HospitalInspections.org

Based on certified registered nurse anesthetist (CRNA) license review, medical staff bylaws review, and interview, the CAH did not provide the current State license for 1 of 3 CRNA licenses requested (Staff HH), and all courtesy staff. The findings included:

1. During the entrance interview on 9/13/2010 at 3:40 PM, the survey team coordinator requested a copy of all current licensure documentation for all personnel who are required to be registered or licensed in a State. On the morning of 9/14/2010, the facility provided licensure documentation for personnel and the State license for Staff (HH) was not included.

2. During an interview on 9/16/10 at 3:30 PM, the medical staff coordinator stated that there was not a list of courtesy consultants. Courtesy consultants are on contract and come from another hospital once a month.

3. The medical staff bylaws approved 8/1/2008 in article IV - categories of the medical staff stated, "The Courtesy/Consultant Medical Staff shall consist of physicians, dentists, and other licensed health professional, qualified for staff membership, but who occasionally attend patients on the outpatient service or in the hospital or who only act as consultants."

The medical staff bylaws approved 8/1/2008 in article VI -determination of qualifications and clinical privileges, section 8 - nurse anesthetists stated, "CRNAs who are active allied health members must have prescription authority in accordance with Billings Area IHS circular No. 00-02. Locum tenens CRNAs may provide services within the scope of their license in accordance with individual state guidelines.

The CAH did not provide documentation of the State license for CRNA (HH) by the survey exit on 9/17/2010 at 10:00 AM and did not provide a list of courtesy staff with license verification.

Based on record review, the CAH did not have an agreement for the development and use of communication systems with the network hospital. The findings included:

During the entrance conference on 9/13/2010 at 3:45 PM, the surveyor requested a list of all agreements.

During the exit conference on 9/17/2010 at 10:00 AM, the surveyor requested a list of all agreements.

On 9/27/2010 at 10:36 AM, the Quality Assurance Coordinator, staff (II) emailed seven agreements to the surveyor and reported that the seven agreements sent were all the agreements. An agreement for the development and use of communication systems with the network hospital was not received.

Based on record review, the CAH did not have an agreement for the provision of non-emergency transortation between the facility and the hospital. The findings included:

During the entrance conference on 9/13/2010 at 3:45 PM, the surveyor requested a list of all agreements.

During the exit conference on 9/17/2010 at 10:00 AM, the surveyor requested a list of all agreements.

On 9/27/2010 at 10:36 AM, the Quality Assurance Coordinator, Staff (II) emailed seven agreements to the surveyor and reported that the seven agreements sent were all the agreements. An agreement for the provision of non-emergency transportation between the facility and the hospital was not received.

Based on observation, record review, and staff interview, it was determined that the CAH failed to provide emergency care necessary to meet the needs of its patients. The Condition of Participation of Emergency Services was not met as evidenced by the following findings:

1. Failed to ensure that equipment, supplies, and medications were available for treating emergency cases. Refer to C202.

2. Failed to assess (Medical Screening Exam) and provide appropriate treatment for the patients seen in the Emergency Department (ED). Examples of these failures included:

a. Failure to do a medical screening exam (MSE) to evaluate the patients' medical status and need for treatment:

1) Record review for patient #42 revealed that patient came to the ED on 9/5/10 at 7:46 PM with complaint of "swollen hands and feet"and her disposition was "referred to another..." (Obstetrics unit) with a departure time of 9:00 PM.

Review of the patient's 9/5/10 Electronic Health Record (EHR) (as provided to the surveyor) evidenced that the patient was triaged at 7:52 PM. The "Short ER Nurse Assessment" included a triage level of "4" and contained the patient's complaints of swelling in hands and feet today and a statement that the patient is 37 weeks pregnant, having some contractions. At 7:53 PM, the patient was noted ambulatory to the lab to provide urine sample. At 8:20 PM, the patient was noted to be sitting comfortably in waiting room awaiting OB floor. At 8:44 PM the patient was sitting quietly in waiting room and respirations non-labored and patient appears in no distress. The chart noted a discharge disposition to OB triage with a time of 9:00 PM. The next note was written at 9:01 PM when the RN went to get patient from the waiting room, could not find the patient, ... on discovery, patient will be escorted to OB triage. At 9:55 PM, Dr ___________(U) provided with patient report and condition update. At 9:30 PM, attempted to contact patient via phone with no luck.

There was no evidence to show that the patient left AMA or was seen in the OB Department.

Review of the ED log evidenced that the patient came to the ED on 9/6/10 at 1:30 PM with complaint of "really bad swollen hand and feet" and the disposition was "observation" with a departure time of 1:30 PM.

There was no medical record found for this ED visit. Due to lack of documentation, it was not possible to determine that this patient received a MSE during either ED visit.

2) Record review for five year old patient #43 revealed that the patient came to the ED on 9/11/10 with complaints of "difficulty breathing and very high fever". The child's temperature when he arrived in the ED was 100.7 (one hour after the mother reported that she had given him Motrin) and his pulse was 143. The child was triaged as level "4".

Based on the ESI Triage Algorithm, v4, which was provided to the surveyor by the ED Nursing Supervisor (A), the child should have been triaged at a level "3". Level 3 suggests a pulse of > (greater than) 140 for 3 to 8 year olds could be a danger zone vital.

The provider diagnosed the child's health issue to be pharyngitis and ordered penicillin and Motrin.

Based on review of the ED log visit time and departure time, the child remained in the ED approximately one hour and twenty minutes. There was no evidence that the child's temperature and pulse were re-assessed/documented prior to departure from the ED.

3) Review of the Standard ER Log Report and the ED EHR for patient #44's 9/11/10 ED visit revealed the following:

The presenting complaint was "chest pains".

The only procedure done was an EKG.

The diagnosis was "acid reflex".

The "Initial Vitals: No Measurements Found"; No vital signs were documented for this visit.

The "Short ER Nurse Assessment" documented that the patient complained of central non radiating burning chest pain x 3 days. Nauseated and dizzy but no vomiting. ...Denies hx (history) of such sx (symptoms). ...Took zantac at 2200 (10:00 PM) with no relief and no analgesia taken. Pt denies hx of CP (chest pain) or ever had an ECG. States mother had MI (heart attack). Pt shows no signs of distress of any discomfort on arrival to triage..."

The patient was given Rinkes GI cocktail which resolved sx (symptoms). (Note: According to WIKIPEDIA - gastrointestinal cocktail, known as a GI cocktail, is a generic term for a mixture of liquid antacid, viscous lidocaine, and an anticholinergic primarily used to treat dyspepsia. The GI cocktail may also deceptively mask pain originating from the heart.)

No laboratory tests were ordered.

The impression was noted to be "GERD; Smoker".

The plan of care was "quit smoking; Omeprazole....; RTC (return to clinic) prn (as needed).

There was no evidence to show that the patient received a thorough MSE to rule out a cardiac
problem.

4) Review of the ER Log for patient #45's ED visits on 9/12/10 evidenced a visit time 3:29 AM with complaint of chest tight, stomach pain and a disposition home at 4:00 AM and a visit time of
6:43 AM with a complaint of stomach pain and a disposition home at 8:05 AM.

(Note: There was only one other patient in the ED from 3:29 AM to 7:56 AM. That other patient was in the ED for a medical clearance from 3:25 AM to 3:36 AM.)

The surveyor requested the medical record for both of these ED visits. The following documentation was all the information that was provided:

For the 3:29 AM visit no vital signs or triage/nursing assessment or MSE were found. The provider (W) wrote his assessment on the visit time of 3:29 AM. However, the time on the note (8:22 AM) and the visit log evidenced that the note was for the 6:43 AM visit.

There was no evidence to show that the patient received any assessment or MSE during the first visit and no triage/vital signs to complete the later visit's MSE for this patient.

5) Review of 21 year old patient #46's 9/12/10 ED visit record evidenced that the visit time was 6:16 PM with a complaint of headache and a disposition of transfer to another hospital at 8:44 PM.

Review of the Triage/Short ER Nurse Assessment: Triage level "3"; Headache for 5 hours; Crying uncontrollably in triage.

Review of the provider's note: Chief complaint was headache. Got headache a couple of hours after going to work. Has gotten progressively worse during the day. Threw up once this afternoon...Denies ST, body aches, etc. "Just 'feels like my head is going to explode'." 8/29 pharyngitis. 9/8/10 sore throat and nauseated. Physical exam: screaming and crying. doesn't stop except for when is talking to provider. ...Pt does c/o (complain of ) pain when putting neck to chest. States that 'it feels like it is pulling something'. Impression; no diagnoses found. Plan: reviewed with physician (Y). Talked with physician at another hospital.

Review of the patient's EHR revealed that multiple doses of Fentanyl and Ativan were administered. Morphine was given after no more Fentanyl was available in the Pyxis.

At 6:40 PM, the nurse (Q) noted that an intravenous was in the right antecubital and labs were drawn. The patient was crying uncontrollably, stating feels like 'head is going to explode'. Pain level 10/10.

Review of the patient's "Most Recent Laboratory Data" reports shows no laboratory work done on 9/12/10.

There was a lack of evidence that the patient received a thorough MSE, including laboratory testing and evaluation for potential diagnoses such as meningitis.

6) Review of 20 year old patient #47's 3/3/10 ED visit evidenced a visit time 6:13 PM with a complaint of ingestion and a disposition of transfer to another hospital at 10:07 PM.

Review of the ER Physician Note revealed the following:

aa) Chief complaint - ingestion

bb) History of present illness -"...took seven Tylenol with codeine; I just wanted the pain to go away; I was not trying to kill myself. denies etoh or drugs or other pain medication; she believes she took the medication between four and five.."

cc) Review of Systems - no acute medical issues presented; did have her gall bladder out two weeks ago and is doing well.

dd) Problem List: Active Problems: Risk for diabetes; MRSA - buttock

ee) Mood: depressed

ff) Drug screen - positive for barbiturates and opiates; acetaminophen equaled 0.0

gg) Impression: overdose, unclear suicidal ideation but clearly depressed, sig risk for post partum depression; Discussed with two doctors at another Hospital who accepted her for ED and psych services

hh) Plan: redraw acetaminophen level at 9 PM; transfer in about two hours.

Review of the RCIS Referral form evidenced that the referral was to "eval (evaluate) and manage overdose suicide?, psych eval".

There was no evidence in the medical record to show that the patient's pain complaint was assessed, that any type of mental status evaluation was done onsite by the psychologist or psychiatrist on the Medical Staff, or that the patient's recent pregnancy/post partum course was reviewed.

7) Review of 2 year old patient #48's 3/3/10 ED visit evidenced that a visit time 11:32 AM with a complaint of croup every time she coughs she can't catch her breath and a disposition of transfer to walk-in clinic at 12:30 PM.

b. Review of the "Emergency Services Urgent - Crow" form evidenced a chief complaint of "cough and loosing voice". Vital signs and oxygen saturation were documented. The purpose of visit was noted to be "medical screening". The only note on the form was "Pt screened by MD. She is stable medically and can be evaluated further in walk in clinic". This was signed by physician (T)

There was no documentation of what screening was done, such as breath/lung sounds or radiology exams. There was no evidence of an appropriate MSE for this patient.

