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Based on the review of documents, medical records, credential files, observations and interviews from 4/22/10 from 8:00 am. till 4:00 pm. through 4/23/10 from 8:00 am till 6:00 pm during the recertification survey, it was determined that the Governing Body failed to carry out its responsibility for the operation and management of the hospital. It did not provide the necessary oversight and leadership as evidenced by the lack of compliance with: (42 CFR 482.57) Respiratory Care Services.

Based on six medical records reviewed (R.R) on 4/22/10 from 8:30 am till 3:30 pm. throught 4/23/10 from 8:30 am till 2:30 pm. for respiratory care services, policies/procedures and interviews, 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 out of six clinical records reviewed (R.R #1, #2, #3, #4, #5 and #6), the respiratory therapy director serves on a part-time basis, failed to ensure that be adequate numbers of respiratory therapist, respiratory therapy technicians and other personnel meet the qualifications specified by the medical staff consistent with State Law, failed to complete all parts of the assessment and failed to perform re-assessments every 72 hours for R.R #1, #2, #3, #4, #5 and #6 and respiratory therapy not administer in accordance with physician orders for R.R #1, #2, #3, #4, #5 and #6.

Based on the review of personnel credential files (C.F) from the medical staff department it was determined that the facility failed to ensure that personnel are licensed in accordance with Federal and State requirements for one out of twelve personnel medical credential files (medical staff-C.F #12) and nine of twenty four respiratory therapist personnel (respiratory therapy staff - C.F.#3, #5, #6, #9, #19, #20, #21, #22 and #23).

Findings include:

1. The facility failed to ensure that one out of twelve medical staff has updated Health Certificates, Cardiopulmonary resuscitation certificates, Mal practice, Privileges, federal and state drug licenses, hepatitis vaccine and annual association (C.F #12).

2. The facility failed to ensure that nine out of twenty four respiratory therapy staff have updated Health Certificates, license, competencies, hepatitis vaccine, register, Cardiopulmonary resuscitation certificates and annual evaluation (C.F #3, #5, #6, #9, #19, #20, #21, #22 and #23).

Based on observations, review of admission package information and interview with a facility clerk, it was determined that the facility failed to promote that patients view television due to the lack of availability of a television remote control.

Findings include:

On 4/23/10 at 9:43 am a patient's relative was observed requesting from the clerk (employee #?) a remote control in order to use the television and deal with the instructions that appeared on the screen and view some channels and programming. The clerk explained to the patient's relative that they do not have a remote control available and if the patient needed a remote control they had to bring in a universal remote control while hospitalized. The patient's relative stated during an interview on 4/22/10 at 9:15 am that this information was not included in the admission package instructions and both patients in room #303 wanted to see television. On 4/23/10 at 11:49 am the physical plant manager (employee #5) was interviewed in order to know if he had a remote control to resolve the situation and he said yes and proceed to solve the situation and later left a remote control on the nurse station in order to use if necessary.

Based on observations made during the patients' rights tour with the Quality Coordinator and records reviewed (R.R), it was determined that the facility failed to ensure that patients participate in the implementation of care plans and physician recommendations of care plans for one out of thirty-one patients reviewed for patient's rights (R.R #37).

Findings include:

During the observational tour of patient's rooms on 4/22/10 at 10:45 am the patient (R.R #37) in room #312A was observed walking in her room without her cervical collar after using the bathroom. The patient sat in a chair and put the cervical collar on. The patient stated during an interview on 4/22/10 at 10:50 am that sometimes she uses it and sometimes she doesn't, it all depends on if she remembers. The patient's record was reviewed on 4/22/10 2:00 pm that the "education record note" on 4/16/10 at 3:20 pm provided evidence that the physical therapist instructed the patient to use the cervical collar during transferring, sitting and when using assistive device for ambulation. Also, the physician ordered universal precautions for falls and use of Philadelphia collar for transfer and standing, during the admission order on 4/15/10 at 5:30 pm.

Based on observations made during the patients' rights tour with the Quality Coordinator, it was determined that the facility failed to ensure that patients receive personal privacy during drug administrations and during physical therapy interventions.

Findings include:

1. During the observational tour of patient's rooms on 4/22/10 at 9:30 am the physical therapists (employee #18) was observed providing therapy to the patient in room #303A (record review (R.R) #28). The physical therapy failed to cover the patient's lower extremities during the physical therapy intervention and she failed to run the curtain completely around the patient's bed. This procedure failed to provide privacy for this patient from her roommate or personnel entering the room.

2. During the observational tour of the patient's therapy area on 4/23/10 at 11:00 am, the nurse was observed (employee #25) administering Lovenox in the abdominal area of a female patient without providing privacy. The patient was observed sitting in her wheelchair while other patients and personnel were receiving physical therapy.

Based on observations made during the patients' rights tour with the Quality Coordinator and review of incidents, it was determined that the facility failed to ensure that nursing personnel provide a safe setting related to the emotional well-being of the patient for record review (R.R) #5.

Findings include:

During the observational tour of the facility all patient's rooms were visited on 4/22/10 from 9:30 am till 12:00 noon with the Quality Coordinator (employee #3). Patient room #317 was visited on 4/22/10 at 10:00 am to obtain information related to patient's rights. Upon opening the door to the room, the patient (R.R #5) was asked if we could enter the room and before the patient's family could answer a nurse (employee #11) who was trying to draw blood from the patient said "If there are a lot of people, it is better not to enter because I get nervous and I already failed to gain access to the vein twice". Upon hearing this the door was closed and the room was not entered. The nurse (employee #11) failed to create an atmosphere of confidence for the patient to reduce the emotional stress level for the patient and to provide care in a safe setting. Upon investigating prior incidence of this nurse (employee #11) on 4/22/10 at 2:45 pm, it was found that she was interviewed on five different occasions (twice in 2008, three times in 2009) related to co-worker incidents. For the last incident on 5/25/09 she was on probation related to the findings of the investigation.

Based on the observational tour with the Quality Coordinator, six medical records reviewed and policies/procedures, it was determined that the facility failed to promote the patients' right to be free of restraints and implement restraints in the least restrictive manner for one out of six restrained patients (record reviewed (R.R) #39).

Findings include:

1. Policies and procedures were reviewed on 4/22/10 from 2:30 pm till 3:30 pm with the Quality Coordinator (employee #3), it was found that the facility's restraints policies and procedures are not followed as established:

a. R.R #39 is a 65 years old male, admitted on 4/21/10 with a diagnosis of Cerebrovascular Accident status post Craniotomy and High Blood Pressure. The patient was observed on 4/22/10 at 11:30 am resting in bed, sleeping, responds to auditive stimuli but did not speak when asked questions. The patient fell on 4/22/10 at 9:15 am after try to go to the bathroom alone. The record was reviewed on 4/22/10 at 1:30 pm and provided evidence that the physician placed orders for vail bed restriction due to the patient's disorientation, pelvic/left shoulder X-ray and neuro check every two hours. On 4/22/10 at 3:30 pm the physician placed an order to omit the vail bed restriction, change to low bed with floor mattress and one to one supervision. Physician progress notes on 4/22/10 at 9:30 am provided evidence that the patient was lying on left side without evidence of ecchymosis or edema, oriented to person but not to time or place and the patient was oriented about fall precautions. The interdisciplinary assessment on 4/21/10 at 10:30 am provided evidence that for the emotional and behavior screening that the quality of the engagement the patient is uncooperative, affect mood the patient is normal, thought content the patient is depressive, disorders of perception the patient has hallucinations, impulse control the patient is normal and judgement the patient is intact. Also for the neurologic level of consciousness the patient is alert and orientation is consistent in person. No evidence was found of the interdisciplinary plan of care and progress notes related to the evaluation of the vail bed or the low bed with floor mattress. No evidence was found of the "Restraint Assessment and Physician Order Form" for this after found lying in the bathroom. No evidence was found of the consent by family members to place the patient on restrictions. On 4/23/10 at 7:30 am the physician orders pelvic restriction when sitting but did not use the "Restraint Assessment and Physician Order Form". Also, the physician orders one to one supervisor even though the facility does not contemplate this modality.

Based on the review of twenty-one nursing credential files (C.F), it was determined that the facility failed to ensure that personnel are licensed in accordance with state and local laws related to health certificates, Cardio-pulmonary Resuscitation Certificates (CPR), 2010 Nursing association and current evaluations for eleven out of twenty-one C.Fs (C.F #3, #6,
#7, #10, #11, #12, #15, #16, #18, #19 and #20).

Findings include:

1. Twenty-one nursing credential files were reviewed with the nursing supervisor (employee #8) on 4/23/10 at 11:30 am and provided evidence of the following:

a. Eight out of twenty-one nursing credential files did not contain evidence of updated Health certificates (C.F #6, #7, #10, #15, #16, #18, #19 and #20).

b. Three out of twenty-one nursing credential files did not contain evidence of current evaluations (C.F #3, #19 and #20).

c. Two out of twenty-one nursing credential files provided evidence of expired cardio-respiratory certificates (C.F #11 (from 10/09) and #15 (from 12/09).

d. One out of twenty-one nursing credential files did not have evidence of their updated nursing association (C.Fs #12).

Based on the review of fifty-four records reviewed (R.R.), interview, policies and procedures, it was determined that the facility failed to ensure that the registered nurse assigns, supervises and evaluates nursing care furnished to patients for two out of fifty-four records reviewed (R.R #39 and #40).

Findings include:

1. One out of fifty-four records reviewed on 4/22/10 from 11:00 am till 4:00 pm and on 4/23/10 from 9:00 am till 12:00 noon (R.R #39 and #40) provided evidence that the patient did not receive treatment in accordance of their needs.

