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.

SOUTH TEXAS HEALTH SYSTEM 1102 W TRENTON ROAD EDINBURG, TX 78539 May 6, 2015
VIOLATION: GOVERNING BODY Tag No: A0043
Based on record review and interview, the facility failed to have a governing body that provided effective oversight of medical staff that was privileged to practice medicine at the facility, and enforce policies and procedures.

Findings were:
a.The governing body failed to ensure that medical staff was accountable for the quality of care provided to 2 kidney transplant recipients (in March 2014 and January 2015), as the course for reporting individuals for peer review was not initiated for 2 adverse events (the event in March 2014 involved a transplant nephrologist/physician #6 and the event in January 2015 involved a transplant surgeon/physician #2). Cross refer Tag A0049 - Medical Staff - Accountability - 482.12(a)(5).
b.The governing body failed to ensure that STAT laboratory tests ordered for patients were completed within the 1 hour time frame per policy. Failure to complete and report tests ordered STAT may result in delayed diagnosis and treatment which could adversely affect all patients needing STAT lab testing. Cross refer Tag A0583 - Emergency Laboratory Services - 482.27(a)(1)
c. The governing body failed to ensure that radiology tests ordered as STAT were assessed for completion within thirty minutes of receiving the order per policy. Failure to complete and report tests ordered STAT may result in delayed diagnosis and treatment which could adversely affect all patients needing STAT radiology testing. Cross refer Tag A0529 - Scope of Radiologic Services - 482.26(a)
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the facility failed to ensure that medical staff was accountable for the quality of care provided to 2 kidney transplant recipients (in March 2014 and January 2015), as the course for reporting individuals for peer review was not initiated for 2 adverse events (the event in March 2014 involved a transplant nephrologist/physician #6 and the event in January 2015 involved a transplant surgeon/physician #2).
Findings were:
a. Facility policy Event Reporting and Healthcare Peer Review (HPR)-PI.1250s, last revised 10/1/13, stated the following, in part:
"IV. POLICY:
A. The Occurrence Reporting System is the risk management function of each facility's peer review process ...
...
C. Responsibility:
The facility Patient Safety Council assumes overall responsibility for the HPR Reporting System to ensure monitoring implemented of proposed corrective actions, appropriate remediation of risk and event reporting compliance.
V. Procedure:
A. Healthcare Facilities
1. Any healthcare facility employee or staff member who discovers, is directly involved in or responds to an occurrence is to complete or direct completion of a risk event report via the MIDAS RDE electronic event reporting system. Submission of the RDE report should occur within 24 hours of the event ...
...
C. Recordkeeping and Trending
...
3. The results of this activity shall be reported to appropriate peer review and patient care evaluation committees of the medical staff ."

Facility policy, HPR-PI.1250s, described identified the following examples for "Severity Classification System for HPR Reporting ...All levels G, H and I require PCR submission ...":
1. A classification described as being level I is "death occurring from, medication error/reaction ..."
2. A classification described as being level G-H is "permanent injury from a fall or procedure, i.e. paralysis ..."
b. Review of the medical record for Patient #6 on 5/6/15 revealed that the patient met the example of a level I severity classification, "death occurring from, medication error/reaction", which was not reported in accordance with facility policy HPR-PI.1250s; the medical record for Patient #6 revealed the following:
- The discharge summary (dated 4/3/15) for Patient #6 (kidney transplant recipient) stated the following, in part, "The patient received the first dose of Thymoglobulin during the OR and the patient (sic) developed significant side effects, which we believe strongly that the patient's (sic) anaphylactoid reaction, the patient (sic) developed with hypotension, most likely secondary to the Thymoglobulin as one of its rare side effects is cytokine release syndrome. The patient improved a few days after the surgery we made a decision to give the patient (sic) second dose of Thymoglobulin, which unfortunately after that the patient crashed and deteriorated after that and that is how we made our suspicion that the patient developed multisystem failure secondary to cytokine release syndrome from Thymoglobulin ...", the discharge summary indicated that despite efforts of medical intervention, Patient #6 "continued to deteriorate" and the patient subsequently passed away during this hospitalization on [DATE].
c. Upon request, the facility's pharmacist provided the manufacturer (Genzyme) information insert for Thymoglobulin, also named Antithymocyte Globulin (AG), on 5/5/15, which stated the following:
"WARNINGS
Thymoglobulin should only be used by physicians experienced in immunosuppressive therapy for the treatment of renal transplants. Medical surveillance is required during Thymoglobulin infusion.

