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.

LAKEWAY REGIONAL MEDICAL CENTER, LLC 100 MEDICAL PARKWAY LAKEWAY, TX Sept. 27, 2012
VIOLATION: GOVERNING BODY Tag No: A0043
Based on extensive record review, observation and interviews, and in conjunction with the findings of the CLIA survey, it was determined that the governing body:

1. failed to insure that the facility is able to provide emergency services appropriate to the needs of the community it serves by not being able to provide necessary laboratory work-ups in its lab. This practice limited the facility's ability to respond to emergencies. In addition, the facility failed to insure that appropriate policies and procedures for patients presenting with symptoms associated with a cerebrovascular accident (stroke) were designed, implemented or enforced in the emergency department, further limiting the facility's ability to respond to emergency situations. Cross refer to A093 - 42 CFR 482.12(f)(2)

2. failed to insure that nursing services included a nurse peer review committee as required by the State of Texas Nurse Practice Act. The facility failed to assign and supervise nursing staff according to their competencies and the individual patient's needs as evidenced by a nurse drawing blood and providing a blood transfusion to a patient based on erroneous lab results and failed to perform an assessment to determine the medical necessity of the transfusion. Cross refer to A 385 - 42 CFR 482.23

3. failed to insure that the facility's Quality Assurance and Performance Improvement committee included the entire scope of the services offered at the facility, i.e.,; laboratory services and the interaction between nursing services and the laboratory; and that the interaction between the QAPI program and the governing body was readily identifiable in the minutes of the Governing Body with actions suggested by the governing body, if any, communicated back to the QAPI staff. Cross refer to A 263 - 42 CFR 482.21

4. further, the governing body failed to insure Patient's Rights were protected and promoted in that an outdated implant was surgically inserted into a patient, leaving the patient susceptible to infection, or the possibility of implant failure. In addition, another patient was prepared for surgery and received an anesthetic agent, and was in the pre-operative area of the facility for an entire afternoon, only to have the surgeon cancel the procedure for the day, requiring the patient to repeat the entire process a second day which required additional time of not being able to eat or drink (NPO status). Cross refer to A 115 - 42 CFR 482.13.
VIOLATION: CONTRACTED SERVICES Tag No: A0083
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on direct observation, record review, and interviews, it was determined that the governing body failed in its responsibility to insure that services were available in compliance with all applicable conditions of participation and standards.

Findings included:

The facility has a policy regarding laboratory services, entitled Communicating Critical Patient Results , which stated, in part,

"Laboratory
Critical test results will be communicated to the responsible licensed caregiver within 1 hour from the time the result is verified in the laboratory. The 1 hour turnaround time is divided into: 10 minutes for the laboratory turnaround time from when the test result is verified as critical to the time when the patient care nurse receives the result ... "

A review of facility provided laboratory data revealed the following turnaround times from laboratory result received to time results were distributed:

Patient #5's STAT PT and PTT results were received at 1400 at 09/20/12 and distributed at 1900 on 09/20/12. There was a 5 hour delay between receiving the lab results and distribution.

Patient #7's STAT PT result was received at 1400 at 09/20/12 and distributed at 1900 on 09/20/12. There was a 5 hour delay between receiving the lab result and distribution.

On 7/12/2012, a female patient was seen in the emergency room , and a Troponin level was ordered to be done STAT. However, the result took well over an hour to be communicated to the emergency room from the laboratory. This same patient presented again to the emergency room on [DATE], again required a STAT Troponin level, and again it took over an hour for the results to be communicated to the emergency department. These were outside of the time frame listed in the laboratory policy regarding STAT labs.

A review of the Medical staff by-laws, under their rules and regulations reveals that they have a policy regarding the closing of patients' records and discharge summaries, which states, in part:

"11.3.3 Medical records must be completed promptly and all reports that require authentication must be authenticated by a physician within fourteen (14) days following the patient discharge.

11.3.4 If a patient's medical record remains incomplete more than thirty (30) days after discharge for any reason, it is delinquent ...

11.8.9 Discharge Summary: A discharge clinical summary shall be entered promptly into the medical record and include the following: reason for hospitalization , significant findings, procedures performed and treatment rendered, condition of patient on discharge relating to diet, medication, activity, and follow-up care."

A review of medical records on 09/26/12, revealed 1 out of 3 patients (Patient # 4) did not have a discharge summary in his medical record. Patient # 4 was discharged from the facility on 08/10/12, six weeks prior to the survey.

