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Based on advanced directive documents reviewed with the nursing director (employee #10) and admission services department director (employee #16) and interview, it was found that the facility failed to inform patients, or when appropriate the patient's representative (as allowed under State law) of the patient's rights in advance of furnishing or discontinuing patient care whenever possible for three out of three records reviewed (R.R) for advanced directives (R.R #62, #63 and #65).

Findings include:

A. On 2/8/11 from 9:07 am through 2:55 pm during the tour of the facility with the Director of Nursing (employee #10) and interview with the admission services department director
(employee #16) the following was found:

1. Closed Reords Reviewed (R.R) #63 and #65 were reviewed with the Director of Nursing (employee #10) and provided evidence that information related with the advanced directives provided to patients and relatives is not included in the medical record (hard copy) in order to provide evidence that the patient is oriented about this matter and/or decides to dictate advance directives if any.

2. R.R # 62 was reviewed with the Director of Nursing (employee #10) and provided evidence that information related with advanced directives provided to patients and relatives is not included in the hard copy medical record in order to provide evidence that the patient is oriented about this matter and/or decides to dictate advance directives if any.

3. According with an interview with the admission services department director (employee #16) on 2/8/11 at 1:00 pm he stated that during the admission process patients and relatives are informed about the right in advance of furnishing or discontinuing patient care and advance directives. However this information was digitalized and filed in the computer in the patient's electronic file and was not included as a copy in the patient's hard copy record.

Based on observations made during the infection control tour with the Infection Control Officer (employee #18), it was determined that the facility failed to promote patients' rights related with personal privacy during a patient's bath and the right to treated with respect and comfort during before Lovenox administration in the medicine/surgery intensive care unit for two out of twenty-four patients at this unit.

Findings include:

1. During observations at the medicine/surgery intensive care unit with the Infection Control Officer (employee #18) and Intensive Care Supervisor (employee #32) the patient at room #240-2 was observed on respiratory ventilation on 2/9/11 at 11:45 am and the registered nurse (employee #33) was observed during a subcutaneus Lovenox administration. The registered nurse (R.N) (employee #33) failed to tell the patient that she was going to administer Lovenox before she administered the medication.

2. During observations at the medicine/surgery intensive care unit with the Infection Control Officer (employee #18) and Intensive Care Supervisor (employee #32) the patient at room #240-4 was observed on 2/9/11 at 11:55 am during the bathing procedure. The registered nurse (R.N) (employee #33) failed to run the curtain completely around the patient's bed to provide privacy for this patient from staff and other persons who entered in the patient's room during the bathing procedure. The patient's bed is near the front door and when the door was opened the patient was visible from the hallway because the curtain was not drawn completely which did not ensure the patients' privacy during bathing.

Based on the review of incident and accident document with the institutional program director (employee #3) and interview, it was found that the facility failed to promote the right of each patient to receive care in a safe setting.

Findings include:

1. Review of incident and accident reports on 2/9/11 from 2:00 pm through 4:00 pm with
the safety program administrative person in charge (employee #42) it was found that during the months of October/2010 and December 2010, several incidents where money and personal property of patients were stolen from their rooms. The facility performed an investigation of these events however the investigation did not include complete information of the circumstances where the incidents happened or interviews with personnel in order to take measures to prevent the recurrence of this type of incident.

2. The complaint log for the months of September/2010, October/2010, November/2010 and December 2010 were reviewed with the patient's representative officer (employee #43) on 2/10/11 at 10:00 am and provided evidence that six complaints were filed by patients and patient's relatives requesting that the facility intervened to improve housekeeping services in facility wards and patient's rooms. Patient satisfaction survey findings for the months of October/2010, November/2010 and December 2010 were reviewed with the institutional program director (employee #3) on 2/10/11 at 1:24 pm and provided evidence that thirteen patients and patient's relatives requested that the facility intervene to improve housekeeping services at the facility's wards and patient's rooms. Housekeeping services performed a change in administrative supervisor recently however the service remains with the same plans and quality assurance activities without performing special provisions in response to the complaint and patient satisfaction survey comments in order to improve cleaning services.


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3. During the observational tour of the pediatric emergency room on 2/8/11 at 10:30 am with the pediatric nursing supervisor (employee #34), three pediatric patients were observed accompanied with by relatives (mother) in cubicles #3, #4 and #6 lying with their babies on the stretchers. In cubicle #6 the patient's relative was lying on the stretcher and the patient (infant) was lying on her. The bed rails for the stretcher available in the emergency room do not provide height enough to safely place pediatric patients. Also, during the observational tour, no cribs were observed in the entire observational pediatric emergency room. The nursing supervisor stated during an interview on 2/8//11 at 10:15 am that policies/procedures states that relatives should not lie down on the stretcher. We have cribs assigned for the pediatric emergency room, but when the patients are admitted they remain at the wards, and if they are needed they are requested from the pediatric ward. The facility failed to provide appropriate safety to protect vulnerable patients (children) when they receive care at the pediatric emergency room.

4. During the observational tour of the pharmacy services with the administrative and clinical pharmacist (employees #19 and #20) on 2/11/11 at 9:45 am, a patient was observed on a stretcher in front of the inpatient hemodialysis area (San Vicente unit). During interview on 2/11/11 at 9:50 am with the patient's wife, she stated that the ambulance dropped them off at 7:00 am, and they needed to go to the ambulatory surgery department to assess her husband's vascular access and he was "nothing by mouth". She stated that at 9:00 am the surgery center called her and she told them that the patient was on a stretcher near the vascular access area. Interview with the vascular access manager (employees #36) on 2/11/11 at 10:00 am provided evidence that they called the waiting area of the surgery center but they did not go to get him. Administrative personnel (employee #35) called the surgery center to come and get the patient. The facility failed to provide appropriate safety to protect vulnerable patients when they receive care at the facility.

Based on the review of one hundred and forty seven nursing credential files (C.F) and nine nursing operating room personnel and five operating room technician personnel, it was determined that the facility failed to ensure that three personnel have updated CPR, one personnel without the Hepatitis B vaccine, twenty personnel did not have updated annual evaluations, nineteen personnel did not have updated competencies in accordance with state and local laws for twenty eight out of one hundred forty seven C.Fs (C.Fs #2, #3, #7, #11,
#21, #34, #37, #42, #59, #64, #77, #83, #90, #94, #98, #103, #105, #111, #114, #115,
#119, #125, #127, #132, #133, #139, #144 and #147) and five out of nine operating room nursing credential files and five out of five operating room technicians credential files (C.F O.R #2, #3, #4, #5, #6, #7, #8, #9, #10 and #11).

Findings include:

1. One hundred forty seven nursing credential files were reviewed with the Director of Nursing (D.O.N) (employee #10) on 2/11/11 at 2:00 pm and provided evidence of the following:

a. Three out of one hundred forty seven nursing credential files did not contain updated cardio-respiratory certificates (C.F #3 (1/26/09), #19 (1/29/09) and #25 (7/9/10).

b. Twenty-three out of one hundred forty seven nursing credential files did not contain evidence of updated annual evaluations (C.F #2, #7, #15, #21, #34, #37, #42, #59, #64,
#77, #83, #90, #98, #103, #105, #114, #115, #127, #132, #133, #139, #144 and #147).

c. Twenty-five out of one hundred forty seven nursing credential files did not contain evidence of updated annual evaluations (C.F #2, #7, #15, #21, #34, #37, #42, #59, #64, #77, #83,
#90, #93, #94, #98, #103, #105, #114, #115, #127, #132, #133, #139, #144 and #147).

2. Fourteen nursing credential files from the operating room of which nine are nursing personnel and five operating room Technicians were reviewed with the Director of Nursing (D.O.N) (employee #10) on 2/11/11 at 2:00 pm and provided evidence of the following:
a. Five out of nine operating room nursing credential files did not contain evidence of updated annual evaluations (C.F O.R #2, #3, #4, #5 and #6).

b. Five out of five operating room technician credential files did not contain evidence of updated annual evaluations (C.F O.R. #7, #8, #9, #10 and #11).

c. Four out of nine nursing credential files did not contain evidence of updated competencies(C.F O.R #2, #3, #5 and #6).

d. Five out of five operating room technicians credential files did not contain evidence of updated competencies (C.F O.R #7, #8, #9, #0 and #11).

Based on the review of six clinical records and policies/procedure with the Director of Nursing (DON) (employee #10), it was found that the facility failed to ensure that nursing staff develop appropriate nursing interventions and implement care plans for one out of six records reviewed (R.R #86)

Findings include:

1. One out of six records reviewed for care plans on 2/9/11 from 1:00 pm through 4:00 pm and 2/10/11 from 9:00 am till 4:00 pm provided evidence that a patient did not have written nursing care plans during the patients' hospitalization.

a. R.R #86 is a 70 years old female who was admitted on 2/5/11 with Chronic Obstructive Pulmonary Disease (COPD). The patient's record was reviewed on 2/10/11 at 10:35 am and no evidence was found that the registered nurse activated the plan of care according to the patient's needs during the hospitalization.

Based on observations with the Director of Nursing (D.O.N) (employee #10), it was determined that the facility failed to follow nursing staff competence for drug administration for six out of nine nursing observations during drug administration for patient's room #4021, ,#4222, #5011, #6141, #7021 and #7221).

Findings include:

1. During the observational tour of the seventh floor ward with the D.O.N (employee #10) and Seventh Floor Manager (employee #45) on 2/10/11 at 9:05 am, the following was observed:

a. Registered Nurse (RN) (employee #46) entered patient's room #7221 to perform the patient's drug administration, in the process the nurse left the medication cart unattended in the hallway with the cart drawers unlocked and the medications were accessible to non authorized persons. The RN failed to follow standards of nursing practice related to the security of the medication cart.

b. Registered Nurse (RN) (employee #47) entered patrient's room #7021 to perform the patient's drug administration, in the process the nurse left the medication cart unattended in the hallway with the cart drawers unlocked and the medications were accessible to non authorized persons. The RN failed to follow standards of nursing practice related to the security of the medication cart.

2. During the observational tour of the sixth floor ward with the D.O.N (employee #10) and Sixth Floor Manager (employee #49) on 2/10/11 at 9:15 am, the following was observed:

a. A Registered Nurse (RN) (employee #50) entered the medication cart into patient's room #6141 accompanied by other RNs (who were being oriented). The RN (employee #50) failed to follow standards of nursing practice related to infection control and medication carts.

3. During the observational tour of the fifth floor ward with the D.O.N (employee #10) and Fifth Floor Manager (employee #52) on 2/10/11 at 9:30 am, the following was observed:

a. Registered Nurse (RN) (employee #54) entered into patient's room #5011 to perform the patient's drug administration, during the process the nurse did not identify the patient previously to proceed to administer the medications. The nurse did not clean the IVF'S ports previously to administering the Lasix I.V and Solumedrol I.V. Then the nurse proceeded to administer Digoxin 0.125 mg, Plavix 75 mg and Vasotec 5 mg by gastrostomy, the nurse mixed the three medications in a small glass of water then administered the medications performing pressure on the gastrostomy and not by gravity according with standards of practice. The nurse was the preceptor of a new registered nurse and during the process the RN (employee #54) did not orient and explain the full process to the new personnel. The RN failed to follow standards of nursing practice related to medication administration and cleaning the area before administering I.V medications.

4. During the observational tour of the fourth floor ward with the D.O.N (employee #10) and Fourth Floor Manager (employee #56) on 2/10/11 at 10:45 am, the following was observed:

a. Registered Nurse (RN) (employee #57) entered to the patient's room #4021 to perform the patient's drug administration, in the process the nurse left the medication cart unattended in the hallway with the cart drawers unlocked and the medications were accessible to non authorized personnel. After the drug administration the nurse washed her hand for less than 15 second. The RN failed to follow standards of nursing practice related to the security of the medication cart and failed to follow infection control Standard of practice related to hand washing.

b. Registered Nurse (RN) (employee #58) entered to the patient's room #4222 to perform the patient's drug administration, in the process the nurse left the medication cart unattended in the hallway with the cart drawers unlocked and the medications were accessible to non authorized persons. The RN failed to follow standards of nursing practice related to the security of the medication cart.

