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On the day of the Recertification Survey based on record review and staff interview, the Critical Access Hospital failed to ensure that the decision to admit a patient to the hospital's Observation Service was determined prior to the initiation of care and services and to limit the length of stay to no more than forty-weight hours per hospital policy.

The findings are:

On 1/20/2010 at 1030, a review of Patient #7's medical record showed the patient was admitted on 1/16/2010 to the hospital's acute care service with the diagnoses of Altered Mental Status, Dehydration, and Urinary Tract Infection (UTI). An order reassigning the patient to the Observation Service was signed by the attending physician on 1/18/2010 which was two days after the initial determination. A discharge to home order was signed by the physician on 1/20/2010 at 930. During an interview with the Utilization Review (UR) Coordinator on 1/20/2010 at 1500, he/she confirmed the finding. The review of Patient #7's medical record showed the patient had a length of stay in the hospital's Observation Service status from 1/16/2010 until 1/20/2010. The finding was confirmed by UR Coordinator at 1500.

Review of Critical Access Hospital's policy, Outpatient Observation Admission Status, reviewed and approved on 2/24/2009, paragraph five reads "This policy regarding outpatient observation admissions affects ONLY MEDICARE and MEDICAID admissions. Medicare/Medicaid regulations permit observations stays of no more than 48 hours...."

On the days of the Recertification Survey based on record review and interview, the facility failed to ensure that all of the hospital's medical equipment was registered for preventative maintenance for 1 of 76 pieces that the equipment records were reviewed and the blanket warmer in the Endoscopy area was not on the equipment list and had never been checked for preventative maintenance.

The findings are:

During the Facility tour on 1/20/10 at 1100, observations showed the Continental blanket warmer (no model visible) did not have a preventative maintenance sticker on it. The Maintenance Director said that the Continental Blanket warmer was not on the identified list of hospital equipment and therefore had never been checked. Review of facility policy showed that all hospital medical equipment must be checked at least annually.

On the day of the Recertification Survey, based on observation, and staff interview, the Critical Access Hospital (CAH) failed to ensure that outdated biologicals were unavailable for patient use in the Emergency Department and the Laboratory.

The findings are:

On 1/19/2009 at 1350, examination of Pediatric Crash cart showed one (1) 500 milliliter (ml) bag of 5% Dextrose solution with an expiration date of 12/2009, one (1) 1000 ml bag of 10% Dextrose solution with an expiration date of 12/2009, and one (1) 250 ml bag of 5% Dextrose solution with an expiration date of 12/2009 in the bottom drawer of the crash cart. The findings were verified by the ED Registered Nurse (RN). At 1310, during review of stock medications and biologicals, the ED Nurse Manager reported that each hospital department shares responsibility with the pharmacy to ensure expired medications and biologicals are removed from the department and returned to the pharmacy for disposal. The ED Nurse Manager reported that it is the ultimate responsibility of the Pharmacy to do monthly checks to remove expired biologicals.




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On 01/19/10 at 1100, a tour of the Laboratory area was conducted with Medical Laboratory Technician (MLT) #2. A cabinet in the diagnostic room revealed #13 boxes of Ca Clean with an expired date of 2009-11-13. The finding was confirmed with MLT#2.

On the days of the Recertification Survey based on observation, interview, and record review, the Critical Care Access Hospital (CAH) failed to adhere to standard infection control practices and hospital policies in the holding area of the operating room by storing disinfected endoscopy scopes in a high traffic area (Holding Room), and by and predisposing the equipment to cross contamination in a dirty to clean decontamination work room, using Oxygen extension tubing in the Operating Room for multiple patients, controls to test sterilization processing were found to be expired in the Radiology Department, Health Care providers failed to adhere to universal precautions by not wearing gloves when performing direct patient care activities in various units of the hospital involving direct patient care, missed opportunities for handwashing while providing direct patient care, and failure to comply with appropriate hand hygiene with glove removal in the Laboratory, Medical Surgical Unit, and Emergency Room

The findings are:

On 01/19/10 at 1150, observation of a random phlebotomist performing a random procedure showed the phlebotomist missed the opportunity for washing hands after he/she removed the gloves. Observation showed MLT#2 performed the procedure with gloves on, prepped the patient's site with alcohol, applied pressure to the site with a 2x2, removed his/her gloves, labeled the specimens, entered the information into the computer, and then left the room. On 01/19/10 at 1230, MLT#2 reported that he/she usually washed the hands after working on the computer.

