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ROAD NUMBER 2 KM 173.4 CAIN ALTO

SAN GERMAN, PR 00683

LICENSURE OF HOSPITAL

Tag No.: A0022

Based on the review of licenses, certificates and endorsements during the physical environment survey with the facility's Safety Officer (employee #67), it was determined that the facility failed to ensure that the Sanitary License, Blood Bank License, Clinical Laboratory License, Pathology Laboratory License and Chemotherapy Storage License are updated and current.

Findings include:

Review of the facility's licenses with the facility's Safety Officer (employee #67) provided evidence that the Sanitary License expired on 3/25/10, Blood Bank License expired on 6/18/10, Clinical Laboratory License expired on 6/18/10, Pathology Laboratory License expired on 6/18/10 and Chemotherapy Storage License expired on 11/16/07. The facility failed to ensure that applicable State and local law licenses are updated and current. The Safety Officer (employee #67) stated during an interview on 6/25/10 at 11:00 am that the licenses have been paid for and requested, however due to the back log of cases at the different government agencies they have not expedited the licenses on time.

GOVERNING BODY

Tag No.: A0043

Based on the review of documents, observations, tests and interviews from 6/23/10 through 6/25/10 from 9:00 am till 4:00 pm, it was determined that the Governing Body failed to carry out its responsibility for the operation and management of the hospital. It did not provide the necessary oversight and leadership as evidenced by the lack of compliance with: (42 CFR 482.41) Physical Environment.

MEDICAL STAFF CREDENTIALING

Tag No.: A0341

Based on the review of fifty-three medical staff credential files, it was determined that the facility failed to examine credential files (C.F) to ensure that medical staff have updated Health Certificates, Cardio-pulmonary Resuscitation Certificates (CPR), Hepatitis B vaccines, State Narcotic License and Federal Narcotic License, Mal practice insurance are not updated and 2010 medical association for thirty-one out of fifty-three medical staff's C.Fs (C.F #2, #3, #6, #8, #11, #12, #14, #17, #21, #23, #24, #25, #26, #27, #28, #29, #30,
#31, #32, #33, #34, #35, #41, #42, #45, #46, #48, #50, #51, #52 and #53).

Findings include:

1. During the review of fifty-three medical staff credential files on 6/24/10 from 8:20 am till 9:20 am the following was found:

a. Seventeen out of fifty-three medical staff's credential files provided evidence of expired Health Certificates (C.F #6, #11, #17, #21 and #31 (from 5/18/10), C.F #8 (from 1/28/10), C.F #23 (from 1/30/10), C.F #24 (from 2/12/10), C.F #25 and #28 (from 10/31/09), C.F
#27 (from 2/23/10), C.F #29 (from 8/31/06), C.F #33 (from 9/29/09), C.F #41 (from 2/9/10), C.F #48 (from 4/10/09), C.F #50 (from 7/17/09) and C.F #52 (from 3/10/10).

b. Eleven out of fifty-three medical staff's credential files provided evidence of expired cardio-respiratory certificates (C.Fs #2 (from 7/7/08), #11 (from 6/5/07), #21 (from 3/30/10), #25 (from 3/14/10), #27 (from 11/30/08), #29 (from 5/31/07), #32 (from 4/15/10), #33 (from 2/28/08), #41 and #50 (from 3/30/10), #53 (from 2/28/10).

c. Thirteen out of fifty-three medical staff's credential files did not have evidence of their hepatitis profiles or responsibility exoneration (C.Fs #2, #3, #8, #11, #12, #26, #28, #33,
#35, #41, #46, #51 and #52).

d. One out of fifty-three medical staff's credential files did not have evidence of their updated federal narcotic license (C.F #27).

e. One out of fifty-three medical staff's credential files did not have evidence of their updated State narcotic license (C.F #27).

f. Fifteen out of fifty-three medical staff's credential files did not have evidence of their updated medical association (C.Fs #3, #6, #8, #14, #24, #27, #28, #29, #30, #34, #41,
#42, #45, #48 and #53).

LICENSURE OF NURSING STAFF

Tag No.: A0394

Based on the review of twenty nursing credential files (C.F), it was determined that the facility failed to ensure that four personnel are licensed in accordance with state and local laws related to health certificates for ten out twenty C.Fs (C.Fs #2, #5, #9, #10, #13, #14, #15,
#16, #18 and #20).

Findings include:

1. Twenty nursing credential files were reviewed with the Director of Nursing (D.O.N)(employee #28) on 6/23/10 at 4:00 pm and provided evidence of the following:

a. Ten out of twenty nursing credential files did not contain evidence of cardio-respiratory certificates (C.F #2, #5, #9, #10, #13, #14, #15, #16, #18 and #20).

PATIENT CARE ASSIGNMENTS

Tag No.: A0397

Based on the documents reviewed with the Director of Nursing (D.O.N) (employee #28), it was determined that the facility failed to assign nursing care for patients related to patient's needs and care at different wards of the hospital.

Findings include:

1. Patient's categories at medicine ward B were reviewed on 6/23/10 at 9:30 am and provided evidence that they were not performed during the followings dates: June 2 shift 11-7, June 3 shift 11-7, June 5 shift 11-7, June 6 shift 7-3 and 11-7, June 7 shift 3-11 and 11-7, June 10 shift 11-7, June 11 shift 11-7, June 12 shift 11-7, June 13 shift 11-7, June 14 shift 3-11 and 11-7, June 15 shift 11-7, June 16 shift 3-11 and 11-7, June 17 shift 11-7, June 18 shift 11-7, June 19 shift 11-7, June 20 shift 11-7 and June 21 shift 11-7.

2. Assignments at medicine ward B were reviewed on 6/23/10 at 9:30 am and provided evidence that they were not performed during the followings dates: June 3 shift 11-7, June 4 shift 3-11 and 11-7, June 5 shift 11-7, June 6 shift 11-7, June 7 shift 11-7, June 9 shift 11-7, June 10 shift 11-7, June 11 shift 11-7, June 12 shift 11-7, June 13 shift 11-7, June 14 shift 11-7, June 15 shift 11-7, June 16 shift 11-7, June 17 shift 11-7, June 18 shift 11-7, June 19 shift 11-7, June 20 shift 11-7, June 21 shift 11-7 and June 22 shift 11-7.

3. Patient's categories at medicine ward A were reviewed on 6/23/10 at 10:20 am and provided evidence that they were not performed during the followings dates: June 8 shift 11-7, June 9 shift 11-7 and June 21 shift 11-7.

4. Assignments at medicine ward A were reviewed on 6/23/10 at 10:40 am and provided evidence that they were not performed during the followings dates: June 8 shift 11-7 and June 9 shift 11-7.

5. Patient's categories at the Maternity/Infant ward were reviewed on 6/23/10 at 11:00 am and provided evidence that they were not performed during the followings dates: June 2 shift 3-11, June 3 shift 3-11 and 11-7, June 4 shift 7-3 and 3-11, June 5 shift 7-3, June 6 shift 3-11, June 7 shift 7-3, June 8 shift 11-7, June 9 shift 3-11, June 10 shift 7-3 and 11-7, June 11 shift 3-11 and 11-7, June 12 shift 11-7, June 16 shift 3-11, June 17 shift 3-11 and June 18 shift 7-3.

6. Patient's categories at the surgery ward were reviewed on 6/23/10 at 11:30 am and provided evidence that they were not performed during the followings dates: June 7 shift 3-11 and 11-7, June 8 shift 7-3 and 11-7, June 9 shift 3-11 and 11-7, June 10 shift 11-7, June 14 shift 11-7, June 15 shift 7-3, June 17 shift 3-11 and 11-7, June 18 shift 11-7 and June 21 shift 3-11.

7. Assignments at the surgery ward were reviewed on 6/23/10 at 1:00 pm and provided evidence that they were not performed during the followings dates: June 1 shift 11-7, June 6 shift 11-7, June 8 shift 11-7, June 9 shift 11-7, June 10 shift 11-7, June 11 shift 11-7, June 14 shift 3-11, June 15 shift 11-7, June 17 shift 11-7, June 18 shift 3-11 and 11-7 and June 22 shift 11-7.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on the observational tour with the Director of Nursing (D.O.N) (employee #28), it was determined that the facility failed to ensure that drugs and biologicals are administered by, or under the supervision of nursing personnel in accordance with Federal and State laws and regulations from pharmacy state Law #247 from 2004 (article number 1.02 and article number 1.03).

Findings include:

During the observational tour of the surgery ward with the Director of Nursing (D.O.N) (employee #28) on 6/23/10 at 10:10 am, a vial of Amlodipine-Benazepril 10/20 tablet 1 orally (PO) daily was observed at the bedside table of the patient in room #316-1. During interview with the patient (patient #7) on 6/23/10 at 10:20 am, the patient stated that the medication is on the bedside table because the medication is not available at the facility and its his.

MEDICAL RECORD SERVICES

Tag No.: A0450

Based on the review of eighty-six closed and active clinical records, it was determined that the facility failed to ensure that medical staff, nursing personnel and other disciplines maintain legible entries for eighty-six out of eighty-six records reviewed (R.R #1 through #86).

Findings include:

Eighty-six clinical records reviewed from 6/23/10 through 6/25/10 from 9:30 am till 4:00 pm contained portions that are not legible. Most notable were the diagnosis, operative reports, informed consent forms, anesthesia reports, physician's orders, signatures (physicians and nurses), progress notes, consults and nurse's notes.

CONTENT OF RECORD: INFORMED CONSENT

Tag No.: A0466

Based on the review of sixteen closed and active clinical records, policies and procedures, it was determined that the facility failed to ensure that informed consent forms for procedures, treatments or anesthesia administration intervention by medical staff are properly executed for three out of sixteen records reviewed (R.R #77, #78 and #79).

Findings include:

1. Two out of sixteen clinical records reviewed on 6/25/10 at 2:00 pm provided evidence that the out-patient procedures' consent form for intravenous sedation for anesthesia administration services did not specify the anesthesia type and physician's name (R.R #77 and #79).

2. Two out of sixteen clinical records reviewed on 6/25/10 at 2:00 pm provided evidence that the out-patient procedures' consent form for intravenous sedation for anesthesia administration services did not specify that pictures could be taken during the gastroscopy and colonoscopy procedures (R.R #78 and #79).

CONTENT OF RECORD: DISCHARGE SUMMARY

Tag No.: A0468

Based on ten closed records reviewed (R.R), it was determined that the facility failed to ensure that discharge summaries are performed with all pertinent information for two out of ten records reviewed (R.R #71 with three different admissions and #86).

Findings include:

R.Rs #71 (with three admissions) and #86 performed on 6/25/10 from 10::30 am till 3:30 pm provided evidence that the information sheet used by medical personnel has an area that describes discharge instructions. The discharge instruction area has different choices to allow medical personnel to perform check marks for those areas that correspond to the patient. However, according with discharge summary regulations "All patient's medical records must contain a discharge summary. A discharge summary discusses the outcome of the hospitalization, the disposition of the patient and provisions for follow-up care. Follow-up care provisions include any post hospital appointments, how post hospital patient care needs are to be met, and any plans for post-hospital care by providers such as home health, hospice, nursing homes, or assisted living".

CONTENT OF RECORD: FINAL DIAGNOSIS

Tag No.: A0469

Based on the review of nine closed clinical records (C.C.R) with the medical records supervisor (employee #78), it was determined that the facility failed to ensure that hospital staff complete the final diagnosis within 30 days following discharge for nine out of nine records reviewed for this documentation (C.C.R #1, #2, #3, #4, #5, #6, #7, #8 and #9).

