The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

SHELBY REGIONAL MEDICAL CENTER 602 HURST STREET CENTER, TX April 25, 2013
VIOLATION: INTEGRATION OF OUTPATIENT SERVICES Tag No: A1077
Based on record review, observation, and interview, the Outpatient Department failed to provide ultrasound services to the patients per the Coordination of Outpatient Services policy and Facility/Hospital Services Available policy.

A procedure report from the radiology department revealed the facility completed in the month of October 2012 (ultrasounds 51), November 2012 (ultrasounds 20), December 2013 (ultrasounds 23), January 2013(ultrasounds 15), and February 2013 (ultrasounds 20). This is the only hospital in the county.

A review of policy titled, "Coordination of Outpatient Services," policy 1.0, revealed outpatient services would provide ultrasound capabilities:

"4.5 Scheduled tests
4.5.1 If a patient presents and the test/modality must be scheduled (MRI, CTs,
Doppler ultrasounds, some Cardiopulmonary tests or rehabilitation services), the Outpatient Services Coordinator/designee will register the patient for the test and then advise the patient what time they must return to the hospital for their test/modality
4. 5.3 Doppler Ultrasounds: The Outpatient Services Coordinator/designee will
coordinate with the tech to schedule to ultrasounds."

A review of policy titled, " Facility/Hospital Services Available," policy 1.4, revealed the facility would provide ultrasound capabilities:

" PURPOSE
Shelby Regional Medical Center is an acute health care institution dedicated to providing appropriate services to sick and injured persons. In providing these services, the hospital strives to provide optimal patient care within our available resources of personnel, equipment and supplies.
2.0 SERVICES AVAILABLE
Medical floor
Outpatient Services
emergency room
Cardiopulmonary Services
EKG
Stress Test
EEG
Respiratory Treatments and Procedures
Laboratory for Inpatient and Outpatient
Radiology for Inpatient and Outpatient
General X-ray
CT Scan
Ultrasound
MRI (Outpatient)
Pharmacy Services (inpatient)
Dietary Counseling
Rehabilitation Services (inpatient and outpatient)"

During an interview on 04/19/2013 at 9:00 AM, staff #5 and #9 reported the ultrasound machine had been out of service since February 23, 2013. Both staff members reported the "ultrasound test is very important to the patients in this community" and the Assistant Administrator had been notified.

An interview with the Assistant Administrator on 04/19/2013 at 2:30 PM confirmed she had reported the issues with the ultrasound machine to the Administrator and the Board of Directors.

An interview with the Administrator on 04/19/2013 at 3:30 PM (who was onsite during the exit conference) confirmed the ultrasound machine was out of service and had been since February 23, 2013. The Administrator is one of the two board members (the owner is the other board member).
VIOLATION: EMERGENCY SERVICES Tag No: A1100
Based on record review, observation, and interview the facility failed to:

A. ensure that Emergency Department Services were under the direction of a qualified member of the medical staff. (Refer to findings A 1102)

B. provide ultrasound testing services to obstetrics patients in emergency situation. The facility also failed to provide vascular ultrasound for detection of blood clots (deep venous thrombosis (DVT) in the major veins of the legs or arms. (Refer to findings A 1103)

C. ensure that the Emergency Department Services were under the supervision of a qualified member of the medical staff. (Refer to findings A 1111)

D. maintain required qualifications established by Medical Staff Bylaws for 5 of 7 physicians working in the emergency room . (Refer to findings A 1112)
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observations, interviews and records review, the Governing Body failed to:

A. have involvement with the appointments of physicians on 6 (#16, #17,#18, #19, #20,
#21) of 7 (#15-#21) physicians presently working at the facility.

Refer to tag A 0046


B. conduct reappraisals on 4 (#18, #19, #20, #21) of 7 (#15-#21) physicians presently working at the facility.

Refer to tag A 0340


C. have an organized nursing service to ensure that laboratory tests were obtained as ordered by the physician , laboratory test results were reported timely and laboratory test results were accurate in order to provide appropriate treatment regimen to the patient in 7 (#s' 2, 4,5,6,8, 9 and 10) of 10 patients reviewed for laboratory services.

D. ensure that the dietary department maintained a clean and safe environment for the patients' and employees' food it served. The facility failed to have properly working equipment for proper storage and preparation of food being prepared in the dietary department.


E. ensure that the Outpatient Department provided ultrasound services to the patients per the Coordination of Outpatient Services policy and Facility/Hospital Services Available policy.

Refer to tag A 1077


F. ensure that the Emergency Department Services were under the direction of a qualified member of the medical staff.

Refer to tag A 1102


G. provide ultrasound testing services to obstetrics patients in emergency situation. The facility also failed to provide vascular ultrasound for detection of blood clots (deep venous thrombosis (DVT) in the major veins of the legs or arms.

Refer to tag A 1103


H. ensure that the Emergency Department Services were under the supervision of a qualified member of the medical staff.

Refer to tag A 1111


I. ensure that physicians maintain required qualifications established by Medical Staff Bylaws for 5 (#17, #18, #19, #20, #21) of 7 physicians working in the emergency room .

Refer to tag A 1112
VIOLATION: MEDICAL STAFF - APPOINTMENTS Tag No: A0046
Based on records review and interviews, the governing body failed to be involved with the appointments of physicians on 6 (#16, #17,#18, #19, #20, #21) of 7 (#15-#21) physicians presently working at the facility.

A review of the record titled, "Rules and Regulations of the Governing Board; Article II, Governing Board-Structure and Procedures, Section 1. Composition." revealed

"The Governing Board shall be appointed by the Board of Directors and shall be composed of no more than six (6) members, including the Hospital Administrator (as defined in Article IX below) as a voting and other hospital representatives as non-voting members; the Chief of the Medical Staff of the Hospital ("Medical Staff "); representatives of the community served by the Hospital; representative(s) of the Corporation; and physicians on the Medical Staff. The Board shall consist of two (2) community members, two (2) physicians, the Hospital Administrator and the CEO.

Section 11. Quorum. A majority of the voting members of the Governing Board shall
constitute a quorum for the transaction of business, and the action of a majority of the voting Governing Board members present at any meeting at which there is a quorum, when duly assembled, is valid."


A review of physician #16's file revealed that his application for reappointment was submitted to the governing body from the medical staff, but review of meetings titled, "Governing Board Meeting" dated February 28, 2012, April 20, 2012, June 14, 2012, July 31, 2012, November 8, 2012, and November 12, 2012 (which was the last governing body meeting held) revealed no evidence for reappointment of physician #16.


A review of physician #17's file revealed that his application for reappointment was submitted to the governing body from the medical staff, but review of meeting titled, "Governing Board Meeting" dated July 31, 2012 revealed that the application was noted in the meeting. The meeting by the governing body on date in question only had 3 voting members present, so quorum was not met. There is no evidence for reappointment of physician #17.


A review of physician #18's file revealed that his application for reappointment to the medical staff had expired January 31, 2013. A review of meetings titled, "Governing Board Meeting" dated February 28, 2012, April 20, 2012, June 14, 2012, July 31, 2012, November 8, 2012, and November 12, 2012 (which was the last governing body meeting held) revealed no evidence for reappointment of physician #18.


A review of physician #19's file revealed that no documentation of an application was submitted for approval by the medical staff or the governing body.


A review of physician #20's file revealed that no documentation of an application was submitted for approval by the medical staff or the governing body.


A review of physician #21's file revealed that no documentation of an application was submitted for approval by the medical staff or the governing body.


On 04/24/2013 at 3:00 PM, an interview with staff #4 confirmed the findings of physician's files and that physicians #16, #17, #18, #19, #20, and #21 were not approved by the governing body for appointment to the medical staff.


An interview with the Administrator on 04/25/2013 at 2:30 PM (who was onsite during the exit conference) confirmed that physician's #16, #17, #18, #19, #20, and #21 were not approved by the governing body for appointment to the medical staff.
VIOLATION: MEDICAL STAFF PERIODIC APPRAISALS Tag No: A0340
Based on records review and interviews, the facility failed to conduct reappraisals on 4 (#18, #19, #20, #21) of 7 (#15-#21) physicians presently working at the facility.

A review of the record titled, " Medical Staff Bylaws; Article II, Purpose and Responsibilities, Section 1- Purposes, subsection-" revealed

"The purposes of the Medical Staff are to:
E. develop and maintain rules of self-governance and conduct of the medical staff that assure the quality of professional care performed within facility, including recommendations for appointment and reappointment to the medical staff;"


A review of physician #18's file revealed that his application for reappointment to medical staff had expired January 31, 2013.


A review of physician #19's file revealed that no documentation of an application was submitted for approval by the medical staff.


A review of physician #20's file revealed that no documentation of an application was submitted for approval by the medical staff.


A review of physician #21's file revealed that no documentation of an application was submitted for approval by the medical staff.


On 04/24/2013 at 3:00 PM, an interview with staff #4 and staff #6 confirmed the findings of physician's files and that physicians #18, #19, #20, and #21 files did not have documentation for appointment or reappointment to the medical staff.
VIOLATION: NURSING SERVICES Tag No: A0385
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and records review, the facility failed to have an organized nursing service to ensure that laboratory test were obtained as ordered by the physician, laboratory test results were reported timely and laboratory test results were accurate in order to provide appropriate treatment regimen for the patient care in 7 (#s' 2,4,5,6, 8, 9 and 10) of 10 patients reviewed for laboratory services.

This deficient practice had the likelihood to cause harm in all patients presenting to the emergency room or in-patients in the hospital.

Findings include:
Review of the policy "Interdepartmental Policy for Laboratory Specimens" dated 11/12/2011 revealed the following:
"Laboratory request will be generated by Nursing Service (for in-house patients) at the time of specimen collection. All laboratory test will be carried to the Nursing station as soon as possible after completion. Nursing personnel will chart the results."