Based on observations and interview with the Director of Nursing (D.O.N) (employee #10), it was determined that the facility failed to ensure that drugs and biological are stored and protected in a proper manner related to medications not secured in the medication cart.

Findings include:

1. During the observational tour of seventh floor ward on 2/10/11 at 9:00 am with the D.O.N (employee #10), the following was found:

a. During interview with the seventh floor manager (employee #45) on 2/10/11 at 9:05 am he stated that the ward has three (3) medication carts.

b. During the observational tour of the seventh floor ward on 2/10/11 at 9:05 am with the D.O.N (employee #10) and seventh floor manager (employee #45), the three medication carts were observed unattended while the nurses were in patient's rooms.

c. During the observational tour of the seventh floor ward on 2/10/11 at 9:10 am with the D.O.N (employee #10) and seventh floor manager (employee #45), the medication cart was observed unlocked and unattended while a nurse administered medications to the patient in room #7021 and the Medication Administration Record (MAR) was open and the patient's medications were observed pre-served in the patient's drawer.

d. During the observational tour of the seventh floor ward on 2/10/11 at 9:10 am with the D.O.N (employee #10) and seventh floor manager (employee #45), the medication cart was observed unlocked and unattended while a nurse administered medications to the patient and in the drawer was observed a multiple dose Lidocaine 1% vial opened without a label with the date and hour opened.

2. During the observational tour of the Sixth floor ward on 2/10/11 at 9:15 am with the D.O.N (employee #10), the following was found:

a. During interview with the sixth floor manager (employee #49) on 2/10/11 at 9:15 am she stated that the ward has two (2) medication carts that did not have keys so that they could be locked.

b. During the observational tour of the sixth floor ward on 2/10/11 at 9:15 am with the D.O.N (employee #10) and sixth floor manager (employee #49), the two medication carts were observed unattended while the nurse was in patient's rooms.

c. During the observational tour of the sixth floor ward on 2/10/11 at 9:15 am with the D.O.N (employee #10) and sixth floor manager (employee #49), the medication cart was in the patient's room while the nurse administered medications to the patient in room #6141 because the medication cart did not have a key to lock it.

d. During the observational tour of the sixth floor ward on 2/10/11 at 9:20 am with the D.O.N (employee #10) and sixth floor manager (employee #49), the medication cart was observed unlocked and unattended while a nurse administered medications to the patient in room #6041 and in the drawer was observed a multiple dose Labetalol 100 mg/20 ml vial opened without a label with the date and hour opened.

3. During the observational tour of Fourth floor ward on 2/10/11 at 10:45 am with the D.O.N (employee #10), the following was found:

a. During interview with the Fourth floor manager (employee #56) on 2/10/11 at 10:45 am he stated that the ward has three (3) medication carts that have functional locks.

b. During the observational tour of the fourth floor ward on 2/10/11 at 10:45 am with the D.O.N (employee #10) and fourth floor manager (employee #56), the medication cart was observed unlocked and unattended while a nurse administered medications to the patient in room #4021.

c. During the observational tour of the fourth floor ward on 2/10/11 at 10:45 am with the D.O.N (employee #10) and fourth floor manager (employee #56), the medication cart was observed unlocked and unattended in the hallway of room #4222 while the RN went to the nursing station to retrieve something that she needed to proceed with the medication administration for the patient in room #4222.

Based on six patient's records reviewed (R.R) and review of policies/procedures with the Director of Nursing (D.O.N) (employee #10), it was determined that the facility failed to ensure that drugs and biological are administered by or under the supervision of a nurse in accordance with Federal and State laws and regulations for two out of six active records reviewed (R.R #85 and #86) related to medication administration standards of practice

Findings include:

1. Two out of six active records reviewed on 2/10/11 from 9:35 am till 4:00 pm provided evidence that the registered nurse (RN) did not administer the medications in accordance with the order prescribed by the physician and in accordance with standards of practice related with the medication administration:

a. R.R #85 was observed during the medication administration process on 2/10/11 at 9:30 am. The Registered Nurse (RN) (employee #54) was observed in patient's room #501 and she did not verify the patient's identification bracelet, she did not explain the Lasix I.V 20 mg and Solumedrol 20 mg I.V procedures to the patient and did not clean the IVF's ports. She mixed three crushed medications in a small glass (Digoxin 0.125 mg, Plavix 75 mg and Vasotec 5 mg) and mixed it with water, the nurse proceeded to administer the mix of medications by gastrostomy and pushed the medication with the syringe and also pushed water with the syringe. The nurse failed to perform drug administration in accordance with medication administration standards of practice.

b. R.R #86 provided evidence that a physician placed an order on 2/5/11 at 6:20 pm for Crestor 10 mg PO (orally) every day, this medication was not available in the pharmaceutical formulary. On 2/6/11 the physician filled out the Justification sheet, the pharmacy provided the medication to the ward on 2/6/11 at 10:00 am. However no evidence was found in the patient's Medication Administration Registry (MAR) that the Crestor was administered and no justification for the omission of the medication was found in the nurse's note. On 2/8/11 at 1:40 pm the physician ordered HCTZ 25 mg 1/2 tablet PO at 2:00 pm, the nurse took the order at 9:00 pm and transcribed it to the MAR HCTZ 25 mg PO daily and administered it on 2/8/11 and 2/9/11. The registered nurse failed to transcript the correct physician order to the MAR, and the patient received a tablet of HCTZ more medications than was ordered by the physician on 2/8/11 and 2/9/11.

Based on the review of the policies and procedure's manual, it was determined that the facility failed to ensure that the hospital complies with requirements of this regulation and other Federal and State laws and regulations for law number 368 from September 16, 2004, which established that there is a "Registry for those cases that have Alzheimer's Disease to report to the Department of Health Commonwealth of Puerto Rico".

Findings include:
No evidence was found of the registry for those cases identified with Alzheimer's Disease and reporting this information to the Department of Health as identified on 2/11/11 at 11:00 am.

Based on the observational tour of the medical records department and review of policies and procedures with the medical record administrator (employee #4), it was determined that the facility failed to ensure that medical records are properly stored and placed in an alternate storage room in boxes directly on the floor, dust covered records and records exposed to possible damage.

Findings include

1. During the observational tour of the medical record storage area with the medical record administrator (employee #63) on 2/10/11 at 9:00 am, it was found that this area has approximately 100 boxes of clinical records directly on the floor and approximately 15 clinical records directly on the floor (they were loose not in boxes) exposing them to possible damage.

2. The storage room used to place medical records for outpatients was observed unlocked on 2/9/11 at 2:30 pm which will not prevent unauthorized access.

3. During review of policies and procedures with the Management Information Director on 2/11/11 at 3:20 pm, no evidence was found of policies/procedures related to the use of the electronic medical record system computers or of the mobile carts used to place the computers on when located at the wards, where they will be placed when reporting and when reporting in hallways how will patient information to guarded..

Based on the review of one hundred and two clinical records, it was determined that the facility failed to ensure that medical staff, nursing personnel and other disciplines maintain legible entries for nineteen out of one hundred and two records reviewed (R.R #66 through #84).
Findings include:
Nineteen out of one hundred and two clinical records reviewed from 2/10/11 from 10:30 am till 3:00 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.

2. During review of three closed medical records from 2/9/11 through 2/11/11 from 9:00 am till 2:00 pm, it was found that the following medical records did not have written evidence that the physician signed telephone orders within 24 hours according with standards of practice and facility policies and procedures:

a. R.R. #62 provided evidence of telephone orders placed on 10/16/10, 10/17/10, 10/18/10, 10/18/10, 10/22/10 and 10/22/10, however no evidence was found that the physician countersigned these orders.


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3. During review of five active records and one closed medical records from 2/8/11 through 2/11/11 from 9:00 am till 3:00 pm, it was found that the following medical record did not have written evidence that the physician signed telephone orders within 24 hours according with standards of practice and facility policies and procedure:
Closed record :
a. R.R #65 was reviewed on 02/09/11 at 3:00 pm. failed to provide evidence of the physician's signature for the telephone order on 10/17/10 at 9:15pm., 10/18/10 at 7:10 am. and 10/18/10 at 7:20 am.
Active records:
b. R.R # 1 was reviewed on 02/08/11 at 9:45 am failed to provide evidence of the physician's signature for the telephone order on 2/1/11 at 6:00 pm., on 2/2/11 at 4:00 am., on 2/2/11 at 8:34 am., on 2/2/11 at 12:16 pm., on 2/3/11 at 2:00 pm., on 2/4/11 at 5:00 pm., on 2/4/11 at 8:30 pm. and on 2/5/11 at 8:20 am.
c. R.R. #5 was reviewed on 02/09/11 at 10:15 am failed to provide evidence of the physician's signature for the telephone order on 1/28/11 at 6:07 am. and on 1/29/11 at 8:15 pm.
d. R.R. #81 was reviewed on 02/10/11 at 1:30 pm failed to provide evidence of the physician's signature for the telephone order on 1/10/11 at 3:00 pm.
e. R.R. #84 was reviewed on 02/10/11 at 1:15 pm failed to provide evidence of the physician's signature for the telephone order on 1/12/11 at 6:17 pm., on 1/13/11 at 12:15 am. and 1/13/11 at 1:50 am.



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Based on the review of one hundred and fourty records reviewed (R.R), it was determined that the facility failed to ensure that all orders including verbal orders, must be dated, timed and authenticated promptly for thirteen out of one hundred and two records reviewed (R.R #1, #5, #62, #65 #68, #74, #76, #77, #78, #79, #80 , #81 and #84).

Findings include:

1. R.R #68, #74, #76, #77, #78, #79, and #80 were reviewed from 2/8/11 through 2/11/11 from 9:00 am till 2:00 pm, failed to provide evidence of the physician's signature for telephone orders.

3. Two out of one hundred and fourty clinical records reviewed on 2/08/11 from 1:00 pm till 3:30 pm and on 2/11/11 from 9:00 am till 1:30 pm with consultation requests lacked of: notified by, to whom and date and time when request, reason for consultation, physician signature and licence number (R.R #73 and #81).

4. Two out of one hundred and fourty clinical records reviewed on 2/08/11 from 1:00 pm till 3:30 pm and on 2/11/11 from 9:00 am till 1:30 pm with consultation requests lacked the date and the hour when the consults request and no evidence of consult answer (R.R #73 and #84).



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Based on the review of one hundred and fourty closed and active clinical records, it was determined that the facility failed to ensure that all records with consultation requests contain evidence of the date when the consultation was answered and the license number of the physician who answered the consultation seven out of one hundred and fourty records reviewed (R.R) #67, #68, #73, #79, #81, and #84).

Findings include:

1. Two out of one hundred and fourty clinical records reviewed on 2/8/11 from 1:00 pm till 3:30 pm and on 2/11/11 from 9:00 am till 1:30 pm with consultation requests lacked the date when the consultation was answered (R.R #67 and #68).

2. One out of one hundred and fourty clinical records reviewed on 2/8/11 from 1:00 pm till 3:30 pm and on 2/11/11 from 9:00 am till 1:30 pm with consultation requests lacked the license number of the physician who answered the consultation request (R.R #79).

Based on one hundred and fourty records reviewed (R.R) with the Management Information Director (employee #63), it was determined that the facility failed to ensure that clinical records have complete documentation related to the form used for internal transfer of patients, pain assessment for nursing notes, pre-operative checks, surgical consent, anesthesia consent, consult reports, nursing care plans and physician orders without signature and hour for twelve out of one hundred and fourty records reviewed (R.R #67, #68, #72,
#73, #75, #76, #77, #78, #79, #80, #81 and #84).

