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Based on record reviews, interviews, and reviews of policies and procedures, it was determined the hospital does not have an effective governing body legally responsible for the conduct of the hospital as an institution as it relates to Condition of Participation for Infection Control at A-0747.

This condition of participation is not met based on the facility failure to ensure that infection control measures are being enforced as it pertains to their policy and procedures, to ensure patient's are free from harmful microorganisms in the preparation of food, failure to ensure appropriate sanitary procedures were followed in treating patients receiving dialysis services, failure to ensure the environment of the dialysis treatment room is maintained in a sanitary manner, failure to ensure linens are handled in a sanitary manner, and failure to maintain a sanitary decontamination room in the Emergency Department.

The findings include:

1. During the initial tour of the kitchen on 9/13/10 at 10:00 a.m. the following was observed: Observation of the dry store room revealed an air vent located in the ceiling above food products that had a large accumulation of dust and dirt on the metal vent slots. Further observation revealed a Food Service Worker (FSW) preparing sliced tomatoes on a plate. FSW was observed with a bandage on her left forearm. After surveyor intervention the employee was removed from food preparation area. After being examined by the Occupational Health Department they determined the FSW had an open area that was covered by the bandaged and at that point the FSW was removed from her assignment of preparing food.

The tour of food service continued on the patient floors where the following was observed: The 3rd floor nourishment room sink was incased by a cabinet. The side of the cabinet had unidentified caked on brown substance on the right side. The 2nd floor nourishment room labeled #1 had a free standing ice machine that was observed to have an accumulation of what appeared to be a calcium build up and corrosion of the nozzle as well as the drain grates. This observation was also observed in the #2 nourishment room on the same floor.

Observation during tray line on 9/14/10 at 11:00 a.m. revealed the following: Observation of 2 male chefs with baseball caps on their head without fully covering their hair. Further observation revealed a male chef who had a full long beard that was not restrained. The chef was observed preparing food. Observation at 11:10 a.m. of the female chef on the tray line with a cap on top of her head, but observed with thick long bangs on her forehead. Further observation of FSW with a hair net hang off a pony tail, and her hair totally exposed.

Review of the facility's policy and procedures in regards to hair restraints reveals the following: "Wear appropriate hair restraints when on duty. Appropriate restraints include: hairnet, uniform cap, and disposable bonnet. Hair must either be short enough or restrained in such manner as to not touch the uniform collar. All hair must be covered or restrained to protect potential contamination of food or food handling equipment."
"Facial hair must be kept neatly trimmed. Beard should not be more than ? " inch."

2. Upon entering the dialysis treatment room on 9/13/10 at 10:45 a.m. the 2 nurses who were administering dialysis to a patient were observed not to be wearing any protective covering. The one nurse was asked by the surveyor for a protective cover so that the surveyor could enter the treatment room, the nurse replied it wasn't necessary, because the patient is off the machine. Upon observing the patient it was evident the patient in fact was attached to the dialysis machine, and was receiving dialysis. Further observation of the room revealed the area where the Reverse Osmosis (RO) portable machine (RO is a process of purifying water for the use and treatment of dialysis patients) is kept, was a converted bathroom. The RO was observed to be running. The gray water from the RO and the drains from the dialysis machine were rigged to drain in what was once a shower stall. Observation of the tubing from the RO was on the floor of the shower stall, and adjacent to the tubing was a black/brown unidentified substance. Observation of the shower stall also revealed the walls and ceiling were visibly dirty. On the grab bars in the shower stall were numerous pieces of tubing that were not in use. The gray water was draining into the shower. On the base/floor of the shower were 3 rows a clear tubing. On the other side of the wall, pipes were observed to be exposed and the tile around the pipes was missing, leaving the surfaces of the wall bare. Noted were numerous other pieces of tubing that were hung over the exposed pipes.

Further observation of the dialysis treatment room revealed an area surrounding the floor near and under the garbage cans with a thick layer of a brown/ rust color unidentifiable substance on the floor.