8) Review of 51 year old patient #49's 3/1/10 ED visit evidenced a visit time 4:55 PM with the purpose being medical clearance and a disposition of jail at 5:16 PM.

Review of the ER Physician Note included the following:

aa) History of present illness - ...drank too much, no other complaints, no chest pain, no shortness of breath, no other distress..."

bb) "Alert and in no acute distress"

cc) Impression was etoh; counseled on rehab; jail clearance done.

dd) Signed by physician (2)

In an interview with the QA Coordinator, she verified that no laboratory results and no orders were found for this patient. There was no evidence to show that an appropriate MSE was completed for a patient with a diagnosis of "etoh".

9) Review of 18 year old patient #50's 8/22/10 ED visit evidenced a visit time 6:33 AM with a purpose of Medical Clearance - Behavioral Health and a disposition of jail at 8:10 AM.

The provider was identified as physician (TT). The provider's narrative noted "medical clearance". The physician orders were for a drug screen of urine stat (as quickly as possible) and a pain management 9+ drug screen of the urine with an indication of "Delusions".

The hospital was requested during the survey and after the survey to provide the laboratory results. The orders were provided but no results were listed.

There was no evidence that the patient received an appropriate MSE to determine the cause of the delusions. No physician note was provided to show that an examination was conducted prior to the patient going to jail.

b. Failure to treatment or provide appropriate care and services based on a thorough assessment of the patients' conditions. Refer to the examples listed above.

Based on staff interview, it was determined that the CAH failed to ensure that equipment, supplies, and medications were available for treating emergency cases. The findings included:

1. On 9/16/10 at 8:35 AM, in a confidential staff interview, an Emergency Department (ED) staff member reported that sometimes supplies, including nasal cannulas, crutches, canes, and intravenous (IV) tubing, are on back order. According to the staff member, these shortages are worse at high volume times, such as during the Fair. She revealed that medications shortages were usually related to National shortages, such as of Fentanyl and Epinephrine.

2. On 9/17/10 at 7:53 AM, in a confidential interview with an ED staff member, she confirmed that they were sometimes short of supplies for basic care, including lap trays, suture removal kits, and nasal cannulas.


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3. On 9/14/10 from 8:30 AM until 11:30 AM a tour of the surgery department was completed with the OR (operating room) supervisor, Nurse (J). The following issues with emergency supplies was identified:

a. A review of the emergency "Malignant Hyperthermia Kit" stored on a cart between the two operating rooms was found to have outdated medications which included:

Mantiol 50 milliliters(ml) - five bottles with expiration dates of March 2010,

Lasix 2 ml -seven bottles with expiration dates of February 2010,

Sodium Chloride 20 ml bottle with expiration date of May 2010,

Also four 1000 cubic centimeters (cc) IV bags of Sterile Water dated July 2010.

b. Interview with Nurse (J) confirmed that the medications were out dated and confirmed that pharmacy and the OR staff was responsible for ensuring outdated and unusable drugs were not available for patient use.

Based on observation, record review, and staff interview, it was determined that the CAH failed to maintain the physical plant in a manner that it provided a safe, clean, and functional environment for the patients, public, and staff. The Condition of Participation of Physical Plant and Environment was not met as evidenced by the following findings:

1. Failure to have in place housekeeping and preventive maintenance programs to ensure that all essential mechanical, electrical, and patient care equipment is maintained in a safe operating condition. Refer to C222.

2. Failure to ensure there is proper storage and disposal of trash, including sharps. Refer to C223.

3. Failure to ensure that drugs and biologicals are appropriately stored. Refer to C224.

4. Failure to ensure the CAH was clean and maintained in an orderly manner. Refer to C225.

5. Failure to meet the 2000 NFPA 101 Life Safety Code. Refer to C231.

Based on observation and interview, it was determined that the CAH failed to maintain the mechanical and patient care equipment in safe operating condition. The findings included:

1. On 9/14/2010 at 11:00 AM, there was an unused floor drain located in soiled utility room B266. Staff reported that the floor drain was for an eye wash that was removed from this location. Unused drains have the potential to dry out and allow sewage gasses to enter the building.


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2. On 9/14/10 at 8:45 AM, during an observation of the newborn nursery, the maintenance sticker on the isolette was marked "2/2/10 - changed filter". There was no clear indication that the Biomed Department had performed the annual maintenance or when the unit was due to be inspected.

3. On 9/14/10 at 9:00 AM, an observation in the Birthing Room (A218) evidenced that the infant warmer bed had a sticker with a date of 2/4/10. There was no indication of when the Biomed annual inspection was due (line was blank).

4. On 9/14/10 at 9:36 AM, during an observation in the Observation Room in the Emergency Department with the Nursing Supervisor (staff member A) present, there was patient equipment (Propac) with a Biomed inspection sticker dated 8/7/09. The nurse revealed that she had submitted work orders for five of these devices as they were past due for the annual inspection.

2. On 9/14/10 from 8:30 AM until 11:30 AM a tour of the surgery department was completed with the OR (operating room) supervisor, Nurse (J). There were issues with disposal of medications, sharps and biohazardous waste identified. The staff in the OR identified two different types of sharps disposal containers for use.

a. One sharps container was mounted on the wall. It was noted to have horizontal drop entry approximately 9 inches by 2 inches. The opening in the container was larger enough to access its contents it did not have a security system to prevent unauthorized access to the contents in the sharps container.

b. The second type of container was a larger floor standing container marked as "Biohazard Sharps Only". The container was approximately 24 inches in height and the lid had an opening 9 inches by 5 inches which allowed access to its contents. The larger container was noted to contain syringes with medications identified by anesthesia as propofol, glass medication bottles and IV (intravenous) fluids and tubing which were to be removed from the container.

[Propofol is a drug that reduces anxiety and tension, and promotes relaxation and sleep or loss of consciousness. Propofol provides loss of awareness for short diagnostic tests and surgical procedures, sleep at the beginning of surgery, and supplements other types of general anesthetics.]

3. On 9/15/10 at 3:15 PM, in OR room #1 the large sharps container was checked. A syringe with white substance was noted. Interview with CRNA (certified nurse anesthetist) (S) confirmed that syringe contained propofol. He also reported that medications should be wasted before disposing of the syringes.

4. On 9/15/10 at 4:30 PM, the Safety Officer (P) reported that the company supplying the containers had been contacted as soon as he was notified of the concerns and pictures had been sent on both types of containers which showed full access to the contents in these devices. He also confirmed that the wall mount sharps containers were being used throughout the CAH.





04748


Based on observation, record review, and staff interview, it was determined that the CAH failed to properly dispose of trash, including sharps and biohazardous items. The findings included:

1. On 9/13/10 at 4:20 PM, during an initial observation of the Emergency Department (ED) in the presence of the Nurse Supervisor for the ED (staff member A), the following observation was made:

In each of the exam rooms and treatment rooms, there was a sharps disposal container. The opening on the top of each container was approximately two inches wide and it extended the length of the plastic box. There was no device in the lid to prevent access to the contents of the containers.

UNSECURED MEDICATIONS

5. On 9/14/10 at 11:20 AM, a check of the operating room (OR) identified as OR #1 following a surgical procedure noted a drawer to the anesthesia cart was open. The OR team had transported the patient to the recovery room and the room was unattended. Nurse (J) who was accompanying the surveyor reported that the anesthesia cart was supposed to be locked and that closing the drawer locked the system. The cart was identified as being part of the "Pyxis" system.

[Pyxis is a medication dispensing device. The point of care dispensing cabinets or carts interface with the Pharmacy computer system. The system is locked and allows for only limited access by approved staff for medication security and accountability.]

However, the failure to close the drawer left the medications in the drawer unsecured. Further investigation found that the drawer left open contained 47 divide bins of different medications.

6. Interview with the Pharmacist (KK) on 9/15/10 at 2:00 PM confirmed that when the Pyxis machine is left unattended the drawers are to be closed to ensure medications are secured. The Pharmacist then attempted to print data from the Pyxis machine found unsecured in surgery OR#1. She identified that she could print data from OR #2 and not OR#1 and would follow up.

7. On 9/15/10 at 3:15 PM, an interview with CRNA (certified nurse anesthetist) staff (S) confirmed that when the anesthesia cart/Pyxis system was left unattended it was to be closed/locked to secure those medications. Further investigation found that the drawer left open on 9/14/10 contained 47 divide bins of different medication. Some of medications included in the drawer found open included pain medication and anesthetic agents, including:

a. Nubain (nalbuphine) is in a group of drugs called narcotic pain relievers. It is similar to morphine which is used to treat moderate to severe pain.

b. Toradol is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat moderate to severe pain.

c. Norcuron (Vecuronium) is used to relax the muscles. It works by blocking the signals between your nerves and your muscles. It is given before general anesthesia in preparing you for surgery.

d. Amidate is used for inducing general anesthesia and with other medications to provide anesthesia during short surgeries.




04748


Based on observation, record review, and staff interview, it was determined that the CAH failed to appropriately store drugs and biologicals. The findings included:

1. On 9/13/10 at 4:20 PM, during an initial observation of the Emergency Department (ED) in the presence of the Nurse Supervisor for the ED (staff member A), the following observation was made:

a. The nurse took a set of keys off a hook which was located above the sink at the nurses' station. She was going to use the keys to open the medication cupboards which were located in the "Observation Room". However, at the time of the observation, the room was occupied, so the keys were hung back on the wall. These keys were visible and available for anyone to use.

b. In the "Trauma Room", there were two crash carts which the nurse identified one as an adult and the other as a pediatric. The Supervisor indicated that the carts are to be checked daily. Review of the logs evidenced the following:

c. On 7/1/10 the cart had been found open but no documentation or explanation was noted on the log from 6/28 through 6/30/10.

d. For the month of July, 2010, the daily check of the pediatric crash cart was not noted nine out of 31 days.

e. For the month of August, 2010, the daily check of the pediatric crash cart was not documented four out of 31 days.

f. Only the pediatric cart's top drawer was observed to be locked. The drawers which were not locked contained intravenous supplies, syringes, as well as respiratory equipment.

2. On 9/14/10 at 8:45 AM and on 9/15/10 at 8:45 AM, during observations of the warming unit located in the newborn nursery, the following items were found in the warmer:

Several blankets,

One 1000 ccs (cubic centimeters) bag of Lactated Ringers, and

One 500 ccs and one 1000 ccs bottles of water for irrigation.

The Lactated Ringers and the sterile water were not dated.

3. Review of the Policy & Procedure Statement for Warming IV Solutions (#8001), with a review date of 4/2008, revealed the following:

"Purpose: To maintain the integrity of warmed IV solutions and to prevent patient injury. "

"Procedure: 1. Twelve (12) bags of each type of IV solution (currently there are two different solutions in the warmer) may be stored in the ER/OB/Surgery warmer for no more than 14 days in their original plastic wrap. The 14-day expiration date for each warmed bag should be marked clearly. At the end of the 14 day period the bags are to be removed. The solutions can be used up to 24 hours after removal, but at the end of the 24 hour period they must be discarded per letter obtained by Hospira, Inc.

