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Based on a Validation survey, 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:

1. The admission packet that each patient receives during admission to receive services was reviewed on 10/21/15 at 8:50 a. m. During the revision it was identified that on page #24 the second section designated to '' Procesos de Quejas " Complaint Process, policies established by the hospital, did not provide the telephone number of the '' Quality Improvement Organization Office '' only provide the extensions numbers. On the second paragraph did not include the telephone numbers of the Puerto Rico State Agency, CMS Region and Livanta telephone numbers. The facility did not provide updated information of the phone numbers and address for lodging a grievance with the State agency, Medicare hot line was not included.
b. On page #44 and #45 the section designated for '' Derecho a Solicitar Copia del Expediente Clinico '' Rights to Receive Copy of the Record, did not indicated how much money the patient had to paid per copy when copies of the medical record were request. The facility did not provide the telephone number of the " Departamento de Manejo de Informacion de Salud del Hospital General Menonita de Aibonito. "

c. On page #50 the section designated for '' Derecho a Querellarse '' Rights to Compliant, did not provide the telephone number of the State Agency and Medicare hot line.''

Based on a Validation survey, medication administration observation in the second floor with the nurse supervisor (employee #4) and Quality Nurse (employee #10) it was determined that the facility fail to ensure that drug and biological are administered accordance to the Center for Disease Control and Prevention and nursing standard of practice.

Findings include:

1. During observation performed in medication administration on the second floor on 10/21/15 at 2:00 pm and on 10/22/15 from 9:45 am till 10:30 am with the nurse supervisor (employee #4) it was observed that nursing personnel fail to administrated medication accordance to nursing standard of practice as observe in the following:

a. On 10/21/15 at 2:00 pm it was observed the RN (employee #8) performing medication administration to patient room #207 B during the process the RN did not clean the primary line septum previous to insert and connects the Toradol piggy bag secondary lines.

b. On 10/22/15 at 9:45 am it was observed the RN #11 performing medication administration after performed the procedure he remove his glove and did not wash his hand as recommended by the CDC hand washing guideline.

c. During Medication administration observation on 10/22/15 at 9:50 am till 10:30 am it was observe that the facility has a medication cart that to assess the medication drawer the RN has to insert an code to opened, during the process it was observed the employee #11 use the medication cart to administrated medication for patient room 220 A and 220 B during the process it was observed that the RN #11 did not close completely the medication cart drawer and the medication cart did not close and proceed to enter to patient room leaving the medication cart unlocked and unattended.

Based ona Validation survey, medical records reviews (R.R.) from 10/21/15 through 10/22/15 with the second floor Nursing Supervisor (employee #9) of the Medicine Unit, it was determined that the facility failed to ensure that the nursing staff comply with policies and procedures (P&P's) established for verbal orders and orders made by telephone for 1 out of 64 records reviewed (RR #25).

Findings include:

1. RR #25 was performed on 10/21/15 at 3:00 pm. The patient was admitted to the Medicine Unit on 10/14/15 with diagnoses of Infected ulcer and Diabetes Mellitus (DM). It was found that on 10/15/15 at 11:15 am the Skin and wound care protocol physician order, ordered Moisturizing cream apply daily, Dermal Wound Cleanser use daily, Solosite Gel to apply on affected area daily, Algisite M 4x4 to apply on affected area and change every 3 days was not sign by the physician. On 10/14/15 at 7:50 pm the physician ordered a telephonic order for Vitamin K 10 milligram (mg) Intravenous (IV) per 1 at 2 hour and Laboratories PT, PTT and INR at 5 am was not countersign by the physician. On 10/14/15 at 6:22 pm physician ordered a subcutaneous Insulin Protocol, however it did not specify if a verbal or telephonic order and was not countersign by the physician.
2. Accordance to facility policies and procedure #26.4-4.1-05 part III. A.8 reviewed on 10/21/15 at 1:00 pm state that the physician countersigns the order in an interval of 24 hour after given the order. The facility failed to follow policies and procedures establish on its policy.

Based on a Validation survey, sixty-four (64) clinical records reviewed (R.R), it was determined that the facility failed to ensure that the patient medical records contain complete information and documentation regarding evaluations, interventions, care provided, services, for 4 out of 64 records reviewed (R.R #29, #30, #31 and #32)

Findings include:

Four out of sixty-four clinical records reviewed (R.R #29, #30, #31 and #32) during the survey performed from 2/20/15 through 2/22/15 did not contain complete information and documentation related to consults, physician history and physical examination, anesthesia records, post anesthesia follow up, physician's orders.

Based on a Vaildation survey, medical records reviewed (R.R.) with the operation room supervisor (employee #4), it was determined that the facility failed to ensure that the medical history and physical examination (H&P) is documented by a physician for each patient no more than 30 days before or 24 hours after admission or registration and updated prior to surgery or procedure requiring anesthesia services when the H&P was performed within 30 days before admission or registration for 4 out of 64 medical record reviewed ( R.R#29, #30, #31 and #32).

Findings include:

1. R.R #29 is a 60 year old female admitted to the facility on 10/16/15 with a diagnosis of Right Shoulder Cuff Tear. During the record review performed on 10/21/15 at 9:30 am it was found that the patient entered to the operating room on 10/16/15 at 9:45 am to perform a Right Shoulder Arthroscopy requiring anesthesia services. However the H&P was performed by the patient's physician on 9/17/15 at 2:00 pm, twenty-nine (29) days before the surgery evidence was found that the H&P was incomplete, lack the physician documented the page #2 of the H&P and lack to document the patient vital sign and no evidence was found that the physician performed an updated H&P previous to the surgery for any change in patient condition.