A follow-up visit to the dialysis treatment room on 9/15/10 at 1:00 p.m. revealed the base board behind the dialysis treatment chairs was in disrepair and was observed to have numerous areas were the sheet rock was crumbling exposing the wall down to the mesh support. Further observation revealed a film like residue on the monitor control screen of the dialysis machines and the floor underneath and surrounding the scale that weighs patient was observed to be rusty and dirty. The scale had a large amount of white residue on the rubber base. Observation of the floor revealed a lot of black residue in the corners. The general condition of the floor appeared to be dirty with numerous areas of scuff marks. When the Nurse Director was question on how often the room is cleaned and who cleans the room, she said housekeeping cleans the room daily even if the room is not in use.

On 09/15/10 at 9:11 a.m. during an observation in the Intensive Care Unit (ICU) of a patient during dialysis treatment the following occurred: Two ICU nurses entered the room without donning any Protective Covering (PC) (which is a requirement during a patient being treated on dialysis). The nurses proceeded to work with the patient leaning over the patient, changing his gown, and fixing the patient's bed linen. Neither nurse was observed washing or sanitizing their hands before they treated the patient, or when the nurses left the room. On the same day at 9:40 a.m. an (Echo Cardiogram) EKG tech entered the same room and proceeded to administer an EKG on the patient without washing or sanitizing the leads of the machine, before proceeding with hooking the patient up to the machine. Furthermore the technician was not observed donning any PC before entering the room, or administering direct care to the patient. When the tech was asked why she did not use PC when working with the patient she replied I don't have to use PC the patient is not in isolation. After the technician completed the EKG she was observed removing the leads, but was not observed washing or sanitizing her hands and did not sanitize the leads of the EKG machine.

Review of the facility's policies and procedures as it pertains to Infection Prevention of Cardio-Pulmonary states the follow: Standard precautions include the following; Hand washing: "Hands are to be washed after touching blood, body, fluids, secretions, excretions, or other contaminated items, whether or not gloves are worn. Hands must be washed immediately after removal of gloves, between any patient contact and when otherwise indicated. This will prevent transmission of microorganisms. To prevent cross contamination of different body sites on the same patient, it may be necessary to wash hands between tasks, and procedures."

On 09/16/10 at 11:05 a.m. a meeting was held with the Administrator and Director of Nursing (DON) in regards to infection control issues in dialysis treatment room, as well as ICU. The DON said the cardiac/pulmonary policies and procedures do speak specifically to cleaning of the leads (EKG Machine) as well as hand sanitation.

Based on record reviews, credentialing files, and interview, it was determined the facility credentialing committee failed to ensure the medical staff examined the credentials for physicians performing surgery using the Makoplasty robotic arm and failed to recommended approval to extend and expand their membership/privileges for their category of practitioner.

The findings include:

Review of orthopedic patient surgery records from May 2010 to September 2010 revealed two orthopedic surgeons were performing partial knee replacement surgery using the Makoplasty robotic knee system procedure. The credentialing files for these two surgeons were requested and reviewed. The facility submitted a letter from the Chairman, Credentials Committee and Chief of Staff with the following notation: "Please be advised the Mako robot arm for single compartment knee replacement is an extension of orthopedic privileges." Review of these files revealed there was no documented evidence in the physicians' files to indicate the medical staff examined the credentials and recommended approval to extend and expand their membership/privileges to include this Makoplasty robotic knee system procedure.

Interview on 9/15/10 at 3:45 p.m. with the Chief Executive Officer, Chief Nursing Officer, and Medical Staff Services liaison reported no credentialing for this procedure had been conducted and confirmed this finding.

Based on interview and clinical record review, the facility failed to ensure medical records contained all necessary information.