Review of the policy "Policies and Procedures For Accu-Check Blood Glucose Monitoring" dated 11/12/11 revealed:
"If the value obtained is not consistent with patient symptoms, perform another test. If the repeated results again indicate unexpected values, obtain a STAT blood glucose by lab and notify the physician of the results. All patients with greater that 400 mg/dl should have a venous lab repeat done on the chemistry analyzer to verify even if treatment had been initiated."

Review of the policy "Critical Lab Values and Read Back Procedure" dated 11/12/2011 revealed the following:
"First event critical lab results must be called to the Nursing staff member or physician as soon after results are obtained. The preliminary report must be called immediately. The patient specimen must be repeated and verified. Document on the report the date, time, the Nursing staff member or physician that was notified of the critical value and that the results were read back to the tech reporting the results".

Review of the policy "Delay of Service" dated 11/12/11 revealed the following:
"It is the Laboratory's policy to result tests as soon as possible according to their order status (STAT, timed, routine). All delays in laboratory due to patient status, refusal of service by patient, equipment malfunctions, etc. will be called to the appropriate nursing unit or physician office depending upon the origin of the order. The notification will be noted on the patients' request with reason(s) for delay of service, along with the caller's initials, the date and time of the call and the name of the person receiving the call."

1. Review of an Emergency Department (ED) record revealed Patient #4 was a [AGE] year old male who presented to the hospital 04/04/13 at 12:14 p.m. with chief complaints of high blood sugars and high blood pressure per family. The patient arrived in the emergency room with a finger stick blood sugar reading of "too high" from the ambulance staff .
Review of the ED physician assessment dated [DATE](no time documented) revealed that Patient #4 had diagnoses of [DIAGNOSES REDACTED]
Review of the initial ED physician orders' dated 04/04/2013(no time documented) were as follows:
"1. Regular insulin 10 units Subcu x1
2. Regular insulin 7 units IV x1
3. Insulin drip with regular insulin 6 units/hr.
4. Foley catheter
5. No BMP following 1530 FSBS
6. NS Bolus"

Review of BMP lab report collected on 04/04/13 at 12:33 p.m. and reported to the ER staff at 1:24 p.m. (over 1 hour later) revealed:
Report (*indicates out of range)
*Sodium 154.3 (Reference range (RR 136.0-145.0)
*Potassium 5.3 (RR 3.5-5.1)
*Chloride 108.3 (RR 98.0- 107.0)
*Carbon dioxide 30.0 (RR 23.0-29.0)
*Glucose 872.0 (RR 70.0-105.0)
*BUN 52.0 (RR 7.0-18.0)
Review of ED nurses record on 4/4/13 at 12:55 p.m., Insulin 10 units subcutaneous to the right upper arm. Forty minutes later ED nurses administered insulin 7 units intravenous push and started an insulin drip to infuse at 6 units per/hour at 1:35 p.m.
Review of ED physician's order on 4/4/13 was for a finger stick to be done at 2:30 p.m.
The lab results of FSBS too high to read on meter. Lab should have collected serum glucose per facility policy, instead lab personnel resulted a BMP with a 30 minute delay without a physician order.
A BMP result of 04/04/13 at 3:00 p.m. was as follows:
*Sodium 161.7 (Reference range (RR 136.0-145.0)
Potassium 3.6 (RR 3.5-5.1)
*Chloride 118.3 (RR 98.0- 107.0)
*Carbon dioxide 30.8 (RR 23.0-29.0)
*Glucose 648.0 (RR 70.0-105.0)
*BUN 50.0 (RR 7.0-18.0)
*Creatinine 1.5 (RR 0.7-1.3)
Review of lab report on 4/4/13 for finger stick to be done at 3:30 p.m., FSBS too high to read on meter, no follow up with serum glucose for verification per facility policy.
Review of ED physician's order on 04/04/13 at 4:30 p.m. was to draw BMP, results as follows:
*Sodium 161.6 (Reference range (RR 136.0-145.0)
*Potassium 3.2 (RR 3.5-5.1)
*Chloride 121.7 (RR 98.0- 107.0)
Carbon dioxide 27.7 (RR 23.0-29.0)
*Glucose 464.0 (RR 70.0-105.0)
*BUN 51.0 (RR 7.0-18.0)
*Creatinine 1.4 (RR 0.7-1.3)
A review of the lab results showed patient's #4's sodium continued to increase with normal saline bolus infusing per physicians orders.
A review of lab dated 04/04/13 at 5:35 p.m. showed a FSBS of 389.0, the record revealed no physician's order for a finger stick at this time.
A review of lab for BMP dated 04/04/13 at 7:10 p.m., revealed no physician's order for BMP.
*Sodium 168.5 (Reference range (RR 136.0-145.0)
*Potassium 3.4 (RR 3.5-5.1)
*Chloride 125.8 (RR 98.0- 107.0)
Carbon dioxide 30.7 (RR 23.0-29.0)
*Glucose 272.0 (RR 70.0-105.0)
*BUN 47.0 (RR 7.0-18.0)
*Creatinine 1.3 (RR 0.7-1.3)
A review of the lab results showed patient# 4's sodium continued to increase with normal saline bolus infusing per physician's orders.
A review of lab dated 04/04/13 at 8:13 p.m. showed a FSBS of 233.0. The record revealed no physician's order for a finger stick at this time.
A review of ED nurse's notes on 04/04/13 at 8:50 p.m. revealed nursing reduced the insulin drip to infuse at 3 units/ hour and changed IV fluids to D51/4 with 20 KCL (Potassium Chloride) at 250 cc/hour. There was no physician order to decrease the insulin drip or to change IV fluids.
Review of lab results dated 04/04/13 at 9:46 p.m., revealed FSBS of 166 and at 10:55 p.m., FSBS of 128. There was no physician's order for these FSBS.
A review of ED nurses notes dated 04/04/13 at 10:35 p.m. revealed patient #4 pulled out insulin drip tubing and the physician notified. There was no physician's order found to discontinue the insulin drip.
A review of lab dated 04/04/13 at 11:55 p.m. showed a FSBS of 145.0, the record revealed no physician's order for a finger stick at this time.
A BMP lab results dated 04/04/13 at 12:20 a.m., was reviewed. The record revealed no physician's order for a BMP. The BMP results were as follows:
*Sodium 168.2 (Reference range (RR 136.0-145.0)
Potassium 4.5 (RR 3.5-5.1)
*Chloride 127.7 (RR 98.0- 107.0)
Carbon dioxide 32.6 (RR 23.0-29.0)
*Glucose 131.0 (RR 70.0-105.0)
*BUN 44.0 (RR 7.0-18.0)
Creatinine 1.2 (RR 0.7-1.3)

A review of the lab results shows patient #4's sodium continued to increase with D5 ? normal saline infusing without a physician's orders.

A review of lab for BMP on 04/05/13 at 3:30 a.m., results was as follows:
*Sodium 167.7 (Reference range (RR 136.0-145.0)
Potassium 4.5 (RR 3.5-5.1)
*Chloride 124.1 (RR 98.0- 107.0)
*Carbon dioxide 30.3 (RR 23.0-29.0)
*Glucose 230.0 (RR 70.0-105.0)
*BUN 44.0 (RR 7.0-18.0)
*Creatinine 1.3 (RR 0.7-1.3)

A review of record "Diabetic Flow Sheet" dated 04/05/13 at 3:40 a.m. revealed glucose of 219 (no lab results of a 219 found on the chart) and nurse documented 4 units of insulin subcutaneous. No mention of the 3:30 a.m. glucose level of 230.

A review of lab for BMP on 04/05/13 collected at 5:15 a.m. Resulted at 6:30 a (1 hour and 15 min delay) result was as follows:
*Sodium 161.0 (Reference range (RR 136.0-145.0)
Potassium 4.5 (RR 3.5-5.1)
*Chloride 120.9 (RR 98.0- 107.0)
*Carbon dioxide 31.7 (RR 23.0-29.0)
*Glucose 304.0 (RR 70.0-105.0)
*BUN 43.0 (RR 7.0-18.0)
*Creatinine 1.3 (RR 0.7-1.3)

A review of record "Diabetic Flow Sheet" dated 04/05/13 at 5:30 a.m. revealed glucose of 294 (no lab results of a 294 found on the chart) and nurse documented 6 units of insulin subcutaneous. No mention of the 5:15 a.m. glucose of level of 304. According to sliding scale patient should have received 8 units of insulin for glucose of 304.
A review of sliding scale insulin protocol was to perform finger stick glucose checks before meals and at bedtime. (AC and HS) A review of lab records on 04/05/13 revealed there was no FSBS prior to lunch as ordered per the sliding scale protocol. Blood sugars were not monitored from 5:15 a.m. till 2:06 p.m.
A review of lab results dated 04/05/13 at 2:06 p.m. revealed an elevated glucose of 416.
A review of lab results on 04/05/13 at 6:05 p.m. showed FSBS of 405, and serum glucose drawn for verification showed glucose 327.0. (Difference of 25% between the finger stick and the serum glucose) An hour later the nurse administered 8 units of insulin based on the 327 glucose.
Review of lab results dated 04/08/13 revealed: BMP collected at 8:00 a.m. resulted at 9:27 a.m., FSBS collected at 10:55 a.m. resulted at 12:05 p.m., and FSBS collected at 4:00 p.m. resulted at 5:13 p.m., all results showed over an hour delay.
A review of lab results on 04/08/13 showed BMP collected at 4:00 p.m. resulted at 4:53 p.m. (BMP was due to be drawn at 2:00 p.m. per physician's order, revealed a 2 hour delay. A review of the record revealed no notification of the delay to nursing.
A review of lab results for FSBS -314 collected on 04/08/13 at 11:00 p.m. revealed no physician orders for the FSBS.
A review of lab results on 04/09/13 showed BMP collected at 6:00 a.m. resulted at 9:52 a.m. (3 hour 52 minute delay) A glucose reading on the lab was a 60.0.
A review of nurse's record on 04/09/13 revealed no notification to the physician of the 60 glucose. Review of the sliding scale protocol nurse was to call the physician with glucose less than 70 and implement the [DIAGNOSES REDACTED] protocol.
A review of lab records on 04/10/13 at 1:30 p.m. revealed no physician's order for BMP and CBC drawn and resulted.
During an interview on 04/25/13 from 9:00 a.m. through 12:00 p.m. with staff #6 (RN) confirmed the errors and delays with the lab results, lack of documentation and notification by lab personnel, and errors in nursing documentation with and without physician's orders.