2. R.R #30 is a 72 year old female admitted to the facility on 10/16/15 with a diagnosis of Left Bimelleolar Fracture. During the record review performed on 10/21/15 at 10:10 am it was found that the patient entered to the operating room on 10/16/15 at 5:20 am to perform an Open reduction until fracture requiring anesthesia services. However no evidence was found that the H&P was performed by the patient's physician.

3. R.R #31 is a 69 year old female admitted to the facility on 10/5/15 with a diagnosis of Sigmoid Polyps. During the record review performed on 10/21/15 at 10:15 am it was found that the patient entered to the operating room on 10/5/15 at 7:55 am to perform a Colonoscopy with Biopsy requiring anesthesia services. However the H&P was performed by the patient's physician on 9/18/15 at 9:00 am, seventeen (17) days before the surgery evidence was found that the H&P the physician lack to document the patient vital sign and no evidence was found that the physician performed an updated H&P previous to the surgery for any change in patient condition.

4. R.R #32 is a 70 year old male admitted to the facility on 10/12/15 with a diagnosis of Back Cyst. During the record review performed on 10/21/15 at 10:30 am it was found that the patient entered to the operating room on 10/12/15 at 8:15 am to perform an Excision of Cyst requiring anesthesia services. However the H&P was performed by the patient's physician on 10/2/15 at 8:07 am, ten (10) days before the surgery evidence was found that the H&P the physician lack to document the patient vital sign.

Based on a Validation survey, medical records reviewed (R.R.) with the operation room supervisor (employee #4), it was determined that the facility failed to ensure that the medical history and physical examination (H&P) is documented by a physician for each patient and updated prior to surgery or procedure requiring anesthesia services when the H&P was performed within 30 days before admission or registration for 4 out of 64 medical record (R.R#29, #30, #31 and #32).

Findings include:

1. R.R #29 is a 60 year old female admitted to the facility on 10/16/15 with a diagnosis of Right Shoulder Cuff Tear. During the record review performed on 10/21/15 at 9:30 am it was found that the patient entered to the operating room on 10/16/15 at 9:45 am to perform a Right Shoulder Arthroscopy requiring anesthesia services. However the H&P was performed by the patient's physician on 9/17/15 at 2:00 pm, twenty-nine (29) days before the surgery evidence was found that the H&P was incomplete, lack to the physician documentation on the page #2 of the H&P and lack to document the patient vital sign and no evidence was found that the physician performed an updated H&P previous to the surgery for any change in patient condition.

2. R.R #30 is a 72 year old female admitted to the facility on 10/16/15 with a diagnosis of Left Bimelleolar Fracture. During the record review performed on 10/21/15 at 10:10 am it was found that the patient entered to the operating room on 10/16/15 at 5:20 am to perform an Open reduction until fracture requiring anesthesia services. However no evidence was found that the H&P was performed by the patient's physician.

3. R.R #31 is a 69 year old female admitted to the facility on 10/5/15 with a diagnosis of Sigmoid Polyps. During the record review performed on 10/21/15 at 10:15 am it was found that the patient entered to the operating room on 10/5/15 at 7:55 am to perform a Colonoscopy with Biopsy requiring anesthesia services. However the H&P was performed by the patient's physician on 9/18/15 at 9:00 am, seventeen (17) days before the surgery evidence was found that the H&P the physician lack to document the patient vital sign and no evidence was found that the physician performed an updated H&P previous to the surgery for any change in patient condition.

4. R.R #32 is a 70 year old male admitted to the facility on 10/12/15 with a diagnosis of Back Cyst. During the record review performed on 10/21/15 at 10:30 am it was found that the patient entered to the operating room on 10/12/15 at 8:15 am to perform a Excision of Cyst requiring anesthesia services. However the H&P was performed by the patient's physician on 10/2/15 at 8:07 am, ten (10) days before the surgery evidence was found that the H&P the physician lack to document the patient vital sign.

Based on a Validation survey, medical records reviewed (R.R), it was determined that the facility failed to ensure that 1 out of 64 records contain documents related to reason to consult, date hour and signature of the professional that request consult for 1 out of 64 records reviewed (R.R #25).

Findings include:

1. R.R #26 is reviewed on 10/21/15 at 2:00 pm and failed to provide evidence of reason to consult, date hour and signature of the professional that request the consult.

Based ona Validation survey, medical records reviewed (R.R), it was determined that the facility failed to ensure that 2 out of 64 records contain appropriate documents related to informed consent forms for procedures and treatments specified by the medical staff, or by Federal or State law, if applicable to require written patient consent (R.R #29 and #30)

Findings include:

1. R.R. #29 is a 60 years old female admitted with diagnosis of Right Shoulder Cuff Tear. During the record review performed on 10/21/15 at 9:30 am it was found that the consent form for surgery intervention or medical procedure was signed by the patient on 9/17/15, the consent form lacks of the Risk of the surgery, Nature and purpose of the procedure, probable consequences of the procedure, Available alternatives, risk consequences and likely effectiveness of each, Forecasts and likely consequences in terms of condition.

