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400 SOLDIER CREEK ROAD

ROSEBUD, SD 57570

GOVERNING BODY

Tag No.: A0043

Based on record review and interview, the governing body failed to effectively govern the conduct of the hospital. The findings included:

The governing body did not have a process to approve medical staff recommendations. Cross refer to A046.

The governing body did not ensure appropriate patient care in the emergency department by the medical staff. Cross refer to A049.

The governing body did not ensure patients rights. Cross refer to A115.

The governing body did not ensure an effective, ongoing, data-driven and hospital-wide Quality Assessment /Performance Improvement Program. Cross refer to A263.

The governing body did not ensure the provision of nursing services to meet the needs of the patient. Cross refer to A385.

The governing body did not ensure an effective utilization review plan. Cross refer to A652.

The governing body did not ensure the safety of patients through maintainance of the physical environment. Cross refer to A700

The governing body did not ensure a hospital-wide infection control program. Cross refer to A747.

The governing body did not ensure that the hospital met the emergency needs of patients. Cross refer to A1100.

The governing bosdy failed to ensure a hosptial-wide infection control program. Cross refer to A747.

MEDICAL STAFF - APPOINTMENTS

Tag No.: A0046

Based on interview and record review, the hospital governing body did not approve the medical staff recommendations from 9/08/2009 to 1/14/2011. The findings included:

On 1/13/2011 at 5:00PM, the area office chief medical officer stated, "The governing body does not have a process to approve medical staff recommendations for privileges and credentialing and that is why approvals are not in the governing body meeting minutes. The governing body bylaws need to be changed to reflect process of approval."

The governing body did not review medical staff recommendations for appointment to the medical staff during the governing body meeting minutes dated 9/08/2009, 10/07/2009, 12/15/2009, 01/05/2010, 1/12/2010, 02/04/2010, 02/22/2010, 03/18/2010, 4/01/2010, 05/27/2010, 05/28/2010, 09/01/2010 (last meeting before this date was 5/28/2010), 10/05/2010, and 12/07/2010.

Governing body approvals of medical staff recommendations were not provided by survey exit conference on 1/14/2011 at 10:45 AM.

MEDICAL STAFF - ACCOUNTABILITY

Tag No.: A0049

Based on observation, record review, and staff interviews, it was determined that the Governing Body failed to ensure that the medical staff, including the contracted medical staff, was accountable for the quality of care provided to the patients. The findings included:

1. On 1/11/11 at 1:20 PM, observation and interview with provider (N) revealed that there was a physician (ED Medical Director) assigned to work 8:00 AM to 8:00 PM and a physician's assistant (PA) assigned to work 12:00 noon to 12:00 midnight today in the ED. The provider commented that at times the providers have to work alone in the ER and this was not good.

2. On 1/12/11 at 8:30 AM, in an interview with the Acting Clinical Director (ACD), he verified that the ED was covered by locums, who are physicians, physician assistant (PA), or certified nurse practitioners(CNP). When the ACD was asked whether or not a physician was in the Hospital at all times (24/7), he revealed that the physician covering may be in the Hospital or on call.

3. On 1/12/11 at 9:05 AM, observation in the ED showed that there was one physician (S) on duty. Interviews with nursing staff (M, G, and T) and the physician (S) revealed that from midnight to noon only one provider was present in the ED.

PATIENTS
1. Patient #14 - OB - 35 week fetal death

a. On 1/11/11 in the morning, Medical Records staff were requested to provide patient #14's medical record. The surveyor was informed that the record was locked up, but that a copy of the entire chart was in the file room. Staff were requested to provide the record, any electronic records, including laboratory reports and radiology, and fetal heart monitoring recordings.

b. Review of patient #14's medical records evidenced that she was seen in the ER on 4/19/10, was admitted to the acute care unit from 4/26 to 4/28/10 with diagnoses of "pregnant, persistent UTI (urinary tract infection) with pyelonephritis, nausea, and dehydration", and was seen again in the ER on 5/6/10.

c. Review of the patient's 5/6/10 "ER Nursing Assessment and Treatment Record" (7:25 PM) revealed "Pt is having labor pain since 5 P", with pain at 10/10, no Fetal Heart Tone (FHT) were documented on the form, and a note indicated "On arrival 2 strips no contractions".

d. Review of the "ER Provider Assessment Record" and "Emergency Room Physician's Order Sheet" for the 5/6/10 visit revealed diagnoses of IUP (intrauterine pregnancy) 34 2/7 weeks, nephrolithiasis, and early labor. The provider ordered straight cath (urine), CBC, BMP, Morphine, Ativan, Terbutaline, Tylenol, Ondansetron, and IV fluids (Normal Saline and Lactated Ringer's).

e. Review of the patient's "Critical Care Flow Sheet" evidenced that the patient's pain was 10/10 at 8:50 PM, 8-9/10 at 9:15 PM, and 7-10/10 at 9:45 PM.

f. Review of the patient's "Out-of-Hospital Transfer Record", signed and dated 5/7/10 at 8:00 AM, documented the following:

No time left

Ambulance

Stable

Criteria for transfer "34 4/7 wks with nephrolithiasis, unresponsive to conservative Tx (treatment). Needs evaluation and treatment not available at RIH".

No FHT were noted on this form.

It was noted that at 9:00 AM the patient received Dilaudid 2 mg IVP (intravenous push) and Zofran 4 mg IVP.

g. On 1/11/11 and on 1/12/11, Medical Records staff were requested to provide patient #14's medical record related to the 5/6/10 ER visit. The surveyor was informed that the record was locked up, but that a copy of the entire chart was in the file room. Staff were requested to provide the record, any electronic records, including laboratory reports and radiology, and fetal heart monitoring recordings. As of 1/14/11 at the exit entrance time (10:45 AM), the Hospital had not provided any electronic records, laboratory reports, or radiology reports related to the patient's 5/6/10 ER visit. The last FHT record provided was dated 5/7/10 at 7:50 AM.

h. Review of the patient's 5/7/10 Operative Report from the hospital where the patient was transferred to revealed the following:

"....arriving at approximately 1:00 in the afternoon secondary to a suspected kidney stone Upon evaluation, the patient was found to a have fetal demise, and she, at that time, became tachypneic and was already tachycardiac. She was evaluate by the hospitalitis and then by the intensivists along with the surgeon, .... On evaluation with CT, free fluid was seen underneath the diaphragm, and it appeared that there was a small bowel perforation. ....intubated in ICU and taken to the operating room for surgery."

Postoperative diagnoses were "pregnancy, uterine, at 34 weeks with a fetal demise and suspected small bowel perforation with sepsis".

i. During an interview with patient #14 on 1/10/11 at 12:40 PM, she revealed that on 5/10/10 (per record review the date was 5/7/10) she was transferred from the Hospital with an undiagnosed perforated bowel. She indicated that this caused the loss of her baby at 35 weeks gestation and she had peritonitis and almost died. The patient alleged that when she came to the ED with complaints of abdominal pain, she was diagnosed as having a kidney stone, did not have an ultrasound or x-rays done. The two doctors (H and I) treated her in the ED. She said that doctor (I) was no longer working here. The patient said that when she was transferred to the other hospital, the EMS dropped her off, without giving a report to ____(name of hospital where the patient was transferred) staff. She said that she had to holler to get any staff to come into the room because they did not know she had arrived. The patient revealed that an emergency cesarean section (C/S) was performed and the bowel perforation which they found was repaired.

2. Patient #10 - 21 - OB - 28 week fetal demise after Preterm Labor

a. Review of 21 year old patient #10's "ER Nursing Assessment and Treatment Record", "ER Provider Assessment Record", and "Emergency Room Physician's Order Sheet" forms evidenced the following visits to the ED (chief complaint, assessment, and orders):

1) 3/18/10 at 9:22 PM - c/o (complained of) "lower back pain. 'don't feel good'," (G4 P3 due 6/18/10), vital signs and pain level not noted; diagnoses were "suprapubic pain, 26 week pregnancy, r/o (rule out) UTI (urinary tract infection)"; urinalysis and culture ordered; Macrobid 2 x daily x 3 days; Discharged home at 11:55 PM.

2) 3/20/10 at 11:38 AM - c/o "having contractions, 27 week IUP. Pt was seen in ER Thursday night was told would have to send out urine culture", Temperature (T) 100.9 degrees Fahrenheit (F), Pulse (P) 100, Blood Pressure (BP) 139/65, pain level 5/10; diagnosis was "contractions"; Terbutaline 0.25 mg subq and Pyridium were ordered. Discharged home at 4:58 PM. (Note: The orders appear to be for one dose of Terbutaline, but three doses were charted as given.)

3) 3/20/10 at 11:39 PM - c/o "I think I'm in labor again.", T 98.9 degrees F, P 104, BP 137/71, pain 6/10; diagnosis "IUP at 27 weeks PTL (pre-term labor)", Ancef ordered, patient seen by consultant doctor and admitted to the acute care unit at 1:04 AM. (Note: Patient was transferred to another hospital on 3/21/10.)

4) 3/25/10 at 10:54 PM - c/o "sent Sioux Falls for (?) meds - terbutaline at 8:30 more ______(? unable to read)"; diagnoses - "IUP 27 2/7 weeks, early contractions, preterm labor"; Terbutaline and Tylenol were ordered and given, patient was admitted to the acute care at 12:49 AM on 3/26/10 and discharged on 3/27/10 .

5) 3/29/10 at 8:37 PM - c/o "lower abd (abdominal) pain/cramping, fever, discharge", T99.7 degrees F, P 125, BP 108/58, pain 4/10, no FHT noted during any of this visit; "ER MD did not see", diagnoses "uterine irritability, UTI, Vaginitis", Terbutaline x 2 and Ancef ordered, "pt offered to be admitted but she declined...". Discharged home at 11:30 PM.

Note: There was a lack of evidence to show that the patient was checked for dilation or ruptured membranes or that fetal monitoring was done during the above visits.

6) 3/30/10 at 9:45 AM - c/o "here with preterm labor. Pt present with foot out of vagina", no T, P 104, BP 130/66, no pain level noted, no FHTs; OB doctor saw and documented "ER doctor was not present", fetal demise. Admitted to Medical/Surgical Floor at 12:00 noon.

3. Patient #18 - Closed record ruptured appy - death

a. Review of 73 year old patient #18's "ER Nursing Assessment and Treatment Records", "ER Provider Assessment Record", "Emergency Room Physician's Order Sheet", "Critical Care Flow Sheet", Laboratory reports, and Radiology reports for 11/10/09 evidenced the following:

1) 11/10/09 at 10:03 PM - c/o "stomach hurts. I haven't gone to bathroom (BM) in 3 days. Vomiting". NKA. Vital signs - T 97.0 P 65 R 20 BP 121/8?. Pain level 8/10. SOB. Abdomen was noted to be tender, no documentation that bowel sounds were assessed. The documentation indicated that the patient was given Zofran, Lactulose, and 1000 cc normal saline IV. The patient was discharged at 1:00 AM in "Stable" condition with no discharge vital signs charted on the form.

2) Review of the patient's "ER Provider Assessment Record" and "Emergency Room Physician's Order Sheet" for this 11/10/09 ER visit revealed a limited examination of the abdomen. The provider ordered lactulose, fleet's enema, GI cocktail 30 cc, Zofran, 1 L NS IV, CBC, CMP, amylase, KUB. The provider noted that "following lactulose and enema, pt had large BM and symptoms resolved". The patient was diagnosed with constipation and given Colace to take twice a day, to follow up for nausea and vomiting for possible EGG Colonoscopy as outpt.

3) Review of the patient's "Critical Care Flow Sheet" evidenced the following information:

11:00 PM - "pt having lg amount loose stool"

11/11/09 12:05 AM - Vital signs - T none charted, P 93, R 16, BP 113/63, pain 5/10; "c/o abd pain - GI cocktail 60 ml. PO at 12:10 AM (Note: GI cocktail order was for 30 ml, not 60.)

12:39 AM - vital signs - T none charted, P 90, R 16, BP 107/70, no pain assessment; "I feel better."

4) Review of the patient's laboratory results for this ER visit revealed the following abnormal laboratory values for blood specimen collected 11/10/09 at 9:28 PM:

Glucose 125 mg/DL (WNL 75 - 99)
Urea Nitrogen 37.7 mg/dL (WNL 7 - 21)
Creatinine 1.5 mg/dL (WNL .5 - 1.4)
RBC 4.1 M/uL (WNL 4.34 - 5.88)
Hemoglobin 12.2 g/dL (WNL 14 - 18)
Hematocrit 36.2 % (WNL 42 - 52)
NE%, Auto 77.2 % (WNL 43 - 65)
LY%, Auto 13.8 % (WNL 20 - 45)
Protime 25 seconds (WNL 8.6 - 11.4).

5) Review of the patient's 11/10/09 9:21 PM Abdomen KUB indicated Findings of "..Vascular calcifications are present in the pelvis" with an Impression of "Changes of osteoporosis and vascular calcification, otherwise normal".

b. Review of the patient's "ER Nursing Assessment and Treatment Records", "ER Provider Assessment Record", "Emergency Room Physician's Order Sheet", "Critical Care Flow Sheet", Laboratory reports, and Radiology reports for 11/14/09 evidenced the following:

1) Review of patient #18's 11/14/09 8:57 AM "ER Nursing Assessment and Treatment Record" revealed the patient present with "diarrhea x 3 days"; NKA (Note: Allergies were documented on the 11/10/09 visit); Vital signs - T 98.2, P 90, R 22, BP 75/52, pain level 7/10; bowel sounds in all four quadrants with last BM 2 days ago; EKG checked; 10:10 AM 1000 ml NS IV. The patient was admitted to the acute care unit at 2:06 PM; noted to be stable at discharge with T 97.7, P 100, R 23, BP 111/57, pain 0/10. No ESI rating was written on the form.

2) Review of the patient's "ER Provider Assessment Record" and "Emergency Room Physician's Order Sheet" for this ER visit evidenced the MSE was done at 10:00 AM; diagnoses included diarrhea (secondary to too much laxatives, history of constipation, dehydration), hypotension secondary to dehydration, coumadin toxicity, CAD s/p MI, Afib with MVR, A 1 CD (??). The provider ordered CMP, CBC, EKG, Cardiac enzyme, PT/INR, KUB, CXR, NS bolus, Klor 40 Meq, and admit to acute care unit.

3) Review of the patient's laboratory values for this ER visit evidenced the following abnormal lab results:

Glucose 132 mg/DL (WNL 75 - 99)
Urea Nitrogen 62.0 mg/dL (WNL 7 - 21)
Creatinine 2.1 mg/dL (WNL .5 - 1.4)
Potassium 3.3 mmol/L (WNL 3.6 - 5)
Albumin, Serum 3.4 G/DL (WNL 3.9 - 5)
WBC 4.4 K/uL (WNL 4.5 - 11)
RBC 4.0 M/uL (WNL 4.34 - 5.88)
Hemoglobin 11.6 g/dL (WNL 14 - 18)
Hematocrit 35.6 % (WNL 42 - 52)
NE%, Auto 90.0 % (WNL 43 - 65)
LY%, Auto 5.7 % (WNL 20 - 45)
MO%, Auto 3.7 % (WNL 5 - 12)
LY# 0.3 K/uL (WNL 1 - 4.8)
Protime 90.3 seconds (WNL 8.6 - 11.4).

This record had whole lines of documentation scribbled out, as well as numerous write-overs.

c. The patient was hospitalized from 11/14/09 to 11/17/09 with diagnoses of acute renal failure, diarrhea, dehydration, and iron deficiency anemia.

d. Review of the patient's "ER Nursing Assessment and Treatment Records", "ER Provider Assessment Record", "Emergency Room Physician's Order Sheet", "Critical Care Flow Sheet", Laboratory reports, and Radiology reports for 11/22/09 evidenced the following:

1) Review of patient #18's 11/22/09 11:22 AM "ER Nursing Assessment and Treatment Record" evidenced that the patient c/o ----------diarrhea-------------(unable to read), NKDA, Vital signs T? P 78 BP 87/46 (?) (Note: On 1/12/11 at 10:00 AM, in an interview with the Medical Record Department Head, she revealed that there was not an ER record for 11/22/09 in the patient's chart. She requested and obtained a copy of the ER visit from the hospital that the patient was transferred to. This copy was difficult to read.)

2) Review of the patient's "Emergency Room Physician's Order Sheet" revealed that the provider ordered blood work, urinalysis, and multiple medications. No "ER Assessment" form was given to the surveyor with the record. The patient was diagnosed with "exacerbation of COPD, CHF, Advanced diabetes, CAD, A 1 CD, History TB, anemia, osteoporosis. The plan was to transfer.

3) Review of the patient's laboratory values for this ER visit evidenced the following abnormal lab results:

Glucose 154 mg/DL (WNL 75 - 99)
Urea Nitrogen 30.1 mg/dL (WNL 7 - 21)
Creatinine 1.5 mg/dL (WNL .5 - 1.4)
Potassium 3.3 mmol/L (WNL 3.6 - 5)
Calcium 7.8 mf/d/L (WNL 8.4 - 10.5)
Total Protein 5.8 g/dL (WNL 6.3 - 8.2)
Albumin, Serum 2.4 G/DL (WNL 3.9 - 5)
Alk Pho 146 U/L (WNL 48 - 135)
WBC 1.9 K/uL (WNL 4.5 - 11)
RBC 3.6 M/uL (WNL 4.34 - 5.88)
Hemoglobin 10.5 g/dL (WNL 14 - 18)
Hematocrit 31.1 % (WNL 42 - 52)
NE%, Auto 85.5 % (WNL 43 - 65)
LY%, Auto 8.4 % (WNL 20 - 45)
Bands 22 % (WNL 0 - 3)
Lymphs 9 % (WNL 25 - 40)
NE# 1.6 K/uL (WNL 1.8 - 7.7)
LY# 0.2 K/uL (WNL 1 - 4.8)
Protime 130.0 seconds (WNL 8.6 - 11.4)
PTT 55.8 seconds (WNL 21 - 39)
BNP 1756.0 PG/ML (WNL 0 - 100).

4) Review of the "Critical Care Flow Sheet" evidenced that the patient's P 126 - 107, R 32 - 36, BP 60/47, 59/29, 70/37, 62/31, 67/38, 64/38.

Review of the patient's transfer form revealed the following:

There was no time when the patient left the Hospital.

It was signed on 11/22/09 at 6:05 AM.

The vital signs were T 98 degrees, P 110, R 26, BP 62/31, pain 9/10.

The patient was listed as critical.

e. The patient was transferred to another hospital on 11/22/09, had surgery on 11/23/09 for "peritonitis, pneumoperitoneum, necrotic perforated appendicitis", and expired on 11/27/09.

4. Patient #6 - Closed record - ER visit for Shortness Of Breath - death within hours of leaving ER

a. Review of 44 year old patient #6's 11/6/10 "ER Nursing Assessment and Treatment Record" evidenced that the patient presented at the ER at 2127 (9:27 PM) with complaints of "SOB (shortness of breath) x about 1 hour - dry heaves". The documentation indicated that the patient's significant medical history included dialysis, do not resuscitate, allergies to Heparin, Plavix, Lovenox, and was on home oxygen at 3 liters/nasal canal at night. The patient's admission vital signs were T 98.5 degrees F, P 120, R 44, BP 136/99, oxygen saturation 93% with 2 liters per nasal canal. The nurse charted that the patient received Phenergan 50 mg at 12:10 AM and Kayexalate 30 grams orally at 1:10 AM. The discharge time was listed as 1:10 AM and the patient's vital signs were noted to be T 99, P 80, R 20 BP 140/80 with no pain.

b. Review of the patient's "ER Provider Assessment Record" and Emergency Room Physician's Order Sheet" revealed that the MSE was done at 9:57 PM with diagnoses of upper respiratory infection and nausea. The provider (N) ordered labs (CBC and CMP) and PA/LAT CXR. The patient's discharge medications were Clindamycin, Cipro, and Phenergan.

c. Review of the patient's PA/LAT chest x-ray results noted a discussion that the results were compared to the 9/6/10 results. "The patient has pronounced cardiomegaly that has been a chronic finding and fullness in the hila. A right-sided jugular dialysis catheter has been placed in the interval. The upper lung vessels are a little prominent but otherwise no interstitial edema or definite effusions to suggest failure. A single lead pacer is in place."

d. Review of the patient's 11/6/10 (collected at 10:31 PM) abnormal laboratory results revealed the following:

Urea Nitrogen 34.3 mg/dL (WNL 7 - 21)
Creatinine 7.7 mg/dL (WNL .5 - 1.4)
Sodium 136 mmol/L (WNL 137 - 145)
Potassium 5.9 mmol/L (WNL 3.6 - 5)
Chloride 95 mmol/L (WNL 98 - 111)
CO2 19 mmol/L (WNL 22 - 31)
Total Protein 9.0 g/dL (WNL 6.3 - 8.2)
Alk Pho 463 U/L (WNL 48 - 135)
Total Bili 4.4 mg/dL (WNL .2 - 1.3)
WBC 12.0 K/uL (WNL 4.5 - 11)
Platelet Count 106 K/uL (WNL 150 - 400).

e. There was no evidence found that an EKG was done during this ER visit.

f. Review of the patient's "Instructions to the Patient After Emergency Care" listed instructions for discharge "Meds as ordered; follow up no improvement, follow up clinic next week." There was no evidence of what the meds were or how these were to be taken.

g. The patient was discharged at the same time as he was given the Kayexalate. There was a failure to re-assess the patient's potassium level after giving the medication. There was no evidence that the patient's vital signs were monitored in the time between the admission and discharge vital signs (approximately 3 hours and 45 minutes).

h. During an interview on 1/13/11 at 3:33 PM with the Acting Clinical Director (ACD) and the Aberdeen Area CD, the care and services provided to patient #6 was discussed. They indicated that they would check the patient's medical record and provide a response to the surveyor's inquiries. On 1/14/11 at 8:30 AM, the ACD provided a summary list of the information found relating to each patient on the list. The information for this patient was "ESRD on dialysis with K+ 5.9. His last dialysis was the day preceding this visit. Kayexalate was given; follow up documented." It was unclear how follow up was done and documented when the patient left the ER at the same time as the Kayexalate was given and expired within hours of the ER visit.

i. Review of the "South Dakota EMS Report" dated 1/7/10 documented that the team responded to a code blue and found the patient had expired. The time of death was noted to be 10:53 AM.