2.) Review of an Emergency Department (ED) record revealed Patient #2 was a [AGE] year old female presented to the hospital 02/07/13 at 9:12 a.m. with chief complaints of a fall and right shoulder pain.
Review of the ED physician assessment dated [DATE], at 10:00 a.m. revealed Patient #2 had diagnoses of [DIAGNOSES REDACTED]. According to the assessment a computer tomography (CT) scan of the head showed Patient #2 had a remote right middle cerebral artery (MCA) territory infarct(stroke).
Review of ED physician orders dated 02/07/13 (no time) revealed the following :
Pro-Brain natriuretic peptide (BNP), Culture & Sensitivity ( C &S) blood x 2, Complete blood count (CBC), Creatinine kinase(CK), CKMB if CK elevated, Protrombin time (PT), Partial thromboplastin time (PTT), Troponin and Urinalysis (UA) with C/S if indicated.
Review of lab reports revealed the lab was collected on 02/07/13 at 12:40 p.m., 3 hours and 28 minutes after Patient #2 presented to the ED.
Three lab reports of the same test collected on 02/07/13 at 12:40 p.m., revealed the following:
*Report #1 (Preliminary)
Sodium 122.8 (Reference range (RR 136.0-145.0)
Potassium 2.8 (RR 3.5-5.1)
Chloride 126.2 (RR 98.0- 107.0)
Carbon dioxide 30.0 (RR 23.0-29.0)
White blood count 12.0 (RR 3.5-10.0)
CK 344.0 (RR 25.0-174.0)
Pro BNP 2651.4 (RR 0.0-620.0)
PTT 44.6 (RR 21.4- 41.8)

*Report #2 (Final copy)
This lab report had the same results as the preliminary lab.

*Report #3 (Revised)
Sodium 143.0 within RR
Potassium 3.2 low
White blood count 12.0 high
CK 344.0 high
Pro BNP 2651.4 high

Review of a "Critical Value Report Lab/Diagnostic Imaging" form dated 02/07/13 revealed the lab department notified nursing of a critical Sodium level of 122.8 (reference ranges being 125-155) at 1:44 p.m., over an hour later. Nursing notified the physician of the lab results at 1:45 p.m. and new orders were received.

Review of physician orders dated 02/07/13 revealed orders for 3% Normal saline (NS) at 50 milliliters (ml), intravenous (IV) times one; NS with 40 milliequivalent (MEQ) of Potassium chloride (KCL) give 500 ml times one at 125 ml/hour; Lasix 20 milligrams (mgs) intravenous time one and a Foley catheter.

Review of ED notes dated 02/07/13 revealed the following:
At 2:05 p.m. the 3% NS at 50 cc per hour was started and NS with 40MEQ at 125 cc per hour were started at the same time.
At 3:15 p.m. Lasix 20 mgs (intravenous push) IVP was administered to Patient #2.
At 3:55 p.m. the intravenous fluids were turned off. There was no documentation of the reason the fluids were turned off, amount of fluids infused, nor was there a physician order
.
Review of an unusual event report on Patient #2 dated 02/07/13, 3:55p.m. revealed 3 % NS was started at 2:05 p.m. and was to receive 50 ml over 1 hour and then staff were to begin NS 500 ml with 40KCL to run over 4 hours. At 3:55 p.m., another critical low sodium was reported on another patient. The unusual event report revealed at 3:55 p.m. labs were rechecked and Patient #2 had an elevated sodium level of 177.8 (indicating hypernatremia). Intravenous fluids were stopped and someone was coming to check the chemistry machine. There was no documented follow-up on the Chemistry machine nor if an improvement plan was was implemented. Patient #2 received treatment for an elevated sodium level when there was a lab which indicated it was in the normal RR.

Review of physician orders dated 02/07/13 at 11:15 p.m. (over 7 hours later after stopping the IV fluids) revealed Patient #2 was being admitted for acute congestive heart failure, hypokalemia and right lower lobe pneumonia. Some of the orders written were for a cardiac diet, 1200 ml/24 hour fluid restriction, Lasix 40 mg, Potassium 20MEQ, antibiotics Rocephin and Azithromycin, Lovenox 60 mg, blood cultures x 2 and sputum gram stain and culture.
Review of ED notes revealed Patient #2 did not receive treatments for her condition until 12:55 midnight, over 8 hours after discontinuing the IV fluids.
The ordered blood cultures could not be found and the sputum culture dated 02/08/13 revealed it was an unacceptable culture. The instructions were to "please resubmit a new specimen." There was no new sputum culture found on Patient #2.

During an interview on 04/24/13 at 10:50 a.m., Staff #8 (RN) reported she gets the lab results and log them on a spread sheet. Staff #8 reported the only problems found last month were with lab forms not being completed. The problems with the increased sodium levels were brought to her attention. A plan of correction was done and it went to Staff #6 (RN).

During an interview on 04/24/13 at 10:55 a.m., Staff #6 (RN) reported the problems with labs go back to October 2012. The chemistry lab machine had an electrode which was cracked and replaced (02/07/13). The lab company who was performing rechecks on their questionable lab results terminated their contract on 04/03/13. If any patient came into the hospital with a Tylenol overdose they did not have the capability or equipment to run levels on them. The lab concerns had been taken to the attention of the governing board, but nothing had been done.

During an interview on 04/24/13 at 4:25 p.m., Staff #6 (RN) confirmed the error with the IV fluids, problems with nursing assessments, untimely interventions implemented, extended ED stay with delayed treatment, the problems with lab results and missing lab results on Patient #2. Staff #6 (RN) reported she did not trust the lab results, nor the information the lab supervisor was provided to Quality assurance. Nothing had been put into place to follow-up on if the lab equipment had been fixed or if it was providing accurate results. Staff #6 checked all three lab reports on Patient #2 which gave the different sodium levels and reported she did not know which one was accurate. Staff #6 reported another lab company they were using would not pick up lab on the weekends and it took them 5-7 days to get the culture results back to the facility.

3.) Review of the ED record on Patient #6 revealed she was a [AGE] year old female admitted on [DATE] at 12:37 p.m. with slurred speech, right sided weakness and a history of insulin dependent diabetes mellitus. Lab ordered on admit was Pro-BNP, CBC, CK, CKMB, CMP, Troponin and UA with C&S if indicated.
Review of the chart revealed all of the lab was collected over an hour later on 04/12/13 at 1:43 p.m.. Some of the results were as follows:
Glucose, Critical high 626 (RR 70.0-105.0)
Pro -BNP high 1982.3 (0.0-230.0)
Review of a "Critical Value Report Lab/Diagnostic Imaging" form dated 04/12/13 revealed nursing was informed of the critical lab value at 2:35 p.m.
Review of the ED record dated 04/12/13 revealed Humulin Regular 10 units was administered at 2:45 p.m.
Review of a lab report dated 04/12/13 revealed Patient #6 had a critical high Glucose of 442.0 at 3:20 p.m. There was documentation on the lab report nursing was called the result at 4:13 p.m.
Review of the chart revealed no other glucose checks nor any more insulin was administered to Patient #6 for this critical Glucose.
Review of the ED record dated 04/12/13 revealed Patient #6 was transferred to another hospital at 5:30 p.m. via helicopter. The discharge diagnosis was CVA rule out cerebral aneurysm.
During an interview on 4/25/13 at 1:30 p.m., Staff # 6 (RN) confirmed the times the labs were drawn and the lack of intervention.

4.) Review of the ED record on Patient #5 revealed he was a [AGE] year old male admitted [DATE], at 7:20 p.m. with a diagnosis of [DIAGNOSES REDACTED]
Review of the ED notes dated 04/14/13 revealed Patient #5 had a blood sugar of 60 at 7:30 p.m. and at 7:32 p.m. he was given 1&1/2 ampule of Dextrose 50% IVP. Review of lab results revealed no reports or documentation of who performed the blood sugar check.
Review of lab collected on 04/15/13 at 7:37 p.m. (5 minutes later) revealed the following:
*FSBS - 97.0 (RR 70.0-105.0)
*CMP - Glucose 72.0 (RR 70.0-105.0)
The difference between the FSBS and the Glucose were over 10 percent.
Review of the manufacturer instructions "Guaranteed Performance HemoCue Glucose Systems" revealed under the accuracy validation section the following:
"Under ideal conditions, the HemoCue Glucose 201 System should, on average, produce results within 10 percent of those obtained by the comparative method."
Review of physician orders dated 04/15/13, 9:00 p.m. revealed Patient #5 was started on Dextrose 5 % 1/2 NS at 100 ml per hour. Stop the drip if the blood sugar is over 250.
Review of three different lab values dated 04/16/13 and collected within 30 minutes of each other revealed the following:
*BMP collected at 6:00 a.m. - Glucose 380 (RR 70.0-105.0)
* Two more labs collected at 6:30 a.m.- Serum Glucose 337.0; FSBS - 358.0
Review of nurses notes dated 04/16/13, 8:10 a.m., revealed the lab draw this AM showed the blood sugar was 337. There was documentation the doctor was notified and orders were received to discontinue IV fluids (Dextrose 5 % ? NS) and administer Novolin insulin 70/30, 20 units SQ. This was a delay in treatment for over 2 hours after the initial glucose check at 6:00 a.m.
Review of lab values collected at 8:30 a.m. revealed the FSBS was too high to read on meter and a Serum Glucose was ordered. The Serum Glucose had increased to 488.0.
Review of nurses notes dated 04/16/13, 9:00 a.m. revealed the glucose was 488 and the doctor was notified . New orders were given for Regular insulin 14 units SQ and next accu check at 11:00 a.m.
Review of lab values collected at 11:00 a.m. revealed the FSBS was too high to read on meter and a Serum Glucose was ordered. The Serum Glucose was 390.0.
Review of nurses notes dated 04/16/13, 12:00 p.m. revealed the glucose was 390 and sliding scale Regular insulin 10 units was given SQ.
Review of lab values collected on 04/17/13 at 6:00 a.m. revealed a FSBS of 187.0 and nursing was notified an hour later at 7:05 a.m. There was no documentation that the sliding scale insulin was administered as needed. At 10:43 a.m. a FSBS was collected and the results were critical at 432.0
Review of medication administration record dated 04/17/13 revealed Patient #5 was given Humulin insulin 70/30, 40 units SQ at 10:50 a.m.
Review of nurses notes dated 04/17/13 revealed Patient #5 was discharged home at 11:00 a.m. There was no documentation of a follow-up call to see if the insulin decreased the critical blood sugar.