2. R.R. #30 is a 72 years old female admitted with diagnosis of Left Bimelleolar Fracture. During the record review performed on 10/21/15 at 10:10 am it was found that the consent form for anesthesia administration was signed by the patient on 10/16/15, the consent form lacks of the name of the physician who administrated the anesthesia.

Based on a Validation survey, records reviewed (R.R) with the second floor nurse supervisor (employee #9), it was determined that the facility failed to ensure that clinical records have documentation related to consult request, history and physical examination, nurse ' s notes,surgery and anesthesia consent, physician orders, vital signs, Dextrose monitoring, anesthesia follow up for 8out of 64 records reviewed (R.R #19, #21, #25, #26, #29, #30, #31 and #32).

Findings include:

1. R.R #25 is reviewed on 10/21/15 at 3:00 pm and failed to have the physician signature in the physician order.

2. R.R #26 is reviewed on 10/21/15 at 2:00 pm and failed to provide evidence of reason to consult, date hour and signature of the professional that request consult, lack of vital sign documentation.

3. R.R #29 is reviewed on 10/21/15 at 9:30 am and failed to documented a completed surgeon informed consent and lacks of the Risk of the surgery, Nature and purpose of the procedure, probable consequences of the procedure, Available alternatives, risk consequences and likely effectiveness of each, Forecasts and likely consequences in terms of condition. The history and physical examination (H&P) lacks the documentation of the second page and updated reevaluation previous to the surgery, The anesthesia follow up (Post operative follow up) performed on 10/19/15 lack of type of anesthesia, if patient was admitted, and the second call due to patient did not answer at the first call.

4. R.R. #30 is reviewed on 10/21/15 at 10:10 am and failed to documented a completed anesthesia informed consent and lacks the name of the physician who administrated the anesthesia. The history and physical examination (H&P) was not found in the medical record. The anesthesia follow up (Post operative follow up) performed on 10/19/15 lack of type of anesthesia, if patient was admitted, and the second call due to patient did not answer at the first call.

5. R.R #31 is reviewed on 10/21/15 at 10:15 am and failed to document a completed H&P lack of vital sign. The anesthesia follow up (Post operative follow up) performed on 10/6/15 lack of type of anesthesia, if patient was admitted.

6. R.R #32 is reviewed on 10/21/15 at 10:30 am and failed to document a completed H&P lack of vital sign. The anesthesia follow up (Post operative follow up) performed on 10/6/15 lack of type of anesthesia, if patient was admitted.


34043


7. R.R#19 is an 86 years old female patient with a diagnostics of Pneumonia and Diabetes Mellitus. This is a close clinical record and was review on 10/21/15 at 8:55 am with the Medical Record Director (employee #12). During the review of the physician orders it was found that it have an order for glucose test Dextrostix (DXT) every 6 hours dated on 5/04/2015 at 8:00 am. The blood glucose assessment chart was review and it was found that the glucose tests were taken out of the DXT order time frame. The blood glucose assessment chart present evidence of following (5/7/15 at 9:00 pm a DXT result 310 mg/dl, 12 hours later 5/08/15 at 9:00 am DXT result 131mg/dl.
The facility fails to document all necessary information needed to monitor the patient's conditions related to glucose test every 6 hours as order by the physician.
8. R.R#21 is a 54 years old female patient with a diagnostics of Acute Cerebrovascular accident and Partial treated infected wound. This is a close clinical record and was review on 10/21/15 at 10:26 am with the Medical Record Director (employee #12). During the review of the physician orders it was found that patient have an order for vital signs (VS) every 2 hours for three times the every four hours dated on 5/24/2015 at 2:02 pm. It have orders for DXT every 30 minutes before meals and bedtimes dated on 5/25/2015 at 12:27 pm The VS chart was review and it was found that the VS were taken out of the VS order time frame. The VS chart present evidence of following ( 5/24/15 at 2:36 pm blood Pressure (BP) on 166/77, 6 hours and 24 minutes later 5/24/15 at 9:00 pm (BP) result on 129/74). The blood glucose assessment chart present evidence of following (5/24/15 at 8:59 pm a DXT result 308 mg/dl, 24 hours later 5/25/15 at 9:00 pm DXT result 275mg/dl, 10 hours later 5/26/15 at 7:00 am DXT result 215mg/dl).
The facility fails to document all necessary information necessary to monitor the patient ' s conditions related to glucose test every 6 hours and VS every four hours as order by the physician.

Based on Validation survey, the review of documents, observational tour with the Administrator (employee #14), it was determined that the facility failed to ensure that drug storage areas are manage accordance with accepted professional principles related with the lack of list with quantity of drugs in floor stock.

Findings include:

1. During the initial observational tour with the Administrator (employee #14), on 10/20/15 from 9:53 am though 11:54 am, the following was observed:

a. The hospital utilizes a combination of Omnicell automated dispensing cabinets medication system and floor stock system to maintain medication through different areas. In the facility outside location of Orocovis and Barranquitas they used floor stock system, on each one of those floor stock they had la list of medication available on the stock; however the quantity of each one of the medications were not included as part of the document. A mechanism to ensure that floor stock system inventory and contents are properly documented was not performed not followed.