On 01/19/10 at 1210, observation of a phlebotomy procedure revealed another missed opportunity for handwashing. Observation showed a random patient sitting in the phlebotomy chair. Phlebotomist #9 was observed to put on gloves without washing his/her hands, performed the procedure on the patient, removed the gloves without washing hands, and left the room. Phlebotomist #9 was then observed as he/she returned to the room in a few minutes, performed a phlebotomy procedure on another patient, and then left the room with the gloves on. A sink and alcohol based soap for handwashing was present in the room where the procedures took place. On 01/19/10 at 1230, Phlebotomist #9 explained that he/she was nervous and forgot to wash his/her hands for five of six areas of the hospital. (Emergency Department, Operating Room and Operating Room Holding Area, Radiology Department, Laboratory, and Decontamination and Strilization areas.

Review of facility infection control policy and procedure, titled, Standard Precautions reads, " Handwashing-...wash hands immediately after gloves are removed, between patient contacts and otherwise indicated to avoid transfer of microorganisms to other patients or environments...Gloves- Wear gloves when touching blood, body fluids, secretions, excretions and contaminated items...Remove gloves promptly after use, before going to another patient, and wash hands immediately to avoid transfer of microorganisms to other patients or environments."


On 01/19/10 at 1110, a tour of the Ultrasound Room in the Radiology Department revealed that 2 containers of Cidex Plus strips had an expiration date of 2009-07 and 2009-11. The finding was confirmed with the RDMS.

On 01/20/10 at 0915, a tour was conducted of the Operating Suite with the Director of Nursing (DON) and Emergency Department Registered Nurse (EDRN). Observation of the Holding Room revealed 3 clean Endoscopes hanging in the room very close to a bed. The bed was covered with stock items that included boxes and Chux. The nurses reported that the endoscopes had been disinfected and were left hanging in the room to dry, and before the room is occupied by a patient, staff removes the endoscopes another area.

Observation of the Operating Room (OR) showed oxygen extension tubing was connected to the meter with a label that read, "DO NOT REMOVE". During an interview with the DON on 1/20/10 at 0930, the DON reported that the oxygen tubing is left connected to the meter so staff can connect it to the patient's oxygen tubing. The DON reported that the oxygen extension tubing is not changed between surgical cases.

During a tour of the Decontamination Room on 01/20/10 at 0935 showed the designated clean side was surrounded by 2 counters that had a small amount of dust and debris on them. The designated clean counters had miscellaneous items such as a large tape dispenser, an iron, and boxes stacked on them. The DON reported that the clean counter where the iron was located was used to iron decals on hospital linen.

Review of Centers for Disease Control (CDC) Guidelines, titled, Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 #5w., reads, "Store endoscopes in a manner that will protect them from damage or contamination." Review of CDC Guidelines, titled, Sterilizing Practices, reads, " Physical facilities. The central processing area(s) ideally should be divided into at least 3 areas: Decontamination, packaging and sterilization storage...The packaging area is for inspecting, assembling and packaging clean, but not sterile materials. The sterile storage area should be a limited access area...".







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On 1/19/09 at 1130, RN#3 was observed administering insulin subcutaneously to the patient in room #52. RN #3 failed to don gloves after performing handwashing and prior to the administration of the insulin to the patient.