During an interview on 04/25/13 at 1:30 p.m., Staff #6 (RN) confirmed the missing physician orders for lab, delay in treatment, delay in lab notification, and discrepancy between the fingerstick and serum glucose. Staff #6 confirmed Patient #5 being discharged with a blood sugar that was too high.

5.) Review of an ED record revealed Patient #8 was a [AGE] year old female who (MDS) dated [DATE] at 5:41 a.m. with chief complaints of chest pain. She had a history of gestational diabetes mellitus and deep vein thrombosis to the right leg. Patient #8 was on the anti-coagulant Coumadin daily. The ED physician was notified at 6:00 a.m. and orders were obtained for an Amylase, Pro BNP, CBC, CK CKMB, CMP, Lipase, PT, PTT UA, Urine HCG.
Review of lab reports collected on 04/22/12 at 7:05 a.m. (over an hour later) revealed the following:
PT- 56.4 high (RR 8.0-14.0)
INR- 5.6 high ( RR 0.8-1.4)
The lab results were printed and reviewed on 04/22/13 at 7:51 a.m.
Review of nurses notes revealed no documentation of when lab informed nursing of the critical lab or when nursing informed the physician.
Review of an ED physician assessment revealed Patient #8 was seen by the physician on 04/22/13 at 8:45 a.m. and a diagnosis was given of Coumadin toxicity.
Review of a blank "Critical Value Report Lab/Diagnostic Imaging" revealed an INR greater than 5 was considered a critical range. Instructions were as follows: "If Physician or the doctor covering for the Physician has not responded within 60 minute timeframe, the Chief of Medical Staff or the ER physician. If Physician not notified, document why."
Review of Patient #8' s record revealed no Critical Value Report.
During an interview on 04/25/13 at 9:45 a.m., Staff #26 (RN) confirmed there was no Critical Value Report completed on Patient #8 and she did not know when the lab was called to nursing. Nursing was suppose to put the Critical Value Report on the patient' s chart. Staff #26 reported she could not find results for the ordered UA. There was no physician order for a D-Dimer and Troponin that were collected on 04/22/13 on Patient #8.

6.) Review of an ED record revealed Patient #9 was a [AGE] year old male who (MDS) dated [DATE] at 6:16 a.m. with chief complaints of confusion and not taking his medication. Patient #9 had a history of hypertension and paranoid schizophrenia. Lab orders written on admit were for a Pro BNP, Blood ETOH, Acetaminophen, Salicylate, CBC, Serum Myoglobin, CK, CKMB, CMP, PT, PTT, Troponin and UA. Repeat CK at 9:00a.m., 1:00 p.m. and 4:20 p.m.
Review of lab reports revealed the following:
*CMP collected on 04/22/13 at 6:41 a.m.
Sodium 126.9 low (RR 136-145)
Chloride 92.2 low (RR 98.0-107.0)
Carbon dioxide low 20.6 (RR 23.0-29.0)
Glucose 144 high (70.0-105.0)
Creatinine 1.7 high (RR 0.7-1.3)
*CBC collected on 04/22/13 at 6:41 a.m.
WBC high 18.8 (RR 3.5-10.0)
Review of a blank "Critical Value Report Lab/Diagnostic Imaging" revealed the WBC, Carbon dioxide, Sodium levels for Patient #9 would be considered in the critical range. Staff were suppose to document physician notification and response. If the physician was not notified they had to document why. Review of Patient #9's record revealed no completed critical value reports.
*CK collected on 04/22/13 at 6:41 a.m. read high at 510 (RR 25.0- 174.0), CK 870 at 9:00 a.m., CK 896 at 1:15 p.m., and CK 1052 at 4:16 p.m. There was no documented physician notification of the continued elevation of the CK after 9:00 a.m.
*UA collected on 04/22/13 at 9:00 a.m (over 2 hours after admit).
* PT, PTT were not collected as of 04/25/13 at 9:20 a.m.
* The Serum Myoglobin, Acetaminophen, and Salicylate results were not on the chart as of 04/25/13 at 9:20 a.m.
During an interview on 04/25/13 at 9:20 a.m., Staff #26 confirmed the lab was ordered on admit into the ED room. She confirmed the lab results, late times of collection, and missing lab on the chart. At the request of the surveyor, Staff #26 checked all lab results on Patient #9 on the computer and they were printed off. According to the reports the Acetaminophen and Salicylate were collected on 04/22/13 at 11:06 p.m and reported 2 days later on 04/24/13 at 3:17 p.m.. The Serum Myoglobin was collected on 04/22/14 at 5:07 p.m., was high at 281 (RR 28-72). The lab was reported 2 days later on 04/24/13 at 6:39 a.m.

7.) Review of an ED record revealed Patient #10 was a [AGE] year old female who (MDS) dated [DATE] at 12:50 p.m. with a diagnosis of [DIAGNOSES REDACTED]. Lab orders written on admit were for a FSBS and basic metabolic panel (BMP).
Review of physician orders dated 04/23/13 at 1:00 p.m. revealed the following:
"Lantus insulin 20 units subcutaneous daily ( pt got 10 units this AM)
Sliding scale regular insulin, FSBS QID a.c. and HS
Humulin R 10 units SQ stat ( BS, 526 per EMS)"
Review of the ED record dated 04/23/13, 1:40 p.m. revealed the FSBS was 482 per lab. At 1:50 p.m. nursing administered 10 units of Regular insulin. Patient #10 received first treatment of insulin one hour after presenting to the hospital.
Review of a lab report dated 04/23/13, collection time of 6:00 p.m. revealed the FSBS was too high to read on the machine so a serum glucose was ordered. The level was critical at 422 (RR 70.0-105.0). The critical value was given to nursing over an hour later at 7:08 p.m.
Review of the "Critical Value Report Lab/Diagnostic Imaging" dated 04/23/13 revealed the Nurse Practitioner was called at 7:10 p.m. about the critical lab.
Review of lab reports dated 04/23/13 revealed a CMP was drawn instead of a BMP as ordered. A hemoglobin A1C, CBC, and UA were performed on 04/23/13 and there was no physician order for the labs.
Review of lab report dated 04/24/13 at 10:50 a.m. revealed Patient #10 had a high FSBS of 377.
Review of a lab requisition dated 04/24/13, 11:00 a.m. revealed documentation on the form that lab made a report to nursing of the FSBS being 327. Review of a diabetic flow sheet revealed Patient #10 received 8 units of Regular insulin for a BS of 327 instead of the 10 units which was required for a BS of 377.

During an interview on 04/25/13 at 11:50 a.m., Staff #25 (RN) confirmed the late notifications by lab and the late administration of the Stat insulin. Staff #25 confirmed the medication error on the insulin as related to inaccurate reporting of lab results on the BS.

It was determined this deficient practice created an Immediate Jeopardy situation and placed patients at risk of potential harm, serious injury, and subsequent death. These failures had the potential to affect all patients admitted to the facility.
VIOLATION: LABORATORY SERVICES Tag No: A0576
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and records review, the facility failed to ensure that laboratory tests were obtained as ordered by the physician, laboratory test results were reported timely and laboratory test results were accurate in order to provide appropriate treatment regimen for a patient in 7 (#s' 2,4,5,6,8, 9 and 10) of 10 patients reviewed for laboratory services. The facility also failed to ensure that laboratory employees had completed job competencies in 5 (#s' 10, 27, 28, 29 and 30) of 9 personnel files reviewed.
This deficient practice could cause harm in all patients presenting or inpatients in the hospital.
Findings include:
Review of the policy "Interdepartmental Policy for Laboratory Specimens" dated 11/12/2011 revealed the following:
"Laboratory request will be generated by Nursing Service (for in-house patients) at the time of specimen collection. All laboratory tests will be carried to the Nursing station as soon as possible after completion. Nursing personnel will chart the results."
Review of the policy "Policies and Procedures For Accu-Check Blood Glucose Monitoring" dated 11/12/11 revealed:
"If the value obtained is not consistent with patient symptoms, perform another test. If the repeated results again indicate unexpected values, obtain a STAT blood glucose by lab and notify the physician of the results. All patients with greater that 400 mg/dl should have a venous lab repeat done on the chemistry analyzer to verify even if treatment had been initiated."
Review of the policy "Critical Lab Values and Read Back Procedure" dated 11/12/2011 revealed the following:
"First event critical lab results must be called to the Nursing staff member or physician as soon after results are obtained. The preliminary report must be called immediately. The patient specimen must be repeated and verified. Document on the report the date, time, the Nursing staff member or physician that was notified of the critical value and that the results were read back to the tech reporting the results".
Review of the policy "Delay of Service" dated 11/12/11 revealed the following:
"It is the Laboratory's policy to report result of tests as soon as possible according to their order status (STAT, timed, routine). All delays in laboratory due to patient status, refusal of service by patient, equipment malfunctions, etc. will be called to the appropriate nursing unit or physician office depending upon the origin of the order. The notification will be noted on the patients's request with reason(s) for delay of service, along with the caller's initials, the date and time of the call and the name of the person receiving the call."
1. Review of an Emergency Department (ED) record revealed that Patient #4 was a [AGE] year old male, presented to the hospital 04/04/13 at 12:14 p.m. with chief complaints of high blood sugars and high blood pressure per family. The patient arrived in the emergency room with a finger stick blood sugar reading of "too high" from the ambulance staff .
Review of the ED physician assessment dated [DATE] (no time documented) revealed that Patient #4 had diagnoses of [DIAGNOSES REDACTED]
Review of the initial ED physician orders' dated 04/04/2013(no time documented) were as follows:
"1. Regular insulin 10 units Sub-cut x1
2. Regular insulin 7 units IV x1
3. Insulin drip with regular insulin 6 units/hr.
4. Foley catheter
5. No BMP following 1530 FSBS
6. NS Bolus"