Based on a Validation survey, observation tour and review of operation room (OR) suite anesthetist cart in four operation room suite with the operation room supervisor (employee #4), it was determined that the facility failed to ensure that all drugs and biological in the operation room anesthetist cart and anesthesia room are kept secure and locked when the operation room suite was not in operation on 1 out of 4 anesthetist cart. (OR Anesthetist Cart on Suite #1)

Findings included:

1. During the observation tour in the operation rooms suites performed on 10/20/15 from 9:50 am till 12:30 pm with the OR supervisor (employee #4) the following was found:

a. On 10/20/15 at 10:40 am the anesthetist cart in suite #1 it was found unlocked and unattended by the anesthetist nurse. The suit #1 was not in use on the day of the observation 10/20/15.

b. On 10/20/15 at 11:00 am the Anesthesia Pediatric Supply Cart was found in the hallway near the suite #2 and #3 unlocked. This cart has emergency medication and Malignancy Hyperthermia medication.

c. On 10/20/15 at 11:30 am the anesthesia room was found unlocked, there was place the medication stock of anesthesia that was observed in a shelf without door and in other shelf was observed the stock of Intravenous solution.

2. During Medication administration observation on 10/22/15 at 9:50 am till 10:30 am it was observe that the facility has a medication cart that to assess the medication drawer the RN has to insert a code to opened, during the process it was observed the employee #11 use the medication cart to administrated medication for patient room 220 A and 220 B during the process it was observed that the RN #11 did not close completely the medication cart drawer and the medication cart did not close and proceed to enter to patient room leaving the medication cart unlocked and unattended.

1) Based on histopathology quality control records review and laboratory testing personnel interview on 10/21/2015 at 10:21 AM, it was determined that the laboratory failed to perform the establishment and verification of performance specification of the new Tissue TekPrisma instrument.

The findings include:

a. The laboratory received a new Tissue TekPrisma instrument in March 3, 2015.

b.The laboratory director did not evaluate the data for establish the performance specifications of the new Tissue TekPrisma instrument prior to use it with patient samples since March 3, 2015.

2. Based on bacteriology quality control records review and laboratory testing personnel interview on 10/21/2015 at 11:21 AM, it was determined that the laboratory failed to check the ability to support growth of culture media with specific organisms each time new lots were used in the laboratory.

The findings include:

a. The laboratory did not document neither check the following new lots of the Rose /Mac Conkey Agar (biplate) on the following dates:

Date lot #
5/15/2015 15113
5/19/2015 15099
5/27/2015 15120
6/04/2015 15120
6/09/2015 15120
6/16/2015 15120
6/23/2015 15120
6/23/2015 15120
6/30/2015 15161
7/08/2015 15182
7/15/2015 15182
7/21/2015 15191
8/04/2015 15191

b. The laboratory testing personnel confirmed that the laboratory failed to check the new lots of the Rose/ MacConkey Agar from 5/15/2015 to 8/04/2015.

3. Based on review of quality control records, interview with the testing personnel and laboratory director on 10/21/2015 at 9:20 AM, it was determined that the laboratory director failed to assure that external quality control procedures were established to monitor the accuracy and precision of the Closure Time tests by the PFA 100 system since 03/02/2015.

The findings include:

a. The records showed that the laboratory performed the validation of the Closure Time tests by the PFA 100 system on 03/02/2015.

b. The quality control records showed that the laboratory included one external control every week and for every new lot of reagents, however it performed patients test each day of the week.

c. The laboratory processed and reported 74 out of 74 Closure Time results from 09/01/2015 to 09/30/2015.

4. Based on transfusion services records review and interview with the laboratory director on 10/21/2015 at 10:20 AM, it was determined that the transfusion services personnel did not follow the manufacturer ' s written instructions to activate the HemoTemp II temperature indicator.

The findings include:

a.The transfusion services procedure manual showed:

i. The transfusion service uses the HemoTemp II indicator to check the temperature of those units that were released for transfusion and later returned without use it.

ii .If the unused unit was returned within thirty minutes or less the transfusion services personnel must verify the unit temperature, with the HemoTemp II indicator, in order to determine if the unit can be used for later transfusion.

iii.Part III of the written instructions showed that to activate the HemoTempII indicator the testing personnel may use hot water contained in a beaker, water or an external source of heat as a dry bath. Microwave cannot be used.

b. Review of manufacturer ' s instructions showed that:

i. The HemoTemp II indicator must be activated prior to use it and must be heated to 38 - 42°C for 60 seconds in the HemoTemp II Activator.

ii. Also instructed the transfusion services not to use microwave and not to
store indicators directly in water.

c. During interview on 10/21/2015 with the testing personnel and the laboratory director stated that the activation of the temperature indicator was performed at the TECAN tube incubator.

d. The TECAN tube incubator temperature chart was reviewed, showing that all recorded temperatures since year 2014 were 37°C.

e. The HemoTemp II box, lot number 4T140214 was in use, the box showed an expiration date of 8/2015.

f. Since January 2015 seven pack cell units were released for transfusion and later returned without use it. All HemoTemp II indicators were activated at 37 °C.

g. On 10/6/2015 the unit W201715449624 was returned to the transfusion services, an expired HemoTemp II indicator was used. The temperature recorded was between 7 - 9 °C.

Based on a Validation survey, kitchen observational tour, review of policies/procedures and interviews, it was determined that the facility failed to ensure that food and dietetic services organization requirements are met, related to non-food items storage on dry food storage area, hand towel paper located out of the dispenser, no system to assure first in first out use of food items, ice scoop located inside ice machine, food department employee bathroom (man and woman) are closed because there is mal-function food department employee bathroom (man and woman) are closed because there is mal-function , which could affect 87 out of 87 hospital admitted patients.