a. R.R #39 is a 65 years old male who was admitted on 4/21/10 with a diagnosis of Subarachnoid Hemorrhage status, post aneurysm clipping, cognitive deficit. During the initial tour on 4/22/10 at 9:15 am the occupational therapist (employee #25) notified that a patient fell. The nursing supervisor (employee #20) arrived to the patient's room and found the patient on the bathroom floor. The floor was observed with feces. The occupational therapist informed the nursing supervisor that the patient went alone to the bathroom and did not notify personnel for help, and he found the patient in the fetal position and sleeping on the bathroom floor. Facility personnel helped the patient to the bed, the physician evaluated the patient and requested an X-Ray.
During the record review performed on 4/22/10 at 11:00 am, the following was found: The patient was admitted on 4/21/10 at 7:30 pm according with the physician's order the patient was to be observed for neurological deterioration, Falls and requested Fall prevention. The nurse performed the interdisciplinary assessment on 4/21/10 at 10:30 pm an provided evidence that the patient was alert, consistent and oriented in person, the emotional and behavior screening that the quality of the engagement the patient is uncooperative. On the "Disorders of perception/psychotic symptom" it was identified that the patient has Hallucination, Judgment Intact Memory at short term, long term and situational was intact. The Morse Fall risk has a score of 55, the legend explain that a score above 45 was for strict fall precautions. The Bed Entrapment score was 7, the legend states that a score of 5-8 was at risk and should be incorporated into the care plan. The interdisciplinary assessment provided evidence that the patient was oriented related to room and safety program review. However, no evidence was found of the development and implementation of the plan of care for the patient according to the patient's needs. The registered nurse did not activate the plan of care for falls risk and Bed entrapment. The patient's educational interdisciplinary assessment provided evidence of the nurse's signature and date however it was not individualized for orientation given to the patient or their relative and no evidence was found related to the signature of the patient or their relative about the orientation of bed control, call bell system, bathroom call system and other pertinent orientation about the facility.
During interview with the nursing supervisor (employee #20) related to the plan of care on 4/22/10 at 11:30 am, she stated that nursing personnel have 24 hours to document the interdisciplinary assessment and activate the plan of care.
The plan of care policy and procedures were reviewed on 4/22/10 at 12:00 noon and provided evidence that the initial plan of care policy and procedure was reviewed in January of 2009 and stated that after the initial evaluation of the patient the interdisciplinary group completed the plan of care, was individualized and each problem was identified on the interdisciplinary assessment to be identified on the plan of care.
During the record review performed on 4/22/10 at 11:00 am the following was found: On 4/21/10 at 8:15 pm the physician ordered Nimotop 60 mg by mouth (PO) every 4 hrs for 8 days, Lovenox 40 mg PO daily, Protonix 40 mg PO daily, Colace 100 mg PO two times a day (BID), Multivitamin 1 tablet PO daily, Calcium Carbonate 500 mg PO every 8 hrs. According to the Medication Administration Registry (MAR) the nurse documented that on 4/22/10 at 12:00 am, at 4:00 am and at 8:00 am the Nimotop was not available, on 4/22/10 at 1:00 am Calcium Carbonate was not available. On 4/22/10 at 11:00 am the following medication was not administrated at 9:00 am nor were Lovenox, Protonix, Colace and Multivitamin. No evidence was found of the intervention of the nursing supervisor to evaluate nursing care for this patient and when appropriate on an ongoing basis in accordance with the patients' care needs and physician's orders to improve the patient's diagnosis in accordance with the patient's laboratory results.
During interview with the nursing supervisor (employee #20) related to the delay in the medication administration on 4/22/10 at 11:30 am, she stated that when a medication is not available in the facility during the 3-11 and 11-7 shifts the nurse refers it to the nursing supervisor and she requests it from another hospital, when the medications arrive at the pharmacy she returns the medications she borrowed to the other facility.
However, no evidence was found of the effort of the facility to provide the patient with the medications that were ordered in accordance with the patients' care needs and physician's orders to improve the patient's diagnosis.

b. R.R #40 is an 81 years old male who was admitted on 4/7/10 with a diagnosis of Left Tristibial Amputation, Post Left gangrene, Diabetes Mellitus, Peripheral Vascular Disease, Hypertension and Chronic Renal Insufficiency. During the record review performed on 4/22/10 at 11:45 am the following was found: On April 14, 2010 at 5:00 am a Complete Blood Count (CBC) was performed and the CBC revealed Hemoglobin (Hgb) of 8.4 grams, Hematocrit (Hct) of 25.3% and Red Blood Cells (RBC) of 3.12 Mills/UL. The physician's progress notes performed on 4/14/10 at 12:00 noon stated that the patient was found pale and fatigue, found with anemia and ordered a Type and Cross for 2 units of Package Red Blood Cells (PRBC). On 4/14/10 at 2:00 pm the patient's physician ordered Type and Cross for 2 units of PRBC and transfuse at 80 millimeter (ml)/ hour (hr) and Lasix 20 milligram (mg) Intravenous (IV) after every transfusion. The order was taken by the registered nurse (RN) at 3:00 pm. On 4/14/10 at 7:40 pm the Internal Medicine physician evaluated the patient and the progress notes stated that the patient was hemodynamically stable. On 4/14/10 at 9:00 pm the nurse's progress notes stated the blood sample for Type and Cross and requested 2 units of PRBC were taken and the next shift was notified about the medical order. On 4/15/10 at 9:45 am the physician's progress notes states that the patient is to be evaluated and to hold therapy until PRBC are transfused due to the asymptomatic anemia. However, no evidence was found in the nursing progress notes related to the efforts to transfuse the patient until 4/16/10 at 8:00 am that provide evidence in the nursing progress note and transfusion record that the patient was transfused one unit of PRBC on 4/16/10 from 8:00 am till 12:30 pm. The physician's progress notes performed on 4/16/10 at 10:00 am provided evidence that the patient was transfused one unit of PRBC for asymptomatic anemia without complications, will order a new CBC to evaluate if PRBC will be needed. Patient continues on hold therapy until Hgb reaches 10.0 grams. On 4/16/10 at 2:10 pm a CBC to be performed and revealed Hemoglobin (Hgb) of 9.7 grams, Hematocrit (Hct) of 28.6% and Red Blood Cells (RBC) of 3.62 Mills/uL. No evidence was found that of the second unit of PRBC ordered on 4/14/10 to be transfused. On 4/17/10 at 8:45 am the physician's progress notes state that the patient with improving with the Hgb level and will continue with one unit of PRBC to ensure Hgb level greater than 10 gram. On 4/17/10 at 1:00 pm the physician ordered Type and Cross for 1 unit of PRBC and transfuse at 80 millimeter (ml)/ hour (hr) and Lasix 20 milligram (mg) Intravenous (IV) after transfusion. The nurse took the order on 4/17/10 at 1:00 pm, nursing notes provided evidence that the blood sample to Type and Cross and request 1 unit of PRBC was taken to be transfused tomorrow at 8:00 am.
The transfusion record provided evidence that the patient be transfused one unit of
PRBC on 4/18/10 from 8:00 am till 12:00 noon. The physician's progress notes from 4/19/10 at 4:00 pm states that the patient's Hgb was on 10.4 grams after two PRBC transfusions. However, no evidence was found on the nurse's notes related with the reason the nurse did not transfuse the two unit of PRBC ordered on 4/14/10 when the physician ordered it. No evidence was found that the physician omitted the initial order to transfuse two units of PRBC to administer only one PRBC on 4/14/010.
During interview with the nursing supervisor (employee #20) related to the delay in the transfusion administration she stated on 4/22/10 at 1:00 pm that what happened was that the Type and Cross sample and 2 units of PRBC requested was sent to Administration of Medical Services of Puerto Rico (ASEM) and the facility does not have an agreement with them and not with the Red Cross, this is what I was told by the Red Cross when I asked about the units of PRBC requested. The administrator was notified about the Type and Cross sample to be sent to ASEM, and ASEM performed the analysis according with the payment from ASEM, the Type and Cross sample were performed but not the 2 units of PRBC. The second time that the Type and Cross sample and 2 unit of PRBC were taken they were requested by the nurse to be sent to ASEM again. The third time it was sent to the Red Cross and to transfuse one time, the physician told the nurse that according with the results of the CBC then he would transfuse. She also stated that the facility evaluated the policy and procedures related to Blood transfusion and because the transfusion process is not frequently performed at the facility, they decided to only transfuse patients during the 7-3 shift when all staff are present. The nursing supervisor also stated that the nurse involved in this case was a Per-diem nurse with many years working at the facility and she was re-oriented about the process of blood transfusion requests from the Red Cross.
During the review of policy and procedures related to blood transfusions on 4/22/10 at 3:00 pm it was found that the policy of blood and derivatives were reviewed in September of 2009 related to Blood transfusion information consent, Blood sample and blood component request, Blood Administration Protocol, Patient identification at the moment of blood transfusion, Transfusion records and hemolytic blood reaction and what to do if suspected. However, no evidence was found related to the policy of only transfusing during the 7-3 shift and not according to patient's needs. No evidence was found that an incident report was documented and no evidence was found that the Quality Assessment and Performance Improvement Program (QAPI) was notified and investigated this case to discard abuse and neglect. No evidence was found of the intervention of the nursing supervisor to evaluate nursing care for each patient and when appropriate on an ongoing basis in accordance with the patients' care needs and physician's orders to improve the patient's diagnosis in accordance with the patient's laboratory results.
The nursing supervisor (employee #20) provided evidence that an in-service related to Blood and derivatives transfusion with an objective that nursing personnel acquire knowledge about the blood transfusion protocol was on January 2010. It provided evidence related to the supervisor report performed on 4/15/10 during 7-3 shift related to this event.
During interview with the nursing director (employee #7) related to the delay in the transfusion administration and the failure to perform an incident report and she stated on 4/23/10 at 9:00 am that she knows about the case that the 7-3 shift nursing supervisor performed a report on the 7-3 report that the case was discussed with the physician and the physician determined to transfuse the second unit of PRBC after the results of the CBC. The nursing supervisor that sent the Type and Cross sample to ASEM was a Per-diem nurse that work in this facility for 9 years, that she know the process to request Blood and derivatives is through the Red Cross.

Based on the review of clinical records, interview and policies/procedures with the nursing supervisor (employee #20) and nursing director (employee #7), it was found that the facility failed to ensure that three out of fifty four records reviewed (R.R. #39, #40 and #44) have developed, updated and implemented nursing care plans.

Findings include:

1. Three out of twenty-one records reviewed for care plans development and implementation for patients according to the patient's needs with the nursing director (employee #7), provided evidence that care plans do not have written evidence of developed, updated, revisions and are implemented during the patients' hospital stay related to their needs:

a. R.R #39 is a 65 years old male who was admitted on 4/21/10 with a diagnosis of Subarachnoid Hemorrhage status, post aneurysm clipping, cognitive deficit. During the initial tour on 4/22/10 at 9:15 am the occupational therapist (employee #25) notified that a patient fell. The nursing supervisor (employee #20) arrived to the patient's room and found the patient on the bathroom floor. The floor was observed with feces. The occupational therapist informed the nursing supervisor that the patient went alone to the bathroom and did not notify personnel for help, and he found the patient in the fetal position and sleeping on the bathroom floor. Facility personnel helped the patient to the bed, the physician evaluated the patient and requested an pelvic/left shoulder X-ray and neuro check every two hours.
During the record review performed on 4/22/10 at 11:00 am, the following was found: The patient was admitted on 4/21/10 at 7:30 pm according with the physician's order the patient was to be observed for neurological deterioration, Falls and requested Fall prevention. The nurse performed the interdisciplinary assessment on 4/21/10 at 10:30 pm an provided evidence that the patient was alert, consistent and oriented in person. On the "Disorders of perception/psychotic symptom" it was identified that the patient has Hallucination, Judgment Intact Memory at short term, long term and situational was intact. The Morse Fall risk has a score of 55, the legend explain that a score above 45 was for strict fall precautions. The Bed Entrapment score was 7, the legend states that a score of 5-8 was at risk and should be incorporated into the care plan. The interdisciplinary assessment provided evidence that the patient was oriented related to room and safety program review. However, no evidence was found of the development and implementation of the plan of care for the patient according to the patient's needs. The registered nurse did not activate the plan of care for falls risk and Bed entrapment. The patient's educational interdisciplinary assessment provided evidence of the nurse's signature and date however it was not individualized for orientation given to the patient or their relative and no evidence was found related to the signature of the patient or their relative about the orientation of bed control, call bell system, bathroom call system and other pertinent orientation about the facility.
During interview with the nursing supervisor (employee #20) related to the plan of care on 4/22/10 at 11:30 am, she stated that nursing personnel have 24 hours to document the interdisciplinary assessment and activate the plan of care.
The plan of care policy and procedures were reviewed on 4/22/10 at 12:00 noon and provided evidence that the initial plan of care policy an procedure was reviewed in January of 2009 and stated that after the initial evaluation of the patient the interdisciplinary group completed the plan of care, was individualized and each problem was identified on the interdisciplinary assessment to be identified on the plan of care.

b. R.R #40 is an 81 years old male who was admitted on 4/7/10 with a diagnosis of Left Tristibial Amputation, Post Left gangrene, Diabetes Mellitus, Peripheral Vascular Disease, Hypertension and Chronic Renal Insufficiency. During the record review performed on 4/22/10 at 11:45 am the following was found: The plan of care was activated on 4/7/10 for Problems with safety concerns related to Fall risk which Score 95, problem with cardiovascular system related to Hypertension, problem with Nutritional/Hydration related to Diet, texture modification, poor intake of food and fluid, overweight, knowledge deficit about diet, fluid intake and food/drug interaction, problem with the genitourinary system related to incontinence, problem with pain/comfort, problem with integumentary system related to wound with stitches on the left stump, problem with mobility and ADL. However, no evidence was found of the weekly update of the plan of care for the patient according to the patient's needs. During interview with the nursing supervisor (employee #20) related to the plan of care on 4/22/10 at 11:30 am, she stated that the plan of care is updated every week in the interdisciplinary plan of care discussion.

c. R.R #44 is a 92 years old female who was admitted on 4/20/10 with a diagnosis of Stroke. During the record review performed on 4/23/10 at 11:00 am no evidence was found that the registered nurse developed and implemented the plan of care for the patient according to the patient's needs.