Findings include:

1. During the review of one hundred and fourty clinical records from 2/8/11 through 2/11/11 from 9:00 am till 2:00 pm with the Management Information Director (employee #63), the following was determined:

a. Seven out of one hundred and fourty clinical records reviewed provided evidence that the form used for internal patient transfers was not complete (R.Rs #67, #68, #73, #76, #77,
#79 and #80).
b. Six out of one hundred and fourty clinical records reviewed did not have pain assessment in the nursing notes (R.Rs #67, #68, #76, #78, #79 and #80).
c. Five out of one hundred and fourty clinical records reviewed did not have a complete pre-operative checklist, lacked of nurse's signature, license number and date and/or hour (R.Rs #72, #73, #75, #76 and #78).
d. Three out of one hundred and fourty clinical records reviewed did not have complete surgical consent, they lacked the patient's initials, date and/or hour (R.Rs #72, #75 and #79).
e. One out of one hundred and fourty clinical records reviewed did not have complete anesthesia consents, it lacked the patient's initials and type of anesthesia (R.R #80).
f. One out of one hundred and fourty clinical records reviewed did not have the consult report (R.R #73).

g. Seven out of one hundred and fourty clinical records reviewed did not have complete nursing care plans related to them being developed, implemented and reviewed according to the patients' needs (R.R #67, #68, #74, #76, #78, #79 and #80).

h. Three out of one hundred and fourty clinical records reviewed did not have complete physician orders, they lacked signatures and the hour of the order (R.R #73, #81 and #84).

Based on observations of the medication carts with the Director of Nursing (D.O.N) (employee #10) and interview, it was determined that the facility failed to ensure that all drugs and biologicals are stored in a proper and safe manner accessible only to authorized personnel.

Findings include:

1. During the observational tour of seventh floor ward on 2/10/11 at 9:00 am with the D.O.N (employee #10), the following was found:

a. During interview with the seventh floor manager (employee #45) on 2/10/11 at 9:05 am he stated that the ward has three (3) medication carts.

b. During the observational tour of the seventh floor ward on 2/10/11 at 9:05 am with the D.O.N (employee #10) and seventh floor manager (employee #45), the three medication carts were observed unattended while the nurses were in patient's rooms.

2. During the observational tour of the Sixth floor ward on 2/10/11 at 9:15 am with the D.O.N (employee #10), the following was found:

a. During interview with the sixth floor manager (employee #49) on 2/10/11 at 9:15 am she stated that the ward has two (2) medication carts that did not have keys so that they could be locked.

b. During the observational tour of the sixth floor ward on 2/10/11 at 9:15 am with the D.O.N (employee #10) and sixth floor manager (employee #49), the two medication carts were observed unattended while the nurse was in patient's rooms.

3. During the observational tour of Fourth floor ward on 2/10/11 at 10:45 am with the D.O.N (employee #10), the following was found:

a. During interview with the Fourth floor manager (employee #56) on 2/10/11 at 10:45 am he stated that the ward has three (3) medication carts that have functional locks.

b. During the observational tour of the fourth floor ward on 2/10/11 at 10:45 am with the D.O.N (employee #10) and fourth floor manager (employee #56), the medication cart was observed unlocked and unattended while a nurse administered medications to the patient in room #4021.

c. During the observational tour of the fourth floor ward on 2/10/11 at 10:45 am with the D.O.N (employee #10) and fourth floor manager (employee #56), the medication cart was observed unlocked and unattended in the hallway of room #4222 while the RN went to the nursing station to retrieve something that she needed to proceed with the medication administration for the patient in room #4222.

Based on observations with the Infection Control Officer (employee #18), the clinical (employee #19) and administrative (employee #20) pharmacist, it was determined that the facility failed to ensure that unusable drugs are not available for patients' and maintained at appropriate temperature in intensive/pediatric care unit and hematology ward.

Findings include:

1. During the observational tour of the Intensive Care unit on 2/9/11 at 12;30 pm with the Infection Control Officer (employee #18) in room 240-8 a bottle of Norvasc 5mg/ml was found on the patient's night table. This medication was dispensed on 2/3/11 by the pharmacy department and states to maintain in a refrigerator. The last dose given was at 9:00 am. The facility failed to ensure that medications are maintained at appropriate temperatures for patient's use.
2. In the pediatric intensive care unit on 2/9/11 at 4:00 pm with the Infection Control Officer (employee #18) the following were found:
a. Two IV piggy bags of normal saline prepared with heparin one from 2/9/11 and the other from 2/9/11. No evidence was found on the IV piggy bag label of the amount of Heparin in the piggy bags.
b. A vial of Vecuronium Bromide was found opened and the manufacturer states it is for single use and the label states to discard after 24 hours and the medication was opened on 2/7/11 at 11:30 am.
3. During the observational tour with the clinical (employee #19) and administrative (employee #20) pharmacist on 2/11/11 at 9:30 am the following was found at the Medicine Ward (second floor):

a. One IV bag with normal saline .9% prepared with 40 milliquevalents of KCL (potassium chloride) without the protective plastic cover in the solution medication cabinets.

b. The medication refrigerator did not have temperature registration for the month of February 2011.

4. The Hematology/Oncology (fourth floor) was visited on 2/11/11 at 11:00 am with clinical (employee #19) and administrative (employee #20) pharmacist and the following was found:

a. A bottle of Synthroid suspension 25 mg/ml prepared on 1/24/11 and with a use date of 1/31/11 was found available for patients use.

b. A tuberculin syringe was found pre-served in the refrigerator with a date prepared of 12/16/10.

c. Novolin and Lantuss insulin were found opened without the date opened. The manufacturer recommends to ensure that medications are safe for use and failed to be aware that multi-use medications are discarded after 28 days

d. An open vial of Mucomyst 20% for nebulizer was found in the refrigerator without the date when opened. The manufactures recommended to discard after the fourth day opened.

Based on review of routine chemistry, hematology, endocrinology patient test reports and interview with the laboratory director and the testing personnel, it was determined that the laboratory failed to include the patient accession number in the final test report.
The findings include:
a. The laboratory used the patient name and accession number to identify the patient sample through the whole testing procedure.
b. The laboratory personnel stated that they did not include the patient accession number in the 100% of the patient ' s final test reports.

1. Based on review of parasitology final test reports and interview with the laboratory director, it was determined that the laboratory failed to include in the test report the method used to perform parasitology tests.

The findings include:

a. The laboratory performed patients samples submitted for parasitology tests by concentration method.

b. The laboratory did not include in the final test report the method used.

2. Based on review of parasitology final test reports and interview with the laboratory general supervisor, it was determined that the laboratory failed to include the date of specimen collection for each one of the samples collected by the patients in different dates.

3. Based on records review and lab. testing personnel interview, it was determined that the laboratory failed to include the negative control material when patient's specimens were tested for cold agglutinin.

The findings include:

a. The records showed that the laboratory did not include the negative control material when the following patient's specimens were tested for cold agglutinin:

Date Patient's specimens
11/24/10 # 400461239
12/17/10 # 500497875 y # 500497680

4. Based on quality control records review and lab. testing personnel interview on 2/9/11, it was determined that the laboratory failed to include a negative control material and a positive control material with graded or tittered reactivity when patient's specimens were tested for quantitative RA and ASOT tests by agglutination method.

The findings include:

a. The laboratory performed qualitative and quantitative test for RA and ASOT tests.

b. Review of serology quality control records showed, that the laboratory did not include a negative control and positive control material with graded or tittered reactivity when patient's specimens were tested for RA and ASOT quantitative test the following days:

Date patient id. Test

11/12/10 # 600739704 RA (10 IU/ml)
11/18/10 # 50041681 ASO (200 IU/ml)
11/29/10 # 200868409 ASO (200 IU/ml)

5. Based on review of records and interview with the testing personnel, it was determined that the laboratory failed to include an external positive and negative control material each day of patient testing.

The findings include:

a. The records showed that the laboratory did not include a negative and positive control material when patient's specimens were tested for ASO qualitative test on 11/18/10 (patient id. # 50041728).

6. Based on records review and lab. testing personnel interview, it was determined that the laboratory failed to include one control material each 8 hours of operation when manual cell counts was performed.

The findings include:

1. The records showed that the laboratory performed manual cell counts (sperm count) by hemacytometer method.

2. The laboratory did not include one control material each 8 hours of operation when manual cell counts were performed since 1/09.

3. The lab general supervisor confirmed on 2/9/11, that the laboratory did not include one control material each 8 hours of operation when manual cell counts were performed.

4. The laboratory performed and reported 41 sperm cells count since 1/09.

Based on medical records reviewed, 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 two out of seven records reviewed (R.R # 63 and # 65) and improper administration and management of equipment required for patients with enteral feedings.

Findings include:

1. The facility failed to ensure that a qualified dietitian consultant provides services for patients who need evaluations based on their diagnosis and health condition as reviewed on 2/9/11 from 8:49 am through 11:45 am:

a. R.R #63 is a 72 years old female patient admitted to the facility on 2/2/11 with a diagnosis of Aspiration Pneumonia. The patient was admitted with a nasogastric tube, and was ordered enteral nutrition of Jevity 1.2 to run at 30 ml/hour. The patient was evaluated by the dietitian on 2/8/11 and recommends to increase the enteral nutrition at 40 ml/hour. The initial evaluation should be performed by the dietitian after the admission, based on the patient's diagnosis and nutritional risk status identified right after admission to the facility. However the initial evaluation was not found documented in the medical record.

b. R.R #65 is a 79 year old male admitted on 10/17/10 with a diagnosis of Stroke in Evolution. The patient was evaluated by the physician who ordered the patient to be admitted to the telemetry ward, 1,200 kilocalories low salt with 3 snacks and requested a nutritional evaluation on 10/17/10 at 2:00 pm. The patient was evaluated by the dietitian on 10/18/10 and recommended Glucerna 1.2 to run at 25ml/hour as tolerated and increased to add 10 ml daily up to 65 ml/hour. On 10/19/10 at 8:15 am the physician insert a nasogastric tube and requests a dietary re-evaluation. The case was not re-evaluated by the dietitian as identified during record review on 2/9/11 at 3:00 pm with dietitian service director (employee #44). Glucerna 1.2 to run at 30 ml/hour to be administer by nasogastric tube was ordered by the physician on 10/19/10 at 7:00 pm. A dietary re-evaluation of the case was requested by the physician on 10/19/10 in order to re-evaluate the patient's nutritional needs but it was not performed.

c. The director of dietary services (employee #44) stated during an interview on 2/9/11 at 9:49 am that according with facility policies patients that are identified at nutritional risk must be evaluated between 24-48 hours from the admission in order to make a dietitian evaluation. Reassessments of patients that were performed initial evaluations by a dietitian and given counseling will be performed based on individualized patient needs or if the patient's physician asks for another consult.

2. Review of incident and accident reports on 2/9/11 from 2:00 pm through 4:00 pm with the institutional program director (employee #3) provided evidence that on 10/27/10 at the emergency room a patient who was ordered Nepro enteral nutrition to be administer at 30 ml/hour by Peg feeding tube received the enteral product with an intravenous pump machine instead of an enteral feeding machine. On the day of this event there was a lack of enteral feeding machines and a nurse used an intravenous pump. The intravenous pump machine manufacturer specification for management were review with the Director of Nursing (employee #10) on 2/11/11 at 1:50 pm and the specifications state that the Hospira
(intravenous pump machine) can be used to administer enteral feeding and some kind of high viscosity fluids with a special intravenous enteral catheter adapter and line. However the kind of enteral feeding (Nepro) that was administered to the patient was not included in the list of enteral feeding that can be administer with this machine (Hospira). The special line that must be used with the Hospira machine to administer enteral feeding and high viscosity fluids was not available at the hospital and the line used to administer the Nepro enteral feeding to the patient was a regular line used to administer intravenous fluids. The facility failed to ensure that treatments are provided with appropriate equipment related with the treatment ordered.

3. The director of nursing (employee #10) stated during an interview on 2/10/11 at 10:39 am that facility has an inventory of 30 enteral feeding machines for patients use. Review of the inventory of enteral feeding machines at the facility on 2/10/11 from 11:54 pm through 1:00 pm with the director of nursing (employee #10) provided evidence that twenty-eight (28) out of the thirty (30) enteral feeding machines were available for use at different departments, however no evidence was found where the remaining two (2) machines were located. Activities and provisions to follow if enteral feeding were ordered when all the machines were in use were not evidenced during the survey procedures.

