12 at 11:15 am that the corpses are not in this room for more than four hours before the family's claim the bodies. The temperature registration log for this room provided evidence that the temperature was maintained between 45ºF to 56ºF from 5/17/12 through 11/1/12. Also, the registration log provided evidence four corpses were maintained for 12 hours in this room. The facility does not have policies and procedures related to an established temperature range which is appropriate for this room nor the maximum time that they can keep the corpse in this area.

b. No evidence was found of a dedicate mop and pail for this room and procedures related to the proper cleaning of this room.

c. Approximately 20 boxes with surgical supplies (surgical trays) were found stored in this room. The facility's Maintenance Director (employee #19) stated on 10/31/12 at 11:15 am that maintenance personnel placed it there because the company that provides this service has not arrived to removed them.

d. A drop in freezer was found with twelve container with placentas and a thermometer was not found in this freezer and no evidence was found of the temperature registration.

8. The following was observed in the medicine ward on 10/31/12 from 11:30 am till 11:45 am related to infection control procedures:

a. In front of patient's room #205 with a label on the door advising contact isolation precautions, an isolation cart used by personnel did not have material on this cart, only a box of gloves.

b. In the storage room, two carts with open packages of clean linen, next to sterile disposable material, respiratory therapy equipment, two blood pressure mobile carts and three trays with venepuncture material.

c. In the ice machine room was observed with an open cart with clean linen, I.V stand, I.V pump and the container where residual ice falls (ice that is not used) was found without a cover to limit the accessibility of this ice to patients and family members. No evidence was found of policies and procedures related to the correct use of this ice dispenser and personnel who are authorized to use it to limit cross contamination.

d. The inpatient hemodialysis area was visited and was found with a small container with a solution of bleach used to disinfect the caps and pick-up tubes of the bicarbonate jugs without the date when the solution was prepared and the caps and pick-up tubes were not completely covered by the solution. Also found in this area were approximately 28 gallons of acid and bicarbonate that were stored horizontally one on the top of another four gallons high. This method of storing gallons does not ensure the safety of its contents due to the chance that the pressure from above can explode the gallons on the bottom which will causes them to leak over the floor.

e. A maintenance employee (employee #34) was observed on 10/31/12 at 12:00 noon emptying a pail with dirty water into the floor sink of the janitor's closet without gloves. This closet does not have a hand sink or hand sanitizer for the employees to clean their hands and two dirty and used mops were found on a shelf and two mops with poles were found on the floor (not hanging to dry). Clean material such as hand paper was also found in this closet exposed to this environment. The facility failed to ensure proper infection control standards to reduce the risk of cross contamination.

9. During the observational tour of the entire facility with the ICO officer (employee #14) from 10/30/12 through 11/2/12 from 9:00 am until 4:00 pm, it was found that all regular trash containers do not have lids. The facility failed to maintain the environment in a manner to reduce possible cross contamination.

10. In M.I.C.U (medicine intensive care unit) the hand sink located near cubicle #9 and isolation room did not have a hand paper dispenser as observed on 10/31/12 at 1:45 pm.

11. In the Neonatal Intensive Care Unit (NICU) visited on 10/31/12 at 2:00 pm, it was found that under the baby scale there is a supply shelf which was found with baby bottle nipples, diapers and gauze which were all uncovered from the environment and were within 6 inches from the floor. Material that is uncovered and close to the floor can be contaminated when the floor is swept and mopped leading to cross contamination.

a. Within the baby warmer cribs it was observed that there were baby wipe containers with clean gauze. The NICU supervisor (employee #35) stated on 10/31/12 at 2:10 pm that after the containers with baby wipes are finished, the containers are cleaned and then they use it to place clean gauze in.

12. During the observational tour of the operating room department on 10/31/12 at 2:30 pm the following was found:

a. A maintenance employee (employee #36) was observed removing a bag with biohazardous material from the restricted area and deposited it into a large dumpster with wheels in the non-restricted area and then with the same gloves on he pushed open the swinging doors before the operating suites and then entered in a operating suite without his mask.