Findings include:

1. During the kitchen observational tour performed with the administrative dietitian (employee #15) on 10//22/15 from 9:00 am till 12:55 pm, the following was observed:

a. Stainless steel buffet serving system trays, boxes with plastic baskets, boxes with plastic cutlery combo, paper napkins, toothpicks, gloves and 13 rolls of toilet paper were observed storage on dry food storage area. Facility failed to maintain only food items storage on dry food storage area.
b. Two rolls of towel paper were observed outside the paper dispenser on the production area and cafeteria production area, facility failed to maintain paper rolls inside paper dispenser in order to prevent cross contamination of the entire roll with ready to eat food and raw food items.
c. A mechanism to ensure that recently purchased food items are located behind existing food was not promoted not followed. Facility kitchen personnel are not labeling food items with paper labels or on the storage container in order to assure that the first food in must be the first food out.

d. Ice scoop were observed inside ice on the ice machine. Accordingly Center of Disease Control Guidelines for Environmental Infection Control in Health -Care Facilities (June 6,2003) ice scoop must be keep on a clean, hard surface when not in use and ice scoop must not be store in the ice bin.

d. Food department employee bathroom (man and woman) are closed because there is mal-function since several days ago. Accordingly with information provided kitchen food personnel administrative dietitian (employee #15) on 10/22/15 at 10:00 am that food department was using bathrooms located in the hallway y in front of the cafeteria. Those bathrooms were used by patients while visiting the hospital.

7. During the observational tour with the infection control officer (employee #13) and review of policies/procedures (P&P) related to deaths or imminent deaths and the designated area to located bodies of person who dies, it was determined that the facility failed to promote sanitary and safe care because the facility lacks of a morgue or cold room. The facility did not have and specific area to located bodies of person who dies and was maintain on the room when the patient dead until the funeral agent pick up the body.

The facility polices/procedures reviewed on '' February of 2015 on item number seven related to dead body management established that the staff personnel was to maintain the body on the room until the funerary agent pick up the body '', however did not established how many hours. Additional on item number eight established '' in case when the body did not delivery or when the procedure was delay per four hours the facility personnel call at '' Valentin Funerary '' to transfer the body to a morgue.

The nurse director (employee #3) was interview on 10/22/15 at 1:30 p. m. and he stated: '' The facility did not have a morgue since long time ago because Department of health of Puerto Rico canceled the use because the morgue is near to the cafeteria and put on risk to cross contamination. Accordance of this decision when the patient dies its maintain on the room until the funerary agent pick up the body.''

During the seven deaths records reviewed for OPO ''Donacion de Organos'' the following was reveled:

a. R.R. #4 is an 31 years old male with diagnosis of '' Multiples Heridas de Balas '' died on 4/15/15 at 10:00 p. m. in Emergency Room and the Valentin Memorial pick up the body on 4/16/15 at 3:30 a. m. 5 hours and 20 minutes later.

b. R.R. #5 is an 48 years old male with diagnosis of Acute Splenoporto Mesenteric Venous / Thrombosis and Diabetes Mellitus, died on 11/11/14 at 7: 25 a. m. and the San José
Funerary pick up the body on 11/11/14 at 1:53 p. m. 6 hours and 28 minutes later.

c. R.R. #7 is an 61 years old female with diagnosis of Respiratory Failure, died on 8/12/14 at 6: 20 a. m. and the Ninoska Funerary pick up the body on 8/12/14 at 12:15 p. m. 5 hours and 55 minutes later.




33725


Based on a Validation survey, tests performed on equipment and observations made during the survey for the physical environment with the Physical Plant engineer (employee #1) at the hospital and outside location at Barranquitas, 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.

Findings include:

1. The diesel tank used to store and provide diesel to the essential electrical system (EES) was found out in the open and walking path for the employees not separated or protected by a fence as observed on 10/21/15 at 9:30 am. The diesel tank is located in an area that makes it accessible to non-authorized persons.

2. One Electricity Generator located at Emergency Department Room in Barranquitas (Sala de Emergencia del Centro de Salud Integral) does not have the appropriate sign posted. During the touring on 10/20/15 at 2:20 pm cars parked near of diesel tank are not allowed. The diesel tanks used to store and provide diesel to the essential electrical system (EES) was found out in the open and not separated or protected by a fence as observed on 10/20/15 at 2:20 pm. The diesel tank is located in an area that makes it accessible to non-authorized persons.

3. In the Emergency Department Room at Barranquitas (Sala de Emergencia del Centro de Salud Integral) parking it was observed broken flowerpots with palm tree and some palm tree without the flowerpots.

Interviewed the Barranquita's Emergency Department Room administrator (employee #14) on 10/20/15 at 2:35 pm stated that the owner of the building used it to prevent visitors park on that side of the parking. This scenario can cause that a visitor, patient or employee falls and get cut.

4. In the Emergency Department Room in Barranquitas at the Adult observation area it was found that the lavatories counters were in wood and Formica. These counters are deteriorated. The faucets do not have hot water.

5. It was found at the pediatric and adult observation areas floor tiles broken at the Emergency Department Room in Barranquitas.

6. As observed during a tour in the Hospital with the Physical Plant Engineer employee #1 on 10/21/15 at 9:00 am thru 4:00 pm, it was found that the facility failed to maintain a physical environment free of hazards.