Based on tests performed on equipment and observations made during the survey for the physical environment with a facility Engineer (employee #5), it was determined that the physical structure and care areas failed to allow staff to provide care in a safe manner ensuring the well being of patients receiving services related to the lack of devices to open bathroom doors, handrails are loose and no evidence was found of the kitchen hood duct and fan maintenance.

Findings include:

1. During visits to the emergency room waiting area bathroom on 2/8/11 at 8:45 am and patient's bathrooms on the eight floor (patient room #828) on 2/9/11 at 9:30 am with a facility Engineer (employee #5), the emergency nursing call systems were activated in these bathrooms. When the nurses arrived at the bathrooms they knocked on the doors but could not gain access to the bathroom because they did not have a device to open the doors from the outside. Patient's bathrooms on all floors and at public waiting rooms can be locked from the inside and nursing staff shall have a device with them at all times to open these doors in the event that a patient needs assistance so that valuable time is not lost when trying to open the bathroom door. In-service related to the use of this new device for all personnel from all shifts is required along with periodic testing for compliance.

2. The handrail in the hallway in front of room #9301 was found loose with a facility Engineer (employee #5) on 2/9/11 at 8:15 am.

3. The handrail in the hallway in front of patient's room #828 was found loose with a facility Engineer (employee #5) on 2/9/11 at 10:55 am.

4. The handrail in the hallway in front of patient's room #3681 was found loose with a facility Engineer (employee #5) on 2/10/11 at 11:15 am.

5. The eight floor pantry area was visited on 2/9/11 at 10:00 am with a facility Engineer (employee #5) and provided evidence that the microwave is plugged into a multi-plug and the ice machine electrical cord needs repair.

6. During the observational tour of the kitchen on 2/10/11 at 8:30 am with a facility Engineer (employee #5) the following was determined:
a. The hood vents located above the cooking stoves were found with spaces between them which will not allow the vents to protect the duct system as designed.
b. The kitchen's hood exhaust system was requested, however no evidence was found of the updated required hood, duct and exhaust fans inspection by a properly trained, qualified and certified company or person in accordance with the manufacturer's exhaust system inspection schedule.

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

Findings include:

The Life Safety from Fire survey was performed from 2/8/11 through 2/11/11 from 8:00 am till 4:00 pm with a facility Engineer (employee #5); for deficiencies related to Life Safety from fire (form 2786R) please see tags with letter K on the 2567 form (K0018, K0021, K0022, K0027, K0046, K0050, K0051, K0064 and K0130).

Based on the review of policies/procedures (P&P) and observations made during the survey for the physical environment with a facility Engineer (employee #5), it was determined that the facility failed to follow established procedures for the storage of biohazardous trash related to two outside metal biohazardous storage container that were found with two of its doors unlocked.

Findings include:

Two outside metal biohazardous storage containers located in the visitor's parking area were visited on 2/10/11 at 9:45 am and provided evidence that two doors were not locked to prevent unauthorized access. Facility policies and procedures reviewed on 2/10/11 at 3:00 pm provided evidence that these doors where biohazardous materials are placed are to be kept in a locked and secure area, away from unauthorized persons.

Based on observations made during the survey for the physical environment with a facility Engineer (employee #5) and interview, it was determined that the structure of this facility is not maintained to protect and safe guard supplies and equipment to ensure safety and quality related to the lack of scale calibration evidence, a long tube connected to the old oxygen system was hanging into a cubicle, air extractors did not work, medical records were not placed safety on the shelves, mops were leaning against walls in the maintenance closets, dirty linen sorting room did not have negative pressure, large bins used for dirty linen and regular trash did not have transport covers, clean ventilators are stored in a room used to store other materials and equipment and no evidence was found of elevator recall documentation.

Findings include:

1. No evidence was found on 2/11/11 at 10:00 am of the preventive maintenance and calibrations of the facility's scales used to weigh patient's throughout the hospital.

2. The fast track room located at the emergency room was visited on 2/8/11 at 9:00 am with a facility Engineer (employee #5) and provided evidence that it is equipped with wall oxygen inlets. However the old oxygen system in this room is located on the ceiling and a long tube connected to this old system was hanging into the first cubicle.

3. The maintenance closet of the inpatient Dialysis Unit at the "San Vicente" building was observed on 2/10/11 at 11:15 am with an air extractor that did not work.

4. Mops and brooms were observed in all ward maintenance closets from 2/8/11 through 2/11/11 from 8:00 am till 4:00 pm leaning up against the wall (mop heads up and the poles down). This procedure contaminates the walls and allows water from the wet mops to leak down the poles and is not an acceptable practice related to infection control standards.

5. The Medical Record department was visited on 2/11/11 at 10:00 am and provided evidence that records are packed up to the ceiling within two feet of the ceiling. Medical records found throughout the department were placed in such a manner that made them easy to fall from the shelves and from the top of the shelves creating a falling object hazard for staff working in this department.

6. During the observational tour of the laundry sorting room on 2/10/11 at 1:30 pm with a facility Engineer (employee #5), it was determined that the air extractor did not provide negative pressure in this room (it was extremely weak). On 2/11/11 at 8:40 am this room was visited again and the negative pressure was tested and it worked properly, the Engineer (employee #5) was interviewed on 2/11/11 at 8:45 am and he stated that the belt of the fan for the extractor was adjusted and the room has negative pressure now.

7. Dirty laundry is placed in large bins and moved throughout the hospital until it arrives at the basement sorting area as observed on 2/11/11 at 8:30 am. The yellow plastic bags that the dirty/contaminated laundry are placed in were all found ripped open due to the weight of the dirty linen. Also, these bins did not have covers to protect persons in hallways and elevators from cross contamination.

8. On 2/10/11 at 3:00 pm a large portable container filled with regular trash was observed coming out of the escort elevator. The elevator that had the container with trash was also transporting persons to different floor, however this container did not have a cover to protect persons in hallways and the elevator from cross contamination.

9. The room used to store six type E oxygen cylinders at the NICU/PICU was observed on 2/10/11 at 3:20 pm with six clean ventilators. This room used to store many objects including different cylinders and can not have the clean ventilators to ensure that possible cross contamination does not occur.

10. No evidence was found on 2/11/11 at 9:35 am with a facility Engineer (employee #5) that the facility is testing the elevator for recall capability (if the fire alarm is activated the elevator opens to the closest floor and remains open or returns to the first floor and opens).

Based on tests performed on equipment and observations made during the survey for the physical environment with a facility Engineer (employee #5), it was determined that this facility's physical structure is not designed in accordance with Federal and State laws to provide protection of patients and staff related to patient lounge chairs in the waiting room, the operating room department is not appropriately designed, maintenance closets did not have air extractors, inappropriate laundry storage, regular and biohazardous trash in the same room, stairs with only one handrail, delivery room is not appropriately designed, regular and biohazardous trash closets are not appropriately designed, a strip is needed at the back door of the pharmacy, Cidex OPA trays used in an inappropriate area and the outside decontamination area is not appropriately designed.

Findings include:

1. The waiting area for the new observation cubicles (six cubicles) of the emergency room was visited on 2/8/11 at 10:15 am and provided evidence that this waiting area has four patient lounge chairs. There were two patients receiving intravenous treatment at these lounge chairs (one male and one female) however, these lounge chairs were touching each other (no space between the chairs) and at least four feet between each chair is needed for privacy and this waiting area is not an appropriate area to receive intravenous treatment related to privacy and cross contamination (the male patient was receiving treatment for diarrhea).

2. The operating room department was visited on 2/8/11 from 1:45 pm till 3:00 pm and provided evidence of the following:
a. The male dressing room is 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. Persons were observed entering and waiting in the semi-restricted area dressed in street clothes among personnel dressed in surgical scrubs.
c. 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.
d. Operating suite #11 was observed with a supply cabinet door that did not have glass, exposing the materials inside to different patients and procedures. Also the glass door of one of the cabinets in the hallway in front of operating suite #11 was missing.
e. The phase II area was found with ceiling damage.
f. The regular trash closet used to place trash from the suites until it is collected was observed with approximately 50 bags of trash that were on top of the trash container and on the floor.
g. The contaminated trash closet used to place contaminated trash from the suites until it is collected was observed with approximately 50 bags of contaminated trash that were on top of the trash container and some of the bags leaked on to the floor (approximately a two foot by two foot puddle).
h. Sharp containers were found throughout the operating suite department without security bases to prevent them from tipping over or non authorized removal.

3. All of the maintenance closets at the "La Milagrosa" building were visited on 2/9/11 and 2/10/11 from 8:00 am till 4:00 pm with a facility Engineer (employee #5) provided evidence that they did not have air extractors.

4. Three cabinets located under the hallway windows were observed on the eight floor near patient's room #830 on 2/9/11 at 10:15 am with a facility Engineer (employee #5) and they contained three yellow containers with dirty linen. These cabinets do not have air extractors, smoke detectors or door closers for the cabinet doors.

5. Regular and biohazardous trash were found in the same closets at the "La Milagrosa" building as observed on 2/9/11 and 2/10/11 from 8:00 am till 4:00 pm with a facility Engineer (employee #5) increasing the risk of cross contamination as personnel enter these rooms to deposit trash and these closets do not have air extractors.

6. The hallway that separates the two sections of the facility on the seventh floor was observed on 2/9/11 at 11:00 am with a facility Engineer (employee #5) and it provided evidence of a five step stair, however there is only one handrail on one side of the stairs.

7. The delivery room department was visited on 2/9/11 at 2:50 pm with a facility Engineer (employee #5) and provided evidence that the maintenance closet does not have a floor sink, it has a sink that is approximately two feet high which will increase the risk for splashing of personnel when emptying dirty mop pails. Also, the air extractors in the regular and biohazardous closets did not work. There is a sprinkler head that is up against a newly moved wall at the delivery room and it has a circular flow pattern where as a specific direction flow is required due to the wall within two inches of the sprinkler head.

8. During an observational tour of the sterilization area on the second floor on 2/9/11 at 3:45 pm with a facility Engineer (employee #5) provided evidence that the hallway was found with a newly constructed regular trash closet and biohazardous trash closet that did not have air extractors or smoke detectors. Also the long hallway located in front of these closets was found with approximately 50 card board boxes on the floor.

9. The pharmacy department was visited on 2/10/11 at 10:00 am with a facility Engineer (employee #5) and it was found with a back door that is in need of a protective strip at the bottom of the door to prevent pest from entering the storage area.

10. The Endoscopy department was visited on 2/10/11 at 10:20 am with a facility Engineer (employee #5) and provided evidence that Cidex OPA trays were found in an open area; 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 maintenance closet on the second floor of the "San Vicente" building was observed on 2/10/11 at 11:50 am without an air extractor.

12. The emergency room was visited on 2/8/11 at 8:35 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). The facility has decided to use an external area for this purpose, however it is located over 200 feet from the emergency room ambulance entrance (according with GDCHCF it needs to be located within 150 feet from the ambulance entrance) and the area is located down a ramp where cars park. This area does not comply with GDCHCF due to its distance and location.


20424


13. The outpatient clinics department was visited with the external clinical manager (employee #64) on 2/10/11 at 2:35 pm and the following was determined:
a. The area where the nurses take vital sign of patients did not provide privacy during interviews if other persons are in this area.

Based on observations made during the survey for the physical environment with a facility Engineer (employee #5), it was determined that the facility failed to ensure that areas supplied by Ultraviolet lights are tested and changed according with manufacturer's recommendations.

Findings include:

The facility has Ultraviolet lights in the air handling system of their air conditioning system for various sites of the hospital such as the emergency rooms and operating suites as determined with a facility Engineer (employee #5) on 2/11/11 at 9:50 am. However, no evidence was found that the facility is periodically testing these Ultraviolet lights to ensure that they are working properly and at full strength. The facility has these Ultraviolet lights for approximately two years and the manufacturer's recommendations are to test periodically and replace lamp at least once a year.