2. The warming temperature for these IV solutions cannot exceed 45 Celsius or 113 Fahrenheit."

4. On 9/14/10 at 8:45 AM, during an observation of the Obstetrics/Newborn unit, the following observation was made:

In the Clean Utility Room/Supply Storage room (A201), a Biohazard Clean-up kit with a large brown stain on the outside of the box was observed. This box was sitting on the top shelf of a multiple wire shelving unit. Other patient care items were located on the shelves below the Clean-up kit creating a potential for contamination.

Based on observation and staff interview, the CAH failed to provide a preventative maintenance program that insured the premises are clean and orderly. The findings included:

1. On 9/14/2010, stained ceiling tiles were found in the following locations:

At 3:25 PM: Room B11-1 each

At 3:25 PM: Room B8- 1 each

At 4:00 PM: Room C117- 5 each

At 4:25 PM: Behavioral Health Waiting room- 4 each.

2. On 9/14/2010 at 10:45 AM, the Labor and Delivery stairwell was found to be littered with dead flies and spider webs. This stairwell door had a delayed egress lock on requiring a key to disable the alarm. This may have inhibited housekeeping staff from entering this area to clean.


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3. On 9/13/10 at 4:20 PM, during an initial observation of the Emergency Department (ED) in the presence of the Nurse Supervisor for the ED (staff member A), the following observations were made:

a. Chemicals were present and in view when the door to room C207 (Soiled Utility Room) was opened. The door did not have a lock on it. This room was located adjacent/near the exam rooms.

b. There were two carts of supplies stored in an alcove area. One of the carts had a box of lancets sitting on it. These carts were accessible to anyone in the hall.

c. In the "Trauma Room", the wall pulse oximetry device was observed to have a used elastic band-aid attached to it.

d. The nurse (A) verified the above observations.

4. On 9/13/10 at 4:30 PM, out of date dental supplies were observed in the dental department. Wax used to make dental impressions was in the supply cabinet with an expiration date on 2/2008. A box of Trine VLC(used in making dental casts) had an expiration date of 9/2006. The dentist (staff NN) verified the expiration dates.

5. On 9/14/10 at 8:45 AM, during an observation of the Obstetrics/Newborn unit, the following observation was made:

In the Soiled Utility Room (A202), there was a gallon of Maxi-Zyme. The door did not have a lock on it.

6. On 9/15/10 11:30 AM, the following chemicals were present in room C207:

Chlora S----- two containers

Arsenal Lemon Disinfectant in a spray bottle

Supox Spray and Wipe Clean RTU in a spray bottle

MaxiZyme in a gallon container with a pump.

Based on observation, record review, and staff interview, the CAH failed to meet the applicable provisions of the 2000 NFPA 101 Life Safety Code. The findings included:

See Life Safety Code survey with completion date 9/17/2010.

Based on record review, observation, and staff interview, it was determined that the CAH failed to ensure that the organizational structure requirements were met. The governing body failed to ensure that the following Conditions of Participation (COPs) were in compliance in order to provide quality of care to all patients:

CFR 42 485.618 - C200 - The CAH failed to provide emergency care necessary to meet the needs of its patients.

CFR 42 485.623 - C220 - The CAH failed to maintain the physical plant in a manner that ensured a safe, clean, and functional environment for the patient, public, and staff.

CFR 42 485.627 - C240 - The CAH failed to ensure that the policies and procedures were updated at least annually and to ensure the delivery of quality health care.

CFR 42 485.631 - C250 - The CAH failed to ensure that the staff qualifications and staff responsibilities were met in order to ensure the delivery of quality health care.

CFR 42 485.635 - C270 - The CAH failed to have current, approved policies and procedures, to provide direct patient care in accordance with policies and procedures, to manage medications storage and accountability, and to monitor infection control.

CFR 42 485.638 - C300 - The CAH failed to ensure author identification in the electronic clinical records system and failed to maintain accurate, complete medical records.

CFR 42 485.639 - C320 - The CAH failed to ensure that acceptable standards of practice for surgical services were followed for surgical counts.

CFR 42 485.641 - C330 - The CAH failed to conduct a periodic evaluation of the total program and did not have an effective quality assurance program.

The deficient practices documented in this Statement of Deficiencies describe the failure of the organization and its governing body to effectively provide quality health care to the patients treated in this CAH.

Polices

CROSS REFERENCE C-270 - Pharmacy Policies and Procedures were not reviewed since 2/16/2006. The facility failed to have a facility wide infection control program.

The governing body meeting minutes dated 2/22/2010 stated "Policies and procedures need to be in place for compliance reasonsfor each individual service unit"

The governing body meeting minutes in a mock survey report dated 5/13/2010 on page 10 stated "Emergency room - There is currently no process for updating policy and having them (clinical director) reviewed and signed-this needs adressed by administration."


Cinical records

Cross reference C300 - Clinical records were not secure, kept confidental, readily accessible, complete, and systmatically organized.

The governing body meeting minutes dated 2/22/2010 stated under the exit report for EHR documentation "Observed lost, misplaced, or unscanned records, providers lacking documentation in EHR".
















04748


Based on staff interview, record review, governing body meeting minutes review, and medical staff by laws review:

The governing body failed to grant privileges and credentials per policy for 2 of 11 providers (staff Y and HH).

The governing body did not ensure a system to provide laboratory services.

The governing body failed to ensure polices and procedures were reviewed and updated.

The governing body failed to ensure accurate, secure, confidential and accessible clinical records including EHR (Electronic Health Records).

The Condition of Participation of Organization Structure was not met as evidenced by the following findings:

Medical Staff Privileges

1. The governing body minutes dated 9/14/10 noted approval of Staff (Y), for two year reappointment to the medical staff as a courtesy locum tenens and approval of clinical privileges. The previous clinical privileges expired on 9/14/2010. The new application was noted as complete.

a. The request for privileges in family medicine signed by Staff Y on July 26, 2010 did not include a request or recommendation for privileges included in the emergency medicine core.
The clinical reference questionnaire for Staff (Y) lacked evaluation of clinical knowledge, clinical competence, character, judgment, and review of clinical practice. Eighteen of twenty clinical reference questions did not have a response concerning the suitability of the applicant, Staff (Y).

2. The facility list of providers dated 8/4/2010 identified Staff as a locum with a specialty in ER (emergency room) and staff (HH) as a certified registered nurse anesthetist.

a. On 9/16/2010 at 4:00 PM the surveyor requested the credential and privileging file for Staff (HH) from the medical staff credentialing coordinator. The medical staff credentialing coordinator stated that the credentialing and privileging file for Staff (HH) was not found.
During an interview on 9/16/10 at 6:00 PM, the clinical director confirmed Staff (Y) worked in the emergency room as a locum emergency room physician and Staff (HH) worked at the facility as a CRNA on a regular basis.

On 9/16/2010 at 6:00 PM the current completed privilege and credential files for Staff (Y) and Staff (HH) were requested from the medical staff credentialing coordinator, the clinical director, and the medical director.

The current completed privilege and credential files for Staff (Y) and Staff (HH) were requested at the survey exit on 9/17/2010 at 10:00 AM. The facility did not provide additional documentation.

Laboratory Tests

1. On 9/15/10 at 2:30 PM, in an interview with the Director of Nursing (DON), the following concerns about the care provided to patient #22 were discussed:

The failure to obtain a PKU sample from patient #22 and to have a system to ensure that newborn babies are tested for PKU.

The governing body meeting minutes dated 2/22/2010 stated under problem for reference laboratory "many missing lab test reports for the year 2009." and under correct action " Working on obtaining missing lab test reports from 2009."

The failure to draw ABGs on patient #22.

The failure of the Hospital staff, including the Laboratory staff, the Medical Staff, and the Nursing Staff to question WBC results of 0.0 for patient #22.

The governing body meeting minutes dated 2/22/2010 stated under problem in hematology "Analyzer only works in open mode: closed mode has been down for all of 2009- though machine only acquired in 2008. Staff routinely report out WBC results of 0.0 (impossible clinically) because of inadequate monitoring of test results prior to test result verification and completion" and under corrective action "hematology - pending"

2. On 9/13/2010 at 5:10 PM during a interview with the laboratory supervisor, the surveyor requested a list of the laboratory tests available onsite to include test performed on a stat basis. A list was not provided by exit on 9/17/2010 at 10:00 PM. The laboratory supervisor stated that the tests on the computer screen and was not able to print the test list. Medical staff had not approved a stat test list.

3. The governing body meeting minutes dated 2/22/2010 stated under problem "No lab resource for lab computer problems at Crow.... no service unit access to EHR (electronic health record) training or creating menus or obtaining particular access to needed areas of EHR. Much outdated information in RPMS which impacts proper test ordering in both RPMS and EHR."

4. On 9/16/10 at 5:05 PM, in an interview with the Medical Director and the Chief of Staff, the above concerns related to patient #22's care was discussed.

5. The governing body meeting minutes in a mock survey report dated 5/13/2010 on page 25 reported that the occult blood test is done by providers. The CAH did not have a laboratory certificate to cover this test. Nursing management planned to obtain a CLIA certificate for this test"

6. On 9/17/2010 at 10:00 AM, the facility did not provide a CLIA certificate for the occult blood test.

Based on record review and interview, the CAH failed to have a policy to notify the CMS regional office when the appointed chief operating officer (CEO) changed for six of six CEO appointments. The findings included:

1. CMS records for the facility listed Staff (Z) as the administrator. On 9/13/2010 at 3:40 PM the current chief operating officer (CEO) Staff (EE) stated that the appointment as CEO occurred in May 2010. Governing body meeting minutes for 6/15/2010 and 7/15/2010 noted Staff (EE) as the acting CEO.

2. Governing body meeting minutes for 5/13/2010 noted Staff (BB) as the acting CEO.

3. Governing body meeting minutes for 4/29/2010 noted Staff (FF) as CEO.

4. Governing body meeting minutes for 2/22/2010 and 3/16/2010 noted Staff (AA) as the acting CEO.

5. Governing body meeting minutes for 9/11/2009 noted Staff (DD) as the CEO.

6. Governing body meeting minutes for 8/19/2009 and 9/15/2009 noted Staff (CC) as the CEO.

7. The facility governing body bylaws stated at Article III page 3, "The Chief Executive Officer is the Service Unit Director and is responsible and held accountable for the administrative and operation activities of the health center and service unit." The governing body bylaws provided lacked approval signatures and date of approval for 9 possible signatures, the area director, area chief executive officer, area chief medical officer, service unit CEO, clinical director, chief medical officer, administrative officer, director of nursing, and performance improvement coordinator.

Based on an interview, the CAH did not have a method to report changes to the position of medical director to the Centers for Medicare and Medicaid Services (CMS) Regional Office. The findings included:

The current medical director stated that the appointment as medical director occurred four years ago and was not aware if the change was reported to the CMS Regional Office.

During the survey exit with chief executive officer and medical chief medical officer on 9/17/2010 at 10:00 AM, the survey team coordinator requested information to show that the change in medical director was reported. No further documentation was provided.