The findings Include:

Review of the closed clinical record for Patient #2 revealed orders, but no results for:
1. Basic metabolic panel which was drawn on 6/19/10 at 2:27 p.m.,
2. Complete blood count drawn on 6/19/10 at 2:27 p.m.,
3. Portable chest x-ray done 6/19/10
4. A regular chest x-ray done again 6/19/10 later in the evening,
5. Cardiac enzymes drawn at 2:27 p.m.
6. All a.m. lab work collected on 6/20/10

On 9/14/10 at 10:31 a.m. the Director of the Medical Records Department confirmed the information was missing from the closed record. On 09/14/10 at 11:20 a.m. the Director of the Medical Records Department submitted the missing results and placed them in the clinical record.

Based on review of closed clinical records, the facility failed to assure all discharged patient records contained discharge summaries that were complete and authenticated in a timely manner. For delegated discharge summaries the MD/DO responsible for the patient during his/her hospital stay failed to co-authenticate and date the discharge summary to verify its content.


The findings include:

1. During review of a closed medical record on 9/14/10, the following information was found.

Patient # 31, an 86 year old patient was admitted to the facility on 8/3/10 with arthritis of the left knee and underwent a left knee Mako arthroplasty procedure. The patient was discharged on 8/5/10. The clinical record revealed a delegated discharge summary dated 8/5/10 dictated by the physician's assistant. The physician responsible for the patient during the hospital stay failed to co-authenticate and date the discharge summary to verify its content. The closed medical record was presented to the surveyor earlier in the day by facility staff as a final and complete record.

2. During review of a closed medical record on 9/14/10, the following information was found.

Patient # 32, a 76 year old patient was admitted to the facility on 8/3/10 with osteoarthritis of the right knee and underwent a right knee Mako arthroplasty procedure. The patient was discharged on 8/5/10. The clinical record review failed to include a discharge summary to indicate the outcome of hospitalization, the disposition of the patient and provisions for follow-up care. The closed medical record was presented to the surveyor earlier in the day by facility staff as a final and complete record.

3. During review of a closed medical record on 9/15/10, the following information was found.

Patient # 35, a 68 year old patient was admitted to the facility on 7/28/10 with osteoarthritis of the left knee and underwent a left knee Mako arthroplasty procedure. The patient was discharged on 7/31/10. The clinical record review failed to include a discharge summary to indicate the outcome of hospitalization, the disposition of the patient and provisions for follow-up care. The closed medical record was presented to the surveyor earlier in the day by facility staff as a final and complete record.

4. During review of a closed medical record on 9/15/10, the following information was found.

Patient # 33, a 72 year old patient was admitted to the facility on 8/11/10 with osteoarthritis of the left knee and underwent a left knee Mako arthroplasty procedure. The patient was discharged on 8/14/10. The clinical record review failed to include a discharge summary to indicate the outcome of hospitalization, the disposition of the patient and provisions for follow-up care. The closed medical record was presented to the surveyor earlier in the day by facility staff as a final and complete record.

5. Patient #18 was admitted to the hospital on 6/28/10 and was discharged on 7/5/10 after death. Review of the clinical record on 9/15/10 revealed no discharge summary on the chart.

Interview with the Director of Health Information Management on 9/15/10 at 2:15 p.m. revealed the practice in the facility is for some of the charts to go to some of the other staff from the Medical Record Department for core measures review. While the chart is out with other staff for core measures review, they are unavailable to the physician for review. She indicated the doctors just come to complete their charts, don't call ahead, and don't give the Medical Record Department a chance to obtain all of the records for them to complete. She indicated this is what happened to Patient #18's clinical record. She also indicated this is what happens to any chart that has no discharge summary longer than 30-60 days after hospital discharge.


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Based on review of closed clinical records, the facility failed to assure all documents were complete and authenticated in a timely manner.