During the tour the following was found:

It was found that the facility has a morgue near to the cafeteria.

Interview with employee #1 on 10/21/15 at 9:45 am reveals that the facility it is not using this morgue because Department of health of Puerto Rico indicated that the morgue is near to the cafeteria and this scenario cannot be possible because it can cause a cross contamination. Morgue: (Cross reference A749)

Surveyor asked to the employee #1 where the located the death body and he indicated that they do not have and specific area to located bodies of person who dies by gun shots and has to be pick up by forensic science of Puerto Rico.

Interview with the nursing director of the emergency department on 10/21/15 at 10:00 am reveals that they located the dead bodies in an area inside the emergency room providing privacy to the body until the Forensic Science of PR employees pick up the body.

Based on a Validation survey, tests to equipment and observations made during the survey for Life Safety from fire with the Physical plant engineer (employee #1) and safety Officer (employee #2), it was determined that the facility do 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 10/21/15 from 9:00 am until 4:00 pm for deficiencies related to Life Safety from fire (form 2786R) please see tags with letter K on the 2567 form (K0018).

Based on a Validation survey, tests performed on equipment and observations made during the survey for the physical environment at the hospital and the location at Barranquitas emergency room, 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. In the Emergency Department Room in Barranquitas at the Adult observation area it was found that the lavatories counters were in wood and Formica. These counters are deteriorated. The faucets do not have hot water.

2. Patient's sleeping room doors are not kept closed at all times on the second floor.
3. Self-closing devices shall be inspected because some of them are not working properly at rooms #201, #217, #218, #222, #223, #318, #322, #323 and #324.
4. In the laundry room it was found aggregate exposed and holes on the floor.
5. Wooden racks were found at the emergency department in the medical supply room.

Based on a Validation survey, observations made during the survey for the physical environment at the offsite location of the hospital, 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 which are not equipped with an air disinfection system such as ultraviolet lights.

Findings include:

1. The emergency room at the hospital and emergency rooms located at Coamo, Barranquitas and Orocovis was visited on 10/20/15 until 10/21/2015 from 9:30 am through 4:00 pm and provided evidence that the waiting area, triage area and the observation area of the adult and pediatric area are not equipped with an air disinfection system (for example: Ultraviolet lights).
According to 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 air disinfection.

Based on a Validation survey, observational tour with the infection control officer (employee #13) and review of policies/procedures (P&P) and interviews, it was determined that the facility failed to promote sanitary and safe care through its infection control program in the Medicine Department, OB Gyn department, Surgery department, Intensive Care Unit saline solution opened without plastic covers, cleansing commode on a dirty utility area, night table with rust and rails of the patient bed with peeling paint.

Findings include:

1. During the observational tour with the infection control officer (employee #13) on 10/20/15 from 9:30 a. m. till 3:00 p. m. the following was found:

a. One vial of ''Morphine Sulfate Injection 300 mgs. / 20 ml.'' opened on March 16/2015 was observed on the emergency crash car.

b. Two cleansing commode it was observed on a dirty utility area.

2. The following was observed on the third floor:

a. The night table was observed with rust on the base, the rails of the patient bed have peeling paint and the vinyl of the rest chair is broken in patient room #318 B.

3. The following was observed on the second floor:

a. One bag of 50 ml. of saline solution .9 % was observed on the drawer of medication cart without plastic cover.

b. Two bags of 100 ml. of saline solution .9 % ware observed on the patient room #215 without plastic cover.

4. The facility failed to establish procedures and responsibilities to ensure that non critical items are disinfected with an EPA registered disinfectant accordingly with CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008.


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5. During observation performed on 10/20/15 from 9:30 am through 4:00 pm and 10/21/15 from 9:30 am through 10:30 pm it was found the following:

a. On 10/20/15 at 9:35 am in the recovery room area it was found in the intubation Tray a vial of Succinylcholine chloride injectable of 200 milligram (mg) (20 mg/Milliliter (ml) expired on 3/1/2015.

b. On 10/20/15 at 9:35 am in the recovery room crash car it was found 2 syringe of insulin expired on 7/2010.

c. On 10/20/15 at 10:00 am in the holding area it was found 3 Defib-Pads used with the metallic shelf where was place all medication used in anesthesia department without door that secure unauthorized personnel access them and the door of the anesthesia room was unlocked.

d. On 10/20/15 at 10:45 am it was observed on operation suite #2 the cautery table with mold in the wheel and in the hand bar.

e. On 10/20/15 at 11:00 am it was observed the anesthesiologist physician (employee #6) in the operation Suite #4 performing an spinal injection procedure at the anesthesiologist finish the procedure he discard all used material, remove his glove put on his dressing gown and did not wash his hand accordance to the Centers for Disease Control (CDC) guideline.

f. On 10/20/15 at 11:30 am it was observed in the operation suite #4 the patient Foley catheter bag place directly in the floor.

g. On 10/20/15 at 11:45 am it was the general surgeon (employee 7) wash his hand after performed surgery and remove his glove, the hand wash procedure was performed least that 15 second not accordance to the Centers for Disease Control (CDC) recommendations for hand washing incorporates rubbing hands together with soap "vigorously" for at least 15-20 seconds are followed.

