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Based on complaint investigation survey PR00000601 conducted on 11/7/17 through 11/10/17, in order to determine compliance with 42 CFR Part 482 Conditions of Participation for Hospitals. During the review of the State Law License regulations, the review of nursing credential file (C.F.), and the review of pharmaceutical service C.F it was determined that the facility failed to updated personnel credential files related to annual evaluations, cardio pulmonary Resuscitation certificates (CPR), health certificates, Hepatitis B vaccine, Influenza vaccine, Association with Puerto Rico Nursing College, job description and Criminal record background check (Antecedentes Penales) for 25 out of 25 credential files reviews, ( Nursing and Pharmaceutical service CF #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #17, #18 #19, #20, #21, #22, #23, #24 and #25).

Findings include:

During credential files review on 11/09/2017 to 11/10/2017 from 11:30pm to 2:30 pm the following was found:

1. One out of Twenty five CF reviews, does not provide evidence of and updated Annual Evaluation (CF #7, #12, #14, #18 and #21).

2.Thirteen out of twenty five CF reviews, does not provide evidence of and updated CPR (CF #1, #2, #4, #5, #6, #7, #9, #10, #11, #12, #13, #16, #17 and #18).

3. Five out of twenty five CF reviews, do not show an updated health certificate, (CF #6, #11, #12, #13, #18 and #19).

4. Eight out of twenty five CF reviews, does not provide evidence of Hepatitis B vaccination. (CF #1, #6, #19, #20, #21, #22, #23 and #24).

5.Twenty three out of twenty five CF reviews, does not provide evidence of an Influenza vaccination, (CF #1, #2,#3 #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #15, #16, #17, #18, #19, #20, #21, #22, #23 and #24). The facility does not comply with Department of Health Administrative Order Number 244 of October 10, 2008.

6. One out of twenty five CF reviews, does not provide evidence of Association with Puerto Rico Nursing College. (CF #10)

7. Four out of twenty five CF reviews, does not provide evidence of the job description (CF #2, #15, #16 and #21).

8. One out of twenty five CF reviews, does not provide evidence of and updated Criminal record background check (Antecedentes Penales) (CF#6)

The facility failed to updated personnel credential files related to annual evaluations, cardio pulmonary Resuscitation certificates (CPR), health certificates, Hepatitis B vaccine, and Influenza vaccine, Association with Puerto Rico Nursing College, job description and Criminal record background check.

Based on a Complaint Investigation survey PR00000601, documents reviewed and interviews conducted on 11/7/17 through 11/10/17, 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: conditions of participation: 42 CFR § 482. 41 Physical Environment and § 482.28 Food and Dietetic, which makes this condition not met.

Based on complaint investigation survey PR00000601 conducted on 11/7/17 through 11/10/17 the review of medical Staff By laws, Rule and Regulation it was determined that the Governing body failed to assure that the medical staff has updated bylaws and that bylaws comply with State and Federal law and requirements of the Medicare hospital Conditions of Participation.

Findings include:

1.On 11/10/17 at 10:00 a. m. during the review of Medical By Laws and the Rule and Regulation it was evidence that the Bylaws was from 2013-2015 and was approved by the governing Body on May 2013.

On the Medical Faculty Bylaws page #39 on Section 16.4: Limitations of Bylaws: on Article 19: Revision; state that "These Bylaws and Appended Rules and Regulations shall be revised every two (2) years and or as needed.'' However, according of the Medical Faculty Bylaws no evidence of revision on May/2015 and on May/2017. These Bylaws and Appended Rules and Regulation not reviewed every Two (2) years according of the Medical Faculty Bylaws.

2. No evidence was provide related to an Updated Bylaws, Rule and Regulations during the survey.

Based on a Complaint Investigation survey PR00000601 conducted on 11/7/17 through 11/10/17, interview and reviewed documents performed on 11/10/17 at 9:30 a.m., it was determined that the facility failed to ensure that the institutional plan provides for capital expenditures for at least a three year period including the operating budget year was not available at the facility.

Findings include:

The facility did not provided evidence of the institutional plan request on 11/7/17 at 9:50 am and no evidence of the annual operating budget. No evidence was provided of a plan for capital expenditures for at least a 3-year period which includes anticipated income and expenses.

During interview with the administration office worker (employee #29) performed on 11/10/17 at 9:30 a. m., stated: "The facility administrator did not have this information because the budget plan information was maintain at the Central Office of the Health Department."

Based on complaint investigation PR00000601, observations made during the emergency room (ER) tour, it was determined that the facility failed to promote the patients' right for personal privacy while receiving care at the facility.

Findings include:

1. On 11/08/2017 at 2:44 pm during a tour on the ER it was observed three patients on stretcher receiving their ER treatment on the hallway however the ER observation area have 12 cubicles empties.

On interview with the ER Supervisor (employee #3) state that those patients in the emergency room hallway are there because they are been seeing by the ER physicians and they are waiting for disposition to see if they are admitted at the observation area or to a Hospital ward or discharge.

2. The facility failed to promote the patients' right for personal privacy while receiving care at the facility.

Based on a Complaint Investigation survey PR00000601 conducted on 11/7/17 through 11/10/17, observational tour of the medical records department with the medical record, it was determined that the facility failed to ensure that medical records are properly stored in a secure location protected from possible damage.

Findings include

1. During the observational tour of the medical record central archive storage area on 11/09/17 at 10:24 am, it was found that in this area are about 250 medical records damage with water with multiples pages unreadable and with darks spots on the covers and pages.

2. The medical record storage room at the lobby area it was observed on 11/09/17 at 10:44 pm a box of medical records damage with water and it was unable to be open.

3. The facility failed to ensure that medical records are properly stored in a secure location protected from possible damage.

Based on a compliant investigation ACTS PR 00000601, medical record review (R.R.) performed from 11/09/17 at 1:53 pm thru 11/10/17 at 9:30 am with the Nursing Sub Director (employee #12) and the OPD department supervisor (employee #11), it was determined that the facility failed to ensure that all patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form, as observed in 2 out of 12 records review (RR). (RR #6 and #9).

Findings include:

1. R.R. #6 is a 71years old male admitted on 11/03/17 at 3:30 pm with a diagnosis of Right Knee Pseudo arthritis during the record review performed on 11/09/17 at 1:53 pm with the Nursing Sub Director (employee #12) it was found the following:

a. The following Medical Orders were found without the physician's federal and state license to order narcotic medications.

i. Medical order from 11/03/17 at 1:30 pm was order Morphine 2mg IV every 6 hours and Percocet 2 tablets PO every 6 hours when needed (PRN).

ii. Medical order from 11/04/17 at 10:00 am was order Oxycodone 10 mg tablet PO every 12 hours and Percocet 2 tablets PO every 6 hours PRN.

During review of the policies and procedures related to Medical Orders on 11/09/17 at 1:55 pm was found that in item #5, it states: "5. All orders of controlled substances of hospitalize patient will have to include the numbers of the federal and state narcotics registry."

2. R.R. #9 is a 41years old male admitted on 08/01/17 at 6:00 am with a diagnosis of Right Calcaneus fracture during the record review performed on 11/10/17 at 9:30 am with the OPD Department Supervisor (employee #11) it was found the following:

a. The Assessment of the Operation Room- waiting room form of 08/01/17 have a section to evaluate and document the vital signs, the Registered Nurse (RN) (employee #13) documented the temperature, pulse, arterial pressure, however it lacks documentation of the evaluation of the respirations of the patient.

b. The discharge of the patient from the ambulatory surgical center form of 08/01/17 at 1:30 pm lacks of documentation of the patient's level of consciousness, and also lack of the signature of the attending physician.

c. The physical examination form was signed by the attending physician, however was not dated and timed.

d. The advance directives medical orders of 07/24/17 were signed by the patient; however the patient did not select any of the alternatives and was not signed by the attending physician.

Based on complaint investigation survey ACTS intake PR00000601 and observations with the Pharmacist (employee #17) and interview it was determined that the facility failed to ensure that narcotics are kept locked and secured from unauthorized persons.

Findings include:

1. During the observational tour performed on 11/07/17 at 10:28 am accompanied by the Pharmacist (employee #17), it was identified that the controlled substance are located in the first room of the pharmacy to the right. Inside the room it was identified more than 20 boxes of expired controlled substance and remaining of Intravenous controlled substance outside a lock box, waiting for be properly discarded.

On interview with the pharmacist (employee #17) state those medications outside the security box are the expired controlled medications and remaining of Intravenous controlled substance, waiting for be properly discarded. There are controlled medications that have been there for more than 2 years. The facility is in negotiation with a company for properly discard those medications."

According to the "Title 21 Code of Federal Regulations (Drug Enforcement Administration) DEA Controlled Substances" scheduled I, II, III, IV and V controlled substances shall be kept in stationary, locked double cabinet, both cabinets, inner and outer shall have key-locked doors with separate keys. The facility failed to ensure that controlled substances are protected from unauthorized access according with DEA standards.