Based on record review and staff interview, the CAH failed to ensure that staff qualifications and staff responsibilities were met. The Condition of Participation of Staffing and Staff Responsibilities was not met as evidenced by the following findings:

1. Failure to have ancillary personnel supervised by professional staff. Refer to C252

2. Failure to ensure that the medical staff, including the physicians and midlevel practitioners participate in developing, executing, and periodically reviewing the written policies and procedures. Refer to C258, C264, and C265.

3. Failure to have a functioning, hospital-wide Quality Assessment and Quality Assurance program to review the care provided to the patients. Refer to C330

Based on interview and organizational chart review, the CAH did not appoint a member of the professional staff to supervise three departments - laboratory, radiology, and Pryor Health Center. The findings included:

During an interview on 9/14/2010 at 9:45 AM, the supervisory medical technologist reported that Staff (MM) was the supervisor of the laboratory staff.

During an interview on 9/14/2010 at 4:15 PM, the supervisory diagnostic radiology technologist reported that Staff (MM) was the supervisor of the diagnostic radiology staff.

During an interview on 9/15/2010 at 2:20 PM, the clinical director and the chief of staff reported that Staff (MM) was not part of the professional medical staff and not on the organizational chart as professional staff.

The organization chart showed a supervisory health specialist as the direct line of responsibility for three diagnostic radiology technologists and the diagnostic radiology technologist supervisor; for seven medical technologists and the medical technologist supervisor, and for 1 medical technologist at Pryor Health Center.

During the entrance conference on 9/13/2010, the surveyor requested a list of all staff with their titles.

During an interview on 9/15/2010 at 10:10 AM, the surveyor requested the organizational chart with all staff and their organizational titles. The facility provided the organizational chart with an approval date of 7/22/2008 on 9/15/2010 at 10:45 AM. The staff list was not provided prior to exit on 9/17/2010.

Based on interview and record review, the CAH failed to ensure policies and procedures were reviewed periodically by the medical doctor. The findings included:

On 9/17/2010 at 7:35 AM during an interview, the chief medical officer reported no review of policies and procedures in the four years as the chief medical officer.

During an interview on 9/17/2010 at 9:00 AM, Staff (II), quality assurance, reported that an annual review was not done since 2007.

The facility did not have a process for periodic review of policies and procedures.

Based on interview and record review, the CAH failed to ensure policies and procedures were reviewed periodically by the medical doctor. The findings included:

On 9/17/2010 at 7:35 AM during an interview, the chief medical officer reported no review of policies and procedures in the four years as the chief medical officer.

During an interview on 9/17/2010 at 9:00 AM, Staff (II), quality assurance, reported that an annual review was not done since 2007.

The facility did not have a process for periodic review of policies and procedures.

Based on interview and record review, the CAH failed to ensure policies and procedures were reviewed periodically by a physician's assistant or mid level practitioner. The findings included:

On 9/17/2010 at 7:35 AM during an interview, the chief medical officer reported no review of policies and procedures in the four years as the chief medical officer.

During an interview on 9/17/2010 at 9:00 AM, Staff (II), quality assurance, reported that an annual review was not done since 2007.

The facility did not have a process for periodic review of policies and procedures.

Based on record review and staff interview, it was determined that the CAH failed to have current approved policies and procedures (P/P) hospital-wide and to provide direct patient care based on established P/P. The Condition of Participation of Provision of Services was not met as evidenced by the following findings:

1. Failure to have current, approved P/P as evidenced by:

a. On 9/16/10 at 3:53 PM, review of the policies and procedures (P/P) for the Nursery revealed dates/review dates ranging from 1990s to 2000s. Review of the P/P for Inpatient - Labor, Delivery, Nursery, & Post Partum had a signature page dated 3/2005.

b. On 9/16/10 at 5:05 PM, in an interview with the Medical Director and the Chief of Staff, they revealed that the online P/Ps were started by the previous Chief Executive Officer (CEO). These P/Ps have been online about one and a half years but have not been approved. They verified that the Emergency Department (ED) P/P manual (printouts of the online P/Ps) were not approved. Additionally, they indicated that they were not aware of which Departments had developed updated P/Ps.

c. Review of nursing policies documented the last date reviewed or revised as 2/2007. The physical therapy department policies and procedures were last reviewed and approved by the clinical director on 3/2004.



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e. A review of the facility policy and procedures for Pharmacy Services was made on 9/14/2010. This review found that the Pharmacy Policy and Procedures provided to the survey team for inspection had last been reviewed and updated on 2/16/2006, according to the signature page located at the front of the policy book.

f. An interview with the facility's Pharmacist (KK) was conducted on 9/16/2010 at 2:30 PM. The Pharmacist was asked if there was a more updated version of the Pharmacy Policy and Procedures for the facility. The Pharmacist stated there was not and confirmed that the Pharmacy Policy and Procedure book reviewed by the team was the current policy the Pharmacy Department was following.



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d. On 9/14/10 at 8:30 AM during the tour of the surgery department Nurse (J) was asked if there were current policies and procedures regarding the issues identified with outdated or unusable drugs. He reported that there were some polices and procedures for the surgery department on line. However those policies and procedures had not gone through the facility's approval process.


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g. On 9/16/10 at 3 PM Staff (MM) provided on line policies regarding EHR (electronic health records) and stated that they were the official policies. The policies were dated May 2007.

h. On 9/16/10 at 5:05 PM, in an interview with the Medical Director and the Chief of Staff, they revealed that the online P/Ps were started by the previous Chief Executive Officer (CEO). These P/Ps have been online about one and a half years but have not been approved.

Refer to C273, C274, C276, C278, C279, C280.

2. Failure to provide patient care. Refer to C271, C294, and C295.

3. Failure to provide direct services. Refer to C281, C282, and C283.

4. Failure to have services provided through agreements/arrangements. Refer to C291 and C293.

Based on observation, record review, and staff interview, it was determined that the CAH failed to ensure patient privacy and security, monitor patients' status, administer medications as physician ordered and in accordance with manufacturer's directions, and ensure newborns were appropriately identified with their mothers. The findings included:

1. On 9/13/10 at 4:20 PM, during an initial observation of the Emergency Department (ED) in the presence of the Nurse Supervisor for the ED (staff member A), the triage area in the ED was visualized. The Supervisor indicated that the nurse or nurse aide (NA) triaged the patients in the area next to the sign-in desk where the receptionist sat. The nurses' station was located across from this area. The area was open on the side which lead into the ED, preventing the patients from having privacy during their initial triage.
2. On 9/16/10 at 8:35 AM, in a confidential staff interview, the ED staff member confirmed that the triage area lacked privacy for patient intake of information and that some patients do not state their actual health concerns until they are moved into the exam rooms. Additionally, the staff member revealed that there was no security in the area, as anyone can enter through the ED doors, which are not locked.

3. On 9/15/10 at 8:30 AM, in an interview with nurses (D and E), they indicated that patient #1 had a baby. In an interview with the patient's physician (staff member F), he revealed that when a baby is born, the child is banded and footprinted. When the physician was asked about the birth certificate process and how name changes are accomplished, he said that Medical Records (MR) staff do the certificates and the changes of name (if requested).

4. On 9/15/10 at 11:05 AM, in an observation made of a newborn baby (#2) in the nursery with nurse (H), it was revealed that the baby had name bands on each ankle. The nurse said that the policy states to place a name band on one wrist and one ankle. However, she commented the wrist band always fall off the wrist. The nurse said that the baby is banded at the time of birth. The nurse was observed placing bracelets on the baby's mother and father (the mother was not banded at the time of birth but several hours later).

5. Review of the Emergency Department (ED) Log for 3/2/10 evidenced that patient #38 was seen in the ED for seizures.

Review of the provider (V)'s documented summary of the patient's ED Course evidenced that the "patient received a total of 3 milligrams (mg) of Ativan and stopped after the 3rd mg of Ativan. He then was loaded with IV Cerebrex d/t his subtherapeutic dilantin..." The Impression was noted to be seizure disorder, subtherapeutic dilantin level, traumatic brain injury, and alcohol abuse.

Review of the Urgent Care nursing notes revealed the following:

Vital signs (no temperatures) and oxygen saturation timed at 9:00 PM, 9:45 PM, 10:30 PM, 12:30 AM, and 1:00 AM.

IV Medications given included:

Ativan 2 mg at 8:59 PM
Ativan 1 mg at 9:20 PM
Ativan 1 mg at 9:30 PM
Total of 4 mg of Ativan

Cerebyx 750 mg started at 9:45 PM and stopped at 10:00 PM.

No monitor strips were found in the ED documentation.

Nursing 2010 Drug Handbook, Lippincott: Administration of IV Cerebyx - "...Monitor patient's ECG, blood pressure and respirations continuously during maximum phenytoin level - about 10 to 20 minutes after end of fosphenytoin infusion. Severe CV complications are most common in elderly or gravely ill patients. ..."

There was no evidence to show that patient was monitored during and after the administration of this medication. Additionally, there was no documentation to clarify why the provider noted that the patient was given 3 mg of Ativan, but the nurse charted that she gave 4 mg.

6. Review of patient #39's ED Log and Summary form (individual printout) revealed the following:

Visit time of 4:04 PM; Triage time of 4:06 PM; Physician time of 4:10 PM; No disposition; No departure time; Chief complaint of "aching stomach and fell in the shower".

Review of the patient's Emergency Services - Urgent, which included triage information evidenced the following:

Chief complaint - "Fell in shower c/o (complained of) R (right) hip pain, sm (small) bruise on L (left) buttox. Migrain HA (headache) just started".

Vital signs, no weight; pain rating of 10/10, oxygen saturation, glucose of 83.

Note at 4:20 PM - "fell and hit floor; L hip hurts".

Provider Orders - D(dextrose)10 @ 50 cc (cubic centimeters) hr (hour)/2 hrs.

Purpose of Visit was L (left) hip fracture to be transferred in stable condition.

Review of the physician note, which was signed at 5:55 PM evidenced the following:

Active Problems included diabetes, type II, chronic kidney disease and ESRD on Hemodialysis.

Laboratory results with numerous abnormal values including critically low sodium (121), low hemoglobin and hematocrit, chloride, calcium, albumin and high urea nitrogen, creatinine, potassium (5.6), and alkaline phosphatase. No additional laboratory results were provided.

Impression was noted to be hip fracture, dialysis patient. "Disc (discussed) with dr ____(name) who accepts".

No additional physician documentation was provided.

Review of the Urgent Care nursing notes evidenced the following:

4:10 PM - start of notes, telling that the patient was assisted to bed and an IV (intravenous) was started.

Next entry was at 6:37 PM and included vital signs (minus temperature) and oxygen saturation. The note was "States hip feels better after pain meds 'but I can still feel some'. Discussed plan to give IV just prior to EMS transfer."

7:07 PM - "Resting with leg elevated on pillow. Family at bedside."

7:40 PM - vital signs (minus temperature), oxygen saturation, and pain rating of 9/10 (first documented since triage pain level of 10/10).

8:55 PM - "Pt c/o nausea. order from Dr. (W) for Zofran 4 mg IV."

9:12 PM - vital signs (minus temperature), oxygen saturation, and pain rating of 10/10. "... preparing for transport with EMS."