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On 1/19/2010 at 1340, the Nurse Manager was observed going into the patient examination room # 1 with a new patient admission to Emergency Department and did not wash hands prior to or after completing the patient's nursing assessment and returning to Nurses Station.

On 1/19/2010 at 1430, Emergency Department Registered Nurse (EDRN) was observed preparing patient medication. The EDRN failed to wash his/her hands before retrieving the patient's medications from cabinet. The EDRN was observed as he/she rummaged around the sink area looking for a pill cutter but could not find a pill cutter. The, EDRN was observed to leave the medicatin room, lock the door, and go to the hospital pharmacy twice to get equipment and additional medications for patients. EDRN failed to wash his/her hands upon returning to the medication room on both occasions to prepare patient medications. EDRN was observed as he/she went into patient rooms, administered the patient's oral medications and applied medication to the patient's chest wall. EDRN failed to wash his/her hands or don gloves prior to administration of the patient's medications. Review of hospital records revealed that EDRN is the designated Infection Control Nurse for the Critical Access Hospital.

During an interview with the Nurse Manager on 1/19/10 at 1545, the Nurse Manager reported that nurses are to wash hands before and after patient contact but stated this is not always done per hospital policy.

Hospital Policy: Infection Control - Hand Hygiene, Effective Date 4/4/2008 and Revised on 7/1/2008, Reviewed and approved on 2/24/2009, reads, "All personnel will use the handwashing techniques as set forth in the following procedure after each patient encounter".

On the day of the Recertification Survey based on observation, record review, and staff interview, the Critical Access Hospital failed to provide ongoing assessment of patient needs for 2 of 2 random patients in the Emergency Department and the 1 of 11 patients in the Medical Surgical Unit. (Patient#6)

The findings are:

On 1/19/2010 at 1317, a tour of the Emergency Department (ED) revealed that the Nurse Manager, Registered Nurse (RN) , was the only nurse in the hospital's ED. At that time, the Nurse Manager was observed to call for more staff from another area since more patients were arriving in the Emergency Department (ED). Another staff member arrived to the ED at 1345.

Prior to the arrival of another nurse to the ED observation on 1/19/2010 at 1320 showed there was no physician or Nursing personnel in the Nurses Station in the ED from 1320 to 1324 to watch the central cardiac monitor for two ED patients on monitors and one patient in the acute care area of the hospital on a monitor. On 1/19/2009, observation of the ED Nurse Station revealed there was no physician or Registered Nurse (RN) in the nurse station to watch the central monitor from 1338 to 1343.

On 1/19/2010 at 1325, observation in Emergency Department revealed a cardiac monitor alarm in Room #4 sounded for three minutes and then stopped. The Nurse Manager was observed in the Triage Room with a patient and the Nurse Manager was the only nurse in the ED at that time. Observation of the patient who was located in Room #4 showed the patient's family member had his/her hand on the wall oxygen meter. The patient reported that the nurse had removed the patient's cardiac monitor, blood pressure cuff, and oxygen nasal cannula so the patient could go to the bathroom. The patient's family member was observed reattaching the equipment to the patient. The patient reported that he/she came to ED for chest pain. Observation showed that no nurse entered the patient's room (#4) until 1410 after the surveyor informed the EDRN of the occurrence. Then, the EDRN went into the patient's room (#4) to reassess the patient. When the EDRN returned from room #4, he/she stated that patient's family member had turned off the oxygen flow to the patient's cannula. Review of the patient who was in room #4's chart at 1415 showed a signed physician order for oxygen at two Liters per minute by nasal cannula. The finding was verified by the ED RN. During an interview with the Nurse Manager at 1135, he/she reported that all medical and nursing staff in the ED were responsible for watching the central heart monitor and that no one person was assigned to this duty.