The findings include:

1. During review of a closed medical record on 9/14/10 at 1:25 p.m. the following information was found.

Patient # 31, a 86 year old patient was admitted to the facility on 8/3/10 with arthritis of the left knee and underwent a left knee Mako arthroplasty procedure. The patient was discharged on 8/5/10. The clinical record review revealed a delegated discharge summary dated 8/5/10 dictated by the physician's assistant and which remained unsigned by the physician at the time of review and to date. The closed medical record was presented to the surveyor earlier in the day by facility staff as a final and complete record.

2. During review of a closed medical record on 9/15/10, the following information was found.

Patient # 35, a 68 year old patient was admitted to the facility on 7/28/10 with a diagnosis of osteoarthritis of the right leg with a partial medial knee replacement completed using the robotic technic using Makoplasty and discharged home on 7/31/10. There was no case management/discharge planning notes contained in the closed medical record. The closed medical record was presented to the surveyor by facility staff as complete.

3. This information and findings were confirmed by the Health Information Department during the survey process.

Based on observation and interview, the facility failed to ensure outdated mislabeled or otherwise unusable drugs are not available for patient use.

The findings include:

On 9/13/2010 at 1:45 p.m., during tour of the Post Anesthesia Care Unit, accompanied by the Director of Pharmacy, a cabinet located across from the "wash station" was found to contain a 500 milliliter Dextrose 5% Injection bag that was expired in December 2009.

On 9/13/2010 at 1:50 p.m., interview with a unit nurse revealed, "no one in particular" reviews expiration dates and confirmed the intra venous bag of Dextrose 5% found by the surveyor had expired in December 2009.

On 9/15/2010 at 3:15 p.m., during review of facility's policy and procedures (Policy No. 06.01.01-1 Nur 801), it is indicated that: Outdated, mislabeled or otherwise unusable drugs and biological must be returned to pharmacy.

This Condition of Participation is not met based on the facility failure to ensure infection control measures are being enforced as it pertains to their policy and procedures, to ensure patient's are free from harmful microorganisms in the preparation of food, failure to ensure appropriate sanitary procedures were followed in treating patients receiving dialysis services, failure to ensure the environment of the dialysis treatment room is maintained in a sanitary manner, failure to ensure linens are handled in a sanitary manner, and failure to maintain a sanitary decontamination room in the emergency department.

The findings include:
1. During the initial tour of the kitchen on 9/13/10 at 10:00 a.m. the following was observed: Observation of the dry store room revealed an air vent located in the ceiling above food products that had a large accumulation of dust and dirt on the metal vent slots. Further observation revealed a Food Service Worker (FSW) preparing sliced tomatoes on a plate. FSW was observed with a bandage on her left forearm. After surveyor intervention the employee was removed from food preparation area. After being examined by the Occupational Health Department they determined the FSW had an open area that was covered by the bandaged and at that point the FSW was removed from her assignment of preparing food.

The tour of food service continued on the patient floors where the following was observed: The 3rd floor nourishment room sink was incased by a cabinet. The side of the cabinet had unidentified caked on brown substance on the right side. The 2nd floor nourishment room labeled #1 had a free standing ice machine that was observed to have an accumulation of what appeared to be a calcium build up and corrosion of the nozzle as well as the drain grates. This observation was also observed in the #2 nourishment room on the same floor.

Observation during tray line on 9/14/10 at 11:00 a.m. revealed the following: Observation of 2 male chefs with baseball caps on their head without fully covering their hair. Further observation revealed a male chef who had a full long beard that was not restrained. The chef was observed preparing food. Observation at 11:10 a.m. of the female chef on the tray line with a cap on top of her head, but observed with thick long bangs on her forehead. Further observation of FSW with a hair net hang off a pony tail, and her hair totally exposed.

Review of the facility's policy and procedures in regards to hair restraints reveals the following: "Wear appropriate hair restraints when on duty. Appropriate restraints include: hairnet, uniform cap, and disposable bonnet. Hair must either be short enough or restrained in such manner as to not touch the uniform collar. All hair must be covered or restrained to protect potential contamination of food or food handling equipment."
"Facial hair must be kept neatly trimmed. Beard should not be more than ? " inch."