5. Patient #9 - 4 month old - probable Meningitis

a. Review of 4 month old patient #9's 9/16/10 "ER (Emergency Room) Nursing Assessment and Treatment Record" form evidenced that the patient was seen in the ER at 1:53 PM for "c/o up all night crying". The assessment form indicated the infant had no known drug allergies (NKDA), a g-tube, temperature of 99 degrees F on arrival assessment, received Rocephin IV, and was transferred at 9:15 PM.

b. Review of the patient's "ER Provider Assessment Record" and "Emergency Room Physician 's Order Sheet" revealed that the ER physician (CC) did the MSE at 2:30 PM, noting a "questionable bulging fontanelle" and the pediatrician (EE) assessed the infant [no time noted for when the pediatrician (EE) was called or did the assessment]. The orders for the blood work and cath (catheterized) ua (urinalysis) were timed at 6:55 PM. The nurse's initials were written next to the orders for the IV hep (heparin lock) and cath ua on the Physician Order sheet at 8:00 PM. The orders for the IV and IV antibiotic were initialed by the nurse at 8:30 PM. The physician and the pediatrician determined that the patient had a bulging anterior fontanelle and needed to be transferred with a diagnosis of probable meningitis. The flight team arrived and the infant was transferred in "stable but guarded"condition at 9:15 PM.

c. During the seven hours and twenty-three minutes the patient was in the ED, the nurses documented vital signs at 1:53 PM (admission assessment), 4:50 PM (three hours after presenting to ED), 7:30 PM (two hours and forty minutes later) , 8:00 PM, 8:30 PM, 9:00 PM, and 9:15 PM (discharge time).

d. On 1/12/11 Medical Records (MR) staff were requested to provide any electronic health records (EHR), laboratory, or radiology reports for this patient. MR staff member (Z) commented that the patient did not have any additional documentation for this ER visit.

e. On 1/14/11 at 8:30 AM, the ACD and the Aberdeen CD provided copies of the patient's chest x-ray, abdominal x-ray, urinalysis, and blood results, including a blood culture. Review of these lab results evidenced that the blood specimens were collected at 7:08 PM and the urine was obtained at 8:15 PM. The patient's WBC (white blood cells) results were 18.4 K/uL (4.5 - 11). There was no evidence that a spinal tap was done or why it took more than seven hours to transfer the infant who had a bulging anterior fontanelle to another hospital.


10406


6. Patient #25 - Chest Pain and SOB

Review of patient #25's medical record revealed the patient was admitted to the ED on 1/6/11 at 17:45 (5:45 PM) with complaints of chest pain and SOB (shortness of breath).

a. Review of the "ER Provider Assessment Record" dated 1/6/11 included, "23 yr. old male, presents to ER for c/o (complaints of) SOB approx. 1 hour after being discharged home from the (facility name) inpatient. Pt. walked to bathroom then symptoms started. (?) unchanged. Pt. states he has an appointment at Mayo Clinic to discuss heart transplant on 1/13/11, but due to transportation issues had to reschedule to 1/30/11. A/P (assessment and plan) Dyspnea, Dilated Cardiomyopathy, Cheat pain.
1) Consult cardiology at Avera Heart, 2) CHF exacerbation treatment, repeat CXR (chest x-ray), 3) Admit.." The patient was admitted to the inpatient unit at 2125 (9:25 PM) and placed on Telemetry and bed rest.

b. Review of the "Doctor 's Orders" included:
1/8/11, "Notify Ambulance Service of transport to Mayo Hospital Monday by ground EMT and paramedic ..."

1/9/11,"May be discharged tomorrow AM to go to Mayo Clinic with ambulance service .. " The note also noted to contact social services about the patient needing assist with a place to stay and transportation back to after work up.

The next entry was at 9:10 AM on 1/10/11 that the patient "may be discharged today ..."

c. Patient #25 was observed as an inpatient on 1/10/11 during the tour of the inpatient unit. Staff reported the patient was going to be transferred to the Mayo Clinic for evaluation for heart transplant.

d. Review of the "Progress Notes" included:
1/9/11 7:00 AM, "Awaiting Rosebud RAS for transport to Mayo".
7:15 AM, "Rosebud RAS reports will attempt transfer at 9:00 AM (1/10/11) due to weather."

1/10/11 9:30 AM social services, "Pt. having transportation problems working with family".

1/10/11 10:00 AM, "Pt. verbalized understanding of discharge instructions. Pt. Mayo Clinic appointment rescheduled due to transportation. Mayo Clinic with appointment rescheduled for Jan. 31 Pt. instructed to return to ER if chest pain returns or if other problems are experienced. Pt. to follow up with the tribe for funding for transportation ..." The nursing note did not include an assessment of the patient prior to discharge.

e. Review of a electronic record showed some of the readmissions into the ED which included:

11/25/10 at 3:40 PM c/o (complaints of) SOB -discharged to home at 5:35 PM,
11/26/10 at 4:16 PM c/o chest pain - transferred to Avera Heart Hospital at 1:30 AM by air,
11/30/10 at 7:57 PM c/o chest tightness left AMA at 1:05 AM,

12/7/10 at 9:13 PM c/o chest pain and SOB-transferred to Avera Heart Hospital at 12:30 AM by air,
12/21/10 at 5:24 PM c/o chest pain discharged to home at 7:00 AM,

1/3/11 at 5:24 PM c/o chest pain discharged to home at 10:30 PM,
1/5/11 at 12:10 AM c/o can 't eat, discharged to home at 4:00 AM,
1/6/11 at 5:45 PM c/o SOB admitted 9:15 PM,
1/13/11 at 3:30 PM. A Family reported the pt. was back in the ED with weakness, SOB and having chest pain.

f. On 1/13/11 at 4:17 PM in an interview with patient #25's family, the family member indicated that her son was in the ER again. She told of the repeated trips to the ER (1/4/11, 1/5/11 when he was admitted and discharged on 1/10/11). The patient's mother was concerned as her son seemed to continue being ill.

She said that they were told to be here for a transport to Rochester on 1/11/11 at 7:45 AM. When they arrived at 7:00 AM, they were told the ambulance could no longer do the transport due to funding issues.

She also reported that they lived approximately 40 miles away and had problems finding transportation to get her son to the hospital when he was sick and he is not well enough to be sent home.

g. On 1/13/11 at 4:39 PM patient #25's care and treatment was discussed with the Acting Clinical Director (ACD) and the Aberdeen Area CD. They indicated that they were looking at this case and would follow up on this patient's plan and determine what could be done to provide transportation for the patient.

h. On 1/14/11 at 8:20 AM, the ACD reported that they were meeting with the Tribe to determine what could be done in relation to the transportation of patient #25 to Rochester.

MEDICAL STAFF - SELECTION CRITERIA

Tag No.: A0050

Based on record review and interview, the governing body failed to ensure the criteria for selection in the medical staff bylaws included individual character and judgment from 6/26/2009 to 1/14/2011. The findings included.

The medical staff bylaws dated 6/26/2009 did not include the criteria individual character and judgment for selection of medical staff. Cross refer to A0357.

CONTRACTED SERVICES

Tag No.: A0083

Based on review of the governing body meeting minutes, the governing body failed to ensure contracted services were assessed for compliance with hospital requirements, identify quality improvement for contracted services, and ensure monitoring of contracted services from 9/8/2009 to 1/14/2011. The findings included:

The governing body did not review contracted service performance, assess for compliance, identify quality improvement for contracted services, or identify monitoring measures during the governing body meeting minutes dated: 9/08/2009, 10/07/2009, 12/15/2009, 01/05/2010, 1/12/2010, 02/04/2010, 02/22/2010, 03/18/2010, 4/01/2010, 05/27/2010, 05/28/2010, 09/01/2010 (last meeting before this date was 5/28/2010), 10/05/2010, and 12/07/2010.

The governing body meeting minutes for 11/07/2009 discussed "Not utilizing the contract for hospitalists. The provider contract will meet the staffing needs". A follow up date for an action report was not indicated on the meeting minutes. Additional review by the governing body was not discussed at subsequent meeting minutes.

The contracted radiologists were not evaluated for competency. Cross refer to A0340.

CONTRACTED SERVICES

Tag No.: A0085

Based on record review and interview, the hospital failed to maintain a list of all contracted services including the scope and nature of the services provided.

During the entrance conference on 1/10/2011 at 9:30 AM, a list of all hospital contracts with the scope and nature of the contract was requested. The contracted service list provided on 1/11/2011, did not include the scope and nature of each contract.

During an interview on 1/12/2011, the contract specialist stated that not all the contracts were hospital contracts. A list of only hospital contracts with the scope and nature was requested at that time.

EMERGENCY SERVICES

Tag No.: A0092

Based on observation, record review, and staff interview, it was determined that the Hospital failed to comply with the requirements of ?482.55. The Hospital failed to have adequate, qualified personnel to ensure that the needs of the patients were met in a safe and timely manner. Cross refer to A1110, A1111, and A1112 for details related to the Emergency Department staff and supervision.

PATIENT RIGHTS

Tag No.: A0115

Based on interview, and record review, the hospital failed to assure patient's rights for 12 requirements and the governing body failed to assure an effective grievance process.
The findings included:

The hospital failed to inform patient's rights in advance of furnishing or discontinuing care. Cross refer to A117.

The hospital failed to establish a process that responded promptly to patient grievances and whom to contact to file a grievance. Cross refer to A118

The hospital failed to ensure the effective operation of the grievance process. Cross refer to A119

The hospital failed to respond to grievances timely and did not develop a mechanism for referral to the Quality Improvement Organization. Cross refer to A120.

The hospital failed to establish at process for verbal grievances. Cross refer to A121.

The hospital failed to respond to grievances timely. Cross refer to A122.

The hospital failed to provide a written response to grievances. Cross refer to A123.

The hospital failed to assure the patient was informed that a doctor of medicine was not present 24 hours per day. Cross refer to A131.

The hospital failed to provide training to appropriate staff. Cross refer to A199.

The hospital failed to identify a qualified trainer. Cross refer to A207.

The hospital failed to document competency in staff records. Cross refer to A208.

The hospital failed to establish a policy for reporting of patient deaths associated with restraints. Cross refer to A214.

PATIENT RIGHTS: NOTICE OF RIGHTS

Tag No.: A0117

Based on record review, policy review, observation, and interview, the hospital failed to inform each patient of patient rights in advance of furnishing or discontinuing patient care for 3 of 3 inpatients reviewed (Patients #47, #25 and #24). The findings included:

Patient Rights:

On 1/11/2011, the quality assurance coordinator provided a copy of the current Patient Rights and Responsibilities Policy revised 1/10. The policy stated that Patient Rights and Responsibilities brochures will be available in all patient care areas. Each patient admitted to the inpatient unit of the Rosebud Comprehensive Care Facility will receive the Patient Rights and Responsibilities. This will be documented in the Inpatient Consent Form. The brochure did not notify patients of their right - to participate in the development and implementation of their care plan; to have a family member or representative of their choice and their physician notified promptly of their admission to the hospital; to be free from all forms of abuse or harassment; and to access information contained in their medical record.

During an interview on 1/11/2011 at 11:15 AM, the quality assurance coordinator explained that the inpatients receive the Patient Rights and Responsibilities brochure and the receipt is indicated by the patient signing and dating the patient consent form.

On 1/11/2011 at 3:15 PM, the quality assurance coordinator said that Patient Rights and Responsibilities brochure was not provided to inpatients, outpatients, or emergency room patients. The hospital ran out of the brochures.

During an interview on 1/12/2011 at 11:00 AM, the director of nursing confirmed that the hospital did not have a supply of the Patient Rights and Responsibilities brochures and they were not posted throughout the hospital.

Observations were made in the emergency department on 1/11/2011 at 1:05 PM. The Patient Rights and Responsibilities were posted above eye level in small print on the left of the emergency department intake window. At 1:20 PM a mother signed her children on the emergency room patient list. The mother was not offered a copy of Patient Rights and Responsibilities brochure or directed to the above eye level posting by the medical support assistant Staff GG.

The patient consent form for Patient #47 signed 8/18/2010, Patient #25 signed 1/6/2011, and patient #24 signed 1/10/2011 stated that the patient received written information on Patient Bill of Rights. The hospital did not have the brochures and the brochure does not notify the patient of all their rights.

Discharge Notice:

During an interview on 1/13/2011 at 11:15 AM, the patient benefits coordinator Staff HH stated, "the hospital practice was to provide a Medicare patient discharge notice within two days of discharge and did not provide a notice within two days of admission."

The hospital is required required to provide a notice for both within two days of discharge and two days of admission unless the patient only stayed for two days.

PATIENT RIGHTS: GRIEVANCES

Tag No.: A0118

Based on record review, policy review and interview, the hospital failed to inform each patient whom to contact with a grievance. The findings included:

On 1/11/2011, the quality assurance coordinator provided a copy of the current Patient Rights and Responsibilities Policy revised 1/10. The policy stated that Patient Rights and Responsibilities brochures will be available in all patient care areas. Each patient admitted to the inpatient unit of the Rosebud Comprehensive Care Facility will receive the Patient Rights and Responsibilities. This will be documented in the Inpatient Consent Form. The Patient Rights and Responsibilities brochure did not inform the patient whom to contact to file a grievance.

During an interview on 1/11/2011 at 11:15 AM, the quality assurance coordinator explained that the inpatients receive the Patient Rights and Responsibilities brochure and the receipt is indicated by the patient signing and dating the patient consent form.

On 1/11/2011 at 3:15 PM, the quality assurance coordinator said that Patient Rights and Responsibilities brochure was not provided to inpatients, outpatients, or emergency room patients. The hospital ran out of the brochures.

During an interview on 1/12/2011 at 11:00 AM, the director of nursing confirmed that the hospital did not have a supply of the Patient Rights and Responsibilities brochures and they were not posted throughout the hospital.

PATIENT RIGHTS: REVIEW OF GRIEVANCES

Tag No.: A0119

Based on interview, record review and policy review, the hospital governing body failed to ensure the effective operation of the grievance process for 5 of 5 complaints reviewed. The findings included:

On 09/08/2009, the governing body approved the current grievance policy titled "Patient Complaint Policy", revision date of 09/2009.

On 12/7/2010, the governing body meeting minutes reported, "Of the 102 complaints received in CY (calendar year) 2010, 34% were completed, and almost 70 complaints had no response from the hospital department."

For 5 of 5 complaints reviewed, the hospital failed to provide a written response that included notice of the decision, name of hospital contact, steps taken of behalf of the patient to investigate the complaint, results of the grievance process, and the date of completion for the 5 reviewed complaints submitted 11/2010 and 10/2010. Cross refer to A123

PATIENT RIGHTS: TIMELY REFERRAL OF GRIEVANCES

Tag No.: A0120

Based on record review and policy review, the hospital governing body failed to ensure the effective operation of the grievance process and did not include a mechanism for timely referral of Medicare patient's concerns regarding quality of care or premature discharge to the Quality Improvement Organization from 09/08/2009 to 01/14/2011. The findings included:

On 09/08/2009, the governing body approved the current grievance policy titled Patient Complaint Policy, revision date of 09/2009. The policy did not include a mechanism for referral of a Medicare patient's grievance regarding quality of care or premature discharge to the Quality Improvement Organization.

On 12/7/2010, the governing body meeting minutes reported that of the 102 complaints received in CY (calendar year) 2010, 34% were completed, and almost 70 complaints had no response from the hospital department.

PATIENT RIGHTS: GRIEVANCE PROCEDURES

Tag No.: A0121

Based on interview and policy review, the hospital did not have a process for patients to submit a verbal grievance from 09/2009 to 1/14/2011. The findings included:

On 1/11/2011, the quality assurance coordinator provided a copy of the current, "Patient Complaint Policy", revision date of 09/09. The policy stated, "Informal complaints are complaints from customers that have been voiced, but have not been committed to writing. ..... The complaint becomes formal when the complainant submits the signed written complaint ..... If the department manager is unable to resolve a customer's informal complaint On the spot, then the department manager will instruct the customer and or family member that the complaint will need to be submitted in writing, using the Complaint form."

On 1/11/2011 at 1:50 PM, Staff E stated if a complainant does not want to fill out a complaint form; they have to go to administration and wait until they are seen.

On 1/11/2011 at 11:15 AM, the quality assurance coordinator explained that verbal complaints are not part of the formal process.

PATIENT RIGHTS: GRIEVANCE REVIEW TIME FRAMES

Tag No.: A0122

Based on interview, record review, and policy review, the hospital did not ensure that a response to grievances were timely for 5 of 5 complaints reviewed (Patients # 48, 49, 50, 51, and 52) . The hospital grievance policy did not require a timely response. The findings included:

On 1/11/2011 at 11:15 AM, the quality assurance coordinator explained the hospital grievance process. Complainants can submit a grievance by placing a signed complaint form in one of the four boxes in the hospital. The complaints are retrieved from the boxes 2 times a week generally Tuesday and Friday. Verbal complaints are not part of the formal process. An acknowledgement letter is sent within 7 days, a supervisor has 10 days to respond to the CEO and then 5 more days to respond with the results to the complainant. The inpatient satisfaction surveys were not connected to the policy. Note: If a patient responded with negative feedback, and the patient identified themselves, then this must be included in the grievance process.

On 1/11/2011, the quality assurance coordinator provided a copy of the current Patient Complaint Policy, revision date of 09/09. The policy stated, "An acknowledgement letter will be sent by the Accreditation Specialist, via mail , to the complainant. The department supervisor upon receiving the formal complaint in writing will review and investigate and provide a written report of their findings within ten days for the Chief Executive Officer and /or their designee and the Risk Manager to review. A response will be generated by the Accreditation Specialist for the Chief Executive Officer's signature that will be sent to the complainant within 5 workdays".

A complaint concerning Patient #48 dated 11/29/2010 lacked a response letter.

A complaint concerning Patient #49 dated 11/10/2010 lacked a response letter.

A complaint concerning Patient #50 dated 11/5/2010 lacked a response letter.

A complaint concerning Patient #51 dated 11/03/2010 lacked a response letter.

A complaint concerning Patient #52 dated 10/19/2010 lacked a response letter.

On 1/11/2011 at 2:30 PM, the quality assurance coordinator stated, "There are no letters. Supervisors are not returning the compliant response."

On 1/11/2011 at 3:50 PM, quality assurance coordinator confirmed that the hospital did not provide a written response to the complainant for the complaints concerning Patients #48, 49, 50, 51, and 52.

PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION

Tag No.: A0123

Based on interview, record review and policy review, the hospital failed to provide a written response that included notice of the decision, name of hospital contact, steps taken on behalf of the patient to investigate the complaint, results of the grievance process, and the date of completion for 5 of 5 complaints reviewed (Patients # 48, 49, 50, 51, and 52). The findings included:

On 1/11/2011, the quality assurance coordinator provided a copy of the current Patient Complaint Policy, revision date of 09/09. The policy stated, " A response will be generated by the Accreditation Specialist for the Chief Executive Officer's signature that will be sent to the complainant within 5 workdays".

A complaint concerning Patient #48 dated 11/29/2010 lacked a response.

A complaint concerning Patient #49 dated 11/10/2010 lacked a response.

A complaint concerning Patient #50 dated 11/5/2010 lacked a response.

A complaint concerning Patient #51 dated 11/03/2010 lacked a response.

A complaint concerning Patient #52 dated 10/19/2010 lacked a response.

On 1/11/2011 at 2:30 PM, the quality assurance coordinator stated, "There are no letters. Supervisors are not returning compliant response."