On 1/20/2010 at 1030, a review of Patient #6's medical record showed the patient was admitted to the hospital's Observation Service with diagnoses of Near Syncope, Weakness, R/O MI(Rule Out Myocardial Infarction) , DM (Diabetes Mellitis), HTN (Hypertension), and Dementia. Review of the Patient #6's care plan, read, "Nursing Interventions - Implement Diabetic Care Plan per protocol, Obtain feedback about learning outcome as teaching plan progresses, Encourage patient family to express feelings, ask questions, and make specific plans for management....". During an interview with Patient #6 at 1100, Patient #6 reported that he/she had received no teaching about his/her diabetes. There was no teaching documentation of education on diabetes in the patient's chart in the nurse's note, or in the dietary notes. Observation of the patient's discharge process on 1/20/10 at 1135 revealed the patient was discharged with a family member who was observed to stop at Nurse Station on the way out and inquired if the Licensed Practical Nurse (LPN) #22 could provide information on types of foods to buy for the patient so the patient can follow a diabetic diet. The findings were confirmed by LPN #22 and the
Director of Nursing on 1/20/10 at 1135.

On the day of the Recertification Survey based on observation, record review, and staff interview, the Critical Access Hospital failed to implement care as described in the patient care plan for 1 of 30 open and closed patient records whose care plan was reviewed for care and services. ( Patient #6)

The findings are:

On 1/20/2010 at 1030, a review of Patient #6's medical record showed the patient was admitted to the hospital's Observation Service with diagnoses of Near Syncope, Weakness, R/O MI(Rule Out Myocardial Infarction) , DM (Diabetes Mellitis), HTN (Hypertension), and Dementia. Review of the Patient #6's care plan, read, "Nursing Interventions - Implement Diabetic Care Plan per protocol, Obtain feedback about learning outcome as teaching plan progresses, Encourage patient family to express feelings, ask questions, and make specific plans for management....". During an interview with Patient #6 at 1100, Patient #6 reported that he/she had received no teaching about his/her diabetes. There was no teaching documentation of education on diabetes in the patient's chart in the nurse's note, or in the dietary notes. Observation of the patient's discharge process on 1/20/10 at 1135 revealed the patient was discharged with a family member who was observed to stop at Nurse Station on the way out and inquired if the Licensed Practical Nurse (LPN) #22 could provide information on types of foods to buy for the patient so the patient can follow a diabetic diet. The findings were confirmed by LPN #22 and the
Director of Nursing on 1/20/10 at 1135.

On the days of the Recertification Survey based on record review and interview, the facility failed to ensure that all treatment consent forms were properly completed for 1 of 30 open and closed patient records reviewed in that there was no physician signature on the treatment consent to give blood. (Patient # 3)

The findings are:

Record review on 1/20/10 at 1610 for Patient #3 who was admitted on 1/13/10 for a Urinary
Tract Infection showed that a consent for blood was blank in the area calling for
a physician's signature. During an interview on 1/20/10 with the Director of Nursing (DON),
the DON confirmed that the physician's signature was missing. Facility policy, "Medical
Records", reads, ".... a physician's signature is required on all patient consents for treatments."

On the days of the Recertification Survey based on interview and record review, the Critical Care Access Hospital failed to ensure that a pre- anesthesia evaluation was performed and documented by the physician Medical Doctor (MD)#1 in the clinical record for 3 of 3 patients reviewed for care and services related to anesthesia. (Patient #8 , 9, 10)

The findings are:

On 01/20/10 at 0900, a review of Patient #8's medical record showed the patient had a Esophagogastroduodenoscopy (EGD)/Peg Tube placement/biopsy on 12/1/09. The patient's record showed that a pre-anesthesia evaluation of the patient prior to the procedure was not documented.

On 0/20/10 at 0900, a review of Patient #9's medical record showed the patient had a UGI (Upper GastroIntestinal) with biopsy on 12/11/09 and that a pre-anesthesia evaluation of the patient prior to the procedure was not documented.

On 01/20/10 at 0900, a review of Patient #10's medical record had a Upper Gastrointestinal(UGI) endoscopy with biopsy on 8/28/09 and that a pre-anesthesia evaluation of the patient prior to the procedure was not documented.