6. During observation performed in medication administration on the second floor on 10/21/15 at 2:00 pm and on 10/22/15 from 9:45 am till 10:30 am with the nurse supervisor (employee #4) it was observed the following:

a. On10/21/15 at 2:00 pm it was observed the RN (employee #8) performing medication administration to patient room #207B during the process the RN did not clean the primary line septum previous to insert and connects the Toradol piggy bag secondary lines.

b. On 10/22/15 at 9:45 am it was observed the RN #11 performing medication administration after performed the procedure he remove his glove and did not wash his hand as recommended by the CDC hand washing guideline.

Based on a Validation survey, the review of the policies and procedures, seven closed medical records with the Nursing Director (employee #3), it was determined that the facility failed to ensure that all deaths or imminent deaths are being referred to the Organ Procurement Organization (OPO) in a timely manner and is documented in the patient's medical records for 3 out of 7 medical records for OPO (R.R #2, #4 and #5).

Findings include:

1. The facility's policies and procedures reviewed on 10/22/15 at 1:30 p. m. states that nursing professional must write on the referral sheet to Lifelink the date and the time of death and date and time that the death is reported to LifeLink. The nurse should write in the medical record the reference number that Lifelink provides and the name of the person who took the information.

2. The facility's policies and procedures reviewed on 10/22/15 at 1:30 p. m. established on the '' Guias para el Desarrollo de Estándares de Calidad para los Hospitales Participantes de la Donación de Organos y Tejidos'' in section number II ''Complaint Areas'' item number two (2) that the facility staff must reported the death to OPO in the term not greater of twenty minutes (20) of the patient death.'' However, three (3) out of seven (7) closed medical records reviewed on 10/22/15 at 1:30 p. m. through 4:00 p. m. provide evidence that the facility reports all information needed in the Life Link referral Sheet, this sheet is part of the medical record, however failed to assure that all of deaths are being referred to the '' OPO '' in a timely manner.

The following was found:

a. R.R. #2 is an 47 years old male with diagnosis of Adrenal Tumor Retractive Pain / Dehydration / Anemia / Pneumonia and Right Pleural Effusions, death was on 9/12/15 at 1:00 p. m. and the nurse (employee #14) notify the death at 1:30 p. m. ten minutes later.

b. R.R. #4 is an 31 years old male with diagnosis of '' Multiples Heridas de Balas '' death was on 4/15/15 at 10:00 p. m. and the nurse (employee #15) notify the death at 10:50 p. m. thirty minutes later.

c. R.R. #5 is an 48 years old male with diagnosis of Acute Splenoporto Mesenteric Venous / Thrombosis and Diabetes Mellitus death was on 11/11/14 at 7: 25 a. m. and the nurse (employee #16) notify the death at 9:00 a. m. one hour and fifteen minutes later.

Based on a Validation survey, observations made of the Surgical Services Department and review of policies/procedures with the Operating Room Supervisor (employee #4), Anesthesia Supervisor (employee #5) and Anesthesiologist (employee #6), it was determined that the facility failed to ensure that surgical services maintains a high standard of medical practice for patient's care.

Findings include:

1. During observation performed on 10/20/15 from 9:30 am through 4:00 pm and 10/21/15 from 9:30 am through 10:30 pm it was found the following:

a. On 10/20/15 at 9:35 am in the recovery room area it was found in the intubation Tray a vial of Succinylcholine chloride injectable of 200 milligram (mg) (20 mg/Milliliter (ml) expired on 3/1/2015.

b. On 10/20/15 at 9:35 am in the recovery room crash car it was found 2 syringe of insulin expired on 7/2010.
c. On 10/20/15 at 10:00 am in the holding area it was found 3 Defib-Pads used with the metallic shelf where was place all medication used in anesthesia department without door that secure unauthorized personnel access them and the door of the anesthesia room was unlocked.
d. On 10/20/15 at 10:40 am in the operation suite #1 that was not in use this date, it was found the anesthetist cart that has medication unlocked and no anesthesia personnel was present.
e. On 10/20/15 at 10:45 am it was observed on operation suite #2 the cautery table with mold in the wheel and in the hand bar.
f. On 10/20/15 at 11:00 am it was found the Pediatric anesthesia material cart place in the halls between operation suite #2 and #3 unlocked and unattended by the anesthetist nurse. This cart has medication used to treat malignancy hypertemia (Dantium Intravenous) and calcium chloride, Amiodarone, Furosemide, Lidocaine 2%, Sodium Bicarbonate and Dextrose 50%.
g. On 10/20/15 at 11:00 am it was observed the anesthesiologist physician (employee #6) in the operation Suite #4 performing an spinal injection procedure at the anesthesiologist finis the procedure he discard all used material, remove his glove put on his dressing gown and did not wash his hand accordance to the Centers for Disease Control (CDC) guideline.
h. On 10/20/15 at 11:30 am it was observed in the operation suite #4 the patient Foley catheter bag place directly in the floor.
i. On 10/20/15 at 11:45 am it was the general surgeon (employee 7) wash his hand after performed surgery and remove his glove, the hand wash procedure was performed least that 15 second not accordance to the Centers for Disease Control (CDC) recommendations for hand washing incorporates rubbing hands together with soap "vigorously" for at least 15-20 seconds are followed.

Based on a Validation survey, medical records reviewed (R.R.) with the operation room (OR) supervisor (employee #4), it was determined that the facility failed to ensure that the medical history and physical examination (H&P) is documented by a physician for each patient no more than 30 days before or 24 hours after admission or registration and updated prior to surgery or procedure requiring anesthesia services when the H&P was performed within 30 days before admission or registration for 4 out of 6 OR medical record reviewed ( R.R#29, #30, #31 and #32).