Based on the observational tour with the infection control officer (employee #18) and interviews and review of policies/procedures (P&P), it was determined that the facility failed to promote sanitary and safe care through its infection control program in the emergency room, laundry room, central supply department, operating room department, medicine intensive care unit and neonatal/pediatric intensive care unit related to improper infection control procedures and failed to follow infection control standards of practice.

Findings include:

1. The following was observed in the emergency room on 2/8/11 from 8:45 am till 3:30 pm with the infection control officer (employee #18) related to infection control procedures:

a. The laboratory technologist (employee #29) was observed with a biohazardous sharp container that she was going to deposit in the biohazardous room. The employee was observed with gloves and when she tried to open the door she found it closed and she returned to the emergency room laboratory with the sharp container. Afterwards a maintenance employee (employee #30) was observed opening the door of the biohazardous room, touching the large biohazardous container without gloves and without washing her hands she touched the nursing observation counter.

b. All large gauze packages were observed open in the surgical area, triage area and critical care area on I.V access trays without protective covers, exposing them to the environment.

c. Rolls of stretcher paper were observed loose in all areas of the emergency room. Also, rolls of stretcher paper were observed directly on the floor of the minor surgery room.

d. Eight rolls used during venepuncture procedures were observed on the top of a table near of the venepuncture tray for use during venepuncture procedures.

e. A large paper package with foam cups was on the top of all nursing counters accessible for use by all personnel to provide water to patients.

f. A kit with personal belonging (bedpan, urinal, basin, etc.), of a patient was found over the biohazardous trash container in the treatment area (cubicle #7).

g. The patient's shower room in the observational area was found with the floor and curtain dirty.

h. The doors that lead to the emergency hallway to pass patient from the isolation room were observed unlocked. The two rooms had patients. P&P were reviewed on 2/8/11 at 11:35 am and provided evidence that these doors are to remain in the closed and locked position at all times.

i. During the observational tour of the emergency room with the emergency room supervisor (employee #17), laundry personnel (employee #31) was observed at the emergency room leaving three packages of clean linen in clear plastic container (CDP area) used to store clean linen. He was observed removing a package of opened clean linen and he placed it on his cart. During interview on 2/8/11 at 10:30 am with employee #31, he stated that he was going to take it to another area to ensure that they have enough linen. The facility failed to ensure procedures related to prevent cross contamination.

2. One out of eight clinical records reviewed from 2/8/11 through 2/9/11 from 1:30 pm till 3:00 pm for emergency room services provided evidence of the following:

a. R.R #92 is a 33 years old male who visited the emergency room on 2/8/11 with a diagnosis of fever and diarrhea and the record review was performed on 2/8/11 at 2:30 pm. The patient was triaged at 9:18 am and was classified non-urgent. The patient was evaluated by the physician at 9:35 am and orders Ringer Lactate 1000 ml to run 250 ml per hour and Lomotil 1 tablet per mouth stat. The nurse moved the patient to the observation waiting area to continue receiving intravenous treatment. The area was observed with two patients receiving intravenous treatment at these lounge chairs (one male and one female) however, these lounge chairs were touching each other (no space between the chairs) and at least four feet between each chair is needed for privacy and this waiting area is not an appropriate area to receive intravenous treatment related to privacy and cross contamination.

3. The following was observed in the laundry room department (LRD) on 2/9/11 from 8:30 am till 9:30 am related to infection control procedures:

a. During the observational tour of the clean and dirty laundry rooms located on the ground floor with the infection control officer (employee #17) on 2/10/11 at 8:30 am, it was determined that the facility was in the process of painting the clean linen storage area. The hallway in front of this room was found with seven (7) large bins stacked with yellow bags filled with dirty linen and a clear plastic container used for clean linen, personnel placed this container and these bins in the hallway while they painted the clean linen storage area. Also, located in this hallway is the main food storage room and personnel from this department were moving food cans and other food products through this hallway. Laundry personnel were observed in the dirty linen sorting room, dressed in disposable gown, gloves masks and shoe covers, counting and separating dirty (contaminated) linen. On 2/10/11 at 8:50 am the room could not be tested for negative pressure, but on 2/10/11 at 2:30 pm when the dirty linen sorting room was being painted it was found that the extractor used to provided negative pressure was not working properly. On 2/11/11 at 9:35 am the dirty linen room was visited again and five (5) (employees #37, #38, #39, #40 and #41) laundry employees were observed in the process of separating and counting the dirty linen, but two out of five (employees #40 and #41) did not have their disposable gowns completely around their bodies which exposed the back of their clothes and the gowns did not go down all the way to their feet. The seven bins were found with broken yellow bags in the hallway and after they were sorted and placed in other yellow bags, these bags were also broken, exposing their content to those passing in this hallway. The bins have ropes used to pull the bins with a protective rubber covering the rope and one bin did not have the protective rubber cover on the rope which did not allow for proper cleaning. The same bins used to bring clean linen to the facility are same bins that are used to collect the dirty (contaminated) linen and remove them from the facility's wards to return them to the contracted laundry services. No evidence was found of the cleaning provided by the contracted linen company, no evidence was found of the facility's quality related to the contracted linen service or the internal process of clean linen delivery or dirty linen sorting and the evaluation related to this process. No evidence was found that the facility is evaluating possible cross contamination between clean and dirty line. (Please cross reference Tag 724 #6 and #7).

4. The following was observed in the central supply department (CSD) on 2/9/11 from 10:00 am till 11:10 am related to infection control procedures:

a. One sharp container (5 gallon size) was observed without a security base during the observational tour of the central supply on 2/9/11 at 9:45 am. The sharp container was observed with scalpel, blades, needles and other parts of instruments removed from trays during surgical procedures. The CSD supervisor (employee #24) stated during an interview on 2/9/11 at 9:45 am that according with policies/procedures, all the trays that arrive from the operating rooms do not have sharp objects.

b. On 2/9/11 from 10:00 am till 10:30 am the central supply was visited with the Infection Control Officer (employee #17). Operation Room technician (employee #26) was observed with a cart with dirty surgery equipment, wheeling the cart from the operating room department and through a non-restricted hallway to get to the central supply dirty room area with her surgical attire including shoe covers. After employee #26 dropped off the dirty equipment she returned to the non-restricted hallway and entered the restricted area of the operating rooms. During the observational tour of this area two other employees (employees #27 and #28) were found entering this area and returning into the operating rooms with their surgical attire. The facility failed to ensure that personnel from this area use appropriate techniques when entering and leaving the operating rooms to reduce possible risk of cross contamination.

c. No evidence was found of the registration log to record temperature and humidity for the room used to maintain the sterile materials and the room did not have a thermometer to measure the temperature or another device to measure the humidity.

5. The following was observed in the endoscopy department on 2/9/11 from 11:15 am till 11:30 am related to infection control procedures:

a. During the observational tour of the endoscopy department on 2/9/11 at 11:20 am, a registered nurse (RN) (employee #22) was observed moving and cleaning endoscopy equipment after used on patients' procedures. The RN cleaned the endoscopy equipment with Cidex OPA solution and when she retrieved the equipment from the Cidex OPA container to rinse them she did not have a face shield. The RN stated during an interview on 2/9/11 at 11:25 am that she did not use a face shield because she has eye glasses.

b. The endoscopy area was observed with three Cidex OPA trays. The registered nurse (RN) (employee #22) was asked on 2/9/11 at 11:30 am to provide evidence of the tests performed on the three trays of Cidex OPA and she said that she only tested one. The facility failed to ensure that Cidex OPA tests are performed for each tray.

6. The following was observed in the medicine intensive care unit (MICU) on 2/9/11 from 11:30 am till 12:00 noon related to infection control procedures:

a. Two irrigation syringes were observed in rooms #240-2 and #240-6 on 2/9/11 at 11:45 am without the date and hour when the syringes was first used.

b. In room #240-8 the patient was observed on a mechanical ventilator. The ambu bag near the mechanical ventilator was observed without the date and hour when the ambu was started and the circuit lines were out of the bag.

7. All inpatient ward were found with regular trash containers (patient's rooms, hallways and bathrooms) on 2/9/11 from 11:00 am till 4:00 pm and provided evidence that they do not have lids. Self closing (foot pedal) garbage containers are needed to ensure that personnel do not have to touch the lids when opening and trash located in the container is separated from the environment.
8. During the observational tour of the facility's wards on 2/9/11 from 8:45 am till 4:00 pm and interview with the maintenance supervisor (employee #23) on 2/10/11 at 9:45 am with the infection control officer (employee #18) it was found that beds without patients have clean bed linens on them at the seventh and eight floors. The nursing manager (employee #14) was interviewed and she stated that the clean beds are maintained with bed linen when we are waiting for admissions. At the seventh floor beds in rooms #7021, #7052, #7081,
#7121, #7181, #7281 and #7351 were observed empty with bed linen on them and next to these beds were beds with patients. A housekeeping personnel (employee #23) was interviewed on 2/9/11 at 9:45 am and he stated that after a patient is discharged, house keeping personnel are assigned an area to clean rooms, patient's beds and then the same personnel places clean linen on the bed. No evidence was found of policies/procedures related to house keeping personnel performing this duty and no evidence was found that they are authorized in writing to perform this task or that they are evaluated related to the performance of this task. The facility failed to ensure that appropriate personnel perform the task of linen changes and that the linen is placed on the beds at an appropriate time which will reduce the possible risk of cross contamination.

9. House keeping personnel (employee #21) was observed on 2/9/11 at 2:15 pm placing a bottle of normal saline that was re-bottled with a yellow solution in a cabinet at the administrative office. She stated during an interview on 2/9/11 at 2:20 pm that the solution was re-bottled with Concur cleaning solution and it did not have a label because her supervisor was not in her office. The bottle with cleaning solution was accessible to non authorized persons. Also, the re-bottled solution was observed without a label indicating the use of the solution, lot number and expiration date.

10. The following was observed in the pediatric/neonatal intensive unit on 2/9/11 from 3:45 pm till 4:30 pm related to infection control procedures:

a. All cubicles with patients were observed on 2/9/11 at 3:50 pm with the Infection Control Officer (employee #18) in neonatal unit with pediatric ambu bags near the patient's unit. The ambu bag were observed hanging from the oxygen meters very close to the floor. The facility failed to ensure that personnel from this area use appropriate techniques to maintain ambu bags clean to reduce the possible risk of cross contamination.

b. In the neonatal intensive care unit was visited on 2/9/11 at 4:00 pm with the Infection Control Officer (employee #18), it was found with a scale used to weight patients. Under the scale were open packages of pampers, under pads and wash clothes and the top of these materials were found dusty. The facility failed to ensure that procedures are followed related to infection control standards to prevent possible cross contamination.

Based on the review of clinical records, policies/procedures and interview with the Social Worker Director (employee #67), it was found that the facility failed to establish the criteria to identify at an early stage of hospitalization for all patients who are likely to suffer adverse health consequences upon discharge.

Findings included:

1. During interview with the social worker director (employee #67) on 2/9/11 at 11:00 am. related to the discharge planning process she stated that discharge planning personnel identify patients' needs on the nurse's admission history or the daily census for the first 24 to 48 hours of the patients' admission. Discharge case management personnel perform the initial assessment for all patients and identify what are patient's needs for discharge planning according to their needs. The discharge planning program is performed for all patients admitted to the hospital and over 65 years old in a period of 24 and 48 hours from admission or when a discharge need is identified. The priority is for high risk patients and patients with other conditions established in the discharge planning program. The rest of the patient with private medical insurance are evaluated by the coordinator and they are identified for patient's needs. The re-assessment is to be performed every 48 to 72 hours during the patient's stay at the hospital.

2. Related to the quality program, no evidence was provided on 2/9/11 at 1:15 pm for the collecting and reporting data for the Quality Assurance Program. No evidence was found of statistical reports for admitted patient, how many are Medicare and other insurance plan. How many patients were interview and separated for interventions.

3. The facility's policies and procedures related to Discharge planning needs were reviewed on 2/9/11 at 1:15 pm and revealed that the Social Worker Department checks the admitted patient's census every day and the cases are distributed to the social worker assigned at the different departments to conduct the initial interview.