Based on documents reviewed with the nursing director (employee #7), it was determined that the facility failed to assign nursing care for patients related to patient's needs and care and failed to ensure that nursing progress notes were performed and completed for one out of fifty-four records reviewed (R.R #42).

Finding include:

1. Assignments and patient's categories were reviewed on 4/23/10 at 12:00 noon and provided evidence that they were performed. However policies/procedure reviewed on 4/23/10 at 1:00 pm provided evidence that patient's needs are classified in four Levels of care, where Level I was Complete Dependency and Level IV was Supervised independent, but the hour of service according to patient's needs, Level I is 3.5 hours and Level IV is 9.0 hours of care.

2. One out of fifty-four clinical records reviewed on 4/22/10 from 11:00 am till 4::00 pm and on 4/23/10 from 9:00 am. till 12:00 noon provided evidence that nursing progress notes were not performed for the following shifts:

a. R.R #42: on 4/17/10 for the 7-3 shift, on 4/19/10 for the 7-3 shift, for the 3-11 shift, for the 11-7 shift and on 4/20/10 for the 3-11.

Based on the records reviewed (R.R) with the clinic respiratory therapist (employee #14 ), it was determined that the facility failed to ensure that telephone orders are signed as soon as possible for two out of six records reviewed for respiratory therapies (R.R #3 and #6 ).

Findings include:

1. Evidence was found on the records reviewed on 4/ 22 /10 from 1:00 pm till 2:00 pm and of review of policies and procedures related to the timeliness of countersignatures when telephone orders are used and it states that the physician has 24 hours to countersign the telephone order.

a. R.R #3 provided evidence on 4/22/10 at 1:00 pm, that a telephone order placed on 4/19/10 (did not provide the hour when taken) to continue Decadron four milligrams every eight hours nine am., dose change to six am., and continue with five pm. and one am., dose, Novolin NPH six units subcutaneous with Decadron dose on one am, and laboratory order of BMP to wound discharge fluid, however no evidence was found that the physician countersigned the order's.

b. R.R #6 provided evidence on 4/22/10 at 1:30 pm, of a telephone order placed on 4/11/10 at 7:45 pm. to administer Protonix 40 mgs. p.o. per one dose, administer Tigan 100 milliliters intramuscular per one dose, however no evidence was found that the physician countersigned the order. A second order on 4/18/10 at 3:30 pm. provided evidence of a telephone order placed to discontinue Coumadin, administer ten (10 mgs.) of Coumadin today, administer seven (7) mgs. of Coumadin tomorrow at ( 5 ) five pm and continue with the same dose, however no evidence was found that the physician countersigned the order.

Based on the observational tour, records reviewed (R.R), interview and review of policies and procedures with the Nursing Director (employee #7), it was determine that the facility failed to ensure that one of one records reviewed for blood transfusions is transfused according with the physician's order (R.R #40).

Findings include:

1. R.R #40 is an 81 years old male who was admitted on 4/7/10 with a diagnosis of Left Tristibial Amputation, Post Left gangrene, Diabetes Mellitus, Peripheral Vascular Disease, Hypertension and Chronic Renal Insufficiency. During the record review performed on 4/22/10 at 11:45 am the following was found: On April 14, 2010 at 5:00 am a Complete Blood Count (CBC) was performed and the CBC revealed Hemoglobin (Hgb) of 8.4 grams, Hematocrit (Hct) of 25.3% and Red Blood Cells (RBC) of 3.12 Mills/UL. The physician's progress notes performed on 4/14/10 at 12:00 noon stated that the patient was found pale and fatigue, found with anemia and ordered a Type and Cross for 2 units of Package Red Blood Cells (PRBC). On 4/14/10 at 2:00 pm the patient's physician ordered Type and Cross for 2 units of PRBC and transfuse at 80 millimeter (ml)/ hour (hr) and Lasix 20 milligram (mg) Intravenous (IV) after every transfusion. The order was taken by the registered nurse (RN) at 3:00 pm. On 4/14/10 at 7:40 pm the Internal Medicine physician evaluated the patient and the progress notes stated that the patient was hemodynamically stable. On 4/14/10 at 9:00 pm the nurse's progress notes stated the blood sample for Type and Cross and requested 2 units of PRBC were taken and the next shift was notified about the medical order. On 4/15/10 at 9:45 am the physician's progress notes states that the patient is to be evaluated and to hold therapy until PRBC are transfused due to the asymptomatic anemia. However, no evidence was found in the nursing progress notes related to the efforts to transfuse the patient until 4/16/10 at 8:00 am that provide evidence in the nursing progress note and transfusion record that the patient was transfused one unit of PRBC on 4/16/10 from 8:00 am till 12:30 pm. The physician's progress notes performed on 4/16/10 at 10:00 am provided evidence that the patient was transfused one unit of PRBC for asymptomatic anemia without complications, will order a new CBC to evaluate if PRBC will be needed. Patient continues on hold therapy until Hgb reaches 10.0 grams. On 4/16/10 at 2:10 pm a CBC to be performed and revealed Hemoglobin (Hgb) of 9.7 grams, Hematocrit (Hct) of 28.6% and Red Blood Cells (RBC) of 3.62 Mills/uL. No evidence was found that of the second unit of PRBC ordered on 4/14/10 to be transfused. On 4/17/10 at 8:45 am the physician's progress notes state that the patient with improving with the Hgb level and will continue with one unit of PRBC to ensure Hgb level greater than 10 gram. On 4/17/10 at 1:00 pm the physician ordered Type and Cross for 1 unit of PRBC and transfuse at 80 millimeter (ml)/ hour (hr) and Lasix 20 milligram (mg) Intravenous (IV) after transfusion. The nurse took the order on 4/17/10 at 1:00 pm, nursing notes provided evidence that the blood sample to Type and Cross and request 1 unit of PRBC was taken to be transfused tomorrow at 8:00 am.
The transfusion record provided evidence that the patient be transfused one unit of
PRBC on 4/18/10 from 8:00 am till 12:00 noon. The physician's progress notes from 4/19/10 at 4:00 pm states that the patient's Hgb was on 10.4 grams after two PRBC transfusions. However, no evidence was found on the nurse's notes related with the reason the nurse did not transfuse the two unit of PRBC ordered on 4/14/10 when the physician ordered it. No evidence was found that the physician omitted the initial order to transfuse two units of PRBC to administer only one PRBC on 4/14/010.

During interview with the nursing supervisor (employee #20) related to the delay in the transfusion administration she stated on 4/22/10 at 1:00 pm that what happened was that the Type and Cross sample and 2 units of PRBC requested was sent to Administration of Medical Services of Puerto Rico (ASEM) and the facility does not have an agreement with them and not with the Red Cross, this is what I was told by the Red Cross when I asked about the units of PRBC requested. The administrator was notified about the Type and Cross sample to be sent to ASEM, and ASEM performed the analysis according with the payment from ASEM, the Type and Cross sample were performed but not the 2 units of PRBC. The second time that the Type and Cross sample and 2 unit of PRBC were taken they were requested by the nurse to be sent to ASEM again. The third time it was sent to the Red Cross and to transfuse one time, the physician told the nurse that according with the results of the CBC then he would transfuse. She also stated that the facility evaluated the policy and procedures related to Blood transfusion and because the transfusion process is not frequently performed at the facility, they decided to only transfuse patients during the 7-3 shift when all staff are present. The nursing supervisor also stated that the nurse involved in this case was a Per-diem nurse with many years working at the facility and she was re-oriented about the process of blood transfusion requests from the Red Cross.

2. During the review of policy and procedures related to blood transfusions on 4/22/10 at 3:00 pm it was found that the policy of blood and derivatives were reviewed in September of 2009 related to Blood transfusion information consent, Blood sample and blood component request, Blood Administration Protocol, Patient identification at the moment of blood transfusion, Transfusion records and hemolytic blood reaction and what to do if suspected. However, no evidence was found related to the policy of only transfusing during the 7-3 shift and not according to patient's needs. No evidence was found that an incident report was documented and no evidence was found that the Quality Assessment and Performance Improvement Program (QAPI) was notified and investigated this case to discard abuse and neglect. No evidence was found of the intervention of the nursing supervisor to evaluate nursing care for each patient and when appropriate on an ongoing basis in accordance with the patients' care needs and physician's orders to improve the patient's diagnosis in accordance with the patient's laboratory results.

The nursing supervisor (employee #20) provided evidence that an in-service related to Blood and derivatives transfusion with an objective that nursing personnel acquire knowledge about the blood transfusion protocol was on January 2010. it provided evidence related to the supervisor report performed on 4/15/10 during 7-3 shift related to this event.

During interview with the nursing director (employee #7) related to the delay in the transfusion administration and the failure to perform an incident report and she stated on 4/23/10 at 9:00 am that she knows about the case that the 7-3 shift nursing supervisor performed a report on the 7-3 report that the case was discussed with the physician and the physician determined to transfuse the second unit of PRBC after the results of the CBC. The nursing supervisor that sent the Type and Cross sample to ASEM was a Per-diem nurse that work in this facility for 9 years, that she know the process to request Blood and derivatives is through the Red Cross.

Based on six close and active patient's records reviewed (R.R) for respiratory service and facility policies/procedure, it was determined that the facility failed to ensure that orders for drugs and biological are documented and signed by a practitioner who is authorized to write orders by hospital policy and in accordance with nursing standards of practice for one out of six records reviewed (R.R #3).

Findings include:

1. One out of six records reviewed for respiratory therapy from 4/22/10 through 4/24/10 from 8:30 am till 3:30 pm (R.R #3) provided evidence that the register nurse did not signed the orders.

a. R.R #3 provided evidence that a physician placed an order to start the patient on diabetic regular diet of 1800 kilocalories with low sodium and low fat ( 2:2:1:2:1) on 4/22/10 at 10:00 (the order do not indicate am or pm ) however no evidence was found that the register nurse signed the order prescribed by the physician.