Based on a complaint investigation ACTS Intake PR00000601, observational tour and interview on 11/07/17 thru 11/10/17 from 8:00 am thru 4:00 pm with the supervisor of the X-ray department (employee #5), it was determined that the facility failed to ensure that the X-ray department is free from hazards for patients and personnel as evidenced by electrical extension cord, stretcher, trash container, and two bags of sand in the halls, a blue gown in the floor for collecting a water leak from the ceiling, lack of exhaust system in the dark room and chemical storage warmer doors left unlocked in the Computed Tomography (CT) area.

Findings include:

1. During the observational tour of the X-ray Department on 11/07/17 thru 11/10/17 from 8:00 am thru 4:00 pm, the following was determined:

a. It was observed at 9:29 am that in the room of the X-ray machine #5 a water leak on the ceiling and a blue gown on the floor to collect the water.

b. It was observed at 9:35 am that in the main hall was a trash container to collect the water thta is leaking from the ceiling. It had a blue pad underneath the trash container and was wet. Also a stretcher was observed in the same hall that was left there. However the trash container, blue pad and stretcher were removed immediately.

c. It was observed at 9:36 am two bags of sand in the side of the halls without any sign of caution that could result in patient falls, however the two bags of san were remove immediately.

d. It was observed at 9:38 am that in the dark room of the X-ray department lacks of exhaust system causing a strong chemical smell in the dark room and irradiates by a fan to the main hall were the patients walk.

e. It was observed on 11/08/17 at 2:54 pm that in the CT room of the X-ray department that the door of the ready-box Body temperature Media Warmer where the contrast bottles are stored was found without a security lock.

During interview on 11/09/17 at 3:00 pm with the Safety Officer (employee #9), she stated: "We have already removed the stretcher and the trash container that collected the water leaking from the hall. The maintenance personnel are going to perform preventives round to maintain dry the area. The sand bags were removed also and the electrical extension was place over the ceiling tiles."

Based on a complaint investigation ACTS intake PR00000601, observations, review of policies and procedures and routine equipment testing on 11/07/17 thru 11/10/17 from 8:00 am thru 4:00 pm with the supervisor of the X-ray department (employee #5) and interview, it was determined that the facility failed to ensure that the physicist periodically verifies the badge exposure for radiation exposure.

Findings include:

1. On 11/07/17 at 9:40 am the supervisor of the X-ray department (employee #5) provided evidence of the three month radiation dosimetry report revision of badges from April 2017 used by X-ray department personnel. However, no written evidence was found of routine inspections of the dosimeters for radiation by the physicist for June and September 2017.

During interview on 11/07/17 at 9:45 am with the X-Ray supervisor (employee #5), she stated: "The dosimeters are sent out every three month and are evaluated by the physicist. The last evidence that the badge reports were reviewed by the physicist was in April of 2017. There was no evidence provided of the June and September routine inspections of the dosimeters for radiation by the physicist."

2. During observational tour in CT area on 11/08/17 at 2:54 pm was observed that the CT staff (employee #15) was not using the radiation dosimeter.

3. During review of the policies and procedures of the Radiation Dosimeter was found on item 1, 5, and 7: 1. All radiologist technologists will use the dosimeter in the frontal area of the body above the waist and under the neck area. 5. The dosimeter will be change every three month to be processed and analyze by the physicist. 7. Every radiologist technologist will be responsible of conserving and use daily the assigned dosimeter.

During interview on 11/07/17 at 11:30 am with the supervisor of the X-ray department (employee #5), she stated: "There are 13 radiation dosimetry in use by X-ray department personnel, and the dosimeters must be reviewed by a physicist three month; however this review was not performed since April 2017."

Based on the review of Thirteen credential files (C.F) (certified by the facility) of X-Ray personnel on 11/09/17 from 10:38 am till 11:20 am with Human Resource Staff (employee #16), it was determined that the facility failed to ensure that X-Ray personnel are qualified in accordance with state and local laws related to Radiologist License, Radiologist license registry, Cardio Pulmonary Resuscitation (CPR) certificates, hepatitis B vaccine, annual health certificates, annual evaluations, annual competencies, and duties and responsibilities for 13 out of 13 C.Fs (C.F #1 through #13).

Findings include:

1. During the review of twenty-one facility certified credential files from X-ray personnel on 11/09/17 from 10:38 am till 11:20 am, the following was determined:

a. Thirteen out of thirteen X-Ray personnel credentials files did not have evidence of their updated Radiologist License (C.F #12).

b. Thirteen out of thirteen X-Ray personnel credentials files did not have evidence of their updated Radiologist License Registry (C.F #7 and #12).

c. Thirteen out of thirteen X-Ray personnel credentials files did not have evidence of their updated annual health certificates (C.F #2, #4, #6, #8, #10, #11, #12, and #13).

d. Twelve out of thirteen X-Ray personnel credential files did not have evidence of their CPR certificates (C.F #2, #6, #10, #11, and #13).

f. Thirteen out of thirteen X-Ray personnel credentials files did not have evidence of their hepatitis B vaccine (C.F #12 and #13).

g. Nineteen out of thirteen X-Ray personnel credentials files did not contain evidence of their annual evaluations (C.F #2, and from #4 through #13).

h. Thirteen out of thirteen X-Ray personnel credentials files did not contain evidence of their annual competencies (C.F #1 through #13).

i. Seven out of thirteen X-Ray personnel credentials files did not contain evidence of their Duties and Responsibilities (C.F #2, #5, #7, #9, #11, #12, and #13).

Based on observations of the clinical laboratory facility on November 7, 2017 and interview with the laboratory director and the technical supervisors it was determined the following:

1. Transfusion facilities area:

a. Two ceiling tiles missing, these were located in the area of transfusion service refrigerators.

b. Corridor adjacent to the transfusion service area, three ceiling tiles missing with dripping water.

2. Hematology area:

a. Ceiling tiles missing (no dripping water)

3. Chemistry area (routine and special):

a. Two pedestal fans were observed in use. The chemistry area air conditioning unit is out of service since September 21, 2017. Although the area is under the hospital ventilation system, the cooling capacity is not enough to keep the instruments within required (15 - 25 °C) temperature range.

b. Several ceiling tiles missing (few dripping water).

4. Bacteriology:

a. One pedestal fan was observed in use. The bacteriology area air conditioning unit is out of service since September 21, 2017. Although the area is under the hospital ventilation system, the cooling capacity is not enough to keep the instruments within required temperature (20 - 30 °C) ranges.

b. Several ceiling tiles missing (no dripping water).

Based on a complaint investigation survey PR00000601, observations, review of policies/procedures and interview with the clinical and administrative dietitian (employee #1), and diet supervisor (employee #2) from 11/7/17 through 11/0917 from 8:30 am until 3:00 pm it was determined that the facility failed to prevent patient from harm related to patient nutritional requirement for 1 out of 32 patients admitted at the facility.

Findings include:

During observations, record review, review of policies/procedures and interview with the clinical and administrative dietitian (employee #1), and diet supervisor (employee #2) from 11/7/17 through 11/0917 from 8:30 am until 3:00 pm the following:

1. On 11/7/17 at 10:30 AM during interview with the dietitian (employee #1) she stated that since June 2017, she was acting as the administrative dietitian and clinical dietitian. Since June 2017 that she was acting as administrative dietitian and it is not enough to cover the two (2) position and to evaluate patient, any answer some telephonic orientation to the physician related to patient diet.

2. On 11/7/17 at 10:30 am the dietitian (employee#1) state that the facility did not have food processor machine to prepare the pureed and specialty diets as order. At this moment the personnel use a domestic blender to perform the puree diet. She state that the use of the blender requires water to be added to provide the correct consistency to be administer through nasogastric tube (NGT) and this decrease the caloric and nutritional requirement of the diet for the patient. On June 15, 2017 at 11:03 am I receive an email notifying that the request for the kitchen grills and to repair the food processor will not be process during the fiscal years 2016-2017. They denied the request.