4. The facility failed to establish a mechanism of screening according to the risk criteria as determined on 2/9/11 at 1:15 pm. Discharge planning services failed to provide surveillance of the issues which need to be assessed to ensure the quality of care offered to patients. The data was not presented as indicators or information obtained in order to present a facility approach of quality improvement and patient health outcomes as the result of the care provided by the service.

Based on interviews with the social worker of the Discharge Planning Program and twenty seven medical records reviewed (R.R) for discharge planning and interview, 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 fifteen out of one hundred and forty patients admitted to the facility (R.R #1, #4, #8, #65, #66, #69, #70, #73, #74, #76, #79, #81, #84, #71 and #72), no evidence of the participation in administrative meetings, minutes with narrative reports and monthly statistics, 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 R.R #1, #4, #8, #65, #66, #69, #70, #73, #74, #76, #79, #81, #84, #71 and #72 did not have discharge planning evaluations as reviewed on 2/9/11 from 11:00 am till 1:30 pm. The social worker (employee #65) was interviewed on 2/9/11 at 11:00 am and she stated: "The facility has twelve social workers to provide services for seven days a week for working hours from 6:30 am till 6:30 pm, on Saturday, Sunday and holidays service is provide from 7:00 am till 4:30 pm. According with policies and procedures for discharge planning at the facility, all patients admitted to the hospital and their families receive information related to the discharge planning services and receive a Brochure with information related to the Discharge planning program and the patient or family signs a document when they received the orientation. The discharge planning coordinator uses the patient's information to identify the initial patient assessment to coordinate the services in accordance with the patient's needs. All of the discharge planning personnel try to do everything with the time they have, but on occasions they do not evaluate some patients".

2. Review of policies/procedures on 2/9/11 at 1:00 pm provided evidence that the social worker is the person responsible for developing plans of care and administrative tasks and all technical aspects to provide efficient services to all patients in accordance with the patient's social needs. The social worker's performs the discharge planning, but she did not perform the discharge planning for all patients admitted at the facility. Interview with the social worker (employee #66) on 2/9/11 at 1:00 pm provided evidence of the following: I verify the daily census and I identify the new admissions, then I interview the patient to identify the patient's needs. However, on occasions I do not see the admissions. I try to evaluate all patients but it's impossible. When I'm over loaded I take the cases that are in need of evaluations and I work with them. There are cases that are left without being seen because I do not have time".

3. No evidence was found on 2/9/11 at 1:00 pm that social workers maintain information through narrative reports and statistics on a monthly basis in accordance with their functions.

4. No evidence was found on 2/9/11 at 1:00 pm of when social workers perform meetings, no evidence of minutes or narrative reports and monthly statistics. No evidence was provided of the participation in the Quality Program.

5. The social worker did not provide evidence on 2/9/11 at 1:00 pm of how many cases individually are attended, no evidence of documentation related to the initial assessment to identify patient's needs during the first 24 hours (biopsychosocial needs, the patient's and caregiver's understanding of their discharge needs and identification of post-hospital care resources) after admission to develop a discharge plan for Medicare, Medicaid and all patients with high risk diagnosis and others patients referred by physicians or the case manager director.

Based on observations made of the surgical department and review of policies/procedures with the Operating Room Associate Administrator (employee #11), Operation room Manager (employee #12) and Anesthesia Manager (employee #13), it was determined that the facility failed to ensure that surgical services maintains a high standard of medical practice for patient's care.

Findings include:

1. Mechanisms were not developed to ensure that infection control practices are followed as reviewed on 2/8/11 from 8:50 am till 4:00 pm to properly maintain a sanitary environment as evidenced by the following:

a. In the Ambulatory preparation area it was found that the crash cart #63 with the last revision by a pharmacist of October 2010, had the following medications that were expired: twelve syringes of Epinephrine 1:10000 (1 mg/ml) expired since February 1, 2011, two vials of Procainamide Hydrochloride 1 gm/10 ml expired since February 1, 2011 as observed on 2/8/11 at 8:50 am.

b. In the Ambulatory preparation area, it was found that the carrying case #9 with a last revision by a pharmacist of October 2010, had the following medications that were expired: one vial of Procainamide Hydrochloride 1 gm/10 ml expired since February 1, 2011 as observed on 2/8/11 at 8:50 am.

c. In operating suite #12, it was observed with the vinyl of the mattress was ripped as observed on 2/8/11 at 9:20 am.

d. In the corridor between operating suites #10 and #11 on 2/8/11 at 9:25 am the following was observed: a transport cart with an operating room instrument tray, a transport cart with four boxes of Presource PBDS, a stretcher with linen, a table used for orthopedic fractures, a saw to remove casts, a hamper of dirty clothes with the lid open, three red mop buckets #10, #11 and #12 and Laparoscopy equipment.

e. In the hallway in front of suite #10 two stretchers with linen were observed on 2/8/10 at 9:45 am.

f. In the hallway that connects suites one through nine, eight red mop buckets (mop buckets
#2, #3, #4, #5, #6, #7, #8, and #9) were observed on 2/8/11 at 9:45 am.
g. In suite #13 the anesthesia cart was found with pre-served medications (one syringe with 9 ml of neosynephrine 1 mg/ml and one syringe of 6 ml of neosynephrine 0.1 mg/ml) and the cart was open and unattended on 2/8/11 at 9:50 am.
h. In the hallway of suites one through nine, sterile materials were observed on transport carts with operating trays, two surgical instrument tables, two tables for hand surgery, a cautery, Laparoscopy equipment and two stretchers on 2/8/11 at 10:10 am.
i. In the hallway between suites five and six, it was found that there were three regular garbage trash cans and three red garbage trash cans on 2/8/11 at 10:30 am.
j. In the hallway between suites seven and eight, three stretchers were observed on 2/8/11 at 10:35 am.

Based on the review of seven medical records and policies/procedures of the operating room with the Operating Room Associate Administrator (employee #11), Operation room Manager (employee # 12) and Anesthesia Manager (employee #13), it was determined that the facility failed to execute complete surgery informed consents that includes the date and hour when the patient's informed consent was obtained for four out of seven records reviewed (R.R #15, #17, #18 and #19).

Findings include:

During the review of seven medical records on 2/8/11 from 3:00 pm till 4:00 pm and on 2/9/11 from 8:30 am till 11:30 am the surgery consent form did not have the date and hour when the patient's informed consent was obtained (R.R #15, #17, #18 and #19).

Based on the review of seven medical records to evaluate anesthesia services with the Operating Room Associate Administrator (employee #11), Operation room Manager (employee #12) and Anesthesia Manager (employee #13), it was determined that the facility failed to ensure that informed consent forms are properly executed for five out of seven records reviewed (R.R #15, #17, #18, #19, #21).

Findings include:

1. During the review of seven medical records on 2/8/11 from 3:00 pm till 4:00 pm and on 2/9/11 from 8:30 am till 11:30 am the anesthesia consent form did not provide evidence of the type of anesthesia that was provided to the patients, the date, hour when the concern was taken and the signature of the anesthesiologist.

a. One out of seven medical records were incomplete for the anesthesia concern due to the lack of type of anesthesia given to the patient (R.R #15).

b. Three out of seven medical records were incomplete for the anesthesia concern due to the lack of the anesthesiologist's signature (R.R #17, #18 and #21).

c. Three out of seven medical records were incomplete for the anesthesia concern due to the lack of the date and hour when the concern was taken (R.R #18, #19 and #21).

Based on the review of seven medical records and review of policies/procedures of the anesthesia service with the Operating Room Associate Administrator (employee #11), Operation room Manager (employee #12) and Anesthesia Manager (employee #13), it was determined that the facility failed to execute a complete pre-anesthesia evaluation within 48 hours prior to surgery for five out of seven records reviewed (R.R #16, #17, #20 and
#21) .

Findings include:

1. R.R #16 is a 19 years old male who was admitted to the operating room on 12/17/10 with a diagnosis of Recurrent Dislocated Shoulder. The record review was performed on 2/8/11 at 3:30 pm and provided evidence that the pre-anesthesia evaluation was performed on 12/10/10 at 10:40 am over six days previous to the surgery.

2. R.R #17 is a 67 years old female who was admitted to the operating room on 12/22/10 with a diagnosis of Cataract Extraction OL Right. The record review was performed on 2/8/11 at 3:53 pm and provided evidence that the pre-anesthesia evaluation was performed on 12/14/10 at 10:40 am over eight days previous to the surgery.


3.. R.R #20 is a 52 years old male who was admitted to the operating room on 1/20/11 with a diagnosis of Right Neck Mass. The record review was performed on 2/9/11 at 10:00 am and provided evidence that the pre-anesthesia evaluation was performed on 1/19/11 at 10:00 am which is 24 hours previous to the surgery.

4. R.R #21 is a 73 years old female who was admitted to the operating room on 2/1/11 with a diagnosis of Arthroscopy left knee. The record review was performed on 2/9/11 at 11:00 am and provided evidence that the pre-anesthesia evaluation was performed on 1/27/11 at 1:57 pm over four days previous to the surgery.

Based on ten medical records reviewed (R.R), policies/procedures manual and the observational tour with the emergency room (E.R) nursing supervisor (employee #17) and interview, it was determined that the facility failed to have signs posted at the admitting area for the notification of the rights of the individuals who enter the E.R, twelve bottles of gastroview radiotherapy were observed located over the counter accessible to non authorized persons, a refrigerator used to store approximately fifty bottles of Barium Sulfate Superior (used for CT studies) was found opened 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 2/8/11 from 8:45 am till 3:30 pm:

a. A sign was not posted at the ambulatory admitting area for the notification of the rights of the individuals who enter this area as observed on 2/8/11 at 2:35 pm.

2. During the observational tour of the cardiorespiratory area (ward A) on 2/8/11 at 9:00 am, twelve bottles of gastroview radiotherapy were observed located over the counter accessible to non authorized persons. A refrigerator used to store approximately fifty bottles of Barium Sulfate Superior (used for CT studies) was found unlocked and accessible to non authorized persons.

3. The following was observed in the emergency room on 2/8/11 from 8:45 am till 12:15 pm related to infection control procedures:

a. The laboratory technologist (employee #29) was observed with a biohazardous sharp container that she was going to deposit in the biohazardous room. The employee was observed with gloves and when she tried to open the door she found it closed and she returned to the emergency room laboratory with the sharp container. Afterwards a maintenance employee (employee #30) was observed opening the door of the biohazardous room, touching the large biohazardous container without gloves and without washing her hands she touched the nursing observation counter.

b. All large gauze packages were observed open in the surgical area, triage area and critical care area on I.V access trays without protective covers, exposing them to the environment.

c. Rolls of stretcher paper were observed loose in all areas of the emergency room. Also, rolls of stretcher paper were observed directly on the floor of the minor surgery room.

d. Eight rolls used during venepuncture procedures were observed on the top of a table near of the venepuncture tray for use during venepuncture procedures.

e. A large paper package with foam cups was on the top of all nursing counters accessible for use by all personnel to provide water to patients.

f. A kit with personal belonging (bedpan, urinal, basin, etc.), of a patient was found over the biohazardous trash container in the treatment area (cubicle #7).

g. The patient's shower room in the observational area was found with the floor and curtain dirty.

h. The doors that lead to the emergency hallway to pass patient from the isolation room were observed unlocked. The two rooms had patients. P&P were reviewed on 2/8/11 at 11:35 am and provided evidence that these doors are to remain in the closed and locked position at all times.

i. During the observational tour of the emergency room with the emergency room supervisor (employee #17), laundry personnel (employee #31) was observed at the emergency room leaving three packages of clean linen in clear plastic container used to store clean linen. He was observed removing a package of opened clean linen and he placed it on his cart. During interview on 2/8/11 at 10:30 am with employee #31, he stated that he was going to take it to another area to ensure that they have enough linen. The facility failed to ensure procedures related to prevent cross contamination.