Findings include:

During the review of nine closed clinical records (ambulatory) on 6/25/10 from 3:30 pm till 4:00 pm to evaluate the final discharge diagnosis for those patients discharged on 5/17/10, failed to provide evidence of the patient's final diagnosis within 30 days following discharge for nine out of thirty-one records reviewed for this documentation (C.C.R #1, #2, #3, #4, #5, #6, #7, #8 and #9).

PHARMACY ADMINISTRATION

Tag No.: A0491

Based on the review of documents, observational tour with the Pharmacist (employee #27 ), it was determined that the facility failed to ensure that drug storage areas are administered in accordance with accepted professional principles related with the lack of medication storage in locked areas, an updated pharmacy formulary was not readily available and lack of documentation of information related with patient's weight and history of allergies in the Medication Administration Record (MAR).

Findings include:

1. During the initial observational tour with the pharmacist (employee #27 ) on 6/24/10 from 9:08 am though 11:56 am and the following was observed:

a. At Medicine Ward "B", the medication storage room was found opened and two medication carts were found inside and they were available to non authorized persons.

b. At Medicine Ward "A", the medication storage room was found opened and two medication carts were found inside with the drawers open and medications inside of the drawers and they were available to non authorized persons.

c. At Medicine Ward "A", the medication storage room was observed with vials of Zosyn
intravenous antibiotic, Dilantin and Solumedrol located on the counter. Several doses
of Pulmicort Repsules 0.5 mgs/2ml to be used in Respiratory therapy treatments were observed located over the medication cart available to non authorized persons.

d. At Medicine Ward "A", five out of twelve Medication Administration Records (MARs)
reviewed lacked information related to the patient's weight, age and history of allergies.

e. The pharmacy formulary found at Medicine wards "A" and "B", Surgery, Intensive Care Unit, Neuro and Maternal Units was last dated 2008. The Pharmacy Formulary reviewed with the Pharmacist (employee #27 ) on 6/24/10 at 10:23 am was reviewed by the facility on
March 2010, however the facility failed to keep this update Pharmacy Formulary at the patient's care units.

CONTROLLED DRUGS KEPT LOCKED

Tag No.: A0503

Based on observations and review of policies and procedures with the Pharmacist (employee #27 ) and interview, it was determined that the facility failed to ensure that narcotics are kept locked and secured from unauthorized persons.

Findings include:

On 6/24/10 at Medicine Ward "A" at 9:00 am, the narcotic box was found with a broken second lock. No evidence was found that this was informed to the pharmacy department or maintenance personnel in order to fix the lock as stated by the Pharmacist (employee #27 ) on 6/24/10 at 9:05 am.

PHARMACY: REPORTING ADVERSE EVENTS

Tag No.: A0508

Based on the review of medication adverse drug reactions reports with the Pharmacist
(employee #27 ), it was determined that the facility failed to promote that drug reactions and drug incompatibilities are immediately reported to the attending physician and if appropriate to the hospital-wide quality assurance program.

Findings include:

This facility dispatches approximately 48,000-50,000 medications monthly. However from the period of January through May of 2010 only two adverse drug reactions were documented. The facility failed to promote the immediate reporting of drug reactions and incompatibilities to the pharmacy department.

SAFETY POLICY AND PROCEDURES

Tag No.: A0535

Based on the observational tour and review of policies/procedures and interview, 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 chemical storage warmer doors left unlocked, inappropriate temperature maintain for the Optiray 320, opened single dose syringe of Optiray 320 injection, inappropriate solution dilution and sharp containers directly on the floor without security bases.

Findings include:

1. No evidence was found on 6/24/10 at 2:00 pm of facility policies/procedures related to the appropriate temperature registration to maintain the Optiray 320 injection warmer in CT, CT 64 and Fluoroscopy room. Also, the door where Optiray bottles are stored was found without a security lock.

2. An open of single dose syringe of Optiray 320 injection was observed on 6/24/10 at 2:20 pm in the warmer of the Fluoroscopy room. Also, an open bottle of Optiray single use was not in accordance with manufacturer's recommendations to discard unused portions after use.

3. Two sharp containers (three and five gallon sizes) were observed on 6/24/10 at 2:30 pm without security bases during the observational tour of the X-Ray department in the CT room and X ray #2 room with biohazardous materials. Security bases are needed to protect the sharp containers from unauthorized removal and prevent the containers from tipping over..

4. All sharp containers in the X-Ray department were observed on 6/24/10 from 1:30 pm till 4:15 pm without labels with the assigned hospital's identification number and the facility's name to ensure responsibility related to its contents, protection and disposition.

5. A bottle with pink solution (32 ounces) labeled with Marzan disinfectant was observed on 6/24/10 at 3:00 pm in CT 64 room without a label indicating the concentration of the solution, lot number and expiration date. The X-Ray supervisor (employee #73) stated during an interview on 6/24/10 at 3:10 pm that the empty bottles of solution are supplied by the maintenance supervisor and the solution is prepared by X-Ray personnel. X-Ray technologist (employee #76) stated during interview on 6/24/10 at 3:15 pm that two ounces of solution is diluted with water in every 32 ounce bottle. The maintenance supervisor stated during an interview on 6/24/10 at 3:25 pm that the dilution is supposed to be two ounces of Marzan per gallon of water and the solution available in the bottle at the X-Ray department is to make the area smell better. Also, no evidence was found of the material safety data sheet for the solutions used and available for housekeeping personnel to use in the event of an accident.

MONITORING RADIATION EXPOSURE

Tag No.: A0538

Based on observations, review of policies and procedures and routine equipment testing with the supervisor of the X-ray department (employee #73) and interview, it was determined that the facility failed to ensure that the physicist periodically verifies the badge exposure for radiation exposure.

Findings include:

On 6/24/10 at 3:45 pm the supervisor of the X-ray department (employee #73) provided evidence of the monthly radiation dosimetry report revision of badges used by X-ray department personnel. However, no written evidence was found of routine inspections of the dosimeters for radiation by the physicist. The X-Ray supervisor (employee #73) stated during an interview on 6/24/10 at 3:20 pm that the dosimeters are sent out on a monthly basis and are evaluated by the physicist every three months. The last evidence that the badge reports were reviewed by the physicist was in September of 2009.

No Description Available

Tag No.: A0545

Based on the review of twenty-one credential files (C.F) (certified by the facility) of X-Ray personnel, it was determined that the facility failed to ensure that X-Ray personnel are qualified in accordance with state and local laws related to Cardio Pulmonary Resuscitation certificates, annual health certificates, annual evaluations and annual competencies for twenty-one out of twenty-one C.Fs (C.F #1 through #21).

Findings include:

1. During the review of twenty-one facility certified credential files from X-ray personnel on 6/25/10 from 3:30 am till 4:00 pm, the following was determined:

a. Thirteen out of twenty-one X-Ray personnel credentials files did not have evidence of their updated annual health certificates (C.F #1, #2, #4, #6, #7, #8, #9, #11, #15, #17, #18, #20 and #21).

b. Twelve out of twenty-one X-Ray personnel credential files did not have evidence of their Cardio Pulmonary Resuscitation certificates (C.F #6, #8, #9, #11, #12, #15 through #21).

c. Nineteen out of twenty-one X-Ray personnel credentials files did not contain evidence of their annual evaluations (C.F #3 through #21).

d. Nineteen out of twenty-one X-Ray personnel credentials files did not contain evidence of their annual competencies (C.F #3 through #21).

ORGANIZATION

Tag No.: A0619

Based on the kitchen observational tour with the administrative dietitian (employee #24 ), review of policies/procedures, food code guidelines, registration temperatures, it was determined that the facility failed to operationalize procedures to ensure that relative humidity and temperatures of dry food storage area are recorded and registered.

Findings include:

On a visit to the kitchen's dry food storage area on 6/23/10 at 9:49 am with the administrative dietitian (employee #24 ), it was identified that the relative humidity and temperature of this area was not measured and registered by kitchen personnel. A mechanism to ensure that this procedure is performed on an ongoing basis was not developed related to relative humidity and temperature registration of dry food storage to verify that they are within established parameters.

QUALIFIED DIETITIAN

Tag No.: A0621

Based on five medical records reviewed (R.R), policies/procedures and interview, it was determined that the facility failed to ensure that patient's nutritional needs are addressed according with professional standards of practice for four out of five records reviewed (R.R #27 #30, #36, #60 and # 42).

Findings include:

1. A mechanism to ensure that patients identified at nutritional risk receive dietitian evaluations as early as possible so interventions can be initiated to prevent complications and adverse outcomes was not performed, nor followed for four out of five records reviewed (R.R #27,
#30, #36 and #60).

a. R.R #27 is a 45 years old female admitted to the facility on 5/21/10 with a diagnosis of Intestinal Obstruction as reviewed on 6/23/10 at 9:50 am. The patient was on a nothing by mouth (NPO) diet for several days after admission and was started on Peptamen enteral nutrition on 6/7/10 when she was evaluated by the dietitian. The patient was identified by nursing personnel as at nutritional risk during admission and referred to the clinical dietitian. A screening conducted in order to identify how this patient was at nutritional risk and could benefit from a comprehensive nutritional assessment was not promoted until the patient was ordered enteral nutrition. The facility failed to intervene and implement specialized nutritional therapies and counseling for this patient's NPO status and may be at risk for nutritional status accordingly with this acute illness episode.

b. R.R #30 is a 71 years old female admitted to the facility on 4/29/10 with a diagnosis of Infected Sacral Ulcer as reviewed on 6/23/10 at 10:00 am. The patient was identified by nursing personnel as at nutritional risk during admission and was referred to the clinical dietitian. The patient was evaluated by the dietitian on 5/4/10. A screening conducted in order to identify how this patient is at nutritional risk and could benefit from a comprehensive nutritional assessment was not promoted. The facility failed to intervene and implement specialized nutrition therapies and counseling for this patient who had alteration of skin integrity and whose nutritional support must be evaluated in order to ensure that the patient maintains adequate nutrition and hydration status.

c. R.R #36 is an 80 years old male admitted to the facility on 6/17/10 with a diagnosis of Acute Neurological Deficit and Diabetes Mellitus as reviewed on 6/24/10 at 11:00 am. This patient was admitted with a PEG for enteral nutrition from his home where he was receiving Glucerna. This patient was identified by nursing personnel as at nutritional risk during admission and referred to the clinical dietitian. The patient was not evaluated by dietitian until 6/23/10. The facility failed to intervene and implement specialized nutritional therapies and counseling on a timely basis for this patient who had alterations of his gastrointestinal system was dependent on a PEG and enteral nutritional status in order to evaluate the patient's nutritional status and identified if the patient had nutritional related problems.

d. R.R #60 is a 68 years old male admitted to the facility on 6/18/10 with a diagnosis of Sepsis as reviewed on 6/24/10 at 9:30 am. During admission the patient was admitted with a lactose free diet. The patient was not evaluated by the dietitian until 6/21/10. The facility failed to intervene and implement specialized nutritional therapies and counseling on a timely basis for this patient who had lactose intolerance in order to ensure that he receives a diet based on his food needs.

2. During interview on 6/23/10 at 11:59 am the clinician dietitian (employee #25 ) stated that
patients who are referred by the physician to be evaluated by the dietitian have priority to be evaluated from those patients identified at nutritional risk by nursing personnel. Consulted patients need to be evaluated within 24 hours of the consult as states the facility's policies and procedures.