The surveyors asked for a copy of the facility's policy for emergency management of patients presenting to the emergency room with stroke-like symptoms and the policy for emergency management of patients presenting to the emergency room with chest pain. A review of facility policies revealed there was no written stroke or chest pain protocol policy in place. The only emergency department documentation related to chest pain was a checklist, group order sheet, and code activation list.

In an interview on 09/27/12, the emergency room Nurse confirmed the facility does not have stroke policy in place to direct patient assessment, care, and treatment. The lack of a policy regarding emergency management of patients presenting with stroke-like symptoms was confirmed by the current Director of Nurses in an interview on 9/27/12.

The facility laboratory did not have a policy in place to define turnaround time parameters for STAT lab values from time of collection to confirming results. The only policy addressing STAT lab turnaround time referenced communication of critical test result to responsible licensed caregiver within 1 hour from the time the test is verified in the lab.

On 09/27/12, in an interview, the Laboratory Director acknowledged that there is currently no policy to issue corrected lab reports or to notify physicians of incorrect and/or corrected lab values.

A review of facility incident reports was conducted on 9/26/12. According to the incident reports, a newborn infant, on 7/7/12, was left unattended at the nursing station on the women's center. There was no staff present at the nursing station at the time that the infant was found. A tour of the women's center was conducted on 9/26/12, and an interview was held with the Director of Women's Services. The Director related that the philosophy of the unit is for the infant to room in with the mother, and that babies are never taken out of the mother's room. The Director was asked about the incident in July, and she admitted that there was "this one time;" but denied that the infant was in any danger, and that it was for a very short time period that the infant was left unattended.
VIOLATION: EMERGENCY SERVICES Tag No: A0093
Based on a review of available documentation and interview, the governing body failed to insure the medical staff had written policies and procedures for appraisal of emergencies and initial treatment.

Findings were:

A review of facility policies revealed there was no written stroke or chest pain protocol policy in place. The only emergency department documentation related to chest pain was a checklist, group order sheet, and code activation list.

In an interview on 09/27/12, the emergency room Nurse confirmed the facility does not have stroke policy in place to direct patient assessment, care, and treatment.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on a review of medical records, facility policies and documents, and staff interviews, the facility failed to promote and protect patient rights:

a) that require for a patient and the patient's representative to be involved in the care plan development and implementation;

b)that patients received care in a safe setting:
1) expired implants were used,
2) patients were not assessed by physician and nurse when critical lab results were received, 3) lab reports were not corrected when determined to be erroneous,
4) a patient received unnecessary anesthetic agents,
5) and a blood transfusion was administered to a patient based on erroneous lab results and no assessment was performed to determine the medical necessity of the transfusion.

An Immediate Jeopardy exists in that the facility failed to insure the right for all patients served or seeking services at the facility to receive care in a safe setting as evidenced by the administration of a blood transfusion based on erroneous lab values and with no correlating assessment, the use of an expired implant in the surgical repair of a fracture, and a delay in the reporting of critical lab values, a delay of up to 7 hours for a STAT order to measure coagulation. Not having accurate critical lab values available to treating physicians jeopardizes the health and safety of all patients served or seeking services at the facility. Utilization of expired implants likewise jeopardizes the health and well-being of patients requiring implants in orthopedic and other surgeries that may utilize implantable devices.

Findings were:

The surgery for Patient #1 was postponed resulting in a delay in repairing the patient's fractured humerus resulting in another inpatient day, increased risk for increased pain and lack of mobility, a delay in healing, and a delay in her return to activities of daily living. Patient #1 and her husband were not notified or involved in the development or implementation of the plan of care related to this postponement. Cross refer CFR 482.13(b)(1).

Patient #1 received an expired implant during surgery to repair a fractured humerus. Sterility cannot be guaranteed after the expiration date and there was no documented evidence to suggest that the patient or the manufacturer were notified. Four patient records included incorrect lab values; inaccurate lab values were not corrected in the medical record; STAT result turn-around times were excessively long (up to 7 hours and 50 minutes); a patient was not assessed by a physician or a nurse on receiving critical lab results; and a patient received a blood transfusion based on erroneous results. Cross refer CFR 482.13(c)(2).
VIOLATION: NURSING SERVICES Tag No: A0385
Based on a review of patient records, facility policies and documents, personnel folders, and staff interviews, the facility failed to ensure that nursing services were provided by nurses with documented competencies, failed to ensure that nursing assessments were documented per policy, and failed to establish a Nursing Peer Review Committee as required by facility policy and state law.