3. On 11/7/17 at 11:00 am the dietitian (employee #1) state that the facility have enteral supplement and provides as enteral nutritional diet (Boost, Boost Breaze, Fiber Source and Peptament 1.5)

4. During the record review on 11/7/17 at 2:30 pm with the dietitian (employee #1) it was found that RR #1 is a 26 years old female admitted on 11/2/17with a diagnosis of sever pneumonia, Human Immunodeficiency Virus (HIV), underweight and anemia. The physician transfer order indicate on 11/2/17 at 4:00 pm that the patient weight 81 pound an ordered diet Peptide 105 enteral by Orogastric tube (OGT) to run at 35 milliliter per hour (ml/hr.); Pre protein 30 ml per mouth (PO) three time a day (TID), Glutapack 1 pack PO TID. ON 11/2/17 at 7:00 pm the physician ordered admit to MICU with a diagnosis of Acute Respiratory Failure on Mechanic Ventilator, Acute Pneumonia, HIV, anemia, underweight and ordered daily weigh and chart, Fiber Source 1 can by OGT every 6 hour, Pre Protein 30 ml by OGT every 8 hr., Folic Acid 1 milligram (mg) by OGT every days.

a. However, no evidence was found related to the daily weight chart.
b. The physician failed to perform a nutritional Service Consult.
c. It was found that in the admission order lack of a nutritional consult due to patient diagnosis.
d. However the patient did not receive the nutritional diet requested by the transfer hospital due to not available in the facility and was changed to Fiber Source 1 can by NGT every 6 hr.
e. The laboratory value reveled that on 11/2/17 the hemoglobin (Hgb) was on 10.1 gram per deciliter (g/dl), Cholesterol 54mg/dl, Iron = 9.0 microgram per deciliter (mcg/dl), Albumin (Alb)2.1 g/dl, Calcium (Ca) 6.8 mg/dl and Total Protein 3.9 g/dl.
f. On 11/4/17 the albumin decrease to 1.8 g/dl, Hgb= 9.1 g/dl, Ca=6.5 mg/dl/
g. On 11/5/17 Hgb decrease 8.0 g/dl.
h. On 11/8/17 at 9:00 am the dietitian (employee #1) was interview related this case and was ask if this diet that the physician order cover the nutritional requirement of this patient, and she stated this diet does not cover all patient nutrition requirement. That acordance to patients' laboratory value was malnutrition.
i. No evidence was found that the nutritional services was requested.
j. No evidence was found that the nursing personnel performed the nutritional risk assessment.
k. No evidence was found that the dietitian evaluate the patient.
l. Review of policy and procedure (p&p) of nutritional Services request on 11/8/17 at 9:30 am state that Multidisciplinary intensive care unit (MICU) patient be evaluate by the clinical dietitian as requested.
m. The facility failed to provide adequate nutritional resulting in malnutrition due to abnormal laboratory value and not being evaluate by the dietitian services causing deterioration of patient nutritional status as reveal in the laboratory value.

Based on a complaint investigation survey PR00000601, observational tour of the facility's kitchen that prepares the patient's meals, review of menus, policies/procedures and interview with the clinical and administrative dietitian (employee #1), and diet supervisor (employee #2) from 11/7/17 through 11/09/17 from 8:30 am until 3:00 pm it was determined that the facility failed to comply with state and federal requirements to promote sanitary environment and procedures for 32 patients (Ptes) admitted at the facility. (Ptes #1 to #32)

Findings include:

1. The following was found during the observational tour of the kitchen service with the administrative and clinical dietitian (employee #1) and diet service supervisor (employee #2) on 11/7/17 through 11/09/17 from 8:30 am till 11:55 am:

a. On the refrigerator #1 it was observed in the last tray 2 portion of chicken thigh with drumstick without covered.
b. The freezer in the front of the refrigerator #1 it was broken accordance to the information provided the administrative dietitian (employee #1) and the supervisor (employee #2), and was observed with termite appearance in the inside of the door and the door frame was observed broken.
c. The cold Storage was observed with peeled paint in the door frame.
d. In the cold storage was observed two opened package of 11 ounce (oz.) of rice flour was unlabeled, a opened package of refine sugar of 5 pound was unlabeled, a opened container of salt was unlabeled, two package of white bread and one package of whole meal bread of 1 pound opened unlabeled, a tray of juice were unlabeled.
d. In the cold storage was observed dented three can of 46 oz. of 100% pineapple juice, 2 can of guava juice, 2 can of pear juice
e. In the cold storage was observed 3 box with 24 can of 18 oz. of Oat over the food processor beside the sink.
f. In the cold storage was observed 2 box of baby nipple and bottle under the sink.
g. In the Storage room was observed a dent can of 5.44 pound of mashed potatoes, a can of 6# of pears slices. 2 can of dice peach, 1 can of 6 pound sliced pineapples.
h. In the kitchen area some pots, pans and trays were observed with a lot of grime. This promote that food does not cook as evenly, and severely damaged cookware which can pose risk of a health hazard.
i. All kitchen area floor and tiles were observed broken, pieces of those tiles do not permit complete cleaning, encourage the growth of bacteria.
j. In the three compartment sink area was observed the sanitize compartment fill with water and power plus the sanitizer used. However they cannot be able to test sanitizer percent to identify if comply with requirements because they did not have available test strips.

During interview with the diet department supervisor (employee #2) on 11/7/17 at 10:00 am she stated that no evidence was available related to a log book of the sanitizer test and that she doesn't know that the test strip was finished. The test strip used was Hydroid Lo-Iodine test kit not available. The facility failed to assure that proper quantity of concentration are used to sanitize items on the three compartment sink.

k. The facility have 5 Stoves in the kitchen, one of them is not in use. 4 of the stoves was observed in use a have a black spot on the back.

The administrative dietician (employee #1) state during interview on 11/7/17 at 10:15 am that the detergent that the personnel use to clean the stove was finish and was requested and the contracted personnel that cleans the fat extractor comes one time per month and she was waiting when they come to clean the extractor to clean and remove the black spot of the stove.

2. No evidence was provided related to Quality indicator to the nutritional Services.
The administrative dietitian state during interview performed on 11/7/17 at 10:30 am that she is acting as administrative dietitian since June 2017, and the other administrative dietitian quit and she was looking for all folders and did not find anything related to the quality of this department.

Based on a complaint investigation survey PR00000601, observational tour of the facility's kitchen where the patient's meals are prepare, review of menus, policies/procedures and interview with the clinical and administrative dietitian (employee #1), from 11/7/17 through 11/09/17 from 8:30 am until 3:00 pm it was determined that the facility failed to ensure that food and dietetic services has sufficient qualified dietitian, full-time, part-time, or on a consultant basis to assess and re-assess patients at nutritional risk.

Findings include:

On 11/7/17 at 10:30 AM during interview with the dietitian (employee #1) she stated that since June 2017, she was acting as administrative dietitian and clinical dietitian. Since June 2017 that she was acting as administrative dietitian, it is not enough to cover the two (2) position and to evaluate patient, and answer some telephonic orientation to the physician related to patient diet.

Based on a complaint investigation survey PR00000601, records reviwed (RR), observations, review of policies/procedures and interview with the clinical and administrative dietitian (employee #1), from 11/7/17 through 11/0917 from 8:30 am until 3:00 pm, it was determined that the facility failed to meet individual patient nutritional needs in accordance with recognized dietary practices that affected 3 out of 3 patient on pureed and specialty diets as order. (RR#4, RR#11 and RR#12)

Findings include:

During observations, record review, review of policies/procedures and interview with the clinical and administrative dietitian (employee #1), from 11/7/17 through 11/0917 from 8:30 am until 3:00 pm the following was found:

On 11/7/17 at 10:30 AM during interview with the administrative and clinical dietitian (employee #1) state that since June 2017, she was acting as administrative dietitian and clinical dietitian. Since June 2017 that she was acting as administrative dietitian it is not enough to cover the two (2) position and to evaluate patient, and answer some telephonic orientation to the physician related to patient diet.

On 11/7/17 at 10:30 am the administrative and clinical dietitian (employee#1) state that the facility did not have food processor machine to prepare the pureed and specialty diets as order. At this moment the personnel uses a domestic blender to perform the pureed diet. She state that the use of blender requires water to be added to provide the correct consistency to be able to administrate through nasogastric tube (NGT) and this decrease the caloric and nutritional requirement of the diet for the patient.

She stated on June 15, 2017 at 11:03 am, "I receive an email that notified that the request for the kitchen grills and to repair the food processor will not be process during the fiscal years 2016-2017. They denied the request.

Based on a complaint investigation survey PR00000601, observations, review of policies/procedures and interview with the clinical and administrative dietitian (employee #1), from 11/7/17 through 11/0917 from 8:30 am until 3:00 pm, it was determined that the facility failed to maintain an current therapeutic diet manual approved by the dietitian and medical staff available to all medical, nursing, and food service personnel.

Findings include:

During the review of nutritional Service Manual on 11/9/17 at 9:00 am it was found that the nutritional manual was review on October 2006 and no other review was performed.

Based on observation and interview with safety officer (employee #9) at 9:15 am, it was determined that the facility fails to prevent patients from harm.

Findings include:

1. During Physical environment and Life Safety tour with safety officer performed on 11/7/17 at 9:15 am at the fourth floor, it was found that in the south section of this floor and the pediatric intensive unit care blue tarps, ceiling tiles and boxes full of papers were there. Smokes detectors were observed hanging and out places.

The safety officer reveals that the fire alarm company indicates that in these areas the smokes detectors are out of services.