Based on documents reviewed with the Nursing Director (employee #7) and the medical record supervisor (employee #19), it was determined that the facility failed to ensure that nursing progress notes and nursing history are performed and completed for two out of fifty- four records reviewed (R.R #42, #48 and #51), and four out of fifty-four medical records failed to have completed all information needed in the medication administration record (MAR) (R.R #45, #46, #47, #52) and one out of fifty-four medical records failed to have complete physician histories related to the lack of medication used by the patient (R.R #50).

Findings include:

1. Two out of fifty-four clinical records reviewed on 4/22/10 from 11:00 am till 4:00 pm and on 4/23/10 from 9:00 am till 12:00 noon provided evidence that nurse's progress notes were not performed for the following shifts:

a. R.R #42: on 4/17/10 for the 7-3 shift, on 4/19/10 for the 7-3 shift, for the 3-11 shift, for the 11-7 shift and on 4/20/10 for the 3-11.

b. R.R #51: on 1/29/10 for the 7-3 shift and for the 3-11 shift.

2. One out of fifty-four clinical records reviewed on 4/23/10 from 2:30 pm till 5:00 pm provided evidence that nurses did not perform the nursing history for R.R #48.

3. Four out of fifty-four clinical records reviewed on 4/23/10 from 2:30 pm till 5:00 pm provided evidence that nurses failed to complete all information needed in the medication administration record (MAR) related to the patient's age, weight, sex, allergies and record number for R.R #45, #46, #47, #52.

4. One out of fifty-four clinical records reviewed on 4/23/10 from 2:30 pm till 5:00 pm provided evidence that physician histories lack the medications used by the patient for
R.R #50.

Based on the review of policies/procedures and interview with the pharmacist, it was determined that the facility failed to operationalize procedures to ensure food and drug interactions interventions, adverse reactions surveillance and report, patients who self administer drugs are not evaluated for the need of the drugs, availability of medications that patients had ordered when the pharmacy is not open, reconciliation and review of patient's drug regimen in order to ensure the therapeutic appropriateness of patient's medications regimen and local wound care items were supplied to patients without the supervision of pharmacy services for record reviews (R.R) #1, #5, #13, #26, #27 and #39.

Findings include:

1. A mechanism to ensure the intervention with patients who need food and drug interaction counseling was not followed, nor operationalized as reviewed on 4/22/10 at 10:00 am.

2. A mechanism to ensure medication adverse reactions surveillance and reported in order to promote patient safety through the appropriate control and distribution of medications, medication-related devices and biologicals was not performed as reviewed on 4/22/10 at 10:10 am.

3. A patient at room 314A (R.R#13) was using Timolol 6.8 mgs/ml ophthalmic solution in both eyes two times a day for Glaucoma as observed on 4/22/10 at 2:34 pm, a patient in room 316 B (R.R 34 ) was using Visine ophthalmic drops as needed (PRN) for eyes redness as observed on 4/23/10 at 9:03 am. No evidence was found in the patient's records review on 4/23/10 at 11:00 am of the physician's order for the use of these drugs and to keep them at bedside and no evaluation was found by the interdisciplinary team for the use of these drugs.

4. R.R #39 is a male patient admitted on 4/21/10 with a diagnosis of Subarachnoid hemorrhage. This patient was ordered Nimotop 60 mgs every 4 hours for 8 days.
The patient was admitted to the facility at 8:15 pm. This medication was not available at the facility medication drug stock. Accordingly with information provided by the pharmacist (employee #6) on 4/22/10 at 2:47 pm if a patient is admitted during the night or between the hours where the pharmacy is not open the nurse needs to borrow the medications from another hospital. However for this case there was no evidence that the medications were solicited to another hospital and the patient did not receive three doses of the medication.

5. Five out of nine records reviewed (R.R #1, #5, #13, #26 and #27) lacked the reconciliation and review of patient drug regimen during admission in order to ensure the therapeutic appropriateness of the patient's medication and as required by facility policies and procedures as reviewed on 4/22/10 at 3:00 pm.

6. In five out of five rooms visited (302A, 304A, 305A, 313A and 316B) on 4/22/10 at 3:19 pm during the observational tour, it was identified that Extra protective cream skin protectant and dermal wound cleanser in spray bottles were used by patients located in these rooms. None of the these patients had this products ordered by the physician. The pharmacist (employee #6) stated during an interview on 4/23/10 at 9:14 am that those products are delivered to all patient admitted to the facility. However no evidence was found in the patient's records on 4/23/10 at 11:33 am of the physician's order for the use of these drugs and to ensure that the patients are used the products according with the manufactures use and indications.

Based on observations of the medication storage room with the Pharmacist, 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:

A plastic container with respiratory therapy medication was observed located at the nursing station in front of the medication storage room on 4/22/10 from 8:55 am. This container does not have a lock, is mobile and readily portable and was observed on 4/22/10 from 8:55 am till 4:15 pm. The container has approximately 30 doses of 3 ml Albuterol and Ipratropium Bromide 0.02 %.

Based on the observational tour of the facility's kitchen that prepares the patient's meals (contracted service), review of menus, policies/procedures and interview, it was determined that the facility failed to store, maintain and prepare food in a safe and sanitary manner related to prepared foods found in the refrigerator on trays without dates when prepared, prepared foods that were not properly wrapped, failure to wash hands after touching contaminated trash with gloves, dented cans and inappropriate freezer temperatures.

Findings include:

1. The following was found during the observational tour of the contracted kitchen service for the hospital on 4/23/10 from 8:30 am till 10:45 am:

a. The ice maker machine was observed on 4/23/10 at 8:30 am and provided evidence that the ice scoop was placed in a metal rack expose to the environment and does not drain to ensure that water does not accumulate within the open rack.

b. One tray with eighteen pre-served cups of orange juice to be serve for the lunch meal was found on 4/23/10 at 8:45 am in a refrigerator without a label indicating when each individual cup was prepared or a label on the tray.

c. Two trays with sea food were observed on 4/23/10 at 8:55 am without a label with the
date prepared and were not covered completely with plastic wrap in freezer #2.

d. In freezer #2 on 4/23/10 at 9:00 am a rack of pork ribs was found on the bottom shelf wrapped in plastic, but the plastic wrap was broken.

e. On 4/23/10 at 9:15 am a food preparer (employee #21) was observed at the vegetable table preparing vegetables. Employee #21 had on a pair of gloves and went to discard trash in the trash container and pushed the trash in the container with his gloves making contact with trash. Employee #21 then change his gloves, but did not wash his hands, put on a new pair of gloves and then from a large cooking container filled with spaghetti, he placed it into a tray for serving.

f. In the dry food storage area within the kitchen, multiple cans were observed on 4/23/10 at 9::30 am dented such as: four cans of fruits cocktail (104 ounces each), five cans of pineapple (104 ounces each) and four cans of pears (104 ounces each).

g. The three compartment sink was observed on 4/23/10 at 9:40 am during the dish washing process. The first compartment was observed with water and soap to wash pots, pans and utensils, the second compartment had dirty utensils with left over food and the third compartment was observed with sanitizing solution. The dish washer (employee #22) stated during an interview on 4/23/10 at 9:45 am that he washes the pots, pans and utensils in the first compartment, rinses in the second sink and then he dunks them in the sanitizing water and then puts them on the shelves to dry. He also stated that he scrapes off the excess food into the second sink because he does not have space to scrape it into a garbage container and when he finishes with the washing process he throws out the left over food from the second sink and cleans it. He was asked if he knew if the sanitizing solution was at the appropriate concentration and he stated on 4/23/10 at 9:45 am that he did not prepare the solution because another employee prepared it. No evidence was found on 4/23/10 at 9:50 am of the registration log book with the previous tests strips related to the appropriate concentration of the third sink.

2. Freezers #1 and #2 were visited on 4/23/10 at 9:40 am and 9:50 am and provided evidence that the thermometer was registering 10 ºF. Review of the registration log provided evidence from the 1st till the 23rd of April 2010 the temperature of freezer #1 did not go below 5ºF during the morning test. For freezer #2 from the 1st till the 23rd of April 2010 eighteen of these days registered temperatures above 5ºF during the morning test. According to the food code for the proper handling of food, it states that freezer temperatures should be at 0º or below to ensure food safety for potentially hazardous foods.

Based on tests performed on equipment and observations made during the survey for the physical environment with the facility's Physical Plant Manager, it was determined that the physical structure and care areas failed to ensure that door closers are adjusted to allow patients to pass through door openings safely and the water temperature at patient's rooms is too hot for patient's safety.

Findings include:

1. The smoke barrier doors located near patient's room #317 and the smoke barrier doors of the physical therapy department were released from their hold open devices on 4/22/10 at 10:00 am with the Physical Plant Manager (employee #5) and they closed too fast (approximately one to two seconds) which could harm a patient passing through these doors if the fire alarm is activated and the doors are released. According with "Americans with Disabilities Act" section 4.13.10 (Door Closers) door closers should be adjusted so that from an open position of 70 degrees, the door will take at least 3 seconds to move to a point 3 inches from the latch.

2. Patient's sleeping room doors at #302 and #310 were opened and released on 4/22/10 at 9:00 am and 9:50 am with the Physical Plant Manager (employee #5) and they closed too fast (approximately one to two seconds) which could harm a patient passing through these doors once opened. According with "Americans with Disabilities Act" section 4.13.10 (Door Closers) door closers should be adjusted so that from an open position of 70 degrees, the door will take at least 3 seconds to move to a point 3 inches from the latch.

3. During the observational tour on 4/22/10 from 9:00 am till 11:45 am, temperature readings were taken at patient's hand sinks with the Physical Plant Manager (employee #5). It was found that the temperatures at hand sinks in patient's rooms reached a temperature of 118ºF. According with the Guidelines for Design and Construction of Health Care Facilities water temperature should range between 95ºF and 110ºF. After the water temperature is adjusted, the facility shall monitor water temperatures to ensure that it is maintained within the required range for patient's comfort and safety.

Based on tests to equipment and observations made during the survey for Life Safety from fire with the facility's Physical Plant Manager (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 4/22/10 through 4/23/10 from 8:30 am till 3:30 pm; for deficiencies related to Life Safety from fire (form 2786R) please see tags with letter K on the 2567 form (K0017, K0018, K0025, K0046, K0048, K0050, K0051, K0064, K0069, K0072, K0076, K0130 and K0147).

Based on tests and observations made during the survey for the physical environment with the facility's Physical Plant Manager, 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 mops placed leaning up against walls (mop heads up and the poles down), paper dispensers are not appropriately designed, sharp containers are not located to reduce accidents, medication cart and dirty linen hamper were found in patient's rooms, an exercise mat had a crack and the biohazardous trash room does not have appropriate containers.

Findings include:

1. The off-site contracted kitchen was visited on 4/23/10 at 8:30 am and the housekeeping closet was found with the mops leaning up against the wall (mop heads up and the poles down) with the Physical Plant Manager (employee #5). 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. On 4/23/10 at 9:15 am, employee #23 was observed mopping the floor in front of the refrigerators and then at 9:50 am this employee was observed emptying patient's food trays from the automatic food tray cleaner. A mop hanger is needed to allow mops to dry properly and to avoid contaminating the mop pole.