2. Upon entering the dialysis treatment room on 9/13/10 at 10:45 a.m. the 2 nurses who were administering dialysis to a patient were observed not to be wearing any protective covering. The one nurse was asked by the surveyor for a protective cover so that the surveyor could enter the treatment room, the nurse replied it wasn't necessary, because the patient is off the machine. Upon observing the patient it was evident the patient in fact was attached to the dialysis machine, and was receiving dialysis. Further observation of the room revealed the area where the Reverse Osmosis (RO) portable machine (RO is a process of purifying water for the use and treatment of dialysis patients) is kept, was a converted bathroom. The RO was observed to be running. The gray water from the RO and the drains from the dialysis machine were rigged to drain in what was once a shower stall. Observation of the tubing from the RO was on the floor of the shower stall, and adjacent to the tubing was a black/brown unidentified substance. Observation of the shower stall also revealed the walls and ceiling were visibly dirty. On the grab bars in the shower stall were numerous pieces of tubing that were not in use. The gray water was draining into the shower. On the base/floor of the shower were 3 rows a clear tubing. On the other side of the wall, pipes were observed to be exposed and the tile around the pipes was missing, leaving the surfaces of the wall bare. Noted were numerous other pieces of tubing that were hung over the exposed pipes.

Further observation of the dialysis treatment room revealed an area surrounding the floor near and under the garbage cans with a thick layer of a brown/ rust color unidentifiable substance on the floor.

A follow-up visit to the dialysis treatment room on 9/15/10 at 1:00 p.m. revealed the base board behind the dialysis treatment chairs was in disrepair and was observed to have numerous areas were the sheet rock was crumbling exposing the wall down to the mesh support. Further observation revealed a film like residue on the monitor control screen of the dialysis machines and the floor underneath and surrounding the scale that weighs patient was observed to be rusty and dirty. The scale had a large amount of white residue on the rubber base. Observation of the floor revealed a lot of black residue in the corners. The general condition of the floor appeared to be dirty with numerous areas of scuff marks. When the Nurse Director was question on how often the room is cleaned and who cleans the room, she said housekeeping cleans the room daily even if the room is not in use.

On 09/15/10 at 9:11 a.m. during an observation in the Intensive Care Unit (ICU) of a patient during dialysis treatment the following occurred: Two ICU nurses entered the room without donning any Protective Covering (PC) (which is a requirement during a patient being treated on dialysis). The nurses proceeded to work with the patient leaning over the patient, changing his gown, and fixing the patient's bed linen. Neither nurse was observed washing or sanitizing their hands before they treated the patient, or when the nurses left the room. On the same day at 9:40 a.m. an (Echo Cardiogram) EKG tech entered the same room and proceeded to administer an EKG on the patient without washing or sanitizing the leads of the machine, before proceeding with hooking the patient up to the machine. Furthermore the technician was not observed donning any PC before entering the room, or administering direct care to the patient. When the tech was asked why she did not use PC when working with the patient she replied I don't have to use PC the patient is not in isolation. After the technician completed the EKG she was observed removing the leads, but was not observed washing or sanitizing her hands and did not sanitize the leads of the EKG machine.

Review of the facility's policies and procedures as it pertains to Infection Prevention of Cardio-Pulmonary states the follow: Standard precautions include the following; Hand washing: "Hands are to be washed after touching blood, body, fluids, secretions, excretions, or other contaminated items, whether or not gloves are worn. Hands must be washed immediately after removal of gloves, between any patient contact and when otherwise indicated. This will prevent transmission of microorganisms. To prevent cross contamination of different body sites on the same patient, it may be necessary to wash hands between tasks, and procedures."