Immune-mediated reactions
Serious immune-mediated reactions have been reported with the use of Thymoglobulin and consist of anaphylaxis or severe cytokine release syndrome (CRS). Fatal anaphylaxis has been reported. If an anaphylactic reaction occurs, the infusion should be terminated immediately. Medical personnel should be available to treat patients who experience anaphylaxis ...Any further administration of Thymoglobulin to a patient who has a history of anaphylaxis to Thymoglobulin is not recommended ...Severe, acute infusion-associated reactions (IARs) are consistent with CRS which is attributed to the release of cytokines by activated monocytes and lymphocytes. Severe acute CRS can cause serious cardiovascular events and/or death".
Patient #6 died following a reaction to a medication.
d. Review of the medical record for Patient #11 on 5/6/15 revealed that the patient met the example of a level G-H severity classification "permanent injury from a fall or procedure, i.e. paralysis ..." Patient #11 was discharged with paralysis. It was unknown if the paralysis was permanent; however, the incident was not reported according to facility policy HPR-PI.1250s, therefore, there was no follow-up by the facility's Patient Safety Council to determine if the paralysis was permanent. The medical record for Patient #11 revealed the following:
- Patient #11 had a surgical operation on 1/21/15. On 1/22/15 the surgeon wrote a post-operative progress note which indicated that the patient had right lower extremity (RLE) numbness. The post-operative extremity numbness was also documented by physician #6, nursing staff, and by transplant staff in a transplant multidisciplinary progress note (dated 1/23/15). Patient #11's medical record also indicated that the patient experienced weakness of the extremity. Patient #11's discharge summary for this hospitalization indicated that the patient was discharged [DATE] with "right thigh numbness still post surgery".
Patient #11 experienced a degree numbness and weakness (paralysis) of an extremity after a procedure and was discharged with this deficit.
e. During an interview with Staff #17 (Clinical Risk Manager) at 2:18pm on 5/6/15 in the administration conference room, it was confirmed that the above mentioned death and paralysis should have been reported in accordance with the above facility policy (HPR-PI.1250s). Staff #17 stated that there was no evidence to indicate that these incidents were reported.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation, interview and record review the facility failed to ensure the physical safety of patients in a patient care unit.
The facility's failure to provide a safe environment in a patient care/treatment area in keeping hand rails unobstructed and repaired put all patients and staff who required assistance in gait and or balance at risk for falls, injuries and possible egress restrictions.
Findings included:
a. During an observation on 05/04/15 at approximately 3:25 p.m. in the Post Anesthesia Care Unit (PACU) with Staff#7 (Director of Surgical Services) revealed the following:
Handrails at the PACU were obstructed on both sides of the hallway near a clearly marked exit doorway with multiple stacked columns of empty boxes measuring above the handrails on one side of the hallway and two wooden pallets leaned against the wall and handrails approximately 48 inches in width by 40 inches in length on the opposite side of the hallway. The patient care/treatment area had current patients
Handrail at the PACU near the "Nurses Station" had an approximate 6 inch surface area that was damaged/broken and loosely attached to the wall
b. Review of the facility's policy "Providing a Safe Environment" last revised on 05/01/09 documented in part:
Interior spaces shall meet the needs of the patient population and are safe and suitable to the care, treatment, and services provided.
Emergency access provision is provided to all locked and occupied spaces.
Furnishings and equipment are maintained to be safe and in good repair.
c. An interview with Staff#7 on 05/04/15 at approximately 3:30 p.m in surgical services department. confirmed handrails at the PACU near a clearly marked exit doorway were obstructed for patient and staff use and against facility policy. Staff#7 indicated the materials were in the hallway throughout the day due to the facility's shipment of supplies which routinely occurred at least weekly. Staff#7 also acknowledged the obstructions in the hallway could cause patient egress restriction and said the empty boxes, trash and pallets would be moved " ...sometime in the evening by housekeeping. " Staff#7 did not indicate he had knowledge of any damaged hand rails in the patient care area.
d. During the Exit Conference on 05/06/15 the facility was given the opportunity to ask questions and provide additional information regarding the deficiency practice identified during the survey. No additional information was given.
VIOLATION: QAPI Tag No: A0263
Based on review of medical record , review of quality assessment and performance improvement date and interview with staff the hospital is not maintaining an effective, ongoing, hospital-wide, performance improvement program:

Findings:

1. Cross refer TAG A0286 Patient Safety. The facility failed to ensure that staff reported 2 adverse events involving transplant kidney recipients as required by facility policy, thereby inhibiting the course of measuring, analyzing and tracking the adverse events.

2. Cross refer TAG A-0583 Laboratory Services tracking of STAT laboratory testing turnaround times in the has been a quality indicator for at least 3 years and the facility has not met the bench mark for overall STAT turnaround times at McAllen Medical center in either 2014 or 2015.

3. Quality Dashboard for Laboratory for McAllen Medical Center the established benchmark for turnaround time for all STAT labs was 60 minutes in 2014 the average for the year was 80 minutes. In 2015 with the same benchmark of 60 min the average time between January -April 2015 was 77 minutes.