3. A mechanism to ensure that patients referred (by the physician) for nutritional services in order to receive nutritional assessments and counseling to identify nutritional related problems in a timely manner was not promoted, nor performed according with professional standards of practice and patients' individualized needs (R.R #42).

a. R.R #42 is a 60 years old female admitted to the facility on 6/22/10 with a diagnosis of Thrombocytopenia and Diabetes Mellitus as reviewed on 6/24/10 at 10:12 am. The patient was referred by the physician to be evaluated by the dietitian on 6/23/10 at 2:26 pm in order to promote specialized nutritional therapies and implement it and to identify if she may benefit from assessments and nutritional interventions. The patient was not evaluated by the dietitian until 6/24/10 at 4:00 pm. The facility failed to intervene and implement specialized nutritional therapies and counseling for patients with acute disease processes who were referred by the physician due to the patient's acute condition as early as possible in order to prevent complications and adverse outcomes.

4. Policies and procedures related with dietitian consults were reviewed with the clinical dietitian (employee #25 ) on 6/23/10 at 1:00 pm. Policies and procedures establishes that when dietitians are consulted they must make their evaluations within a period of no more than 24 hours.

5. Patients who receive initial evaluation of nutritional services to implement specialized nutritional therapies and counseling do not receive further assessments and nutritional interventions on an ongoing basis and according with patients' needs. Policies and procedures for the nutritional re-assessment was reviewed with the clinician dietitian (employee #25 ) and administrative dietitian (employee # 24) on 6/23/10 at 11:08 am. This policy establishes that the nutritional re-assessment is performed based on the clinical dietitian's availability. This mechanism established by the facility does not ensure that nutritional re-assessments are performed based on the patient's needs and according with professional standards of practice.

6. A mechanism to ensure that nutritional assessments, re-assessments and nutritional therapies and counseling are documented by the dietitian was not readily available in the medical records and were not performed nor promoted by the facility. Seven out of seventeen record review ( #26,#27,#28,#29,# 30,# 31 and # 36 ) with the clinical dietitian (employee #25 ) does not include information related with the initial assessments and re-assessments of nutritional interventions. The clinician dietitian (employee # 25) stated during an interview on 6/23/10 at 10:45 am that if the medical record increases in volume, the clerk removes progress notes from some disciplines in order to maintain the record more manageable. Nutritional notes and assessments were removed and located in a folder. However, if any health care professional needs to reference some of these notes and assessments their are not readily available for review. This mechanism does not ensure that relevant information related with nutritional status assessments, counseling and interventions for review for health care professionals who intervene with the patient.

7. Policies and procedures related with dietitian consults were reviewed with the administrative dietitian (employee #24 ) on 6/23/10 at 10:00 am. Policies and procedures establishes that when dietitians are consulted they make their evaluation within a period of no more than 24 hours.

PHYSICAL ENVIRONMENT

Tag No.: A0700

Based on tests performed on equipment, interviews, review of documents and observations made during the survey for the physical environment and Life Safety with the facility's Engineer (employee #65) and Safety Officer (employee #67) from 6/23/10 through 6/25/10 from 8:30 am till 4:00 pm, it was determined that the physical structure and care areas failed to ensure that door closers are adjusted to allow patients to pass through door openings safely, the water temperature at patient's rooms is too hot for patient's safety, bathrooms at the waiting area of the emergency room can be locked from the inside but nursing staff did not have a device to open it, male bathroom at the waiting area of the emergency room has the emergency call systems pull cord tied to the grab bar, patient's bathroom located near the medical examination rooms of the emergency room and isolation bathrooms do not have pull cords for the emergency call system, fire hose cabinets have glass doors, crash carts do not have oxygen cylinders attached to them at the Intensive Care Unit, third and fourth floors, CT Scan department was found with piece of wood on the floor without floor tiles, biohazardous waste closet and the regular trash closet do not have air extractors, regular trash bags and boxes of biohazardous trash were directly on the floor, it was also determined that the structure of this facility is not maintained to protect and safe guard supplies and equipment to ensure safety and quality related to the medication storage area of the fast track emergency room was unattended, the medication cabinets did not lock properly which did not limit its access to non authorized persons, the access doors to the emergency room from the main hospital lobby did not lock, the biohazardous waste closet located at the emergency room was found unlocked and the dirty linen closet was found with bags of dirty linen and bags of contaminated linen directly on the floor, an outside metal storage container/compactor found with the hatch in the opened position, it was determined that this facility's physical structure is not designed to provide protection of patients and staff related to the emergency room ambulance entrance drop off that does not have a cover large enough to provide shelter for both patients and emergency medical personnel from the vehicle to the building, the emergency room does not have a designated decontamination area, parking spaces located near the emergency room are not for handicapped persons, the bathroom located near the medical examination offices of the emergency room does not have grab bars, isolation rooms throughout the hospital need negative pressure meters, the location of the triage room does not permit staff observations and access control of the treatment area, no emergency call systems at the pediatric cubicles, nine lounge chairs used to provide respiratory therapy to patients were found too close to each other and no privacy curtains, the operating room department is not maintained or constructed appropriately, a Cidex OPA tray was found at the Intensive Care Unit without proper ventilation, drying racks at the kitchen are within twelve inches from the floor, the CT Scan department and X-ray department did not have benches to sit on when changing clothes, the rehabilitation department located at the medical office building is not appropriately designed, no evidence was found of routine and preventive maintenance and testing activities incorporated into the hospital's Quality Assessment Performance Improvement program, no evidence was found that representatives of the physical environment and life safety are attending committee meetings and no evidence was found of the annual cistern cleaning, the emergency rooms' waiting area, triage area and observation areas are not equipped with an air disinfection system, also it was determined that the facility does not meet some applicable provision of the 2000 edition of Life Safety Code of the NFPA 101, cited tags are K0022, K0027, K0046, K0048, K0050, K0051, K0064, K0130, K0144 and K0147. All of the above findings makes this condition "Not Met".

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on tests performed on equipment and observations made during the survey for the physical environment with the facility's Engineer (employee #65) and interview, it was determined that the physical structure and care areas failed to ensure that door closers are adjusted to allow patients to pass through door openings safely, the water temperature at patient's rooms is too hot for patient's safety, bathrooms at the waiting area of the emergency room can be locked from the inside but nursing staff did not have a device to open it, male bathroom at the waiting area of the emergency room has the emergency call systems pull cord tied to the grab bar, patient's bathroom located near the medical examination rooms of the emergency room and isolation bathrooms do not have pull cords for the emergency call system, fire hose cabinets have glass doors, crash carts do not have oxygen cylinders attached to them at the Intensive Care Unit, third and fourth floors, CT Scan department was found with piece of wood on the floor without floor tiles, biohazardous waste closet and the regular trash closet do not have air extractors, regular trash bags and boxes of biohazardous trash were directly on the floor.

Findings include:

1. The smoke barrier doors located near the medical record department and near the waiting area for the operating rooms were released from their hold open devices on 6/25/10 at 11:00 am with the facility's Engineer (employee #65) and they closed too fast (approximately one to two seconds) which could harm patients or visitors passing through these doors if the fire alarm is activated and the doors are released. According with "Americans with Disabilities Act" section 4.13.10 (Door Closers) door closers should be adjusted so that from an open position of 70 degrees, the door will take at least 3 seconds to move to a point 3 inches from the latch.

2. During the observational tour on 6/24/10 from 1:20 pm till 1:35 pm, temperature readings were taken at patient's hand sinks on the third and fourth floors with the facility's Engineer (employee #65). It was found that the temperatures at hand sinks in patient's rooms on the third floor reached a temperature of 127?F and on the fourth floor reached a temperature of 118?F. According with the Guidelines for Design and Construction of Health Care Facilities water temperature should range between 95?F and 110?F. After the water temperature is adjusted, the facility shall monitor water temperatures to ensure that it is maintained within the required range for patient's comfort and safety.

3. The waiting area of the emergency room was visited on 6/23/10 at 9:05 am and provided evidence that there are two patient's bathrooms. Both bathrooms can be locked from the inside, however nursing staff did not have a device to open the doors in the event that a patient needs assistance. The facility's Engineer (employee #65) stated on 6/23/10 at 9:05 am that a special key is used to open this door and maintenance personnel have it. When the emergency call system was activated in these bathrooms a nurse arrived but could not open the doors and she left to find maintenance personnel. A device to open these doors is needed for these bathrooms and must be carried by nursing personnel and also located at the nursing station to minimize time lost to find a device to open these doors. In-service related to the use of these new devices for all personnel from all shifts is required along with periodic testing for compliance.

4. The male bathroom located at the waiting area of the emergency room was visited on 6/23/10 at 9:15 am and provided evidence that the emergency call system pull cord was tied to the grab bar.

5. The patient's bathroom located near the medical examination offices of the emergency room was visited on 6/23/10 at 9:35 am and provided evidence that the emergency call system does not have a pull cord.

6. The isolation room of the emergency room (located near the ambulance entrance) was visited on 6/23/10 at 9:25 am and provided evidence that the bathroom's emergency call system does not have a pull cord.

7. The isolation room of the emergency room (cubicle #16) was visited on 6/23/10 at 10:20 am and provided evidence that the bathroom's emergency call system does not have a pull cord.

8. During the observational tour of the facility with the facility's Engineer (employee #65) from 6/23/10 through 6/25/10 from 9:05 am till 4:00 pm, it was determined that fire hose cabinets have glass doors. The fire hose cabinets are located throughout the hallways and staircases of the hospital. The fire hose cabinets do not require a key to open or a device to break the glass to gain access to the hoses. The fire hose glass doors are approximately two by two feet in size and pose a potential hazard if broken by accident. The glass is not tempered, laminated or wire mess to prevent shattering.

9. Emergency crash carts were observed near nursing stations at the Intensive Care Unit, third and fourth floors on 6/23/10 from 3:00 pm till 4:00 pm and on 6/24/10 from 8:30 am till 4:00 pm with the facility's Engineer (employee #65). The crash carts did not have oxygen cylinders attached to them (they were close by) to ensure that where the crash cart goes so does the oxygen cylinder.

10. The biohazardous waste closet and the regular trash closet on the fourth and third floors were visited on 6/24/10 at 9:30 am with the facility's Engineer (employee #65) provided evidence that the closets do not have air extractors, regular trash bags on the floor and four boxes of biohazardous trash directly on the floor.

11. The CT Scan department was visited on 6/24/10 at 1:00 pm with the facility's Engineer (employee #65) and provided evidence that a wood board was nailed on the floor and did not have floor tiles on it which will not allow for proper cleaning.

12. The emergency room was visited on 6/23/10 at 10:00 am and provided evidence that cubicle #17 did not have a paper dispenser.

LIFE SAFETY FROM FIRE

Tag No.: A0709

Based on tests to equipment and observations made during the survey for Life Safety from fire with the facility's Engineer (employee #65) and the Life Safety Officer (employee #67), it was determined that the facility does not meet some applicable provision of the 2000 edition of Life Safety Code of the NFPA 101.

Findings include:

The Life Safety from Fire survey was performed from 6/23/10 through 6/25/10 from 8:30 am till 4:00 pm with the facility's Engineer (employee #65) and the Life Safety Officer (employee #67); for deficiencies related to Life Safety from fire (form 2786R) please see tags with letter K on the 2567 form (K0022, K0027, K0046, K0048, K0050, K0051, K0064, K0130, K0144 and K0147).

DISPOSAL OF TRASH

Tag No.: A0713

Based on the review of policies/procedures (P&P) and observations made during the survey for the physical environment with the facility's Engineer (employee #65), it was determined that the facility failed to follow established procedures for the storage of regular trash related to an outside metal storage container/compactor found with the hatch in the opened position.