9:25 PM - "Report to _______(name) RN at _______(name of hospital) ER."

The medications which were charted as given were documented as follows:

5:45 PM - Fentenyl 50 mcg (microgram) IM (intramuscular) R hip

6:20 PM - Zofran 4 mg IVP (intravenous push)

7:07 PM - Fentanyl 50 mcg IV

7:50 PM - Fentanyl 50 mcg IV

8:03 PM - D10 50 cc/hr IV

8:55 PM - Zofran 4 mg IV

9:20 PM - Fentanyl 50 mcg IV.

Review of the patient's "All Medications for Last 180 Day(s) evidenced the pharmacy had the following medication orders dated 3/1/10:

Fentanyl 100 mcg/2 ml (milliliters) with Sig (direction) "Inject 25 mcg intravenously now"

Fentanyl 100 mcg/2 ml (milliliters) with Sig "Inject 50 mcg into the muscle now"

Fentanyl 100 mcg/2 ml (milliliters) with Sig "Inject 50 mcg intravenously now"

Ondansetron (Zofran) 2 mg/ml with Sig "Inject 4 mg (2 ml) intravenously now".

There was no documentation to show that the patient's level of pain was assessed (using the hospital's pain scale) before and after pain medication was given. The doses of medication differ from the doses provided by the pharmacy (based on physician orders).

7. Review of patient #40's medical record revealed that on 5/31/10 the patient was brought to the ED for a head injury. The patient arrived via ambulance with CPR in progress.

Review of the Cardiac Arrest Record evidenced that the patient was given Atropine and Epinephrine twice each in the ED. No other medications were charted to have been given.

Review of the patient's "All Medications for Last 180 Day(s) evidenced the pharmacy had the following medication orders dated 5/31/10 and ordered by a Nurse Practitioner (SS):

Diphenhydramine 12.5 mg/5 ml syrup with Sig "Take 25 mg (10 ml) by mouth every 6 hours if needed for cough/cold symptoms".

Triamcinolone 40 mg/ml injection with Sig "Inject 40 mg (1 ml) into the muscle now".

The surveyor requested the patient's entire medical record for 5/31/10. There was no evidence that Diphenhydramine (antihistamine) or Triamcinolone (steroidal anti-inflammatory) were given to this patient. It was unclear why these medications were signed out to this patient.

Based on interview and record review, the CAH failed to provide a description of current services furnished directly and indirectly through agreement or arrangement. The findings included:

The facility Plan for Patient Services dated 02/07 table of contents listed patient care services in appendix A, patient support services in appendix B and affiliated organizations providing patient care and patient care support services in appendix C.

Under the patient care service offered, laboratory, the list of laboratory tests offered did not include type and crossmatch, pregnancy tests, hemoccult for occult blood in stool specimens, or primary culturing for transmittal to a certified laboratory.

The surveyor requested a list of all services provided by the CAH at the entrance conference on 9/13/2010 at 3:40 PM.

The surveyor requested a list of laboratory services provided by the facility from the laboratory manager on 09/13/2010 at 5:10 PM, the clinical director and the chief medical officer on 09/15/2010 at 2:55 PM, and from the Staff (II) on 09/17/2010 at 9:00 AM.
The CAH did not provide by the survey exit conference on 09/17/2010 at 10:00 AM a list of affiliated organizations or appendix C.

Audiology was listed on the Medicare database worksheet as provided by arrangement or agreement. The emergency department, laboratory, pharmacy, psychiatric services in emergency, forensic, geriatric, and outpatient, and social services were listed as provided through a combination of facility staff and through agreement on the Medicare database worksheet.
At the time of survey exit on 09/17/2010, the facility had not provided a current policy reflecting the services offered by the CAH and the services offered through agreements or arrangement.

Based on record review and staff interview, it was determined that the CAH failed to have current, approved policies and procedures for the provision of emergency medical services. The findings included:

On 9/14/10 at 8:15 AM, in an interview with the Director of Nursing (DON), she revealed that the Emergency Department (ED) policies and procedures (P/P) were online. She verified that these P/P had not been approved.

Copies of the online ED P/P were reviewed. These P/Ps were not signed or dated as approved P/Ps.

Based on observation, staff interview, and record review, it was determined that the CAH failed to store and maintain drugs and biologicals in accordance with accepted professional standards. The findings included:

1. On 9/14/10 from 8:30 AM until 11:30 AM, a tour of the surgery department was completed with the OR (operating room) supervisor, Nurse (J). The following issues were identified:

a. A review of the emergency "Malignant Hyperthermia Kit" stored on a cart between the two operating rooms was found to have outdated medications which included:

Mannitol 50 milliliters (ml) - five bottles with expiration dates of March 2010,

Lasix 2 ml -seven bottles with expiration dates of February 2010,

Sodium Chloride 20 ml bottle with expiration date of May 2010,

Also four 1000 cubic centimeters (cc) IV bags of Sterile Water dated July 2010.

b. Interview with Nurse (J) confirmed that the medications were outdated and confirmed that pharmacy and the OR staff were responsible for ensuring outdated and unusable drugs were not available for patient use.

c. Additionally, Nurse (J) was asked if there were current policies and procedures regarding the issues identified; outdated or unusable drugs and unsecured medications. He reported that there were some polices and procedures for the surgery department on line. However, those policies and procedures had not gone through the facility's approval process.

2. Observation was made of the general inpatient unit on 9/13/2010 at approximately 4:00 PM. Inspection was made of the primary drug storage area for the unit. This included a refrigerator used for the storage of medications used by patients on the unit.

Observation was made of a bottle of "VASHE" wound therapy. The bottle had been opened and was not dated. Directions on the bottle stated that the contents were to be used within five days of opening. The charge nurse (PP) for the unit at the time of the observation stated that the bottle should have been dated when opened per the facility policy.

Based on staff interviews, record review, and review of the infection control tracking, the CAH failed to have a facility wide IC (infection control) in place to ensure early detection, control and prevention of infections in the facility. This failure created a potential for negative patient and staff outcome and spread of infections within the facility. The findings included:

1. On 9/16/10 at 3:00 PM, an interview with nurse (UU) identified as the Infection Control Coordinator was conducted. She confirmed she was assigned the duties of ICC. However she did not cover all departments. She reported she had been detailed from April 2009 to December 2009 to do infection control. Then she was reassigned in April 2010 until present as ICC and that her contract would be ending soon. She reported she had six days of orientation to the position by the prior ICC but has not had any formal training in infection control.

The current surveillance program involved her picking up and reviewing lab reports once a week and logging those patients identified with infections. The tracking of patients coming through the outpatient departments and emergency room were not being tracked through the infection control program. She reported that those areas would come under Public Health. Additionally she was keeping a log for MDRO (Multidrug-resistant organisms) infections for MSRA (methicillin-resistant Staphylococcus aureus).

She stated, "I don't really get involved with those areas that fall under Public Health. The dietary area is the same thing. I don't get informed or consulted with issues with food safety or food borne illness."

ICC was informed of the issues found in the dietary department which included " Healthshake "not being dated when thawed. The label on the Healthshake stated, "Thaw under refrigeration 40 degrees or below. After thawing keep refrigerated USE within 14 days after thawing." Staff in dietary reported the Healthshake had been in refrigerator for approximately 2 months and were not aware of the label "USE within 14 days after thawing." The use of the product out side of the label recommendation has a potential for food borne illness.

Further interview with the ICC revealed she had attempted to do chart reviews and audits for infection control but found charts were incomplete. She reported difficulty in finding information in either the paper records or EHRs (electronic health record) to do any type of audit.

2. Review of the infection control tracking sheets provided included:

"Nosocomial Investigation & Tracking Log" for 2009 which showed last infection dated 3/24/09. The form indicated it was to be used to track potential and confirmed nosocomial infections and review by the infection control committee. There were no tracking logs provided for 2010 for review during the survey.

"Patient Confirmed Infectious Disease Log, VRE (vancomycin-resistant enterococci), VISA (vancomycin intermediate Staphylococcus aureus), C.difficle etc." had one patient listed on 2/28/09.

[VISA and VRSA are specific types of antimicrobial-resistant staph bacteria. While most staph bacteria are susceptible to the antimicrobial agent vancomycin some have developed resistance. VISA and VRSA cannot be successfully treated with vancomycin because these organisms are no longer susceptible to vancomycin.

Clostridium difficile is a bacterium that causes diarrhea and more serious intestinal conditions.]

3. Review of the "1st Quarter Infection Control Report" from 1/2/2010 to 3/31/2010 identified the following:

0 (zero) healthcare acquired infections,

20 estimated not tracked on log MDRO (Multiple Drug Resistant Organisms),

Communicable disease summary which identified infections including Hepatitis C, Chlamydia, Campylobacter, Gonorrhea and RSV.

The summary did not address actions taken or follow up by the infection control committee.

4. Review of the "2nd Quarter Infection Control Report" from 4/1/2010 to 6/30/2010 identified the following:

0 (zero) healthcare acquired infections,

39 cases of MRSA (methicillin staphylococcus aureus)/all outpatients community acquired skin infections (new and carriers).

The summary did not address actions taken or follow up by the infection control committee.

5. Review of a line listing of MRSA infections showed from 1/1/2010 to 9/10/2010 there were 98 patients identified with MRSA infections. The listing identified education provided to 10 of the 98 patients regarding their infection. There was no further documentation of actions taken or follow up provided for these patients.

There was no evidence provided that the facility ensured that appropriate strategies are fully implemented, regularly evaluated for effectiveness, and adjusted to address in the incidence of these targeted MDROs.

The facility failed to ensure an infection control system was an active program, which includes specific measures for prevention, early detection, control, education, and investigation of infections and communicable diseases that included all departments (CAH-wide) and that are program-specific.

The facility failed to ensure the designated ICC was provided training to oversee the infection control program.

2. A tour of the general inpatient unit was conducted on 9/13/10 at approximately 4:30 PM and an inspection of the unit's nutritional room refrigerator was made at this time.

a. A thawed carton of Resource Health Shake supplement was observed stored in the refrigerator. The carton was not dated or marked in any way to indicate how long it had been thawed.

b. An opened multi-serving size carton of orange juice was observed in the refrigerator. The carton was not dated or marked in any way to indicate how long it had been in the refrigerator.




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Based on staff interview and record review, the CAH failed to ensure nutritional needs of inpatients were met in accordance with recognized dietary practices and safety practices for food handling were followed. The findings included:

1. On 9/14/10 from 2:30 to 3:00 PM, a tour of the dietary department was completed with staff (XX) and dietary staff (VV) and following issues identified:

a. There were approximately 41 Healthshakes setting in the refrigerator. There was no date to show when they had been thawed. The label on the Healthshake stated, "Thaw under refrigeration 40 degrees Fahrenheit (F) or below. After thawing keep refrigerated USE within 14 days after thawing. "Staff in dietary reported the Healthshake had been in refrigerator for approximately 2 months and were not aware of the label "USE within 14 days after thawing." The use of the product outside of the label recommendation has a potential for food borne illness.

b. Staff reported ongoing issues with the dish machine. Staff (VV) reported that when the problems with the dish machine were identified, a work order was sent. However, it took a long time to get it fixed. She stated, "We were told if the rinse got hot enough the wash cycle didn't matter." The dish machine was a hot water temperature machine and was supposed to reach 140 degrees F on the wash cycle and 180 degrees F on the rinse cycle. Review of the logs showed on 1/18/10 wash temperature of 120 degrees F and a note for work order.