The critical value reporting compliance for McAllen Medical Center
- Critical value reported in 15 minutes met the benchmark of greater than or equal to 95%
- Documentation call/read back Ok met the benchmark of greater than or equal to 95%
- Reported results to licensed independent practitioner (LIP) within 45 minutes did not meet the benchmark of greater than or equal to 95% in 2015 in January 2015 it was at 24% and February 2015 at 30%.

4. Interviewed staff #25, systems director of quality management at 10:15 am on May 6,
2015 in the administration conference room who admits overall laboratory STAT turnaround
times has been an ongoing problems with the current performance improvement projects
there has been some progress with this project through the years but they are still working on
improving the process to meet and exceed the established benchmark. Observation and
review of recent STAT laboratory results demonstrated this is currently still an ongoing
problem and the current performance improvement is not effective.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the facility failed to ensure that staff reported 2 adverse events involving transplant kidney recipients as required by facility policy, thereby inhibiting the course of measuring, analyzing, and tracking the adverse events, and determining the necessity of reporting involved individuals for peer review by the facility's Patient Safety Council (the event in March 2014 involved a transplant nephrologist/physician #6 and the event in January 2015 involved a transplant surgeon/physician #2).

Findings were:
a. Facility policy Event Reporting and Healthcare Peer Review (HPR)-PI.1250s, last revised 10/1/13, stated the following, in part:
"IV. POLICY:
A. The Occurrence Reporting System is the risk management function of each facility's peer review process ...
...
C. Responsibility:
The facility Patient Safety Council assumes overall responsibility for the HPR Reporting System to ensure monitoring implemented of proposed corrective actions, appropriate remediation of risk and event reporting compliance.
V. Procedure:
A. Healthcare Facilities
1. Any healthcare facility employee or staff member who discovers, is directly involved in or responds to an occurrence is to complete or direct completion of a risk event report via the MIDAS RDE electronic event reporting system. Submission of the RDE report should occur within 24 hours of the event ...
...
C. Recordkeeping and Trending
...
1. The Risk Manager shall see that all necessary parties are informed of the incident, regardless of severity classification assignment and document notification via proper functioning of MIDAS worklists.
2. Trending reports will be compiled and distributed to facility leadership staff to allow corrective action strategies to be developed. Oversight of this trending and corrective process will reside with the facility Patient Safety Council."
3. The results of this activity shall be reported to appropriate peer review and patient care evaluation committees of the medical staff ."

Facility policy, HPR-PI.1250s, described identified the following examples for "Severity Classification System for HPR Reporting ...All levels G, H and I require PCR submission ...":
1. A classification described as being level I is "death occurring from, medication error/reaction ..."
2. A classification described as being level G-H is "permanent injury from a fall or procedure, i.e. paralysis ..."

b. Review of the medical record for Patient #6 on 5/6/15 revealed that the patient met the example of a level I severity classification, "death occurring from, medication error/reaction", which was not reported in accordance with facility policy HPR-PI.1250s; the medical record for Patient #6 revealed the following:
- The discharge summary (dated 4/3/15) for Patient #6 (kidney transplant recipient) stated the following, in part, "The patient received the first dose of Thymoglobulin during the OR and the patient (sic) developed significant side effects, which we believe strongly that the patient's (sic) anaphylactoid reaction, the patient (sic) developed with hypotension, most likely secondary to the Thymoglobulin as one of its rare side effects is cytokine release syndrome. The patient improved a few days after the surgery we made a decision to give the patient (sic) second dose of Thymoglobulin, which unfortunately after that the patient crashed and deteriorated after that and that is how we made our suspicion that the patient developed multisystem failure secondary to cytokine release syndrome from Thymoglobulin ...", the discharge summary indicated that despite efforts of medical intervention, Patient #6 "continued to deteriorate" and the patient subsequently passed away during this hospitalization on [DATE].

c. Upon request, the facility's pharmacist provided the manufacturer (Genzyme) information insert for Thymoglobulin, also named Antithymocyte Globulin (AG), on 5/5/15, which stated the following:
"WARNINGS
Thymoglobulin should only be used by physicians experienced in immunosuppressive therapy for the treatment of renal transplants. Medical surveillance is required during Thymoglobulin infusion.

Immune-mediated reactions
Serious immune-mediated reactions have been reported with the use of Thymoglobulin and consist of anaphylaxis or severe cytokine release syndrome (CRS). Fatal anaphylaxis has been reported. If an anaphylactic reaction occurs, the infusion should be terminated immediately. Medical personnel should be available to treat patients who experience anaphylaxis ...Any further administration of Thymoglobulin to a patient who has a history of anaphylaxis to Thymoglobulin is not recommended ...Severe, acute infusion-associated reactions (IARs) are consistent with CRS which is attributed to the release of cytokines by activated monocytes and lymphocytes. Severe acute CRS can cause serious cardiovascular events and/or death".