Review of BMP lab report collected on 04/04/13 at 12:33 p.m. and reported to the ER staff at 1:24 p.m. (over 1 hour later) revealed:
Report (*indicates out of range)
*Sodium 154.3 (Reference range (RR 136.0-145.0)
*Potassium 5.3 (RR 3.5-5.1)
*Chloride 108.3 (RR 98.0- 107.0)
*Carbon dioxide 30.0 (RR 23.0-29.0)
*Glucose 872.0 (RR 70.0-105.0)
*BUN 52.0 (RR 7.0-18.0)
Review of ED nurses record on 4/4/13 at 12:55 p.m. Insulin 10 units subcutaneous to the right upper arm. Forty minutes later ED nurses administered insulin 7 units intravenous push and started an insulin drip to infuse at 6 units per/hour at 1:35 p.m.
Review of ED physician's order on 4/4/13 was for a finger stick to be done at 2:30 p.m.
The lab results of FSBS too high to read on meter. Lab should have collected serum glucose per facility policy, instead lab personnel resulted a BMP with a 30 minute delay without a physician order.
A BMP result of 04/04/13 at 3:00 was as follows:
*Sodium 161.7 (Reference range (RR 136.0-145.0)
Potassium 3.6 (RR 3.5-5.1)
*Chloride 118.3 (RR 98.0- 107.0)
*Carbon dioxide 30.8 (RR 23.0-29.0)
*Glucose 648.0 (RR 70.0-105.0)
*BUN 50.0 (RR 7.0-18.0)
*Creatinine 1.5 (RR 0.7-1.3)
Review of lab report on 4/4/13 for finger stick to be done at 3:30 p.m., FSBS too high to read on meter, no follow up with serum glucose for verification per facility policy.
Review of ED physician's order on 04/04/13 at 4:30 p.m. was to draw BMP, results as follows:
*Sodium 161.6 (Reference range (RR 136.0-145.0)
*Potassium 3.2 (RR 3.5-5.1)
*Chloride 121.7 (RR 98.0- 107.0)
Carbon dioxide 27.7 (RR 23.0-29.0)
*Glucose 464.0 (RR 70.0-105.0)
*BUN 51.0 (RR 7.0-18.0)
*Creatinine 1.4 (RR 0.7-1.3)
A review of the lab results showed patient's #4's sodium continued to increase with normal saline bolus infusing per physicians orders.
A review of lab dated 04/04/13 at 5:35 p.m. showed a FSBS of 389.0, the record revealed no physician's order for a finger stick at this time.
A review of lab for BMP dated 04/04/13 at 7:10 p.m., revealed no physician's order for BMP.
*Sodium 168.5 (Reference range (RR 136.0-145.0)
*Potassium 3.4 (RR 3.5-5.1)
*Chloride 125.8 (RR 98.0- 107.0)
Carbon dioxide 30.7 (RR 23.0-29.0)
*Glucose 272.0 (RR 70.0-105.0)
*BUN 47.0 (RR 7.0-18.0)
*Creatinine 1.3 (RR 0.7-1.3)
A review of the lab results showed patient# 4's sodium continued to increase with normal saline bolus infusing per physician's orders.
A review of lab dated 04/04/13 at 8:13 p.m. showed a FSBS of 233.0. The record revealed no physician's order for a finger stick at this time.
A review of ED nurse's notes on 04/04/13 at 8:50 p.m. revealed nursing reduced the insulin drip to infuse at 3 units/ hour and changed IV fluids to D51/4 with 20 KCL (Potassium Chloride) at 250 cc/hour. There was no physician order to decrease the insulin drip or to change IV fluids.
Review of lab results dated 04/04/13 at 9:46 p.m., revealed FSBS of 166 and at 10:55 p.m., FSBS of 128. There was no physician's order for these FSBS.
A review of ED nurses notes dated 04/04/13 at 10:35 p.m. revealed patient #4 pulled out insulin drip tubing and the physician notified. There was no physician's order found to discontinue the insulin drip.
A review of lab dated 04/04/13 at 11:55 p.m. showed a FSBS of 145.0, the record revealed no physician's order for a finger stick at this time.
A BMP lab results dated 04/04/13 at 12:20 a.m., was reviewed. The record revealed no physician's order for a BMP. The BMP results were as follows:
*Sodium 168.2 (Reference range (RR 136.0-145.0)
Potassium 4.5 (RR 3.5-5.1)
*Chloride 127.7 (RR 98.0- 107.0)
Carbon dioxide 32.6 (RR 23.0-29.0)
*Glucose 131.0 (RR 70.0-105.0)
*BUN 44.0 (RR 7.0-18.0)
Creatinine 1.2 (RR 0.7-1.3)

A review of the lab results shows patient #4's sodium continued to increase with D5 ? normal saline infusing without a physician's orders.

A review of lab for BMP on 04/05/13 at 3:30 a.m., results was as follows:
*Sodium 167.7 (Reference range (RR 136.0-145.0)
Potassium 4.5 (RR 3.5-5.1)
*Chloride 124.1 (RR 98.0- 107.0)
*Carbon dioxide 30.3 (RR 23.0-29.0)
*Glucose 230.0 (RR 70.0-105.0)
*BUN 44.0 (RR 7.0-18.0)
*Creatinine 1.3 (RR 0.7-1.3)

A review of record "Diabetic Flow Sheet" dated 04/05/13 at 3:40 a.m. revealed glucose of 219 (no lab results of a 219 found on the chart) and nurse documented 4 units of insulin subcutaneous. No mention of the 3:30 a.m. glucose level of 230.

A review of lab for BMP on 04/05/13 collected at 5:15 a.m. Resulted at 6:30 a (1 hour and 15 min delay) result was as follows:
*Sodium 161.0 (Reference range (RR 136.0-145.0)
Potassium 4.5 (RR 3.5-5.1)
*Chloride 120.9 (RR 98.0- 107.0)
*Carbon dioxide 31.7 (RR 23.0-29.0)
*Glucose 304.0 (RR 70.0-105.0)
*BUN 43.0 (RR 7.0-18.0)
*Creatinine 1.3 (RR 0.7-1.3)

A review of record "Diabetic Flow Sheet" dated 04/05/13 at 5:30 a.m. revealed glucose of 294 (no lab results of a 294 found on the chart) and nurse documented 6 units of insulin subcutaneous. No mention of the 5:15 a.m. glucose of level of 304. According to sliding scale patient should have received 8 units of insulin for glucose of 304.
A review of sliding scale insulin protocol was to perform finger stick glucose checks before meals and at bedtime (AC and HS). A review of lab records on 04/05/13 revealed there was no FSBS prior to lunch as ordered per the sliding scale protocol. Blood sugars were not monitored from 5:15 a.m. till 2:06 p.m.
A review of lab results dated 04/05/13 at 2:06 p.m. revealed an elevated glucose of 416.
A review of lab results on 04/05/13 at 6:05 p.m. showed FSBS of 405, and serum glucose drawn for verification showed glucose 327.0. (Difference of 25% between the finger stick and the serum glucose) An hour later the nurse administered 8 units of insulin based on the 327 glucose.
Review of lab results dated 04/08/13 revealed: BMP collected at 8:00 a.m. result reported at 9:27 a.m., FSBS collected at 10:55 a.m. result reported at 12:05 p.m., and FSBS collected at 4:00 p.m. result reported at 5:13 p.m., all results showed over an hour delay in reporting.
A review of lab results on 04/08/13 showed BMP collected at 4:00 p.m. result reported at 4:53 p.m. BMP was due to be drawn at 2:00 p.m. per physician's order, revealed a 2 hour delay in reporting. A review of the record revealed no notification of the delay to nursing.
A review of lab results for FSBS - 314 collected on 04/08/13 at 11:00 p.m. revealed no physician orders for the FSBS.
A review of lab results on 04/09/13 showed BMP collected at 6:00 a.m., result reported at 9:52 a.m. (3 hour 52 minute delay). A glucose reading on the lab was a 60.0.
A review of nurse's record on 04/09/13 revealed no notification to the physician of the 60 glucose. Review of the sliding scale protocol nurse was to call the physician with glucose less than 70 and implement the [DIAGNOSES REDACTED] protocol.
A review of lab records on 04/10/13 at 1:30 p.m. revealed no physician's order for BMP and CBC drawn and result reported.

During an interview on 04/25/13 from 9:00 a.m. through 12:00 p.m. with staff #6 (RN) confirmed the errors and delays with the lab results, lack of documentation and notification by lab personnel, and errors in nursing documentation with and without physician's orders.

