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 March 12, 2012
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation, record review and interview, the hospital did not have an effective governing body that was legally responsible for the conduct of the hospital. The hospital's Board of Directors did not provide the hospital's Governing Board with the authority to ensure that the hospital services provided complied with all applicable conditions of participation and standards as follows:

A. The governing body failed to follow the hospital's Governing Body rules and regulations in appointing a Chief Executive Officer (Administrator).(Cross refer to findings at A057, Chief Executive Officer);

B. The governing board failed to ensure that diagnostic laboratory services were available to meet the needs of the patients who were provided care in the hospital's emergency
department and/or admitted to the hospital. (Cross Refer to findings A0576, Laboratory
Services);

C. The governing board failed to ensure that the hospital had an effective ongoing hospital wide quality assessment performance improvement program. (Cross refer to findings at A0263, Quality Assurance and Performance Improvement.)
VIOLATION: CHIEF EXECUTIVE OFFICER Tag No: A0057
Based on interview with the hospital's "Owner / Board of Director" (Staff # 25) and 4 members of the Governing Board (Staff #2, Staff #4, Staff #12, and Staff #13) and review of the hospital document titled, " Rules and Regulations of the Governing Board ", the hospital's governing board failed to follow the governing board rules and regulations when "owner / Board of Director" appointed the hospital's chief executive officer
(Administrator) without the approval of the Governing Board.

Findings were:

1. Review of " Rules and Regulations of the Governing Board " revealed the following:
"Article IX, Administrator, Section 1. Appointment. The Board of Directors or its designee shall appoint a Administrator of the Hospital (referred to herein as the " Hospital Administrator " ) in accordance with such criteria as may be adopted
by the Board of Directors subject to approval by the Governing Board " .

2. Review of the document titled, " Memorandum " dated January 30, 2012 from the hospital "Owner/Board of Director" (Staff # 25), with the subject line, "Administrator", addressed to the medical staff and the hospital employees, revealed the following announcement: " Please welcome Mr. (Staff #1) as " Hospital ' s " new Administrator."

3. During the investigation, the survey team requested the "Governing Board Minutes" for the meetings conducted November 14, 2011 and February 28, 2012. The minutes were not provided to the surveyors to review during the investigation survey.

4. During a phone interview on 03/13/2012 at approximately 3:30PM, the surveyor asked Staff #25 if Staff #1 had been approved by the Governing Board. Staff #25 responded:
" Yes, (Staff #2) who serves as Chairman of the Governing Board had taken care of the approval of Staff #1 as the Administrator. "

5. An interview with the corporate Chief Financial Officer (Staff #2) who serves as Chairman of the Governing Board on 03/12/2012 at 3:00PM in the Administrator ' s office revealed Staff #1 was appointed and approved by Staff #25 as the Administrator. Staff #2 reported he had just met Staff #1 at the facility on 03/09/2012 and was not
present at the 02/28/2012 Governing Body Meeting . Staff #2 then confirmed that Staff #1 had been functioning as the Hospital Administrator effective 01/30/2012.

6. Based on interview, Staff #1 confirmed he had not met Staff #2 until 03/09/2012.

7. During an interview on 03/08/2012 at approximately 3:00PM, the survyeor asked Staff
# 4 if the new Administrator had been approved by the Governing Body. Staff #4 replied " No."

8. In an interview with Governing Board Member (Staff #12) on 03/12/2012 at 12:30PM in the Administrator ' s office, it was revealed that Staff #1 was present at the 02/28/2012 Governing Board Meeting Staff #12 was asked if the Governing Body approved Staff #1 as the Administrator, Staff #12 stated " No " .

9. Interview with Governing Board Member (Staff #13) on 03/12/2012 at 2:00PM revealed that Staff #13 was present at the 02/28/2012 Governing Board Meeting. The surveyor asked Staff #13 if the Governing Body approved Staff #1 as the Administrator. Staff #13 replied " No "
VIOLATION: QAPI Tag No: A0263
Based on document review and by interview, the hospital's governing body failed to develop, implement, or maintain an effective hospital wide quality assessment and performance improvement program: Findings were:

A. Based on document review and by interview, the following hospital departments did not report outcomes to the Quality Program:

1. Materials Management
2. Plant Operations,
3. Dietary, Housekeeping,
4. Medical Records,
5. Nursing,
6. Radiology,
7. Respiratory,
8. Pharmacy,
9. Laboratory,
11. Therapy Services,
12. Linen /Laundry, and
13. Surgery departments
(Refer to findings at A0265, QAPI Health Outcomes)

B. Based on document review and by interview, the hospital laboratory failed to select relevant quality indicators required to participate in the hospital's QAPI program. (Refer to findings at A0267, QAPI Quality Indicators)

C. Based on document review and interview, the hospital laboratory failed to collect and submit relevant laboratory data to the Quality Assurance
/Performance Improvement Committee which is required to participate in the hospital's QAPI program. (Refer to findings at A0273, Program Data)

D. Based on document review and interview, the hospital did not have an effective system in place to collect QAPI data from hospital departments with which to monitor the effectiveness and safety of services and quality of care provided. (Refer to findings at A0275, QAPI Quality of Care)

E. Based on review of Shelby Regional Medical Center Rules and Regulations of the "Governing Board Article VIII Governing Board Operational: Section 5. Performance Improvement (P1)", and by interview, the Governing Board was not granted authority by the hospital's Board of Directors to define, implement, and maintain an ongoing program for quality improvement. (Refer to findings at A0310, Executive Responsibilities)
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on record review and interview the facility failed to ensure Materials Management, Plant Operations, Dietary, Housekeeping, Medical Records, Nursing, Radiology, Respiratory, Pharmacy, Laboratory, Therapy Services, Linen /Laundry, and Surgery departments were reporting outcomes to the Quality Program.

Review of the Quality Assurance /Performance Improvement Meetings minutes dated November 23, 2011 and February 10, 2012 revealed no evidence that Materials Management, Plant Operations, Dietary, Housekeeping, Medical Records, Nursing, Radiology, Respiratory, Pharmacy, Laboratory, Physical Therapy, Linen /Laundry, and Surgery were reporting quality outcomes. Quality meetings were being held, but there was no documentation of actions that would resolve the problems found by the departments with the data collected by the departments to promote healthy outcomes for patient care and safety.