Patient #6 died following a reaction to a medication.

d. Review of the medical record for Patient #11 on 5/6/15 revealed that the patient met the example of a level G-H severity classification "permanent injury from a fall or procedure, i.e. paralysis ..." Patient #11 was discharged with paralysis. It was unknown if the paralysis was permanent; however, the incident was not reported according to facility policy HPR-PI.1250s, therefore, there was no follow-up by the facility's Patient Safety Council to determine if the paralysis was permanent. The medical record for Patient #11 revealed the following:
- Patient #11 had a surgical operation on 1/21/15. On 1/22/15 the surgeon wrote a post-operative progress note which indicated that the patient had right lower extremity (RLE) numbness. The post-operative extremity numbness was also documented by physician #6, nursing staff, and by transplant staff in a transplant multidisciplinary progress note (dated 1/23/15). Patient #11's medical record also indicated that the patient experienced weakness of the extremity. Patient #11's discharge summary for this hospitalization indicated that the patient was discharged [DATE] with "right thigh numbness still post surgery".

Patient #11 experienced a degree numbness and weakness (paralysis) of an extremity after a procedure and was discharged with this deficit.

e. During an interview with Staff #17 (Clinical Risk Manager) on 5/6/15, it was confirmed that the above mentioned death and paralysis should have been reported in accordance with the above facility policy (HPR-PI.1250s). Staff #17 stated that there was no evidence to indicate that these incidents were reported.
VIOLATION: MEDICAL STAFF ACCOUNTABILITY Tag No: A0347
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the facility failed to ensure that the medical staff executive committee held physicians accountable for the quality of medical care provided to patients, as 2 adverse events occurred involving care provided by physicians (physician #6 - transplant nephrologist & physician #2 - transplant surgeon) in the facility's transplant program. These two physicians were not submitted for peer review for their involvement in the adverse events.

Findings were:
a. Review of the medical record for Patient #6 on 5/6/15, revealed that after the patient received a kidney transplant in March 2014, the patient died most likely secondary to a transplant specific medication that was ordered (in a circumstance that was contraindicated by the manufacturer) by the facility's transplant nephrologist (physician #6). There was no physician peer review for this incident. The medical record for Patient #6 revealed the following:
- The discharge summary (dated 4/3/15) for Patient #6 (kidney transplant recipient) stated the following, in part, "The patient received the first dose of Thymoglobulin during the OR and the patient (sic) developed significant side effects, which we believe strongly that the patient's (sic) anaphylactoid reaction, the patient (sic) developed with hypotension, most likely secondary to the Thymoglobulin as one of its rare side effects is cytokine release syndrome. The patient improved a few days after the surgery we made a decision to give the patient (sic) second dose of Thymoglobulin, which unfortunately after that the patient crashed and deteriorated after that and that is how we made our suspicion that the patient developed multisystem failure secondary to cytokine release syndrome from Thymoglobulin ...", the discharge summary indicated that despite efforts of medical intervention, Patient #6 "continued to deteriorate" and the patient subsequently passed away during this hospitalization on [DATE].
b. Upon request, the facility's pharmacist provided the manufacturer (Genzyme) information insert for Thymoglobulin, also named Antithymocyte Globulin (AG), on 5/5/15, which stated the following:
"WARNINGS
Thymoglobulin should only be used by physicians experienced in immunosuppressive therapy for the treatment of renal transplants. Medical surveillance is required during Thymoglobulin infusion.

Immune-mediated reactions
Serious immune-mediated reactions have been reported with the use of Thymoglobulin and consist of anaphylaxis or severe cytokine release syndrome (CRS). Fatal anaphylaxis has been reported. If an anaphylactic reaction occurs, the infusion should be terminated immediately. Medical personnel should be available to treat patients who experience anaphylaxis ...Any further administration of Thymoglobulin to a patient who has a history of anaphylaxis to Thymoglobulin is not recommended ...Severe, acute infusion-associated reactions (IARs) are consistent with CRS which is attributed to the release of cytokines by activated monocytes and lymphocytes. Severe acute CRS can cause serious cardiovascular events and/or death".

c. Review of the medical record for Patient #11 on 5/6/15, revealed that post kidney transplant surgery, the patient experienced lower extremity numbness and weakness, which was still present upon the patient's discharge from the facility. There was no physician peer review for this incident. The medical record for Patient #11 revealed the following:
- Patient #11 had a surgical operation on 1/21/15. On 1/22/15 the surgeon wrote a post-operative progress note which indicated that the patient had right lower extremity (RLE) numbness. The post-operative extremity numbness was also documented by physician #6, nursing staff, and by transplant staff in a transplant multidisciplinary progress note (dated 1/23/15). Patient #11's medical record also indicated that the patient experienced weakness of the extremity. Patient #11's discharge summary for this hospitalization indicated that the patient was discharged [DATE] with "right thigh numbness still post surgery".

d. During an interview with Staff #17 (Clinical Risk Manager) on 5/6/15, it was confirmed that the above mentioned death and paralysis should have been reported in accordance with the above facility policy (HPR-PI.1250s). Staff #17 stated that there was no evidence to indicate that these incidents were reported, thusly, there was no peer review of the physicians involved in providing medical care to the patients who experienced the adverse events.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on record review and interview, it was determined that the facility failed to ensure that nursing staff administered medications in accordance with a physician's orders for 1 of 2 patients who received a transplant specific anti-rejection medication.