On 1/11/2011 at 3:50 PM, quality assurance coordinator confirmed that the hospital did not provide a written response to the complainant for the complaints concerning Patients #48, 49, 50, 51, and 52.

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on record review and interview, the hospital failed to inform patients for 9 of 9 days (November 1 - 9, 2009) when a doctor of medicine was not present on-site 24 hours per day. The findings included:

Review of the November 2010 emergency room schedule showed only nurse practitioners and physician assistants scheduled on the day and evening shift for November 1, 2, 4, 5, 6, 7, 8, and 9, 2010 and on the evening shift for November 3, 2010.

During an interview on 1/11/2011 at 1:50 PM, Staff E stated, "Two months ago there were 4 times for a 12 hour shift that a doctor of medicine was not available to come into the emergency room. Locums did not show up."

During an interview on 1/12/2011 at 9:50 AM, a nurse practitioner Staff II explained that the inpatient doctor of medicine on call was expected to stay on-site and provide coverage in the emergency room. This was discussed with all the doctors and an e-mail was sent on this coverage. At this time, a copy of the e-mail was requested. The email was not provided prior to the exit conference on 1/14/2011 at 10:45 AM.

During an interview on 1/12/2011 at 10:25 AM, Doctor of Medicine Staff JJ stated that he was not privileged in emergency medicine, did not supervise the emergency room, and had not stayed overnight at the hospital.

Staff JJ requested privileges in Internal Medicine and was recommended by the clinical director on 4/19/2010 for those privileges.

During an interview on 1/12/2011 at 10:30 AM, the chief of staff stated that there were specific credentialing and privileging for the emergency room and Staff JJ was not privileged for emergency medicine.

During an interview on 1/13/2011, the patient benefits coordinator stated "A notice was not provided when a doctor of medicine was not available on-site 24 hours a day."

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0169

Based on record review and interview, the hospital policy permitted restraint order to be ordered as an on needed basis from 2/10 to 1/14/2011. The findings included:

The hospital wide " Restraint and Seclusion" policy revised 2/10 was provided by the quality assurance coordinator on 1/12/2011 at 8:45 AM. The process section titled "Medical Restraint Use under Removal Guidelines" stated, "If the need for restraint recurs following removal, the restraint may be reapplied if the time specified in the order is still effective (Treat as a new restraint episode in the concurrent review)"

During an interview on 1/13/2011 at 9:40 AM, the DON (director of nursing) explained, "the key code #10 indicted that the patient was "out of restraints" and the nurse could reapply restraints after discontinuing as long as the order was within the 24 hours." Note: 24 hours is the time frame that the order for restraint is effective.

The "Medical Restraint Flowsheet" for documentation of the ongoing nursing assessment showed two options for nursing to check for when the patient was out of restraints: "family in attendance" or "compliant behavior." The Restraint and Seclusion policy included "Medical Restraint Flowsheet" as attachment E.

During an interview on 1/13/2011 at 10:30 AM, the ADON (assistant DON) stated, "the nurse educator provides annual training, will demo(demonstrate) back on restraint application, and reviews the policy."

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0199

Based on interview and record review, the hospital failed to provide training to appropriate staff on techniques to identify staff and patient behaviors, events, and environmental factors that may trigger circumstances that require the use of restraint or seclusion. The findings included:

During an interview on 1/13/2011 at 11:30 AM, the nurse educator described the training program for nursing. The training was provided to nurses at the annual skills fair 12/2010. The annual skills fair did not include staff training on techniques to identify staff and patient behaviors, events, and environmental factors. The former security guard supervisor had provided that program and was certified to give the training. There is no formal program now. Leather restraints are not used. There is no seclusion.

During an interview on 1/13/11, the current security guard supervisor described the training on workplace violence for all hospital staff. The Workplace Violence power point did not include this training requirement.

During the exit conference on 1/14/2011 at 10:45 PM, documentation was not provided of this training for appropriate staff.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0208

Based on record review and interview the hospital failed to document that all staff had received training and demonstrated competence with Patient Rights.

On 1/13/2011 at 9:30 AM, a review of the Rosebud Indian Health Service's current employee list dated 01/11/2011 and the Mandatory CMS (Center for Medicare and Medicaid Services) Patient Rights Training sign in sheets for dates 12/7/2010, 12/9/2010, 12/21/2010 & 12/28/2010 found that 3 of the 5 sampled employees' signatures did not appear on the lists, identifying them as having received the Patient Rights Training.

On 1/13/2011 at 11:15 AM, and interview with Staff (A) confirmed that all the sign in sheets containing employee signatures, identifying them as having completed the Patient Rights Training, had been provided.

PATIENT RIGHTS: INTERNAL DEATH REPORTING LOG

Tag No.: A0214

Based on interview and policy review, the hospital failed to have a policy for reporting deaths associated with the use of seclusion or restraint to the CMS (Centers for Medicare and Medicaid Services) Regional Office from 02/10 to 01/14/2011. The findings included:

On 1/12/2011 at 8:45 AM, the quality assurance coordinator provided a copy of the hospital policy, "Restraint and Seclusion' with a revision date of 2/10. This policy did not include a process to report to CMS Regional Office on deaths associated with the use of seclusion or restraint.

During an interview on 1/13/2011 at 10:45 AM, the quality assurance coordinator stated that there was no policy to report to CMS Regional Office on restraint deaths. The QA coordinator provided the Sentinel Event Policy dated with a revision 2/05 and confirmed that this policy did not include reporting of restraint deaths to CMS.

During the exit conference on 1/14/2011 at 10:45 AM a policy for reporting deaths associated with the use of seclusion or restraint to the CMS Regional Office was not provided.

QAPI

Tag No.: A0263

Based on record review and staff interview, it was determined that the facility failed to have a fully functioning, effective, ongoing, hospital-wide, data-driven Quality Assessment/Performance Improvement (QAPI) Program. The findings included:

1. An interview with the facility's Quality Assurance (QA) Coordinator and with the Aberdeen Area Deputy Director was conducted on 1/13/2011 at 1:15 PM. The interview focused on the Quality Assessment/Performance Improvement (QAPI) Program for the facility.

a. The QA Coordinator stated that the facility's QAPI Program utilized the Performance Improvement (PI) Committee with the goal to identify at least three to four issues in a department and set goals for those issues. The QA Coordinator commented that the PI Committee had not been getting the involvement of most of the facility's departments. The only departments currently involved were Maintenance, Nursing, Infection Control, and Medical Staff. The remaining departments had either no involvement or very little involvement with the PI Committee. The QA Coordinator did state that there was some involvement by the Radiology department up until August of 2010 and that Pharmacy was involved only in the issues of medication error reporting and drug diversions.

b. During the interview the QA Coordinator provided information that the PI Committee had scheduled meetings monthly throughout the year 2010. The QA Coordinator stated that it was difficult to get department heads and others on the PI Committee to attend meetings and participate in the QAPI process.

A review on 1/13/2010 of the past six months of PI Committee meeting minutes found that the Committee had not met for three of those six months. One meeting was cancelled due to inclement weather and two of the cancelled meetings were due to no attendees or scheduling conflicts and department heads being unavailable.

c. The QA Coordinator stated that the review of hospital complaints had fallen behind by several months. A record review on 1/13/2011 was made of the Governing Body minutes PI report. The minutes for the 3/4/2010 and 3/18/2010 minutes indicated that the PI reports for both dates identified that the facility was behind at that time in addressing complaint issues received or identified by the facility. Governing Body minutes reviewed after 3/8/ did not comment as to whether the facility had been able to address the issue of complaints not being addressed timely.

d. The QA Coordinator confirmed that Contractors utilized by the facility were not reviewed as part of the QAPI process. A review of the PI Committee meeting minutes and the Governing Body meeting minutes for the past six months found nothing to indicate that a review of contracts had ever been made. (Cross refer to A083)

e. During the interview the question was asked about the high number of patient returns to the facility Emergency Department (ED). These are patients that had previously been seen in the ED and later returned with continuing issues related to the initial ED visit or medical complications that should have or could have been addressed on the initial visit. The QA Coordinator stated that no study or review had been made by the PI Committee related to ED returns.

f. During the interview the QA Coordinator was asked about issues the PI Committee had attempted to identify, address and resolve. The example provided was the issue related to monitoring of fetal heart tones in the Emergency Department (ED). After it was determined that the ED needed to improve on this issue the decision was made to create a new Obstetrics form to be used in the ED that included monitoring of fetal heart tones. The QA Coordinator stated that the PI group had finished the creation of the form, but that the project was stalled because there had been no action taken on approving the form by the Medical Staff. The goal of the PI Committee was to have the form implemented by 9/25/2010. However, the goal had yet to be met at the time of the survey. A review of the PI Committee meeting minutes found nothing addressing the issue over the last six month period.

g. The QA Coordinator stated that some issues related to PI were followed up without revising approaches that were not proving effective. The QA Coordinator explained that in cases where department PI monitors had identified issues, implemented plans to improve situations, and when no improvement occurred, the same approach used initially was re-implemented to address the issue, rather than reassessing the problem and considering or attempting another approach.

h. The Area Director commented during the interview that she believed the issue may be a lack of understanding by all hospital staff of the QAPI process and how it applies to each department. Both the Area Director and the QA Coordinator stated that staff had training on the Performance Improvement program once since 2009. The Area Director stated that she believe that the former administrator at the facility may not have been focused, active and encouraging on the QAPI aspect of the hospital's PI program. During the interview the Area Director suggested that the current QA Coordinator could have used additional training in the performance of the QA Coordinator's position. The Area Director and the QA Coordinator both agreed during the interview that the hospital's PI program was not working and that more was needed to address the facility's multiple issues. Both individuals made comment that they believed the lack of participation and involvement by facility staff may have been what prevented the QAPI program from being fully effective.

2. An interview with the facility's Chief Pharmacist was conducted during a tour of the facility pharmacy on 1/12/2011. During the interview the Chief Pharmacist was asked about the Pharmacy Department's involvement with the QAPI process. The Pharmacist stated that he provided information related to medication errors and medication diversions, but that he really had no other involvement in the QAPI area or the PI Committee.





14268

On 1/11/2011at 9:30 AM, Staff WW, in an interview, stated that the Medical Records Qaulity Assurance and Performance Improvement is reported on a quarterly basis. The most recent report submitted was dated June 2010. The September and December 2010 reports were not complete and had not been submitted.


04748

MEDICAL STAFF

Tag No.: A0338

Based on record review and staff interview, it was determined that the Medical Staff failed to evaluate the care provided by the Medical Staff and to do periodic appraisals, to credential staff as required, and to ensure qualifications for those appointments. The findings included.

See the following for details:

A0340 - Standard: Medical Staff Periodic Appraisals. The Medical Staff failed to do periodic appraisals of its members.

A0341 - Standard: Medical Staff Credentialing. The Medical Staff failed to examine credentials of candidates for Medical Staff membership and make recommendations to the Governing Body on the appointment of candidates.

A0347 - Standard: Medical Staff Accountability. The Medical Staff failed to be accountable for the quality of care provided to patients.

A0357 - Standard: Medical Staff Qualifications. The Medical Staff failed to require qualification for appointment to the medical staff included the criteria of individual character and judgment.

MEDICAL STAFF PERIODIC APPRAISALS

Tag No.: A0340

Based on interview and record review, the medical staff failed to conduct periodic appraisals of three of three radiologists that are part of the medical staff and the medical staff approved three privileges in radiology for procedures that the hospital did not conduct. The findings included:

During an interview on 1/12/2011 at 2:20 PM, the chief of staff stated that the radiologist provided data from hospital A and not this hospital.

The hospital medical providers list dated 1/2011 showed Staff QQ, Staff RR, Staff MM and Staff SS as contracted courtesy status with a specialty in diagnostic radiology.

During an interview on 1/13/2011 at 1:45 PM, radiology Staff TT stated, "The contract radiology group included Staff QQ, Staff RR, Staff MM, and Staff SS. Staff SS came to the hospital on Thursday for onsite readings".

On 1/13/2011, a radiologist cross-review from July 2010, August 2010 and September 2010 was provided for the contract radiologists. The sample was from hospital A and did not break out the competency of individual radiologists.

During an interview on 1/14/2011 at 8:35 AM, the chief of staff confirmed that there was not a process to evaluate the contract radiologists for the competency of hospital specific interpretations.

Medical staff MM requested and was recommended for the radiology core privileges on 11/04/2009. The core privileges included: Routine MRI for head, spine, body, and major joints; performing and interpreting venography of the major vessels; Supervising and interpreting the images contained in nuclear medicine procedure using radioisotopes.

During an interview on 1/12/2011 at 2:20 PM, the chief of staff stated that the Radiology core privileges form was a template from the area office and the hospital did not perform venography, MRI, or nuclear medicine.

MEDICAL STAFF CREDENTIALING

Tag No.: A0341

Based on interview and record review, the medical staff failed to assure that one of eight medical staff (Staff J)credentials met the privileges for emergency medicine qualifications prior to appointment to the medical staff and that three of three medical staff (Staff LL, Staff NN, Staff OO) were granted privileges to supervise a CRNA during anesthesia. The findings included:

In a letter dated 1/21/2011, Staff J was granted provisional contracted associate privileges. Staff J requested Privileges in emergency medicine. The emergency medicine criteria for granting privilege required current certification in an American Trauma Life Safety (ATLS) course. Staff J's credential file showed a certification in ATLS with an expiration date of 10/14/2009.

During an interview on 1/12/2011 at 1:15 PM, the credentialing specialist stated, "the credential file just came back from the area office today. I notified the chief of staff and the area office chief of staff of the expired ATLS certification. I will check on current ATLS certification."

During an interview on 1/12/2011 at 3:20 PM, the chief of medical staff confirmed that Staff J was privileged in emergency medicine and did not have evidence of current ATLS certification.

During the exit conference on 1/14/2011 at 10:45 AM, verification of a current ATLS certification for Staff J was not provided.

Privileges in obstetrics and gynecology were requested and recommended by the clinical director for Staff NN on 8/23/2010 and for Staff OO on 9/27/2010. Privileges in general surgery were requested and recommended by the clinical director for Staff LL on 1/5/2010. The privileges were not granted to supervise the CRNA during anesthesia.

During an interview on 1/12/2010 at 5:05 PM, the clinical director verified that Staff LL was not granted privileges for supervision of the CRNA. The clinical director stated that the general surgeon supervised the CRNA during anesthesia.

During an interview on 1/14/2011 at 8:35 AM, the clinical director confirmed that supervision of the CRNA was not in the list of privileges granted for general surgery or obstetrics and gynecology.

MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY

Tag No.: A0347

Based on record review and family and staff interview, it was determined that the Medical Staff failed to be accountable for the quality of care provided to the patients. The following examples included six of 42 samples patients reviewed who had identified quality of medical care concerns. The findings included:

1. Patient #14 - OB - 35 week fetal death

a. On 1/11/11 in the morning, Medical Records staff were requested to provide patient #14's medical record. The surveyor was informed that the record was locked up, but that a copy of the entire chart was in the file room. Staff were requested to provide the record, any electronic records, including laboratory reports and radiology, and fetal heart monitoring recordings.

b. Review of patient #14's medical records evidenced that she was seen in the ER on 4/19/10, was admitted to the acute care unit from 4/26 to 4/28/10 with diagnoses of "pregnant, persistent UTI (urinary tract infection) with pyelonephritis, nausea, and dehydration", and was seen again in the ER on 5/6/10.

c. Review of the patient's 5/6/10 "ER Nursing Assessment and Treatment Record" (7:25 PM) revealed "Pt is having labor pain since 5 P", with pain at 10/10, no Fetal Heart Tone (FHT) were documented on the form, and a note indicated "On arrival 2 strips no contractions".

d. Review of the "ER Provider Assessment Record" and "Emergency Room Physician's Order Sheet" for the 5/6/10 visit revealed diagnoses of IUP (intrauterine pregnancy) 34 2/7 weeks, nephrolithiasis, and early labor. The provider ordered straight cath (urine), CBC, BMP, Morphine, Ativan, Terbutaline, Tylenol, Ondansetron(?), and IV fluids (Normal Saline and Lactated Ringer's).

e. Review of the patient's "Critical Care Flow Sheet" evidenced that the patient's pain was 10/10 at 8:50 PM, 8-9/10 at 9:15 PM, and 7-10/10 at 9:45 PM.

f. Review of the patient's "Out-of-Hospital Transfer Record", signed and dated 5/7/10 at 8:00 AM, documented the following:

No time left

Ambulance

Stable

Criteria for transfer "34 4/7 wks with nephrolithiasis, unresponsive to conservative Tx (treatment). Needs evaluation and treatment not available at RIH".

No FHT were noted on this form.

It was noted that at 9:00 AM the patient received Dilaudid 2 mg IVP (intravenous push) and Zofran 4 mg IVP.

g. On 1/11/11 and on 1/12/11, Medical Records staff were requested to provide patient #14's medical record related to the 5/6/10 ER visit. The surveyor was informed that the record was locked up, but that a copy of the entire chart was in the file room. Staff were requested to provide the record, any electronic records, including laboratory reports and radiology, and fetal heart monitoring recordings. As of 1/14/11 at the exit entrance time (10:45 AM), the Hospital had not provided any electronic records, laboratory reports, or radiology reports related to the patient's 5/6/10 ER visit. The last FHT record provided was dated 5/7/10 at 7:50 AM.

h. Review of the patient's 5/7/10 Operative Report from the hospital where the patient was transferred to revealed the following:

"....arriving at approximately 1:00 in the afternoon secondary to a suspected kidney stone Upon evaluation, the patient was found to a have fetal demise, and she, at that time, became tachypneic and was already tachycardiac. She was evaluate by the hospitalitis and then by the intensivists along with the surgeon, .... On evaluation with CT, free fluid was seen underneath the diaphragm, and it appeared that there was a small bowel perforation. ....intubated in ICU and taken to the operating room for surgery."

Postoperative diagnoses were "pregnancy, uterine, at 34 weeks with a fetal demise and suspected small bowel perforation with sepsis".

i. During an interview with patient #14 on 1/10/11 at 12:40 PM, she revealed that on 5/10/10 (per record review the date was 5/7/10) she was transferred from the Hospital with an undiagnosed perforated bowel. She indicated that this caused the loss of her baby at 35 weeks gestation and she had peritonitis and almost died. The patient alleged that when she came to the ED with complaints of abdominal pain, she was diagnosed as having a kidney stone, did not have an ultrasound or x-rays done. The two doctors (H and I) treated her in the ED. She said that doctor (I) was no longer working here. The patient said that when she was transferred to the other hospital, the EMS dropped her off, without giving a report to ____(name of hospital where the patient was transferred) staff. She said that she had to holler to get any staff to come into the room because they did not know she had arrived. The patient revealed that an emergency cesarean section (C/S) was performed and the bowel perforation which they found was repaired.


2. Patient #10 - 21 - OB - 28 week demise after Preterm Labor

a. Review of 21 year old patient #10's "ER Nursing Assessment and Treatment Record", "ER Provider Assessment Record", and "Emergency Room Physician's Order Sheet" forms evidenced the following visits to the ED (complaint; assessment, and orders):

1) 3/18/10 at 9:22 PM - c/o (complained of) "lower back pain. 'don't feel good'," (G4 P3 due 6/18/10), vital signs and pain level not noted; diagnoses were "suprapubic pain, 26 week pregnancy, r/o (rule out) UTI (urinary tract infection)"; urinalysis and culture ordered; Macrobid 2 x daily x 3 days; Discharged home at 11:55 PM.

2) 3/20/10 at 11:38 AM - c/o "having contractions, 27 week IUP. Pt was seen in ER Thursday night was told would have to send out urine culture", Temperature (T) 100.9 degrees Fahrenheit (F), Pulse (P) 100, Blood Pressure (BP) 139/65, pain level 5/10; diagnosis was "contractions"; Terbutaline 0.25 mg subq and Pyridium were ordered. Discharged home at 4:58 PM. (Note: The orders appear to be for one dose of Terbutaline, but three doses were charted as given.)

3) 3/20/10 at 11:39 PM - c/o "I think I'm in labor again.", T 98.9 degrees F, P 104, BP 137/71, pain 6/10; diagnosis "IUP at 27 weeks PTL (pre-term labor)", Ancef ordered, patient seen by consultant doctor and admitted to the acute care unit at 1:04 AM. (Note: Patient was transferred to another hospital on 3/21/10.)

4) 3/25/10 at 10:54 PM - c/o "sent Sioux Falls for (?) meds - terbutaline at 8:30 more ______(? unable to read)"; diagnoses - "IUP 27 2/7 weeks, early contractions, preterm labor"; Terbutaline and Tylenol were ordered and given, patient was admitted to the acute care at 12:49 AM on 3/26/10 and discharged on 3/27/10 .