Interview with the Staff #6 on 3/9/2012 at 2:30 PM in the survey office confirmed there were no quality outcomes being reported to the Performance Improvement Committee from the departments.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on record review and interview the Laboratory department failed to monitor, measure, analyze, and track quality indicators and /or occurrences that have occurred in the department and report to the Quality Assurance /Performance Improvement committee.

Review of records titled "Quality Assurance /Performance Improvement Meetings" dated November 23, 2011 and February 10, 2012 revealed no evidence the Laboratory department had chosen indicators (specific to the department) to report to Quality Assurance /Performance Improvement Committee.

Interview with the Staff #6 on 3/9/2012 at 2:30 PM in the survey office confirmed the Laboratory had not chosen indicators and/or reported quality patient care issues or occurrences to the Quality Assurance /Performance Improvement Committee. Staff #6 also confirmed the Lab Department had never submitted any type of Quality reports to the committee.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on record review and interview the Laboratory department failed to monitor, measure, analyze, and track quality indicators and /or occurrences that have occurred in the department and report to the Quality Assurance /Performance Improvement committee.

Review of records titled "Quality Assurance /Performance Improvement Meetings" dated November 23, 2011 and February 10, 2012 revealed no evidence the Laboratory department had chosen indicators (specific to the department) to report to Quality Assurance /Performance Improvement Committee.

Interview with the Staff #6 on 3/9/2012 at 2:30 PM in the survey office confirmed the Laboratory had not chosen indicators and/or reported quality patient care issues or occurrences to the Quality Assurance /Performance Improvement Committee. Staff #6 also confirmed the Lab Department had never submitted any type of Quality reports to the committee.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on record review and interview the Laboratory department failed to collect data and submit to the Quality Assurance /Performance Improvement Committee.

Review of records titled "Quality Assurance /Performance Improvement Meetings" dated November 23, 2011 and February 10, 2012 revealed no evidence the Laboratory department had collected any type of data related to patient care issues or occurrences to the Quality Assurance /Performance Improvement Committee.

Interview with the Staff #6 on 3/9/2012 at 2:30 PM in the survey office confirmed there was no data being reported to the Quality Assurance /Performance Improvement Committee from the Laboratory department.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on record review and interview the Board of Directors failed to provide the Governing Board with the authority to identify opportunities for improvement and changes to improve the quality of patient care in the facility.

Review of the Quality Assurance /Performance Improvement Meetings minutes dated November 23, 2011 and February 10, 2012 revealed no evidence that the following departments reported quality improvement from the data that had been collected:

1. Materials Management,
2.Plant Operations,
3.Dietary, Housekeeping,
4.Medical Records,
5. Nursing, Radiology,
6.Respiratory,
7.Pharmacy,
8. Surgery,
9. Laboratory,
10.Physical Therapy,
11.Linen /Laundry Services

Quality meetings were held, but there were no documented action plans to resolve problems and promote healthy outcomes for patient care and safety identified by the departments that collected data were available for review.

Interview with the Staff #6 on 3/9/2012 at 2:30 PM in the survey office confirmed there were no quality improvements reported to the Performance Improvement Committee by the hospital departments and were not reviewed by the Governing Board.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based record review and interview the Board of Directors failed to provide the Governing Board with the authority to ensure that an ongoing program for hospital wide quality improvement was defined, implemented, and maintained.

Finding were:

1. Review of the Shelby Regional Medical Center Rules and Regulations of the Governing Board Article VIII Governing Board Operational:
Section 5. Performance Improvement (P1).
"The Governing Board shall require the Medical Staff and staffs of the Hospital departments/services to implement and report on the activities and mechanisms for monitoring and evaluating the quality of patient care, for identifying opportunities to improve patient care, and for identifying and resolving problems. The Governing Board, through the Hospital Administrator, shall support these activities and mechanisms. The Governing Board shall provide for resources and support systems for the quality assessment and improvement and risk management functions related to patient care and safety. The Governing Board shall consider and, if necessary, act upon the results reported from P1 activities, which activities shall strive to satisfy the following objectives: (i) quality patient care provided by members of the medical and allied professional staffs, employees of the Hospital and all others who provide patient care services at this Hospital, (ii) use of planned and systematic procedures to objectively assess the quality of care provided, (iii) implementation of corrective action when problems or opportunities for improvement are identified, and (iv) the provision of one level of patient care throughout the Hospital."

2. Review of records titled Governing Board Meeting revealed no documentation of any Governing Board meetings at which expectations from implemention of the Quality
Assurance/Performance Improvement program at the facility were discussed.

3. Interview with the Staff #4 on 3/12/2012 at 2:30 PM in the survey office confirmed the document reviewed by the surveyor was the notebook that contained the Governing Board Meetings. The notebook contained no documentation of Quality Assurance/Performance Improvement program activities discussed at the Governing Board Meetings. Surveyor was informed that meetings at which the quality improvement of patient care was discussed occurred on November 23, 2011 and February 28, 2012.
VIOLATION: LABORATORY SERVICES Tag No: A0576
Based on document review and by interview, the hospital failed to maintain or have available, adequate laboratory services to meet the needs of patients.

Findings were:

A. Based on document review and by interview, the hospital failed to have laboratory services available either directly or through a contractual agreement with a certified laboratory that meets part 493 of this chapter (1) lack of appropriate reagents required to perform ordered diagnostic testing;
(2.) malfunctioning analyzers requiring repair and
(3.) instructions from hospital Owner / Board of Directors to not refer CKMB testing to other laboratories. (Refer to findings at A0582, Adequacy of Laboratory Services)

B. Based on document review and by interview, results of diagnostic tests ordered by emergency room physicians deemed necessary for assessing the cardiac condition of patients presenting to the Emergency Department with cardiac related symptoms were not available in accordance with the laboratory policy and procedure. (Refer to findings at A0583, Emergency Laboratory Services)

C. Based on document review and by interview the facility failed to accurately perform laboratory tests ordered by the attending physician citing 10 of 39 medical records reviewed. (Refer to findings at A584, Written Description of Services)
VIOLATION: ADEQUACY OF LABORATORY SERVICES Tag No: A0582
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview the facility failed to

A. ensure emergency laboratory services were available to meet the needs of the patients who were provided care at the facility emergency room and/or as an in-patient. Citing 18 of 39 patient medical records reviewed. (Medical records reviewed for patient #1 thru #39).