Findings were:
a. Review of the medical record for Patient #6 on 5/6/15 revealed the following:
- Antithymocyte Globulin-Thymoglobulin (AG) infusion was ordered for the patient on 3/23/14 using a "South Texas Health System" order set. The order set included the following, in part, under the section titled Monitoring, "Stop infusion immediately and notify MD if patient experiences ...blood pressure changes."
- A nursing note on 3/23/14 indicated that the AG infusion was started by Staff #13 (RN) at 4:25 PM. (This is the second dose of AG the patient received at the facility, the first being on 3/21/14)
- A subsequent nursing note on 3/23/14 stated that the following occurred at 7:15 PM, "physician #6 (sic) called 4 times via his phone but no response; then he called back and he was informed of all critical lab reports, patient's low BP despite dopamine drip and updated him about patient's general condition; orders given." (According to the above "South Texas Health System" order set, the medication should have been stopped "immediately" and then the physician should have been notified.)
- The intake and output section of the medical record indicated that the AG infused at the rate of 8.3 ml/hr from the 4:00 PM hour on the 23 rd to the 2:00 AM hour on the 24th. This was a total of 11 hours of AG infusing at a rate of 8.3 ml/hr, resulting in a total volume of 91.3 ml being administered; the total original volume of the medication was documented as 100 ml.
- There was no documentation found in the medical record of Patient #6 to indicate that the AG infusion was stopped when the RN identified the blood pressure changes. This was confirmed by Staff #8 (Clinical Supervisor) and Staff #17 (Clinical Risk Manager).

b. During an interview with Staff #17 (Clinical Risk Manager) on 5/6/15, it was confirmed that the facility reviewed some of the circumstances surrounding this incident. However, no action was taken by the facility to address the error made by Staff #13 regarding the failure follow the "South Texas Health System" order set and immediately stop the infusion of AG prior to notifying the treating physician.

c. The discharge summary for Patient #6 (Performed By/Author date 4/3/15) stated the following, in part, " ...we made a decision to give Patient #6 (sic) second dose of Thymoglobulin, which unfortunately after that the patient crashed and deteriorated after that ...".
d. Upon request, the facility's pharmacist provided the manufacturer (Genzyme) information insert for AG on 5/5/15, which stated under the heading WARNINGS, "Serious immune-mediated reactions have been reported with the use of Thymoglobulin and consist of anaphylaxis or severe cytokine release syndrome (CRS). Fatal anaphylaxis has been reported. If an anaphylactic reaction occurs, the infusion should be terminated immediately."

e. Facility policy, Administration of Drugs: General (MM. 5100) last revised 4/1/15, stated the following, in part, "III. Policy: ... N. Patients will be monitored based on parameters specified in the medication order".
VIOLATION: SCOPE OF RADIOLOGIC SERVICES Tag No: A0529
Based on review of patient electronic medical records (EMR), staff interview, and review of policies and procedures, the governing body failed to ensure that radiology tests ordered as STAT were assessed for completion within thirty minutes of receiving the order per policy. Failure to complete and report tests ordered STAT may result in delayed diagnosis and treatment which could adversely affect all patients needing STAT radiology testing.

Findings included:

a. Review of the South Texas Health System, Policy " Radiology Order Priority, RAD.1004c, effective date 8/1/2014, stated, in part,

"II. Policy: ...
B. STAT orders require immediate attention.
a. STAT orders shall be assessed for completion within thirty minutes of order received.
b. STAT orders for radiology procedures received after normal hours of operation may require the notification of the on-call associate.
i. On-call associate shall be notified and order assessed for completion within one hour of notification of the on-call associate.
c. STAT orders received after normal hours of operation for a particular specialty and there is no on-call associate for that specialty, the order will be assessed next business day."


b. Review of the medical record for Patient #10 revealed an order for NM Pulmonary Perfusion w/Ventilation which was ordered STAT on Thursday, 9/4/14 at 1:14 AM. The order was not completed until Friday, 9/5/14 at 0300, over 24 hours later.

c. The above findings were confirmed in an interview with Staff #8 (Clinical Supervisor) on 5/5/15.
VIOLATION: EMERGENCY LABORATORY SERVICES Tag No: A0583
Based on review of patient electronic medical records (EMR), staff interviews, and review of policies and procedures, the governing body failed to ensure that STAT laboratory tests ordered for patients were completed within the 1 hour time frame per policy. Failure to complete and report tests ordered STAT may result in delayed diagnosis and treatment which could adversely affect all patients needing STAT lab testing.