5) 3/29/10 at 8:37 PM - c/o "lower abd (abdominal) pain/cramping, fever, discharge", T99.7 degrees F, P 125, BP 108/58, pain 4/10, no FHT noted during any of this visit; "ER MD did not see", diagnoses "uterine irritability, UTI, Vaginitis", Terbutaline x 2 and Ancef ordered, "pt offered to be admitted but she declined...". Discharged home at 11:30 PM.

Note: There was a lack of evidence to show that the patient was checked for dilation or ruptured membranes or that fetal monitoring was done during the above visits.

6) 3/30/10 at 9:45 AM - c/o "here with preterm labor. Pt present with foot out of vagina", no T, P 104, BP 130/66, no pain level noted, no FHTs; OB doctor saw and documented "ER doctor was not present", fetal demise. Admitted to Medical/Surgical Floor at 12:00 noon.


3. Patient #18 - Closed record ruptured appy - death

a. Review of 73 year old patient #18's "ER Nursing Assessment and Treatment Records", "ER Provider Assessment Record", "Emergency Room Physician's Order Sheet", "Critical Care Flow Sheet", Laboratory reports, and Radiology reports for 11/10/09 evidenced the following:

1) 11/10/09 at 10:03 PM - c/o "stomach hurts. L haven't gone to bathroom (BM) in 3 days. Vomiting". NKA. Vital signs - T 97.0 P 65 R 20 BP 121/8?. Pain level 8/10. SOB. Abdomen was noted to be tender, no documentation that bowel sounds were assessed. The documentation indicated that the patient was given Zofran, Lactulose, and 1000 cc normal saline IV. The patient was discharged at 1:00 AM in "Stable" condition with no discharge vital signs charted on the form.

2) Review of the patient's "ER Provider Assessment Record" and "Emergency Room Physician's Order Sheet" for this 11/10/09 ER visit revealed a limited examination of the abdomen. The provider ordered lactulose, fleet's enema, GI cocktail 30 cc, Zofran, 1 L NS IV, CBC, CMP, amylase, KUB. The provider noted that "following lactulose and enema, pt had large BM and symptoms resolved". The patient was diagnosed with constipation and given Colace to take twice a day, to follow up for nausea and vomiting for possible EGG Colonoscopy as outpt.

3) Review of the patient's "Critical Care Flow Sheet" evidenced the following information:

11:00 PM - "pt having lg amount loose stool"

11/11/09 12:05 AM - Vital signs - T none charted, P 93, R 16, BP 113/63, pain 5/10; "c/o abd pain - GI cocktail 60 ml. PO at 12:10 AM (Note: GI cocktail order was for 30 ml, not 60.)

12:39 AM - vital signs - T none charted, P 90, R 16, BP 107/70, no pain assessment; "I feel better."

4) Review of the patient's laboratory results for this ER visit revealed the following abnormal laboratory values for blood specimen collected 11/10/09 at 9:28 PM:

Glucose 125 mg/DL (WNL 75 - 99)
Urea Nitrogen 37.7 mg/dL (WNL 7 - 21)
Creatinine 1.5 mg/dL (WNL .5 - 1.4)
RBC 4.1 M/uL (WNL 4.34 - 5.88)
Hemoglobin 12.2 g/dL (WNL 14 - 18)
Hematocrit 36.2 % (WNL 42 - 52)
NE%, Auto 77.2 % (WNL 43 - 65)
LY%, Auto 13.8 % (WNL 20 - 45)
Protime 25 seconds (WNL 8.6 - 11.4).

5) Review of the patient's 11/10/09 9:21 PM Abdomen KUB indicated Findings of "..Vascular calcifications are present in the pelvis" with an Impression of "Changes of osteoporosis and vascular calcification, otherwise normal".

b. Review of the patient's "ER Nursing Assessment and Treatment Records", "ER Provider Assessment Record", "Emergency Room Physician's Order Sheet", "Critical Care Flow Sheet", Laboratory reports, and Radiology reports for 11/14/09 evidenced the following:

1) Review of patient #18's 11/14/09 8:57 AM "ER Nursing Assessment and Treatment Record" revealed the patient present with "diarrhea x 3 days"; NKA (Note: Allergies were documented on the 11/10/09 visit); Vital signs - T 98.2, P 90, R 22, BP 75/52, pain level 7/10; bowel sounds in all four quadrants with last BM 2 days ago; EKG checked; 10:10 AM 1000 ml NS IV. The patient was admitted to the acute care unit at 2:06 PM; noted to be stable at discharge with T 97.7, P 100, R 23, BP 111/57, pain 0/10. No ESI rating was written on the form.

2) Review of the patient's "ER Provider Assessment Record" and "Emergency Room Physician's Order Sheet" for this ER visit evidenced the MSE was done at 10:00 AM; diagnoses included diarrhea (secondary to too much laxatives, history of constipation, dehydration), hypotension secondary to dehydration, coumadin toxicity, CAD s/p MI, Afib with MVR, A 1 CD (??). The provider ordered CMP, CBC, EKG, Cardiac enzyme, PT/INR, KUB, CXR, NS bolus, Klor 40 Meq, and admit to acute care unit.

3) Review of the patient's laboratory values for this ER visit evidenced the following abnormal lab results:

Glucose 132 mg/DL (WNL 75 - 99)
Urea Nitrogen 62.0 mg/dL (WNL 7 - 21)
Creatinine 2.1 mg/dL (WNL .5 - 1.4)
Potassium 3.3 mmol/L (WNL 3.6 - 5)
Albumin, Serum 3.4 G/DL (WNL 3.9 - 5)
WBC 4.4 K/uL (WNL 4.5 - 11)
RBC 4.0 M/uL (WNL 4.34 - 5.88)
Hemoglobin 11.6 g/dL (WNL 14 - 18)
Hematocrit 35.6 % (WNL 42 - 52)
NE%, Auto 90.0 % (WNL 43 - 65)
LY%, Auto 5.7 % (WNL 20 - 45)
MO%, Auto 3.7 % (WNL 5 - 12)
LY# 0.3 K/uL (WNL 1 - 4.8)
Protime 90.3 seconds (WNL 8.6 - 11.4).

This record had whole lines of documentation scribbled out, as well as numerous write-overs.

c. The patient was hospitalized from 11/14/09 to 11/17/09 with diagnoses of acute renal failure, diarrhea, dehydration, and iron deficiency anemia.

d. Review of the patient's "ER Nursing Assessment and Treatment Records", "ER Provider Assessment Record", "Emergency Room Physician's Order Sheet", "Critical Care Flow Sheet", Laboratory reports, and Radiology reports for 11/22/09 evidenced the following:

1) Review of patient #18's 11/22/09 11:22 AM "ER Nursing Assessment and Treatment Record" evidenced that the patient c/o ----------diarrhea-------------(unable to read), NKDA, Vital signs T? P 78 BP 87/46 (?) (Note: On 1/12/11 at 10:00 AM, in an interview with the Medical Record Department Head, she revealed that there was not an ER record for 11/22/09 in the patient's chart. She requested and obtained a copy of the ER visit from the hospital that the patient was transferred to. This copy was difficult to read.)

2) Review of the patient's "Emergency Room Physician's Order Sheet" revealed that the provider ordered blood work, urinalysis, and multiple medications. No "ER Assessment" form was given to the surveyor with the record. The patient was diagnosed with "exacerbation of COPD, CHF, Advanced diabetes, CAD, A 1 CD, History TB, anemia, osteoporosis. The plan was to transfer.

3) Review of the patient's laboratory values for this ER visit evidenced the following abnormal lab results:

Glucose 154 mg/DL (WNL 75 - 99)
Urea Nitrogen 30.1 mg/dL (WNL 7 - 21)
Creatinine 1.5 mg/dL (WNL .5 - 1.4)
Potassium 3.3 mmol/L (WNL 3.6 - 5)
Calcium 7.8 mf/d/L (WNL 8.4 - 10.5)
Total Protein 5.8 g/dL (WNL 6.3 - 8.2)
Albumin, Serum 2.4 G/DL (WNL 3.9 - 5)
Alk Pho 146 U/L (WNL 48 - 135)
WBC 1.9 K/uL (WNL 4.5 - 11)
RBC 3.6 M/uL (WNL 4.34 - 5.88)
Hemoglobin 10.5 g/dL (WNL 14 - 18)
Hematocrit 31.1 % (WNL 42 - 52)
NE%, Auto 85.5 % (WNL 43 - 65)
LY%, Auto 8.4 % (WNL 20 - 45)
Bands 22 % (WNL 0 - 3)
Lymphs 9 % (WNL 25 - 40)
NE# 1.6 K/uL (WNL 1.8 - 7.7)
LY# 0.2 K/uL (WNL 1 - 4.8)
Protime 130.0 seconds (WNL 8.6 - 11.4)
PTT 55.8 seconds (WNL 21 - 39)
BNP 1756.0 PG/ML (WNL 0 - 100).

4) Review of the "Critical Care Flow Sheet" evidenced that the patient's P 126 - 107, R 32 - 36, BP 60/47, 59/29, 70/37, 62/31, 67/38, 64/38.

Review of the patient's transfer form revealed the following:

There was no time when the patient left the Hospital.

It was signed on 11/22/09 at 6:05 AM.

The vital signs were T 98 degrees, P 110, R 26, BP 62/31, pain 9/10.

The patient was listed as critical.

e. The patient was transferred to another hospital on 11/22/09, had surgery on 11/23/09 for "peritonitis, pneumoperitoneum, necrotic perforated appendicitis", and expired on 11/27/09.

4. Patient #6 - Closed record - ER visit for Shortness Of Breath - death after leaving ER

a. Review of 44 year old patient #6's 11/6/10 "ER Nursing Assessment and Treatment Record" evidenced that the patient presented at the ER at 2127 (9:27 PM) with complaints of "SOB (shortness of breath) x about 1 hour - dry heaves". The documentation indicated that the patient's significant medical history included dialysis, do not resuscitate, allergies to Heparin, Plavix, Lovenox, and was on home oxygen at 3 liters/nasal canal at night. The patient's admission vital signs were T 98.5 degrees F, P 120, R 44, BP 136/99, oxygen saturation 93% with 2 liters per nasal canal. The nurse charted that the patient received Phenergan 50 mg at 12:10 AM and Kayexalate 30 grams orally at 1:10 AM. The discharge time was listed as 1:10 AM and the patient's vital signs were noted to be T 99, P 80, R 20 BP 140/80 with no pain.

b. Review of the patient's "ER Provider Assessment Record" and Emergency Room Physician's Order Sheet" revealed that the MSE was done at 9:57 PM with diagnoses of upper respiratory infection and nausea. The provider (N) ordered labs (CBC and CMP) and PA/LAT CXR. The patient's discharge medications were Clindamycin, Cipro, and Phenergan.

c. Review of the patient's PA/LAT chest x-ray results noted a discussion that the results were compared to the 9/6/10 results. "The patient has pronounced cardiomegaly that has been a chronic finding and fullness in the hila. A right-sided jugular dialysis catheter has been placed in the interval. The upper lung vessels are a little prominent but otherwise no interstitial edema or definite effusions to suggest failure. A single lead pacer is in place."

d. Review of the patient's 11/6/10 (collected at 10:31 PM) abnormal laboratory results revealed the following:

Urea Nitrogen 34.3 mg/dL (WNL 7 - 21)
Creatinine 7.7 mg/dL (WNL .5 - 1.4)
Sodium 136 mmol/L (WNL 137 - 145)
Potassium 5.9 mmol/L (WNL 3.6 - 5)
Chloride 95 mmol/L (WNL 98 - 111)
CO2 19 mmol/L (WNL 22 - 31)
Total Protein 9.0 g/dL (WNL 6.3 - 8.2)
Alk Pho 463 U/L (WNL 48 - 135)
Total Bili 4.4 mg/dL (WNL .2 - 1.3)
WBC 12.0 K/uL (WNL 4.5 - 11)
Platelet Count 106 K/uL (WNL 150 - 400).

e. There was no evidence found that an EKG was done during this ER visit.

f. Review of the patient's "Instructions to the Patient After Emergency Care" listed instructions for discharge "Meds as ordered; follow up no improvement, follow up clinic next week." There was no evidence of what the meds were or how these were to be taken.

g. The patient was discharged at the same time as he was given the Kayexalate. There was a failure to re-assess the patient's potassium level after giving the medication. There was no evidence that the patient's vital signs were monitored in the time between the admission and discharge vital signs (approximately 3 hours and 45 minutes).

h. During an interview on 1/13/11 at 3:33 PM with the Acting Clinical Director (ACD) and the Aberdeen Area CD, the care and services provided to patient #6 was discussed. They indicated that they would check the patient's medical record and provide a response to the surveyor's inquiries. On 1/14/11 at 8:30 AM, the ACD provided a summary list of the information found relating to each patient on the list. The information for this patient was "ESRD on dialysis with K+ 5.9. His last dialysis was the day preceding this visit. Kayexalate was given; follow up documented." It was unclear how follow up was done and documented when the patient left the ER at the same time as the Kayexalate was given and expired within hours of the ER visit.

i. Review of the "South Dakota EMS Report" dated 1/7/10 documented that the team responded to a code blue and found the patient had expired. The time of death was noted to be 10:53 AM.

5. Patient #9 - 4 month old - probable Meningitis

a. Review of 4 month old patient #9's 9/16/10"ER (Emergency Room) Nursing Assessment and Treatment Record" form evidenced that the patient was seen in the ER at 1:53 PM for "c/o up all night crying". The assessment form indicated the infant had no known drug allergies (NKDA), a g-tube, temperature of 99 degrees F on arrival assessment, received Rocephin IV, and was transferred at 9:15 PM.

b. Review of the patient's "ER Provider Assessment Record" and "Emergency Room Physician 's Order Sheet" revealed that the ER physician (CC) did the MSE at 2:30 PM, noting a "questionable bulging fontanelle" and the pediatrician (EE) assessed the infant [no time noted for when the pediatrician (EE) was called or did the assessment]. The orders for the blood work and cath (catheterized) ua (urinalysis) were timed at 6:55 PM. The nurse's initials were written next to the orders for the IV hep (heparin lock) and cath ua on the Physician Order sheet at 8:00 PM. The orders for the IV and IV antibiotic were initialed by the nurse at 8:30 PM. The physician and the pediatrician determined that the patient had a bulging anterior fontanelle and needed to be transferred with a diagnosis of probable meningitis. The flight team arrived and the infant was transferred in "stable but guarded"condition at 9:15 PM.

c. During the seven hours and twenty-three minutes the patient was in the ED, the nurses documented vital signs at 1:53 PM (admission assessment), 4:50 PM (three hours after presenting to ED), 7:30 PM (two hours and forty minutes later) , 8:00 PM, 8:30 PM, 9:00 PM, and 9:15 PM (discharge time).

d. On 1/12/11 Medical Records (MR) staff were requested to provide any electronic health records (EHR), laboratory, or radiology reports for this patient. MR staff member (Z) commented that the patient did not have any additional documentation for this ER visit.

e. On 1/14/11 at 8:30 AM, the ACD and the Aberdeen CD provided copies of the patient's chest x-ray, abdominal x-ray, urinalysis, and blood results, including a blood culture. Review of these lab results evidenced that the blood specimens were collected at 7:08 PM and the urine was obtained at 8:15 PM. The patient's WBC (white blood cells) results were 18.4 K/uL (4.5 - 11). There was no evidence that a spinal tap was done or why it took more than seven hours to transfer the infant who had a bulging anterior fontanelle to another hospital.

6. Patient #16 - no physician documentation

a. Review of 20 year old patient #16's 1/10/11 "ER (Emergency Room) Nursing Assessment and Treatment Record" form evidenced that the patient was seen in the ER for "was hit with a metal bar to L (left) shoulder". The assessment form indicated no alcohol, there was no assessment or indication of a wound or injury, and the patient was noted to have left at 2330 (11:30 PM) without being seen.

b. Review of the patient's "ER Provider Assessment Record" and "Emergency Room Physician 's Order Sheet" revealed that these forms were blank.

c. There was no "Instructions to the Patient After Emergency Care" form found in the record.

d. On 1/12/11 Medical Records (MR) staff were requested to provide any electronic health records (EHR), laboratory, or radiology reports for this patient on 1/10/11. MR staff member (Z) verified that the patient did not have any additional documentation for this ER visit.

e. On 1/14/11 at 8:30 AM, the ACD provided the surveyor with a "Emergency Visit Record" note written on 1/13/11 by the physician (J) who saw this patient in the ED on 1/10/11. The ACD indicated that the physician had thirty days to write the note. The physician's documentation summarized why the patient was being seen with a limited description of the examination that occurred prior to the patient and physician incident related to the use of the cell phone in the ED.

f. On 1/11/11 at 9:00 AM, during an interview with family members of patient #16, they expressed concerns the treatment that the patient received in the ER on the evening of 1/10/11. One of the family members said that the patient was assaulted, had a cut on his arm, and came to the ER for treatment. The family met and stayed with the patient in the ER. The family alleged that when the doctor (J) was examining the patient, the patient's cell phone rang, making the doctor angry. According to the family, the doctor attempted to take the phone away, refused to treat the patient, threatened to call security, threatened to call social services because the patient's young child was present and the patient had been drinking, and got right in the patient's face. The complainant alleged that security staff (K) and another staff member (L) were present when the patient left the ER. She said that both of these staff members reported that the doctor was rude to other patients and was given a complaint form to complete.

g. On 1/11/11 at 2:00 PM, during an interview with provider (N), he indicated that he was working in the ER on 1/10/11 and overheard part of the patient/physician interaction between patient #16 and physician (J). Provider (N) revealed that although he was not in the room with the physician, patient, and patient's family, he heard the verbal exchanges with the patient threatening the physician, saw the patient going out of the door cursing, but did not see the patient's family. The provider (N) verified that he believed the doctor (J) was frustrated with the patient's use of the cell phone while the physician was trying to do an assessment and that he (N) was not aware of the physician having similar problems with any other patients.

h. On 1/11/11 at 7:15 PM, during interviews with two nurses (P and Q) who were working in the ED on the evening of 1/10/11, they revealed that neither one was in the room when the physician (J) and the patient (#16) had the loud verbal disagreement. They were both aware that the issue was the use of the cell phone in the ED. Nurse (P) was assigned to the patient and had triaged and placed him in room, and requested the physician see the patient. Nurse (P) stated that she was in another room but heard the patient threaten the physician, saying "I will find you.". She was aware that security was called. Nurse (Q) was not involved in caring for the patient but had heard the cursing and called security. This nurse indicated that the patient threatened the physician by saying "I know where you live.".

i. During the interview with nurse (P), she was questioned about the triage assessment she had done on patient #16 who she believed had been drinking. Review of the nursing assessment completed by this nurse revealed that the nurse marked that the patient had not had alcohol and no injury was described. When interviewed, nurse (P) said that the patient denied the use of alcohol, so she charted no alcohol. She commented that the patient had a small open wound on his shoulder and that since she had not observed it, she had not charted the injury to the patient's shoulder on the nursing assessment form.

j. On 1/11/11 at 7:32 PM, in an interview with the security staff member (R), he verified that he was responding to the call from the ED, just when the patient (#16) was coming out of the ED. He said that the patient spoke to him and walked on out of the ED. The security staff member indicated that it was not a big deal, the doctor and patient just had words. Review of the security reports for incidents for the evening of 1/10/11 evidenced that no report had been written about the physician/patient interaction.

The Hospital failed to ensure that the patients received medical care, assessment, and treatment to address their medical conditions.


08581



II. Based on interview and record review, the hospital failed to require that a doctor of medicine or osteopathy was responsible for the organization and conduct of the medical staff from 5/2010 to 11/2010. The findings included:

During an interview on 1/12/2011 at 2:20 PM, the chief of staff stated the medical staff bylaws did not require a temporary appointment as the clinical director (chief of staff) to be a doctor of medicine. Staff KK was the acting clinical director from 5/2010 to 11/2010.

Staff KK, a psychologist, signed as the acting clinical director (chief of staff) on the approval letter for medical staff appointment of medical staff members Staff PP on 2/04/2010, Staff OO on 9/13/2010 and Staff JJ on 5/10/2010.

MEDICAL STAFF QUALIFICATIONS

Tag No.: A0357

Based on record review, the medical staff bylaws failed to require qualification for appointment to the medical staff includes the criteria of individual character and judgment from 6/29/2009 to 1/14/2011. The findings included:

The current medical staff bylaws with an approval date of 6/29/2009 were reviewed. Under the Article V, the appointment qualifications listed professional education, post graduate training, board certification, recent work history, drug enforcement agency registration, and continuing education. Individual character and judgment were not included as a criteria for appointment to the medical staff.

NURSING SERVICES

Tag No.: A0385

Based on observations, record review and staff and family interviews it was determined that the hospital failed to ensure the provision of nursing care to meet the needs of the patients. This related to the failure to: 1) provide adequate interventions to prevent falls, and timely assessment after a fall with injury, 2) provide timely assessments of patients having chest pain and/or diagnoses or symptoms requiring increased monitoring, 3) provide interventions to meet the needs of the patient having skin breakdown, 4) ensure patients are assessed and appropriate for discharge from the hospital, 5) provide patients with discharge instructions to meet their needs and 6) ensure care plans were reflective of each patient's needs.