B. The facility also failed to ensure the Laboratory department had a contract with the hospital where patient lab specimens had been taken to obtain lab results.

A. Findings include: Review of medical records for patients #1 thru #39 was conducted on 3/8/2012, 3/9/2012, and 3/12/2012.

Review of medical record for patient #1 revealed on 2/28/2012 patient was admitted to room 103 A . Review of Physician Orders dated 2/28/2012 at 3:25 pm revealed order for Basic Metabolic Panel (BMP) to be drawn in am. Review of BMP results dated 2/29/2012 revealed at 12:15 pm a notation written per staff #23, "Where is the rest of my BMP? Lytes??". Electrolytes received and reviewed per staff #23 on 2/29/2012 at 1:05 pm. No documentation found in medical record to explain missing electrolyte panel results. Physician order dated 3/1/2012 written at 8:55 am revealed order for STAT Creatine Kinase (CK), Creatine Kinase Myocardial Band (CKMB), and Troponin. Lab results dated 3/1/2012 and printed at 9:52 am revealed results for CK and Troponin. No results found for CKMB in medical record.
Review of medical record for patient #2 revealed patient arrived to emergency room on [DATE] at 6:15 pm with complaint of (c/o) vomiting and diarrhea. Review of orders written per Physician Assistant (PA) revealed order for following labwork: Complete Blood Count (CBC), CK, CKMB, Comprehensive Metabolic Panel (CMP), Troponin, and Urinalysis (UA). Results found for all labwork ordered with exception to the CKMB.
Review of medical record for patient #3 revealed patient arrived to emergency room on [DATE] at 10:15 pm with c/o chest pain radiating to both arms. Review of orders written per emergency room (ER) physician revealed order for following labwork: Pro-Brain natriuretic peptide (Pro-BNP), CBC, CK, CKMB, Prothrombin Time (PT), Partial thromboplastin time (PTT), and Troponin. Results found for all labwork with exception to CKMB, PT, and PTT.
Review of medical record for patient #9 revealed the patient arrived to emergency room on [DATE] at 6:15 pm with c/o heart palpitations. Review of orders written per ER physician revealed order for following labwork: B-NP, CBC, CK, CKMB, CMP, and Troponin. Results found for all labwork ordered with exception to the CKMB.
Review of medical record for patient #10 revealed the patient arrived to emergency room on [DATE] at 4:21 pm with c/o "he stopped breathing". Review of orders written per ER physician revealed order for following labwork: Blood Cultures x2, CBC and CMP. Results found for all labwork ordered with exception to the Blood Cultures x2. No documentation found to confirm Blood Cultures were collected and/or result found on chart.
Review of medical record for patient #19 revealed the patient arrived to emergency room on [DATE] at 8:23 pm with c/o seizure. Review of orders written per ER physician revealed order for following labwork: CBC, CK, CKMB, PT, PTT, and Troponin. Results found for all labwork ordered with exception of CKMB, PT, and PTT. No documentation found to confirm these labs were drawn as ordered.
Review of medical record for patient #22 revealed the patient admitted to room 103 B on 2/27/2012. Admit orders reveal Diagnostic Studies ordered as follows: CBC, Fasting Blood Sugar (FBS), CK, CKMB every 6 hours x3, Troponin, BNP, Blood Cultures X2, and UA. Results found for all labwork ordered with exception of CKMB every 6 hours x3. No documentation found to confirm this labwork was drawn as ordered.
Review of medical record for patient patient #24 revealed the patient arrived to emergency room on [DATE] at 1:39 am with c/o shortness of breath all day. Review of orders written per ER physician revealed order for following labwork: CBC, Pro-BNP, CK, CKMB, PT, PTT, and Troponin. Results found for all labwork ordered with exception of CKMB, PT, and PTT. No documentation found to confirm these labs were drawn as ordered.
Review of medical record for patient #25 revealed the patient arrived to the emergency room on [DATE] at 3:05 pm with c/o bilateral arm pain-feels like I'm having a heart attack. Review of orders written per ER physician revealed order for following labwork: CBC, Pro-BNP, CK, CKMB, PT, and Troponin. Results found for all labwork ordered with exception of CKMB. No documentation found to confirm CKMB was drawn as ordered.
Review of medical record for patient #26 revealed the patient arrived to the emergency room on [DATE] at 11:19 am with c/o shortness of breath and sharp pain. Review of orders written per ER physician revealed order for following labwork: Amylase, CBC, CK, CKMB, CMP, Lipase, and Troponin. Results found for all labwork ordered with exception of CKMB. No documentation found to confirm CKMB was drawn as ordered.
Review of medical record for patient #27 revealed the patient arrived to the emergency room on [DATE] at 8:00 pm with c/o chest pain x30 minutes. Review of orders written per ER physician revealed order for following labwork: Amylase, CBC, CK, CKMB, CMP, Lipase, and UA. Results found for all labwork ordered with exception of CKMB. No documentation found to confirm CKMB was drawn as ordered.
Review of medical record for patient #28 revealed the patient arrived to the emergency room on [DATE] at 12:20 am with c/o chest pain. Review of orders written per ER physician revealed order for following labwork: CBC, Pro-BNP, CK, CKMB, CMP, PT, PTT, Troponin, and UA. Results found for all labwork ordered with exception of CKMB, PT, PTT, and UA. No documentation found to confirm these labs were drawn and/or collected as ordered.
Review of medical record for patient #29 revealed the patient arrived to the emergency room on [DATE] at 12:09 pm with c/o syncopal episode. Review of orders written per ER physician revealed order for following labwork: CBC, CK, CKMB, CMP, and Troponin. Results found for all labwork ordered with exception of CKMB. No documentation found to confirm CKMB was drawn as ordered.
Review of medical record for patient #31 revealed the patient arrived to the emergency room on [DATE] with c/o involved in motor vehicle accident. Review of orders written per ER physician revealed order for following labwork: amylase, CBC, Pro-BNP, CK, CKMB, CMP, PT, PTT, Troponin, and UA. Results found for all labwork ordered with exception of PT and PTT. No documentation found to confirm these labs were drawn and/or collected as ordered.