The fire alarm panel indicates trouble and did not indicate where the trouble is. The facility knows about this situation since September 23 and reports on 10/26/17.

2. Facility failed to provide a physical environment that is safe from fire smoke and environmental hazard to ensure patient safety.

After the pass of Hurricane Maria on PR, the hospital was severe affected mainly on the roof. This has cause many leaks and water infiltrations damage in the hospital. The fourth floor is the one with the most water infiltrations registered. This infiltrations affected the fire alarm as a result the safety officer calls the company Honeywell to perform an initial assessment. They will perform a full assessment during the next week and begin the repairs.

Based on a complaint investigation survey intake PR00000601, tests performed on equipment and observations made during a survey for the physical environment with the facility's Safety Officer (employee #9) and performed on 11/7/17 thru 11/10/17, 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 32 out of 32 patients (Ptes.) receiving services. (Ptes #1 to #32)

Findings include:

During the observational tour performed on the roof top, fourth floor, third floor, second floor, first floor, ground floor on 11/7/2016 thru 11/10/17 from 8:30 am thru 4:00 pm the following was found:

Rooftop:

1. The roof of the facility measures 239,000 square feet and had total detachment from it.

2. Detachment of the lightning rod system.

3. The wind took the lights of air traffic. Only 5 spotlights were found.

4. Extractor (EF-1 N) was detached from connecting the building's duct.

5. Removal of extractor behind the fourth elevator mechanic. The winds took him away.

6. Detachment of (A / C, SF or EF) unit located behind the fourth mechanical lift (not existing by force of wind).

7. EF-4N extractor roof / south section lost top cover.

8. Lack of walling on the east side wall of the mechanical room (exterior)

Fourth Floor:

1. Rooms in section A #403, #408, #410, #416, #417, #419, #420, #425, #428, #429 with off-site ceiling acoustics due to humidity and filtration ceiling.

2. Section A computer storage room with broken glass covered with PVC sheets. Two were observed on the floor.

3. Section A corridors with detached floor tiles in vinyl.

4. Ceiling tiles section B corridors detached by moisture and water infiltration

5. Section aisle B vinyl floor tiles detached, lifted by water and puddles of water are observed throughout the area.

6. Section south broken glass and detached from the windows.

7. Strobe Light of the southern section detached from the acoustic ceiling tile.

8. It is observed as a mitigation plan on this floor, 6 blue tarps placed in the middle of the corridors to collect the water that is falling from the ceiling.

Third floor:

1. Section A patient rooms #302, #303, #304, #305, #306, #307, #308, #309, #312, #313, #314, #315, #316, #317, #318, #319 #320 with off-site ceiling acoustic tile due to humidity and water infiltration.

2. Medical room section A the windows are detached.

3. MICU Intensive adult care with water infiltration problems.

4. MICU Intensive adult care smoke detector damaged and does not appear on the panel of the fire alarm.

5. MICU cardiac monitor in cubicle #2, damaged by humidity.

6. Area disinfection of ventilators with ceiling tiles detached by moisture and infiltration.

7. Respiratory therapy area without floor tiles, detached floor tiles and a large accumulation of water on the floor.

8. Area of gastro floor tiles detached and lifted by water.

9. Hallway behind Respiratory Therapy Southern Section with floor tiles detached and lifted by water, broken window and ceiling acoustics tiles out of place due to moisture and infiltration.

10. ESRD treatment room with rubber base detach from the walls, floor tiles broken and with rust and mold. Walls with rust. Beds with rust. It was observed a sterling steel counter with rust.

Interview with RN (employee #18) on 11/7/17 at 10:18 am indicates that the counter it is out of service, but they used it for the preparation of the patient's medications.

Second floor:

1. Section B patient room #221, #223, #226, #228, #231, #232, #234, #237, #238 and #239 offsite by moisture and roof filtration.

2. Fourth Patient Section #201, #202, #205, #206, # 207, #208, #209, #211, #212, #214, #216, #217 and #218 out of site for moisture and filtration of roof.

3. Fan coils on patients rooms #212, #213 #238, #239 and #240 out of service.

First floor:

1. Pediatrics patient room #159, #160, #162, #167, #168, #170, #174 and #177 acoustics off-site due to moisture and roof filtration.

2. Patient rooms #171 and #172 leaking water through the ceiling

3. Ice machine bouncing a lot of water underneath

Emergency room:

1. General Storage
a. Without smoke detectors.
b. No Air conditioning
c. No thermometer. The temperature 78 F and relatives 73%, this temperature is out of range.

2. Minor Surgery
a. Stretcher covered with tape.
b. Floor tiles with mold.
c. The facility failed to record temperature and humidity for this room to ensure that it complies with appropriate perimeters. At the moment of the visit 11/8/17 at 2:15 pm the temperature was taken with a laser thermometer and revels 87F.

3. All treatment stretchers/beds were found with rust.

Ground Floor:

X-ray Department:

a. The X-ray machine #5 a water leak on the ceiling and a blue gown in the floor to collect the water.
b. The dark room of the X-ray department lacks of exhaust system causing a strong chemical smell in the dark room and irradiates by a fan to the main hall were the patients walk.
c. The CT room of the X-ray department that the door of the ready-box Body temperature Media Warmer where the contrast bottles are stored was found without a security lock.

Kitchen:

a. The freezer in the front of the refrigerator #1 it was broken accordance to the information provided the administrative dietitian (employee #1) and the supervisor (employee #2), and was observed with termite appearance in the inside of the door and the door frame was observed broken.
b. The cold Storage was observed with peeled paint in the door frame.
c. In the kitchen area some pots, pans and trays were observed with a lot of grime. This promote that food does not cook as evenly, and severely damaged cookware pose risk of a health hazard.
d. All kitchen area floor and tiles were observed broken.
e. The emergency light in the freezer area does not work.
f. Refrigerator #3 of vegetables does not work.
g. Freezer #1 and #2 does not work.
h. Area of sinks 10 lamps that need replacement of light tubes. The lighting in the kitchen is very poor.
i. Area of the production line 3 lamps that need replacement of light tubes.

Pharmacy:

a. Air conditioning vent was observed rust
b. Ceiling tiles with water leaking spots.
c. Three missing tiles.

Respiratory Therapy area provides evidence of the following:

a. Ceiling tiles in the treatment room was observed bended and with mold.
b. Missing floor tiles and puddle of water all over the floor.
c. Clean and disinfecting ventilator room without air conditioning.

During the observational tour of the facility from 11/7/17 through 11/10/17 from 8:00 am until 4:00 pm with the facility's Safety Officer (employee #9), it was found that the air extractor system of the hospital is not working. Bathrooms, dirty utility rooms and housekeeping closets did not have working air extractors.

The facility's Engineer (employee #10) stated during an interview on 11/9/17 at 3:45 pm that the main extractor on the roof is out of balance and in need of repair and this effects the entire facility

Maintenance closets located were observed with the Safety Officer (employee #14) and on 11/7/17 from 8:00 am until 4:00 pm these closets were found at the emergency room, operating room department and both wards with chemicals and equipment to clean the facility and were found unlocked and accessible to non-authorized persons.

There is an accumulation of trash around and near the garbage dumpster in the parking area as observed on 11/7/17 at 8:00 am.

Based on tests to equipment and observations made during the survey for Life Safety from fire with the safety officer (employee #9) , it was determined that the facility does not meet some applicable provision of the 2012 edition of Life Safety Code of the NFPA 101.

Findings include:

The Life Safety from Fire survey was performed from 11/7/17 through 11/10/17 from 8:00 am until 4:00 pm; for deficiencies related to Life Safety from fire (form CMS2786R) please see tags with letter K on the CMS 2567 form (K 0211, K0223, K0291, K0293,K0324, K0341, K0363, K0372,K0511, K0711, K0754 and Tag K0915).

Based on the observations made during the survey for the physical environment , it was determined that the facility failed to follow established procedures for the storage and prompt disposal of biohazard trash related to, outside metal biohazard storage container found unlocked and all biohazard closets (emergency room and hospital) were found unlocked with unauthorized access.

Findings include:

1. The outside metal biohazard storage container located at the back of the facility was visited on 11/7/17 at 8:10 am provided evidence that one of the doors was wide open and unlocked which does not prevent unauthorized access.

2. An outside metal trash container/compactor located at the back of the hospital was visited on 11/7/17 at 8:10 am and provided evidence that the main hatch where small trash containers are emptied was found wide open with an accumulation of trash.

Also the regular trash were around the metal trash container covering the walls of it. The trash container/compactor does not have a metal or plastic door that can be swung over the hatch after the trash is compacted to ensure that trash is not accessible to pigeons, pests and rodents; the trash container/compactor is approximately 100 feet from the hospital.