See the following for details:

A392-The Hospital failed to ensure nursing service had adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed.


A 395- The Hospital failed to ensure the registered nurses supervised and evaluate the nursing care for each patient.


A 396- The Hospital failed to ensure the nursing staff developed and maintained a current care plan reflective of the needs of each patient.




04748

STAFFING AND DELIVERY OF CARE

Tag No.: A0392

Based on observation, record review, and patient and staff interview, it was determined that the Hospital failed to have adequate numbers of nursing staff to provide care to meet the needs of the patients in the Emergency Department (ED) and Outpatient Departments (OPD). The findings included:

1. On 1/11/11 at 1:00 PM, observation and interview with nurse (M) evidenced that there were three nurses assigned to the ED. Nurse (M) revealed that she was working "a lot of overtime", as she frequently does to cover for staff that do not work as scheduled.

2. On 1/12/11 at 2:45 PM, in an interview with a patient (#54), the patient expressed concerns about the long waits between the Outpatient Clinic visit time to the time when medications could be obtained from the Pharmacy. The patient was questioning if medical records were getting lost going from the OPC to Pharmacy because after waiting a long time, she questioned the pharmacy staff about her medications. She revealed that this has happened on other visits, also. She commented that she was told that the pharmacy had not received her medical record in order to process the prescription. When the complainant returned to clinic, the staff member (U) at the window asked her what the medication was for and said that she would send for the record. The patient said that she waited another hour and the pharmacy still did not have the record. The patient said that finally the chart was found, but that the doctor had to sign it.

a. According to the patient's report, she was seen in the clinic at 8:30 AM and at 9:30 AM the pharmacy did not have the medication orders. She said that she lives close, so she did some shopping, returning about 1:30 PM only to discover that the medication was still not ready for pick up because the pharmacy did not have the medical record. At approximately 3:15 PM, the patient was observed to be waiting in the pharmacy line with five or six patients ahead of her. The patient's name was now observed on the screen above the pharmacy.

b. Patient (#54) said that she was concerned for other patients who were observed waiting all day, either because they did not question the whereabouts of their medication or they left without their medications because they had transportation issues and could not wait all day for the medications or they would not have a ride home.

c. Patient (#54) expressed concerns about the "new" walk-in system and the difficulty getting an appointments. The patient indicated that most regular appointments are made at the first of the month and that appointments are scheduled at 8:00 AM. The patient described the difficulty trying to call in at 8:00 AM, getting put on hold, or getting cut-off. She talked about the all day trips to the outpatient, giving the example of being diabetic, requiring going to the lab for the blood draw, then going to the clinic for an appointment, and finally, waiting for the prescriptions to be filled. The patient revealed that she was not aware of staff checking the status of the patients while they waited in the OPD.

d. During an interview on 1/13/11 at 11:25 AM with the Chief Pharmacist, the topic of processing OPD medications was discussed. He revealed that the Hospital does not have a DEA waiver so every controlled drug needs a hard copy before it can be filled. He indicated that every once in a while there is a problem with the medical record not getting to the pharmacy, so sometimes the patient's other medications get filled and the pharmacy staff have to wait on the hard copy for the controlled medication. He confirmed that this would be the same issue for patients in the ED. He commented the OPD nurses usually bring the record over to the pharmacy. Since there can no longer by prescription pad, the chart is needed. The Pharmacist said that the surgeon is able to send the prescription electronically, so his patients don't have to wait for their medications.

e. During an interview on 1/13/11 at 3:05 PM with OPD staff member (U), she revealed that the medication orders that have to be taken hard copy to pharmacy are placed at the front desk. She said that the nurses or the MSA (including herself) take the records to the pharmacy. The staff member commented that she was alone this week and was very busy.

f. On 1/13/11 at 9:03 AM, in an interview with the Director of Nursing (DON), she explained that the medications orders go to the pharmacy electronically, unless there is a narcotic ordered. A hard copy must be sent to the pharmacy for narcotics.

3. On 1/13/11 at 9:03 AM, in an interview with the Director of Nursing (DON), she was questioned about the need for the nurses in the ED to frequently work overtime (OT). She verified that currently one of the nurses was taking leave often The DON described the nurse staffing pattern plan that she is currently using for the ED and OPD as follows:

ED - Day shift - 3 RNs; Night shift - 3 RNs; 12 - 12 split nurse; 1 RN in triage

OPD - 6 RNs, 3 LPNs to cover the OPD which are 8:00 AM to 6:30 or 7:00 PM.

4. A review of the Number of emergency cases (patients) for each of the last six months as provided to the surveyor on 1/11/11 evidenced the following:

7/10 - 1707 emergency cases
8/10 - 1688
9/10 - 1626
10/10 - 1429
11/10 - 1296
12/10 - 1048
1/11 - 293 to 1/10/11.

5. Cross refer to A1112 for the multiple number of days when the Registered Nurses (RNs) worked overtime (OT) to provide the coverage as planned by the DON.

NURSING CARE PLAN

Tag No.: A0396

Based on medical record review and staff interview the Hospital failed to ensure the nursing staff developed and maintained a current nursing care plan reflective of patient needs for 3 of 25 (#1, #19, and #20) sampled patients. The findings include:

1. Patient #1
Patient #1's medical record review revealed the patient was admitted to the hospital on 1/7/11 from the ED (emergency department). The patient had been brought into the ED on 1/6/11 at 2251 (10:51 PM) by ambulance with complaints of chest pain. The patient had an extended stay in the ED and was transferred to the floor at 10:45 AM on 1/7/11 with admitting diagnoses of angina chest wall pain and ETOH (alcohol) intoxication.

a. Review of the ED "Critical Care Flow Sheet" dated 1/7/11 noted that before the patient was transferred to the inpatient unit the patient reported he/she had fallen down hard at home and was complaining of pain (8 of 10) left side and tightness. The patient received Toradol 30 mg IV push at 8:27 AM and Nitro paste ? inch to chest at 9:00 AM.

b. Review of the physician admission orders included:
1/7/11 at 9:45 AM admit to obs. (observation): "1) AM Chest pain R/O (rule out) MI, 2) HX (history) of CAD with CABG (coronary artery disease with Coronary artery bypass graft ), 3) acute ETOH intoxication". The orders on 1/8/11 at 1:10 PM noted , "discharge to home Dx chest pain - MI (myocardial infarction) ruled out... condition at discharge good..." The patient was discharge at 1:30 PM and collapsed 45 minutes later in the lobby.
Review of patient's plan of care identified: "Assess VS with pulse ox, include skin color, peripheral pulses on admit and q 4 hours" and "EKG with report of chest pain and notify provider" was not followed.

Interview with staff D with concerns of frequency and monitoring identified in the plan of care of this patient with known cardiac history, heart surgery in Sept. 2010 and reported fall for this patient on a blood thinner. Staff confirmed that the plan of care did not address this patient's needs.

2. Patient #19
Patient #19's closed medical record review revealed the patient was admitted to hospital on 10/17/09 from the ED (emergency department). The patient's admitting diagnoses included: Acute onset dizziness, R/O (ruling out inner ear disease), hypertension, left ventricular dysfunction, moderate pulmonary hypertension and R/O evolving stroke with right side paralysis of the face.


Review of the patient's nursing care plan dated 10/17/09 identified the patient at risk for falls. It did not address the use of the bed side commode to prevent falls. The care plan was also not updated to address the use of the front wheeled walker or interventions put in place by PT.


3. Patient #20
Patient #20's medical record review revealed the patient was admitted to the inpatient unit on 1/11/11 at 2130 (9:30 PM) from the ED (emergency department). The patient had been brought into the ED on 1/10/11 at 2348 (11:48 PM) by ambulance with complaints of having "missed dialysis today". The patient had an extended stay in the ED, was transferred for emergent dialysis at 6:00 AM next morning (1/11/11) and returned to the ED at 11:42 AM for another extended ED stay (9 1/2 hours) until being transferred to the inpatient bed at 9:30 PM.

a. The ED record stated , "Diabetic with chronic renal failure with profound weakness sudden onset of nausea and vomiting..." The diagnoses included: hyperkalemia, bradycardia, chronic renal failure, hypermagnesemia, hypercalcemia. The notes also identified discussion with a consultant nephrologist, "Will provide critical care here patient too ill to transport will transfer for emergent dialysis in AM than back for admission". A note from 4:30 AM on 1/11/11 also identified the patient as having a decubitus on the right side of the coccyx.

b. Staff D was also asked to review the patient's plan of care. The interventions for skin breakdown included an "Egg crate mattress" and did not address the air mattress. Staff D confirmed that egg crate mattresses are not used and the care plan was not accurate. The air mattress was in use but not provided timely.

c. Review of the"Progress Notes" dated 1/12/11 identified the patient having a drop in BP (blood Pressure) to 69/32 at 5:00 AM. The physician was notified and orders for a fluid bolus of "one liter of normal saline at 250 ml/hr" was given. The patient's vital signs were then monitored every fifteen minutes until 6:30 AM with B/P at 129/64. The physician order on admit 1/11/11 included "vital signs q 4 hours".

d. Review of the plan of care dated 1/11/11 included:
"Monitor vital signs every four hours.
Assess lung sounds, respiratory pattern, SOB and signs of edema q 12 report to provide.
Assess location of edema q 12 hours..."
There was no indication the plan of care was revised to address the the monitoring require for the severity of this patient's care and monitoring needs.

Interview with Staff D confirmed that the care plan did not address the patient's needs for timely care and monitoring.

(Cross refer to A 395 for further details on each patient.)

4. Interview on 1/13/11 with Staff D confirmed that the preprinted care plans were supposed to be individualized to meet the needs of the patients. Additionally staff had been inserviced on care planning and ensuring care plans were updated or revised when the patient's needs changed. Staff D confirmed that the patients listed above did not have accurate plans of care.


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MEDICAL RECORD SERVICES

Tag No.: A0450

Based on record review and staff interview, the Hospital failed to ensure patient medical record entries were legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures. The findings included:

FAILURE TO ENSURE MEDICAL RECORDS ARE LEGIBLE:

1. Patient #3 medical record review revealed the patient was admitted in the Emergency Department (ED) on 1/7/11 at 11:29 AM. The patient was brought in by ambulance unresponsive and later transferred to another facility by a flight team.

Review of the "ER Provider Assessment Record" and "Physician Orders" were not legible.

Interview on 1/11/11 the provider was asked to interpret the above documents. The provider reported, "I am asked all the time by staff to review orders. I'm available 24 hours a day seven days a week and always available if the staff has questions with what I written".

Interview with the QAC (Quality Assurance Coordinator) confirmed that the issues with medical records being illegible had been brought up. She also reported that they had been working on getting a voice to text system for the provider. However due to budget issues the system had not been approved.

Medical record that are not legible have the potential to be misread or misinterpreted and may lead to medical errors or other adverse patient events.


FAILURE TO ENSURE THE MEDICAL RECORD IS COMPLETE:

1. Patient #1's medical record review revealed the patient was admitted to the hospital on 1/7/11 from the ED (emergency department).

a. The sheet showed Vicodin one tab had been given at 0145 (1:45 AM) on 1/8/11 for neck pain of 8 of 10. There was no follow up documentation under "results" to show the patient was rechecked for the effectiveness of the pain medication or that the physician was notified.

b. Review of the inpatient "Critical Care Flow Sheet" dated 1/7/11 and 1/8/11 included VS (vital signs) included:
(1/7/11)-10:45 T (temperature) 97, P (pulse) 57, R (respiration) 18, B/P 113/70, O2(oxygen) 94%,

13:45 (1:45 PM) T-97.8, P-54, R-18, B/P 118/68, O2 95%,

17:45 (5:45 PM) T-97.6, P-55, R-18, B/P 118/64, O2 97%.

The next set of documented vital signs on the "Critical Care Flow Sheet" was on 1/8/11 at 10:00 AM (17 hours later). The VS noted, T-97.8, P-62, R-20, B/P 128/98, O2 97%. The notes showed the patient complained of neck and back pain at 1:45 AM (1/8/11). The patient rated his/her pain at 8 of 10 and was given a pain medication. There was no documentation of a full assessment by the nurse with the patient's complaints of pain.

c. Review of the "Progress Notes" dated 1/8/11 at 9:15 AM by nursing noted the patient's heart rate at 54. It noted the patient denied chest pain at this time and asked about going home. The next note at 1330 (1:30 PM) include, "Pt. verbalized understanding of discharge instructions, Instructed to return in one to two weeks or sooner if chest pain returning, educated about risk for continued drinking, discussed cardiac output ...refuses alcohol treatment ... Pain R/T inflammation. Denies pain. Discharge to home."

There was no patient assessment documented.

The documentation at discharge did not identify how the patient left or who the patient left with.

The was no documentation of a patient assessment prior to discharge or from the last VS documented at 10:00 AM, three and a half hours from the time the patient was discharged. (Cross refer to A 395)


FAILURE TO COMPLETE DISCHARGE INSTRUCTIONS:

Review of patient records, staff interviews and review of facility policies revealed the discharge instructions were not being completed for post-hospital services and care, and educating patient/family/caregivers providers about home care. This was identified in patient records for 7 of 25 ( #1, #4, #27, #53, #23, #34 and #35) inpatients and 2 (#8 and #7) emergency room records reviewed. (Cross refer to A 820)




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INCOMPLETE ED PATIENT RECORDS AND LOG ENTRIES:

1. Patient #15 was an 84 year old seen in the ER on 3/16/10 and admitted to acute care unit. Review of the patient's ER and inpatient record evidenced that there was inaccurate information documented, documentation was written over, especially times, progress notes were not consecutive, and physician documentation was illegible.

Review of the patient's 3/16/10 3:05 PM "ER (Emergency Room) Nursing Assessment and Treatment Record" form evidenced that the patient was seen in the ER for "c/o (complaint of off balance...dizzy X 1 week" and "acting weird" (since 3/3/10 per the daughter). The patient was assessed as having unsteady gait, orientated X 2, and having a blood sugar of 165 done at 3:37 AM. The patient was noted to have no known allergies (NKA). The patient's vital signs were temperature (T) 97.8 degrees Fahrenheit (F), pulse (P) 87, respirations (R) 20, blood pressure (BP) 146/73, oxygen saturation 96 % on room air (RA). There were no other vital signs, including discharge/transfer, noted in the ER record.

Review of the patient's "ER Provider Assessment Record" and "Emergency Room Physician 's Order Sheet" evidenced that the documentation was illegible. The physician ordered labs and an intravenous (IV) fluids. The provider's diagnoses for the patient was "hyponatremia and altered mental status" (written in a different handwriting). The line for allergies was not filled in.

Review of the patient's "Progress Notes" revealed that the times and dates were not consecutive, making the information confusing and placing the actual time of documentation in question. The following documentation was found (listed in the order written in the Progress Notes):

3/16/10 at 2155 (9:55 PM) - nursing admit note

3/17/10 at 5:20 AM - physician note

3/17/10 at 1630 (4:30 PM) - nursing note related to confusion, IV being pulled out, unsteady gait

3/17/10 2355 (11:55 PM) - physician note related to patient's fall

3/18/10 at 0700 (7:00 AM) - nursing note referring to critical care sheets in nurses notes

3/17/10 2000 (written over number) (8:00 PM), 2100 (9:00 PM), 2215 (10:15 PM), 2230 (10:30 PM), 2330 (11:30 PM) - nursing notes

3/18/10 10:00 AM - physician note about bruising on face

3/18/10 10:15 AM - nursing note.

Throughout this patient's medical record related to the ER visit and the inpatient admission, there were multiple written over entries. Additionally, the patient's record listed allergies to Pneumovax, Clindamycin, Codeine, and Bacitracin. The patient's 3/16/10 ER nursing assessment form listed no known allergies. The patient's admission orders on 3/16/10 listed "NKA ?Clinda, Codeine".

Review of the patient's "Neurological Assessment Record" evidenced the following:

Started on 3/17/10 at 10:00 AM

Done on 3/17/10 at 2:00 PM and 6:00 PM

Done on 3/18/10 at 10:00 AM, 2:00 PM, 6:00 PM, and 10:00 PM

Done on 3/19/10 at 2:00 AM and 6:00 AM.

Review of the patient's physician orders evidenced the following:

3/17/10 at 5:00 AM - Telemetry Bed; Vitals and Neuro checks every four hours

3/17/10 at 11:30 PM - Neuro check every two hours

3/18/10 10:00 AM - Discontinue telemetry.

There was no evidence to show that the nursing staff accurately documented assessments and/or did appropriate monitoring per physician orders or nursing standards. No records of telemetry were provided to show that the patient was in a telemetry bed.

2. Review of patient #18's 11/14/09 8:57 AM "ER Nursing Assessment and Treatment Record" revealed the patient present with "diarrhea x 3 days"; NKA (Note: Allergies were documented on the 11/10/09 visit); Vital signs - T 98.2, P 90, R 22, BP 75/52, pain level 7/10; bowel sounds in all four quadrants with last BM 2 days ago; EKG checked; 10:10 AM 1000 ml NS IV. The patient was admitted to the acute care unit at 2:06 PM; noted to be stable at discharge with T 97.7, P 100, R 23, BP 111/57, pain 0/10. No ESI rating was written on the form.

Review of the patient's "ER Provider Assessment Record" and "Emergency Room Physician's Order Sheet" for this ER visit evidenced the MSE was done at 10:00 AM; diagnoses included diarrhea (secondary to too much laxatives, history of constipation, dehydration), hypotension secondary to dehydration, coumadin toxicity, CAD s/p MI, Afib with MVR, A1CD (??). The provider ordered CMP, CBC, EKG, Cardiac enzyme, PT/INR, KUB, CXR, NS bolus, Klor 40 Meq, and admit to acute care unit.

This record had whole lines of documentation scribbled out, as well as numerous write-overs.

3. Review of the Hospital's ED logs revealed that there were crossed out entries, written over information, names written in where there were no lines, changed information with no initials to indicate who made the changes in the logs or the changed information was illegible, including the initials.

The following were examples of the inaccurate entries in the ED logs:

The log page starting with 1/10/11 1900 had several written over names, times, and medical record numbers. Most of these changes were not initialed by the person who changed them.

The log page starting with 11/12/10 1724 had a name written in between the sections and one name crossed off and "registered" written in.

The log page starting with 11/15/10 1342 had one name crossed off with "registered" written in.

The log page starting with 11/16/10 1048 had dispositions and times written over and one name totally changed.

The log page starting with 11/23/10 2130 had a name written in between the sections.

The log page starting with 11/24/10 1340 had a name written in between the sections and a line crossed off with multiple crossed words.

4. On 1/13/11, in an interview with the Director of Nursing, the ED log inaccuracies were discussed and verified.



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5. On 1/12/2011 at 10:00 AM, during a medical record review of sample patient #5 with an emergency room exam date of 9/05/2010, it was observed that the Authorization for Emergency Treatment was not signed and had been left entirely blank.

On 1/21/2011 at 10:30 AM, Staff B reviewed the record and confirmed that the Authorization for Emergency Treatment was not signed and had been left entirely blank.

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on observation and staff interviews, the Hospital failed to ensure drugs and biologicals were properly stored. The findings included:

1. During an initial walk through in the Emergency Department (ED) on 1/10/11 at 10:23 AM in the presence of nurse (G), the supply storage room (1B-126) was observed. This room contained dressings, irrigation solutions, supplements, and an ice machine. The room was warm.

The ambient temperature in the IV (intravenous)/medication storage room was hot.

2. On 1/13/11 2:40 PM, observation in the ED IV room revealed the following:

- The room temperature was 84.6 degrees Farenheit (F).

-. Numerous medications were stored in this room including -
1) Metronidazole - 500 mg/100 cc - 6 bags - storage temperature 68 - 77 degrees F
2) Ciprofloxacin - 400 mg/200 cc - 6 bags - storage temperature 68 - 77 degrees F
3) Cipro - 200 mg/100 cc - 6 bags - storage temperature 41 - 77 degrees F
4) Replacement drawers for the crash cart, including Albuterol 0.083% 2.5 mg/3 ml.

3. On 1/13/11 at 2:53 PM, an observation of the supply storage room (1C-140) in the presence of staff member (X) was made. The temperature of the room was 79.2 degrees F. There were twelve liter bottles of Normal Saline for irrigation and five liter bottles of water for irrigation in the room. The manufacturer's storage temperatures for these two items were 68 - 77 degrees F and 25 degrees C, respectively.

RADIOLOGIST RESPONSIBILITIES

Tag No.: A0546

Based on observation, interview, and record review, the hospital failed to assure the consulting radiologist supervised the radiology services for security of patient medical records, safety of patients prior to administering contrast media, and enforcing infection control standards. The findings included:

1. During an interview on 1/13/2011 at 2:15 PM, the radiology supervisor stated, "the visiting radiologist does not provide administrative oversight."