Findings include:

An outside metal trash container/compactor located at the back of the hospital was visited on 6/25/10 at 11:20 am and provided evidence that the main hatch where small trash containers are emptied was found wide open with an accumulation of trash. Facility policies and procedures provided evidence that regular trash is to be compacted to ensure that trash does not remain in the hatch. 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 150 feet from the hospital's back doors.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on tests and observations made during the survey for the physical environment with the facility's Engineer (employee #65), it was determined that the structure of this facility is not maintained to protect and safe guard supplies and equipment to ensure safety and quality related to the medication storage area of the fast track emergency room was unattended, the medication cabinets did not lock properly which did not limit its access to non authorized persons, the access doors to the emergency room from the main hospital lobby did not lock, the biohazardous waste closet located at the emergency room was found unlocked and the dirty linen closet was found with bags of dirty linen and bags of contaminated linen directly on the floor.

Findings include:

1. The medication storage area located at the fast track emergency room was visited on 6/23/10 at 9:40 am and provided evidence that the area was unattended and the medication cabinets did not lock properly which did not limit medication access to non authorized persons.

2. Access doors to the emergency room from the main hospital lobby were tested on 6/23/10 at 10:00 am. The doors have security magnets to maintain the doors closed and locked, however this system was not working on 6/23/10 and unauthorized persons were observed entering the emergency room and a person who was not receiving therapy was found sitting in the respiratory therapy area with patients receiving therapy.

3. The biohazardous waste closet located at the emergency room was observed on 6/23/10 at 10:30 am with the Engineer (employee #65). This closet was found unlocked with three bags of biohazardous waste directly on the floor and was also found with boxes of clean sharp containers.

4. The dirty linen closet used to placed dirty linen until it is collected by an outside company was visited on 6/25/10 at 11:20 am with the facility's Engineer (employee #65). The room was found with ten bags of dirty linen and five bags of contaminated linen directly on the floor mixed together (not in containers). In order to avoid or minimize contact for personnel in this room and to reduce the risk of cross contamination, dirty linen and contaminated linen bags shall be placed in containers to minimize contact. Also, a door closer is needed for the door of this room.

COMPLEXITY OF FACILITIES

Tag No.: A0725

Based on tests performed on equipment and observations made during the survey for the physical environment with the facility's Engineer (employee #65) and interview, it was determined that this facility's physical structure is not designed to provide protection of patients and staff related to the emergency room ambulance entrance drop off that does not have a cover large enough to provide shelter for both patients and emergency medical personnel from the vehicle to the building, the emergency room does not have a designated decontamination area, parking spaces located near the emergency room are not for handicapped persons, the bathroom located near the medical examination offices of the emergency room does not have grab bars, isolation rooms throughout the hospital need negative pressure meters, the location of the triage room does not permit staff observations and access control of the treatment area, no emergency call systems at the pediatric cubicles, nine lounge chairs used to provide respiratory therapy to patients were found too close to each other and no privacy curtains, the operating room department is not maintained or constructed appropriately, a Cidex OPA tray was found at the Intensive Care Unit without proper ventilation, drying racks at the kitchen are within twelve inches from the floor, the CT Scan department and X-ray department did not have benches to sit on when changing clothes, the rehabilitation department located at the medical office building is not appropriately designed, no evidence was found of routine and preventive maintenance and testing activities incorporated into the hospital's Quality Assessment Performance Improvement program, no evidence was found that representatives of the physical environment and life safety are attending committee meetings and no evidence was found of the annual cistern cleaning.

Findings include:

1. During the initial observational tour on 6/23/10 at 9:05 am the emergency room ambulance entrance was visited. This drop off entrance does not provide a cover large enough to provide shelter for both patients and emergency medical personnel from the vehicle to the building. According to the Americans with Disabilities Act (ADA) section 6.2, "At least one accessible entrance shall be protected from the weather by canopy or roof overhang. Such entrances shall incorporate a passenger loading zone". According with the Guidelines for Design and Construction of Health Care facilities (GDCHCF) from 2006, chapter 2.1, section 5.1.2.2 and GDCHCF from 2001 section 7.9.D1 states that a covered entrance shall be provided. The emergency entry cover shall provide shelter for both the patient and the emergency medical crew during transfer from an emergency vehicle into the building.

2. The emergency room was visited on 6/23/10 at 9:15 am and provided evidence that they do not have a decontamination area according with Guidelines for Design and Construction of Health Care facilities (GDCHCF) chapter 2.1, section 5.1.3.7, number 5 and A5.1.3.7(5). This area should measure at least 80 square feet, there needs to be at least two hand held shower heads, the walls, floor and ceiling need to be non-porous (for cleaning) there needs to be an outside door to enter this room and there needs to be a water drain trap to collect the used water. If the facility determines to use an external area for this purpose, it needs to be located within 150 feet from the ambulance entrance, there are water and electrical outlets, the area has to be well lighted and the paved ground needs to be marked off in yellow paint with the word "Decon".

3. Parking spaces located near the emergency room were observed from 6/23/10 through 6/25/10 from 8:30 am till 3:00 pm with parked cars during the duration of the day. The facility's Engineer (employee #65) was interviewed on 6/23/10 at 9:05 am and he stated that of the four cars presently parked in these spaces, three belong to hospital physicians and one belongs to a patient who arrived last night and is receiving treatment at the emergency room. According to the Americans with Disabilities Act (ADA) section 4.6.2, "Location" "Accessible parking spaces serving a particular building shall be located on the shortest accessible route of travel from adjacent parking to an accessible entrance". If these spaces are used for the designated exterior "Decontamination area" (please cross reference #2 above) the handicapped parking spaces in the main parking area are acceptable, if not handicapped parking shall be moved closer to the entrance.

4. The bathroom located near the medical examination rooms of the emergency room was visited on 6/23/10 at 9:35 am and provided evidence that grab bars are needed behind and at one side of the toilet to comply with Americans with Disabilities Act (ADA).

5. The observational tour of the facility was performed from 6/23/10 through 6/25/10 from 8:30 am till 4:00 pm with the facility's Engineer (employee #65) and provided evidence that the facility has eleven (11) isolation rooms (located at the emergency room and wards). However, these isolation rooms do not have negative pressure meters to monitor the pressure inside of these rooms when used by patients who require this special condition. The Engineer (employee #65) stated during an interview on 6/23/10 at 9:25 am that once a week he performs a paper test, where he places a piece of paper on the floor near the door and observes if the paper is sucked into the room. Negative pressure meters are required where patients' conditions warrant their use, the pressure levels are recorded on a daily basis to ensure it is functioning properly and is extremely important when patient use these rooms and the pressure drops it emits an alarm to notify personnel that the room is not maintaining its negative pressure.

6. The emergency room was visited on 6/23/10 at 9:05 am and provided evidence that the triage area is located within the observation treatment area near the fast track. The triage area is separated from the waiting room by a wall which fails to allow staff to observe patients in the waiting room or as they come into the waiting room. According with "Guidelines for Design and Construction of Health Care Facilities" (GDCHCF) section 5.1.3.4 and appendix A5.1.3.4, triage shall be located to permit staff observations and control of access to treatment areas, pedestrian and ambulance entrances and public waiting area.

7. The pediatric treatment area of the emergency room with four cubicles was visited on 6/23/10 at 11:15 am and provided evidence that this area does not have emergency call systems at the cubicles.

8. The hospital's emergency room was visited on 6/23/10 at 10:35 am and provided evidence that there are nine lounge chairs that are placed in a room that is used to provide respiratory therapy to patients. The nine lounge chairs were placed side by side with no space between them (arm rests were touching) and no curtains were found between the lounge chairs. In order to provide emergency treatment to a patient at least four feet between lounge chairs is needed to accommodate emergency staff and equipment and the curtains are needed to provide privacy during treatment.

9. The operating room department was visited on 6/23/10 from 1:20 pm till 3:00 pm and provided evidence of the following:
a. The male and female dressing rooms are not constructed to provide one-way traffic. Staff enter through a door located in a non restricted hallway, into the dressing room where they change from their street clothes into their scrubs and then access the same non restricted hallway in their scrubs and then pass through a door that opens into the operating room area (semi-restricted).
b. Observations made during the initial tour provided evidence that the operating room department (dressing room-street clothes to operating room attire, pre-induction room, surgical area and recovery room) are not divided into different designated areas (unrestricted, semi-restricted and restricted) with signs at each area indicating the surgical attire required.
c. Maintenance employees (employees #68, #69 and #70) were observed cleaning operating suites after surgical procedures without masks on.
d. Seven out of seven operating suites (#1 through #7) were found with the observational windows blocked to restrict vision inside the operating suites. Common household venetian blinds and blue pads are being used to block the windows. Blue pads and venetian blinds can not be cleaned appropriately and observation windows must allow viewing in the event of an emergency or to verify suite status.
e. Seven out of seven operating suites (#1 through #7) were found with chipped paint on the metal front doors.
f. Seven out of seven operating suites (#1 through #7) were found with large sharp containers directly on the floor because the wall brackets were broken.
g. Seven out of seven operating suites (#1 through #7) were found with trash basket for regular waste without lids.
h. Cidex OPA trays were found in a portable hood in the hallway in front of the operating suites. However, the portable hood was not working and the trays were only placed in the hood because they did not have a place to store them. Manufacturers' recommendations suggests that the solution is used in a well-ventilated area and in closed containers with tight fitting lids, and the user must use gloves, eye protection and fluid-resistant gowns. The use of Cidex OPA should be in an area that is ventilated with a local exhaust hood which contains a filter media.
i. There are seven operating suites and the facility has seven mops and seven pails, however a pail and mop dedicated for contaminated cases was not found. Also, the pails were found with water and the mops placed in them and after cleaning the suites the dirty mop water was not observed changed.
j. A maintenance employee (employee #70) was observed on 6/23/10 at 2:30 pm coming from the maintenance closet with a mop and carrying it suspended in the air throughout the semi restricted area and into the restricted area (operating suite #2). A mop pail must be used to reduce the risk of cross contamination to avoid accidental contact with employees in scrubs and also for the maintenance employee who enters the operating room and uses scrubs.
k. The housekeeping closet was found without a Material Safety Data Sheet (MSDS) with the different cleaning solutions used in the operating department.
l. Seven out of seven operating suites (#1 through #7) were found without working intercom systems.
m. The housekeeping closet was found without a door closer, air extractor or mop hangers to ensure that mops dry properly.
n. An open Cidex OPA tray was found in operating suite #4 on the top of a cart with wheels. This was brought to the attention of a maintenance employee (employee #68) and he entered the suite, placed the cover over the tray, removed it from the suite and placed it into the hood. Due to the manner in which the employee removed the Cidex OPA, he was asked what he would do if the solution tipped over and fell on the floor and he stated on 6/23/10 at 2:50 pm that he would call to have maintenance personnel mop it up. No evidence was found that the operating room department has a spill kit to deal with spills and the tray of Cidex OPA can not be left in the suite with the lid off, can not be placed on a cart that is not designed to transport the tray and the use of Cidex OPA should be in an area that is ventilated with a local exhaust hood which contains a filter media.
o. An empty small Cidex OPA tray was found in the scrub sink and a large tray was found leaning against the wall near the scrub sink. No evidence was found that the facility is testing the Cidex OPA before discarding it and the scrub sink is not the appropriate sink to discard this solution.

10. A Cidex OPA tray was found in the dirty utility room of the Intensive Care Unit on 6/23/10 at 3:00 pm without a portable hood or other ventilation system. Manufacturers' recommendations suggests that the solution is used in a well-ventilated area and in closed containers with tight fitting lids, and the user must use gloves, eye protection and fluid-resistant gowns. The use of Cidex OPA should be in an area that is ventilated with a local exhaust hood which contains a filter media.

11. The kitchen was visited on 6/24/10 at 10:00 am with the facility's Engineer (employee
#65) and provided evidence that the bottom shelf of the drying rack used to place pots and pans on is located within twelve inches from the floor.