3. All biohazard closets (emergency room and hospital) were visited from 11/7/17 through 11/10/17 from 8:00 am until 4:00 pm. These closets were found with biohazard trash containers and the doors were all found unlocked and the closets were accessible to non-authorized persons.

Based on observations made during the survey for the physical environment with the facility's safety officer (employee #9), 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.

Findings include

1. It is observed that in rooms B and C of the first, second and third floors the bathrooms do not have hot water.

In an interview with the physical plant engineer (employee #10) on 11-8-17 at 3:30 p.m., he stated: "A boiler was purchased 5 years ago, due to how old this building is, it has not been possible to install it anymore, that the system is too expensive, line heater is being used in the area of rooms C.

2. The swing type doors that separates the restricted area (surgical suites) from the semi-restricted area did not close flush to its frame or the doors (in the closed position) as observed on 11/9/17 at 9:00 am.

3. The 8 doors of the operating rooms do not seal completely.

4. All the walls were designed with tiles, they have cracks and does not has sufficient sealer that made the tiles hard to scrub and does not look monolithic way.

5. Mattress covers of the operating table scratch with old tapes and deteriorated.

6. The floor is not monolithic. In the area of the table it was observed broken tiles.

7. The base of the equipment carts, portable oxygen cylinder, screws of the operating lamps and the base of the operating tables was observed rusty.

8. The ceilings were observed with perforation and were not sealed to make the ceilings washable, scrub able and make it monolithic.

9. The facility did not have a back-up electric generator.

On 11/9/17 at 11:35 am during the complaint investigation there was an electrical power outage throughout the island due to a general electrical failure. It was observed that none of the patients' rooms had light and the A / C was not working.

The area of preparation of medicines in the floors and treatment area also had no light; thus hindering the preparation of medications or the administration of treatments.

Interview with safety officer (employee #9) on 11/7/17 at 11:45 am stated: " FEMA brought an electric generator it is a big one and it can supply power to all the hospital but we cannot used it because this hospital it is too old and needs special cables to connected the generator. The installation of the generator is too expensive. That is why you can see the cables crossing the hallway in the basement area without being connected. We have a protocol when rooms are left in the dark we use flashlights and walkie talkies when we have communication problems until the light arrives. During the emergency, it was run".

Based on a complaint, tests performed on equipment and observations made during the survey for the physical environment , it was determined that this facility's physical structure is not designed in accordance with Federal and State laws to provide protection of patients and staff.

Findings include:

1.The hospital's emergency room (adult and pediatric) was visited on 11/9/17 from 11:30 am until 3:00 pm and provided evidence that there are six lounge chairs that are placed up against a wall in the observation area that are used to provide respiratory therapy and give intravenous solutions to patients. The lounge chairs are placed side by side with out space between them and no curtains were found between the lounge chairs.

In order to provide emergency treatment to a patient at least four feet between lounges chairs is needed to accommodate emergency staff and equipment and curtains are needed to provide privacy during treatment.

2. Maintenance closets throughout the Hospital Dr. Ramon Ruiz Arnau located in hallways, emergency room and operating room department were observed on 11/7/17 and 11/10/17 from 8:00 am until 4:00 pm with the Safety Officer (employee #9).
These closets were found with chemicals and equipment to clean the facility and did not have air extractors or smoke detectors connected to the fire alarm system.

Based on a complaint investigation survey PR00000601 conducted on 11/7/17 through 11/10/17, the observational tour with the Infection Control Coordinator (employee #14) and Nursing Sub Director (Employee 12), review of policies/procedures, observation of procedures, it was determined that the facility failed to ensure that appropriate dialysis treatment, operating room , outpatient services standards of practice are followed for infection control practice, which can affect 40 out of 40 patients (Ptes.) admitted. (Ptes. #1 to #40).

Findings include:

A.On 11/7/17 at 9:30 a.m. till 9:55 a.m. and at 1:00 p. m. till 3:55 p. m. during the performed visual Inspection on different department's with the Infection Control Coordinator Nurse (employee #14) and the Nurse Supervisor (employee #2) the following was found:

1. The fourth floor designated to Pediatric Department and Intensive Care Unit was maintain closed per years however, the Pediatric Department had a lot of structural damage due to flood and rain from the hurricane. No air conditioner. A big blue plastic tarp forming a conen is located on the ceiling and at the end of the tarp a regular trash disposal and a biohazard trash disposal were observed used to avoid the water leak cross the ceiling acoustic tiles to fall to third floor. Much water was observed on a large corridor to the exit side of the Pediatric Intensive Care Unit. Much dust and humidity odor was detected on all areas of the pediatric department and all of the corridor lacks of acoustics ceiling and deteriorate floor.

2. The third floor designated to Medicine Department Ward A, Ward B, Intensive Care Unit, Endoscopy Area and Hemodialysis Treatment Unit. All of this areas are completely affected per the flood provoked by leak on the roof. Every ceilings acoustics and many floor tiles are missing. The Medicine Ward B, Endoscopy and Hemodialysis Treatment Unit was maintain closed to admit patients, no air conditioner.

All patients who is admitted at the facility to receive hemodialysis treatment, received the treatment on the Intensive Unit Care per the hemodialysis nurse (employee #3).

A Medical Shelter Logistics was localized on Medicine Ward A this area had many issues during the Hurricane Maria related to air conditioner, wall system oxygen not working, no hot water is available on patient's rooms and others structural problems were identified. However, this area is not ready to received hospitalized patients and then discharge home. At this moment this area only received patients discharge from other facilities. Much dust and humidity odor was detected on all areas of the Medicine Department and all of the corridor lacks of acoustics ceiling and deteriorate floor.

B. At 10:00 a.m. till 10:40 a. m. the Dialysis Unit located on the third floor near the Intensive Unit Care was visited and the following was found:

1. The area lacks of air conditioner related to electric problems post - Hurricane Maria.

2. The main door was observed in poor condition dirty and deteriorate paint.

3. On the interior of all of this area was detected much dust, humidity odor and disorganizer.

4. The area has two hemodialysis stations # 7 and # 8, the tiles of those stations were observed on deteriorate conditions with yellow color, mush dust, land slide tiles.

5. The right side of the metal wall divided the station #7 and # station #8 were observed much rust on all of the borders of the wall.

6. On the right side on back of the station # 8 a hand sink a sharp container was placed under the hand sink to collect a water leak drain from the hand sink.

7. The unit has a large metal medication area with a deteriorate washstand on left side, the wood placed on the border on back of the washstand was observed loosen with black spots, water and humidity odor. On 11/7/17 at 10:05 a. m. at left side of the medication area cabinet was observed a ''sign" reading '' Aut of Service '' this medication area was observed on very poor condition, dirty and with much dust, much mold, pieces of mold on the interior of the shelves and under the cabinet, however, twenty one (21) vials of Heparin, one vial of Sodium Bicarbonate and one Sterile Water were observed on the interior of the shelve. On the interior of the metal cabinet and on the floor of this, medical surgical materials and .9% of Saline Solutions 1000 ml. used for hemodialysis patients were observed however, the area was very dirty, much dust and mold were observed. The cabinets was maintain open all the time expose to dust and did not maintain security of all of medical surgical materials located on the interior of the cabinets.

8. The area designated ''Spare '' Technician Area and dirty area '' lacks of illumination. The door and walls were observed with much dust and mold. Disorganized.

9. The room designated to receive and maintain the hemodialysis materials '' store area '' lacks of air conditioner. During the visual inspection it was observed that this area lacks of thermometer. On this area were observed all of the materials used for hemodialysis patients the following were observed: Write Distilled Vinegar, fourteen (14) boxes of Hemodialysis Blood Tubing set, Naturalyte, twenty (20) boxes of Optiflux F160 NR, fourteen (14) units of Hemodialysis concentrate and others materials used for hospitalized patients. This area was observed disorganizer, not clean, the floor was observed with yellow spots, dirty with dust and humidity odor.

10. Outside of this room a blue regular trash can without lid and plastic bag, it was observed on the interior of the trash can, two used gloves. It was observed that the hemodialysis register nurse (employee #18) has a blue glove on both hands he takes the trash can and turns it then the two gloves falls to the floor, he takes the two gloves from the floor and discard the gloves on the regular trash can however, the employee #3 never removed his dirty gloves, never wash his hands and continue with the same gloves not following infection control standards of practice.

The hemodialysis register nurse (employee #18) was interviewed on 11/7/17 at 10:05 a. m. related to the daily temperature and humidity log and he stated: '' I work on this area since six years however, I do not have a log an on this area never took a daily temperature and humidity on this room, never had a thermometer.'' The temperature and humidity was taken per the surveyor at 10:07 a. m. and revealed that the temperature was on 80 Grades Fahrenheit and the Humidity was on 42%. According of the design parameters for hemodialysis room is be maintain between 70 - 75 Grades Fahrenheit and Humidity maximum 60%.