Review of medical record for patient #33 revealed the patient arrived to the emergency room on [DATE] at 7:05 am with c/o I need my head checked out. Review of orders written per ER physician revealed order for following labwork: CBC, BNP, CK, CKMB, CMP, PT, PTT, Troponin, Lipase, and UA. Results found for all labwork ordered with exception of PT and PTT. No documentation found to confirm these labs were drawn and/or collected as ordered.
Review of medical record for patient #34 revealed the patient arrived to the emergency room on [DATE] at 3:40 pm with c/o shortness of breath and hands tingling. Review of orders written per ER physician revealed order for following labwork: CBC, BNP, CK, CKMB, CMP, FBS, D-Dimer, INR, PT, PTT, Troponin, and UA. Results found for all labwork ordered with exception of PTT. No documentation found to confirm these labs were drawn and/or collected as ordered.
Review of medical record for patient #37 revealed the patient arrived to the emergency room on [DATE] at 10:15 pm with c/o chest pain. Review of orders written per ER physician revealed order for following labwork: CBC, Pro-BNP, CK, CKMB, CMP, PT, PTT, and Troponin. Results found for all labwork ordered with exception of CKMB, PT and PTT. No documentation found to confirm these labs were drawn and/or collected as ordered. Review of Physician order written 2/28/2012 revealed order written for patient admit including order for labwork: CK, CKMB, Troponin every 6 hours x3. No results for CKMB that was ordered on [DATE] and/or 2/28/2012 found on chart. No results found for third set of cardiac enzymes ordered every 6 hours x3.
Review of medical record for patient #38 revealed the patient arrive to the emergency room on [DATE] at 7:11 pm with c/o chest pain x1 hour. Review of orders written per ER physician revealed order for following labwork: CBC, BNP, CK, CKMB, CMP, and UA. Results found for all labwork ordered with exception of CKMB. No documentation found to confirm these labs were drawn and/or collected as ordered.
Shelby Regional Medical Center- Laboratory Policy manual
Reviewed date: 11/12/2011 Policy Number: Lab 1.17 Stat Laboratory Tests and Results
I. Policy
Laboratory tests to be performed on an emergency basis STAT must be written upon the request of a member of the medical staff, those physicians, and nurse practitioner of the medical staff who have authorization to request such support services to the extent permitted by law, and other person authorized by the hospital and licensed to engage in direct treatment of patients.
II. Procedure
1. STAT laboratory tests are to be ordered due to clinical necessity of test result information. Clinical necessity includes, but may not be limited to:
A. Tests results necessary in establishing a diagnosis for the patient, the delay of which may result in lack of the provision of necessary treatment requited to stabilize the patient's physical condition.
B. Test results necessary in the determination of implementation or revision of treatment for the patient, the delay of which may result in lack of the provision of treatment required to stabilize the patient's physical condition.
2. The following laboratory test have been established for STAT ordering purposes:
A. CBC with differential
B. BMP
C. Cardiac Profile
D. BNP
E. D-Dimer
F. CMP
G. Individual Electrolyte levels
H. Liver profile
I. Known toxic medication levels(phenytoin levels, etc.)
J. Urine drug screen
K. Strep Test
L. Influenza screening
M. RSV
3. Those individuals approved to order laboratory tests may request any laboratory test that is able to be returned on a STAT basis, as a STAT return, based on his/her clinical judgement- if STAT return is expected to benefit the care of the patient. However, these individuals are encouraged to follow the necessity rationale as outlined in this policy. Unnecessary ordering of STAT laboratory testing will be monitored as a performance improvement process measure by the Clinical laboratory Department.
A. All orders for STAT laboratory testing will be forwarded to the Clinical Laboratory immediately upon receipt of the order.
B. The Clinical Laboratory will obtain the appropriate patient specimen if this has not been obtained by Nursing, physician or other clinical staff, within 15 minutes of receipt of STAT request.
C. All STAT request result will be forwarded tot he requesting unit with in one hour, after receipt of STAT request by the Clinical Laboratory.
A phone interview with Staff #14 on 03/09/2012 at approximately 10:00AM with another surveyor present, and lab staff #16, #21, and #33 present was conducted. Staff #14 identified himself as the lab supervisor. Staff #14 was asked if he was aware there were 64 unprocessed tubes of blood (specimens) being held in the lab refrigerator with physicians ' orders requesting the cardiac lab test (CKMB ' s). Staff #14 responded, " No. " Staff #14 was asked if he had instructed the lab staff to ignore the physicians' orders and not process the lab specimens for CK-MB. Staff #14 responded "No." Staff #14 was told there were multiple interviews stating the Staff #14 had instructed lab staff to ignore the physician's order and not process the CKMB's. Staff #14 changed his previous answers given in the interview and reported he was aware of the unprocessed labs and he had instructed staff to ignore the physicians' orders. Staff #14 reported he was instructed by Staff #1 and Staff #25 to ignore the physicians' orders and not process the CKMB's.





B. An interview with staff # 16 on 3/8/2012 at 12:00 PM revealed patients' specimens were being taken to the hospital which is 30 miles away, when reagents are unavailable to test the patient's blood.

An interview with staff #4 on 3/12/2012 at 10:00 AM confirmed the hospital did not have a contract with the hospital where patient lab specimens had been taken to obtain test results.
VIOLATION: EMERGENCY LABORATORY SERVICES Tag No: A0583
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review,observation, and interview the facility failed to

A. ensure emergency laboratory services were available to meet the needs of the patients who were provided care at the facility emergency room and/or after admission as an in-patient. Citing 18 of 39 patient medical records reviewed. (Medical records reviewed for patient #1 thru #39.)