12. The CT Scan department and X-ray department were visited on 6/24/10 from 10:50 am till 11:10 am with the facility's Engineer (employee #65) and provided evidence that the rooms used by patients to change clothes do not have benches to sit on when changing clothes.

13. The Rehabilitation department located at the medical office building was visited on 6/24/10 at 11:20 am with the facility's Engineer (employee #65) and provided evidence of the following:
a. The department does not have a designated patient's bathroom.
b. The department does not have a designated housekeeping closet.

14. Written evidence about cleaning performed on the water cistern was requested on 6/25/10 at 10:00 am. No evidence was provided of the annual cleaning of this cistern in accordance with state law requirements (Chapter XXV, Article #1, from November 7, 1999).

15. No evidence was found on 6/25/10 at 11:30 am of routine and preventive maintenance and testing activities incorporated into the hospital's Quality Assessment Performance Improvement program. Also, no evidence was found that representatives of the physical environment and life safety are attending committee meetings.

VENTILATION, LIGHT, TEMPERATURE CONTROLS

Tag No.: A0726

Based on observations made during the survey for the physical environment with the facility's Engineer (employee #65), 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, they are not equipped with an air disinfection system.

Findings include:

The emergency room was visited with the facility's Engineer (employee #65) on 6/23/10 from 9:05 am till 11:45 am and provided evidence that the waiting area, triage area and the observation area of the emergency room 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 an air disinfection system.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on the observational tour with the Infection Control Officer (employee #17), review of policies/procedures and interview, it was determined that the facility failed to provide standards for infection control related to adequate infection control standards at the medicine ward, maternal/infant ward, surgery ward, hemodialysis area, central supply area, intensive care unit, endoscopy area and linen storage.

Findings include:

A. During the observational tour with the infection control officer (employee #17) on 6/23/10 from 9:00 am till 4:00 pm and on 6/24/10 from 9:00 am till 11:30 am, to the medicine ward, maternal/infant ward, surgery ward, hemodialysis area, central supply area, intensive care unit, endoscopy area and linen storage the following was found:

1. In the medicine ward the following was observed on 6/23/10 at 9:10 am:

a. A physical plant employee (employee #81) went out of the intensive care unit at the fourth floor and entered into the elevator with a yellow gown at 9:10 am.

b. A housekeeping cart with broom and mop used by environment service department employee #3 was observed near the medication cart used at this moment by the registered nurse to administer medications and near ulcer and wound care cart used at this moment by the practical nurse to provide wound and ulcer care at 9:20 am in the corridor of medicine ward B.

c. Patient room #421-1 received chemotherapy and hemodialysis during the observational tour and was observed with her daughter at 9:25 am with non sterile gloves to provide local care of the patient's ulcer of the left elbow, the patient's daughter has a gauze and touched the ulcer with the gauze then cleaned the ulcer up to down and outside to inside. On interview with the patient's daughter she stated "The nurse provides the bath early in the morning and my father does not want the bath early in the morning, he like the bath later because he is cold, I provide the bath and the ulcer local care and I applied a mixed cream with Silvadine and Caltrate on the ulcer area to we brought with us". The mixed cream was observed on the transparent plastic case not prepared by the pharmacy department. During the observational tour of the patient's room a nun entered the patient's room and went to the patient and touched the ulcer area without gloves. The patient's oxygen nasal canula was observed around the I.V pump machine without a cover. A plastic medication bottle with a label that read "Renvela 800 mgs 2 tablets t.i.d" indicating medication hold" was observed on the top of the patient's night table without personnel supervision. The infection control officer (employee #17) called the patient's nurse to obtain information related to the patient's treatment, medication and the ulcer care and the registered nurse (employee #12) did not know the patient's treatment and stated on 6/23/10 at 9:30 am that the patient was transferred to this ward on 6/22/10 and did not provided information related to this patient.

d. An open storage of clean linen exposed to dust and without security was observed at the corridor near the patient's room #420, on interview with the nursing supervisor (employee #2) on 6/23/10 at 10:00 am she stated "Only one key to open the door and this storage is maintained opened so personnel take the linens used for patients".

e. All used sharps containers were observed without hospital identification labels and without signature and date when placed.

f. During the initial tour for infection control observations on 6/23/10 at 10:00 am the medication room was observed with two doors and maintained open all the time without security lock. The area lacks hand paper, paper towels were observed on the top of the sharp container rack without a cover.

g. One plastic and transparent gallon with Alcohol (Isopropyl Alcohol 70 %) was observed under the sink of the medication room.

h. On the top of the wash stand of the medication area of the medicine ward on 6/23/10 at 10:00 am, an opened hand towels dispenser without cover was observed inside directly on the right side of the sink.

i. One bottle of alcohol and one Aerosol Cytology Fixative bottle used by physicians on Bone Marrow and Paracentesis procedures were observed in the drawer of the left side of the medication cabinet.

j. The refrigerator used for medications lacks a security lock. Two plastic canisters contain fruits used for patients and four blood samples tubes were observed in the interior of the medication refrigerator.

k. One opened bottle of Mucomist (acetylcysteine 10%) used for respiratory therapy patient's treatment was observed in the medication refrigerator without the hour and signature of the personnel who opened it.

l. Three transfusion bags used on the 11-7 shift were observed in a plastic tray on 6/23/10 at 10:20 am on the top of the medication cabinet.

m. The biohazardous containers lack identification labels.

n. In the housekeeping area accompanied with the infection control officer (employee #17) and environment service supervisor (employee #13) the following was observed on 6/23/10 at 10:25 am: one mop directly on the floor, water was observed directly on the floor, one plastic bottle contained a clear liquid without identification label, blue pads used for patients, four plastic sharp containers covers were observed on the top of the shelf, one duster and one mop were observed directly on the floor, the door was observed opened without a security lock.

o. The housekeeping employee (employee #4) was observed on 6/23/10 at 10:27 am taking blue pads and plastic bottle and going to the biomedical waste storage area and discarded the plastic bottle and the blue pads in the biohazardous waste canister then the housekeeping employee threw out the garbage and put it in a red plastic bag and discarded in the regular waste. The biohazardous storage was observed opened without a security lock because the lock was broken.

p. In the isolation room were observed on the shelf in the closet the MSDS and lack of revision on December 2009. One bottle of fantastik, one gallon of Neutral -Q, one gallon of Disinfectant Cleaner and odor counteractant, one gallon of T/B concentrated Hospital Disinfectant Cleaner and one sharp container were observed inside of the cabinet of the isolation room. One mop and one broom were observed directly on the floor. A regular waste container was observed with a red plastic bag and a pair of gloves were observed inside the waste, the waste lacked a lid and the isolation room lacked biohazardous waste container. The sharp container lacked identification label.

q. The room designed for physicians and nurses to document located at the corridor lacked a door and security lock to protected all papers forms used by the personnel as observed on 6/23/10 at 10:40 am. Two opened cartons boxes of saline solution of 50 ml, a plastic food tray and one saline solution bottle on the top of the counter. One sharp container was observed under the counter directly on the floor. Two I.V stands and one sphygmomanometer were observed in the front of the cabinet designed only to complete documentation.

r. A used saline solution bottle and a carton box contained gauzes, adhesive tape and gloves were observed on the top of the patient night table at patient's room #439 (2).

2. In the maternal/infant ward the following was observed on 6/23/10 at 11:10 am:

a. During the initial tour for infection control observations on 6/23/10 at 11:00 am the medication room was observed with two doors, the doors were observed closed without security locks. Two opened medications carts used to provide medications for patients from 318 to 328 B and 329-1 to 337. One operating room scrub and one opened bottle of Infant's suspension drops acetaminophen (Mapap) was observed in the medication stock and lacks the date and hour when opened and the signature of the person who opened it. Non sterile gloves were observed on the top of both medications carts without protection. One opened bottle of Lidocaine 10 mgs/ml without identification label, pre-served medications .9% saline solution 50 ml with Reglan 5 mgs for the patient in room #334-1, Flagyl 500 mgs pre-served for the patient in room #332-2 and Mefoxin 1 gm were observed on the top of the medication carts and lacks the hour and date when prepared.

b. The refrigerator used for medications lacks the security lock and the following medications and other materials were observed without labels with the nurse's signature, date and hour when opened:

-One opened box of Glycerin suppositories adult.
-One Glycerin suppositories infant size.
-Four multiple vials of Celestone soluspan of 5 ml.
-One vial of Novolin N 10 ml per vial.
-One vial of Novolog 100 units/ml.
-One vial of Novolin 70/30.
-One vial of Lantus 100 ml.
-One vial of Novolin R.
-One green blood tube for Amonia test.
-Three grey blood tubes used for specials samples.
-Two extension sets.

c. Sharps containers of 5.1 and 11.3 pounds were observed without identification labels and lacks a security rack.

d. The area lacks hand paper and paper towels were observed on the top of the sharp container rack without covered.

e. Culture bottles, chloraprep-swaps, anniotest, urine collectors, labels, non sterile gauzes, culture and sensitive bottle samples, solution for enteric pathogens and others materials were observed on the cabinet in the medication room area on 6/23/10 at 11:13 am.

f. One gallon of urine collection was observed under the cabinet of the medication area.

g. In the medication storage area a plastic tray was observed with one opened bottle of Povidine Iodine 10 % solution used to provide local care without identification labels and exposed gloves without protective cover used to provide patient's local care.

h. No evidence of daily medication temperature registration on January 5, 6, 7, 11, 14, 15, 20, 21, 23, 24, 25, 26, 27, 30 and 31, 2010. On February 4, 9 and 10, 2010. On March 20, 24, 28 and 29, 2010. On April 5, 7, 8, 12, 22, 24 and 30, 2010. On May 7, 9, 10, 12, 20, 21, 22, 23, 24, 25, 26 and 30, 2010 and on June 7, 2010.

i. The daily temperatures of the medication refrigerator was reviewed on 6/23/10 at 11:15 am and provided evidence that the maternal/infant area did not provide evidence of what actions are taken when the temperatures exceeds or stay under the established parameters authorized by the facility of 36?F through 46?F. On March 17 and 18 the temperatures was taken and registered 50 ?F however it indicates accepted temperature and no evidence of actions taken by the personnel for this temperature. On June 7, 2010 it provides evidence that the temperature was taken and registered at 50?F and indicates altered value and no evidence of corrective actions.

j. No evidence of daily foods temperature registration on January 5, 6, 7, 14, 15, 20, 21, 23, 24, 25, 26, 27, 30 and 31, 2010. On February 4, 9, 10 and 24, 2010. On March 20, 24, 28 and 29, 2010. On April 7, 8, 12, 22 and 30, 2010. On May 9, 10, 12, 20, 21, 22, 23, 24, 25 and 26, 2010 and on June 7, 2010.

k. The biomedical garbage storage area of the maternal/infant area did not have lights, regular garbage was observed in the interior of the biohazardous garbage, empty garbage bags were observed directly on the floor.

l. On 6/23/10 at 1:40 pm a crash cart number 000434 was observed with dust, opened in the corridor without security lock.

3. In the surgery ward, the following was observed on 6/23/10 at 1:43 pm:

a. The housekeeping storage area was observed without a security lock.

b. The last revision of the MSDS manual was performed on December of 2008.

c. No hand paper and liquid soap were observed at the housekeeping storage.

d. The ceiling at the housekeeping storage was observed damaged, lacked acoustic ceiling tiles, the air conditioning blows hot air and water was observed on 6/23/10 at 1:45 pm from the air conditioner at the back right of the storage room, the air conditioner lacks a protective cover, and the water falls in a plastic pail exposing personnel to falls and accidents on the top of the deteriorated and humid wood shelves.

e. A broom and mop were observed in the interior of a yellow pail, three dusters were observed directly on the floor.