The hemodialysis register nurse (employee #18) was interviewed on 11/7/17 at 10:10 a. m. related to the daily cleaning and he stated: '' This area is clean per the hospital maintenance personnel and he referred that this area did not have a maintenance room and the housekeeping employee used the same cube, mop and others materials used on the Intensive Unit Care to provide service on this area.'' The facility did not designated another area to locate the housekeeping materials and equipment.

11. The facility failed to designated areas for medical surgical materials, gallons of vinegar used for dialysis treatment, equipment to dispose, unused equipment and maintenance materials including bleach.

12. Failed in environmental cleaning and security and failed to designate a separated area for medical surgical supplies, equipment and maintenance supplies.

At 10:25 a. m. the hemodialysis register nurse (employee #18) was interviewed related to on what scale he took the daily patient weight before and after the patient received the hemodialysis treatment and when received the patients on wheelchair and stretcher because during the visual tour was observed a regular scale located near the medical surgical material cart. The scale was observed on deteriorate condition, peeling paint, mold and dust. He stated: '' This unit only has this scale however, this unit has been used for twelve years to administered hemodialysis treatment and never have weighted the patient's". When the surveyor asked how he knows if the patient if over or under his dry weight to adjust the weight, he stated: '' I know per experience.''

13. The Hemodialysis Treatment Area including the floor, ceiling, walls and other areas used to maintain the sterile materials, hemodialysis machines used for all of the patients to received hemodialysis treatment services, failed to ensure that appropriate standards of practice are followed for infection control practice and dialysis treatment.

C. At 10:43 a. m. the Intensive Unit Care was visited and the following was found:

1. The hand paper dispenser was observed with rust and yellow spots was observed on the faucet on the employee's bathroom.

2. All of the Intensive Care Units rooms were observed on deteriorate conditions, the floor tiles and the borders of the rooms was observed dirty and dust.

3. All of the regular trash cans did not have lid.

4. Room #4 was observed with a '' label '' and reading '' Aut of Service '' This room has leak cross the ceiling acoustic tiles, fire alarm and the borders of the walls.

5. Room #1 has leak cross the ceiling acoustic tiles in front of the main door.

6. The right side of the nursing counter has leak cross from the ceiling acoustic tiles.

7. In front of the patient room #2 has leak cross from the ceiling acoustic tiles near the air conditioner.

8. Leak cross from the ceiling acoustic tiles in front of the patient room #1 and in front of the physician's office.

D. The Second floor Ward B and Ward C was used at this moment for medicine and surgery patients. The Ward A was maintain closed. This department had a lot of structural damage due to flood and rain.

1. A large piece of peel paint and humidity were observed on the borders of the windows on patient rooms.

2. On patient room #223 water leak cross from the ceiling acoustic tiles, yellow and black spots on the ceiling acoustic tiles, a large piece of peel paint and humidity on the borders of the windows and deteriorate floor tiles were observed.

3. On patient room #231 was out of service related to leak cross from the ceiling of the third floor, the acoustic tiles of the ceiling are broken and two blue plastic trash cans were observed to collect water. The floor was observed dirty, with much dust, black spots on the interior of this room.

4. No hand sanitizer on patient room #235. During the visual inspection it was observed an empty plastic water bottle with a yellow liquid on the top of the night table, the patient referred that he urinate on the bottle because did not have urinal and the bathroom was occupied. Near the bottle of urine fruits and other articles was observed.

5. The medicine department lacks of hot water on all of the areas included the patient's bathrooms during the visual inspection all patients referred that they had to take a bath with cold water every day.

6. On patient's rooms #238 and #239 the air conditioner was out of service.

7. No hand sanitizer and paper towel on the utility room.

8. On 11/8/17 at 11:00 a.m. during performed the visual inspection on second floor Medicine ward with the Infection Control Nurse Coordinator (employee #14) and the Medicine Nurse Supervisor (employee #20) it was observed approximately ten plastics bags, a carton box and a regular trash can contain regular garbage located on the corridor outside of the nurse station directly on the floor.

According to the nurse supervisor the house keeping personnel did not removed the garbage on shift 3:00 p. m. till 11:00 p. m. Addition the biohazard room located on back of this corridor near the nurse station was observed without security lock the lock of the door did not closed and approximately fifteen biohazard garbage was maintain in this room because the housekeeping personnel did not removed it on shift 3:00 p. m. till 11:00 p. m. This situation maintain the biohazard and regular garbage expose to the patients, patients families, personnel and others. The room did not ensure the quality control and the security. The facility failed to ensure that appropriate standards of practice are followed for infection control practice and security.

On 11/8/17 at 11:15 a. m. the housekeeping supervisor on shift 7:00 a. m. till 3:00 p. m. ( employee #23) was interview related to the reason the employee on shift 3:00 p. m. till 11:00 p. m. did not removed the regular and biohazard garbage and she stated: '' The designated employee was (employee #24) on her assignment she supposed to remove the regular and biohazard garbage however, I not to know the reason why the garbage stay on this area until yesterday. However, I ordered to remove both garbage now. ''

9. On equipment storage room #248 was observed I.V. stands, stretcher, bathroom curtains, bedroom curtains, I. V. pumps and others equipment. The ceiling lacks of acoustics tiles dust was observed on the interior of the ceiling.

10. The acoustics tiles on the patient room #248 was observed with brown spots water leak was observed.

11. The air conditioner on patient room #252 was out of service.

E. The Second floor Ward C was used for medicine, surgery and gynecology patients. During perform the visual inspection on 11/8/17 at 11:30 a. m. the following was observed:

1. Many acoustic tiles with black spots, dust and dirty were observed on the acoustics located in front of the elevators.

2. The shower bath on patient's rooms #241 and #242 have obstructive problems and accumulated water was observed. Every ceiling tiles are missing, enlarge paint and humidity on the borders of the windows and deteriorate floor tiles were observed. Two patient's beds with plastic mattress were observed with brown color on the middle of the mattress provoked by the leak on the roof. Humidity odor was detected.

3. The ward did not have a ''pantry'' the dirty and used linens were placed in a bathroom located on the corridor.

4. On patient's rooms #252 and #253 the air conditioner was out of service

5. The wall located at the right side of the main entrance of the patient room #253 was observed with much black spots provoked by the leak on the roof and the humidity. Much water was observed on the floor. No hand sanitizer on this room.

6. The medical surgical material storage lacks of acoustic tiles, on this storage was observed three metals cabinets with sterile materials (I.V. lines, syringes, adhesive tape, gloves, gauzes, primary and secondary lines, urinary sterile trays and other medical surgical materials). Others non sterile materials and equipment were observed block of papers, hospital forms and one stair.

7. The acoustics tiles of the utility room was observed with yellow spots and black dust was observed around the air conditioner vent. The utility room lacks of hand soap and hand paper.

F. At 11:30 a. m. the Pediatric unit was visited and the following was found:

1. The patient room #163 lacks of hand sanitizer.

2. The patient room's #164 and #174 and the housekeeping room lacks of illumination.

3. The ice machine was located on back of the corridor the acoustics tiles of the roof located inside of the ice machine was observed with much yellow spots, much humidity and very fluffed moisture provoked per the leak on the roof, a blue pad was observed to cover the surface of the ice machine. Much water was observed on the floor around the ice machine and a plastic canister was observed under the ice machine to collect the water leak.

4. The equipment storage room #165 was observed two fans, two stretchers, three basinets, two incubators, I.V. stands, a large electric extension and others equipment's, the area was observed disorganized and lacks of acoustic tiles.

5. The acoustic tiles of patient room #170 and #172 was observed with much humidity and very fluffed moisture provoked per the leak on the roof.

6. The patient room #171 lacks of acoustic tiles. Leak was observed drain per the air conditioner and a cube was observed to collect the water.

7. The acoustic tiles of room #173 designated as nurses locker was observed with yellow and black spots provoked per the leak on the roof. The faucet was broken and was out of service.

8. The patient bed on room's #175 lacks of mattress.

9. The medication room located near the housekeeping room lacks of wood door only have an '' iron bars door". This door has spaces between iron bars and ' during the visual inspection through the spaces it was observe the acoustic tiles with humidity and much fluffed moisture provoke by leak on the roof. The medication room lacks of wood door, was located on the corridor near the housekeeping room and near the exit side and elevators. The medications and the materials used by the nurses to prepare the medications for patients was exposed to dust and no security.

G. The outpatient clinics was visit on 11/8/17 at 1:30 p. m. for visual inspection with the infection control coordinator (employee #14) and the outpatient clinic nurse supervisor (employee #11) and the following was observed:

1. At the left side of the main entrance two refrigerators used to maintain all of the vaccines used for patients and employees. The ceiling lacks of acoustic tiles and near the refrigerators two large trash cans were observed to collect the water leak drain per the roof. The acoustics tiles was observed much fluffed moisture provoke by water leak.