On 09/16/10 at 11:05 a.m. a meeting was held with the Administrator and Director of Nursing (DON) in regards to infection control issues in dialysis treatment room, as well as ICU. The DON said the cardiac/pulmonary policies and procedures do speak specifically to cleaning of the leads (EKG Machine) as well as hand sanitation.

3. During a tour of the facility on 9/13/10 at 12:30 p.m., a large pile of linen was observed on the floor against the wall in room 306-A. This was an occupied room, the patient was in bed with visitors at bedside.

Additional observation was made of an underpad (pad placed under patient to keep him/her and inens clean/dry) was on the floor against the wall in room 307-A. A patient was observed to be in the bed. This observation was brought to the attention of a random staff nurse. She stated, "They just changed him/her." The tour was continued and the linen on the floor was brought to the attention of the Unit's Clinical Coordinator.

Facility policy review included the Infection Control Policy "Standard and Extended Precautions" (IP-123) last revised 7/09. Under II E (Standard Precautions, Linen) the policy states: "Although soiled linen may be contaminated with pathogenic microorganisms, the risk of disease transmission is negligible if it is handled, transported and laundered in a manner that avoids transfer of microorganisms to patients, personnel and environments." "Assume all linen is contaminated..."

4. The "decontamination room" off the Emergency Department was found in an unclean, unsafe, and disorderly condition:

On 9/14/10 at 9:11 a.m., during a tour of the facility, the "decontamination room" next to the ambulance entrance to the Emergency Department was visited. The floor was observed littered with syringe caps, paper (a partially completed ambulance run sheet), plastic pieces, small metal parts, and dirt. Several used foam pads were stuck onto 2 slideboards leaning up against the walls. A used cardiac monitor lead was stuck on another slideboard on the floor against the wall. In the ceiling, 2 of the 3 overhead lights were not operational.

In an interview on 9/14/10 at 9:19 a.m., the Director of the Emergency Department confirmed these observations. She stated that Emergency Medical Services (EMS) personnel managed the equipment and housekeeping maintained the room.



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26933

Based on record review and interview, the facility failed to ensure pre-anesthesia evaluation were completed and documented for 2 (Patients #52 and #53) of 6 surgery patients sampled.

The findings include:

On 9/16/2010, the facility's General Rules and Regulations approved by the Board on 7/15/2010 were reviewed. Item 45 (page G-7) entitled Pre & Post Anesthesia Evaluations included "the pre-anesthesia evaluation must be preformed within 48 hours prior to any inpatient or outpatient surgery or procedure requiring anesthesia services." Item 46 (page G-7) entitled Elements for a Complete Pre-Anesthesia included, "Notation of anesthesia risk; anesthesia, drug and allergy history; any potential anesthesia problems identified; patient's condition prior to induction of anesthesia."

1. On 8/14/2010, Patient #52 was observed undergoing a surgical procedure with anesthesia.

On 8/15/2010, the records for Patient #52 were reviewed. The records documented the surgical procedure and the anesthesia administration. Review of the Pre-Anesthesia Evaluation revealed some notations, the signature of the patient, but no signature by an individual qualified to administer anesthesia.

In an interview on 9/15/10 at 1:35 p.m. the Director of Surgical Services confirmed there was no anesthesia signature on Patient #52's Pre-Anesthesia Evaluation.

2. On 8/15/10, the records for Patient #53 were reviewed. The records documented the surgical procedure and the anesthesia administration performed 9/14/10. Review of the Pre-Anesthesia Evaluation revealed some notations, the signature of the patient, but no signature by an individual qualified to administer anesthesia.

In an interview on 9/15/10 at 1:36 p.m. the Director of Surgical Services confirmed there was no anesthesia signature on Patient #53's Pre-Anesthesia Evaluation.

In an interview on 9/15/10 at 1:48 p.m., after reviewing the unsigned Pre-Anesthesia Evaluations for Patients #52 and #53, the anesthesiologist on duty said, "I'm surprised, we usually make notes, fill out and sign (the Pre-Anesthesia Evaluation form)."