The logs showed from 1/19/10 to 1/25/10 the wash temperature did not meet proper temperature and was from 111 to 135 degrees F.

The logs showed from 1/27/10 to 3/29/10 (2 months) the wash temperature did not meet proper temperature and was from 110 to 132 degrees F.

The facility failed to provided timely follow up to ensure dishes and utensils were effectively sanitized to destroy potential food borne illness.

c. On the tour a copy of the current menus being used were provided. Review found the last time the menus were reviewed by the RD (registered dietitian) was 3/31/05. There were no indication that the RD had reviewed or update the menus in the past five years. Staff (VV) confirmed there had been no reviews or changes to the current menus dated 3/31/05.

d. Interview with staff (XX) revealed he had been assigned to oversee the dietary department on 9/13/10. He reported that the RD was on vacation and would be leaving the facility by the end of the month (9/10). He reported he was not a RD but would be overseeing the department until there was a replacement hired. Staff (XX) was asked for any documentation by the RD of recommendations made in the dietary department. However no documentation was provided during the survey.

e. Interview with two staff members on the inpatient unit, who did not want to be identified, reported lack of involvement from the RD for patient education, specifically diabetic patients and patients having nutritional concerns. Staff also reported there has been issues with not having food available for patients between meals. An example was also given of nursing staff having to go out and buy "Pedialyte" for a pediatric patient.

The facility failed to ensure the qualified dietitian supervised the nutritional aspects of patient care which included: current review patient menus, collaborating with CAH services (e.g., medical staff, nursing services, pharmacy service, social work service, etc.) to plan and implement patient care to meet the nutritional needs of the patients, and ensure service and procedures were being followed in the dietary department to prevent food borne illness.

Based on interview and record review, the CAH failed to ensure policies and procedures were reviewed periodically by the medical doctors. The findings included:

On 9/17/2010 at 07:35 AM during an interview, the chief medical officer reported no review of policies and procedures in the four years as the chief medical officer.

During an interview on 9/17/2010 at 9:00 AM, Staff (II), quality assurance, reported that an annual review was not done since 2007.

The facility did not have a process for periodic review of policies and procedures.

Based on observation, interview, and review of the governing body meeting minutes, the CAH failed to perform one of six basic laboratory services with a current Clinical Laboratory Improvement Amendment (CLIA) waiver (hemoccult). Additional necessary laboratory tests were not accurately provided to meet the needs of the patients, examples included, PKU (phenylamine) and WBC ( white blood cells). The findings included:

1. During an interview on 09/15/2010 at 10:30 AM, the laboratory manager reported that the hemoccult, a test for occult blood in stool specimens, was not under the main laboratory CLIA certificate.

2. The governing body meeting minutes dated 5/13/2010 reviewed the findings of a mock survey and stated "Occult blood is done by providers. The waived lab test, CLIA does not cover this test."

3. A CLIA waived certificate was not provided during the exit interview on 9/17/2010 at 10:00 AM.

4. On 9/13/10 at 4:20 PM, during an initial observation of the Emergency Department (ED) in the presence of the Nurse Supervisor for the ED (staff member A), the following observation was made:

Hemoccult supplies (solution and cardboard) were found in the bedside stand drawers in each exam/treatment room in the ED.

5. On 9/15/10 at 9:18 AM, in an interview with Laboratory Director (staff member G) , she explained that the Hospital's CBC analyzer had a history of giving a "0.0" error report on WBC (white blood count) results. She indicated that she thought it was an interface problem and the lab staff need to put the correction in manually. When the surveyor asked if the lab staff had been trained about the error, she said that it was posted. The Lab Director said that no QA (Quality Assessment) had been done for quite a while and it would take years to fix all the issues in the Laboratory.

The Lab Director was asked about how the Hospital ensures that PKU (phenylamine) testing was completed on all newborn babies. She stated that there is no system in the Hospital to ensure that babies are tested and that she finds out when the State calls her to notify her that they had not received results on a given baby.

6. On 9/15/10 at 10:25 AM, in an interview with the Laboratory Director, she confirmed that she had contacted the State and verified that the PKU testing should be done in 24 to 72 hours. Additionally, she verified that at three months of age, the PKU testing was past due.

7. On 9/15/10 at 11:05 AM, in an observation made of a newborn baby (#2) in the nursery with nurse (H), it was revealed that the baby had name bands on each ankle. The nurse said that the policy states to place a name band on one wrist and one ankle. However, she commented the wrist band always fall off the wrist. The nurse said that the baby is banded at the time of birth. The nurse was observed placing placing bracelets on the baby's mother and father (the mother was not banded at the time of birth but several hours after).

8. On 9/15/10 at 2:20 PM, the Laboratory Director provided the surveyor with a copy of the State's letter related to PKU testing. Review of the letter evidenced that "The birth hospital is responsible for obtaining the newborn screen between 24 and 72 hours of life for babies with birth weight > 1500 g (grams). If the screen must be obtained prior to 24 hours, arrangements must be made to get a second screen later. The specimen must be adequate,
which means the birth hospital must arrange for a repeat screen if the first screen was an unsatisfactory specimen. .... We encourage birth hospitals to have procedures in place so all newborns receive both a metabolic (bloodspot) and hearing screen prior to discharge."

Based on interview, observation, and record review, it was determined that the CAH failed to assure that protective aprons used in radiology were checked for safety according to policy. The findings included:

1. On 9/13/10 at 4:20 PM, the facility dentist (staff NN) stated that he kept records of the annual safety check of the patient protective aprons used in the dental clinic. The protective aprons were used to shield the patients from X-rays . The dentist stated that the facility department of radiology conducted the tests and provided documentation. The documentation provided had no title, was from the department of radiology and read, "Subject: Crow Leaded Dental Aprons." It was dated 9/24/09 and signed. The form did not mention the number of adult and pediatric aprons and did not state that they had passed an inspection.

2. On 9/14/10 at 4:15 PM the radiology supervisor stated that his staff was responsible to do the annual safety check of leaded aprons. He stated that he had developed a form for documenting the annual safety check of leaded aprons. The approved form contained the number of aprons, verification that they were safe, a date, and signature. He stated he was unaware that a different form had been used.

Based on record review, the CAH did not provide a current list of services provided by arrangement or agreement. The findings included:

During the entrance conference on 9/13/2010 at 3:45 PM, the surveyor requested a list of contracts, agreements, and arrangements.

The facility provided three lists of vendors. The vendor lists did not describe the nature and scope of services and twelve dates of service for the vendor were not current with the survey dating back to 12/31/2009. The vendor list received on 9/16/2010 at 8:40 AM, did not include arrangements or agreements and did not describe the nature and scope of services.

The facility did not provide a complete list by survey exit conference on 9/17/2010 at 10:00 AM.

Based on governing body bylaws review and vendor list review, the CAH did not demonstrate that services furnished under contractor of services enabled the CAH to comply with all applicable conditions of participation and standards for contracted services. The findings included:

The facility did not provide a current list of contracted services. Cross refer to C291

The governing body bylaws did not identify the chief executive officer as responsible for ensuring contractors of services enable the CAH to comply with CAH conditions of participation and standards.

Based on record review and staff interview, the CAH failed to ensure that nurses were able to meet the needs of the patients. The findings included:

1. On 9/17/10 at 7:53 AM, in a confidential interview with an Emergency Department (ED) staff member, she revealed that the hospital nursing staff, specifically the Medical-Surgical staff, could benefit from training and that less transfers (from the Emergency Department) would have to occur. She commented that years ago patients who required certain procedures, such as insulin drips, chest tubes, etc., could be kept in the Hospital as the nurses were qualified to care for these patients, but now the nurses were not able to provide that level of care.

2. On 9/14/10, the surveyor requested a list of ED nurses and their competencies. This request was made to the ED Supervisor, the Quality Assurance Coordinator, and/or the Director of Nursing daily. As of 9/17/10 at the exit conference, the Administrative staff did not provide documentation to show that any of the CAH nurses' competencies were reviewed.


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3. Patient #18 medical record review revealed the patient was admitted to the facility on 8/3/10 for vaginal hysterectomy.

a. Review of the "Perioperative Nursing Record" dated 8/3/10 had marked "drains/tubes/packing" as none. The record did not have documentation of the vaginal packing left in place upon discharge to the recovery room.

b. Review of the "Nurses Notes" for 8/3/10 showed the patient was brought back from the recovery room at 1545 (3:45 PM). The "Nurses Notes" for 8/4/10 documented that the physician was in to see the patient at 8:00 AM and "vaginal packing removed..." There was no documentation by nursing that the patient's vaginal packing was checked and monitored for bleeding post operatively from admission on 8/3/10 at 3:45 PM until 8/4/10 at 8:00 AM (approximately 16 hours), until the physician removed the vaginal packing.

c. Review of the "Patient Treatment Profile" used to guide the patient's #18 plan of care revealed the vaginal packing was not added to the profile until after it had been removed by the physician on 8/4/10.

d. On 9/15/10 at 11:30 AM interview with Nurse (J) with review patient's medical record and confirmed the operative record was incorrect and did not show the vaginal packing in place upon discharge from the operating room and the nurse notes did not show the patient had been properly monitored post operatively for vaginal drainage and/or bleeding.

4. Patient #24 medical record review revealed the patient was admitted to the facility on 6/28/10 with diagnoses which included: hypoglycemia, diabetes and hypertension, iron deficiency anemia, hypokalemia, and chronic kidney disease. The patient had been admitted from the emergency room with hypoglycemia with blood sugar 32.

a. Review of the medication administration sheet showed that on 6/28/10:

At 1:30 AM the patient received "1 AMP (ampule) D50 (dextrose) IVP (intravenous push)" for BS (blood sugar) of 40 with recheck at 2:00 AM BS 115.

At 3:30 AM the patient received "1 AMP D50 IVP " for BS (blood sugar) of 40 with recheck at 4:00 AM BS 104. There was no documentation of a recheck of the patient's BS for remainder of the shift.

There was no nursing documentation provided to show the signs and symptoms the patient was having with the low BS or if the patient was responsive or other nursing care being provided.

Based on record review and staff interview, it was determined that the CAH failed to ensure that the nursing staff, including the nurse aides, were competent and/or received training to provide care to meet the needs of the patients. The findings included:

1. On 9/14/10 at 9:36 AM, during an interview with the Emergency Department (ED) Nursing Supervisor (staff member A), she confirmed that the nurses and the nurse aides run electrocardiograms (EKGs) on patients.

2. On 9/16/10 at 8:35 AM, in a confidential staff interview, an Emergency Department (ED) staff member stated that in the past, the nurses could "triage" patients (do the medical screen). However, this policy changed with the new Director of Nursing (DON). The staff member revealed that she was not sure who could do the screening due to the lack of guidance which was being provided to the staff currently. She revealed that there was not currently a nurse or diabetic educator and had not been one for quite a while. The staff member said that the ED had two nurse aides (NA) who did vital signs, weights, blood glucose monitoring, EKGs, transport patients, and pull medical records.