2. Paper dispensers were found throughout the facility (patient's rooms, staff area, patient care areas and bathrooms) on 4/22/10 from 8:45 am till 3:45 pm with the Physical Plant Manager (employee #5). The paper dispensers are not appropriate related to infection control standards due to the user needing to reach into the dispenser to roll out the paper. This reaching in causes the paper to be touched, wet or contaminated for the next user.

3. Sharp containers located in patient's rooms were observed on 4/22/10 from 8:45 am till 3:45 pm with the Physical Plant Manager (employee #5). The placement of these sharp containers does not allow for patient's safety due to the close proximity to the patient's heads. The sharp containers are located on the same back wall where the head boards of the patient's beds are located.

4. During the observational tour of patient's sleeping room #317 with the Physical Plant Manager (employee #5) on 4/22/10 at 10:45 am provided evidence that a medication cart was left in this room. Also a dirty linen hamper was found in patient's room #313 on 4/22/10 at 10:20 am with the Physical Plant Manager (employee #5). Equipment and supplies used on various patients and transported throughout the facility shall not enter patient's rooms to reduce the risk of cross contamination.

5. The biohazardous trash storage room was visited on 4/22/10 at 11:20 am with the Physical Plant Manager (employee #5). The room was found with four open trash containers and loose biohazardous trash in the containers. The containers did not have plastic bag liners and lids. In order to avoid and minimize contact for personnel in this room and to reduce the risk of cross contamination, biohazardous trash from patient care areas shall be placed in containers that are lined with plastic bags and covered with lids.

6. The therapy gym was visited with the Physical Plant Manager (employee #5) on 4/22/10 at 2:35 pm and provided evidence that it has two exercise bed mats. The exercise mat closest to the door was found with a crack and tape was placed over it, which does not allow for proper cleaning between patients.

7. The dirty pots and trays cleaning room of the off-site contracted kitchen was visited on 4/23/10 at 9:40 am with the Physical Plant Manager (employee #5) and provided evidence that the back door was held open by a large trash container which could allow pests to enter from the hallway.

Based on tests performed on equipment and observations made during the survey for the physical environment with the facility's Physical Plant Manager, it was determined that this facility's physical structure is not designed to provide protection of patients and staff related to the lack of floors sinks and the therapy gym did not have privacy screens.

Findings include:

1. Maintenance closets located throughout the facility were observed with the Physical Plant Manager (employee #5) on 4/22/10 from 8:35 am till 3:30 pm and provided evidence that these closets do not have a floor sink (they have high flush sinks) to facilitate filling and emptying of mop pails to ensure that staff do not hurt themselves when emptying their pails.

2. The therapy gym was visited with the Physical Plant Manager (employee #5) on 4/22/10 at 2:35 pm and provided evidence that it has two exercise bed mats. A female patient was found at the back mat and a male patient was found at the mat nearest the front door. The male patient was lying on the mat and exercising, however there was no privacy curtain between the mats and the patients in this room can also be seen from the hallway when exercising.

Based on the observational tour with the Infection Control Officer, review of policies and procedures, it was determined that the facility failed to provide standards for infection control related to the medication cart inside patient's rooms and respiratory therapy kits did not have information labels.

Findings include:
During the observational tour with the Infection Control Officer (employee #1), on 4/22/10 from 8:30 am till 4:00 pm of patient's rooms, waste storage area, supply area and clean utility room, the following was found:

1. In the corridor, observations on 4/22/10 at 10:20 am were made during the initial tour and provided evidence that :

a. In the corridor outside room #312 was observed a cleaning cart with a coat hanger, a balloon and a bag belonging to the cleaning lady.
b. A maintenance cart was observed in the hallway in front of patient's room #303 and #312 unattended and with cleaning solutions on the top of the cart accessible to non authorized persons (Fullsan, Sani-Cloth, Spray Away and B-way).
c. Housekeeping employee carrying dirty sheets through the corridors on 4/22/10 at 1:49 pm.

2. In patient's rooms, the following were observed on 4/22/10 at 11:00 am:

a. In room #312 the housekeeping cart was observed in the patient's room.
b. In room #313 a container with of regular garbage was found with gloves and blue pads.
c. In room #317 the medication cart was found in the patient's room.
d. In room #304B the patient's nasal cannula was found hanging from the oxygen inlet meter exposed to the environment.
e. In room #304A one bottle of sterile water for irrigation was observed open. The manufacturer's instructions states to discard unused portions.
f. In room #303B respiratory therapy kits in plastic bags without labels with the date and hour when started.
g. In room #302 a container of regular garbage was found with gloves and blue pads.

3. In the biohazardous waste storage area the following was observed on 4/22/10 from 11:50 am till 11:50 am:

a. Four container of biohazardous trash were found without garbage without plastic bags or lids.

4. In the general storage area the following was observed on 4/22/10 from 1:00 pm:

a. One cart with clean linen not covered in protective plastic covers and were exposed to the environment. The cart is used to transport clean sheets does not close completely. This procedure does not ensure that patients receive clean linen and does not protect patients from cross contamination due to the location of the linen and being unprotected.

5. In the clean utility room the following was observed on 4/22/10 from 1:20 pm:

a. The storage area used as the clean utility room with material was observed with two shelves with material: pampers, anti-embolism elastic stockings, sterile gauze sponge, bandage, alcohol prep pad, wound care tray and sterile water for irrigation. In the same place in the back part gives access to a sliding door where two machines are stored for transfusions, five sphygmomanometers, eight machines of nutrition enteral feeding, six vacuum meters, one machine for suction, three IV stands and a one mattress.

6. All sharp containers were observed on 4/22/10 from 9:00 am till 2:00 pm without labels with the assigned hospital's identification number and the facility's name to ensure responsibility related to its contents, protection and disposition.

7. No evidence was found on 4/22/10 at 2:15 pm of the daily registration of cleaning and disinfecting of the patient refrigerator in the lunch area.

8. The storage area used for clean utilities and materials was observed 4/22/10 from 2:40 pm, with eight enteral feeding machines without plastic covers, not labeled with the date and hour when disinfected which were located near the sterile materials.

9. The ice machine was observed on 4/22/10 from 3:05 pm, located in the lunch area of the hospital used for employees and patients was not working. The Infection Control Officer (employee #1), provided evidence of policies/procedures that states that housekeeping personnel are to provide the daily cleaning, however no evidence was provided of the ice machine daily cleaning. In January the only cleaning was on 25, 26, 27, 30 (4 out of 31 days). In February 1, 7, 8, 9, 12, 16, 19, 20, 22, 24, 28 (10 out of 28 days). In March 2, 4, 6, 7, 8, 14, 16, 19, 23, 30 (10 out of 31 days). April 7, 11,12, 21 (4 out of 22 days).

10. In the employee lounge area on 4/22/10 at 3:25 pm, the freezer was used to store six large bags of bought ice for patients, two of these bags were broken. The Infection Control Officer stated during an interview on 4/22/10 at 3:30 pm, that employees must place an ice pack in small foam cooler and use it to deliver ice to patients. This procedure does not ensure that patients are protected from cross contamination from the foam cooler or the manner in which the ice bags were found opened.

11. In the area of the therapy gym a mattress was found broken and with tape on 4/22/10 at 3:40 pm.

Based on medical record director reviewed (R.R) for respiratory care services, policies/procedures and interviews it was determined that the facility failed to ensure that
the respiratory therapy director serves on a part-time basis, the time spent directing the department should be appropriate to the scope and complexity of services provided.

Findings include:

1. The credential file #12 of respiratory medical director was review on 4/23/10 at 2:45 pm and provided evidence that did not maintain updated credentials of Health Certification, Hepatitis vaccine, Mal practice, Cardio respiratory certification (CPR), Narcotic and Federal license, privileges and annual association.

2. During interview with the respiratory therapy department general supervisor (employee #13) on 4/22/10 at 3:20 pm. related to the medical director she stated '' the medical director of respiratory therapy department is an anesthesiology and is the same director of respiratory therapy of ASSEM he occasionally visits this hospital.''

3. During the review of logs for incident reports 4/22/10 at 3:20 pm of patients related to medication errors, documentation problems, delay on patients respiratory treatments, absent on patient respiratory treatments and other situations of the respiratory therapy department the respiratory therapy director (employee # 13) did not provided evidence of documentation and no evidence that the medical director participate on respiratory therapy meetings. The respiratory therapy department did not established a mechanisms to communicate the respiratory therapy problems to the medical director to provided and respond to the respiratory care needs of the patient population being served.

Based on six medical records reviewed (R.R) for respiratory care services, policies/procedures, respiratory therapists staffing pattern and interviews, it was determined that the facility failed to ensure that be adequate numbers of respiratory therapist, respiratory therapy technicians and other personnel who meet the qualifications specified by the medical staff consistent with State Law and to provide respiratory therapy for six out of six patients, records reviewed R.R #1, #2, #3, #4, #5 and #6.

Findings include:

1. During interview with the respiratory therapy department general supervisor ( employee #13) on 4/22/10 at 3:20 pm, she stated '' the therapy department provides respiratory services at the four Hospitals of Medical Center including Health South Rehabilitation Hospital, Universitary Hospital, Industrial Hospital, ASSEM and covers all emergencies in the emergency rooms of the four hospitals. Currently the respiratory department has sixty respiratory therapist, one therapist was assigned on shift 7 -3 to cover the patients at HealthSouth Rehabilitation Hospital if this therapist has only two patients she covers the surgery department, but if she has three or more she only covers Health South Rehabilitation Hospital. There are three patient's shifts at Health South Hospital (7:00 am till 3:00 pm, 3:00 pm till 11:00 pm and 11:00 pm till 7:00 am). Additional functions of the therapist during their shift includes documentation, verify medical orders, patient and family education, pulse oxymetry before treatments, performed the arterial blood gases, evaluation of respiratory patient conditions and other functions related to the respiratory department. Due to this situation, patients are affected because they did not receive their treatment on time in accordance with physician orders or patient may not receive their treatment or the department does not comply with infection control measures and others problems related to staff pattern. A study was conducted related to all problems of the respiratory department and it showed that we need another twenty one therapists to cover patients respiratory needs and complete the respiratory pattern.'' Related to the respiratory therapy physician director she stated: the physician director has an agreement with the rehabilitation hospital and he respond directly at the administration personnel.''

2. During the review of six medical records on 4/22/10 from 9:00 am till 3:30 pm and on 4/23/10 from 8:30 am till 2:30 pm it was determined that the facility failed to perform patient ' s assessments at the moment that respiratory treatment was performed and failed to complete all parts of the assessment and failed to perform re-assessments every 72 hours for R.R #1, #2, #3, #4, #5 and #6.

3. Six medical records were reviewed on 4/22/10 from 9:00 am till 2:30 pm and on 4/23/10 from 9:00 am till 11:30 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 #6. Records reviewed provided evidence that patients did not receive respiratory treatment on a timely basis (some received treatment two hours before the scheduled time and other received treatment from twenty four hours up to twenty six hours after the scheduled establish treatment hours).