B. The facility laboratory also failed to complete lab test ordered by the physicians to meet the needs of the patients who were provided care at the emergency room and/or admitted to the hospital.

Findings include: Review of medical records for patients #1 thru #39 was conducted on 3/8/2012, 3/9/2012, and 3/12/2012.

Review of medical record for patient #1 revealed on 2/28/2012 patient was admitted to room 103 A . Review of Physician Orders dated 2/28/2012 at 3:25 pm revealed order for Basic Metabolic Panel (BMP) to be drawn in am. Review of BMP results dated 2/29/2012 revealed at 12:15 pm a notation written per staff #23, "Where is the rest of my BMP? Lytes??". Electrolytes received and reviewed per staff #23 on 2/29/2012 at 1:05 pm. No documentation found in medical record to explain missing electrolyte panel results. Physician order dated 3/1/2012 written at 8:55 am revealed order for STAT Creatine Kinase (CK), Creatine Kinase Myocardial Band (CKMB), and Troponin. Lab results dated 3/1/2012 and printed at 9:52 am revealed results for CK and Troponin. No results found for CKMB in medical record.
Review of medical record for patient #2 revealed patient arrived to emergency room on [DATE] at 6:15 pm with complaint of (c/o) vomiting and diarrhea. Review of orders written per Physician Assistant (PA) revealed order for following labwork: Complete Blood Count (CBC), CK, CKMB, Comprehensive Metabolic Panel (CMP), Troponin, and Urinalysis (UA). Results found for all labwork ordered with exception to the CKMB.
Review of medical record for patient #3 revealed patient arrived to emergency room on [DATE] at 10:15 pm with c/o chest pain radiating to both arms. Review of orders written per emergency room (ER) physician revealed order for following labwork: Pro-Brain natriuretic peptide (Pro-BNP), CBC, CK, CKMB, Prothrombin Time (PT), Partial thromboplastin time (PTT), and Troponin. Results found for all lab work with exception to CKMB, PT, and PTT.
Review of medical record for patient #9 revealed the patient arrived to emergency room on [DATE] at 6:15 pm with c/o heart palpitations. Review of orders written per ER physician revealed order for following labwork: B-NP, CBC, CK, CKMB, CMP, and Troponin. Results found for all labwork ordered with exception to the CKMB.
Review of medical record for patient #10 revealed the patient arrived to emergency room on [DATE] at 4:21 pm with c/o "he stopped breathing". Review of orders written per ER physician revealed order for following labwork: Blood Cultures x2, CBC and CMP. Results found for all labwork ordered with exception to the Blood Cultures x2. No documentation found to confirm Blood Cultures were collected and/or result found on chart.
Review of medical record for patient #19 revealed the patient arrived to emergency room on [DATE] at 8:23 pm with c/o seizure. Review of orders written per ER physician revealed order for following labwork: CBC, CK, CKMB, PT, PTT, and Troponin. Results found for all labwork ordered with exception of CKMB, PT, and PTT. No documentation found to confirm these labs were drawn as ordered.
Review of medical record for patient #22 revealed the patient admitted to room 103 B on 2/27/2012. Admit orders reveal Diagnostic Studies ordered as follows: CBC, Fasting Blood Sugar (FBS), CK, CKMB every 6 hours x3, Troponin, BNP, Blood Cultures X2, and UA. Results found for all labwork ordered with exception of CKMB every 6 hours x3. No documentation found to confirm this labwork was drawn as ordered.
Review of medical record for patient patient #24 revealed the patient arrived to emergency room on [DATE] at 1:39 am with c/o shortness of breath all day. Review of orders written per ER physician revealed order for following labwork: CBC, Pro-BNP, CK, CKMB, PT, PTT, and Troponin. Results found for all labwork ordered with exception of CKMB, PT, and PTT. No documentation found to confirm these labs were drawn as ordered.
Review of medical record for patient #25 revealed the patient arrived to the emergency room on [DATE] at 3:05 pm with c/o bilateral arm pain-feels like I'm having a heart attack. Review of orders written per ER physician revealed order for following labwork: CBC, Pro-BNP, CK, CKMB, PT, and Troponin. Results found for all labwork ordered with exception of CKMB. No documentation found to confirm CKMB was drawn as ordered.
Review of medical record for patient #26 revealed the patient arrived to the emergency room on [DATE] at 11:19 am with c/o shortness of breath and sharp pain. Review of orders written per ER physician revealed order for following labwork: Amylase, CBC, CK, CKMB, CMP, Lipase, and Troponin. Results found for all labwork ordered with exception of CKMB. No documentation found to confirm CKMB was drawn as ordered.
Review of medical record for patient #27 revealed the patient arrived to the emergency room on [DATE] at 8:00 pm with c/o chest pain x30 minutes. Review of orders written per ER physician revealed order for following labwork: Amylase, CBC, CK, CKMB, CMP, Lipase, and UA. Results found for all labwork ordered with exception of CKMB. No documentation found to confirm CKMB was drawn as ordered.
Review of medical record for patient #28 revealed the patient arrived to the emergency room on [DATE] at 12:20 am with c/o chest pain. Review of orders written per ER physician revealed order for following labwork: CBC, Pro-BNP, CK, CKMB, CMP, PT, PTT, Troponin, and UA. Results found for all labwork ordered with exception of CKMB, PT, PTT, and UA. No documentation found to confirm these labs were drawn and/or collected as ordered.
Review of medical record for patient #29 revealed the patient arrived to the emergency room on [DATE] at 12:09 pm with c/o syncopal episode. Review of orders written per ER physician revealed order for following labwork: CBC, CK, CKMB, CMP, and Troponin. Results found for all labwork ordered with exception of CKMB. No documentation found to confirm CKMB was drawn as ordered.