The findings were confirmed with the Director Of Nursing on 01/20/10 at 1030.

Review of facility policy and procedure titled Surgical Services reads, " 6. The anesthetist shall maintain a complete anesthesia record to include evidence of pre anesthetic evaluation...."

On the days of the Recertification Survey based on interview and facility record review, the Critical Care Access Hospital failed to ensure that its policy and procedure (Use of Propofol in the Operating Room)(OR) provided that only health care professionals qualified to administer anesthetics for sedation were entitled to do so within their scope of practice, and had the required Advanced Cardiac Life Support(ACLS) credentials. (MD#1)

The findings are:

During an interview with the Director Of Nurses (DON) and Emergency Department Registered Nurse (EDRN) on 01/20/10 at 1130, they revealed that Propofol was used for sedation during procedures in the Operating Room (OR). They reported that the Propofol was administered by the physician and not the nurse in the OR.

Review of Surgical Services Policy and Procedure Manual, titled, Use of Propofol in the OR, reads, " Policy:1. If patients receive NAPS (Nurse Administered Propofol Sedation), they must be evaluated by the physician prior to the procedure to determine if the patient is able to receive mediations utilized in the procedure or requires anesthesia support....8. Additional sedative agents that may be administered by the Registered Nurse(RN) include:....".

Review of the South Carolina Department of Labor, Licensing and Regulation Advisory Opinion #25, reads, " Registered Nurses(RN) who are not qualified anesthesia providers: 1. May not administer agents used primarily as anesthetics, including but not limited to Ketamine, Propofol..... 2. May not be authorized to manage deep sedation or anesthesia for short term diagnostic, therapeutic, or surgical procedures. This statement is an advisory opinion of the Board of Nursing as to what constitutes competent and safe nursing practice."

On 01/21/10 at 0930, a review of the personnel record of MD#1 revealed an expired Advanced Cardiac Life Support certificate dated 2008. This was confirmed with DON who could not produce a current certificate.

Review of hospital Surgical Services Policy and Procedure Manual, titled, Use of Propofol in the OR, reads, " Policy: 3. All physicians and RNs involved in NAPS must be ACLS certified, have critical care experience, and be proficient with airway management skills."

On the days of the Recertification survey based on record reviews, interview, and review of hospital policy and procedure, the facility failed to ensure the development of a comprehensive care plan for each resident to include quantifiable and measurable objectives with timetables to meet the residents's needs for eight of eight resident records reviewed in the swing beds. (Residents #1, 2, 3, 4, 5, 6, 7, and 8))

The findings included:

On 1/19/10 at 1400, a review of Resident #1's open medical record revealed the eighty year old was admitted on 12/03/09 with diagnoses of Chronic Renal Failure, Congestive Heart Failure, Hypertension, and COPD (Chronic Obstructive Pulmonary Disease). The nursing problems listed on the patient's comprehensive care plan included Anemia, impaired physical mobility, and COPD with nursing interventions identified. A timetable was not individualized for the resident as the target date for all of the outcomes, and the outcome was documented as "During hospital stay".

On 1/19/09 at 1445, a review of Resident #2's open medical record revealed the eighty-five year old was admitted on 12/18/09 with diagnoses of status post Fractured Right Femur, Dementia and Hypertension. The nursing problems listed on the patient's comprehensive care plan included potential for Urinary Tract Infection since the resident had a Foley catheter, alteration in nutrition, fractures, and impaired physical mobility with nursing interventions identified. A timetable was not individualized for the resident as the target date and for all of the outcomes staff documented "During hospital stay".