Medical Records Storage:
2. During an observation of the dental clinic on 1/10/11 at 10:08 AM in the presence of staff member (E), she indicated that the dental films were kept in a large file cabinet. The unlocked cabinet was in room 1C-172; the door on this room did not have a lock on it. The films had the patient names and numbers on them. The staff member verified that these records were not kept locked up.

3. On 1/11/2011 at 10:15 AM during a tour of radiology department with the radiology supervisor, the patient X ray films were stored under a material cover that draped the top and sides. Additionally, the door to radiologist reading room was unlocked and contained 80 patient files with patient name, birth date, medical record number, and reports from the radiologist. The radiologist reading room was located next to the emergency department(ED) staff break room. The partial wall connecting the break room had a gap approximately 2 feet from the ceiling. During the tour, the radiology supervisor staff WW stated, "the radiologist came to the hospital every other Thursday to dictate patient X-ray impressions. One could hear the dictations in the ED break room. The radiology department was staffed by one radiology staff after midnight and the radiology department was not locked to secure the patient X-ray films." Two additional doors were observed unlocked and both opened to hospital corridors. An outpatient was observed to open the door leading to the laboratory outpatient draw station and enter the radiology department. Radiology personnel were not immediately alerted to the patient entering the department.

4. On 1/13/2011 at 2:10 PM, the radiology Staff VV stated, "the door to the emergency room is not locked. People walk through the X-ray department to go the emergency room. One X-ray staff works at night. The X-ray tech must leave the X-ray department to use the portable X-ray at night."

Patient Safety Prior to Administration of Contrast Media:

5. The radiology policy, CT scanning, ordering , sedation, contract injection, billing revised on 1/09 was reviewed. The section titled contrast studies stated " Consent form titled " Consent to Administer Contrast Media will be completed by the Technologist and placed in the patients Medical Record.

6. During an interview on 1/13/2011 at 1:45 PM, Staff CTT stated, "For outpatients, the technologist completed the "Contrast Media Form" and for emergency room and inpatients the medical doctor reviewed the contrast media with the patient."

Infection Control

7. During an interview on 1/11/2011 at 10:15 AM, the radiology supervisor, Staff WW explained the process to use the disinfectant product, Re Juv Nal. The surface was spayed with Re Juv Nal and then wiped off. The product was used in every room after patient use.

8. An interview with the facility Housekeeping Supervisor was conducted on 1/12/2011 regarding the facility's use of a product called Re Juv Nal?, a combination disinfectant, detergent, virucide, and fungicide. The product direction insert for use of the product require that the product be applied to the surface to be cleaned and left wet for ten minutes and then removed to be effective.

In the interview the Housekeeping Supervisor confirmed that the directions did require that after applying the cleaning agent on the surface to be cleaned it should be left wet for a period of at least ten minutes. No other information was provided by the facility to show the product could be used effectively in a manner inconsistent with its listed directions.

Assuring Adequate Shielding for Patients and Personnel


04748


9. During an observation of the dental clinic on 1/10/11 at 10:08 AM in the presence of staff member (E), the patient bays were observed to each have lead aprons hanging on the wall. Staff member (E) revealed that there were approximately 12 aprons in the dental clinic. She verified that the aprons had been tested for safety in 11/10, but that the clinic had not received a report with the results.

10. During an interview on 1/13/2011 at 3:20 PM, the lead dental assistant, Staff E explained, "the dental aprons were taken to X-ray at the beginning of 11/2010. A preliminary report was received, but not a final report. The dental department no longer had a copy of the preliminary report. Apron D9 had a circle on the upper part of the apron and did not know what that meant." At that time, dental clinic aprons D12, D13, D14, #4, #6, #3, D5, D9, D10, and D11 were located in the dental clinic. Staff E confirmed that these aprons were available for patient use.

11. During an interview on 1/14/2011 at 8:10 AM, radiology Staff F stated, the dental aprons were scanned about six weeks ago on the weekend. A hand written note was forwarded to the dental department. The note was left with the dental aprons. The department is closed on the weekends.

12. A memo dated 3/3/2009 from the radiology supervisor showed Aprons D3, D4, D6, D9, D10, D11, D12, D13, D14 and D15 had passed inspection and were safe to use. A report from 11/2010 was not provided prior to exit on 1/14/2011.

WRITTEN DESCRIPTION OF SERVICES

Tag No.: A0584

Based on record review and interview, the laboratory failed to provide a current written description of laboratory services. The findings included:

On 1/12/2011 at 9:35 AM, the laboratory supervisor explained that the new process would be implemented with the next medical director. The unapproved process titled, Laboratory Provider Orientation, included a laboratory test STAT list, the laboratory panic value notification policy, and the hospital laboratory test menu.

During an interview on 1/12/11 the chief of staff stated, "The laboratory test list is not current".

POLICIES FOR LABORATORY SERVICES

Tag No.: A0586

Based on record review and interview, the hospital failed to have a policy that described which tissue specimens require a macroscopic examination and which require both macroscopic and microscopic evaluation. The findings included:

During a tour of the laboratory on 1/10/2011 at 3:30 PM, the laboratory supervisor explained that all tissue specimens were sent out to a reference laboratory and the reference laboratory decided whether a microscopic and macroscopic examination was performed. A policy was requested for tissue specimens at that time.

On 1/11/2011 at 9:25 AM, the chief of staff stated that a breast biopsy would require both microscopic and macroscopic examination otherwise it was up to the physician.

On 1/11/2011 at 10:10 AM, the laboratory supervisor showed the surveyor a tissue policy dated 8/6/1998 and explained that the policy was not current. The policy had a list of tissues that would not be submitted to the reference laboratory.

On 1/12/2011 at 4:30 PM, the laboratory supervisor showed the surveyor a new policy that was not approved by the medical staff.

UTILIZATION REVIEW

Tag No.: A0652

Based on interview, the hospital failed to demonstrate that it had implemented the Utilization Review plan since April 2009.

On 1/11/11 at 10:30 AM, Staff A stated, in an interview, that that Utilization Review (UR) function has not been performed, as identified in the plan, since approximately April 2009.

(Cross refer to findings at: A653, A654, A655, A656, A657, and A658)

APPLICABILITY

Tag No.: A0653

Based on interview the hospital failed to demonstrate that it had implemented the Utilization Review plan since April 2009.

On 1/11/11 at 10:30 AM, Staff A stated, in an interview, that that Utilization Review (UR) function has not been performed, as identified in the plan, since approximately April 2009 and that the hospital does not have an agreement with a Quality Improvement Organization or have a waiver.

UTILIZATION REVIEW COMMITTEE

Tag No.: A0654

Based on interview the hospital failed to demonstrate that it had implemented the Utilization Review plan since April 2009.

1. On 1/11/11 at 10:30 AM, Staff A stated, in an interview, that Utilization Review (UR) committee has not met or performed its function, as identified in the plan, since approximately April 2009.

SCOPE AND FREQUENCY OF REVIEW

Tag No.: A0655

Based on interview the hospital failed to demonstrate that it had implemented the Utilization Review plan since April 2009.

On 1/11/11 at 10:30 AM, Staff A stated, in an interview, that the Utilization Review (UR) Committee has not performed a review of medical necessity of Medicare and Medicaid admissions, duration of stays and professional services since approximately April 2009.

DETERMINATIONS OF MEDICAL NECESSITY

Tag No.: A0656

Based on interview the hospital failed to demonstrate that it had implemented the Utilization Review plan since April 2009.

On 1/11/11 at 10:30 AM, Staff A, during an interview, stated that Utilization Review (UR) has not been completed since approximately April 2009. Therefore, an assessment by the committee of non medically necessary admissions or continued stays of Medicare and Medicaid patients was not completed and the appropriate notice was not provided.

EXTENDED STAY REVIEW

Tag No.: A0657

Based on interview the hospital failed to demonstrate that it had implemented the Utilization Review plan since April 2009.

On 1/11/11 at 10:30 AM, Staff A, during an interview, stated that Utilization Review (UR) has not been completed since approximately April 2009. Therefore, a periodic assessment by the committee of current Medicare and Medicaid in patients receiving hospital services patients was not completed on reasonably assumed outlier cases within the time period identified in the plan.

REVIEW OF PROFESSIONAL SERVICES

Tag No.: A0658

Based on interview the hospital failed to demonstrate that it had implemented the Utilization Review plan since April 2009.

On 1/11/11 at 10:30 AM, Staff A, during an interview, stated that Utilization Review (UR) has not been completed since approximately April 2009. Therefore, an appropriate review by the committee of professional services to promote efficient use of available services had not been completed.

PHYSICAL ENVIRONMENT

Tag No.: A0700

Through observation and staff interview during the health recertification survey completed 1/14/2011 and the Life Safety Code survey completed 1/12/2011, it was determined the Hospital failed to meet the Condition of Participation: PHYSICAL ENVIRONMENT ( 42 CFR 482.41 ) due to the nature of Standards not met.


The Hospital failed to meet the requirements of the federal register at 42 CFR 482.41(b) using the standards of the 2000 National Fire Protection Association (NFPA) 101 Life Safety Code and failed to maintain the facilities, supplies, and equipment of the Hospital to ensure an acceptable safety level for the patients.

LIFE SAFETY FROM FIRE

Tag No.: A0709

Based on the survey completed on 1/12/2011 and observation during the tour of the Hospital, it was determined the Standards of the 2000 National Fire Protection Association (NFPA) 101 Life Safety Code were not met.

See the attached CMS form 2567 for specific Life Safety Code deficiencies and details.

LIFE SAFETY FROM FIRE

Tag No.: A0710

Based on the survey completed on 1/12/2011 and observation during the tour of the Hospital, it was determined the Standards of the 2000 National Fire Protection Association (NFPA) 101 Life Safety Code were not met.

See the attached CMS form 2567 for specific Life Safety Code deficiencies and details.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

I. Based on observation, record review and staff interview, it was determined the Hospital failed to maintain the facilities, supplies, and equipment of the hospital to ensure an acceptable level of safety and quality. The findings included:

1. During an initial walk through in the Emergency Department (ED) on 1/10/11 starting at 10:23 AM in the presence of nurse (G), Quality Assurance Coordinator (QAC), and the Acting Clinical Director (ACD), the following observations were made:

a. In the soiled utility room (1B-162), there was a flip top needle bucket. A used syringe was observed lying on top of the movable section of the lid.

b. In the janitor closet (1B-163), the floor, walls, and sink were dirty.

c. In patient bay three, a used syringe was observed lying on top of the movable section of the needle disposal container lid.

d. In front of the nurses' station, there was a large unlocked cart which contained several drawers full of syringes and needles.

e. The patient bathroom was located next to the triage room, out of the direct sight of the staff in the nurses station and obscured from staff in other patient care areas of the ED. When the emergency call light located in this bathroom was activated, a red light came on over the door. Nurse (G), the QAC, and the ACD verified that no audible sound was heard. Nurse (G) revealed that there was not a panel or device located at the nurses station to alert the nurses when the call light was activated.

f. The ambient temperature in the IV (intravenous)/medication storage room was hot.

g. In the entrance area to the ED, there was a sign posted to use masks if the person entering had respiratory symptoms. The table which the QAC indicated was where the supplies should be available was empty. When the staff member at the sign-in desk was asked about these supplies, she provided them. The supplies were not accessible for patients/visitors to use.

h. In the ED waiting room, there was a bathroom (1B-177) which did not have an emergency call light in it. This bathroom and one wall of chairs in the waiting room were out of view of the staff at the sign-in desk. At this time, staff commented that they viewed/checked the waiting room at least once an hour.

2. During an initial walk through in the Outpatient Department (OPD) on 1/10/11 starting at 11:20 AM in the presence of the OPD nursing supervisor and the QAC, the following observations were made:

a. In the soiled utility room (1C-112), there were two red buckets which according to the OPD supervisor, each contained dirty instruments. She verified that usually the instruments are picked up at the end of the day, so she commented that these must be left from Friday.

b. In room 1C-127, there was a needle sticking out of the needle disposal bucket.

c. On 1/13/11 2:40 PM, observation in the ED IV room revealed the following:

- The room temperature was 84.6 degrees Farenheit (F).

-. Numerous medications were stored in this room including -
1) Metronidazole - 500 mg/100 cc - 6 bags - storage temperature 68 - 77 degrees F
2) Ciprofloxacin - 400 mg/200 cc - 6 bags - storage temperature 68 - 77 degrees F
3) Cipro - 200 mg/100 cc - 6 bags - storage temperature 41 - 77 degrees F
4) Replacement drawers for the crash cart, including Albuterol 0.083% 2.5 mg/3 ml.

d. On 1/13/11 at 2:53 PM, an observation of the supply storage room (1C-140) in the presence of staff member (X) was made. The temperature of the room was 79.2 degrees F. There were twelve liter bottles of Normal Saline for irrigation and five liter bottles of water for irrigation in the room. The manufacturer's storage temperatures for these two items were 68 - 77 degrees F and 25 degrees C, respectively.


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3. An environmental tour of the facility was conducted with the facility's Maintenance Engineer and Housekeeping Supervisor on 1/12/2011. The following items were noted to the Maintenance Engineer and the Housekeeping Supervisor during the tour:

a. The linoleum flooring in the Emergency Department was observed to have separating seams between the sheets of the flooring, presenting uncleanable surfaces. The buildup of dirt and grime was observed along the edges of the flooring and in the separated seams of the flooring.

b. The wall areas of the Emergency Department were observed to have numerous areas that were worn, dented, or in need of repainting. This presented an unmaintained and uncleanable surface.

c. The linoleum flooring in the public areas and walkways of the facility were noted to have separating seams in many areas of the hospital, presenting uncleanable surfaces. Two examples of such separations were observed and discussed at length with the facility Maintenance Engineer and Housekeeping Supervisor in the hallways of Labor and Delivery near room 2A-158 and room 2B-118, the Outpatient hallways, and the Inpatient hallways. During the discussion the Maintenance Engineer stated that the facility was aware of the issue regarding the separating seams that the facility believed were a result of possible improper installation.

d. Observation of the bathroom located in the Emergency Department (ED) waiting area found that the bathroom 1B177 did not have a call light installed to summon help in the event a patient needed assistance from ED staff. This was confirmed by the Maintenance Engineer at the time of the observation.

e. A test of the call light system was made of individual patient call lights on the second floor In-patient rooms and Pre-Operative holding rooms. Each room had a wired remote device with a button that when depressed activated the call light system with an audible alarm at the nurse's station and activated a light over the each room door. The test found that room 2A-127 did not have a functional remote that would activate the call system for that room. This was verified with the Maintenance Engineer at the time of the test.

A test was made of room 2A124 in the Pre-Operative holding area. During an interview on 1/12/2011, nursing staff # AA stated this room was used primarily for Outpatient services and the call light was monitored by the nursing station in the Inpatient area. A test of the call light system for this room found that the call light did not activate the call system at the Inpatient nurse's station. Instead it activated the call system at the Operating Room nurse's station, which was not monitored at all times a patient may be located in room 2A124. This was verified by nursing staff # BB and the facility Maintenance Engineer at the time of the test.

f. Observation was made with maintenance staff and housekeeping staff of disposable sharps containers located in individual patient rooms and other areas of the facility. The containers were noted to be locked to the walls, but the top lid of the container operated in such a way as to allow an individual to place a hand completely into the container.

During the tour the Housekeeping Supervisor obtained an empty sharps container and verified with the surveyor that the lid did not prevent an individual from placing a hand into the container allowing easy access to its contents.

The facility's Chief Pharmacist stated in an interview on 1/11/2011 that facility medical and nursing staff disposed of unused medications, including narcotics, into the sharps container as a way of wasting and disposing of unused medications.

4. An interview with the facility Housekeeping Supervisor was conducted on 1/12/2011 regarding the facility's use of a product called Re Juv Nal?, a combination disinfectant, detergent, virucide, and fungicide. The product direction insert for use of the product require that the product be applied to the surface to be cleaned and left wet for ten minutes and then removed to be effective.
In the interview the Housekeeping Supervisor confirmed that the directions did require that after applying the cleaning agent on the surface to be cleaned it should be left wet for a period of at least ten minutes. No other information was provided by the facility to show the product could be used effectively in a manner inconsistent with its listed directions.

Examples were identified during the survey that the product was not being utilized as directed to provide the acceptable level of cleaning and disinfecting.

5. In the Dental department of the facility Sani-Cloth? Germicidal Disposable Wipes were used for cleaning the dental chairs. The label directions state that the product should only be used on hard, non-porous surfaces. Information provided by the facility housekeeping and maintenance department on 1/14/2011 was found to indicate that the product my cause discoloration and eventual breakdown of vinyl material, such as used on the facility's dental chairs.

No other information was provided by the facility to show the product could be used effectively in a manner inconsistent with its listed directions.


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II. Based on the facility tour, staff interview and record review the hospital failed to ensure equipment was maintained and in adequate repair to ensure acceptable levels of safety and quality. Specifically the hospital failed to ensure the washer/disinfector unit and the Autoclave in the central processing area were maintained and running properly to ensure disinfection and sterilizing of surgical instruments. This failure has the potential to negatively affect patient care and staff safety. The findings included:

6. On 1/12/10 a tour of the area identified as the rooms used for sterile processing was done with the surgical staff (A and B). Staff (B) reported that the washer/disinfector and Autoclave was not currently working. She was currently hand washing all surgical instruments and dirty instruments brought in from the outpatient departments. She reported that after instruments were soaked and washed they were put into an Ultrasound machine for 20 minutes. The instruments are then taken into the clean side, wrapped and marked, transported back through an operating room into a small room which has a small Autoclave. Staff (B) reported she had to start processing the instruments using this process due to the main equipment not working.

Review of the work orders included:
1) Washer /disinfector which identified the following problems, leak around detergent and lubricant bottles, broken plastic the shelf rolls on in order to clean screen, second level spinning arm not turning and washer has gone through 1 gallon of lubricant in 2 days and left white film on all the instruments. The unit was shut off on 7/22/10 and not in use.

2) The Autoclave failed the DART test on 4/9/10 and 4/12/10. (The DART -Daily Air Removal Test is the testing done for removal of air from the chamber during the pre-vacuum stage for steam sterilizers.)

Interviews with staff (B) on 1/12/10 confirmed that neither machine had been used since the work orders were sent. Both staff (A and B) reported they were not aware of the QA (quality assurance) committee or infection control coordinator being involved in how sterile processing was currently processing surgical instruments. Additionally, there was no monitoring or follow up to ensure there were no adverse effects with hand washing and sterilizing of surgical instruments.

Interview with the Infection Control Coordinator on 1/14/10 confirmed she was not aware or involved in the current process being used to hand wash dirty surgical instruments.

Interview with Maintenance Engineer prior to exit on 1/14/10 reported she was aware that the equipment had been broken for six to eight months. She reported it was a budget issue and they were trying to work it into the budget to get it repair or replaced.

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

Based on record review, observation, and interview, the hospital failed to ensure a hospital -wide infection control program. The findings included:

The hospital failed to maintain a sanitary environment and to evaluate the process to disinfect and sterilize surgical instruments. Cross refer to A724 and A749.

The hospital failed to maintain a log of incidents related to infections and communicable diseases that included staff. Cross refer to A750

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on interview, observation and record review, the hospital failed to have an active surveillance system to maintain a sanitary environment, a system to approve procedures for instrument cleaning and sterilization, and procedures for mitigating risks associated with patients presenting to the emergency room and outpatient area. The findings included:

1. On 1/13/2011 at 3:40 PM, the infection control nurse stated that housekeeping products were not reviewed. The contact time for the product, Re Juv Nal is ten minutes.

During an observation in the ED on 1/11/11 at 2:00 PM, nurse (O) sprayed a liquid cleaner on an ED gurney and a bedside table after a patient left the bay. She was observed to wipe the solution off of the bed and table within two minutes. The surveyor requested to see the bottle which the nurse used for cleaning. The bottle was labelled ReJuvNal. The required contact time was not being followed.

2. The infection control committee meeting was cancelled for January 6, 2011. Most of the infection control monthly meetings were cancelled.

The hospital provided four infection control committee (ICC) meeting minutes dated 10/09/2009, 1/28/2010, 4/28/2010, and 10/28/2010. The ICC meeting dated 1/28/2010 stated, "the ICC needed to conduct an annual review of disinfectants for the facility." An action plan was not identified. The ICC meeting dated 4/28/2010 stated, "Unable to have IC meeting, no provider available." The ICC meeting dated 10/28/2010 did not address an annual review of disinfectants.

3. The radiology department infection control policy for CAT Scan revised 1/09 instructed personnel to damp wipe the equipment with approved disinfectant daily and after every patient. The disinfectant in use, Re Juv Nal, manufacturers instructions required a ten minute contact time.

4. The infection control officer did not have a system for surveillance of the disinfection of surgical instruments, of the environment in the emergency department, and cleaning and disinfecting of environmental surfaces. Cross refer to A724.