Based on the observational tour, six medical records reviewed (R.R), interview and review of policies and procedures with the respiratory therapist clinic supervisor it was determined that the facility failed to ensure that services are provided in accordance with acceptable standards of practice related to appropriate measures of disinfecting, the appropriate solutions used to perform equipments disinfecting, the respiratory medication exposed and without security lock, failed to ensure that services are delivered in accordance with medical staff directives related to performing and completing patient's assessments and patient's are oriented about receiving respiratory care according to facility policies and procedures for six out of six medical records reviewed (R.R #1, #2, #3, #4, #5 and #6 ).

Findings include:

1. During the review of six medical records and reviewed of policies and procedures on 4/22/10 from 9:00 am till 3:30 pm and 4/23/10 from 8:30 am till 3:30 pm the following was found:

a. The area where respiratory therapy personnel clean and disinfect respiratory therapy materials and used mechanical ventilator was observed a plastic bag with contain a single dose saline solution used to provide traqueostomy care with ventilator patients, this bag was observed under the stainless steel sink used to perform materials disinfecting and mechanical ventilators disinfecting. The stainless steel sink was observed dirty with black spots in the corner and under the sink.

b. The floor area was observed on 4/23/10 at 3:10 pm. with black spots and dirty.

c. A blue plastic tray with contain a solution without an identification label and lacks the date when prepared the solution, the hour, the name of the solution and the signature of the person who prepared this solution was observed in the top of the stainless steel sink.

On interview with clinic respiratory assistant(employee #16) on 4/23/10 at 3:15 pm he stated: The name of this solution was EmPower is an dual enzymatic detergent and used to disinfected the equipments used on the ventilators and then carry at sterile area. He stated this product was provided per operating room department.''

d. During the review of MSDS (Material Safety Data Sheep) on 4/23/10 at 3:30 pm. with the respiratory director ( employee #13) no evidence was found of this product used on the facility.

2. During the observational tour with the clinic respiratory therapy supervisor ( employee # 14) on 4/22/10 at 2:40 pm to review the respiratory medication stock it was observed an opened multiple dose bottle with contain 20 mililiters of Albuterol Sulfate Inhalation Solution 0.5% with expiration date on September of 2011 (the bottle lacks of identification label and lack of the date when opened, the hour and the person who opened ), one bottle of Albuterol, two packages of Atrovent 0.5 mgs, one package of Albuterol with countain 30 vials per package and (3) vials without covered, two packages of Pulmicort 0.25 mgs / 2 ml. and one package of five vials of Pulmicort 0.5 mgs. / 2ml. All of respiratory medications were observed in the interior of a plastic box in the nurse station exposed and without security lock.

3. Saline solution of 3 ml. arterial blood gases kits, ventury mask and power nebulizer were observed in the interior of nurse station shelve without security lock on 4/23/10 at 3:35 pm.

4. Interview with the respiratory therapist clinic supervisor ( employee #14 ) on 4/22/10 at 2:40 pm provided evidence that respiratory therapy personnel perform and fill out the patient's assessments ( respiratory addendum ) for all patients that are admitted to the ward and then the therapist placed on patient record a ''reminder respiratory therapy label'' to be re-evaluated every 72 hours from the initial treatment and the physician is to re-evaluate and re-order the patient every 72 hours however if the physician did not performed the documentation on the label the therapy service was discontinue automatically by the therapist.''

5. During the review of the quality assurance program performed by the respiratory therapy director ( employee #13 ) on 4/22/10 at 3:20 pm provided evidence that during the year of 2009 quality vigilance plan only included adequacy in documentation of treatment with power nebulizers. The vigilance was performed in January from March, April from June, July from September and October from December of 2009. The respiratory therapy director (employee # 13) did not perform the quality vigilance plan for 2010. Evidence was found during medical record review that respiratory therapy personnel failed to provide respiratory therapy in accordance with patient's needs and the physician's order for R.R #1 through #6.

6. The facility's policies and procedures were reviewed on 4/23/10 at 1:00 pm and provided evidence that they develop individualized assessment for every patient who is admitted and respiratory treatment is ordered. Respiratory assessments are performed when the patients begin with the service. Respiratory therapists perform initial assessment where they determine and indicate what are the patients' needs or what respiratory problems exist. According with the needs identified of the patients provided respiratory modalities. Respiratory therapists are performing assessment on initial treatment and performed a respiratory notes when the respiratory treatment is administered, however the respiratory therapy department lack of a form to evaluated the patient every 72 hours that they are receiving treatment to verify and identified if the patient improved, is stable, has gotten worse and to recommend new treatment to the physician and nurse in charge of the patient. The form did not provide patients and family education and no reflected if the patient or families are involved to determine the best plan according with their needs and patient's rights after they are oriented related to this matter. The form did not provide space to assess and oriented the patient and family when the patient needs arterial blood gases.

7. During the review of six medical records on 4/22/10 from 9:00 am till 3:30 pm and on 4/23/10 from 8:30 am till 2:30 pm it was determined that the facility failed to perform patient ' s assessments at the moment that respiratory treatment was performed and failed to complete all parts of the assessment and failed to perform re-assessments every 72 hours for R.R #1, #2, #3, #4, #5 and #6.



a. R.R #1, the patient assessment was performed per respiratory therapist on 4/19/10 (did not provided the hour when performed). The assessment lacks laboratory values, diagnostic exams, history of smoking, exposure (environmental) and disease process. The form did not provide to evaluate respiratory rate, oxygen saturation and heart rate. No evidence of the re-assessment at 72 hours and no evidence was found that the patient and family was oriented.

b. R.R #2, the patient was started on respiratory therapy on 4/22/09 (did not provided the hour when was performed) and lacks the patient's laboratory values and diagnostic exams. The form did not provide to evaluate respiratory rate, oxygen saturation and heart rate. No evidence of the re-assessment at 72 hours and no evidence was found that the patient and family was oriented.

c. R.R #3, the patient assessment was performed by the respiratory therapist on 4/11/10
(did not provided the hour when was performed ) and lacks the patient's laboratory values and diagnostic exams. The form did not provide to evaluate respiratory rate, oxygen saturation and heart rate. No evidence of the re-assessment at 72 hours and no evidence was found that the patient and family was oriented.

d. R.R #4, the patient was admitted on 12/18/09 and physician ordered respiratory therapy on 12/19/09 at 4:05 pm. the initial assessment was performed on 12/19/09 at 10:00 pm. started on respiratory therapy on 12/19/09 at 10:00 pm. and lacks the patient's pulmonary diagnosis and condition, laboratory values and diagnostic exams. The form did not provide to evaluate respiratory rate, oxygen saturation and heart rate. No evidence of the re-assessment at 72 hours and no evidence was found that the patient and family was oriented.

e. R.R #5, the patient was admitted on 4/19/10, the initial assessment was performed on 4/22/10 (did not provided the hour when was performed) and started on respiratory therapy on 4/22/10 and lacks of laboratory values and diagnostic exams. The first respiratory therapy was provided on 4/22/10 at 12:40 pm. The form did not provide to evaluate respiratory rate, oxygen saturation, heart rate, treatment at home and the last treatment. No evidence of the re-assessment at 72 hours and no evidence was found that the patient and family was oriented.

f. R.R #6, the patient was admitted 3/29/10 at 9:00 pm. and the physician ordered respiratory treatments on admission. The initial assessment was performed on 4/1/10 ( did not provided the hour when was performed ) and lacks of laboratory values, diagnostic exams and history of smoking, exposure and disease process. The patient started on respiratory therapy on 4/01/10 at 2:25 am treatment at home and the last treatment. The form did not provide to evaluate respiratory rate, oxygen saturation, heart rate, treatment at home and the last treatment. No evidence of the re-assessment at 72 hours and no evidence was found that the patient and family was oriented.

Based on six medical records reviewed (R.R) for respiratory care services, policies/procedures, respiratory therapists staffing pattern and interviews, it was determined that the facility failed to ensure that be adequate numbers of respiratory therapist, respiratory therapy technicians and other personnel who meet the qualifications specified by the medical staff consistent with State Law, for eight of twelve credential files reviewed. ( C.F. #12, #17, #18, #21, #31, #32, #33 and #34 ).

Findings include:

1. Twelve credentials files of medical staff and twenty four respiratory therapy staff credentials files were reviewed on 4/23/10 from 2:45 pm till 3:30 pm and provided evidence that respiratory therapy staff did not maintain updated the credentials files.

a. Credential file #12 did not provided evidence of health certification, hepatitis vaccine, malpractice assurance, cardio respiratory certification (CPR), narcotic and federal license, privileges and annual association.

b. Credential file #17 did not have updated health certification expired on April 5, 2010.

c. Credential file #18 did not have evidence of respiratory therapy license.

d. Credential file #21 did not have evidence of competencies related to her functions of clinic assistant.

e. Credentials files #31 and #33 did not have evidence of hepatitis vaccine.

f. Credential file #32 did not have evidence of health certification expired date on March/31/10.

g. Credential file #34 did not have evidence of health certification expired date on October/2009.

h. Credential file #35 did not have updated Health Certificates, registration, hepatitis vaccine, Cardiopulmonary resuscitation certificates, job descriptions and annual evaluation.

Based on six medical records reviewed (R.R) for respiratory care services, policies/procedures and interviews, 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 out of six clinical records reviewed (R.R #1, #2, #3, #4, #5 and #6).

Findings include:

Six medical records were reviewed on 4/23/10 from 9:00 am till 2:30 pm and on 4/24/10 from 9:00 am till 11:30 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 #6. Records reviewed provided evidence that patients did not receive respiratory treatment on a timely basis (some received treatment two hours before the scheduled time and other received treatment from twenty four hours up to twenty six hours after the scheduled establish treatment hours).

1. R.R #1 is a 78 years old female admitted on 4/19/10 at 11:48 am with a diagnosis of Cardiovascular Accident and secondary diagnosis of Right hemipharesis. The record review was performed on 4/23/10 at 9:00 am and provided evidence that the physician ordered Albuterol 2.5 mgs. / 3 ml. with Normal Saline (N/SS) by power nebulizer (PN) every 6 hours on 4/19/10 at 5:00 pm. The nurse takes the order on 4/19/10 at 10:30 pm. (ten hours and thirty minutes later than the physician order) and notifies the respiratory therapy department to provide respiratory therapy on 4/19/10 at 10:30 pm. Respiratory therapy was provided to the patient on 4/19/10 at 10:30 pm ( ten hours and 30 minutes later then the physician's order). The next treatments were provided on 4/20/10 at 3:45 am. (one hour and twenty five minutes before), at 8:00 am ( one hour and forty five minutes before ), at 1:40 pm. ( twenty minutes before), at 7:30 pm. (ten minutes later ), on 4/21/10 at 1:20 am. ( ten minutes before), at 8:35 am. ( one hour and fifteen minutes later), at 2:15 pm. (twenty minutes later), at 8:00 pm. (fifteen minutes before), on 4/22/10 at 2:10 am. (ten minutes later) and at 8:45 am. (thirty five minutes later). The therapeutic objective of respiratory therapy label form was not performed by the physician on 4/19/10. No evidence was found when the physician re-evaluated the patient's needs to determine to continue or discontinue the patient respiratory therapies. The therapy department lack of a therapist notification treatment form to included the patient name, respiratory therapy treatment ordered by the physician, date and hour of the notification. The nurse department establishes that the nurse notifies the respiratory therapy department to provide the treatment and has a form to documented the patient name, date and hour of notification however the treatment form provided evidence that the nurse did not notified the first treatment accordance to patient needs and physician ordered. The record reveals that the patient did not received the respiratory therapy treatments in accordance with the physicians' orders and patient ' s respiratory needs. The interdisciplinary respiratory assessment form (respiratory addendum) lack information related to history of smoking, exposure to environmental and disease process.