4. One out of ten clinical records were reviewed from 2/8/11 through 2/9/11 from 1:30 pm till 3:00 pm for emergency room services and provided evidence of the following:

a. R.R #92 is a 33 years old male who visited the emergency room on 2/8/11 with a diagnosis of fever and diarrhea and the record review was performed on 2/8/11 at 2:30 pm. The patient was triaged at 9:18 am and was classified non-urgent. The patient was evaluated by the physician at 9:35 am and orders Ringer Lactate 1000 ml to run 250 ml per hour and Lomotil 1 tablet per mouth stat. The nurse moved the patient to the observation waiting area to continue receiving intravenous treatment. The area was observed with two patients receiving intravenous treatment at these lounge chairs (one male and one female) however, these lounge chairs were touching each other (no space between the chairs) and at least four feet between each chair is needed for privacy and this waiting area is not an appropriate area to receive intravenous treatment related to privacy and cross contamination.

Based on the observational tour with the Associate Administrator (employee #35), it was determined that the facility failed to ensure that services are provided according to the scope of services offered related to the temperature registry for cold pads, hot pads, paraffin wax and water therapy.

Findings include:

No evidence was found on 2/10/11 at 2:00 pm of the temperature registry for cold pads, hot pads, paraffin wax and water therapy.

Based on one hundred and four clinical records and review of policies/procedures with the physical medicine manager (employee #61), it was determined that the facility failed to ensure that the physician writes complete orders for treatment for five out of seven active records reviewed (R.R #22, #23, #24, #25 and #26).

Finding include:

1. Five out of seven active records reviewed on 2/8/11 from 10:00 am till 11:00 am provided evidence that the physician did not mark the treatment for patient, frequency of treatment, the date of medical order and name of patient:

a. R.R #22 provided evidence that a physician placed an order on 2/1/11. However no evidence was found that the physician marked the treatment for the patient.
b. R.R #23 provided evidence that a physician placed an order for treatment. However no evidence was found of the date of the medical order and frequency of treatment.

c. R.R #24 provided evidence that a physician placed an order for treatment on 2/8/11. However no evidence was found of the name of patient.

d. R.R #25 provided evidence that a physician placed an order for treatment on 2/8/11. However no evidence was found of the name of the patient.

e. R.R #26 provided evidence that a physician placed an order for treatment on 2/9/11. However no evidence was found of the frequency of treatment in the medical order.

Based on a compliant investigation PR00000425, six medical records reviewed (R.R) for respiratory therapy services, interview and review of policies/procedures and interviews with the Respiratory Therapy Director (employee #1), Associate Administrator (employee #34) and respiratory therapist (employee #60), it was determined that the facility failed to ensure that the organization of respiratory therapy services is appropriate to the scope and complexity of the services provided for six of six clinical records reviewed (R.R #1, #2, #3, #4, #5 and #65).

Findings include:

A. Six medical records were reviewed on 2/8/11 from 9:30 am till 3:00 pm. and on 2/9/11 from 9:00 am till 11:45 am of patients who received respiratory therapy and provided evidence that respiratory therapists did not administer respiratory therapy treatment in accordance with physician orders for R.R #1, #2, #3, #4, #5 and #65. Records reviewed provided evidence that patients did not receive respiratory treatment on a timely basis (some received treatment one hour before the scheduled time and other received treatment from twenty four hours up to thirty five hours after the scheduled establish treatment hours).

1. R.R # 65 is 79 years old male arrived at Emergency Room on 10/16/10 at 11:53 am and admitted at the eight floor Telemetry ward on 10/17/10 at 1:00 am with a diagnosis of Acute ILL- Defined Cardiovascular Disease (CVD). The record review was performed on 2/9/11 at 3:00 pm and provided evidence that the physician ordered in the emergency room ABG's (arterial blood gases) on 10/16/10 at 12:40 pm and was taken by the respiratory therapist at 2:10 pm (one hour and thirty minutes later not in accordance with the patient's needs and physician's order). The patient was placed on oxygen therapy at 3 liters by nasal canula and no evidence was found of the physician's orders for this therapy. The initial respiratory assessment was performed by the therapist on 10/16/10 at 2:10 pm and referred the patient has hypoxemia, regular cardiac rhythm but weak, clear respiratory sounds and arterial blood gase (ABG's) reported hydrogen ion concentration- (pH) 7.491 meq, carbon dioxide content of blood -(PCO2) 35.1 mmHg, oxygen content of blood- (PO2) 125.4 mmHg, HCO3 27.1 MMDL/L, TCO2 28.1 MMDL/L, BE 4.5 MMDL/L and Oxcygen (O2) Sat. 99.1 %. The physician ordered Albuterol 0.083 % every twenty minutes for two treatments on 10/16/10 at 3:30 pm. No evidence was found when the order was taken by the nurse and by the respiratory therapist lacks both signatures. However, the initial respiratory therapy treatment of Albuterol 0.083 % every 20 minutes for 2 treatments by power nebulizer (PN) was given at 3:40 pm and 4:15 pm. The record review provided evidence that the patient was admitted to the eight floor at the telemetry ward on 10/17/10 on nurse shif (11:00 pm. till 7:00 am ) room #832-01 to continue treatment however nurse note reveled the patient was transferred to the emergency room on again on 10/18/10 at 1:00 am. because the assigned bed at the eight floor was un operable. The patient was admitted at the Telemetry unit located on eight floor on 10/18/10 at 4:00 am in accordance with the nurse note. On 10/17/10 at 9:15 pm the physician ordered by telephone Albuterol 1.25/3 ml normal saline solution (NSS) every 4 hours and oxygen therapy at 2 liters, the registered nurse took the telephone order at 9:15 pm (no evidence was found of the physician's signature and no evidence was found when the respiratory therapist initiated the order). Respiratory therapy notes provided evidence that the initial treatment of Albuterol 0.042 % / 3 ml of N/SS by power nebulizer per 15 minutes at 8 liters/min was given to the patient on 10/19/10 at 8:30 am (35 hours later not in accordance with physician's order and the patient's needs), at 6:00 pm (one hour and thirty minutes later), the therapist's notes revealed that the therapy was not administered at 10:00 pm because the re-estimate was performed by the therapist on 10/19/10 at 9:30 pm and revealed that the patient has secretions, rails, regular cardiac rhythm but weak, administered the therapy and tolerated. The next respiratory therapy was given on 10/20/10 at 12:20 am (6 hours and 20 minutes later), at 4:20 am, at 8:20 am, at 12:40 pm, at 5:00 pm (forty minutes later) and at 9:00 pm. The next therapy was given on 10/21/10 at 12:40 am, at 4:30 am and at 9:15 am (forty five minutes later). The therapist treatment notes revealed that the patient did not received respiratory therapy treatments in accordance with the physician's orders and patient's needs. No evidence was found of the patients' re-evaluation by the therapist of the respiratory needs in accordance with policies/procedures. No evidence was found of the physician's signature, the order in accordance with policies/procedures for the first 24 hours. No evidence was found that the respiratory therapist initiated the order in accordance with policies/ procedures.
2. R.R #1 is an 87 years old male admitted at the Emergency room on 1/30/11 at 9:30 pm. and the physician ordered oxygen by nasal canula at one liter per hour and the order was taken by the nurse on 1/30/11 at 9:30 pm. The patient was admitted at the medicine ward on 1/31/11 at 8:35 pm with a diagnosis of Acute Pancreatitis. The record review was performed on 2/8/11 at 9:45 am and provided evidence that the physician ordered on 2/6/11 at 12:30 pm Xopenex 0.63 mgs ampule and Atrovent 0.02 % ampule by nebulizer every 4 hours for 3 days. The nurse took the order on 2/6/11 at 12:30 pm, no evidence of the hour when the nurse notified the respiratory therapy department to provide respiratory therapy, the first therapy was provided to the patient on 2/6/11 at 1:00 pm. The second respiratory therapy was provided to the patient on 2/6/11 at 4:23 pm (30 minutes before) and at 8:25 pm. The next treatment was provided on 2/7/11 at 12:30 am, at 4:35 am and 7:30 am (one hour and thirty minutes before), no evidence of respiratory treatment at 11:30 am. A new order was placed by the physician on 2/7/11 at 10:00 am for Xopenex 0.63 mgs ampule and Atrovent 0.02 % ampule by nebulizer every 8 hours. No evidence of the hour when the nurse notified the respiratory therapy department to provide respiratory therapy, however the next therapy was provided to the patient on 2/7/11 at 4:00 pm (one hour before). On 2/8/11 the respiratory therapy was provided at 12:20 am and 8:30 am. The therapeutic objective of respiratory therapy label form was not placed on the patient record by the respiratory therapist on 2/8/11. No evidence was found when the physician re-evaluated the patient's needs to determine to continue or discontinue the patient respiratory therapies. The patient record lacks the reminder respiratory therapy label to re-evaluate the therapy treatments by the physician. The therapy department lacks a therapist notification treatment form to include the patient's name, respiratory therapy treatment ordered by the physician, date and hour of the notification. The nursing department did not establish that the nurse notifies the respiratory therapy department to provide the treatment and has a form to document the patient's name, date and hour of notification however the treatment form did not provided evidence that the nurse did not notify the first treatment in accordance to the patient's needs and physician order. The record revealed that the patient did not receive the respiratory therapy treatments in accordance with the physicians' orders and patient's respiratory needs.

3. R.R #2 is a 72 years old female admitted on 2/2/11 at 10:31 am at the Emergency room and then admitted at the Medicine ward on the second floor with a diagnosis of Pneumonia. The record review was performed on 2/8/11 at 10:20 am and provided evidence that the physician ordered on 2/22/11 at 5:30 pm, respiratory therapy with Albuterol 0.042 % and Atrovent 0.02 % every 4 hours by PN and administered oxygen by nasal cannula at 50 % and arterial blood gases (ABG's) to be taken by the therapist and Pneumology consult. The order was taken by the nurse on 2/2/11 at 6:00 pm (30 minutes later). The therapist progress notes revealed that the first therapy was administered on 2/2/11 at 8:00 pm (two hours and thirty minutes later) not in accordance with the patient's needs and physician order. The next respiratory therapy treatment was administered on 2/3/11 at 12:25 am, 4:42 am, 9:00 am, 1:25 pm, 5:10 pm and 9:20 pm. On 2/4/11 the respiratory therapies were administered at 12:45 am (one hour before), at 4:45 am, at 8:30 am, at 12:15 pm, at 4:00 pm (15 minutes before), at 8:00 pm and 12:00 midnight. On 2/5/11 the respiratory therapies were administered at 4:00 am, at 8:30 am, at 2:00 pm (two hours later), at 6:05 pm and at 9:45 pm. On 2/6/11 the respiratory therapy notes revealed that the respiratory therapist administered the same treatment at 1:10 am and 1:20 am and the note revealed that the patient tolerated the treatments without complications, however the therapist notes lacks the therapist's license number. The patient received the next treatment on 2/6/11 at 10:20 am (one hour later). On 2/6/11 at 12:30 pm the physician re-evaluated the patient and discontinued Atrovent and ordered to continue Albuterol 0.042 % every four hours. No evidence when the nurse notified the respiratory therapy department for this re-evaluation. On 2/6/11 no evidence was found that respiratory treatment was administered to the patient at 2:20 pm, however the respiratory therapist treatment notes revealed that the patient received Albuterol 0.042 % and Atrovent 0.02 % at 6:00 pm not in accordance with the physician's re-evaluation order and not in accordance with the patient's needs. The respiratory therapy notes revealed that the patient did not receive the next therapy of Albuterol 0.42 % by power nebulizer on 2/6/11 at 10:00 pm. The respiratory therapist note revealed that the patient received the next therapy on 2/7/11 at 1:30 am (three hours and 30 minutes later), at 5:30 am, at 9:01 am, at 1:34 pm at 5:14 pm and at 9:20 pm. On 2/8/11 at 1:13 am, at 4:47 am, at 8:00 am and 12:53 pm. No evidence was found that the respiratory therapy label form was placed in the patient's record by the therapist to ensure the re-evaluation 72 hours as is in accordance with respiratory therapy policies/procedures. Respiratory therapy department policies/procedures establishes that respiratory treatments are to be provided in accordance with the physician's orders and the therapist is to re-evaluate the patient's respiratory needs when there is a change in treatment or the patient has significant changes every 72 hours. No evidence was found of the patient's re-evaluation by the therapist for her respiratory needs in accordance with policies/procedures.