2.) Review of an Emergency Department (ED) record revealed that Patient #2 was an [AGE] year old female, presented to the hospital 02/07/13 at 9:12 a.m. with chief complaints of a fall and right shoulder pain.
Review of the ED physician assessment dated [DATE], at 10:00 a.m. revealed that Patient #2 had diagnoses of [DIAGNOSES REDACTED]. According to the assessment a computer tomography (CT) scan of the head showed that Patient #2 had a remote right middle cerebral artery (MCA) territory infarct (stroke).
Review of ED physician orders dated 02/07/13 (no time) revealed the following :
Pro-Brain natriuretic peptide (BNP), Culture & Sensitivity ( C &S) blood x 2, Complete blood count (CBC), Creatinine kinase (CK), CKMB if CK elevated, Protrombin time (PT), Partial thromboplastin time (PTT), Troponin and Urinalysis (UA) with C/S if indicated.
Review of lab reports revealed the lab specimen was collected on 02/07/13 at 12:40 p.m., 3 hours and 28 minutes after Patient #2 presented to the ED.
Three lab reports of the same test collected on 02/07/13 at 12:40 p.m., revealed the following:
*Report #1 (Preliminary)
Sodium 122.8 (Reference range (RR 136.0-145.0)
Potassium 2.8 (RR 3.5-5.1)
Chloride 126.2 (RR 98.0- 107.0)
Carbon dioxide 30.0 (RR 23.0-29.0)
White blood count 12.0 (RR 3.5-10.0)
CK 344.0 (RR 25.0-174.0)
Pro BNP 2651.4 (RR 0.0-620.0)
PTT 44.6 (RR 21.4- 41.8)

*Report #2 (Final copy)
This lab report had the same results as the preliminary lab.

*Report #3 (Revised)
Sodium 143.0 within RR
Potassium 3.2 low
White blood count 12.0 high
CK 344.0 high
Pro BNP 2651.4 high

Review of a "Critical Value Report Lab/Diagnostic Imaging" form dated 02/07/13 revealed that the lab department notified nursing staff of a critical Sodium level of 122.8 (reference ranges being 125-155) at 1:44 p.m., over an hour later. Nursing notified the physician of the lab results at 1:45 p.m. and new orders were received.

Review of physician orders dated 02/07/13 revealed orders for 3% Normal saline (NS) at 50 milliliters (ml), intravenous (IV) times one; NS with 40 milliequivalent (MEQ) of Potassium chloride (KCL) give 500 ml times one at 125 ml/hour; Lasix 20 milligrams (mgs) intravenous times one and insert a Foley catheter.

Review of ED notes dated 02/07/13 revealed the following:
At 2:05 p.m. the 3% NS at 50 cc per hour was started and NS with 40MEQ at 125 cc per hour were started at the same time.
At 3:15 p.m. Lasix 20 mgs (intravenous push) IVP was administered to Patient #2.
At 3:55 p.m. the intravenous fluids were turned off. There was no documentation of the reason the fluids were turned off, amount of fluids infused, nor was there a physician order
.
Review of an unusual event report on Patient #2 dated 02/07/13, 3:55p.m. revealed that a 3 % NS was started at 2:05 p.m. and was to receive 50 ml over 1 hour and then staff were to begin NS 500 ml with 40 MEQ KCL to run over 4 hours. At 3:55 p.m., another critical low sodium was reported on another patient. The unusual event report revealed that at 3:55 p.m., labs were rechecked and Patient #2 had an elevated sodium level of 177.8 (indicating hypernatremia). Intravenous fluids were stopped and someone was coming to check the chemistry machine. There was no documented follow-up on the Chemistry machine nor an improvement plan was implemented. Patient #2 received treatment for an elevated sodium level when there was a lab which indicated it was in the normal range.

Review of physician orders dated 02/07/13 at 11:15 p.m. (over 7 hours later after stopping the IV fluids) revealed that Patient #2 was being admitted for acute congestive heart failure, hypokalemia and right lower lobe pneumonia. Some of the orders written were for a cardiac diet, 1200 ml/24 hour fluid restriction, Lasix 40 mg, Potassium 20MEQ, antibiotics Rocephin and Azithromycin, Lovenox 60 mg, blood cultures x 2 and sputum gram stain and culture.
Review of ED notes revealed Patient #2 did not receive treatments for her condition until 12:55 midnight, over 8 hours after discontinuing the IV fluids.
The ordered blood cultures could not be found and the sputum culture dated 02/08/13 revealed it was an unacceptable culture. The instructions were to "please resubmit a new specimen." There was no new sputum culture found on Patient #2.

During an interview on 04/24/13 at 10:50 a.m., Staff #8 (RN) reported she gets the lab results and log them on a spread sheet. Staff #8 reported the only problems found last month were with lab forms not being completed. The problems with the increased sodium levels were brought to her attention. A plan of correction was done and it went to Staff #6 (RN).

During an interview on 04/24/13 at 10:55 a.m., Staff #6 (RN) reported the problems with labs go back to October 2012. The chemistry lab machine had an electrode which was cracked and replaced (02/07/13). The lab company who was performing rechecks on their questionable lab results terminated their contract on 04/03/13. If any patient came into the hospital with a Tylenol overdose they did not have the capability or equipment to run levels on them. The lab concerns had been taken to the attention of the governing board, but nothing had been done.

During an interview on 04/24/13 at 4:25 p.m., Staff #6 (RN) confirmed the error with the IV fluids, problems with nursing assessments, untimely interventions implemented, extended ED stay with delayed treatment, the problems with lab results and missing lab results on Patient #2. Staff #6 (RN) reported she did not trust the lab results, nor the information the lab supervisor was provided to Quality assurance. Nothing had been put into place to follow-up that the lab equipment had been fixed or if it was providing accurate results. Staff #6 checked all three lab reports on Patient #2 which gave the different sodium levels and reported she did not know which one was accurate. Staff #6 reported another lab company they were using would not pick up lab on the weekends and it took them 5-7 days to get the culture results back to the facility.

3.) Review of the ED record on Patient #6 revealed that she was a [AGE] year old female admitted on [DATE] at 12:37 p.m. with slurred speech, right sided weakness and a history of insulin dependent diabetes mellitus. Lab ordered on admit was Pro-BNP, CBC, CK, CKMB, CMP, Troponin and UA with C&S if indicated.
Review of the chart revealed all of the lab was collected over an hour later on 04/12/13 at 1:43 p.m.. Some of the results were as follows:
Glucose, Critical high 626 (RR 70.0-105.0)
Pro -BNP high 1982.3 (0.0-230.0)
Review of a "Critical Value Report Lab/Diagnostic Imaging" form dated 04/12/13 revealed that nursing staff was informed of the critical lab value at 2:35 p.m.
Review of the ED record dated 04/12/13 revealed Humulin Regular 10 units was administered at 2:45 p.m.
Review of a lab report dated 04/12/13 revealed Patient #6 had a critical high Glucose of 442.0 at 3:20 p.m. There was documentation on the lab report that nursing staff was called the result at 4:13 p.m.
Review of the chart revealed no other glucose checks nor any more insulin was administered to Patient #6 for this critical Glucose.
Review of the ED record dated 04/12/13 revealed Patient #6 was transferred to another hospital at 5:30 p.m. via helicopter. The discharge diagnosis was CVA rule out cerebral aneurysm.
During an interview on 4/25/13 at 1:30 p.m., Staff # 6 (RN) confirmed the times the labs were drawn and the lack of intervention.

4.) Review of the ED record on Patient #5 revealed he was a [AGE] year old male admitted [DATE], at 7:20 p.m. with a diagnosis of [DIAGNOSES REDACTED]
Review of the ED notes dated 04/14/13 revealed Patient #5 had a blood sugar of 60 at 7:30 p.m. and at 7:32 p.m. he was given 1&1/2 ampule of Dextrose 50% IVP. Review of lab results revealed no reports or documentation of who performed the blood sugar check.
Review of lab collected on 04/15/13 at 7:37 p.m. (5 minutes later) revealed the following:
*FSBS - 97.0 (RR 70.0-105.0)
*CMP - Glucose 72.0 (RR 70.0-105.0)
The difference between the FSBS and the Glucose were over 10 percent.
Review of the manufacturer instructions "Guaranteed Performance HemoCue Glucose Systems" revealed under the accuracy validation section the following:
"Under ideal conditions, the HemoCue Glucose 201 System should, on average, produce results within 10 percent of those obtained by the comparative method."
Review of physician orders dated 04/15/13, 9:00 p.m. revealed Patient #5 was started on Dextrose 5 % 1/2 NS at 100 ml per hour. Stop the drip if the blood sugar is over 250.
Review of three different lab values dated 04/16/13 and collected within 30 minutes of each other revealed the following:
*BMP collected at 6:00 a.m. - Glucose 380 (RR 70.0-105.0)
* Two more labs collected at 6:30 a.m.- Serum Glucose 337.0; FSBS - 358.0
Review of nurses notes dated 04/16/13, 8:10 a.m., revealed the lab draw this AM showed the blood sugar was 337. There was documentation the doctor was notified and orders were received to discontinue IV fluids (Dextrose 5 % ? NS) and administer Novolin insulin 70/30, 20 units SQ. This was a delay in treatment for over 2 hours after the initial glucose check at 6:00 a.m.
Review of lab values collected at 8:30 a.m. revealed the FSBS was too high to read on meter and a Serum Glucose was ordered. The Serum Glucose had increased to 488.0.
Review of nurses notes dated 04/16/13, 9:00 a.m. revealed the glucose was 488 and the doctor was notified . New orders were given for Regular insulin 14 units SQ and next accu check at 11:00 a.m.
Review of lab values collected at 11:00 a.m. revealed the FSBS was too high to read on meter and a Serum Glucose was ordered. The Serum Glucose was 390.0.
Review of nurses notes dated 04/16/13, 12:00 p.m. revealed the glucose was 390 and sliding scale Regular insulin 10 units was given SQ.
Review of lab values collected on 04/17/13 at 6:00 a.m. revealed a FSBS of 187.0 and nursing was notified an hour later at 7:05 a.m. There was no documentation that the sliding scale insulin was administered as needed. At 10:43 a.m. a FSBS was collected and the results were critical at 432.0
Review of medication administration record dated 04/17/13 revealed Patient #5 was given Humulin insulin 70/30, 40 units SQ at 10:50 a.m.
Review of nurses notes dated 04/17/13 revealed Patient #5 was discharged home at 11:00 a.m. There was no documentation of a follow-up call to see if the insulin decreased the critical blood sugar.