The register nurse (employee #25) was interviewed and she stated: '' Before the Hurricane Maria it only leak a small drops then the hurricane increase the leak and provoked several acoustics damage. During the hurricane the hospital did not have electric energy and the refrigerators used for the vaccines was maintain without refrigeration and 549 vaccines of the Reforma Health and 98 privacy health vaccines received harm because lacks of refrigeration.''

H. The '' Pharmacy Storage '' located on the basement was visit on 11/9/17 at 9:15 a. m. for visual infection control inspection and the following was observed:

1. A fan was observed and the area was detected warm. The employee #26 person responsible of this storage was interviewed and she stated: '' This area did not have problems during the hurricane Maria but this storage never had air conditioner.'' Parenteral solutions, I.V. fluids, medications and others pharmacy materials, solutions and medications were observed on this storage without adequate temperature and the manufactured recommendations. All of the carton boxes was observed inside of wood pallets and expose to dust, humidity, insects and fire risk.

I. The '' Housekeeping Department '' located on the basement was visit on 11/9/17 at 9:39 a. m. for visual infection control inspection and the following was observed:

1. The area lacks of many acoustics tiles, no air conditioner and the air conducts on the conditioner canal much dust was observed, visual humidity and black spots with apparently fungus. Three trash cans were observed directly on the roof area to collect the leak provoked per the air conditioner conduct. The area was observed on poor condition and mush dust and very dirty area was observed. Humidity odor was detected.

J. The '' Morgue '' located on the basement was visit on 11/9/17 at 11:30 a. m. for visual infection control inspection and no evidence that the temperature was taken on 11/6, 11/7 and 11/9/17.

K. The following was observed during the visual inspection for Infection Control on 11/9/17 from 1:10 p. m. till 2:45 p. m. on the Operating Room Department:

1. Different scrubs were placed on the last metal shelve located on the secretary's office maintained closed at all the time however, the scrubs was observed without cover with plastic clear bags to ensure that personnel do not have to touch different scrubs when looking for specific sizes.

2. Personnel can move directly into the surgical suites area after changing clothes and when ended the surgeries many personnel physicians and nurses were observed go out of the operating room department including outside to the hospital parking with the operating room scrubs. Additional on occasions was observed the personnel entering at the operating room department and suites with the same scrubs however, no evidence of detailed policies and procedures that must include what to do with different staff (male/female, physicians/nurses, housekeeping, etc) and toilet, hand sink, routes of travel, where to place street clothes. Staff must also be instructed that once they leave of the operating room they cannot re-enter unless they have finished for the day.

3. On 11/9/17 at 1:55 p. m. on the '' Suite number one '' an orthopedic surgery was performed and was observed trough the crystal door one of the personnel with brown scrub using the cellular phone during the surgery.

The nurse supervisor (employee #21) was interview related to this and she stated this person is from an external company of Home Orthopedic. However, no evidence of policies and procedures related to when external personnel needs to enter at the operating suites to assist the orthopedic physicians to provide the material or orthopedic equipment.

4. This practice did not ensure the quality control and the security for the patients. The facility failed to ensure that appropriate standards of practice are followed for infection control practice and security.

5. The housekeeping maintenance closet lacks of illumination.

6. The surgery department have seven wash stands for scrubs the first scrub lacks of hot water and was out of service because have a drainage problem.

7. One box of sterile water for injection expired on October of 2016 was observed on the operating suite #2.

8. The air conditioner of the operating suite #4 was out of service.

9. The operating suites #5, #6, #7, #8 and #9 was out of service however, the suite #6 was used to locate the operating room equipment ( laparoscopy, orthopedic and others equipment's ).

10. The operating suite #9 used to locate all of the materials and equipment to discard. During the visual inspection for infection control a deteriorate surgery department was observed all of the floors were observed opaque, dust and dirty and with deteriorate tiles.

11. The operating suites #5, #6, #7, #8 and #9 observed dirty, with dust, peeling paint, black stain, humidity, all of the clocks on the suites did not function, rust and brown color was observed on the interior and exterior. Doors, the corridor walls and others areas of the department was observed with deteriorate condition.

12. No evidence of temperature and the relative humidity of the operating suites #1, #2, #3 and Recovery room area on 11/9/17.

The anesthesia assistant (employee #28) provide evidence of the anesthesia room refrigerator from January 2017 through November 10/2017 however, the temperature stay on 50.0 ºF to 54.0 ºF not according of the facility's policies and procedures establish that the temperature stays between 35.0 ºF to 46.0 ºF.
The facility nurse supervisor ( employee #21 ) did not provided evidence of the anesthesia room daily temperature and humidity and all of the others areas of the operating room suites, recovery room, medical surgical sterile room and others areas of the operating room department.

13. On 11/9/17 at 1:45 p. m. on the '' Anesthesia Room '' plastic trays, suction catheters, two syringes of 60 ml. used for suctioning, one open bottle of sterile water, swap sticks, fenestrated towels, one open box of gloves, rolls of gauzes and others materials were observed under the hand washing sink. The metal cabinet was observed with rust and dust on the base of the cabinet and was covered with blue pads and inside the blue pads were observed all of them.

14. The refrigerator used to maintain the stomach tube that are used during procedures at cold temperature lacks the daily temperature registry log. The plastic borders around the refrigerator door was observed with black color and dirty.

15. The padlock of the first refrigerator used for medications on the anesthesia room was observed open and various medications without security lock, were observed in the interior of the refrigerator expose to unsecure.

16. The medication stock was observed on 11/9/17 at 1:48 p. m. opened without security lock and the keys was maintain on the lock.

17. Two syringes without plastic cover, one vial of Calcium Gluconate 10% expired on September / 2017were observed in the interior of a plastic tray located on the top of the counter.

On 11/9/17 at 2:20 p. m. the OR nurse supervisor (employee #21) did not provide evidence of what kind of methods is utilized to evaluate staff and ensure that all of the staff comply with policies and procedures on the operating room department.

On interview related to her functions she stated: ''The operating time is Monday through Friday. At this time we only used three operating suites #1, #2 and #3 the others operating suites was out of use because has many structural problems. I have two register nurses on shift 8:00 a.m. till 4:00 p. m. and one LPN and one RN at 10:00 a. m. till 6:00 p. m. and one LPN. The facility has an anesthetist contract for physicians and anesthesiologist personnel. ''

18. No evidence of quality indicators related to operating room department and anesthesia department.


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Based on a Complaint Investigation survey PR00000601 conducted on 11/7/17 through 11/10/17, the observational tour, review of policies/procedures, observation of procedures, it was determined that the facility failed to ensure that appropriate standards of practice are followed for infection control practice for 2 out of 2 observed procedures (Record #6 and #13), fans in treatment areas, and the administrative order #284 of July 12, 2001 from the Health Department of Puerto Rico to prevent infections and communicable diseases and to ensure that appropriate standards of practice are followed for infection control practice related to use of dark color nail polish that was chipped and a bracelet.

Findings include:

1. During the observational tour of the X-ray Department on 11/07/17 from 8:00 am thru 12:00 pm, the following was determined:

a. It was observed at 9:29 am that in the room of the X-ray machine #5 there was 4 ceiling tiles missing because of the ceiling water leaks. A fan was observed in the room because there is no air conditioning unit working in the area. The temperature was 73.5' F.

b. It was observed at 9:37 am that in the room of the Sonography machine there was a fan installed on the wall, the room temperature was 78.0' F.

c. It was observed at 9:38 am that in the Dark room there is no exhaust system for the smell of the chemical to be eliminated and a fan that causes that the strong chemical smell gets to the main hall. The dark room temperature was 78.5' F and the main hall temperature was 75.5' F.

2. R.R. #6 is a 2 year old female admitted to the facility on 11/09/17 with a diagnosis of Acute Enteritis and Mild Dehydration. On 11/09/17 at 1:27 pm a venipuncture process for Intravenous medications was observed and the following was found:

a. It was observed that the Registered Nurse (RN) (Employee #6) poured liquid soap over her dried right hand, opened the faucet, and then wet her hand to perform hand hygiene not following the Centers for Disease Control and Prevention (CDC) guidelines.

b. It was observed that the RN (employee #6) took a pair of gloves from her uniform's pocket to perform the procedure to the patient.

c. It was observed that another RN (employee #7) was assisting the RN (employee #6) during the procedure; however the RN (employee #7) did not perform hand hygiene and was without gloves during all the procedure. At the end of the procedure was observed that the RN (employee #7) took gauze that had blood and other waste without gloves and threw them in the biohazard trash can.

3. It was observed in the Pediatric Area on 11/09/17 at 1:35 pm that a RN (employee #7) had dark color nail polish.

4. It was observed in the Pediatric Area on 11/09/17 at 1:40 pm that a RN (Employee #8) of the organizational improvement department was using a dark color nail polish that was chipped and a bracelet.