13. On 10/31/12 at 3:10 pm on the second floor it was found that a maintenance employee (employee #37) was removing biohazardous and regular trash from patient's bedroom #218. This room has a sign advising that the patient is on contact precautions, however the employee was found carrying the bags and they were touching his body when he went to deposit them in the closet down the hallway. When the employee returned he removed his gloves and went to the linen cart and removed two bed sheets which he also carried against his body and then he entered the room and dressed the bed in this room. The ICO (employee #14) stated on 10/31/12 at 3:15 pm that policies and procedures related to patients on contact precautions requires the use of a protective garment, mask and gloves. The facility failed to ensure that policies and procedures are followed to reduce infection control risks related to contact precaution patients.

14. On 11/2/12 at 11:45 am with the ICO officer (employee #14), it was found that all medication carts on the second floor were found with boxes of gloves on the top of the cart's sharp container.


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15. The following was observed during the initial tour on 10/30/12 from 10:30 am through 11:50 am related to infection control issues:

a. Two irrigation syringes were observed in patient's rooms #302 A, #320 B which did not have a label with the date when started. Standards of practice requirements and recognized guidelines (National Standards for Prevention and Control of Hospital Acquired Infection 2008) establishes that enteral feeding irrigation syringes must be changed between 48-72 hours.



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16. During observations at patient room #420 on 10/31/12 at 4:00 pm with the facility's Engineer (employee #1) and Physical Plant Manager (employee #2), it was found that this room had a sign on the front door advising "Contact Precautions". Kitchen personnel (employees #31 and #32) were in the process of handing out dinner food trays. These employees were observed with gloves on and entered patient's room #420 and placed the food tray on the food tray table of the room and moved it close to the patient. When these employees left the room they did not remove their gloves nor wash their hands before going on to the next patient food tray delivery. The facility failed to ensure that infection control measures are followed to reduce the risk of cross contamination from patient to patient.

Based on the observational tour with the Infection Control Officer (employee #14) and review of policies/procedures (P&P), it was determined that the facility failed to maintain a log of all incidents related to infections to promote sanitary and safe care through its infection control program in the emergency room, laundry room, central supply department, operating room department, medicine intensive care unit and pediatric care unit related to improper infection control procedures and failed to follow infection control standards of practice.

Findings include:

The Infection Control Officer (ICO) (employee #14) has statical information as reviewed on 11/2/12 at 3:00 pm related to events in the hospital, however she does not have the capability with her documents to identify specific events that have occurred at the hospital, if further information is required by other departments. No evidence was found that the ICO has an infection control log to document all incidents and take the appropriate measures.

Based on operation room area observation, review of policies and procedure with Operation Room (OR) Supervisor (employee #24), it was determined that the facility failed to ensure that Surgical Services maintains a high standard of medical practice and patient care related to the delineation of the non restrictive, semi restrictive and restrictive area, broken acoustic tiles, medication stored without a lock, multi-dose vials opened without a label when opened, anesthesiologist nurse's medication cart unlocked and pre-served medications, the housekeeping room was unlocked, unused large and medium sharp container stored in the housekeeping room, 3 mops were on the floor, small laryngoscope exposure to the environment, clean linen was found between two hamper, no paper dispenser and soap dispenser in the recovery and holding area.

Findings include:

A. During observations performed at the OR area during the initial tour on 10/30/12 from 9:30 am till 3:30 pm with the OR Supervisor (employee #24) the following was found:

1. On 10/30/12 at 9:30 am it was observed that the cleaning personnel scrub was in the pantry and lunch area on a hanger exposed to the environment. There are shelves with other personnel scrubs where all personnel place their scrubs.

2. It was observed during the initial tour that the area lacks delineation lines of non restrictive, semi restrictive and restrictive areas.