Review of medical record for patient #31 revealed the patient arrived to the emergency room on [DATE] with c/o involved in motor vehicle accident. Review of orders written per ER physician revealed order for following labwork: amylase, CBC, Pro-BNP, CK, CKMB, CMP, PT, PTT, Troponin, and UA. Results found for all labwork ordered with exception of PT and PTT. No documentation found to confirm these labs were drawn and/or collected as ordered.
Review of medical record for patient #33 revealed the patient arrived to the emergency room on [DATE] at 7:05 am with c/o I need my head checked out. Review of orders written per ER physician revealed order for following labwork: CBC, BNP, CK, CKMB, CMP, PT, PTT, Troponin, Lipase, and UA. Results found for all labwork ordered with exception of PT and PTT. No documentation found to confirm these labs were drawn and/or collected as ordered.
Review of medical record for patient #34 revealed the patient arrived to the emergency room on [DATE] at 3:40 pm with c/o shortness of breath and hands tingling. Review of orders written per ER physician revealed order for following labwork: CBC, BNP, CK, CKMB, CMP, FBS, D-Dimer, INR, PT, PTT, Troponin, and UA. Results found for all labwork ordered with exception of PTT. No documentation found to confirm these labs were drawn and/or collected as ordered.
Review of medical record for patient #37 revealed the patient arrived to the emergency room on [DATE] at 10:15 pm with c/o chest pain. Review of orders written per ER physician revealed order for following labwork: CBC, Pro-BNP, CK, CKMB, CMP, PT, PTT, and Troponin. Results found for all labwork ordered with exception of CKMB, PT and PTT. No documentation found to confirm these labs were drawn and/or collected as ordered. Review of Physician order written 2/28/2012 revealed order written for patient admit including order for labwork: CK, CKMB, Troponin every 6 hours x3. No results for CKMB that was ordered on [DATE] and/or 2/28/2012 found on chart. No results found for third set of cardiac enzymes ordered every 6 hours x3.
Review of medical record for patient #38 revealed the patient arrive to the emergency room on [DATE] at 7:11 pm with c/o chest pain x1 hour. Review of orders written per ER physician revealed order for following labwork: CBC, BNP, CK, CKMB, CMP, and UA. Results found for all labwork ordered with exception of CKMB. No documentation found to confirm these labs were drawn and/or collected as ordered.
Shelby Regional Medical Center- Laboratory Policy manual
Reviewed date: 11/12/2011 Policy Number: Lab 1.17 Stat Laboratory Tests and Results
I. Policy
Laboratory tests to be performed on an emergency basis STAT must be written upon the request of a member of the medical staff, those physicians, and nurse practitioner of the medical staff who have authorization to request such support services to the extent permitted by law, and other person authorized by the hospital and licensed to engage in direct treatment of patients.
II. Procedure
1. STAT laboratory tests are to be ordered due to clinical necessity of test result information. Clinical necessity includes, but may not be limited to:
A. Tests results necessary in establishing a diagnosis for the patient, the delay of which may result in lack of the provision of necessary treatment requited to stabilize the patient's physical condition.
B. Test results necessary in the determination of implementation or revision of treatment for the patient, the delay of which may result in lack of the provision of treatment required to stabilize the patient's physical condition.
2. The following laboratory test have been established for STAT ordering purposes:
A. CBC with differential
B. BMP
C. Cardiac Profile
D. BNP
E. D-Dimer
F. CMP
G. Individual Electrolyte levels
H. Liver profile
I. Known toxic medication levels(phenytoin levels, etc.)
J. Urine drug screen
K. Strep Test
L. Influenza screening
M. RSV
3. Those individuals approved to order laboratory tests may request any laboratory test that is able to be returned on a STAT basis, as a STAT return, based on his/her clinical judgement- if STAT return is expected to benefit the care of the patient. However, these individuals are encouraged to follow the necessity rationale as outlined in this policy. Unnecessary ordering of STAT laboratory testing will be monitored as a performance improvement process measure by the Clinical laboratory Department.
A. All orders for STAT laboratory testing will be forwarded to the Clinical Laboratory immediately upon receipt of the order.
B. The Clinical Laboratory will obtain the appropriate patient specimen if this has not been obtained by Nursing, physician or other clinical staff, within 15 minutes of receipt of STAT request.
C. All STAT request result will be forwarded tot he requesting unit with in one hour, after receipt of STAT request by the Clinical Laboratory.
A phone interview with Staff #14 on 03/09/2012 at approximately 10:00AM with another surveyor present, and lab staff #16, #21, and #33 present was conducted. Staff #14 identified himself as the lab supervisor. Staff #14 was asked if he was aware there were 64 unprocessed tubes of blood (specimens) being held in the lab refrigerator with physicians ' orders requesting the cardiac lab test (CKMB ' s). Staff #14 responded, " No. " Staff #14 was asked if he had instructed the lab staff to ignore the physicians' orders and not process the lab specimens for CK-MB. Staff #14 responded "No." Staff #14 was told there were multiple interviews stating the Staff #14 had instructed lab staff to ignore the physician's order and not process the CKMB's. Staff #14 changed his previous answers given in the interview and reported he was aware of the unprocessed labs and he had instructed staff to ignore the physicians' orders. Staff #14 reported he was instructed by Staff #1 and Staff #25 to ignore the physicians' orders and not process the CKMB's.