4. In the dialysis unit accompanied by the charge nurse (employee #16) and the infection control officer (employee #17) the following was observed on 6/23/10 at 1:50 pm:

a. The cart of machine #A-6, #A-8 and #A-9 used to moved the arrow was observed with mold.

b. Two peritoneal dialysis solution boxes 2.5% and two peritoneal dialysis solutions with 4.5% dextrose were observed directly in the infusion storage area.

c. One vial of 10 ml of Heparin Sodium 5 thousand units/ml. Lot. 203931 with an expiration date of October of 2011 was observed without labels with the nurse's signature, date and hour when opened.

d. Two biohazardous garbage containers and the sharp containers of the unit lacks identification labels.

e. Dust was observed and detected on visual observation at the Electrocardiogram machine.

5. The central supply area was visit and the following was observed on 6/15/10 at 2:15 pm:

a. During the initial tour for infection control observations on 6/23/10 at 2:15 pm at the central supply area accompanied by the infection control officer (employee #17) two used and deteriorated disposable gowns were provided by operating room technician (employee #8) to initiate the infection control tour. Interview with employee #8 on 6/23/10 at 2:20 pm related to the gowns and he stated "the gowns are used for all the personnel when they visit the central supply". The gowns were discarded and he provide two new gowns to performed the inspection.

b. No evidence of daily medication temperature registration for January 2, 2010.

c. The daily temperatures of the medication refrigerator was reviewed on 6/23/10 at 2:15 pm and did not provide evidence of what actions are taken when the temperature exceeds or stay under the established parameters authorized by the facility of 36?F through 46?F. On January 2, 2010 the temperatures was taken and registered 35?F, however no evidence of actions taken by the personnel for this temperature.

6. In the Neonatal Intensive care unit the following was observed on 6/23/10 at 2:30 pm:

a. No evidence of daily breast milk refrigerator temperature registration on January 5, 7, 13, 17, 20, 28 and 29, 2010. On February 1, 2, 20, 21 and 24, 2010. On March 14, 18, 21 and 29, 2010. On April 7, 25, 27 and 30, 2010. On May 14, 22, 24, 26, 28, 29, 30 and 31, 2010 and on June 1, 2, 7, 8 and 15, 2010.

b. No evidence of daily formulas temperature registration on January 5, 7, 8, 9, 13, 14, 17, 20, 29 and 30, 2010. On February 1, 2, 11, 14, 16, 17, 20, 21, 24 and 27, 2010. On March 14, 18, 21 and 29, 2010. On April 6, 7, 25, 27 and 30, 2010. On May 14, 22, 24, 26, 28, 29, 30 and 31, 2010 and on June 1, 2, 7, 8, 15 and 18, 2010.

c. No evidence of daily medication temperature registration on March 21, 2010. On May 18, 28 and 29, 2010 and on June 4 and 21, 2010.

d. One vial of Amphotericin B 50 mgs. for injection was observed inside the medication refrigerator, however the vial was observed without the cap cover.

e. One vial of Vancomycin Hydrochloride 500 mgs. was observed without nurse signature.

7. In the Intensive Unit care the following was observed on 6/23/10 at 3:30 pm:

a. During the observational tour on 6/23/10 at 3:30 pm of the intensive unit care it was observed that two nurses (employee #82 and #83) providing care to the patient at isolation room #10, two pillows that were the property of the patient were observed on the top of the biohazardous garbage container.

8. In the Endoscopy are, the following was observed on 6/23/10 at 3:40 pm:

a. During the observational tour on 6/23/10 at 3:40 pm of the endoscopy area department, it was observed that a coffee maker, cups, one box of coffee stirrers, one box of gauzes, two opens boxes of non sterile gloves, patient glasses, a plastic tray, adhesive tape, exposed gauzes, syringes, scissors, alcohol swabs, tourniquet and sharp container were on the top of a cabinet.

9. During the observational tour of the first floor accompanied by the infection control nursing officer (employee #17) and environmental service supervisor (employee #13) on 6/23/10 at 4:00 pm, it was observed that the door of the storage designed to maintain the dirty and contaminated linens and operating room scrubs located near the exit door of the general storage was open. Approximately ten bags of dirty linens were observed directly on the floor. During interview with the environmental service supervisor (employee #13) on 6/23/10 at 4:10 pm he stated "This door is supposed to be closed, the personnel of the private company "La Tina Uniforms" went to the hospital to look for the dirty and contaminated linens and operating room scrubs and brings the washing, dryer and disinfecting linens". This storage was observed unorganized, with dust and dirty, lacks identification label and precautions measures to protect personnel, patients and visitors exposed to this area and constitutes a hazard and the security for all persons who pass by this exit site.

10. During interview with the infection control nursing officer (employee #17) on 6/23/10 at 4:15 pm related to the sanitary condition of the environment, the risks associated with the management of the contaminated linens, regular linens and scrubs, monitoring compliance with all policies, procedures, protocol and other infection control requirements of management and she stated "The facility's contracted a new company "La Tina Uniforms and Dry Cleaning, Inc." to provide this service because the other company did not complied with infection control measures, security and quality of the process to manage the hospital's contaminated linens, regular linens and operating room scrubs. During the decision to contract this company I did not participate with this procedure to evaluate this company".

11. Interview with the purchase officer ( employee #21) on 6/24/10 at 1:35 pm related to the contract of the new laundry services and she stated "The facility contracted a new laundry company, however I did not provide information related to this contract because the director of the purchase department did not stay at the facility". The documents provided by the purchase officer to described the procedure to collect, wash and deliver regular and contaminated linens and operating room scrubs did not complied with the requirements of infection control measures, security, collection, techniques for cleaning and disinfecting, storage, distribution, internal and external transportation and quality control measures.

12. No evidence was provided on 6/24/10 at 2:05 pm related to the monitoring and quality control measures for the laundry contract services to assure and prevent infections and communicable diseases.

14. No evidence was found on 6/24/10 at 2:00 pm of facility policies/procedures related to the appropriate technics of management, security, collection, techniques for cleaning and disinfecting, storage, distribution, internal and external transportation and quality control measures.

No Description Available

Tag No.: A0756

Based on interviews with the nurse in charge of Infection Control (employee #17), it was determined that the facility failed to ensure that Material Safety Data Sheets (MSDS) are maintained updated.

Findings include:

1. During the Infection Control survey with the nurse in charge of infection control (employee #17) on 6/23/10 from 9:00 am till 4:00 pm and 6/24/10 from 9:00 am. till 11:30 the following was found:

a. No evidence was provided related to the Material Safety Data Sheets (MSDS) orientation directed toward housekeeping personnel.

b. No evidence was provided related to the orientation given to the housekeeping personnel about infection control measures.

c. No evidence was provided related to the Material Safety Data Sheets (MSDS) maintained update: on the fourth floor the next revision was not performed in December 2009. The Maternal/Infant housekeeping area lacked MSDS. In the Surgery housekeeping area and Dialysis area the last revision of the MSDS was performed in December of 2008.

DISCHARGE PLANNING EVALUATION

Tag No.: A0806

Based on interviews with the discharge planning personal (employee #23) and ten medical records reviewed (R.R) for discharge planning, it was found that the facility failed to ensure that discharge planning evaluations are performed or the final dispositions are complete for patient's during the first 24 hours for six out of ten patients admitted to the facility (R.R #50,
#51, #52, #53, #54 and #56), no evidence of participation in administrative meetings, maintaining informed through narrative reports and statistics monthly, no evidence was found of an in-service training program and no evidence was provided of the participation in the Quality Program.

Findings include:

1. Discharge planning evaluations are not performed for all patients admitted at the facility as evidence by records reviewed on 6/24/10 from 9:00 am till 3:00 pm, R.R #50, #51, #52,
#53, #54 and #56 did not have discharge planning evaluations. The discharge planning personnel was interviewed (employee #23) on 6/24/10 at 9:00 am and she stated "The facility has one social worker and three discharge planning personnel to realized discharge planning service for all patients conforming to the work dynamic however on occasions some are not performed because the capacity of admissions is to much, I try to evaluate all the cases and cases that are referred by the physician, the nurses or other professionals".

2. Policies/procedures were reviewed on 6/24/10 at 3:00 pm and provided evidence that the social worker responds directly to the director of case management and is the person responsible for developing plans of care and administrative tasks and all technical aspects to provide efficient services for all patients in accordance with the patient's social needs. IT is the professional who identified the patient's needs and intervenes to meet the maximum benefits for the patient's medical care and utilizes the community resources to help resolve the patients' necessities and problems identified during the patient admission to perform the discharge planning. According with the essential social worker function she must perform the initial social evaluation for all patients admitted at the hospital, conduct interviews, oriented patients, families or patient's care givers to coordinated the necessary social worker services of patients' needs. Intervene and apply all protocols of social services, document all patients interventions an answer all consults. Which was not done at the facility.

3. No evidence was found on 6/24/10 at 3:00 pm that the social worker (MTS) participated in administrative meetings as needed and she did not maintain informed through narrative reports and statistics on a monthly basis the administrator in accordance with her functions.

4. The discharge planning personnel did not provide evidence on 6/24/10 at 9:00 am of how many cases are attended at this facility.

5. No evidence of documentation related to performed initial assessment to identify patient's needs during the first 24 hours (biopsychosocial needs, the patient's and caregiver's understanding of discharge needs and identification of post-hospital care resources) after admission to develop a discharge plan for all patients with high risk diagnosis and others patients that are referred by physicians or the case manager director.

6. Six out ten records reviewed (R.R #50, #51, #52, #53, #54 and #56) did not have social worker initial evaluations and discharge planning evaluations as reviewed on 6/24/10 from 9:00 am till 3:00 pm with the discharge planning personal (employee #23) and infection control officer nurse (employee #17):

a. R.R #50 is a 75 years old female who was admitted at Medicine ward on 5/15/10 with Persistent pain of right leg and foot as reviewed on 6/24/10 at 10:00 am with the discharge planning personal (employee #23). No evidence was found of social workers' initial assessment to identify the patients' social needs.

b. R.R #51 is an 80 years old female who was admitted at Medicine ward on 7/4/10 with Lumbar Stenosis as reviewed on 6/24/10 at 10:10 am with the infection control officer nurse (employee #17). No evidence was found of the social workers' initial assessment to identify the patients' social needs.

c. R.R #52 is a 62 years old female who was admitted on 6/21/10 with Diverticulitis and Depressive Disorder as reviewed on 6/24/10 at 10:30 am with the infection control officer nurse (employee #17). No evidence was found of social workers' initial assessment to identify the patient's social needs.

d. R.R #53 is a 75 years old male who was admitted on 6/13/10 at Surgery ward with Cerebral Vascular Accident as reviewed on 6/24/10 at 10:45 am with the infection control officer nurse (employee #17). No evidence was found of social workers' initial assessment to identify the patients' social needs.

e. R.R #54 is a 57 years old male who was admitted at the Surgery ward on 6/11/10 at 2:35 am with Right Foot Cellulitis as reviewed on 6/24/10 at 11:00 am with the infection control officer nurse (employee #17). This case was referred on 6/11/10 for social services however no evidence was found of social workers' initial assessment to identify the patients' social needs.

f. R.R #56 is a 47 years old female who was admitted on 6/21/10 at the Medicine ward with Hypersensitivity, Hypoxemia, Diabetes Mellitus and Hypothyroidism as reviewed on 6/24/10 at 2:00 pm with the infection control officer nurse (employee #17). No evidence was found of the social workers' initial assessment to identify the patients' social needs.