Findings included:

a. Review of hospital policy, "Reporting of STAT Results" LAB. 1600, revised date 10/01/10, stated, in part, "Purpose: To ensure STAT results are reported in a timely basis. STAT results are to be completed within one hour from time of order."

b. During review of STAT lab orders in 8 out of 20 patient electronic medical records with Staff #21, RN Clinical Supervisor and EMR navigator on 5/5/15 and 5/6/15 in the administrative conference room, the following lab tests were observed to be ordered STAT and not reported within an hour of the order as required by policy:

-Patient #6 had STAT labs that were ordered and not completed within one hour as required by policy.
Review of STAT lab orders for Patient #6 revealed the following:
Comprehensive Metabolic Panel STAT order entered: 3/23/14 at 1943. Completed: 3/23/14 at 2327, exceeding 1 hour.
Lactic Acid Level STAT order entered: 3/22/14 at 0636. Completed: 3/22/14 at 1059, exceeding 1 hour.
Basic Metabolic Panel (BMP) STAT Lab order entered: 3/22/14 at 0818. Completed: 3/22/14 at 1050, exceeding 1 hour.
Review of nursing notes for Patient #6 revealed the following:
3/22/14 at 0750 "Page lab for Stat lactic acid."
3/22/14 at 0807: "Page lab again for stat lactic acid."
3/22/14 at 0901: "Finally spoke with [staff member name] in lab regarding stat BMP and lactic acid. Will send phlebotomist."

-Review of the medical record for Patient #4 revealed STAT lab orders not completed within one hour as required by policy, including the following:
Lipase Level STAT Order entered: 4/22/15 at 1710. Completed: 4/23/15 at 0828, exceeding 1 hour.
Hepatic/Liver Function Panel STAT Order entered: 4/11/15 at 2302. Completed: 4/12/15 at 0125, exceeding 1 hour.
Comprehensive Metabolic Panel STAT Order entered: 4/11/15 at 2302. Completed: 4/12/15 at 0036, exceeding 1 hour.

-Review of the medical record for Patient #1 revealed STAT lab orders not completed within one hour as required by policy, including the following:
CBC no Diff STAT Order entered: 04/12/15 at 0917. Completed: 04/12/15 at 1036, exceeding 1 hour.
Comprehensive Metabolic Panel STAT Order entered: 04/12/15 at 0917. Completed: 04/12/15 at 1055, exceeding 1 hour.
Procalcitonin STAT Order entered: 4/16/15 at 1024. Completed: 4/16/15 at 1340, exceeding 1 hour.
Lipase Level STAT Order entered: 4/20/15 at 1018. Completed: 4/20/15 at 1149, exceeding 1 hour.
Amylase Level STAT Order entered: 4/20/15 at 1018. Completed: 4/20/15 at 1149, exceeding 1 hour.
Procalcitonin STAT Order entered: 4/20/15 at 1018. Completed: 4/20/15 at 1202, exceeding 1 hour.
CBC with Diff STAT Order entered: 4/26/15 at 1214. Completed: 4/26/15 at 1356, exceeding 1 hour.
CBC with Diff STAT Order entered: 4/29/14 at 0957. Completed: 04/29/15 at 1106, exceeding 1 hour.

-Review of the medical record for Patient #17 revealed STAT lab orders not completed within one hour as required by policy, including the following:
PT INR STAT Order entered: 4/29/15 at 1213. Completed: 4/29/15 at 1618, exceeding 1 hour.

-Review of the medical record for Patient #5 revealed STAT lab orders not completed within one hour as required by policy, including the following:
B Type Natriuretic Peptide STAT Order entered: 5/2/15 at 1242. Completed: 5/2/15 at 1501, exceeding 1 hour.
PT INR STAT Order entered: 5/2/15 at 1242. Completed: 5/2/15 at 1431, exceeding 1 hour.
Comprehensive Metabolic Panel STAT Order entered: 5/2/15 at 1242. Completed: 5/2/15 at 1416, exceeding 1 hour.

-Review of the medical record for Patient #16 revealed STAT lab orders not completed within one hour as required by policy, including the following:
ABO+ Rh STAT Order entered: 5/1/15 at 0719. Completed: 5/1/15 at 0837, exceeding 1 hour.

-Review of the medical record for Patient #10 revealed STAT lab orders not completed within one hour as required by policy, including the following:
D Dimer Ultrasensitive STAT Order entered: 9/3/14 at 2146. Completed: 9/3/14 at 2332, exceeding 1 hour.

-Review of the medical record for Patient #18 revealed STAT lab orders not completed within one hour as required by policy, including the following:
Troponin I STAT Order entered: 5/4/15 at 0632. Completed: 5/4/15 at 0828, exceeding 1 hour.