B. During the tour on 3/8/2012 of the Lab and the emergency room , it was reported by staff #5, #6, #7, #17, #19, #21, # 22, and #27, the facility does not have the capabilities of testing PTT (partial thromboplastin time is a blood test that looks at how long it takes for blood to clot. It can help tell if patient has a bleeding or clotting problem.) In the emergency room , surveyor observed a posting that read "LAB; ER Trauma Panel consist of CBC, UA, UDS, ETOH, AMYLASE, CMP, CKMB, TROPONIN, PT, PTT, SERUM PREGANCY." On 3/12/2012 at 9:00 AM confirmed with the emergency room Physician and ER staff nurses #6, #7, and #8 the lab specimens are drawn, but not all lab test will be completed.

Staff members #5, #6, #7, #17, #19, #21, # 22, and #27, interviewed during the tour at various times confirmed the PTT's are ordered and drawn, but the facility does not have the capabilities of running the PTT test.

On 3/8/2012 at 12:00 PM in the Lab refrigerator observed 34 patients' specimen in a rack (not frozen) (64 total specimens). When questioned Lab staff members #17, # 19, and #21, (present at the time specimens were observed) what are these specimens for? The answer was we are waiting for reagent supplies to run CK-MB (CKMB- Creatine Kinase Myocardial Band) (Creatine phosphokinase MB isoenzyme Cardiology A CK isoenzyme usually in acute MI) (CK-MB levels, along with total CK are tested in persons who have chest pain to diagnose whether they have had a heart attack, since a high total CK could indicate damage to either the heart or other muscles, CK-MB helps to distinguish between these two sources.) Observed the 39 patient blood tubes were from 12/16/2011 thru 3/5/2012. During the interview with the lab members it was discussed that reagents had arrived in the facility on 3/1/2012 and specimens were still present in the refrigerator, each lab staff reported we have to save the reagents for the ER patients (who are more critical) because we will run out of reagent supplies again by the time the weekend arrives. Staff members reported staff #14 instructed them not to send CK-MB's out to the other labs. Posted on the computer in the lab was a note *Note* No Send out on CK-MB's. The staff members reported the blood tubes still present are CK-MB ' s the physicians have ordered when the patients were admitted to the hospital and some of the specimens are from the emergency room admits when the reagents were not available. Lab staff #17, # 19, and #21 reported, if the emergency room physician insisted on having a CK-MB test, then a staff member will take the serum to the hospital which is 30 miles away by courier. Lab staff members reported the main chemistry machine has been broken for three months.

In the emergency room , surveyor observed a posting that read "LAB; Cardiac Work- Up consist of CMP, CBC, CK, CK-MB, TROPONIN, BNP." On 3/12/2012 at 9:00 AM confirmed with the emergency room Physician and ER staff nurses #6, #7, and #8 the lab specimens are drawn, but not all lab test will be completed.

An interview with ER staff #7 on 3/12/2012 at 9:00 AM stated "when the emergency room shift starts, I call the lab to see what tests are available for the day."
VIOLATION: WRITTEN DESCRIPTION OF SERVICES Tag No: A0584
Based on record review and interview the facility failed to accurately perform laboratory tests ordered by the attending physician citing 10 of 39 medical records reviewed. (Reviewed medical records for patients #1 thru #39)

Findings include:
Review of medical records for patients #1 thru #39 were conducted on 3/8/2012, 3/9/2012, and 3/12/2012.

Review of medical record for patient #5 revealed on 3/6/2012 at 3:17 pm blood was collected and a Pro-BNP was analyzed by the lab. Documentation of lab results found in the medical record. No documentation found to verify the Pro-BNP was ordered by the physician.

Review of medical record for patient #6 revealed on 3/6/2012 at 9:50 pm blood was collected and a Troponin and Pro-BNP was analyzed by the lab. Documentation of the lab results found in the medical record. No documentation found to verify the Troponin and Pro-BNP were ordered by the physician.

Review of medical record for patient #12 revealed on 2/25/2012 at 3:30 am blood was collected and tests for H. Influenza A was analyzed by the laboratory personnel. Documentation of lab results found on the chart. No documentation found to verify the H. Influenza A was ordered by the physician.

Review of medical record for patient #21 revealed on 3/3/2012 at 5:00 pm blood was collected an a BMP was analyzed by the lab. Documentation of the lab results found in the medical record. No documentation found to verify the BNP was ordered by the physician.

Review of medical record for patient #22 revealed on 2/27/2012 at 4:52 pm urine was collected and sent to the lab for a urinalysis. Documentation of the lab results found in the medical record. No documentation found to verify the urinalysis was ordered by the physician.

Review of medical record for patient #23 revealed on 2/17/2012 at 11:50 am blood was collected and the following lab test were done: CMP, CBC, CK, Pro-BNP, and Troponin. Documentation of results found in the medical record. No documentation found to verify the labwork was ordered by the physician.

Review of medical record for patient #28 revealed on 2/22/2012 at 12:30 am specimen for H. Pylori was collected and analyzed by lab personnel. Documentation of lab results found in the medical record. No documentation found to verify the lab test for H. Pylori was ordered by the physician.

Review of medical record for patient #36 revealed on 2/29/2012 at 4:28 pm urine was collected and sent to the lab for a urinalysis. Documentation of the lab results found in the medical record. No documentation found to verify the urinalysis was ordered by the physician.

Review of medical record for patient #38 revealed on 3/5/2012 at 4:45 am urine was collected and sent to the lab for a urinalysis. Documentation of the lab results found in the medical record. No documentation found to verify the urinalysis was ordered by the physician.

Review of medical record for patient #39 revealed on 2/6/2012 at 2:20 pm blood was collected and sent to the lab for a potassium level. Documentation of the lab results found in the medical record. No documentation found to verify the potassium level was ordered by the physician.

Interview with staff #6 on 3/9/2012 at 11:00 am confirmed the the labwork done on the patients did not have an documentation of an order in the medical record.


Abbreviations and Definitions:
BMP- Basic Metabolic Panel
BNP- B-Type Natriuretic Peptide (The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable.)
CBC- Complete Blood Count