WRITTEN POLICIES AND PROCEDURES

Tag No.: A0885

Based on the review of the policies and procedures manual, medical records with the Quality Assurance officer (employee #33), it was determined that the facility failed to notify in a timely manner the Organ Procurement Organization (OPO) of individuals whose death is imminent as evidenced by evaluations performed in order to determine if the facility was complying with state Law #325 from the year 2000 notifying the Organ Procurement Organization (OPO) of individuals whose death is imminent was not performed for two out of six records reviewed (R.R #20 and #21).

Findings include:

1. The facility could not provide evidence of policies related to the notification of cases in a timely manner to Life Link as reviewed on 6/24/10 at 11:20 am.

2. One out of six closed medical records reviewed on 6/24/10 at 11:30 am did not have evidence of the hour when the referral to Life Link was made (R.R #21).

3. Two out of six closed medical records reviewed on 6/24/10 at 11:40 am did not have evidence of the date when the referral to Life Link was made (R.R #20 and #21).

OPERATING ROOM POLICIES

Tag No.: A0951

Based on the observational tour, interview and review of policies/procedures with the Operating Room (OR) Supervisor (employee #35), it was determined that the facility failed to maintain standards of practice for patients' care, related to personnel without shoe covers in the restrictive area, personnel using short sleeves and long sleeves under their surgery scrubs, personnel using coats over their surgery scrubs, I.V lines without labels with the date, hour and signature of the person that open it, medication refrigerator found unlocked, equipment with dust and rust, night table with detached formica, open exhaust hood to manage Cidex OPA, lack of a paper dispenser and paper at the sink, a box of Glycine irrigation and saline solution directly on the floor, I.V pump machine directly on the floor and sharp container without security racks.

Findings include:

1. During the observational tour of the operating room department on 6/23/10 from 9:20 am till 2:00 pm the following was found:

a. On 6/23/10 at 9:20 am six boxes of 1.5% of Glycine irrigation and fourteen box of saline solution for irrigation were found directly on the floor in the hallway near the lithotripsy room.
b. On 6/23/10 at 9:25 am nine patients intravenous (I.V) lines were observed without a label with the date, hour and signature or initial of the person that started it
c. On 6/23/10 at 9:25 am a Foley bag was observed without a label with the date, hour and signature or initial of the person that opened it.
d. On 6/23/10 at 9:30 am the holding medication refrigerator was observed unlocked.
e. On 6/23/10 at 9:50 am the anesthesia room was found with the door to access the medication room opened and unlocked and the medication cabinet was found unlocked with medications unattended.
f. On 6/23/10 at 10:00 am the Meti tray system universal 2000 with Cidex OPA was observe in the hallway near suite #4 and the housekeeping room with the hood open and without a filter media. Manufacturers' recommendations suggests that the use of Cidex OPA should be in an area that is ventilated with a local exhaust hood which contains a filter media.
g. On 6/23/10 at 10:00 am the Meti tray system universal 2000 was stored with used Cidex solution and observed with dust and rust.
h. On 6/23/10 at 10:10 am house keeping personnel (employee #63) open the house keeping closet and took a mop without a pail and went to operating suite #4 to mop the floor, he then returned the mop to the house keeping closet in the same manner.
i. The defibrillator was observed with dust.

2. On 6/23/10 at 10:20 am, the following was observed in operating suite #4 during the preparation of the patient for a Cesarea operation.
a. Employee #39, employee #45, employee #46 and employee #47 were observed in the restrictive area with long sleeve shirts under their surgical scrubs.
b. Employee #44 and employee #48 were observed in the restrictive area with a sweater or coat over their surgical scrubs.
c. Employee #39 was observed in restrictive area without shoe cover.

3. On 6/23/10 at 10:25 am, the following was observed in operating suite #3 during the preparation of the patient and surgery for a natural arteriovenous fistula operation.
a. Employee #40, employee #50 and employee #44 were observed in the restrictive area with long sleeves under their surgical scrubs.
b. Employee #40 and employee #49 were observed in the restrictive area without shoe covers.

4. On 6/23/10 at 11:20 am, the following was observed in operating suite #2 during a Cataract operation.
a. Employee #52 was observed in the restrictive area with long sleeves under the surgical scrubs and without shoe cover.

5. On 6/23/10 at 11:45 am, the following was observed in operating suite #6 during a Cervical decompression operation.
a. Employee #37 and employee #57 were observed in the restrictive area with long sleeve and short sleeves under their surgical scrubs.
b. Employee #57 was observed in the restrictive area without shoe covers.

6. On 6/23/10 from 9:20 am till 4:00 pm, it was observed that in the semi-restrictive area and restrictive area personnel with short sleeves, long sleeves under surgical scrubs and personnel with coats over their surgical scrubs and personnel without shoe covers.

7. Interview with the O.R Supervisor (employee #35) on 6/24/10 at 9:00 am related to personnel without shoe covers in the restrictive area and she stated that personnel do not use shoe cover because they use their shoes inside the operation suites area and if they go outside of the unit they change their shoes. No evidence was found related to policies and procedure related to personnel shoe cleaning when not using shoe covers. Evidence was provide related to the attire used in the different areas of the operation room (non restrictive 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 face masks.

8. On 6/23/10 at 2:00 pm the following was observed in the recovery room:
a. One out of five lounge chairs in the phase II area was found with broken vinyl which does not allow for proper cleaning.
b. The phase II sink area lacks a paper dispenser and paper.
c. Two I.V pump machines were found directly on the floor in the phase I area between the third and fourth cubicle on the right.
d. The phase I sink area lacks a paper dispenser and paper.
e. A table was found in the phase I area near the sink on the bottom of the area with broken formica which does not allow for proper cleaning.
f. A humidifier bottle with corrugated lines was found opened over the lamp, available for patient's use in the second cubicle on the left of phase I.
g. The manual resuscitator (AMBU) was observed over the side table in the eight cubicle.
h. The phase I area lacks a sharp container at each cubicle, personnel have to go to the counter area to discard all sharp objects in the sharp container.
i. A large sharp container was found over the crash cart without a security rack.

INFORMED CONSENT

Tag No.: A0955

Based on the review of ten closed medical records and policies/procedures of the operating room with the Operating Room Supervisor (employee #35), it was determined that the facility failed to execute complete surgery informed consents that includes date, hour, procedure complications, if consented to take pictures and consent the presence of student to the Operation Room and if consented to transfusion for ten out of ten records reviewed (R.R #43, #44, #45, #46, #47, #48, #62, #63, #64 and #65).

Findings include:

1. During the review of ten closed records on 6/24/10 from 9:40 am till 4:30 pm, the following was determined:

a. R.R #43 provided evidence that the surgical procedure consent form did not include possible procedure complications.

b. R.R #44 provided evidence that the surgical procedure consent form did not include possible procedure complications, lack of the date and hour that the consent was taken and was illegible. The consent was signed by the patient's son and did not provide the justification of why the patient did not sign.

c. R.R #45 provided evidence that the surgical procedure consent form lacks the date and hour when the consent was taken.

d. R.R #46 provided evidence that the surgical procedure consent form did not include if the patient consented to having pictures taken during the procedure, if the patient consented the presence of students in the Operation Room, did not include the possible procedure complications and lacks the date and hour that the consent was taken.

e. R.R #47 provided evidence that the surgical procedure consent form lacks the date that the consent was taken.

f. R.R #48 provided evidence that the surgical procedure consent form did not include the possible procedure complications, lack of the date and hour that the consent was taken and was illegible. The consent was signed by the patient's son and did not provide the justification of why the patient did not sign.

g. R.R #62 provided evidence that the surgical procedure consent form did not include if the patient consented to having pictures taken during the procedure, if the patient consented the presence of students in the Operation Room.

h. R.R #63 provided evidence that the surgical procedure consent form did not include if the patient consented to having pictures taken during the procedure, if the patient consented the presence of students in the Operation Room.

i. R.R #64 provided evidence that the surgical procedure consent form did not include if the patient consented to having pictures taken during the procedure, if the patient consented the presence of students in the Operation Room.

j. R.R #65 provided evidence that the surgical procedure consent form did not include if the patient consented to having pictures taken during the procedure, if the patient consented the presence of students in the Operation Room.

ORGANIZATION OF ANESTHESIA SERVICES

Tag No.: A1001

Based on the observational tour through the operating rooms (O.R) and review of nine credential files with the anesthesiologist (employee #37) and anesthesiologist secretary (employee #62), it was determined that the facility failed to maintain updated credential files for anesthetist nurses (CRNA) for Credential files related to nursing registration, nursing association, lack of evidence of hepatitis B vaccine and updated health certificates for six out of nine credential files (C.F #2, #3, #4, #5, #6 and #7) to ensure appropriate scope of anesthesia services.

Findings include:

1. Anesthetist credential files were reviewed on 6/24/10 from 3:00 pm till 4:20 pm, the following was found:

a. One out of nine anesthetist nursing credential files provided evidence of an expired Health Certificate (C.F #6).

b. Six out of nine anesthetist nursing credential files did not have evidence of their hepatitis profiles or responsibility exoneration (C.Fs #2, #3, #4, #5, #6 and #7).

c. One out of nine anesthetist nursing credential files did not have evidence of their updated nursing association (C.F #3).

d. One out of nine anesthetist nursing credential files did not have evidence of the updated nursing registration (C.Fs #3).

DELIVERY OF ANESTHESIA SERVICES

Tag No.: A1002

Based on the review of ten closed records to evaluate anesthesia services, it was determined that the facility failed to ensure that informed consent forms are properly executed for ten out of ten records reviewed (R.R #43, #44, #45, #46, #47, #48, #62, #63, #64 and #65).

Findings include:

1. During the review of ten closed records on 6/24/10 from 9:40 am till 4:30 pm the anesthesia consent form did not provide space to write the hour that the consent was taken.

a. Ten out of ten closed medical record were incomplete due to the lack of the hour when the consent was taken (R.R #43, #44, #45, #46, #47, #48, #62, #63, #64 and #65).

POST-ANESTHESIA EVALUATION

Tag No.: A1005

Based on the review of ten closed records to evaluate anesthesia services, it was determined that the facility failed to ensure that a post-anesthesia evaluation is completed and documented legibly with the date and hour for four out of ten records reviewed (R.R #44,
#47, #64 and #65).

Findings include:

1. During the review of ten closed records on 6/24/10 from 9:40 am till 4:30 pm the following was determined:

a. R.R #44 provided evidence that the post-anesthesia evaluation was incomplete due to the lack of post-anesthesia evaluations.

b. R.R #47 provided evidence that the post-anesthesia evaluation was incomplete due to the lack of the date and hour of the evaluation.

c. R.R #64 provided evidence that the post-anesthesia evaluation was incomplete due to the lack of post-anesthesia evaluation.

d. R.R #65 provided evidence that the post-anesthesia evaluation was incomplete due to the lack of the hour of the evaluation.

RADIOACTIVE MATERIALS STORAGE & DISPOSAL

Tag No.: A1035

Based on observations during the tour of the nuclear medicine department with the Nuclear Medicine Medical Director (employee #79), it was determined that the room used to store radioactive materials does not protect patients and personnel from radiation hazards.

Findings include:

1. During the observational tour of the nuclear medicine department on 6/24/10 at 9:30 am with the Nuclear Medicine Medical Director (employee #79), the "Hot Room" was observed with its door opened and radioactive materials were found inside. The facility failed to ensure that radioactive materials are stored in accordance with Federal and State laws and regulations and acceptable standards of practice to protect patients and personnel in this area.