Facility fails to comply with the administrative order #284 of July 12, 2001 from the Health Department of Puerto Rico to prevent infections and communicable diseases and to ensure that appropriate standards of practice are followed for infection control practice


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5. During a tour of different department, procedure observations, verifications of medication cabinets and verifications of the medications and emergency carts on 11/07/17 to 11/09/17 from 8:00 am thru 3:00 pm, the following was determined:

a. On 11/08/17 at 1:30 pm it was found on the 2nd floor Ward C emergency cart a number 20 needle expire on 04/17.

b. On 11/08/17 at 1:54 pm it was found on the 2nd floor Ward B emergency cart five red labs tube expire on 10/31/17.

c. On 11/08/17 at 2:00 pm it was found in the Medicine Intensive Care Unit (MICU) Thirty Digoxin 500 micrograms in 2 milliliters (ml) injection expire on 10/17 and one Heparin 5,000 units per milliliters open and without a label with of the opening date and initials.

d. On 11/08/17 at 2:32 pm it was found on the Emergency room (ER) Cardio area emergency cart two Insulin syringe 1ml expire on 04/17.

e.On 11/09/17 at 1:31 pm it was found on the Pediatric ward a handmade wood cart with medical surgical material.

f.On 11/09/17 at 2:29 pm it was found on the 2nd floor ward C a cart with a wood shelve with medical surgical material.

6. R.R. #13 is a 57 year old male patient admitted to the facility on 11/07/17 with a diagnosis of fluid overload. On 11/09/17 at 2:12 pm a medications administration was observed and the following was found:

a. It was observed that the Registered Nurse (RN) (Employee #22) washing her hands and at the same time holding her gloves on the armpit then the RN put her gloves on and proceed to clean the septum and administered the intravenous medication to the (RR#13).

Based on a complaint investigation survey PR00000601 conducted on 11/7/17 through 11/10/17, the observational tour, interview and review of policies/procedures it was determined that the facility failed to ensure that surgical services maintain a high standards of medical practice and patients' care for 3 out of 9 operating suites (Stes). (Stes #1 to #3)

Findings include:

l. The following was observed during the visual inspection for Infection Control on 11/9/17 from 1:10 p. m. till 2:45 p. m. on the Operating Room Department:

a. Different scrubs when looking for specific sizes was placed on the last metal shelve located at the secretary office it is maintained closed all the time however, the scrubs was observed without covered with plastic clear bags at all time to ensure that personnel do not have to touch different scrubs when looking for specific sizes.

b. Personnel can move directly into the surgical suites area after changing clothes and when ended the surgeries many personnel physicians and nurses were observed go out of the operating room department included outside of the hospital parking with the operating room scrubs. Additional on occasions was observed the personnel entering at the operating room department and suites with the same scrubs however, no evidence of detailed policies and procedures that must include what to do with different staff (male/female, physicians/nurses, housekeeping, etc.) and toilet, hand sink, routes of travel, where to place street clothes. Staff must also be instructed that once they leave of the operating room they cannot re-enter unless they have finished for the day.

c. On 11/9/17 at 1:55 p. m. on the '' Suite number one '' an orthopedic surgery was performed and was observed per the crystal door one of the personnel with brown scrub using the cellular phone during the surgery.

The nurse supervisor (employee #21) was interview related to this and she stated this person is from an external company of Home Orthopedic.

However, no evidence of policies and procedures related to when external personnel needs to enter at the operating suites to assist the orthopedic physicians to provide the material or orthopedic equipment.

This practice did not ensure the quality control and the security for the patients. The facility failed to ensure that appropriate standards of practice are followed for infection control practice and security.

d. The housekeeping maintenance closet lacks of illumination.

e. The surgery department have seven wash stands for scrubs the first scrub lacks of hot water and was out of service because have a drainage problem.

f. One box of sterile water for injection expired on October of 2016 was observed on the operating suite #2.

g. The air conditioner of the operating suite #4 was out of service.

h. The operating suites #5, #6, #7, #8 and #9 were out of service however, the suite #6 is used for located the operating room equipment ( laparoscopy, orthopedic and others equipment's ). The operating suite #9 is used to locate all of the materials and equipment to dispose. During the visual inspection for infection control a deteriorate surgery department was observed, all of the floors were observed opaque, dust and dirty and with deteriorate tiles.

The operating suites #5, #6, #7, #8 and #9 observed dirty, with dust, peeling paint, black stain, humidity, all of the clocks on the suites did not functioning, rust and brown color was observed on the interior and exterior. Doors, the corridor walls and others areas of the department was observed with deteriorate condition.

i. No evidence of temperature and the relative humidity of the operating suites #1, #2, #3 and Recovery room area on 11/9/17. The anesthesia assistant (employee #28) provide evidence of the anesthesia room refrigerator until January 2017 through November 10/2017 however, the temperature staid at 50.0 ºF to 54.0 ºF not according of the facility's policies and procedures establish that the temperature stay between 35.0 ºF till 46.0 ºF. The facility nurse supervisor ( employee #21 ) did not provided evidence of the anesthesia room daily temperature and humidity and all of the others areas of the operating room suites, recovery room, medical surgical sterile room and others areas of the operating room department.

j. On 11/9/17 at 1:45 p. m. on the '' Anesthesia Room '' plastic trays, suction catheters, two syringes of 60 ml. used for suctioning, one open bottle of sterile water, swap sticks, fenestrated towels, one opening box of gloves, rolls of gauzes and others materials were observed under the hand washing sink. The metal cabinet was observed with rust and dust on the base of the cabinet and was covered with blue pads and inside the blue pads were observed all of them.

k. The refrigerator used to maintain the stomach tube on cold temperature lacks of daily temperature registry log. The plastic borders around the refrigerator door was observed with black color and dirty.

l. The padlock of the first refrigerator used for medications on the anesthesia room was observed opening and various medications without security lock were observed in the interior of the refrigerator expose to security.

m. The medication stock was observed on 11/9/17 at 1:48 p. m. opened without security lock and the keys was maintain on the lock.

n. Two syringes without plastic cover, one vial of Calcium Gluconate 10% expired on September / 2017were observed the interior of a plastic tray located on the top of the counter.

o. On 11/9/17 at 2:20 p. m. the OR nurse supervisor (employee #21) did not provide evidence of what kind of methods utilized to evaluate staff and ensure that all of the staff comply with policies and procedures on the operating room department.

On interview related to her functions she stated: ''The operating time is Monday through Friday. At this time only we used three operating suites #1, #2 and #3 the others operating suites are out of use because they have many structural problems. I have two register nurses on shift 8:00 a.m. till 4:00 p. m. and one LPN and one RN at 10:00 a. m. till 6:00 p. m. and one LPN. The facility has an anesthetist contract for physicians and anesthesiologist personnel. ''

No evidence of quality indicators related to operating room department and anesthesia department.

p. Evidence was provide related to the clothes used in the different areas of the operation room (nonrestrictive area, semi- restrictive area and restrictive area) and refers that in the restrictive area, all personnel need to use scrub, hair cap, shoe covers and faces masks. However, the operating room department did not have the nonrestrictive area, semi- restrictive area and restrictive area delineate accordance of operating room policies and procedures.

Based on a complaint investigation survey PR00000601, observation tours and review policies/procedures manual with the emergency room (E.R) nursing supervisor (employee #3) and the ER head nurse (employee #4), it was determined that the facility failed to maintain infection control standards of practice.

Findings include:

During the observational tour in the Emergency Room (E.R) on 11/10/17 from 8:30 am till 11:45 am the following was found:

1. In the medical evaluation area cubicle #2 it was observed that the examination stretcher mattress was broken, do not permit an appropriated cleaning and disinfection of the mattress.

2. In the trauma area was review the laryngoscope function and was found that the laryngoscope did not performed appropriated connection with the blade and function intermittent.

3. In the trauma area was observed a metal counter that has two drawers that did not close appropriated and staid opened.

4. In the trauma area was observed two vial of 50 milliliter (ml) of Xilocaine 2% 20 milligram (mg) per ml (mg/ml) opened without label with the date, hour and initial of the personal that opened.

5. In the trauma area was observed a bottle of 250 ml of sterile water single use, opened available to use. The manufactured recommended discard after use.

6. In the trauma area was observed a bottle of 16 ounce (oz.) of Peroxide water opened without label with the date, hour and initial of the personal that opened.

7. The medication preparation storage room of the evaluation area was observed without lock and was observed a 250 ml bag of normal saline solution (NSS) at 0.9% used without label with the date, hour and initial of the personal that opened.

8. In the medication preparation storage room of the evaluation area was observed a sharp container over the counter without a security rack.

9. In the evaluation area was observed a Metallic cabinet with mediation and the padlock was unlocked.

10. In the evaluation area was observed a Metallic cabinet over the sink with respiratory Therapy medication with the padlock unlocked.