3. In the equipment storage area near OR suite #7 on 10/30/12 at 9:40 am, it was observed that there was a Big Ban directly in the floor and an acoustic ceiling tile was observed broken over the communication cable storage shelf.

4. In the front of Suite #7, it was observed that it lacked an acoustic tile on 10/30/12 at 9:45 am.

5. In the sterile room, it was observed on 10/30/12 at 9:45 am that the medication shelves were unlocked and the key was in the lock.

6. Eye medication shelves near to the sterile room were observed unlocked.

7. In OR suites #1, #2, #3, #4, #5, #6 and #7 visited on 10/30/12 from 9:50 am till 12:00 noon, it was observed that supply carts are used by the registered nurses, on these carts nurses store different types of medications, however these carts do not have locks to ensure the safety of these medication.

8. It was observed in Suites #1, #3, #6 visited on 10/30/12 from 9:50 am till 12:00 noon that anesthesiologist and the nurse anesthetist did not use masks in the restricted area inside the operating room suites (employees #25, #26, #27, #28 and #29).

9. In Suites #1 though #7, it was observed that an anesthetist's cart had a Control Sheet with the medications to document January, April, May and October with the expiration dates, however the anesthetist personnel did not documented this information on the Control Sheet and left it in blank.

10. The malignant hypothermia cart placed near suite #3 was observed unlocked and the key was in the lock.

11. The crash Cart near suite #3 was observed opened without a lock on 10/30/12 at 10:10 am.

12. In Suite #3, it was found that the anesthetist cart was not locked and inside this cart was a small metal box with narcotics such as: Fentanyl 8 ampules and Mydazalon 5 vials and it was found opened without a security lock and the anesthetist in charge of Suite #3 was not present in the Suite on 10/30/12 at 10:10 am.

13. In the housekeeping room near Suite #4, it was observed on 10/30/12 at 10:30 am with four (9.5quart) sharp containers and sixteen (5.6 quart) sharp containers stored in the housekeeping room. These sharp containers were used inside the restrictive area (operating room suites).

14. The housekeeping room near Suite #4 was observed with 3 mops draining directly on the floor.

15. The housekeeping room near Suite #1 was observed with 1 mop draining up side.

16. Operating room housekeeping personnel has only three pails for seven suites and hallways.

17. In the hallway of Suites #1, #2, #3, it was observed on 10/30/12 at 10:45 am with open container with a small tray with a laryngoscope with blade (#0) uncovered and exposed to the environment.

18. It was observed near Suite #2, a clean linen cart with four bags of clean linen and on each side of the cart was placed the dirty linen hamper and when personnel discarded dirty linen in the hamper the lid touched the clean linen bag contaminating the clean linen bags.

19. In the room used to wash equipment near Suite #4 which was visited on 10/30/12 at 11:00 am, it was observed with one small tray and 2 large trays with Cidex OPA. According with the Manufacturers' recommendations, they suggest that the solution is used in a well-ventilated area and 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 and no evidence was found that the facility has a spill kit to use if Cidex OPA accidentally falls on the floor. The supervisor (employee #21) stated on 10/30/12 at 11:05 am that the emergency kit was placed at the secretary's counter.

20. Suite #4 was visited on 10/30/12 at 11:10 am and was found without a patient and without personnel, the medication shelf was found with its door opened, the anesthesia cart was found opened without being locked, two vials of Glycopyrrolate 0.2 mg/ml and one vial of Glycopyrrolate 1 mg/5 ml opened without a label with the hour, date when opened and the signature of the person that opened it. On the top of the anesthetist cart between the monitor, it was found that two pre-served syringes with a label with the following: Sandoz 10 mg/ml was dated 10/21/12 and the other was Atropine Sulfate 0.1 mg/ml.