2. R.R #2 is an 85 years old female admitted on 4/22/10 with a diagnosis of Right Femoral Fracture and secondary diagnosis of Pulmonary Fibrosis. The record review was performed on 4/23/10 at 8:10 am and provided evidence that the physician ordered by telephone order on 4/22/10 at 11:50 am, respiratory therapy with Albuterol 2.5 in 3 ml. with N/SS every 6 hours by PN and administered oxygen by nasal cannula at 40 % and arterial blood gases (ABG ' s) to be taken by therapist. The therapist progress notes revealed that the first therapy was administered on 4/22/10 at 10:30 pm. (three hours and forty five minutes later) not in accordance with patient needs and physician order. The initial respiratory addendum was performed on 4/22/10 (did not provided the hour when it was performed) and revealed that the ABG's was performed on shift 3-11 pm. (did not provided the hour when performed) and reveled that treatment, the modalities and the goals. On 4/23/10 at 1:00 am the physician orders added Pulmicort 0.5 mgs. by PN every twelve hours because he received a nurse call at 11:30 am. and revealed that the patient presented difficulty breathing and a CO2 of 49 was reported on the ABG's. The respiratory therapy of pulmicort 0.5 mgs by PN was provided to the patient on 4/23/10 at 2:25 am (one hour and 25 minutes later than the physician's order). The next treatment of Albuterol 2.5 mgs in 3 ml. of N/SS .9% was provided on 4/23/10 at 5:10 am (one hour before). The therapeutic objectives of respiratory therapy label form was performed by the physician on 4/23/10 but lacks the patient name, room, name of physician, kind of therapy and hour when performed.

3. R.R #3 is a 66 years old female admitted on 4/10/10 at 12:10 pm. with a diagnosis of Brain Tumor. The record review was performed on 4/23/10 at 12:02 pm and provided evidence that the physician ordered respiratory therapy with Proventyl 2.5 in 3 ml. of N/SS every 6 hours by PN on 4/10/10 at 12:00 pm. The nurse takes the order on 4/10/10 at 12:40 pm. (forty four minutes later than the physician order). No evidence of the signature when the therapist takes the order. The therapeutic objective of the respiratory therapy label form was not performed by the physician on 4/10/10. The nurse department establishes that the nurse notifies the respiratory therapy department to provide the treatment and has a form to documented the patient name, record number, date and hour when the physician ordered the treatment, the nurse who takes the order, date and hour the respiratory therapy department was notified, who notifies, the name of the person who notify to the respiratory therapy department, date and hour when the therapies are indicated and comments. The respiratory therapy register form provided evidence that the nurse notified at therapy department on 4/10/10 at 5:24 pm. however, the first treatment was provided to patient on 4/11/10 at 2:30 am. (nine hours and forty four minutes later not in accordance to patient needs and physician order ). The next therapy treatment was not provided by the therapist at 2:30 pm. the therapy was provided on 4/11/10 at 6:00 pm. (twelve hours and thirty minutes later). On 4/12/10 at 1:20 am. (one hour and twenty minutes later), at 8:20 am.( one hour and twenty minutes later), at 2:35 pm., at 7:55 pm., on 4/13/10 at 12:30 am. (one hour and twenty five minutes before ), at 7:10 am. (ten minutes later) at 1:20 pm. and at 8:20 pm. ( one hour later). On 4/13/10 a re-evaluation respiratory therapy label was placed by the therapy department however the physician re-orders on 4/14/10 at 3:40 pm. Pulmicort 2.5 mgs. every 6 hours by PN and the nurse takes the order at 5:30 pm. ( one hour and fifty minutes later) and the respiratory therapist takes the order on 4/15/10 at 6:30 am. On 4/14/10 at 7:20 am. Albuterol 0.5 mgs in 3 ml. of .9% N/SS was administered by the therapist (eleven hours and twenty minutes later). On 4/15/10 at 6:30 am. the therapist notes revealed that the respiratory therapist did not administer respiratory therapy of Pulmicort 2.5 mgs by PN every 6 hours because the physician order dose is incorrect, the therapist notified the nurse to inform the physician to change the dose. On 4/15/10 at 7:25 am., at 12:50 pm. and 7:10 pm. Pulmicort 0.25 mgs. in 3 ml. of .9% of N/SS was administered by the respiratory therapist. On 4/16/10 at 3:30 am. the patient received Albuterol 2.5 mgs. in 3 ml. of N/SS by the respiratory therapist ( two hours and twenty five minutes later) and at 7:30 am., at 2:00 pm. the patient did not received the therapy because she performed study, however the respiratory therapy was administered at 3:30 pm., the patient did not received the next therapy at 9:30 pm. and no evidence was found on the respiratory therapist progress notes the reason of the omission. On 4/16/10 a physician re-ordered Proventyl 2.5 mgs. in 3 ml. of N/SS.9% by PN every 6 hours ( the order lack of the hour when the physician write the order) the nurse takes the order at 6:45 pm. and the therapist takes the order on 4/17/10 at 7:10 pm.( twelve hours and twenty five minutes later than the physician ordered ). On 4/17/10 at 2:35 am. ( eleven hours and five minutes later ) the patient received the respiratory therapy, at 7:10 am. ( one hour and twenty five minutes before ), at 2:45 pm. ( one hour and thrity five minutes later ), at 7:40 pm. ( one hour and five minutes before),
On 4/18/10 at 12:00 am. (ten minutes later), at 7:00 am. (one hour later). On 4/19/10 at 1:15 am. the respiratory therapy was administered and a re-minder respiratory therapy label for physician to re-evaluated the patient respiratory therapy was placed, the re-order was performed by the physician on 4/21/10 at 10:00 am. to administer Albuterol 2.5 mgs. /3 ml. of N/SS by PN every 12 hours, the nurse takes the order at 1:00 pm. (three hours later) and no evidence was found when the respiratory therapist takes the re-evaluation order. The record revealed that the patient did not receive respiratory treatment therapies in accordance with physician orders and his respiratory needs. 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.

4. R.R #4 is a 62 years old male admitted on 12/18/09 with a diagnosis of Ischemic Stroke. The record review was performed on 4/23/10 at 10:30 am and provided evidence that the physician orders respiratory therapy with Albuterol 0.3 mgs./3 ml of NSS by PN every 8 hours on 12/19/09 at 4:05 pm. to provide the patient with respiratory treatment. The order was taken by the nurse at 4:30 pm and then takes by the respiratory therapist at 10:00 pm. ( ten hours later than the physician ordered). The record review provided evidence that the therapeutic objectives of respiratory therapy label did not performed by the physician. notified the first treatment on 4/16/08 at 10:00 am, The respiratory addemdum was performed by the therapist on 12/19/09 at 10:00 pm. and the first treatment was on 12/19/09 at 10:00 pm. On 12/20/09 at 8:10 am. ( 2 hours and 10 minutes later ), at 6:15 pm. ( administered 2 hours and 5 minutes later). On 12/21/09 at 2:00 am., at 8:00 am. (administered 2 hours before) and at 4:05 pm. A reminder respiratory therapy label was placed by therapist to physician re-evaluated the patient respiratory needs and re-ordered therapies on 12/21/09 at 4:05 pm. The physician re-ordered the patient treatments of Albuterol 0.3 mgs. /3 ml. N/SS by PN every 8 hours on 12/22/09 at 3:00 pm., the nurse takes the order on 12/22/10 at 3:00 pm. and notified at respiratory therapist at 4:00 pm.( one hour later ) and no evidence when the therapist taken the order. The patient received the respiratory therapy treatments on 12/22/09 at 12:00 am., at 8:00 am. and at 4:00 pm. On 12/23/09 at 1:20 am. ( one hour and twenty minutes later). The physician order was re-evaluated on 12/24/09 at 12:00 pm. to discontinue Albuterol therapy and start in Albuterol 0.3 ml. in 3 ml. of N/SS by PN every 12 hours. the nurse takes the order at 12:42 pm. and the respiratory therapist taken the order on 12/26/09 at 7:20 pm. ( 2 days than the physician ordered the treatment ). On 12/28/09 at 7:07 pm. a reminder respiratory therapy label was placed, the physician order to re-evaluated the respiratory therapies was written on 12/28/09 at 7:00 pm. taken by the nurse at 7:00 pm. and notify at respiratory therapy department at 7:30 pm. ( 30 minutes later). On 12/31/09 a reminder respiratory therapy label was placed (did not performed the hour ) to the physician re-evaluated the respiratory therapies, the order was written on 12/31/09 at 11:50 am. taken by the nurse at 12:50 pm. ( one hour later ) and notify at respiratory therapy department at 2:00 pm. ( one hour and 10 minutes later). On 1/03/10 a reminder respiratory therapy label was placed (did not performed the hour ) to the physician re-evaluated the respiratory therapies, a telephone order for Albuterol 0.3 mgs. in 3 ml. of N/SS every 12 hours was ordered by physician and signed 0n 1/04/10 at 10:00 pm. taken by the respiratory therapist at 12:50 pm. ( one hour later ) and notified at respiratory therapy department at 2:00 pm. ( one hour and 10 minutes later). However, during the record reviewed on 4/23/10 at 10:30 am. the respiratory progress notes revealed that the last respiratory treatment was administered to the patient on 12/23/09 at1:20 pm. The record revealed that the patient did not receive the respiratory treatment therapies in accordance with physician orders and his respiratory needs. Respiratory therapy department policies/procedures establishes that respiratory treatments are to be provided in accordance with physician orders and the therapist is to re-evaluate the patient every 72 hours if the patient present respiratory changes or the physician changes the patients' treatment. No evidence was found of the patients' re-evaluation by the therapist related to the patients' respiratory needs in accordance with policies/procedures.

5. R.R #5 is a 16 years old male admitted on 4/19/10 with a diagnosis of Phyladelphy Chromosome Positive. The record review was performed on 4/23/10 at 8:45 am and provided evidence that the physician orders respiratory therapy with Albuterol 0.083% by power nebulizer 4 times daily and arterial blood gases (ABG's) on 4/22/10 at 11:45 am. The order lack of nurse signature and taken by the respiratory therapist on 4/22/10 at 11:55 am. The record review provided evidence that the patient respiratory addendum was performed on 4/22/10 however the form did not provide the hour when the therapist performed the addendum. The ABG's was performed on 4/22/10 at 12:40 pm. and the received the first treatment on at 12:50 pm (one hour and 5 minutes later after the physician ordered it). The patient received the next respiratory therapy treatments on 4/22/10 at 7:00 pm. (2 hours and 10 minutes later), on 4/23/10 at 1:40 am. (one hour and forty minutes later ) and at 7:55 am. (2 hours and 10 minutes later). No evidence was found of the patients ' re-evaluation by the therapist for his respiratory needs in accordance with policies/procedures related to the arterial blood gases result.