During an interview on 04/25/13 at 1:30 p.m., Staff #6 (RN) confirmed the missing physician orders for lab, delay in treatment, delay in lab notification, and discrepancy between the fingerstick and serum glucose. Staff #6 confirmed Patient #5 being discharged with a blood sugar that was too high.

5.) Review of an ED record revealed Patient #8 was a [AGE] year old female who (MDS) dated [DATE] at 5:41 a.m. with chief complaints of chest pain. She had a history of gestational diabetes mellitus and deep vein thrombosis to the right leg. Patient #8 was on the anti-coagulant Coumadin daily. The ED physician was notified at 6:00 a.m. and orders were obtained for an Amylase, Pro BNP, CBC, CK CKMB, CMP, Lipase, PT, PTT UA, Urine HCG.
Review of lab reports collected on 04/22/12 at 7:05 a.m. (over an hour later) revealed the following:
PT- 56.4 high (RR 8.0-14.0)
INR- 5.6 high ( RR 0.8-1.4)
The lab results were printed and reviewed on 04/22/13 at 7:51 a.m.
Review of nurses notes revealed no documentation of when lab informed nursing of the critical lab or when nursing informed the physician.
Review of an ED physician assessment revealed Patient #8 was seen by the physician on 04/22/13 at 8:45 a.m. and a diagnosis was given of Coumadin toxicity.
Review of a blank "Critical Value Report Lab/Diagnostic Imaging" revealed an INR greater than 5 was considered a critical range. Instructions were as follows: "If Physician or the doctor covering for the Physician has not responded within 60 minute timeframe, the Chief of Medical Staff or the ER physician. If Physician not notified, document why."
Review of Patient #8' s record revealed no Critical Value Report.
During an interview on 04/25/13 at 9:45 a.m., Staff #26 (RN) confirmed there was no Critical Value Report completed on Patient #8 and she did not know when the lab was called to nursing. Nursing was suppose to put the Critical Value Report on the patient' s chart. Staff #26 reported she could not find results for the ordered UA. There was no physician order for a D-Dimer and Troponin that were collected on 04/22/13 on Patient #8.

6.) Review of an ED record revealed Patient #9 was a [AGE] year old male who (MDS) dated [DATE] at 6:16 a.m. with chief complaints of confusion and not taking his medication. Patient #9 had a history of hypertension and paranoid schizophrenia. Lab orders written on admit were for a Pro BNP, Blood ETOH, Acetaminophen, Salicylate, CBC, Serum Myoglobin, CK, CKMB, CMP, PT, PTT, Troponin and UA. Repeat CK at 9:00a.m., 1:00 p.m. and 4:20 p.m.
Review of lab reports revealed the following:
*CMP collected on 04/22/13 at 6:41 a.m.
Sodium 126.9 low (RR 136-145)
Chloride 92.2 low (RR 98.0-107.0)
Carbon dioxide low 20.6 (RR 23.0-29.0)
Glucose 144 high (70.0-105.0)
Creatinine 1.7 high (RR 0.7-1.3)
*CBC collected on 04/22/13 at 6:41 a.m.
WBC high 18.8 (RR 3.5-10.0)
Review of a blank "Critical Value Report Lab/Diagnostic Imaging" revealed the WBC, Carbon dioxide, Sodium levels for Patient #9 would be considered in the critical range. Staff were suppose to document physician notification and response. If the physician was not notified they had to document why. Review of Patient #9's record revealed no completed critical value reports.
*CK collected on 04/22/13 at 6:41 a.m. read high at 510 (RR 25.0- 174.0), CK 870 at 9:00 a.m., CK 896 at 1:15 p.m., and CK 1052 at 4:16 p.m. There was no documented physician notification of the continued elevation of the CK after 9:00 a.m.
*UA collected on 04/22/13 at 9:00 a.m (over 2 hours after admit).
* PT, PTT were not collected as of 04/25/13 at 9:20 a.m.
* The Serum Myoglobin, Acetaminophen, and Salicylate results were not on the chart as of 04/25/13 at 9:20 a.m.
During an interview on 04/25/13 at 9:20 a.m., Staff #26 confirmed the lab was ordered on admit into the ED room. She confirmed the lab results, late times of collection, and missing lab on the chart. At the request of the surveyor, Staff #26 checked all lab results on Patient #9 on the computer and they were printed off. According to the reports the Acetaminophen and Salicylate were collected on 04/22/13 at 11:06 p.m and reported 2 days later on 04/24/13 at 3:17 p.m.. The Serum Myoglobin was collected on 04/22/14 at 5:07 p.m., was high at 281 (RR 28-72). The lab was reported 2 days later on 04/24/13 at 6:39 a.m.

7.) Review of an ED record revealed Patient #10 was a [AGE] year old female who (MDS) dated [DATE] at 12:50 p.m. with a diagnosis of [DIAGNOSES REDACTED]. Lab orders written on admit were for a FSBS and basic metabolic panel (BMP).
Review of physician orders dated 04/23/13 at 1:00 p.m. revealed the following:
"Lantus insulin 20 units subcutaneous daily ( pt got 10 units this AM)
Sliding scale regular insulin, FSBS QID a.c. and HS
Humulin R 10 units SQ stat ( BS, 526 per EMS)"
Review of the ED record dated 04/23/13, 1:40 p.m. revealed the FSBS was 482 per lab. At 1:50 p.m. nursing administered 10 units of Regular insulin. Patient #10 received first treatment of insulin one hour after presenting to the hospital.
Review of a lab report dated 04/23/13, collection time of 6:00 p.m. revealed the FSBS was too high to read on the machine so a serum glucose was ordered. The level was critical at 422 (RR 70.0-105.0). The critical value was given to nursing over an hour later at 7:08 p.m.
Review of the "Critical Value Report Lab/Diagnostic Imaging" dated 04/23/13 revealed the Nurse Practitioner was called at 7:10 p.m. about the critical lab.
Review of lab reports dated 04/23/13 revealed a CMP was drawn instead of a BMP as ordered. A hemoglobin A1C, CBC, and UA were performed on 04/23/13 and there was no physician order for the labs.
Review of lab report dated 04/24/13 at 10:50 a.m. revealed Patient #10 had a high FSBS of 377.
Review of a lab requisition dated 04/24/13, 11:00 a.m. revealed documentation on the form that lab made a report to nursing of the FSBS being 327. Review of a diabetic flow sheet revealed Patient #10 received 8 units of Regular insulin for a BS of 327 instead of the 10 units which was required for a BS of 377.
During an interview on 04/25/13 at 11:50 a.m., Staff #25 (RN) confirmed the late notifications by lab and the late administration of the Stat insulin. Staff #25 confirmed the medication error on the insulin as related to inaccurate reporting of lab results on the BS.

It was determined this deficient practice created an Immediate Jeopardy situation and placed patients at risk of potential harm, serious injury, and subsequent death. These failures had the potential to affect all patients admitted to the facility.
VIOLATION: FOOD AND DIETETIC SERVICES Tag No: A0618
Based on record review, observation, and interview, the dietary department failed to maintain a clean and safe environment for the patients' and employees' food it served.

During a tour of the dietary department on 04/18/2013 at 11:30 AM with staff #12, the following was observed:

The dietary walk-in refrigerator was not working. Staff #12 reported the refrigerator had been out of service since March 14, 2013.

Observed in one of the dietary refrigerators were meat, eggs, fruits, and vegetables stacked together, due to shortage of storage space. Lack of food storage was because the large walk-in refrigerator was out of service.

As required by the, "Texas Food Establishment Rules 229.164(f)":
"Food shall be protected from cross contamination by: (A) Food shall be protected from cross contamination by: (i) separating raw animal foods during storage, preparation, holding, and display from: (I) raw ready-to-eat food including other raw animal food such as fish for sushi or molluscan shellfish, or other raw ready-to-eat food such as vegetables; and (II) cooked ready-to-eat food; (ii) except when combined as ingredients, separating types of raw animal foods from each other such as beef, fish, lamb, pork, and poultry during storage, preparation. Holding, and display by: (I) using separate equipment for each type; or (II) arranging each type of food in equipment so that cross contamination of one type with another is prevented."

The dietary department had total of 4 refrigerators, and of those 4, only one was connected to an emergency plug. There were no other emergency plugs in the dietary area for the other refrigerators.

The oven door was not working due to the "holders" being rusted through on the oven door. This caused a safety hazard to the personnel trying to prepare food in the dietary department.

Observed in the main dietary area and in the food storage area were air conditioning vents with a rust looking appearance and dust particles hanging from the vents.

While reviewing records in the dietary department, the surveyor felt water dripping on her head and observed water coming through the air conditioner vent. While observing the food storage area, she felt more water dripping on her head from the return air vent. It was raining outside at the time.

A review of the record titled, "Consultant Dietitian's Monthly PI Report," for dates 03/20/2013 and 04/17/2013, revealed the broken walk-in refrigerator had been reported to administration. The dietitian wrote, "refrigerator is cramped and need more refrigeration space."

A review of the record titled, "2013 QI Review for March," revealed the Board of Directors had been notified the oven door "holders" were rusted through and maintenance was unable to fix the oven door. The walk-in refrigerator had been reported x 3, and 8 flats of eggs had to be thrown away due to the broken refrigerator. The report revealed the Board of Directors had been notified with "no changes and this is causing food to be improperly stored, food has been discarded due to spoilage."