On 1/19/09 at 1500, a review of Resident #3's open medical record revealed the seventy-nine year old was admitted on 4/04/08 with diagnoses of Dementia, Hypertension, and bowel and bladder in-continence. Nursing problems listed on the patient's comprehensive care plan, included potential for infection as the resident had a Foley catheter. The goal read, "Resident will be free from signs/symptoms or complications related to UTI (urinary tract infection) through next review as AEB (as evidenced by) : No noted urinary tract infection, foul smelly, cloudy urine, fever." The date for the next review was not documented.

On 1/19/09 at 1600, a review of Resident #4's open medical record revealed the seventy-one year old was admitted on 1/1/09 with diagnoses of DM (Diabetes Mellitus), COPD, and CAD (Coronary Artery Disease). Problems identified on the patient's comprehensive care plan included alteration in nutrition, risk for impaired skin integrity, and impaired physical mobility. A timetable was not individualized for the resident and the target date for all of the outcomes was documented as "through next review".

On 1/19/09 at 1630, a review of Resident #5's open medical record revealed the eighty year old was admitted on 1/15/10 with diagnoses of left sided multiple rib fractures, Hypertension, DM (diabetes mellitus), and CAD. Problems on the comprehensive care plan included potential for infection, alteration in bowel elimination, fractures, CAD, and DM. A timetable was not individualized for the resident as the target date for all of the outcomes staff documented "During hospital stay".

On 1/20/09 at 1045, a review of Resident #6's open medical record revealed the seventy-three year old was admitted on 1/2/10 with diagnoses of Pneumonia, IDDM (Insulin Dependent Diabetes Mellitus), Hypertension and Anemia. Problems on the comprehensive care plan included Pneumonia, alteration in nutrition, impaired skin integrity, Hypertension, and DM. A timetable was not individualized for the resident as the target date, and for all of the outcomes staff documented "During hospital stay".

On 1/20/09 at 1115, a review of Resident #7's open medical record revealed the eighty-one year old was admitted on 12/8/09 with diagnoses of Pneumonia, Decubitus Ulcers, and COPD. Problems identified on the patient's comprehensive care plan included impaired airway exchange, cognitive loss, and impaired skin integrity. A timetable was not individualized for the resident and the target date for all of the outcomes was "through next review".

On 1/20/09 at 1240, a review of Resident #8's closed medical record revealed the forty-nine year old was admitted on 1/08/10 with diagnoses of acute Pyelonephritis, acute Chronic Renal Insufficiency, and Bronchitis. Problems identified on the patient's comprehensive care plan included Bronchitis, and Anemia. A timetable was not individualized for the resident and the target date for all of the outcomes was "During hospital stay".

Review of hospital Nursing Policy, "Care Planning", read, "It is the policy of Allendale County Hospital to provide an individualized interdisciplinary Plan of Care for all patients through the use of computerized care planning. Procedure: ... The Plan of Care shall be individualized, based on the diagnoses and patient assessment ... After the initiation of the Plan of Care by nursing, those disciplines consulting in the care shall contribute to the plan as appropriate to the patient's assessed needs ... The Plan of Care shall be updated daily, with revisions reflecting the reassessment of needs of the patient. All staff using the Plan of Care are responsible for interdisciplinary collaboration to establish goals and appropriate interventions, as well as ongoing evaluations and revisions..."

Review of the hospital policy, "Comprehensive Care Plan", in the "S&S Food Administrators at Allendale Hospital", revised 2/18/08 and reviewed 1/12/10, read, "An interdisciplinary care plan will be developed for each patient. The purpose is (1) to develop measurable objectives for the highest level of functioning the patient may be expected to obtain, and (2) to develop care directives to maintain the optimal health status when the patient is dependent on the staff for needs. The comprehensive care plan for each patient must include measurable objectives and timetables to meet the patient's medical, nursing, and psycho-social needs, identified in the comprehensive assessment..."

The Director of Nursing reported in an interview on 1/20/09 at 1130 that if additional problems developed or interventions changed, the revisions would be documented on the resident's plan of care at that time. All care plans are formally reviewed and updated every three months at the interdisciplinary team conference.