INFECTION CONTROL SURVEILLANCE, PREVENTION

Tag No.: A0750

Based on record review and interview, the Hospital failed to maintain a log of incidents related to infections and communicable diseases that included employees, contract employees and volunteers for 14 of 14 months.

On 1/13/2011 at 3:40 PM the infection control nurse said that there was not a log of employee illness. The infection control committee meeting was cancelled for January 6, 2011. Most of the infection control monthly meetings were cancelled.

The hospital provided four infection control committee (ICC) meeting minutes dated 10/09/2009, 1/28/2010, 4/28/2010, and 10/28/2010. The ICC meeting dated 10/09/2009 stated, under the item employee health: "seven employee illness report forms in September." The ICC meeting dated 1/28/2010 did not address employee health. The ICC meeting dated 4/28/2010 stated, "Unable to have IC meeting, no provider available." The ICC meeting dated 10/28/2010 stated, " Employee illness report form not being turned into IC."

IMPLEMENTATION OF A DISCHARGE PLAN

Tag No.: A0820

Based on record review, staff interviews and facility policies the hospital failed to ensure implementation of a discharge plan including arrangements of post-hospital services and care, and educating patient/family/caregivers providers about post-hospital care plans. This was identified for 7 of 25 ( #1, #4, #27, #53, #23, #34 and #35) inpatient records reviewed. The findings included:

1. Review of the hospital's policies and discharge instruction form included:

a. "Discharge Instructions" policy dated 1/10 which stated,
"All patients discharged from the any Department will receive condition appropriate instructions for home care and appropriate referrals:

-The Physician or RN/PN will verbally instruct patient on specific discharge instructions.

-Patient will verbally state understanding of discharge instructions.

-Patient will verbalize and demonstrate any skill given by Rn/PN as a part of discharge instructions. (i.e. crutch walking).

-The physician and /or RN/PN will document all instructions and understanding of discharge instructions on the ER- PCC, Inpatient-Progress Notes , OPD-EHR, OR-PACU Sheet."

b. "Discharge Medication Counseling" policy dated 1/10 which stated,
Policy: "To advise the patient and responsible family members, whenever possible, on the importance and correct use of medications to be taken following discharge, in the interest of assuring safe and correct self-administration.

Procedure: Discharge medication instructions will be provided by the appropriate person and documentation of the counseling will be made on the discharge summary form.

Discharge instructions will be provided by pharmacist when discharge medications are provided by (Hospital Name) Comprehensive Health care Pharmacy.

Discharge instructions may be provided by a clinical dietitian when requested if a potential drug interaction exists."

c. An attached form entitled "Patient Discharge Instructions" had three copies labeled "Patient Copy, Medical Record Copy and Referral Copy" which was to be used to document patient discharge instructions. The form instructions included: "... Teaching done with the patient prior to discharge is documented on this form and original given to the patient.

Items listed to be included dietitian instructions when indicated, pharmacist section, specific treatments such as post operative care, wound care, postural drainage and physical therapy. It also listed special instructions not considered treatments such as feeding of infants, vaporizers etc.

RECORD REVIEWS:
2. Review of the inpatient records found the hospital policy was not being followed to ensure patients were receiving the information needed for discharge instructions for home care. The examples included:

a. Patient #1's medical record review revealed the patient was admitted to the hospital on 1/7/11 from the ED (emergency department). The patient had been brought into the ED on 1/6/11 at 2251 (10:51 PM) by ambulance with complaints of chest pain. The patient had an extended stay in the ED and was transferred to the floor at 10:45 AM on 1/7/11 with admitting diagnoses of angina chest wall pain and ETOH (alcohol) intoxication.

Review of the physician admission orders included:
1/7/11 at 9:45 admit to obs. (observation): "1) AM Chest pain R/O (rule out) MI, 2) HX (history) of CAD with CABG (coronary artery disease with Coronary artery bypass graft ), 3) acute ETOH intoxication". The orders on 1/8/11 at 1:10 PM noted , "discharge to home Dx chest pain - MI (myocardial infarction) ruled out... condition at discharge good..."

Patient #1"s review of the "Patient Discharge Instructions" sheet dated 1/8/11 was incomplete. The sheet that is given to the patient noted "see chart" under medications. There was no evidence the resident was given a list of medication or they were reviewed with the pharmacist. Under treatments it said "take medication as ordered and stop drinking". There was no documentation the patient was provided written instructions for cardiac health, phone numbers or contacts for referrals such as social services, alcoholism counselors, community health etc.

Staff D confirmed the information for discharge instructions for patient #1 was incomplete.

b. Patient #4 was admitted to the ED on 1/5/11 and had an emergency appendectomy. The patient was discharged on 1/6/11. The patient was also identified as being five weeks pregnant.

Review of the "Patient Discharge Instructions" sheet did not include patient instructions for care of the incision and instruction watching for signs and symptoms of wound infection, fever and post operative care. There were no treatments or special instructions documented both areas were left blank.

c. Patient #27 was admitted on 12/3/10 for a vaginal hysterectomy and was discharged on 12/4/10.
Review of the "Patient Discharge Instructions" sheet did not include post operative instructions. The additional comments noted the patient was to call for a time for the walk in clinic for a follow up appointment.

d. Patient #53 was an infant admitted on 1/8/11 for viral pneumonia and croup. The patient was discharged on 1/10/11. Review of the "Patient Discharge Instructions" sheet noted under medication "see chart". The area under treatment noted "return sooner if increase in fever or short of breath". There was a follow up appointment noted. There was no documentation of instructions on how to give an infant medication and if the parents were shown any special instructions to care for an infant with croup and pneumonia.

e. Patient #23 was admitted on 1/9/11 through the ED with acute alcohol intoxication, abdominal pain, gastritis and hepatitis. The patient had expressed he/she was unable to care for self. Interview with the Social Services staff identified that she had been trying to get this patient assistance. Review of the "Patient Discharge Instructions" sheet noted, "Take all prescriptions as prescribed". However the area was not signed by the pharmacist. The other instruction listed was "return to the ED if needed". The area under referrals was blank and there were no numbers for the patient to call for assistance at home or any home care instructions identified. Interview with the Charge nurse reported she had not referred the patient to the Public Health Service for home care follow up.



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f. Record review was completed for patient #34 on 1/13/2011. The patient had been admitted to the facility with a diagnosis that included alcohol delirium. The patient was discharged from the facility on 1/13/2011. The "Patient Discharge Instructions" page given to the patient at discharge only showed the following listed under the special instructions section, "Contact alcohol program as needed" and "Do not use alcohol". Under the "Treatments" portion of the "Patient Discharge Instructions" was written, "Pt (patient) received social services reference".

g. Record review was completed for patient #35 on 1/13/2011. The patient had been admitted to the facility with a diagnosis that included alcohol abuse and suicidal gestures. The patient was discharged from the facility on 1/12/2011. The "Patient Discharge Instructions" page given to the patient at discharge only stated that the patient should return to the hospital if suicidal thoughts return and for the patient to not drink alcohol.

OPO AGREEMENT

Tag No.: A0886

Based on record review and interview, the hospital failed to have agreement with an organ procurement organization (OPO). The findings included:

On 1/14/2011 during exit conference, the DON (Director of Nursing) provided the Organ Procurement Policy for nursing service with a revision date of 1/10. The policy described the process to identify all potential donors and contact information for the OPO. The policy did not inlude a signed agreement between the OPO and the hospital.

An agreement between the OPO and the hospital was not provided prior to exit on 1/14/2011.

TISSUE AND EYE BANK AGREEMENTS

Tag No.: A0887

Based on record review, the Hospital failed to have an agreement with at least one tissue bank and one eye bank. The findings included:

During the exit conference on 1/14/201, an agreement with an eye and tissue bank was provided. The agreement was with the area office and not the hospital. The agreement was not signed or dated. An agreement with the hospital was not provided prior to exit on 1/14/2011.

EMERGENCY SERVICES

Tag No.: A1100

Based on review of medical records, policy review, review of administrative records/logs, and family and staff interviews, it was determined that the Hospital failed to administer medications/tests in a timely manner or as ordered by the physician/QMP, failed to ensure the accuracy and adequacy of triage assessments, failed to accurately and legibly document patient information in the medical records, and failed to have adequate ED staff. The findings included:

I. PATIENT CARE

1. Patient #9 - 4 month - probable meningitis

Review of 4 month old patient #9's 9/16/10"ER (Emergency Room) Nursing Assessment and Treatment Record" form evidenced that the patient was seen in the ER at 1:53 PM for "c/o up all night crying". The assessment form indicated the infant had no known drug allergies (NKDA), a g-tube, temperature of 99 degrees F on arrival assessment, received Rocephin IV, and was transferred at 9:15 PM.

Review of the patient's "ER Provider Assessment Record" and "Emergency Room Physician 's Order Sheet" revealed that the ER physician (CC) did the MSE at 2:30 PM and the pediatrician (BB) assessed the infant [no time noted for when the pediatrician (BB) was called or did the assessment]. The orders for the blood work and cath (catheterized) ua (urinalysis) were timed at 6:55 PM. The nurse's initials were written next to the orders for the IV hep (heparin lock) and cath ua on the Physician Order sheet at 8:00 PM. The orders for the IV and IV antibiotic were initialed by the nurse at 8:30 PM. The physician and the pediatrician determined that the patient had a bulging anterior fontanelle and needed to be transferred with a diagnosis of probable meningitis. The flight team arrived and the infant was transferred in "stable but guarded"condition at 9:15 PM.

During the seven hours and twenty-three minutes the patient was in the ED, the nurses documented vital signs at 1:53 PM (admission assessment), 4:50 PM (three hours after presenting to ED), 7:30 PM (two hours and forty minutes later) , 8:00 PM, 8:30 PM, 9:00 PM, and 9:15 PM (discharge time).

The only intake and output that was documented was 10 cc of urine when the patient was catheterized at 8:00 PM. The patient was started on an IV at 20 cc/hour at 8:30 PM. There was no evidence that the physicians were aware of the limited fluid intake/output.

On 1/12/11 Medical Records (MR) staff were requested to provide any electronic health records (EHR), laboratory, or radiology reports for this patient. MR staff member (Z) commented that the patient did not have any additional documentation for this ER visit.

On 1/14/11 at 8:30 AM, the ACD and the Aberdeen CD provided copies of the patient's chest x-ray, abdominal x-ray, urinalysis, and blood results, including a blood culture. Review of these lab results evidenced that the blood specimens were collected at 7:08 PM and the urine was obtained at 8:15 PM. The patient's WBC (white blood cells) results were 18.4 K/uL (4.5 - 11). There was no evidence that a spinal tap was done or why it took more than seven hours to transfer the infant who had a bulging anterior fontanelle to another hospital.

2. Patient #14 - OB - 35 week fetal death

a. On 1/11/11 in the morning, Medical Records staff were requested to provide patient #14's medical record. The surveyor was informed that the record was locked up, but that a copy of the entire chart was in the file room. Staff were requested to provide the record, any electronic records, including laboratory reports and radiology, and fetal heart monitoring recordings.

b. Review of patient #14's medical records evidenced that she was seen in the ER on 4/19/10, was admitted to the acute care unit from 4/26 to 4/28/10 with diagnoses of "pregnant, persistent UTI (urinary tract infection) with pyelonephritis, nausea, and dehydration", and was seen again in the ER on 5/6/10.

c. Review of the patient's 5/6/10 "ER Nursing Assessment and Treatment Record" (7:25 PM) revealed "Pt is having labor pain since 5 P", with pain at 10/10, no Fetal Heart Tone (FHT) were documented on the form, and a note indicated "On arrival 2 strips no contractions".

d. Review of the "ER Provider Assessment Record" and "Emergency Room Physician's Order Sheet" for the 5/6/10 visit revealed diagnoses of IUP (intrauterine pregnancy) 34 2/7 weeks, nephrolithiasis, and early labor. The provider ordered straight cath (urine), CBC, BMP, Morphine, Ativan, Terbutaline, Tylenol, Ondansetron(?), and IV fluids (Normal Saline and Lactated Ringer's).

e. Review of the patient's "Critical Care Flow Sheet" evidenced that the patient's pain was 10/10 at 8:50 PM, 8-9/10 at 9:15 PM, and 7-10/10 at 9:45 PM.

f. Review of the patient's "Out-of-Hospital Transfer Record", signed and dated 5/7/10 at 8:00 AM, documented the following:

No time left

Ambulance

Stable

Criteria for transfer "34 4/7 wks with nephrolithiasis, unresponsive to conservative Tx (treatment). Needs evaluation and treatment not available at RIH".

No FHT were noted on this form.

It was noted that at 9:00 AM the patient received Dilaudid 2 mg IVP (intravenous push) and Zofran 4 mg IVP.

g. On 1/11/11 and on 1/12/11, Medical Records staff were requested to provide patient #14's medical record related to the 5/6/10 ER visit. The surveyor was informed that the record was locked up, but that a copy of the entire chart was in the file room. Staff were requested to provide the record, any electronic records, including laboratory reports and radiology, and fetal heart monitoring recordings. As of 1/14/11 at the exit entrance time (10:45 AM), the Hospital had not provided any electronic records, laboratory reports, or radiology reports related to the patient's 5/6/10 ER visit. The last FHT record provided was dated 5/7/10 at 7:50 AM.

h. Review of the patient's 5/7/10 Operative Report from the hospital where the patient was transferred to revealed the following:

"....arriving at approximately 1:00 in the afternoon secondary to a suspected kidney stone Upon evaluation, the patient was found to a have fetal demise, and she, at that time, became tachypneic and was already tachycardiac. She was evaluate by the hospitalitis and then by the intensivists along with the surgeon, .... On evaluation with CT, free fluid was seen underneath the diaphragm, and it appeared that there was a small bowel perforation. ....intubated in ICU and taken to the operating room for surgery."

Postoperative diagnoses were "pregnancy, uterine, at 34 weeks with a fetal demise and suspected small bowel perforation with sepsis".

i. During an interview with patient #14 on 1/10/11 at 12:40 PM, she revealed that on 5/10/10 (per record review the date was 5/7/10) she was transferred from the Hospital with an undiagnosed perforated bowel. She indicated that this caused the loss of her baby at 35 weeks gestation and she had peritonitis and almost died. The patient alleged that when she came to the ED with complaints of abdominal pain, she was diagnosed as having a kidney stone, did not have an ultrasound or x-rays done. The two doctors (H and I) treated her in the ED. She said that doctor (I) was no longer working here. The patient said that when she was transferred to the other hospital, the EMS dropped her off, without giving a report to ____(name of hospital where the patient was transferred) staff. She said that she had to holler to get any staff to come into the room because they did not know she had arrived. The patient revealed that an emergency cesarean section (C/S) was performed and the bowel perforation which they found was repaired.


3. Patient #10 - 21 - OB - 28 week fetal demise after Preterm Labor

a. Review of 21 year old patient #10's "ER Nursing Assessment and Treatment Record", "ER Provider Assessment Record", and "Emergency Room Physician's Order Sheet" forms evidenced the following visits to the ED (complaint; assessment, and orders):

1) 3/18/10 at 9:22 PM - c/o (complained of) "lower back pain. 'don't feel good'," (G4 P3 due 6/18/10), vital signs and pain level not noted; diagnoses were "suprapubic pain, 26 week pregnancy, r/o (rule out) UTI (urinary tract infection)"; urinalysis and culture ordered; Macrobid 2 x daily x 3 days; Discharged home at 11:55 PM.

2) 3/20/10 at 11:38 AM - c/o "having contractions, 27 week IUP. Pt was seen in ER Thursday night was told would have to send out urine culture", Temperature (T) 100.9 degrees Fahrenheit (F), Pulse (P) 100, Blood Pressure (BP) 139/65, pain level 5/10; diagnosis was "contractions"; Terbutaline 0.25 mg subq and Pyridium were ordered. Discharged home at 4:58 PM. (Note: The orders appear to be for one dose of Terbutaline, but three doses were charted as given.)

3) 3/20/10 at 11:39 PM - c/o "I think I'm in labor again.", T 98.9 degrees F, P 104, BP 137/71, pain 6/10; diagnosis "IUP at 27 weeks PTL (pre-term labor)", Ancef ordered, patient seen by consultant doctor and admitted to the acute care unit at 1:04 AM. (Note: Patient was transferred to another hospital on 3/21/10.)

4) 3/25/10 at 10:54 PM - c/o "sent Sioux Falls for (?) meds - terbutaline at 8:30 more ______(? unable to read)"; diagnoses - "IUP 27 2/7 weeks, early contractions, preterm labor"; Terbutaline and Tylenol were ordered and given, patient was admitted to the acute care at 12:49 AM on 3/26/10 and discharged on 3/27/10 .

5) 3/29/10 at 8:37 PM - c/o "lower abd (abdominal) pain/cramping, fever, discharge", T99.7 degrees F, P 125, BP 108/58, pain 4/10, no FHT noted during any of this visit; "ER MD did not see", diagnoses "uterine irritability, UTI, Vaginitis", Terbutaline x 2 and Ancef ordered, "pt offered to be admitted but she declined...". Discharged home at 11:30 PM.

Note: There was a lack of evidence to show that the patient was checked for dilation or ruptured membranes or that fetal monitoring was done during the above visits.

6) 3/30/10 at 9:45 AM - c/o "here with preterm labor. Pt present with foot out of vagina", no T, P 104, BP 130/66, no pain level noted, no FHTs; OB doctor saw and documented "ER doctor was not present", fetal demise. Admitted to Medical/Surgical Floor at 12:00 noon.


4. Patient #18 - Closed record ruptured appy - death

a. Review of 73 year old patient #18's "ER Nursing Assessment and Treatment Records", "ER Provider Assessment Record", "Emergency Room Physician's Order Sheet", "Critical Care Flow Sheet", Laboratory reports, and Radiology reports for 11/10/09 evidenced the following:

1) 11/10/09 at 10:03 PM - c/o "stomach hurts. L haven't gone to bathroom (BM) in 3 days. Vomiting". NKA. Vital signs - T 97.0 P 65 R 20 BP 121/8?. Pain level 8/10. SOB. Abdomen was noted to be tender, no documentation that bowel sounds were assessed. The documentation indicated that the patient was given Zofran, Lactulose, and 1000 cc normal saline IV. The patient was discharged at 1:00 AM in "Stable" condition with no discharge vital signs charted on the form.

2) Review of the patient's "ER Provider Assessment Record" and "Emergency Room Physician's Order Sheet" for this 11/10/09 ER visit revealed a limited examination of the abdomen. The provider ordered lactulose, fleet's enema, GI cocktail 30 cc, Zofran, 1 L NS IV, CBC, CMP, amylase, KUB. The provider noted that "following lactulose and enema, pt had large BM and symptoms resolved". The patient was diagnosed with constipation and given Colace to take twice a day, to follow up for nausea and vomiting for possible EGG Colonoscopy as outpt.

3) Review of the patient's "Critical Care Flow Sheet" evidenced the following information:

11:00 PM - "pt having lg amount loose stool"

11/11/09 12:05 AM - Vital signs - T none charted, P 93, R 16, BP 113/63, pain 5/10; "c/o abd pain - GI cocktail 60 ml. PO at 12:10 AM (Note: GI cocktail order was for 30 ml, not 60.)

12:39 AM - vital signs - T none charted, P 90, R 16, BP 107/70, no pain assessment; "I feel better."

4) Review of the patient's laboratory results for this ER visit revealed the following abnormal laboratory values for blood specimen collected 11/10/09 at 9:28 PM:

Glucose 125 mg/DL (WNL 75 - 99)
Urea Nitrogen 37.7 mg/dL (WNL 7 - 21)
Creatinine 1.5 mg/dL (WNL .5 - 1.4)
RBC 4.1 M/uL (WNL 4.34 - 5.88)
Hemoglobin 12.2 g/dL (WNL 14 - 18)
Hematocrit 36.2 % (WNL 42 - 52)
NE%, Auto 77.2 % (WNL 43 - 65)
LY%, Auto 13.8 % (WNL 20 - 45)
Protime 25 seconds (WNL 8.6 - 11.4).

5) Review of the patient's 11/10/09 9:21 PM Abdomen KUB indicated Findings of "..Vascular calcifications are present in the pelvis" with an Impression of "Changes of osteoporosis and vascular calcification, otherwise normal".

b. Review of the patient's "ER Nursing Assessment and Treatment Records", "ER Provider Assessment Record", "Emergency Room Physician's Order Sheet", "Critical Care Flow Sheet", Laboratory reports, and Radiology reports for 11/14/09 evidenced the following:

1) Review of patient #18's 11/14/09 8:57 AM "ER Nursing Assessment and Treatment Record" revealed the patient present with "diarrhea x 3 days"; NKA (Note: Allergies were documented on the 11/10/09 visit); Vital signs - T 98.2, P 90, R 22, BP 75/52, pain level 7/10; bowel sounds in all four quadrants with last BM 2 days ago; EKG checked; 10:10 AM 1000 ml NS IV. The patient was admitted to the acute care unit at 2:06 PM; noted to be stable at discharge with T 97.7, P 100, R 23, BP 111/57, pain 0/10. No ESI rating was written on the form.