21. The recovery room was visited on 10/30/12 at 2:30 pm, the two sinks in the front of cubicle #11 and #12 and the two sinks in the front of cubicle #3 and #4 were observed with three boxes of non sterile glove placed between the sinks. When personnel wash their hands the water splashes inside the non sterile glove box. The sink areas lacked soap dispensers and paper dispensers. Soap and paper were placed in the middle between the sinks which were exposed to splashing water and contamination.

22. The holding area visited on 10/30/12 at 3:00 pm, the two sinks in the front of the nursing station were observed with three boxes of non sterile gloves, a tray with gowns and hair covers placed between the two sinks. When personnel wash their hands the water splashes all over the materials placed there. The area lacks a soap dispenser and paper dispenser. Soap and paper were placed in the middle of the two sinks which exposed them to splashing water and contamination.

23. During the initial tour performed on 10/30/12 from 9:30 am till 12:00 noon, it was found that the humidity of operating suites was higher than 60% which is recommended by the Guidelines for Design and Construction (should be between 30% and 60%). Suite #5 Humidity 66%, Suite #7 Humidity 65%. The daily temperature and relative humidity sheet reviewed on 10/31/12 at 10:00 am revealed that during the month of October 2012 the Relative Humidity (RH) was high. Suite #1, the Relative Humidity was on 10/1/12- 63%, on 10/2/12 -61%, 10/5/12- 63%, 10/8/12- 76%, 10/9/12- 73%, 10/10/12- 70%, 10/11/12- 66%, 10/12/12- 70% 10/15/12- 80%, 10/16/12- 80%, 10/17/12- 75%, 10/18/12- 68%, 10/19/12- 70%, 10/22/12- 64%, 10/23/12- 64%, 10/24/12- 62%, 10/25/12- 64%, 10/26/12- 61%, 10/29/12- 64%. Suite #2 the Relative Humidity was on 10/8/12- 69%, 10/9/12- 68%, 10/10/12- 67%, 10/11/12- 67%, 10/12/12- 70%, 10/15/12- 73%, 10/16/12- 73%, 10/17/12- 70%, 10/18/12- 69%, and 10/19/12- 68%. Suite #3 the Relative Humidity was on 10/10/12- 61%, 10/11/12- 61%, 10/12/12- 68%, 10/15/12- 67%, 10/16/12- 66%, 10/17/12- 62%, 10/18/12- 62%, and 10/19/12- 62%. Suite #5 the Relative Humidity was on 10/1/12- 66%, on 10/2/12- 66%, 10/3/12- 67%, 10/4/12- 68%, 10/5/12- 67%, 10/8/12- 84%, 10/9/12- 71%, 10/10/12- 78%, 10/11/12- 68%, 10/12/12- 75%, 10/15/12- 75%, 10/16/12- 75%, 10/17/12- 76%, 10/18/12- 68%, 10/19/12- 75%, 10/22/12- 69%, 10/23/12- 68%, 10/24/12- 68%, 10/25/12- 67%, 10/26/12- 66%, 10/29/12- 70%. Suite #6 the Relative Humidity was on 10/1/12- 65%, on 10/2/12- 64%, 10/3/12- 66%, 10/4/12- 65%, 10/5/12- 66%, 10/8/12- 81%, 10/9/12- 76%, 10/10/12- 79%, 10/11/12- 66%, 10/12/12- 73%, 10/15/12- 75%, 10/16/12- 79%, 10/17/12- 72%, 10/18/12- 66%, 10/19/12- 72%, 10/22/12- 68%, 10/23/12- 67%, 10/24/12- 66%, 10/25/12- 65%, 10/26/12- 65%, 10/29/12- 67%. Suite #7 the Relative Humidity was on 10/1/12- 71%, on 10/2/12- 69%, 10/3/12- 69%, 10/4/12- 71%, 10/5/12- 71%, 10/8/12- 77%, 10/9/12- 80%, 10/10/12- 71%, 10/11/12- 70%, 10/12/12- 76%, 10/15/12- 71%, 10/16/12- 70%, 10/17/12- 70%, 10/18/12- 68%, 10/19/12- 67%, 10/22/12- 72%, 10/23/12- 68%, 10/24/12- 67%, 10/25/12- 66%, 10/26/12- 68% and 10/29/12- 67%.