4. R.R #3 is a 70 years old female admitted at Emergency Room on 2/5/11 at 1:27 pm. with a diagnosis of Bronchial Asthma Exacerbation. The record review was performed on 2/8/11 at 11:00 am and provided evidence that the physician evaluated the patient in the emergency room and ordered respiratory therapy with Albuterol 0.83% in 3 ml of N/SS by power nebulizer on 2/5/11 at 2:35 pm (the physician's order did not establish the frequency of the respiratory treatment). The emergency room nurse took the order on 2/5/11 at 3:00 pm (forty five minutes later than the physician order), (the nurse signature was not legible). No evidence of the signature when the therapist took the order. The first treatment of Albuterol 0.83 % by power nebulizer was provided by the respiratory therapist on 2/5/11 at 2:30 pm. The next respiratory therapy of Albuterol 0.63 % was administered on 2/5/11 at 6:30 pm which is not in accordance with the physician's order and patient's needs. No evidence was found when the therapist consulted the physician related to the medication doses and frequency of treatments. According with the frequency established by the physician on 2/5/11 at 6:45 pm the next respiratory therapy was given at 9:00 pm, however no evidence on the respiratory notes of this therapy. The next therapy was given on 2/6/11 at 1:00 am (six hours later) and at 5:00 am. No evidence on the respiratory notes of the respiratory treatment on 2/6/11 at 9:00 am. The next therapy was given at 12:40 pm (seven hours later) and at 4:22 pm. On 2/6/11 at 6:00 pm the patient was admitted at the Renal Unit on the third floor and a new order was placed by the physician to administer Xopenex 0.63 % and Atrovent 0.02 by PN every 4 hours and place nasal canula at 5 liters/hour (the physician order lacks the hour when the order was placed). No evidence was found if the patient received the respiratory therapy treatments according with the patient's respiratory needs as ordered by the physician on 2/6/11 at 6:00 pm of Xopenex 0.63 % and Atrovent 0.02 % by power nebulizer every four hours. The respiratory notes revealed that the patient did not receive respiratory therapy treatments until 2/6/11 at 4:22 pm, 2/7/11 at 5:30 am (thirteen hours later not in accordance with the patient's needs and physician's order). The patient continued on 50% oxygen with ventury mask, rapid test for Influenza was taken by respiratory therapist and the respiratory therapy was administered on 2/7/11 at 5:30 am. The next therapies were given on 2/7/11 at 9:00 am, 1:43 pm, 5:30 pm and 9:30 pm. On 2/8/11 the respiratory therapies were given at 1:00 am, 5:17 am, 9:00 am and 1:46 pm. Respiratory therapy department policies/procedures establishes that respiratory treatments are to be provided in accordance with the physician's orders and the therapist is to re-evaluate the patient's respiratory needs when there is a change in treatment or the patient has significant changes every 72 hours. No evidence was found of the patient's re-evaluation by the therapist for his respiratory needs in accordance with policies/procedures.

5. R.R #4 is a 52 years old male arrived at Emergency Room on 2/1/11 at 11:30 pm with a diagnosis of Cardiac Heart Failure,Chronic Obstructive Pulmonary Disease (COPD), Diabetes Mellitus. The record review was performed on 2/9/11 at 8:40 am and provided evidence that the physician ordered on 2/1/11 at 11:30 pm oxygen by nasal canula at 3 liters. On 2/1/11 at 11:45 pm the physician ordered ABG's stat and respiratory therapy with Xopenex 0.63 mgs by power nebulizer every six hours. The order was taken by the nurse at 5:00 am lacked the respiratory therapist's signature. The record review provided evidence that the patient admitted to the eight floor at the telemetry ward on 2/2/11 at 9:00 pm. A pulmonary function test was taken by the respiratory therapist on 2/2/11 at 5:30 pm. The physician re-evaluated the patient on 2/3/11 at 9:35 am and ordered to continue with Xopenex every six hours however no evidence was found that the dose and frequency of the respiratory treatments were administered to the patient. On 2/3/11 at 1:10 pm a new order was written by the physician and revealed to continue with Xopenex treatment every six hours but did not establish the dose and the time. The physician re-evaluated the respiratory therapy treatment on 2/5/11 at 11:45 am for Xopenex 0.63 and Atrovent 0.02 % every 6 hours. On 2/5/11 at 4:50 pm and 2/8/11 at 5:20 pm new orders were written by the physician to continue in Xopenex with Atrovent every 6 hours however the orders did not provided the doses of the medications and did not establish the time. According with the record review the patient received the first treatment on 2/3/11 at 8:45 am (two hours and 45 minutes later after the physician ordered it). The patient received the next respiratory therapy treatments on 2/3/11 at 12:45 pm (2 hours before) and then at 1:40 pm (one hour before) and at 7:40 pm. The next respiratory therapy was given on 2/4/11 at 2:00 am and at 10:00 am (2 hours before) at 4:00 pm and 10:00 pm, no evidence was found on the therapist's notes for therapy treatment for these hours. The next respiratory therapy was given on 2/5/11 at 1:10 am (fifteen hours later), at 8:00 am, 2:00 pm and 8:00 pm. The next therapies were given on 2/6/11 at 2:00 am, the new physician ordered Xopenex 0.63 % and Atrovent 0.02 % every 6 hours on 2/5/11 at 11:45 am and was initiated at 8:30 am (20 hours later not accordance with the physician's order or the patient's needs). No evidence of respiratory therapies given on 2/6/11 at 2:30 pm and 8:30 pm on 2/6/11. On 2/7/11 the therapies were given at 2:30 am, 8:00 am, 1:30 pm, and 8:06 pm. On 2/8/11 the therapies were given at 2:08 am, at 8:08 am (no evidence of therapist's notes of this therapy administration), the next therapy was given at 5:08 pm, at 4:50 pm therapist's notes revealed that the patient was not in his room and the respiratory therapy was given at 5:28 pm however no evidence of respiratory treatment administration at 11:28 pm. The next treatment was given on 2/9/11 at 1:00 am (8 hours later. During the observational tour of the eight floor (telemetry area) on 2/9/11 at 8:40 am with the Associate Administrator (employee #34) the patient was found in room #801-01 sitting on a chair in the reclined position, the patient was interviewed on 2/9/11 at 9:00 am and he stated that he receives respiratory therapy during the night but today he did not receive therapy, he said that he has been coughing, however he felt better. During interview with the respiratory therapist (employee #60) on 2/9/11 at 9:30 am, she stated "I have two areas designated to provide respiratory therapies for the pediatric ward and telemetry area, I know that I we are late to provided some respiratory treatments to the patients but I have twelve patients at the telemetry ward and five pediatric patients to provide therapies to at the same hours such as 7:00 am". Respiratory therapy department policies/procedures establishes that respiratory treatments are to be provided in accordance with the physician's orders and the therapist is to re-evaluate the patient's respiratory needs when there is a change in treatment or the patient has significant changes every 72 hours. No evidence was found of the patient's re-evaluation by the therapist for his respiratory needs in accordance with policies/procedures. The facility failed to ensure the respiratory treatments were provided in accordance with the patient's needs and physician's orders.

6. R.R #5 is a 23 years old male who arrived at the Emergency Room on 1/25/11 at 11:30 pm and admitted to the Surgery ward on 1/26/11 at 12:45 pm with a diagnosis of Post- operative Gall Bladder surgery. The record review was performed on 2/9/11 at 10:15 am and provided evidence that the physician ordered respiratory therapy with Atrovent 0.5 /3ml of .9 % NSS by power nebulizer every 4 hours on 2/7/11 at 4:10 pm and intensive spirometry every hour for 3 to 5 minutes. The order was taken by the nurse on 2/7/11 at 4:10 pm and no evidence when the respiratory therapy department took the order. The first therapeutic respiratory therapy was given on 2/8/11 at 9:30 am (fifteen hours later than the physician ordered it), at 2:30 pm (1 hour later) and at 6:35 pm. The therapist's treatment notes revealed that the patient did not receive respiratory therapy treatments on 2/8/11 at 10:35 pm and on 2/9/11 at 2:35 am and 6:35 am which is not in accordance with the physician's orders and patient's needs. No evidence was found of the patients' re-evaluation by the therapist of his respiratory needs in accordance with policies/procedures.

7. During interview with the respiratory therapy director (employee #1) on 2/8/11 at 9:45 am related to the respiratory therapy department, she stated "the respiratory department covers all patients of the hospital, however the therapy department has an agreement and they have to comply with all patient's needs". She stated that respiratory therapy treatments for patients are very important and it is a priority and that she has implemented a plan that will provide all patients with good care which includes respiratory needs.

8. During interview with the Associate Administrator of the Respiratory Therapy Department (employee #34) on 2/8/11 at 10:00 am related to respiratory therapy problems she stated that respiratory therapy services are not supervised by the nursing department. The facility has a therapist supervisor designated to review the patient's records related to this service and the supervisor is the person responsible to identified all problems related to respiratory care. Quality is performed by the respiratory therapy supervisor (employee #1) and she includes it into the hospital's samples, but it is not individualized per unit and did not identify problems.

9. During interview with a respiratory therapist (employee #60) on 2/9/11 at 9:30 am related to she respiratory therapy functions at the pediatric and telemetry units, she stated: the respiratory department covers all patients of the Hospitals, I am assigned to cover this unit for 7:00 am. till 3:00 pm shift, however today I have twelve patients in the telemetry unit to provide respiratory care to in rooms 801 (1), 804 (1), 806 (1), 807 (2), 811 (1), 815 (1), 820 (1), 824 (1), 825 (1), 827 (2), 829 (2) and 831 (1) and five patients in the pediatric unit to provide respiratory care to in rooms 869 (2), 872 (1), 872 (2), 874 (1) and 874 (2). It is difficult for me because the patients do not receive their treatments on time, because patients have different needs and I have seven patients at the same time 7:00 am to provide respiratory therapy to and each therapy takes approximately fifteen minutes, this includes the indicated therapy and patient and family orientation and I try to comply with all my patients".

10. During interview with the respiratory therapist (employee #26) on 2/9/11 at 8:45 am. related to "his respiratory therapy functions at the rehabilitation unit and he stated: "When I receive the nurses call I go to the rehabilitation department and verify the physician's order and then identify the record with a respiratory label to indicate the patient's therapy. I indicate the therapy and include the patient and family orientation".

11. During interview with the Respiratory Therapist Director (employee #1) on 2/8/11 at 9:00 pm related to her respiratory therapy functions at the hospital and the delay and omission of patient's treatments and she stated: The emergency room area has a respiratory therapist for three shifts, twenty-four hours a day, seven days a week. When patients are admitted to different areas of the hospital and the physician orders respiratory therapy the nurse takes the order and notifies it to the respiratory therapy department via "Fax" and the therapist receives the order by printer. The patients do not receive the respiratory therapies on time because the nurses do not take the orders immediately, the delay during the first and second hour are related to taken the orders. The nurses are responsible to notify the orders and this problem affects the patients because it delays the treatment and it is not received on time. On the respiratory therapy functions it establishes that when received, the nurses call or fax the therapist and they go to the department and verify the physician's order and then identify the record with a respiratory label to indicate the patient's therapy and include patient and family orientation. I assign therapist only to the Intensive Care Unit and other special areas, but the Operating Room and Nursery need to call us".

12. The therapy department lacks a therapist notification treatment form to include the patient's name, respiratory therapy treatment ordered by the physician, date and hour of the notification as determined on 2/9/11 12:05 pm. The nursing department did not establish that the nurse notifies the respiratory therapy department to provide the treatment and has a form to document the patient's name, date and hour of the notification, however the treatment form does not provide evidence that the nurse notifies the first treatment in accordance with the patient's needs and physician ordered. The therapy department does not have Quality indicators to detect the delay and the omissions of respiratory therapy treatments ordered by the physician in accordance with patient's needs.