2) Review of the patient's "ER Provider Assessment Record" and "Emergency Room Physician's Order Sheet" for this ER visit evidenced the MSE was done at 10:00 AM; diagnoses included diarrhea (secondary to too much laxatives, history of constipation, dehydration), hypotension secondary to dehydration, coumadin toxicity, CAD s/p MI, Afib with MVR, A 1 CD (??). The provider ordered CMP, CBC, EKG, Cardiac enzyme, PT/INR, KUB, CXR, NS bolus, Klor 40 Meq, and admit to acute care unit.

3) Review of the patient's laboratory values for this ER visit evidenced the following abnormal lab results:

Glucose 132 mg/DL (WNL 75 - 99)
Urea Nitrogen 62.0 mg/dL (WNL 7 - 21)
Creatinine 2.1 mg/dL (WNL .5 - 1.4)
Potassium 3.3 mmol/L (WNL 3.6 - 5)
Albumin, Serum 3.4 G/DL (WNL 3.9 - 5)
WBC 4.4 K/uL (WNL 4.5 - 11)
RBC 4.0 M/uL (WNL 4.34 - 5.88)
Hemoglobin 11.6 g/dL (WNL 14 - 18)
Hematocrit 35.6 % (WNL 42 - 52)
NE%, Auto 90.0 % (WNL 43 - 65)
LY%, Auto 5.7 % (WNL 20 - 45)
MO%, Auto 3.7 % (WNL 5 - 12)
LY# 0.3 K/uL (WNL 1 - 4.8)
Protime 90.3 seconds (WNL 8.6 - 11.4).

This record had whole lines of documentation scribbled out, as well as numerous write-overs.

c. The patient was hospitalized from 11/14/09 to 11/17/09 with diagnoses of acute renal failure, diarrhea, dehydration, and iron deficiency anemia.

d. Review of the patient's "ER Nursing Assessment and Treatment Records", "ER Provider Assessment Record", "Emergency Room Physician's Order Sheet", "Critical Care Flow Sheet", Laboratory reports, and Radiology reports for 11/22/09 evidenced the following:

1) Review of patient #18's 11/22/09 11:22 AM "ER Nursing Assessment and Treatment Record" evidenced that the patient c/o ----------diarrhea-------------(unable to read), NKDA, Vital signs T? P 78 BP 87/46 (?) (Note: On 1/12/11 at 10:00 AM, in an interview with the Medical Record Department Head, she revealed that there was not an ER record for 11/22/09 in the patient's chart. She requested and obtained a copy of the ER visit from the hospital that the patient was transferred to. This copy was difficult to read.)

2) Review of the patient's "Emergency Room Physician's Order Sheet" revealed that the provider ordered blood work, urinalysis, and multiple medications. No "ER Assessment" form was given to the surveyor with the record. The patient was diagnosed with "exacerbation of COPD, CHF, Advanced diabetes, CAD, A 1 CD, History TB, anemia, osteoporosis. The plan was to transfer.

3) Review of the patient's laboratory values for this ER visit evidenced the following abnormal lab results:

Glucose 154 mg/DL (WNL 75 - 99)
Urea Nitrogen 30.1 mg/dL (WNL 7 - 21)
Creatinine 1.5 mg/dL (WNL .5 - 1.4)
Potassium 3.3 mmol/L (WNL 3.6 - 5)
Calcium 7.8 mf/d/L (WNL 8.4 - 10.5)
Total Protein 5.8 g/dL (WNL 6.3 - 8.2)
Albumin, Serum 2.4 G/DL (WNL 3.9 - 5)
Alk Pho 146 U/L (WNL 48 - 135)
WBC 1.9 K/uL (WNL 4.5 - 11)
RBC 3.6 M/uL (WNL 4.34 - 5.88)
Hemoglobin 10.5 g/dL (WNL 14 - 18)
Hematocrit 31.1 % (WNL 42 - 52)
NE%, Auto 85.5 % (WNL 43 - 65)
LY%, Auto 8.4 % (WNL 20 - 45)
Bands 22 % (WNL 0 - 3)
Lymphs 9 % (WNL 25 - 40)
NE# 1.6 K/uL (WNL 1.8 - 7.7)
LY# 0.2 K/uL (WNL 1 - 4.8)
Protime 130.0 seconds (WNL 8.6 - 11.4)
PTT 55.8 seconds (WNL 21 - 39)
BNP 1756.0 PG/ML (WNL 0 - 100).

4) Review of the "Critical Care Flow Sheet" evidenced that the patient's P 126 - 107, R 32 - 36, BP 60/47, 59/29, 70/37, 62/31, 67/38, 64/38.

Review of the patient's transfer form revealed the following:

There was no time when the patient left the Hospital.

It was signed on 11/22/09 at 6:05 AM.

The vital signs were T 98 degrees, P 110, R 26, BP 62/31, pain 9/10.

The patient was listed as critical.

e. The patient was transferred to another hospital on 11/22/09, had surgery on 11/23/09 for "peritonitis, pneumoperitoneum, necrotic perforated appendicitis", and expired on 11/27/09.

5. Patient #6 - Closed record - ER visit for SOB - death after leaving ER

a. Review of 44 year old patient #6's 11/6/10 "ER Nursing Assessment and Treatment Record" evidenced that the patient presented at the ER at 2127 (9:27 PM) with complaints of "SOB (shortness of breath) x about 1 hour - dry heaves". The documentation indicated that the patient's significant medical history included dialysis, do not resuscitate, allergies to Heparin, Plavix, Lovenox, and was on home oxygen at 3 liters/nasal canal at night. The patient's admission vital signs were T 98.5 degrees F, P 120, R 44, BP 136/99, oxygen saturation 93% with 2 liters per nasal canal. The nurse charted that the patient received Phenergan 50 mg at 12:10 AM and Kayexalate 30 grams orally at 1:10 AM. The discharge time was listed as 1:10 AM and the patient's vital signs were noted to be T 99, P 80, R 20 BP 140/80 with no pain.

b. Review of the patient's "ER Provider Assessment Record" and Emergency Room Physician's Order Sheet" revealed that the MSE was done at 9:57 PM with diagnoses of upper respiratory infection and nausea. The provider (N) ordered labs (CBC and CMP) and PA/LAT CXR. The patient's discharge medications were Clindamycin, Cipro, and Phenergan.

c. Review of the patient's PA/LAT chest x-ray results noted a discussion that the results were compared to the 9/6/10 results. "The patient has pronounced cardiomegaly that has been a chronic finding and fullness in the hila. A right-sided jugular dialysis catheter has been placed in the interval. The upper lung vessels are a little prominent but otherwise no interstitial edema or definite effusions to suggest failure. A single lead pacer is in place."

d. Review of the patient's 11/6/10 (collected at 10:31 PM) abnormal laboratory results revealed the following:

Urea Nitrogen 34.3 mg/dL (WNL 7 - 21)
Creatinine 7.7 mg/dL (WNL .5 - 1.4)
Sodium 136 mmol/L (WNL 137 - 145)
Potassium 5.9 mmol/L (WNL 3.6 - 5)
Chloride 95 mmol/L (WNL 98 - 111)
CO2 19 mmol/L (WNL 22 - 31)
Total Protein 9.0 g/dL (WNL 6.3 - 8.2)
Alk Pho 463 U/L (WNL 48 - 135)
Total Bili 4.4 mg/dL (WNL .2 - 1.3)
WBC 12.0 K/uL (WNL 4.5 - 11)
Platelet Count 106 K/uL (WNL 150 - 400).

e. There was no evidence found that an EKG was done during this ER visit.

f. Review of the patient's "Instructions to the Patient After Emergency Care" listed instructions for discharge "Meds as ordered; follow up no improvement, follow up clinic next week." There was no evidence of what the meds were or how these were to be taken.

g. The patient was discharged at the same time as he was given the Kayexalate. There was a failure to re-assess the patient's potassium level after giving the medication. There was no evidence that the patient's vital signs were monitored in the time between the admission and discharge vital signs (approximately 3 hours and 45 minutes).

h. During an interview on 1/13/11 at 3:33 PM with the Acting Clinical Director (ACD) and the Aberdeen Area CD, the care and services provided to patient #6 was discussed. They indicated that they would check the patient's medical record and provide a response to the surveyor's inquiries. On 1/14/11 at 8:30 AM, the ACD provided a summary list of the information found relating to each patient on the list. The information for this patient was "ESRD on dialysis with K+ 5.9. His last dialysis was the day preceding this visit. Kayexalate was given; follow up documented." It was unclear how follow up was done and documented when the patient left the ER at the same time as the Kayexalate was given and expired within hours of the ER visit.

i. Review of the "South Dakota EMS Report" dated 1/7/10 documented that the team responded to a code blue and found the patient had expired. The time of death was noted to be 10:53 AM.

6. Patient #16 - no physician documentation

a. Review of 20 year old patient #16's 1/10/11 "ER (Emergency Room) Nursing Assessment and Treatment Record" form evidenced that the patient was seen in the ER for "was hit with a metal bar to L (left) shoulder". The assessment form indicated no alcohol, there was no assessment or indication of a wound or injury, and the patient was noted to have left at 2330 (11:30 PM) without being seen.

b. Review of the patient's "ER Provider Assessment Record" and "Emergency Room Physician 's Order Sheet" revealed that these forms were blank.

c. There was no "Instructions to the Patient After Emergency Care" form found in the record.

d. On 1/12/11 Medical Records (MR) staff were requested to provide any electronic health records (EHR), laboratory, or radiology reports for this patient on 1/10/11. MR staff member (Z) verified that the patient did not have any additional documentation for this ER visit.

e. On 1/14/11 at 8:30 AM, the ACD provided the surveyor with a "Emergency Visit Record" note written on 1/13/11 by the physician (J) who saw this patient in the ED on 1/10/11. The ACD indicated that the physician had thirty days to write the note. The physician's documentation summarized why the patient was being seen with a limited description of the examination that occurred prior to the patient and physician incident related to the use of the cell phone in the ED.

f. On 1/11/11 at 9:00 AM, during an interview with family members of patient #16, they expressed concerns the treatment that the patient received in the ER on the evening of 1/10/11. One of the family members said that the patient was assaulted, had a cut on his arm, and came to the ER for treatment. The family met and stayed with the patient in the ER. The family alleged that when the doctor (J) was examining the patient, the patient's cell phone rang, making the doctor angry. According to the family, the doctor attempted to take the phone away, refused to treat the patient, threatened to call security, threatened to call social services because the patient's young child was present and the patient had been drinking, and got right in the patient's face. The complainant alleged that security staff (K) and another staff member (L) were present when the patient left the ER. She said that both of these staff members reported that the doctor was rude to other patients and was given a complaint form to complete.

g. On 1/11/11 at 2:00 PM, during an interview with provider (N), he indicated that he was working in the ER on 1/10/11 and overheard part of the patient/physician interaction between patient #16 and physician (J). Provider (N) revealed that although he was not in the room with the physician, patient, and patient's family, he heard the verbal exchanges with the patient threatening the physician, saw the patient going out of the door cursing, but did not see the patient's family. The provider (N) verified that he believed the doctor (J) was frustrated with the patient's use of the cell phone while the physician was trying to do an assessment and that he (N) was not aware of the physician having similar problems with any other patients.

h. On 1/11/11 at 7:15 PM, during interviews with two nurses (P and Q) who were working in the ED on the evening of 1/10/11, they revealed that neither one was in the room when the physician (J) and the patient (#16) had the loud verbal disagreement. They were both aware that the issue was the use of the cell phone in the ED. Nurse (P) was assigned to the patient and had triaged and placed him in room, and requested the physician see the patient. Nurse (P) stated that she was in another room but heard the patient threaten the physician, saying "I will find you.". She was aware that security was called. Nurse (Q) was not involved in caring for the patient but had heard the cursing and called security. This nurse indicated that the patient threatened the physician by saying "I know where you live.".

i. During the interview with nurse (P), she was questioned about the triage assessment she had done on patient #16 who she believed had been drinking. Review of the nursing assessment completed by this nurse revealed that the nurse marked that the patient had not had alcohol and no injury was described. When interviewed, nurse (P) said that the patient denied the use of alcohol, so she charted no alcohol. She commented that the patient had a small open wound on his shoulder and that since she had not observed it, she had not charted the injury to the patient's shoulder on the nursing assessment form.

j. On 1/11/11 at 7:32 PM, in an interview with the security staff member (R), he verified that he was responding to the call from the ED, just when the patient (#16) was coming out of the ED. He said that the patient spoke to him and walked on out of the ED. The security staff member indicated that it was not a big deal, the doctor and patient just had words. Review of the security reports for incidents for the evening of 1/10/11 evidenced that no report had been written about the physician/patient interaction.

7. Patient #11 - self reported

a. Review of 31 year old patient #11's 11/19/10 "ER (Emergency Room) Nursing Assessment and Treatment Record" form evidenced that the patient was seen in the ER for "cx's (contractions) started @ noon. Received 2 bags blood yesterday". The assessment form indicated the EDC (expected date of confinement) was 11/22/10, G3P2, FHT (fetal heart tones) 120's, scheduled for C-section, BP 158/73, and pain assessment was 10 out 10. The patient presented at the ER at 3:04 AM and was transferred out at 5:49 AM, with a BP of 152/85.

b. Review of the patient's "ER Provider Assessment Record" and "Emergency Room Physician 's Order Sheet" revealed that FHT were 130/min and uterine contractions were occurring every three minutes with good variability. The note indicated that the pelvic was "deferred by pt (patient). The assessment was IUP at term. The physician ordered Morphine and Phenergan and consulted with another physician (FF). Physician (FF) completed the "Out-of-Hospital Transfer Record", noting that the patient was "booked to have her 3 rd C-section at Pierre". The ER physician indicated that the patient's condition was "guarded". The consulting physician (FF) noted on the transfer form that the patient was "stable".

c. At the time of the ER visit, there was no documentation that the patient received a complete MSE as the patient's cervical dilation was not checked or that the patient's elevated BP or pain level were assessed prior to transfer.

This failure to provide an appropriate MSE was recognized, reported to CMS (Centers for Medicare and Medicaid Services), and evaluated by the Hospital. The Hospital provided copies of Late Entry notes written by the nurse and physician (FF) and dated 11/24/10.

d. There was no "Instructions to the Patient After Emergency Care" form found in the record.

e. On 1/12/11 Medical Records (MR) staff were requested to provide any electronic health records (EHR), laboratory, or radiology reports for this patient on 1/10/11. MR staff member (Z) verified that the patient did not have any additional documentation for this ER visit.

8. Patient #12 - self reported
a. Review of 22 year old patient #12's 11/26/10 "ER (Emergency Room) Nursing Assessment and Treatment Record" form evidenced that the patient was seen in the ER for "female previous C Section x 4 (written over 2)". The assessment form indicated no FHT (fetal heart tones) charted and pain 8 out 10. The patient presented at the ER at 3:56 AM and was transferred out at 5:50 AM, with pain 8 out of 10.

b. Review of the patient's "ER Provider Assessment Record" and "Emergency Room Physician 's Order Sheet" revealed that FHT were 130s/min, uterine contractions were occurring every four minutes (per patient), dilation 2 - 2 1/2 cm (centimeters) by digital exam as patient refused speculum exam, mild effacement, and no obvious bleeding. The patient was given two doses of Terbutaline and refused the third dose. The patient also refused procardia XL and Tylenol. The assessment was "Pregnancy, 39 weeks, 4 days gestation, in early labor, and history of 2 c-sections with c section scheduled for 12/2/10". Additionally, the physician noted that the Hospital was on OB diversion and there was no surgeon available. The physician documented that the patient was in the ER greater than 2 hours and that the ER was busy and the staff had difficulty getting an ambulance.

c. Review of the patient's "Critical Care Flow Sheet" revealed that the patient continued to have contractions and was 4 cm dilated at 5:30 AM. Vital signs at transfer were stable, but the patient's T was noted to be the admit temp. Ambulance transported the patient at 5:50 AM. The nurse charted that the patient's pain scale never got any better....1st terbutaline did improve contractions slightly."

d. Review of the patient's "Out-of-Hospital Transfer Record" evidenced that the patient was transported out at 5:50 AM, via ambulance. The patient's pain scale was 8 out of 10 and her condition was listed as stable.

The Hospital failed to ensure that the patients received medical care, assessment, and treatment to address the patients' emergency medical conditions.

INCOMPLETE AFTER CARE INSTRUCTIONS

1. Patient #8
Review of five year old patient #8's 11/14/10 "ER (Emergency Room) Nursing Assessment and Treatment Record" form evidenced that the patient was seen in the ER for "sore in mouth since yesterday and headache".

Review of the patient's "Emergency Room Physician 's Order Sheet" revealed the provider's diagnosis was "Molluscum Contagiosum (skin rash) and Viral Respiratory Infection" with the discharge medication of Motrin #120 ml (milliliters) 100/5 10 ml po (oral) q 6 hr (every 6 hours) noted to be dispensed in the ER.

Review of the patient's "Instructions to the Patient After Emergency Care" form indicated to call to arrange an appointment to see _____(name of the pediatrician) with no number of days specified. The diagnoses were listed on the form using medical terminology. The other instructions were "Take Motrin for headache." No information was given related to the dosage.

2. Review of five year old patient #8's 11/6/10 "ER (Emergency Room) Nursing Assessment and Treatment Record" form evidenced that the patient was seen in the ER for "return from Winner - got U/S (ultrasound)".

Review of the patient's "Emergency Room Physician 's Order Sheet" revealed the provider's diagnosis was "Testicle Pain/R (right) swollen testicle" with the discharge medication of Ibuprofen (100/5 ml) 7.5 ml po q 6 hr prn (as needed) #120 ml and APAP/Codeine .5 ml po q 4-6 prn #30 ml noted to be dispensed in the ER.

Review of the patient's "Instructions to the Patient After Emergency Care" form indicated the other instructions were "Ibuprofen. Tylenol with Codeine 5 ml every 4 hours." No information was given related to the dosage of the Ibuprofen and the Tylenol with Codeine was listed to be given every four hours (not prn).

2. Patient #7
Review of 18 year old patient #7's 11/6/10 "ER (Emergency Room) Nursing Assessment and Treatment Record" form evidenced that the patient was seen in the ER for "pregnant - knocked down". The assessment included 20 weeks pregnant and that the patient was not eating and had a flat affect.

Review of the patient's "Emergency Room Physician 's Order Sheet" revealed the provider's diagnosis was depression, IUP (intrauterine pregnancy) at 20 weeks, urinary tract infection with the discharge medication of Cephalexin

QUALIFIED EMERGENCY SERVICES PERSONNEL

Tag No.: A1112

Based on staff interview and record review, it was determined that the Hospital failed to ensure adequate staffing in the ED to meet the needs of the patients. The findings included:

-------------Staff interview revealed that the nurse staffing in the ED in the month of 10/10 was very inadequate. The RN was working the ED alone, except for the ED Nurse Supervisor who was only doing triage.

Review of the Pay Period reports from September 26, 2010 through January 15, 2011 for the ED evidenced the following:

Multiple days when the RNs were scheduled to work overtime (OT) in order to provide coverage in the ED. Examples included:

9/28/10 - 3 D8 (7:00 AM to 3:30 PM) RNs were working OT 4 hr (hours)
2 N8 (11:00 PM to 7:30 PM) RNs were working OT 4 hr - no third RN scheduled

9/29/10 - 2 D8 (7:00 AM to 3:30 PM) RNs were working OT 4 hr - 4 hr with only 2 RNs
3 N8 (11:00 PM to 7:30 PM) RNs were working OT 4 hr

10/12/10 - 2 D8 (7:00 AM to 3:30 PM) RNs were working OT 4 hr - 4 hr with only 2 RNs
3 N8 (11:00 PM to 7:30 PM) RNs were working OT 4 hr

10/13/10 - 2 D8 (7:00 AM to 3:30 PM) RNs were working OT 4 hr - one was indicated to be late - 4 hr with only 2 RNs
2 N8 (11:00 PM to 7:30 PM) RNs were working OT 4 hr -no third RN scheduled







On 1/11/11at 1:00 PM, observation and interview with nurse (M) evidenced that there were three nurses assigned to the ED. Nurse (M) revealed that she was working "a lot of overtime", as she frequently does to cover for staff that do not work as scheduled.

On 1/13/11 at 9:03 AM, in an interview with the Director of Nursing (DON), she was questioned about the need for the nurses in the ED to frequently work overtime (OT). She verified that currently one of the nurses was taking leave often The DON described the nurse staffing pattern plan for the ED as follows:

ED - Day shift - 3 RNs; Night shift - 3 RNs; 12 - 12 split nurse; 1 RN in triage.