Based on observation performed during the initial tour with the operation Room supervisor (employee #24), it was determined that the facility failed to ensure that a call-in system (intercom) is available in all operating room suites (suites #1, #2, #3, #5, #6, #7).

Findings include:

During the initial tour of the operating room (OR) suites on 10/30/12 from 9:30 am till 12:00 noon with the OR supervisor (employee #24), it was observed that OR Suites #1, #2, #3, #5, #6, #7 do not have call-in systems to use in the event of an emergency in the operating room. OR suite #4 has a call-in system that communicates with the emergency room, in the event of an emergency, emergency room personnel are notified and then they go up to the operating room after they get changed into OR attire.

Based on the review of seven records reviewed (R.R), review of policies and procedures and interview with the operating room supervisor (employee #24), it was determined that the facility failed to ensure that outpatients are evaluated and called after 24 hours after the surgery was performed to ensure acceptable standards of practice for five out of seven records reviewed (R.R #11, #12, #14, #15 and #16).

Findings includes:

1. During the review of seven records on 10/31/12 at 11:30 am it was found that five out of seven records reviewed (R.R #11, #12, #14, #15 and #16) provide evidence that the facility performed one phone call to the telephone number that was provided by the patient at the moment of the admission, however no body answered the phone. The facility's policies and procedures postoperative follow-up evaluation reviewed on 10/31/12 at 11:30 am states the following:
a. For every patient intervention a post operative call will be made.
b. Before discharge the nurse will inform the patient of the follow-up phone call which will be made to all outpatient case and to inquire about the best time to call.
c. Personnel must fill out a sheet an document evidence of this call.
d. The patient will be instructed to call the surgeon if they have any problems. Additional education, counseling or referrals should be provided according to the initial assessment.
e. Keep the log sheet as evidence of the phone call and the response of the patient.

2. During the review of the Postoperative follow-up evaluation reviewed on 10/31/12 at 11:30 am performed by the registered nurse, it was observed that the sheet had space to record two phone calls made to patients, however no evidence was found that the second call was made to the patient to ensure that the patient was recovery well.

Based on the review of ten closed and active records reviewed (R.R), policies/procedures manual, interview and the observational tour of the emergency room (ER) with the E.R Supervisor (employee #13) and ER Administrator (employee #12), it was determined that the facility failed to comply with sign posting to identify in the E.R where the triage rooms are located, the emergency department manual was not updated and did not have the last revision date nor was it approved by the Governing Body, drug preparation area of the different drug compatibilities or drug dilutions for nursing staff to adhere to, a crash cart used to administer medications located in critical area #1 was found open and accessible to non authorized persons, an incubator did not maintained proper temperature, the decontamination room is not properly maintained, nursing personnel did not use a mask with a patient on isolation precaution, clean linen and curtains are stored with dirty equipment, the isolation cart was found in the clean utility room with 10 boxes of open gloves, the ER is not following infection control standards to prevent cross contamination, the facility failed to ensure that R.R #41 condition was re-evaluated by an E.R physician to monitor the patient's needs related to medication treatment (Morphine and Vasotec) and the position of the patient in the sitting position for possible changes in the patient's status, two out of four transfers of closed records provided evidence that the physician failed to document the condition at the moment that the patient was transferred for (R.R #52) and risk/benefit at the moment that the patient was transferred for (R.R #53), the facility failed to verify essential medical equipment such as the defibrillator monitor to ensure it is working properly, the facility failed to ensure that the material and medications are stored and maintained at the appropriate temperature and humidity and utility rooms were found with Cidex OPA without appropriate ventilation and the test strips used to validate its concentration and effectiveness expired in August 2012.