Findings were:

Review of the facility policy regarding Nursing Peer Review and the Texas Administrative Code revealed a requirement for a Nursing Peer Review Committee. In an interview with Staff #2, Risk Management Director on 9/27/12, she stated that the hospital had a policy requiring a hospital nursing peer review committee, but that the hospital did not have a nursing peer review committee. Staff #2 was unable to provide documented evidence of an established nursing peer review committee. Cross refer CFR 482.23 (a).

Review of the medical record for Patient #1 revealed a critical lab result which indicated a dramatic decline in hemoglobin over 16 hours; however there was no documented evidence of a nursing assessment to determine why the patient's hemoglobin dropped so dramatically or to determine the source of such a rapid loss of a high percentage of the blood or any signs and symptoms of hemorrhaging. Cross refer CFR 482.23(b)(3).

Review of the personnel record for Staff #6 revealed no documented evidence that Staff #6 RN was competent in phlebotomy lab specimen draws, Staff #6 incorrectly obtained a lab specimen from Patient #1 from an IV which was diluted and yielded erroneous results, resulting in Patient #1 receiving an unnecessary blood transfusion. Cross refer CFR 482.23(b)(5).

The above findings were confirmed in an interview with the Nurse Manager, Staff #4 the afternoon of 9/27/12 in the conference room.
VIOLATION: PATIENT RIGHTS: PARTICIPATION IN CARE PLANNING Tag No: A0130
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a review of patient records, the facility failed to ensure that the patient and the patient's representative were involved in the development and implementation of her plan of care as surgery was canceled without involving or notifying the patient and her husband.

Findings were:

Review of the medical record for Patient #1 revealed that she was admitted to the facility on [DATE] for a 4-part right proximal humerus fracture, displaced (impacted and comminuted). Surgery was scheduled for 8/23/12.

The patient was taken to surgery per nursing note dated 8/23/12 which stated, "1220- pt to surgery."

Patient #1 was anesthetized at 12:35 on 8/23/12. The anesthesiologist documented:
12:35 Anesthesia Time Out * Participated in anesthetic timeout prior to block insertion.
12:35 Fentanyl Citrate (PF) 50 mcg/ml IV Bolus. Amount Delivered 50 mcg
12:35 Midazolam 1 mg/ml IV Bolus Amount Delivered 1 mg

At 16:55 on 8/23/12, the anesthesiologist documented that "Case canceled per surgeon. He states that it is getting too late for him to do it today. He plans on doing this as outpatient surgery. Surgeon is aware that patient had interscalene nerve catheter placed in pre-op."

Patient #1 was in the OR from 12:20 until 18:30. There is no documented evidence in the record to suggest that Patient #1 or her husband were informed of the changed plan of care, and neither Patient #1 or her husband were provided the opportunity to be involved in the development or allowed to provide input to the plan of care when the surgeon canceled the surgery for Patient #1. Nursing note dated 8/23/12 stated, "1830 - pt back from preop. Canceled surgery. pt husband upset as nobody contacted him for updates, reassured husband."

At 20:15 on 8/23/12, Staff #13, the orthopedic surgeon, documented, "surgery canceled today because of scheduling conflicts in the OR and the late hour. I offered the patient and the family to have her discharged and we can do this later as an outpatient, but they want to have this done ASAP during this hospitalization . [Staff #9, physician for Patient #1] states that she is not able to be discharged home, that she will probably go to a nursing home. Therefore, I will schedule her for tomorrow afternoon."

The canceled surgery and delay in repairing the patient's fractured humerus resulted in another inpatient day for Patient #1, put her at risk for increased pain and lack of mobility, for a delay in healing, and for a delay in her return to activities of daily living. Patient #1, who was diagnosed on [DATE] with "Protein-calorie malnutrition with low albumin" was required to be NPO yet another day due to the canceled surgery. As pre-op medications (Fentanyl and Midazolam) were already administered to Patient #1 prior to canceling the surgery at 16:55, the patient was subjected to excessive medications unnecessarily, as they had to be re-administered on 8/24/12 when the surgery ultimately did occur.

The above findings were confirmed in an interview with the Nurse Manager, Staff #4 the afternoon of 9/27/12 in the conference room.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a review of medical records, facility policies and documents, and staff interviews, the facility failed to ensure that patients received care in a safe setting in that a patient received expired shoulder implants during a surgical procedure, patients were not assessed by physician and nurse when critical lab results were received, lab reports were not corrected when determined to be erroneous, and a blood transfusion was administered to a patient without an assessment to determine medical necessity and based on erroneous lab results.