The above findings for each patient were confirmed during the medical records review for STAT lab orders and results with Staff #21 the afternoon of 5/6/15 in the administrative conference room.

c. An interview was conducted with Staff #10 (pathologist), Staff #12 (system laboratory director), and Staff #11 (assistant laboratory director) at 3:10 pm on 5/5/15 in the laboratory, who stated that phlebotomists are scheduled 24 hours a day and 7 days a week for lab draws, however for the nursing units, the physician is required to specify in the lab order whether a nurse or a phlebotomist will draw the lab specimen. The phlebotomist staffing schedule was provided to the surveyors. Per interview, when a patient has an IV line or other line, the nurse is required to collect the specimen. Turnaround time is being monitored by the lab, in particular for cardiac enzymes, and STAT labs are a lab quality indicator, with a goal of 75% of STAT labs completed within a 30 minute turnaround time from when the specimen is received in the lab.

d. The South Texas Health System Job Description for RN's was provided to the surveyors by the Systems Education Director, Staff #16 on 5/6/15 in the hospital administrative conference room. The RN job description revealed nursing tasks of "Venipuncture / Fingersticks" and "Collection of specimens containing blood".

e. In an interview with Staff #15, RN 6 East, transplant competent nurse, at 10:45 am on 5/6/15 in the unit break room, she stated that the phlebotomists draw patient labs on the unit. Staff #15 stated that when a STAT lab order is entered, in addition to entering the order in the EMR, the lab is called to draw the specimen. Staff #15 stated that if the patient has a central line, such as a PICC line or portacath, the nurse will wait until the phlebotomist arrives from the laboratory. When the phlebotomist arrives, the nurse will withdraw the blood in a syringe and hand the syringe to the phlebotomist to transfer the blood to the right lab tubes. When Staff #15 was asked if she knew the time requirement in the policy for STAT labs, she stated , "I don't know."

f. In an interview with Staff #14, RN, 6 West, transplant competent nurse at 11:25 am on 5/6/15 in the unit break room, she stated that phlebotomists draw the patient lab specimens. Staff #14 stated that nurses are trained to draw blood, but "we don't have lab tubes on the floor" and the nurse will "wait for the phlebotomist to get here." Staff #14 stated that they can "send a nurse to the lab to get the tubes" if needed. Staff #14 stated that she was unsure of the time requirement in the policy for STAT labs, stating, "I think 30 minutes?"

The above interviews were reviewed with Staff #4, Director of Med/Surg at 4:15 pm on 5/6/15 in the administrative conference room.

g. In an interview with Staff #13, RN, ICU, transplant competent nurse at 11:55 am on 5/6/15 in the Director's office, she stated that "the phlebotomist draws labs. If the patient has an art-line [arterial line], or a PICC or central line, the nurse will draw the blood and give it to the phlebotomist." Staff #13 stated that "when a STAT lab order is entered, then we page or call the lab to let them know and if they don't come, we overhead page them." Staff #13 stated "if the phlebotomist doesn't come, we tell the charge nurse who can get the lab supervisor or the house supervisor intervenes." Staff #13 stated that "We can draw labs if needed; I think we have lab tubes in the med room" and that on nights and weekends there is not as much personnel to cover lab and "it is difficult to get somebody to draw labs."