Findings include:

1. R.R #29 is a 60 year old female admitted to the facility on 10/16/15 with a diagnosis of Right Shoulder Cuff Tear. During the record review performed on 10/21/15 at 9:30 am it was found that the patient entered to the operating room on 10/16/15 at 9:45 am to perform a Right Shoulder Arthroscopy requiring anesthesia services. However the H&P was performed by the patient's physician on 9/17/15 at 2:00 pm, twenty-nine (29) days before the surgery evidence was found that the H&P was incomplete lacks the physician documentation on the page #2 of the H&P and lack to document the patient vital sign and no evidence was found that the physician performed an updated H&P previous to the surgery for any change in patient condition.

2. R.R #30 is a 72 year old female admitted to the facility on 10/16/15 with a diagnosis of Left Bimelleolar Fracture. During the record review performed on 10/21/15 at 10:10 am it was found that the patient entered to the operating room on 10/16/15 at 5:20 am to perform an Open reduction until fracture requiring anesthesia services. However no evidence was found that the H&P was performed by the patient's physician.

3. R.R #31 is a 69 year old female admitted to the facility on 10/5/15 with a diagnosis of Sigmoid Polyps. During the record review performed on 10/21/15 at 10:15 am it was found that the patient entered to the operating room on 10/5/15 at 7:55 am to perform a Colonoscopy with Biopsy requiring anesthesia services. However the H&P was performed by the patient's physician on 9/18/15 at 9:00 am, seventeen (17) days before the surgery evidence was found that the H&P the physician lack to document the patient vital sign and no evidence was found that the physician performed an updated H&P previous to the surgery for any change in patient condition.

4. R.R #32 is a 70 year old male admitted to the facility on 10/12/15 with a diagnosis of Back Cyst. During the record review performed on 10/21/15 at 10:30 am it was found that the patient entered to the operating room on 10/12/15 at 8:15 am to perform an Excision of Cyst requiring anesthesia services. However the H&P was performed by the patient's physician on 10/2/15 at 8:07 am, ten (10) days before the surgery evidence was found that the H&P the physician lack to document the patient vital sign.

Based on a Validation survey, the review of medical records and policies/procedures of the operating room with the Operating Room (OR) supervisor (employee #4), it was determined that the facility failed to execute complete surgery informed consents that includes the name of the physician who administrated the anesthesia, Risk of the surgery, Nature and purpose of the procedure, probable consequences of the procedure, Available alternatives, risk consequences and likely effectiveness of each, Forecasts and likely consequences in terms of condition for 1 out of 6 OR medical records reviewed (R.R. #29)

Findings include:

1. R.R. #29 is a 60 years old female admitted with diagnosis of Right Shoulder Cuff Tear. During the record review performed on 10/21/15 at 9:30 am it was found that the consent form for surgery intervention or medical procedure was signed by the patient on 9/17/15, the consent form lacks of the Risk of the surgery, Nature and purpose of the procedure, probable consequences of the procedure, Available alternatives, risk consequences and likely effectiveness of each, Forecasts and likely consequences in terms of condition.

Based on a Validation survey, the review of six medical records to evaluate anesthesia services with the Operating Room (OR) supervisor (employee #4), it was determined that the facility failed to ensure that informed consent forms are properly executed for 3 out of 6 OR records reviewed (R.R. #30, #31 and #32)

Findings include:

1. R.R. #30 is a 72 years old female admitted with diagnosis of Left Bimelleolar Fracture. During the record review performed on 10/21/15 at 10:10 am it was found that the consent form for anesthesia administration was signed by the patient on 10/16/15, the consent form lacks of the name of the physician who administrated the anesthesia. The anesthesia record performed on 10/16/15 at 5:20 pm the anesthetist nurse documented in the post operative diagnosis "same" and no the diagnosis.

2. R.R. #31 is a 69 years old female admitted with diagnosis of Sigmoid Polyps. During the record review performed on 10/21/15 at 10:15 am it was found that the anesthesia record performed on 10/16/15 at 5:20 pm the anesthetist nurse documented in the post operative diagnosis "same" and no the diagnosis.

3. R.R. #32 is a 70 years old male admitted with diagnosis of Back Cyst. During the record review performed on 10/21/15 at 10:30 am it was found that the anesthesia record performed on 10/12/15 at 8:15 am the anesthetist nurse documented in the post operative diagnosis "same" and no the diagnosis.

Based on a Validation survey, the review of six records reviewed (R.R), review of policies and procedures with the operating room (OR) supervisor (employee #4), 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 2 out of 6 OR records reviewed (R.R #29 and #30).

Findings include:

1. During the review of the Postoperative follow-up evaluation reviewed on 10/21/15 at 10:30 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 recovering well if not answer the first call in RR #29 and #30.

2. The facility's policies and procedures Protocol for telephone calls after surgery reviewed on 10/21/15 at 10:30 am states the following:

a. At the next day of surgery proceed to make the phone call.

b. If the patient is not available the day of the call, it will be called again the next day. Not getting the patient is documented in the form of the action taken.

3. The facility's policies and procedures Protocol for telephone calls after surgery reviewed on 10/21/15 at 10:30 am do not take in consideration when the surgery was performed on Friday and holyday that the call was performed more than 24 hour.