CK-Creatine Kinase
CKMB- Creatine Kinase Myocardial Band (Creatine phosphokinase MB isoenzyme Cardiology A CK isoenzyme usually ? in acute MI) (CK-MB levels, along with total CK </understanding/analytes/ck>, are tested in persons who have chest pain to diagnose whether they have had a heart attack </understanding/conditions/heart-attack>. Since a high total CK could indicate damage to either the heart or other muscles, CK-MB helps to distinguish between these two sources.)
CMP- Comprehensive Metabolic Panel.
D-Dimer- D dimer is a protein fragment that is found in the blood after someone has had a blood clot
FBS- Fasting Blood Sugar
Pro-BNP (B-type natriuretic peptide (BNP) and amino-terminal pro-BNP (NT-proBNP) plasma levels are commonly high at the early phase of septic shock and have been suggested to be prognostic markers for this condition)
PT- Prothrombin Time (A blood clotting test)
PTT- Partial thromboplastin time (blood test that measures the time it takes your blood to clot)
UA- Urinalysis (Urinalysis is the physical, chemical, and microscopic examination of urine)
Troponin- (Troponin level is a type of blood test used to check for damage to the heart)
Shelby Regional Medical Center: Laboratory Policy Manual
Reviewed date: 11/12/2011 Policy number 1.1
Mission
The mission of the Clinical Laboratory of Shelby Regional Medical Center is to provide the highest quality of care and superior customer service. This well be achieved through:
1.0 Ongoing development, implementation, and evaluation of quality control methods appropriate to each department.
2.0 Testing performed efficiently and accurately.
3.0 Continuous evaluation and revision of current laboratory procedures.
Vision
The Clinical Laboratory at Shelby Regional Medical Center will provide the highest quality of service to the hospital's medical staff by encouraging it's personnel to continuously update its educational and laboratory experience and to utilize only precise and accurate methods and equipment. The Clinical Laboratory will always provide the medical staff with competent reliable laboratory testing.
Objective
Main Objective:
1.0 To efficiently and accurately perform the test ordered by the attending physician.
Continuing Objective
1.0 Ongoing development, implementation and evaluation of quality control methods appropriate to each department.
2.0 Continuous evaluation and revision of current laboratory procedures; introduction of new procedures as they are available and adaptable tot he needs of the hospital.
3.0 Clinical Laboratory personnel will participate in continuing education program in order to update their knowledge of laboratory theory and practice.
4.0 Encourage laboratory personnel to hold membership in MLT/MT-AMT, ASCP, and other professional organizations.
VIOLATION: MAINTENANCE OF PHYSICAL PLANT Tag No: A0701
Based on observation, record review, and interview the facility failed to repair a collapsing floor and malfunctioning grease trap in the dietary department. This has the potential for harm to all dietary employees working in the kitchen area with risk for injury and exposure to infectious waste.

Findings include:
Touring the dietary department on 3/8/2012 at 12:00 noon revealed on entrance into the kitchen area the grease trap was observed. The metal plate was in place, but all screws to secure the plate to the floor were missing. The floor surrounding the grease trap appeared to slope slightly the entire circumference of the grease trap.

Interview with staff #32 on 3/8/2012 at 12:15 pm in the dietary department confirmed the grease trap was not properly secured to the floor. Advised that the last incident of the grease trap backing up and flooding the entire kitchen area was last 11/2011. In 2/2012 the grease trap was vacuumed out as part of routine maintenance to try and prevent it from backing up and flooding the kitchen again. Staff #32 also confirmed the grease had been an on-going problem due to the age of the facility. She also advised that from time to time very foul odors were emitted from the drain pipes in the kitchen floor into the entire kitchen area.

Shelby Regional Medical Center
Explanation of Repair Needs
Date: 2/3/2011
Problem: Grease trap in the kitchen has rusted out and is allowing mud to mix with the grease.

Rationale for Repair:
1) The substructure for the floor in the kitchen (the dirt under the floor) is being sucked out with the grease every time the trap is cleaned. This has been a problem for 3-5 years. There is a hole that has to be getting bigger every time we clean the trap, thus leaving the possibility of a structural failure of the floor and casing substantial damage to the kitchen and possible environmental damage to the soil around the trap.
2) If the kitchen is shut down due to environmental problems, the whole facility could be shut down until it meets code again.
We have a quote in place from Nacogdoches Sheet Metal to install a new trap. The quote also has a quote to repair the main sewer line going from the hospital to the street. It has roots growing into it and has potential to collapse and totally block the flow of sewage from the hospital to the street.
Both issues need to be addressed as quickly as possible.

E-mail received by staff #3 from Liquid Environmental Shreveport La.
Dated July 13, 2011 at 4:29 pm.

Thanks for taking the time to visit with me today on the phone about the condition of your grease trap. As you are aware your grease trap is in extremely poor condition, so much so the walls have caved in and my service tech is sucking up dirt and rocks from under your building each time we service your trap. If this continues the danger of your floor loosing enough support from the surrounding area is real enough to cause the floor around your grease trap to completely cave in. If this were to happen when an employee was walking past the trap it could produce disastrous results for your hospital.
In addition to the safety concerns caused by the very poor condition of your grease trap there's always the possibility of the local pretreatment inspector making a surprise visit to check on the trap. With the condition your trap is in not only could the hospital be forced to pay a fine, the inspector could also issue a cut-off notice which would allow the hospital to discharge any water to the city until the trap was replaced.
It is my strong recommendation that the hospital replace there trap in question as soon as possible in order to avoid any of the many safety or regulatory dangers associated with a trap in such poor condition. You are due for service now and I would love to coordinate that service around the replacement of your trap.

Bids for replacement of grease trap was reviewed and revealed the following:

Nacogdoches Sheet Metal and Plumbing, Ltd. dated 3/10/2099
To: Shelby Regional Medical Center
Nacogdoches Sheet Metal and Plumbing Ltd is pleased to replace existing grease interceptor to new Jonespec GT-27-2-50 polyethylene.
Price includes saw-cut and busting out of flooring. No concrete work or floor repairs included in quote.
Total Price.........$10,995.00 +tax
No pavement, concrete, or floor covering quoted.

Bid from Nacogdoches Sheet Metal and Plumbing, Ltd. dated 1/5/2011 revealed the following:
To: Shelby Regional Medical Center
Nacogdoches Sheet Metal and Plumbing, Ltd is please to quote the removal of the grease interceptor in the kitchen. We will tie onto the grease line and run thru the kitchen, across hall to the outside, and set a 750 gallon grease trap and tie-in.
We will leave the grease trap and run a line toward the front of the hospital and tie-into the existing sewer line. We will have the concrete busted up, poured back, and tile replaced where we have to run new line in kitchen and hall.
Total Price...........$21,869.00
Note: This bid does no include any dust clean-up. Any repairs of underground utilities that are not marked. No landscaping, asbestos survey/fees.
Alternate: To replace the sewer line in front of the hospital on South side about 80 feet out to the bad spot. ADD.........$3883.00.
One-half of total bill is due up front, and balance due upon completion of job.