The above interview was reviewed with Staff #24, Director of ICU at 4:50 pm on 5/6/15 in the administrative conference room.
VIOLATION: MAINTENANCE OF PHYSICAL PLANT Tag No: A0701
Based on observation interview and record review the facility failed to maintain its physical and sanitary environments with routine preventive maintenance and performed as necessary in accordance with Federal and State laws, regulations and guidelines to assure the safety and well-being of patients.
The facility's failures to maintain its physical and sanitary environments put at risk the safety and well-being of all patients.
Findings included:
a. During inspection of the facility's Post Anesthesia Care Unit (PACU) on 05/04/15 at approximately 3:25 p.m. with Staff#7 (Director of Surgical Services) revealed several waste receptacle containers to be full of trash including contaminated patient care equipment near patient care areas. Several of the containers were observed to have cracked lids, others had broken pieces missing and others had no lids.
b. Observation of the facility's sterilization unit on 05/05/15 at approximately 10:00 a.m. with Staff#7 revealed the following:
Damaged wall approximately 8 inches in width by 20 inches in length behind and adjacent an autoclave machine (machine used to sterilize surgical equipment) revealed exposed wall debris, dust particles and peeling paint in and around an irregularly shaped hole.
Wall behind the autoclave machine did not have an intact base board exposing debris and dust particles in and around the lower wall and adjacent area.
Counter top laminate next to sink had areas of chipped and broken pieces approximately 2 inches by 2 inches irregularly shaped
Cabinet door below sink had damaged areas of outer laminate material separated from the inner compressed wood.
Several floor files were loose, broken and a few tiles were missing
c. Interview on 05/05/15 with Staff#7 at approximately 4:30 p.m. confirmed the facility had identified the physical environment deficiencies in the Sterilization Unit and had budgeted finances for the repairs. Staff#7 confirmed the damages to the walls, lower baseboards, counter tops and sink cabinet door in the Sterilization Unit did not provide adequate surfaces to properly clean and or decontaminate those areas. The loose, broken and missing floor tiles were potentially safety related issues. Staff#7 acknowledged the facility's physical environment was in need of significant repair. The facility did not show a documented plan for routine repairs to the sterilization unit and an estimated date of completion. Staff#7 indicated no knowledge of any sanitary environment issues in PACU including the management of the waste receptacle containers.
d. Review of the facility's " Providing a Safe Environment " policy last revised 05/01/09 documented in part:
Interior spaces shall meet the needs of the of the patient population and are safe and suitable to the care, treatment and services provided
Areas used by patients are clean and clean of offensive odors
Furnishing and equipment are maintained to be safe and in good repair
e. Review of the facility's PACU Infection Prevention and Control (IPC) Measures policy last revised 03/01/11 documented in part:
Engineering and Environmental Services departments to perform and document the IPC measures specific to that department
All surfaces and non-disposable equipment to be cleaned with hospital germicide
All horizontal surfaces and furnishings to be cleaned and disinfected ...
Sinks and faucets to be thoroughly cleaned daily and as needed with an approved germicide
Trash containers will be emptied and cleaned daily
f. During the Exit Conference on 05/06/15 the facility was given an opportunity to provide additional information regarding the deficient practices identified during the survey process. No additional information was given.
VIOLATION: SURGICAL PRIVILEGES Tag No: A0945
Based on record review and interview, the facility failed to ensure that the peer review process was utilized for determining surgical privileges and competencies of practitioners, as an adverse event occurred post-operatively that involved a transplant surgeon (physician #2).
Findings were:
a.Review of the medical record for Patient #11 on 5/6/15, revealed that post kidney transplant surgery, the patient experienced lower extremity numbness and weakness, which was still present upon the patient's discharge from the facility. There was no physician peer review for this incident. The medical record for Patient #11 revealed the following:
- Patient #11 had a surgical operation on 1/21/15. On 1/22/15 the surgeon wrote a post-operative progress note which indicated that the patient had right lower extremity (RLE) numbness. The post-operative extremity numbness was also documented by physician #6, nursing staff, and by transplant staff in a transplant multidisciplinary progress note (dated 1/23/15). Patient #11's medical record also indicated that the patient experienced weakness of the extremity. Patient #11's discharge summary for this hospitalization indicated that the patient was discharged with "right thigh numbness still post surgery, but it is improving".

b. During an interview with Staff #17 (Clinical Risk Manager) on 5/6/15, it was confirmed that the above mentioned paralysis should have been reported, but was not, which would have led to a possible peer review of this incident.
VIOLATION: POST-OPERATIVE CARE Tag No: A0957
Based on observation and interview, it was determined that the facility failed to ensure that provisions available for immediate post-operative care were monitored for quality as 10 expired 500 ml bags of D5W were present in the Post Anesthesia Care Unit (PACU).
Findings were:
a. During a tour of the PACU (immediate post-operative care area) on 5/4/15, ten expired 500 ml bags of a D5W solution were found among other patient care supplies that were ready for use. All of the D5W expired in April 2015.
b. Staff #7 (Operating Room Director) was present at the time of the above finding; he confirmed that the D5W solution was present and that it should not have been in the PACU.
VIOLATION: OPERATIVE REPORT Tag No: A0959
Based on record review and interview, it was determined that the facility failed to ensure that surgeons completed operative reports for 4 of 8 patients that had kidney transplants at the facility within the timeframe established in the Medical Staff Policies.
Findings were:
a. The facility's Medical Staff General Policies, dated 1/1/2015, stated the following, in part, "2.5 OPERATIVE/PROCEDURAL REPORTS ...2.5(b) Full operative/procedural report ...A full operative/procedural report shall be written or dictated immediately following surgery, and the report made a part of the patient's current medical record within twenty-four (24) hours after completion of surgery. Any practitioner failing to dictate operative/procedural notes as required herein will be brought to the attention of the Chief of Staff for appropriate action."
4 of 8 medical records (kidney transplant recipients) reviewed on 5/6/15, revealed the following:
- Patient #6 had an operation on 3/21/14 by physician #2; the full operative report was completed over 24 hours after the operation on 3/24/14.
- Patient #10 had an operation on 8/20/14 by physician #2; the full operative report was completed over 24 hours after the operation on 11/20/14.
- Patient #11 had an operation on 1/21/15 by physician #2; the full operative report was completed over 24 hours after the operation on 1/24/15.
- Patient #13 had an operation on 2/9/15 by physician #2; the full operative report was completed over 24 hours after the operation on 2/12/15.

b. Half of the transplant recipient operative reports reviewed were not completed as required by the Medical Staff General Policies, within 24 hours. This was confirmed by Staff #8 , Clinical Supervisor at the time the records were reviewed.