An interview with staff #12 on 04/18/2013 at 11:30 AM while in the dietary department confirmed the observations during the tour. Staff #12 voiced concern she had reported the issues with the oven and improper storage of food and lack of refrigeration space for food to the Assistant Administrator.

An interview with the Assistant Administrator on 04/18/2013 at 2:30 PM confirmed she had reported the issues with dietary to the Administrator and the Board of Directors.

An interview with the Administrator on 04/19/2013 at 3:30 PM (who was onsite during the exit conference) confirmed the walk-in refrigerator was out of service and had been since March 14, 2013. The Administrator is one of the two board members (the owner is the other board member).
VIOLATION: QUALIFIED EMERGENCY SERVICES PERSONNEL Tag No: A1112
Based on record review and interview the facility failed to maintain required qualifications established by Medical Staff Bylaws for 5 (#17, #18, #19, #20, #21) of 7 (#15-#21)physicians working in the emergency room . This has the potential to provide an environment for possible patient harm by not having the properly trained physicians to meet the patients' needs.

Findings:

A review of record titled, "Medical Staff Bylaws; ARTICLE VII Corrective Actions, Section 3 -Automatic Suspension, Termination, or Reduction of Privileges, subsection-" revealed
"E. ACLS/ATLS Certification: If a Practitioner fails to maintain Advanced Cardiac Life Support certification, the Practitioner's privileges to attend to cardiac patients shall automatically be suspended until such time as certification is achieved. If a Practitioner fails to maintain Advanced Trauma Life Support certification, the Practitioner's privileges to act as Emergency Department Physician shall be automatically suspended until such time as ATLS certification is achieved. Action automatically imposed under this Section does not entitle the Practitioner to hearing and appeal under these bylaws."

A review of the emergency room physicians' schedule from January through April 2013 revealed physician # 17, #18, #19, #20, and #21 had worked in the emergency room in this facility.

A review of Physician # 17's file revealed no documentation of Advanced Trauma Life Support (ATLS) certification found in the physician's file.

A review of Physician # 18's file revealed no documentation of Advanced Trauma Life Support (ATLS) certification found in the physician's file.

A review of Physician # 19's file revealed no documentation of a file existed.

A review of Physician # 20's file revealed no documentation of a file existed.

A review of Physician # 21's file revealed no documentation of a file existed.

On 04/24/2013 at 3:00 PM an interview with staff #4 and staff #6 confirmed the findings of physician's files and that physicians # 17, 18, 19, 20, and 21 had worked in the emergency room in this facility.

An interview with the Administrator on 04/25/2013 at 3:30 PM (who was onsite during the exit conference) confirmed the physicians working in the Emergency Department did not have the required qualifications as per the Medical Staff Bylaws.
VIOLATION: ORGANIZATION OF EMERGENCY SERVICES Tag No: A1102
Based on record review and interview the facility failed to ensure that Emergency Department Services were under the direction of a qualified member of the medical staff.

Findings:
Review of the organizational chart for the facility on 04/24/2013 at 12:20 PM in the assistant administrator's office revealed no delineation for Emergency Department Medical Director on the chart. A review of meetings titled, "Governing Board Meeting" dated July 31, 2012, revealed Physician #18 was reappointed to medical staff for only 6 months (which expired January 31, 2013) due to peer review issues that had transpired in the emergency room .

A review of record titled, "Medical Staff Bylaws; ARTICLE VII Corrective Actions, Section 3 -Automatic Suspension, Termination, or Reduction of Privileges, subsection-" revealed

"E. ACLS/ATLS Certification: If a Practitioner fails to maintain Advanced Cardiac Life Support certification, the Practitioner's privileges to attend to cardiac patients shall automatically be suspended until such time as certification is achieved. If a Practitioner fails to maintain Advanced Trauma Life Support certification, the Practitioner's privileges to act as Emergency Department Physician shall be automatically suspended until such time as ATLS certification is achieved. Action automatically imposed under this Section does not entitle the Practitioner to hearing and appeal under these bylaws."

A review of Physician # 18's file revealed no documentation of Advanced Trauma Life Support (ATLS) certification found in the physician's file.

On 04/24/2013 at 12:20 PM in an interview with staff #4, she reported she thought the Medical Director over the Emergency Department was Physician #18. Staff #4 was asked has physician #18 had privileges suspended due to not meeting qualifications set by the medical staff bylaws; she stated "no."

On 04/24/2013 at 12:20 pm in an interview with staff #6 she stated " Physician #18 is what we call the Emergency Director, but all he really does is make out the emergency room physician schedule." Staff #6 was asked if the facility had a policy on what the emergency room Director's responsibilities were; she stated "we don't have a policy." Staff #6 was asked has physician #18 had privileges suspended due to not meeting qualifications set by the medical staff bylaws; she stated "no."

An interview with Administrator on 04/19/2013 at 3:30 PM (who was onsite during the exit conference) confirmed the facility did not have a Medical Director over the Emergency Department and Physician #18 needed to be reappointed by the Governing Board.
VIOLATION: INTEGRATION OF EMERGENCY SERVICES Tag No: A1103
Based on record review, observation, and interview, the Emergency Department failed to provide ultrasound testing services to obstetric patients in emergency situations. The facility also failed to provide vascular ultrasound for detection of blood clots (deep venous thrombosis-DVT) in the major veins of the legs and arms.
The Assistant Administrator reported this hospital is the only one in the county and there is no other available obstetrics for delivery of a baby. One transferring facility is 40 minutes away, but does not have a neonatal unit (a unit to care for premature newborns). The other facility is an hour and 30 minutes away, and does have a neonatal unit. The ultrasound is important to determine the gestational age of the fetus in this facility. In emergency situations, the facility has to transfer pregnant mothers to another facility. The accepting facility needs to know the gestational age of the fetus before the facility can accept the pregnant mother, due to the possible intensive care needs of the baby. The emergency room census for this facility in the last 6 months had been October 2012 (ER visits 800) (ultrasounds 51), November 2012 (ER visits 853) (ultrasounds 20), December 2012 (ER visits 851) (ultrasounds 23), January 2013 (ER visits 873) (ultrasounds 15), February 2013 (ER visits 665) (ultrasounds 20), and March 2013 (ER visits 650) (no ultrasound tests completed due to machine went out of service on February 23, 2013).

A review of policy titled, "Facility/Hospital Services Available," policy 1.4, revealed the facility would provide ultrasound capabilities:

"PURPOSE
Shelby Regional Medical Center is an acute health care institution dedicated to providing appropriate services to sick and injured persons. In providing these services, the hospital strives to provide optimal patient care within our available resources of personnel, equipment and supplies.
2.0 SERVICES AVAILABLE
Medical floor
Outpatient Services
emergency room
Cardiopulmonary Services
EKG
Stress Test
EEG
Respiratory Treatments and Procedures
Laboratory for Inpatient and Outpatient
Radiology for Inpatient and Outpatient
General X-ray
CT Scan
Ultrasound
MRI (Outpatient)
Pharmacy Services (inpatient)
Dietary Counseling
Rehabilitation Services (inpatient and outpatient)"

An interview with Staff #9 on 04/19/2013 at 9:30 AM confirmed she had reported the issues with the ultrasound machine to the Assistant Administrator.

An interview with the Assistant Administrator on 04/19/2013 at 2:30 PM confirmed she had reported the issues with the ultrasound machine to the Administrator and the Board of Directors.

An interview with the Administrator on 04/19/2013 at 3:30 PM (who was onsite during the exit conference) confirmed the ultrasound machine was out of service and had been since February 23, 2013. The Administrator is one of the two board members (the owner is the other board member).
VIOLATION: SUPERVISION OF EMERGENCY SERVICES Tag No: A1111
Based on record review and interview the facility failed to ensure that Emergency Department Services were under the supervision of a qualified member of the medical staff.

Findings:
A review of meetings titled, "Governing Board Meeting" dated July 31, 2012, revealed Physician #18 was reappointed to medical staff for only 6 months (which expired January 31, 2013) due to peer review issues that had transpired in the emergency room .

A review of record titled, "Medical Staff Bylaws; ARTICLE VII Corrective Actions, Section 3 -Automatic Suspension, Termination, or Reduction of Privileges, subsection-" revealed

"E. ACLS/ATLS Certification: If a Practitioner fails to maintain Advanced Cardiac Life Support certification, the Practitioner's privileges to attend to cardiac patients shall automatically be suspended until such time as certification is achieved. If a Practitioner fails to maintain Advanced Trauma Life Support certification, the Practitioner's privileges to act as Emergency Department Physician shall be automatically suspended until such time as ATLS certification is achieved. Action automatically imposed under this Section does not entitle the Practitioner to hearing and appeal under these bylaws. "

A review of Physician # 18's file revealed no documentation of Advanced Trauma Life Support (ATLS) certification found in the physician's file.

On 04/24/2013 at 12:20 PM in an interview with staff #4 (Director of Medical staff), revealed physician #18 privileges expired January 31, 2013. Staff #4 was asked has physician #18 had privileges suspended due to not meeting qualifications set by the medical staff bylaws; she stated "no."

On 04/24/2013 at 12:20 pm in an interview with staff #6 she stated "Physician #18 is what we call the Emergency Director, but all he really does is make out the emergency room physician schedule." Staff #6 was asked if the facility had a policy on what the emergency room Director's responsibilities were; she stated "we don't have a policy." Staff #6 was asked has physician #18 had privileges suspended due to not meeting qualifications set by the medical staff bylaws; she stated "no."

An interview with Administrator on 04/25/2013 at 3:30 PM (who was onsite during the exit conference) confirmed the facility did not have a Medical Director over the Emergency Department and Physician #18 needed to be reappointed by the Governing Board.