Findings include:

1. The following was observed related to the review of the policies/procedures manual and observations of the emergency department with the E.R Supervisor (employee #13) and Emergency Room Administrator (employee #12) on 10/30/12 from 9:30 am till 3:00 pm, the offsite ERs on 11/1/12 from 9:00 am till 1:00 pm and 11/2/12 from 8:00 am till 10:00 am:

a. No evidence was found on 11/2/12 at 2:30 pm with the E.R Supervisor (employee #13) that the emergency department manual was updated and did not have the last revision date nor was it approved by the Governing Body.

2. The three ambulatory triage rooms were located in the waiting area near of the observation area as observed on 10/30/12 at 10:00 am, however the triage area did not have a sign posted notifying patients that arrive to the E.R where the triage is located.

3. No evidence was found on 10/30/12 at 1:45 pm in the drug preparation area of the different drug compatibilities or drug dilutions for nursing staff to adhere to.

4. A crash cart in the critical area #1 was observed unlocked on 10/30/12 at 9:55 am which could allow unauthorized access to the medications inside without breaking the plastic lock.

5. The OB-Gyn area used for the management of gynecology patients was visited on 10/30/12 at 2:00 am. An incubator (warmer) was found in this area and it was plugged into a receptacle but was found to not maintain proper temperature in the event that it has to be used in an emergency.

6. The decontamination room used for the management of contaminated patients was visited on 10/30/12 at 12:20 pm and was found without a sign on the door identifying it as such and no material or equipment was found to deal with patients who need the use of this room.

7. In critical care cubicle #3 of the ER with a patient (R.R #39) with diagnosis of Septic Shock and R/O Leptospirosis and on airborne droplet precautions as found on 10/30/12 at 11:30 am. Nursing personnel (employee #30) was observed entering and intervening with the patient, however shy did not have a mask on as an isolation precaution barrier.

8. The clean utility room was visited on 10/30/12 at 10:30 am and was found with a large open cabinet with clean bed sheets for patients use. Also, the room was observed with other equipment (I.V stand, privacy screen, I.V pump and maintenance cart) and no evidence was found if this equipment was clean or dirty.

9. Approximately 30 bags with clean curtains were observed in the janitor's closet near the observation area on 10/30/12 at 10:55 am, however the room was observed with dust and was used to store dirty maintenance equipment.

10. The isolation cart was observed in the clean utility room on 10/30/12 at 2:00 pm with 10 boxes of open gloves. The facility failed to prevent cross contamination related to the use of 10 open boxes of gloves and placed this cart which is used for isolation room patients in the clean utility room.

11. The following was observed in the emergency room on 10/30/12 from 9:30 am till 3:30 pm related to infection control procedures:

a. Ear and nose speculums were found loose on the adult/pediatric physician's desk in the evaluation room in a plastic container, but it could not be determined which were clean and which were used and they were exposed to the environment.

b. Two boxes with isolation room material were observed on 10/30/12 at 1:30 pm in the supply room directly on the floor.

c. One I.V bag of 250 .9 normal saline with 1,200 mg of octreotide acetate prepared on 10/22/12 was observed in the refrigerator of the medication room with an expiration date of 10/23/12 as observed on 10/30/12.

d. One multi-use vial of Xylocaine 2% (20 ml) used for local anesthesia was observed in the minor surgery room without a label indicating the date when it was opened as reviewed on 10/30/12 at 11:15 am which is not in accordance with CDC guidelines to label and discard after 28 days from opened.

e. Two bottles of .9% normal saline and sterile water (single use) for irrigation was observed on 10/30/12 at 2:30 pm in the medication room and triage area without labels indicating the date when they were opened.

f. Nineteen tubes of 2.5 ml PT/PTT were observed in the pediatric tray area and treatment area with an expiration date of March 2012 and September 2012. Also, three tubes with green caps were observed in the pediatric area with an expiration date of March 2011.