6. R.R # is a 71 years old female admitted on 3/29/10 at 9:00 pm with a diagnosis of Bronchial Asthma, Obesity and complicated with pneumonia. The record review was performed on 4/23/10 at 9:40 am and provided evidence that the physician ordered respiratory therapy with Albuterol 0.83 mgs. by power nebulizer every 6 hours on 3/29/10 at 9:00 pm. The order was taken by the nurse on 3/29/10 at 10:00 pm and no evidence when the respiratory therapy department took the order. The patient respiratory addendum was performed by the respiratory therapist on April 1/2010 (three days later when the physician ordered it) and no evidence of the hour when performed. The first therapeutic respiratory therapy was given on 4/1/10 at 2:25 am. (three days later than the physician ordered it ), at 7:30 am. (1 hour and 25 minutes before) and at 11:20 pm. (sixty hours later). On 4/2/10 at 1:00 am a reminder respiratory therapy label was performed by the respiratory therapist to re-evaluated the therapy treatments by the physician, the new order of Albuterol 0.083 % by PN every 8 hours was performed by the physician on 4/2/10 at 7:00 pm. The order was taken by the nurse on 4/3//10 at 1:20 am. (6 hours and 20 minutes later than the physician ordered it) and no evidence when the therapist took the order. On 4/2/10 was given at 1:20 am. (2 hours before) and at 7:50 pm. (thirty five minutes later). On 4/3/10 was given at 1:30 am., at 7:15 am. and at 4:00 pm ( 2 hours and forty five minutes later ). On 4/4/10 was given at 12:00 am. (2 hours later), at 7:15 am. ( 1 hour and fifteen minutes later), at 4:30 pm. ( 3 hours and fifteen minutes later ), the next therapy was given on 4/4/10 however it did not provide the hour when the therapist gave the therapy, the next therapies were given on 4/5/10 at 7:40 am. and at 6:50 pm. ( 5 hours and 10 minutes later ). On 4/5/10 a reminder respiratory therapy label was performed by the respiratory therapist to re-evaluated the therapy treatments by the physician the label lack of hour, the new order of Albuterol 0.083 % by PN three times daily was performed by the physician on 4/5/10 at 1:30 pm., taken by the nurse at 2:00 pm. ( 30 minutes later) and notify at therapist at 6:50 pm. ( 4 hours and fifty minutes later). On 4/6/10, 4/7/10, 4/12/10 and 4/15/10 the patient was re-evaluated by the physician and continue with Albuterl 0.083 % by PN tid, however the treatments were administered by the therapist not in accordance with the physician orders and patient needs. On 4/16/10 at 5:00 pm the physician reevaluated the patient and Albuterol 0.083 % by PN two times daily was ordered however the respiratory progress notes revealed that the last therapy was administered on 4/15/10 at 7:30 pm. The therapist treatment notes provide evidence that respiratory treatments were performed but not in accordance with physician orders. 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 department general supervisor ( employee #13) on 4/22/10 at 3:20 pm, she stated '' the therapy department provides respiratory services at the four Hospitals of Medical Center including Health South Rehabilitation Hospital, Universitary Hospital, Industrial Hospital, ASSEM and covers all emergencies in the emergency rooms of the four hospitals. Currently the respiratory department has sixty respiratory therapist, one therapist was assigned on shift 7 -3 to cover the patients at HealthSouth Rehabilitation Hospital if this therapist has only two patients she coveres the surgery department, but if she has three or more she only covers Health South Rehabilitation Hospital. There are three patient's shifts at Health South Hospital (7:00 am till 3:00 pm, 3:00 pm till 11:00 pm and 11:00 pm till 7:00 am). Additional functions of the therapist during their shift includes documentation, verify medical orders, patient and family education, pulse oximetry before treatments, performed the arterial blood gases, evaluation of respiratory patient conditions and other functions related to the respiratory department. Due to this situation, patients are affected because they did not receive their treatment on time in accordance with physician orders or patient may not receive their treatment or the department does not comply with infection control measures and others problems related to staff pattern. A study was conducted related to all problems of the respiratory department and it showed that we need another twenty one therapists to cover patients respiratory needs and complete the respiratory pattern.''

8. During interview with the executive director (employee #17) on 4/24/10 at 3:00 pm. related to the respiratory therapy department, he stated: '' the respiratory department covers all patients of the Hospitals and HealthSouth Rehabilitation Hospital, however the therapy department has an agreement and they have to comply with all patients needs.'' He stated that rehabilitation for his patients is very important and it is a priority and that he has implemented a plan that will provide all patients with good care which includes respiratory needs " .

9. During interview with the nursing supervisor (employee #20) on 4/22/10 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 not designated a person to review the patient's records related to this service. Quality is performed by the respiratory therapy supervisor (employee #13) and she includes it into the hospital's samples, but it was not individualized per unit and did not identify the problem " .

10. During interview with the respiratory therapist ( employee #15) on 4/23/10 at 11:05 am related to his respiratory therapy functions on the rehabilitation unit, she stated: '' the respiratory department covers all patients of the Hospitals and HealthSouth Rehabilitation Hospital, I ' m assigned to covered this unit on shift 7:00 am. till 3:00 pm., however today I have five patients in this unit to provided respiratory care ( rooms 302 A and B, 303 B, 310 and 317) and additional I covered general surgery department and I have seven patients to provide respiratory care today on rooms 302 B, 304, 306 B, 317, 321 B, 322 B and 323 B. It's difficult for me because the patients did not received the treatments on time, because the patient who has a traqueostomy needs more time approximately thirty minutes to provide the care. I try to comply with all patients.''

10. During interview with the respiratory therapist ( employee #26) on 4/23/10 at 2:55 pm related to his respiratory therapy functions on the rehabilitation unit, he stated: '' I received the nurses call, then I go to the rehabilitation department and verify the physician order and then identified the record with a respiratory label to indicating the patient therapy. I indicated the therapy and included the patient and family orientation.''

11. During interview with the respiratory therapist clinic supervisor ( employee #14) on 4/23/10 at 1:20 pm related to her respiratory therapy functions on the rehabilitation unit and the delay on patients treatments she stated: '' the patients did not received the respiratory therapies on time because on the 11:00 pm. till 7:00 am shift the nurse is the responsible to open the door, this door has a button system to open, if the therapist touch the button and the nurse is not available because she is providing patient care on a patient room, the therapist '' has to wait for the nurse to open the door, this problem affected the patients because it delays the treatment and it is not received on time.''

Based on the review of patient's incidents and accidents reports with the Facility's Quality Improvement Officer and records reviewed (R.R), it was determined that the facility failed to identify opportunities for improvement and changes that will lead to improvement in cases that involved falls during their stay at the facility (R.R #14, #31, #32 and #33).

Findings include:

1. Review of 37 out of 37 incident reports of patients with falls (from June 2009 through march 10) on 4/22/10 from 10:00 am/pm till 1:00 pm provided evidence that patients who experienced falls were identified as candidates for the fall prevention protocols and mechanisms established by the facility. However no evidence was found for these cases of the review of the fall prevention protocol after the incidents of the falls in order to identify the need of the additional preventive measures to avoid future falls.

2. A mechanism to ensure that after a first fall, a patient does not fall again was not promoted nor followed. In two out of 37 incidents of falls reviewed on 4/22/10 at 10:47 am with the quality assurance officer (employee #3), it was identified that after a first fall the facility did not established safety measures in order to prevent future falls.

a. R.R #14 is a 53 year old male patient admitted to the facility on 1/15/10 with a diagnosis of Traumatic Brain Injury as reviewed on 4/22/10 from 10:30 am till 11:00 am. This patient was found on the floor on 2/13/10 at 11:40 am by nursing staff. The patient was identified as a risk for falls during admission and was ordered to use vail bed restriction in order to avoid falls. However the patient fell to the floor despite being on vail bed restriction on 2/25/10 at 2:30 am, the patient was found on the floor despite being on vail bed restriction. Review of this incident on 4/22/10 from 10:45 am till 1:00 pm provided evidenced that after the incident the facility did not take measures in order to ensure that an incident like this does not happen again. No evidence was found of documentation by the facility regarding the investigation of the circumstances where the incident occurred or how the patient using a vail bed restriction fell down to the floor. Facility's efforts to remove or modify risk factors and underlying causal factors were not evidenced. No investigation of the circumstances where the patient fell down was found during review of the incident on 4/21/10 at 11:55 am.

b. R.R #33 is an 81 year old male admitted to the facility on 12/21/09 with a diagnosis of Stroke as reviewed on 4/22/10 from 10:50 am till 11:55 am. The patient fell down while he was transferring himself from the bed to the wheelchair on 1/1/10 at 3:55 pm according with the incident report information as reviewed on 4/22/10 from 11:00 am till 11:50 am. No evidence was found of documentation by the facility regarding the investigation of the circumstances where the incident occurred in order to educate the patient in the transfer process. On 1/3/10 at 5:00 pm the patient fell down again while he was manipulating his dinner tray at his room. Investigation of the circumstances where the second fall occurred in order to identify risk factors and underlying causal factors were not documented.

3. In two out of 37 incidents of falls reviewed on 4/22/10 at 10:47 am with the quality assurance officer (employee #3), it was identified that after a fall the physician ordered to use a vail bed as the first choice measure in order to prevent future falls for two patients who fell when they were ambulating in the facility's hallway or walking to the bathroom.

a. R.R #32 is a 39 years old male admitted to the facility on 10/1/09 with a diagnosis of Left Ischemic Stroke as reviewed on 4/22/10 from 10:00 am till 10:30 am. This patient fell down in the hallway near his room on 10/1/10 at 8:30 pm according with the incident reports reviewed on 4/22/10 at 11:30 am. After the fall the physician ordered vail bed restriction for the patient in order to prevent future falls even though the patient fell while ambulating with a relative. The facility failed to explore other measures in order to improve patient fall prevention measures in addition to the vail bed restriction measure.

b. R.R #31 is a 63 years old male admitted to the facility on 12/8/09 with a diagnosis of Brain Ischemic Stroke as reviewed on 4/22/10 from 11:20 am till 11:34 am. This patient fell while he was ambulating to the bathroom on 12/19/09 at 1:25 am. After the fall the physician ordered vail bed restriction for the patient in order to prevent future falls even though the patient fell while ambulating to the bathroom. The facility failed to explore other measures in order to improve patient fall prevention measures in addition to the vail bed restriction measure.

Based on observations of the medication drug cart with the nursing supervisor (employee #20), it was determined that the facility failed to ensure that drugs and biologicals are stored and protected in a proper manner related to medications not secured in the medication cart.

Findings include:

1. During the observational tour on 4/22/10 at 9:40 am and on 4/23/010 at 9:00 am with the nursing supervisor (employee #20), the medication cart was observed unattended while the nurse was in patient's rooms.

a. The medication cart was observed unlocked and unattended while a nurse administered medications to the patient in room #415 at 9:40 am, during interview with the nursing supervisor (employee #20), she stated that the medication cart has a lock and the key was broken and that she was waiting for it to be repaired. On 4/23/10 at 9:00 am the medication cart was observed unlocked and unattended, during interview with the medication nurse (employee #4) on 4/23/10 at 9:00 am related to if the cart has a key to lock the cart during the time she is inside patient's rooms and she stated that the medication cart has a key, she tried to close it and it was difficult until she finally locked the medication cart and took the key with her.