2. During the observational tour of the nuclear medicine department on 6/24/10 at 10:30 am with the Nuclear Medicine Medical Director (employee #79) the storage room was observed with used radioactive materials in plastic biohazardous bags and it was also used to store clerical paper work. The facility failed to ensure that radioactive materials are stored in accordance with Federal and State laws and regulations and acceptable standards of practice to protect patients and personnel in this area.

INTEGRATION OF EMERGENCY SERVICES

Tag No.: A1103

Based on the review of the policies/procedures manual with the emergency room nursing supervisor (employee #72), it was determined that the facility failed to comply with procedures related to the integration or coordination between the emergency room and other departments.

Findings include:

1. The following was determined related to the emergency department's policies/procedures reviewed on 6/23/10 from 3:00 pm till 4:00 pm:

a. No evidence was found of procedures related to the integration and coordination between the Emergency Department with the other departments of the hospital such as: the delivery room, surgical services, laboratory, intensive care unit, admission department, diet services and the radiology department. The hospital must be able to demonstrate how the hospital's other departments provide emergency patients the care and services needed within a safe environment, within a timely manner and with appropriate/available personnel.

EMERGENCY SERVICES POLICIES

Tag No.: A1104

Based on twelve medical records reviewed (R.R), policies/procedures manual and the observational tour with the emergency room (E.R) nursing supervisor (employee #72), it was determined that the facility failed to have signs posted at the entrance (ambulatory) and admitting area for the notification of the rights of the individuals who enter the E.R, emergency room personnel do not have a plan or assignments for all specific tasks in the event of an emergency, the triage room does not provide auditory privacy, medications are not protected from non authorized access and the emergency room failed to follow infection control standards to prevent cross contamination.

Findings include:

1. The following was observed related to the review of the policies/procedures manual and observations of the emergency department on 6/23/10 from 9:30 am till 4:30 pm :

a. No signs were posted at the entrance (ambulatory) and admitting area for the notification of the rights of the individuals who enter the E.R as observed on 6/23/10 at 9:40 am.

b. No evidence was found on 6/23/10 at 11:00 am that emergency personnel have a plan or assignments for all specific tasks in the event of an emergency. All personnel trained related to emergency procedures must be instructed related to their assignments and periodically tested for its implementation and the assignment must be posted for review by staff.

c. Policies and procedures related to compliance with EMTALA requirements did not include the following related to: receiving hospitals must report suspected incidences of individuals with an emergency medical condition transferred in violation, sign posting to notify the rights of the individuals who enter the emergency room, maintain transfer records for five years, on call physicians roster, complete emergency room log, appropriate medical screening, stabilizing treatment, no delay in examination or treatment to inquire about payment status, appropriate transfer, whistleblower protection and recipient hospital responsibilities.

2. The triage room located near the waiting area was found on 6/23/10 at 10:00 am did not have visibility of the patients that arrive at the emergency room for nursing interviews and to categorize the patients. The triage room was observed with a computer that was turned on and the computer screen had the names of the patients in order of their arrival at the emergency room to be evaluated after the triage process. The triage nurse (employee #80) stated during an interview on 6/23/10 at 10:10 am that the patients are called in the order that they appear in the computer for triage and not related to the condition of the patient at the moment that they arrive at the emergency room. This triage room does not comply with minimum construction requirements related to it location and failure to determine the patient's category during the triage process and any changes in patient's status when in the waiting room (Please cross reference Tag A725 #6).

3. Two medication rooms were observed in the emergency room on 6/23/10 from 10:45 am till 11:00 am and provided evidence that one is located in front of the fast track area and other near the nursing counter located in the observation area in front of patient's cubicles. A cabinet used to store medications, syringes, angio-catheters and intravenous solutions located in front of the fast track area were found open (no door to protect this area) and could be accessed by non authorized persons. The door of the medication room located in the observation area was found unlocked and open at the superior aspect of the walls which can allow for non authorized access.

4. No evidence was found on 6/23/10 at 10:55 am of the daily registration of the refrigerator temperature for nine out of twenty-three days for the month of June of 2010.

5. No evidence was found on 6/23/10 at 11:10 am of the daily registration of the Precision PCX blood glucose testing for twenty-eight out of thirty-one days for the month of May of 2010 and seventeen out of twenty-three for the month of June of 2010.

6. The examination beds in examination rooms #4 and #5 in the emergency room were observed on 6/23/10 at 11:35 am and provided evidence that the bed in examination room were dirty, ripped and cover with tape.

7. The following was observed in the emergency room on 6/23/10 from 9:30 am till 4:30 pm related to infection control procedures:

a. All sharp containers in the emergency room were observed without labels with the assigned hospital's identification number and the facility's name to ensure responsibility related to its contents, protection and disposition.

b. I.V lines and I.V sites were observed in cubicles #11, #12, #14, #15, #17 and #18 in the observation area without a label indicating the date started, hour, catheter number and nurse's signature when the I.V was started.

c. A plastic container with tongue depressors were observed in three physician examination areas (#1, #2 and #4) and minor surgery without protective covers exposing them to contamination when personnel take them out of the container.

d. All venopuncture access tray were observed in the emergency room (pediatric/adult observation area, minor surgery and fast track area) with non-sterile gauze without protective covers, exposing them to the environment. Also, venopuncture access trays were observed with heparin vials to irrigate the heparin lock.

e. A dirty bed pan was found on the patient's side table in cubicle #11.

f. Approximately ten ear speculums were observed in a plastic glass in the examination room without protective covers, exposing them to the environment and without labels if they were dirty or clean. Also, three ear speculums were observed on the venopuncture tray in the same area.

g. Two bottles of normal saline for irrigation were observed on the top of a table in the fast track area and minor surgery area without the date and hour when they were opened. The manufacturer's specification states to "discard unused portion" of normal saline after opened.

h. Hand dispensers were observed without paper at cubicles #11, #14 and #15 in the observation area.

i. Approximately fifty-six boxes with I.V solutions were found directly on the floor in the passage way near the medication storage room . Also, approximately twenty-five boxes with I.V solutions were found directly on the floor in the material storage of the observation area.

8. One out of twelve clinical records were reviewed from 6/23/10 through 6/25/10 from 10:30 am till 4:00 pm for emergency room services and provided evidence of the following:

a. R.R #71 is a 69 years old male who visited the emergency room on 6/23/10 with a diagnosis of Chronic Liver Disease and Ascitis. The patient was observed walking in the observation area on 6/23/10 at 10:30 am accompanied by her daughter and he had respiratory difficulty and a distended abdomen. The patient stated during an interview on 6/23/10 at 10:30 am that he comes every Wednesday so his physician can drain fluid from his abdomen and he is discharged after the procedure. The record was reviewed on 6/23/10 at 3:30 pm and provided evidence that the patient was triaged at 10:07 am and was classified urgent. The laboratory results from the emergency room services provided evidence that the patient's hemoglobin was 10.8 mg/ml, Amonia 24 g/dl, Albumin serum 2.40g/dl, Potassium 5.50 mmol/l and Blood Urea Nitrogen 28.00 mg/dl. The patient was evaluated by the emergency room physician with the principal diagnosis of Hyperkalemia and Descompensated Chronic Liver Disease with Tensional Ascitis and was consult to the internal medicine physician on 6/23/10 at 10:30 am for the therapuetic paracentesis procedures. On 6/24/10 the physician's progress notes indicates that he drained 4,000 ml of fluid from the patient's abdomen and the patient's procedure note states that if the patient has abdominal pain, fever and bleeding to come back to the emergency room. The patient's complete closed record history was reviewed on 6/25/10 at 2:00 pm and provided evidence that the patient was treated at the emergency room for the same procedure on nine different occassions (from 4/14/10 through 6/23/10). The patient's medical provided that the patient was admitted to the hospital from 3/8/10 through 3/16/10, from 3/27/10 through 3/30/10, from 4/7/10 through 4/8/10 and from 6/23/10 through 6/24/10. During interview with the Medical Director (employee #74) on 6/24/10 at 9:30 am he stated that he discussed this with the patients' physician and he stated that he is performing this procedure in the emergency room because he believes the patient is stable under his current condition. The emergency room medical director (employee #71) stated during an interview on 6/25/10 at 3:30 pm that there are no policies and procedures related to performing this procedure in the emergency room. The facility failed to have policies and procedures in the emergency room related to the therapuetic paracentesis procedures of patients according to their condition, risks and monitoring after the patient is discharged home. Standards of practice should indicate where these types of procedures should take place (for example as an admitted patient) due to the history of complications and number of time that the patient was admitted and received treatment in the emergency room.

9. No evidence was found on 6/23/10 from 1:30 pm till 4:00 pm that emergency room personnel are reassessing patient's pain levels after the initial assessment or duration of pain mangement for patients' seen at the triage of the emergency room for seven out of twelve records reviewed (R.R #70, #71, #72, #74, #75, #76 and #80).

10. Three out of four closed records were reviewed for transfer procedures on 6/23/10 from 2:30 pm till 3:00 pm for emergency room services and provided evidence that the physician's risks for transfer was unexpected events, instead of a risk related to the health condition (R.R #80, #82 and #83) and no evidence was found of the physician's documentation of benefits for the transfer of R.R #83.

QUALIFIED EMERGENCY SERVICES PERSONNEL

Tag No.: A1112

Based on the review of the policies/procedures manual, physician's on-call list, interview and the observational tour with the emergency room nursing supervisor (employee #72), it was determined that the facility failed to comply with EMTALA regulations related to on-call surgeons roster to cover the emergency room in the event that this specialty is needed.

Findings include:

1. No evidence was found on 6/23/10 at 2:30 pm of an on-call surgeon roster to cover the Emergency Room in the event that this specialty is needed. The Emergency Room Medical Director (employee #71) stated during an interview on 6/23/10 at 2:45 pm that there is a problem with this specialty for on-call services and it is being discussed with the Medical Staff to reach an agreement with these physicians so that they can comply with an on-call program for surgeons. The Medical Director of the hospital (employee #74) stated during an interview on 6/23/10 at 3:00 pm that they have an on-call list of surgeons for the month of June 2010, but it is not complete for every day of the month. He said that some days of the month are not covered by the schedule (every Thursday and another four days of the month). He also stated that they have always stressed the importance of having a complete on call schedule for surgeons for the entire month, and even though some days are not covered all consultations are answered.

a. No evidence was found of the first call or second call on the surgeon program for the days of the month that are not covered by the schedule.

ORGANIZATION OF REHABILITATION SERVICES

Tag No.: A1124

Based on the observational tour, review of policies/procedures, five records reviewed (R.R) with the Physical Therapy Supervisor (employee #34), it was determined that the facility failed to ensure that services are provided according to the scope of services offered to implement policies/procedures related to services, temperature registry for cold pads, hot pads, paraffin wax, water therapy, infection control standards and three out of four medical staff credential files provided evidence of expired Health Certificates (C.F #1, #2 and #4).

Findings include:

1. No evidence was found on 6/24/10 at 2:00 pm of the temperature registry for cold pads, hot pads, paraffin wax and water therapy.

2. During the review of four medical staff credential files on 6/24/10 at 3:00 pm, the following was found:

a. Three out of four credential files provided evidence of expired Health Certificates (C.F #1, #2 and #4).

3. The house keeping closet for the physical therapy department located at the medical office building (MOB) was visited on 6/24/10 at 2:30 pm and provided evidence of four boxes of contaminated garbage, one sharp container, twenty-seven rolls of toilet paper were found on a shelf along with six rolls of hand paper, two gallons of H/F disinfectant, one gallon of glass cleaner, rolls of red and black garbage bag liners, a floor polisher, three brooms and one bucket. During interview with the house keeping employee (employee #64), he stated that the equipment used to clean the MOB (mop, bucket and brooms) are used for the physical therapy department, molecular laboratory and the corridors.