12. Ten active and closed clinical records were reviewed on 10/30/12 from 1:30 pm till 3:30 pm and 11/2/12 from 1:00 pm till 4:00 pm for emergency room services and provided evidence of the following:

a. R.R #41 is a 63 years old female who visited the emergency room on 10/30/12 at 6:00 am with right upper quadrant pain and status post back trauma two weeks ago. The triage was performed at 6:00 am and the patient was categorized as "urgent". The patient was observed sitting in the treatment area with IV fluids accompanied by her husband. She stated on 10/30/12 at 9:45 am during interview that they gave her medications for pain and she has been sitting since she arrived and she is dizzy. The record was reviewed on 10/30/12 at 1:30 pm and provided evidence that the ER physician evaluated the patient related to abdominal pain and ordered Morphine 4 mg IV for pain and Vasotec 2.5 mg IV for her blood pressure of 190/90 on 10/30/12 at 6:50 am. The registered nurse administered the medication on 10/30/12 at 7:40 am. The facility failed to ensure that the patient's condition was re-evaluated by an E.R physician to monitor the patient's needs related to medication treatment (Morphine and Vasotec) and the position of the patient in the sitting position for possible changes in the patient's status.

13. Two out of four transfers of closed records were reviewed on 11/2/12 at 1:30 pm and provided evidence that the physician failed to document the condition at the moment that the patient was transferred for (R.R #52) and risk/benefit at the moment that the patient was transferred for (R.R #53).

14. The offsite ER in "Cidra" was visited on 11/1/12 at 9:00 am with the E.R Supervisor (employee #17) and the following was observed:

a. The triage area was visited on 11/1/12 at 9:30 am with the E.R Supervisor (employee #17) located near the entrance area and was observed with a medication tray with (Tylenol, Maalox and Robitussin and a venepuncture tray with blood sample tubes, small vein Angiocatheter's and Vacutainer's needles were available to non-authorized persons.

b. Ear and nose speculum were found loose on the physician's desk and in a plastic container, but it could not be determined if they were clean and which were used.

c. Two sterile sheets were observed in the minor surgery room on 11/1/12 at 9:45 am with the expiration date of May 2011.


15. The offsite ER in "Aguas Buenas" was visited on 11/1/12 at 11:30 am with the ER Supervisor (employee #18) and the following was observed:

a. No sign was posted at the entrance (ambulance) area for the notification of the rights of the individuals who enter the E.R as observed on 11/1/12 at 11:35 am.

b. No evidence was found on 11/1/12 at 11:45 am that emergency personnel have a plan or assignments for all specific tasks in the event of an emergency. All personnel trained related to emergency procedures must be instructed related to their assignments and periodically tested for its implementation and the assignment must be posted for review by staff.

c. The cardiac monitor was found without the battery light on when observed on 11/1/12 at 11:55 am. When the monitor's cable was observed it was not plugged into the receptacle. When it was plugged into the receptacle the cardiac monitor was found with the battery light on low. Review of the preventive maintenance of this monitor provided evidence that the last revision by the biomedical technician was in October of 2011. The monitor was tested with electrical power and it worked, however when tested using the battery it did not. The facility failed to verify essential medical equipment to ensure it is working properly.

d. The medication and material storage room was visited on 11/1/12 at 12:00 noon and was found that the temperature was 21ºC and humidity on 80%. The storage room has bathroom and it was observed that the window of the bathroom was open and did not have a screen. The facility failed to ensure that the material and medications in this storage room is maintained at the appropriate temperature and humidity.

e. The utility room was visited on 11/1/12 at 12:10 pm and was found with one container of Cidex OPA. The tray with Cidex OPA solution was found with the date prepared of 10/18/12, however the test strips used to validate its concentration and effectiveness expired in August 2012.