3. On 9/17/10 at 9:30 AM, in an interview with the Director of Nursing (DON), nurse education and competency testing was discussed. The DON had been in Hospital since 4/10. She found and provided competency test results for the nurses in 1997. Additionally, she provided a copy of the ED Supervisor's orientation/evaluation file.

4. Review of the "ER Yearly Competencies Checklist" evidenced the following areas/topics that were to be reviewed annually:

Emergency Room Systems

Crash Cart/Peds Cart

Supplies: know what is in each area, how much to stock & where extras are kept

Rapid Sequence Intubation protocols

Drug drip factoring book

Flu Vaccine log

Phone system

IVs (intravenous)

Daily Staff Responsibilities

Policies, procedures, standing orders,

Equipment use.

5. Based on staff interviews and review of the ED nursing schedule, two nurse aides (L and M) were assigned to the ED.

6. The Director of Nursing (DON) was requested to provide a position description for the nurse aides working in the ED. Review of the position description entitled "Nursing Assistant (Outpatient)" noted "May be required to rotate to outpatient and emergency settings within documented competency levels." The description included the following Major Duties and Responsibilities":

"1. ...Activities include, but are not limited to: dressing changes, whirlpool, EKG's and transporting/escorting patient to other departments.

2. ... Activities include, but are not limited to: vital signs and other measurements, blood sugar testing, Snellen eye exams, and assisting with exams and treatments.

6. Administers CPR as appropriate during emergencies. ..."

Additionally, the position description included "Factor II Supervisory Controls", which stated:

"... The employee plans work in accordance with information obtained from the registered nurse and acts independently to complete assignments in accordance with established policies, and procedures.... Work is reviewed for appropriateness, completion and technical accuracy...."

7. Documentation of the competencies of the ED nursing staff were repeatedly requested during the survey. The following information was provided:

No competencies completed on the two nurse aides (L and M).

No evidence was provided to show that competencies were evaluated for the ED nursing staff.

Review of the "Required Nursing Education/Nursing License" documentation revealed the following:

ACLS - Two nurses (I and K) were "due" - both expired 3/10

PALS - One nurse (N) was "August, 2010"

ENPC - Three nurses (N, O, and P) were "due"

NRP - Six (Q, K, R, N, O, and A) of seven nurses were not listed as having this

ATCN - Six (Q, K, R, N, O, and A) of seven nurses were not listed as having this.

Based on interviews and records reviews, the CAH failed to ensure author identification in the electronic health records (EHR) system and failed to maintain accurate, complete medical records. The Condition of Participation of Medical Records was not met as evidenced by the following findings:

1. On 9/13/10 at 4:00 PM, the Ophthalmologist stated that he had medical students in his area during the last year. They had trouble gaining access to the electronic clinical records to write and sign notes. He stated that he submitted written permission to allow access but it was not granted until the last week of their study at the facility. He stated that he had reported the problem but there was only one person in control of the system.

2. On 9/14/10 at 2:00 PM, the information systems officer (ISSO) for the facility stated that she was responsible for the final steps in granting author identification and access to the electronic health records system. She provided two documents which she identified as the policies and procedures for author access to electronic clinical records. The first document was titled: Indian Health Service Office of Information Technology Division of Information Security, General User Security handbook, SOP 06-11a, Updated July 20, 2009. The second document was titled: Indian Health Service Office of Information Technology Division of Information Security, Information Technology Access Control (ITAC) System, December 2009.

The ISSO stated that she followed ITAC policy when granting access to new employees. The ITAC policy in section 5.1 lists 4 roles : supervisors, approvers, granters, and administrators. She stated that after a supervisor completes a written form requesting access for a new employee, she would complete the next 3 roles.

The ISSO was unable to produce original requests for access which she granted during the last year . She stated that she had no quality assurance data regarding the time it took to grant access to new employees.

The first document (SOP06-11a) stated on page 8 that the ITAC form (requesting access) is considered an administrative record and should be retained for two years. In addition, the original form and any subsequent forms should be in easily retrievable files. The ISSO could provide no records to show that this provision of their policy was met.


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3. On 9/16/10 at 8:35 AM, in a confidential staff interview, an Emergency Department (ED) staff member reported that nurses are required to do peer review on other ED nurses. The staff member indicated that the medical records were disorganized and incomplete. The hard copies of records were not always scanned into the computer, and the Medical Records staff were not able to find the paper versions. The staff member revealed that the hard copies were filed in boxes in a storage shed. According to the staff member, the lack of the complete medical record made the task of peer review impossible.

4. On 9/16/10 at 1:00 PM, in an interview with the Medical Records (MR) Supervisor (Staff QQ), she revealed that she had been in this position since 4/10. She confirmed that the medical records were kept for three years and then they are archived. She had not been aware of the outside medical record storage area, but she obtained a key from maintenance staff for the surveyor to observe the area.

5. Review of the Multidisciplinary Trauma Committee - 19 May 2010 report evidenced the following:

"Missing medical records - Entire visits missing from pts (patients) hard charts. ER (emergency room) to scan any paper charts prior to sending to medical records. Target Date - June 11."


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6. Interview with the Medical Records Supervisor (QQ) on 9/16/10 at 1:20 PM reported that problems with EHR had been identified. She had started in the facility in April and was given a list of "Critical Department -Corrective Action" from 3/12/09. She had attempted to have a meeting, however could not get attendance and get active participation to help get the issues addressed and corrected.

7. Review of the "EHR Team Meetings" showed the meetings for July 20, 2010 and August 31, 2010 had been cancelled. The August 31, 2010 blank sign in sheet had an attached list which identified issues with included:

NO notes in EHR, wrong notes on patients, poor documentation in EHR,

Lab training no notes in EHR for orders and a process for Lab Only visits needed,

Departments need to have an action plan for when EHR is down.

8. Refer to C302 and C308.

Based on record review and staff interview it was determined that the facility failed to maintain medical records in a systematically organized, readily accessible, accurately documented, legible and compete manner. The findings included:

1. On 9/15/10 at 8:30 AM, in an interview with nurses (D and E), they verified that patient #1 delivered a baby 14 minutes after arriving on the Obstetric (OB) floor. Nurse (E) delivered the baby, who had a nuchal cord times one (cord wrapped around the baby's neck one time). Nurse (D) commented that the patient had received prenatal care at the Lame Deer clinic, so the Hospital staff did not have access to her records.

2. On 9/15/10 on 9:00 AM, the medical record for patient #22 was reviewed. A page with medical information from patient #41's record was incorrectly filed in patient #22's record.

3. Record review for patients seen in the Emergency Department (ED) revealed that the medical records were a combination of electronic (EHR) and hard copy records. A sample of 27 records were requested for the ED. Partial records were provided to the surveyor. After four days of the staff repeatedly being requested to provide the complete medical records for the 27 patients, the patients' medical records were found to be inaccurate and/or incomplete. The following were examples:

a. Patient #35 was seen in the ED for "bloating, nauseated, pain stomach, feet swollen" and "abdominal pain"on 8/28/10 and on 8/30/10, respectively. Based on the ED log, the 8/28/10 visit lasted from 11:52 PM (on 8/27/10) to 2:00 PM and the patient was discharged home. The 8/30/10 visit lasted from 7:27 AM to 2:00 PM when the patient was transferred to another hospital. The medical record lacked documentation to show nursing assessments, medication administration, and nursing notes. There was no evidence of the care and treatment during the patient's stay in the ED.

b. Review of the documentation related to patient #34's 6/15/10 Emergency Department (ED) visit evidenced the following discrepancies in the documentation:

ED log - Time of visit 2:23 AM; Presenting complaint was chest pain.

Cardiac Arrest Record - Arrival ED 1:43 AM; Diagnosis Cardiac Arrest; Time CPR concluded 1:45 AM.

Physician note - Patient presented around 1:30 AM and code called at 1:45 AM; Visit time 2:23 AM.

c. Review of the ED log for patient #9's 8/6/10 visit revealed that the patient's visit time was 3:47 AM and the departure time was 4:35 AM (a total of 48 minutes). The chief complaint was a "mvc" (motor vehicle accident). The log indicated that the patient was transferred to another hospital.

Review of the patient's "Emergency Department Adult/Pediatric Trauma Record" evidenced that the patient arrived at 3:03 AM and departed at 4:35 AM. Additionally on this same form, another patient's name, birthdate, medical record number, allergies, and current medications were crossed off (marked through with single or double lines) with no initials noted to determine who made the changes. Patient #9's name, birthdate, medical record number, allergies, and current medications (none) were written in next to the crossed off information. The date of the last DT (diptheria tetanus) immunization was written over.

A Nurse Note documented that the patient had been incorrectly identified when she arrived in the ED.

Review of the ambulance report from the ambulance that transported the patient to this hospital evidenced that the correct patient name and information (including allergies) was documented. It was not clear where or when the information was changed.

The surveyor requested a copy of the written orders for this patient. The Laboratory Director was unable to find the written orders for the labs which were drawn for this patient on 8/6/10. The system noted that the labs were drawn at 2:30 AM (prior to when the patient arrived in the ED). The following problems were identified by the Laboratory Director:

"No SF-518 could be located that corresponded to the Type & Screen order; Type & Screen results were written in Blood Bank logbook.

Chemistry results are missing from the machine printout...

Blood gas results ... are missing ...

CBC results - no printout or record in the analyzer...

Report stating 'No ID' corresponds to the results...

No downtime forms for U/A (urinalysis) or drug screen results.

No printout from ..... for urine results."


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6. On 9/15/10 at 11:00 AM, the facility pharmacist (staff KK) stated that the facility had two places that a drug allergy could be noted in the electronic health record. The pharmacy had a separate electronic record system which did not directly share information with the medical record. The pharmacist stated that she could not find a policy for records reconciliation related to drug allergy data. The records for patient #37 were reviewed and an allergy to penicillin was noted on the pharmacy record but not on the medical record. This created the potential for a preventable medication error.




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4. A record review was completed for patient #26 on 9/15/2010. The record documented that the patient was admitted to the facility on 9/3/2010. Review of the Medication sheet for the period from 9/3/2010 through 9/16/2010 for this patient found that facility staff were not documenting the results of the effect of pain medications, anti-anxiety and antiemetic medications in 30 of 125 medication passes where these medications were administered.

5. A record review was completed for patient #31 on 9/15/2010. The record documented that the patient was admitted to the facility on 9/3/2010.

a. Review of the Medication sheet for the period from 9/3/2010 through 9/16/2010 for this patient found that facility staff were not documenting the results of the effect of anti-anxiety medications in one of three medication passes where these medications were administered.

b. Review of the Medication sheet for insulin administration for the period from 9/3/2010 through 9/14/2010 found that the patient was ordered a sliding scale insulin dosage that included insulin to be administered if blood sugars for the patient were tested at 151 milligrams per deciliter (mg/dl) or above. For the dates and times of 9/3/2010 at 10:00 PM, 9/6/2010 at 9:50 PM, 9/12/2010 at 8:35 PM, 9/13/2010 at 9:30 PM the blood sugars were all documented to be over the 150 mg/dl. In each instance there was no insulin documented to be given and no explanation as to why no insulin had been administered to the patient as ordered.

2. Interview with Medical Records (QQ) supervisor on 9/16/10 at 12:55 PM revealed closed records were being kept in an outside trailer. She reported that she had just found out about the records kept in another location when medical records was looking for an old patient chart.

3. Medical records staff (QQ) accompanied the surveyor to the maintenance area where the maintenance staff reported the trailer was at the back of the property and proceeded to the trailer. The trailer was approximately 40 feet in length. Upon arriving at the trailer, the maintenance staff (RR) found the trailer was not locked and opened the doors.Upon inspection of the trailer, patient records were found. The medical records supervisor verified that these were patient records. The example of patient records included:

10 bound ER (emergency) log books contained patient names, identification numbers, and diagnoses,

20 boxes of scanned patient information from 2003-2005 and 2006,

21 boxes of deceased patient records,

70 file boxes of patient records,

58 large boxes of patient records.

4. Interview with maintenance staff (RR) reported that the trailer was supposed to be locked and that the four maintenance staff did have the keys to the trailer.

The facility failed to ensure patient records are kept secured from unauthorized use and are only viewed when necessary by those persons having a part in the patient's care.





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Based on observation and staff interview, the facility failed to ensure that clinical records were safe and prevent unauthorized access. The findings included:

1. On 9/13/10 at 4:20 PM, during an initial observation of the Emergency Department (ED) in the presence of the Nurse Supervisor for the ED (staff member A), the door which led into the Medical Records (MR) Department was visualized. The nurse was asked about how the ED staff obtained records when the MR staff were not present in the hospital. She said that the MR Department was open 7:30 AM to 6:00 PM and that when the Department was closed, a nurse or nurse aide could access the MR Department and remove the records. The door had a key pad, instead of a key type lock.

Based on observation, record review, and staff interview, it was determined that the CAH failed to ensure acceptable standards of practice for surgical services were followed for surgical counts. This was related to surgical counts for items which included sponges, swabs, instruments, and sharps. The Condition of Participation of Surgical Services was not met as evidenced by the following findings:

1. During tour of the operating rooms (OR) with nurse supervisor (J), on 9/14/10 at 8:30 AM, it was reported that counts for sponges, sharps and instruments were documented on a "Perioperative Nursing Record". A second form was used for the instrument counts which was placed on each instrument pack when set up. The form identified as an "Instrument Count Sheet" was not kept and did not become part of the patient record.

2. Review of the Perioperative Nursing Record currently being used has an area identified as "Counts". There is an area to check a box for None or write the number of counts. There are other boxes to check for Sponge, Needles, Blades, Instruments and other. Under these boxes there is a box to indicate the count was correct with options of yes or no and action taken.

3. Review of four of seven surgical patient records (#17, #18, #19 and #14 ) and interview with nurse (J) confirmed the surgical counts were incomplete. The findings included:

a. Patient #17 (tonsillectomy) no documentation of tonsil sponges opened. Interview with Nurse (J) confirmed tonsil sponges are opened on all tonsil cases and should be counted and documented in the patients report.

b. Patient #18 (vaginal hysterectomy) did not have documentation of the vaginal packing left in place upon discharge to the recovery room. The count did not show the actual count for sponges used.

c. Patient #19 (suction dilatation and curettage) the count sheet identified the number of counts as 2 for sponges and needles. However, no indication that final count was correct (not marked).

d. Patient #14 (vaginal hysterectomy) did not have documentation of the vaginal packing left in place upon discharge to the recovery room.

4. On 9/15/10 at 11:30 AM during an interview with Nurse (J), he reported there were some polices and procedures for the surgery department online. However, those policies and procedures had not gone through the facility's approval process. There were no approved policy and procedures for surgical counts related to sponges, sharps, and instruments.

5. Refer to C321.

Based on staff interview and record review, the CAH failed to maintain a current roster listing each practitioner's specific surgical privileges in surgery and the area where the scheduling of surgical procedures is done. The findings included:

During tour of the operating rooms (OR) with nurse supervisor (J), on 9/14/10 at 8:30 AM, it was reported there was a list of the types of surgeries performed in the department. However, the list did not identify the practitioners and each of their specific surgical privileges.

At the time of exit on 9/17/20210 at 10:00 AM, there was no documentation provided to show a list of practitioners and each of their surgical privileges.

Based on interview and record review, the facility did not conduct a periodic evaluation of the total program and did not have an effective quality assurance program. The Condition of Participation of Periodic Evaluation and QA Review was not met as evidenced by the following findings:

The facility did not provide a review of the total program prior to survey exit on 9/17/2010 at 10:00 AM. Cross refer to C331, C332, C333, C334 and C335.

The facility did not provide evidence of an effective quality assurance program prior to survey exit on 9/17/2010. Cross refer to C336.

Based on interview, the CAH did not conduct a yearly review of the total program for three of three years (2008, 2009, and 2010). The findings included:

During the entrance conference on 9/13/2010 3:35 PM, the surveyor requested a copy of the annual program evaluation to include policies and procedures, minutes from meetings, and reports.

On 9/16/10 at 12:18 PM, in an interview with the QA Coordinator, she revealed that she had been in this position and actually worked 3/3/10 to 4/9/10 and 5/1/10 to current. She confirmed that this was her first position related to doing QA in a hospital.

On 9/17/2010 at 9:00 AM, the quality assurance coordinator reported starting the quality assurance position in May 2010. The last annual review occurred in 2007. The most recent medical staff data was from 2007.

The facility did not provide annual evaluations for 2008, 2009, or 2010 of the total program prior to survey exit on 9/17/2010 at 10:00 AM.

Based on interview, the CAH did not conduct a yearly review of the utilization of CAH services to include the number of patients served and the volume of services for three of three years (2008, 2009, and 2010). The findings included:

During the entrance conference on 9/13/2010 3:35 PM, the surveyor requested a copy of the annual program evaluation to include policies and procedures, minutes from meetings, and reports.

On 9/17/2010 at 9:00 AM, the quality assurance coordinator reported starting the quality assurance position in May 2010. The last annual review occurred in 2007.

The facility did not provide annual evaluations for 2008, 2009, or 2010 of the utilization of CAH services prior to survey exit on 9/17/2010 at 10:00 AM.

Based on interview, the CAH did not conduct a yearly review of a representative sample of both active and closed records for three of three years (2008, 2009, and 2010). The findings included:

During the entrance conference on 9/13/2010 3:35 PM, the surveyor requested a copy of the annual program evaluation to include policies and procedures, minutes from meetings, and reports.

On 9/17/2010 at 9:00 AM, the quality assurance coordinator reported starting the quality assurance position in May 2010. The last annual review occurred in 2007. The most recent medical staff data was from 2007.

The facility did not provide a review of the utilization of CAH services for 2008, 2009, or 2010 prior to survey exit on 9/17/2010 at 10:00 AM.

Based on interview, the CAH did not conduct a yearly review of the CAH's health care policies for three of three years (2008, 2009, and 2010). The findings included:

During the entrance conference on 9/13/2010 3:35 PM, the surveyor requested a copy of the annual program evaluation to include policies and procedures, minutes from meetings, and reports.

On 9/17/2010 at 9:00 AM, the quality assurance coordinator reported starting the quality assurance position in May 2010. The last annual review occurred in 2007. The most recent medical staff data was from 2007.

The facility did not provide a review of the facilities health care policies for 2008, 2009, or 2010 of the utilization of CAH services prior to survey exit on 9/17/2010 at 10:00 AM.

Based on interview, the facility did not conduct a yearly review of the appropriateness of the utilization of services for three of three years (2008, 2009, and 2010). The findings included:

During the entrance conference on 9/13/2010 3:35 PM, the surveyor requested a copy of the annual program evaluation to include policies and procedures, minutes from meetings, and reports.

On 9/17/2010 at 9:00 AM, the quality assurance coordinator reported starting the quality assurance position in May 2010. The last annual review occurred in 2007. The most recent medical staff data was from 2007.

The facility did not provide a review of the appropriateness of the utilization of services for 2008, 2009, and 2010 prior to survey exit on 9/17/2010 at 10:00 AM.

Based on interview and record review, the CAH did not have an effective quality assurance (QA) program. The findings included:

1. On 9/16/10 at 12:18 PM, in an interview with the QA Coordinator, she revealed that she had been in this position and actually worked 3/3/10 to 4/9/10 and 5/1/10 to current. She confirmed that this was her first position related to doing QA in a hospital.

2. On 9/17/2010 at 2:55 PM, the chief of staff reported that the facility did not have a process for ongoing clinical care review. A policy was proposed for reviewing 10% of monthly patient visits provided by mid-level practitioners. The resources were not available and the policy was not approved.

A medical staff peer review policy was proposed and a demonstration project conducted by a contractor whose contract ended 12/2009.

The new QA coordinator proposed a different policy for medical staff review. The clinical director reported 27 indicators were reviewed as an organization. The information was not by individual provider and another process did not occur for individual providers.

3. On 9/17/2010, the QA coordinator reported starting QA in May 2010. The QA program needed performance improvement (PI) for improvement. The QA coordinator sent forms to staff for planning performance improvement and has not received the forms back. Policies are sent to the medical executive committee for review.

4. The QA coordinator provided the facility PI monthly reporting schedule for year 2010 and a second document titled "Organization PI Reports Received From Departments". The reporting schedule identified every area reporting on a quarterly basis. The schedule included ambulatory care, emergency room, infection control, community health, medical staff, OR/central supply, utilization review, public health nursing, labor and delivery, safety, dietary, laboratory, radiology, dental, physical therapy, facilities, optometry, pharmacy, medical records, housekeeping, and patient registration. Facilities, radiology and OR/central supply were marked as providing reports.

5. The organizational PI plan dated 06/2008 stated " the primary goal of the Organizational PI plan is to continually plan, design, measure, assess, and improve performance of hospital-wide key functions and process relative to patient safety and patient care."

6. The physical plant was not maintained for patient safety. Cross refer C220

7. Ancillary staff were not supervised by professional staff and Medical staff responsibilities were not performed. Cross refer C250

8. Facility policy and procedures were not updated and approved. Cross refer C240 and C270

9. The facility did not ensure acceptable standards of practice for surgical services and emergency department services. Cross refer C320 and C200 respectively

10. The medical records were not secure, systematically organized, readily available, or complete. Cross refer C300

The facility did not provided additional information during the survey exit on 9/17/2010 to demonstrate an effective QA program.

Based on record review, the facility did not have an agreement with an organ procurement organization (OPO) to determine organ suitability for donation. The findings included:

During the entrance conference on 9/13/2010 at 3:45 PM, the surveyor requested a list of all agreements.

During the exit conference on 9/17/2010 at 10:00 AM, the surveyor requested a list of all agreements.

On 9/27/2010 at 10:36 AM, Staff (II) emailed seven agreements to the surveyor and reported that the seven agreements sent were all the agreements the CAH had. An agreement with an OPO for determination of organ suitability was not received.