Findings were:

Review of the medical record for Patient #1 revealed that she had a right ORIF humeral fracture hemiarthroplasty on 8/24/12 to repair a fractured humerus. The Stem Humeral ReUnion Fracture 8 MM right arm implant she received expired on [DATE], per the Nursing Intraop Record. The use of an implant after the expiration date increases the risk of infection and the sterility of the implant is not assured after the expiration date. There was no documented evidence in the record that the patient was notified, or that the manufacturer was notified of the expired implant used in the surgical procedure.

3 of 3 patient records reviewed revealed incorrect Troponin lab values were documented in the medical record on 08/09/12.

Patient # 2 had three elevated Troponin levels, documented as 0.052 on 08/09/12 at 12:02 AM, 0.052 on 08/09/12 at 05:50 AM, and 0.053 on 08/09/12 at 11:50 AM in the medical record. According to documentation, the laboratory retested these three specimens on 08/09/12 at 06:28 PM with resulting corrected Troponin levels of 0.010, all within normal limits.

Patient # 3 had one elevated Troponin level documented as 0.054 on 08/09/12 at 12:36 PM, in the medical record. According to documentation, the laboratory retested this specimen on 08/09/12 at 06:28 PM with a resulting correct Troponin level of 0.010, within normal limits.

Patient # 4 had one elevated Troponin level documented as 0.052 on 08/09/12 at 02:20 PM, in the medical record. According to documentation, the laboratory retested this specimen on 08/09/12 at 06:28 PM with a resulting correct Troponin level of 0.010, within normal limits.

The corrected Troponin levels were not found in 3 of the 3 patient medical records (Patients # 2, 3, and 4), nor is there documented evidence that nursing staff caring for these patients were made aware of the corrected Troponin levels.

According interviews with laboratory personnel, the incorrect elevated Troponin levels on 08/09/12 were the result of one chemical analyzer malfunctioning in the laboratory. There were no corrected lab values for the Troponin levels entered into these patients' medical charts. The incorrect elevated Troponin levels remained on the medical records. The laboratory did not contact or document contacting these patients' physicians regarding the elevated Troponin levels reported in error on 08/09/12.

1 of 1 patient records reviewed revealed incorrect hematology and chemistry lab values were documented in the medical record on 8/21/12.

Patient #1 had critical hematology lab results, documented as a hemoglobin of 7.5, hematocrit of 22.3, sodium as "Pending" and potassium as "Pending" reported on 8/21/12 at 05:12 AM. The hemoglobin was an erroneous result due to an incorrectly collected specimen. However, there was no documented evidence in the record that the lab report was corrected. The "Pending" results were not reported and not discovered until 11:15 AM when the laboratory manager noticed and called the nurse.

Review of the facility "Patient Safety Event/Incident Report" regarding Patient #1 dated 8/21/12 at 1230 from the Laboratory stated, in part, "pt came in w/hgb 13.1 on 8/20 1200. 7.5 Hgb was reported out on 8/21 @ 0512. Sample was contaminated w/IV fluid. 2 units crossmacth (sic) was ordered and one unit was started before the results were questioned by [Staff #11, General Lab Supervisor] due to the fact that some chemistry results were still on the pending list looked at the results on the [lab specimen analyzer] an (sic) realized that the sample was contaminated with IV fluid. Called to [Staff #12, RN] @1115 to redraw and to have the physician notified and to have the Dr. call the lab."


On 09/27/12, in an interview, the Laboratory Director acknowledged that there is currently no policy to issue corrected lab reports or to notify physicians or floor nursing staff of incorrect and/or corrected lab values.

2 of the 3 patients (Patients # 2 and 3) had cardiac catheterizations performed based partially on the incorrect Troponin lab values.

Facility policy & procedure titled Communicating Critical Patient Results stated, in part,

"Laboratory
Critical test results will be communicated to the responsible licensed caregiver within 1 hour from the time the result is verified in the laboratory. The 1 hour turnaround time is divided into: 10 minutes for the laboratory turnaround time from when the test result is verified as critical to the time when the patient care nurse receives the result ... "

"Laboratory Critical Limits" included Coagulation with the following critical limits: PT low >4 and high >25.0 and PTT low 18.0 and high 70.0.

A review of facility provided laboratory date revealed the following turnaround times from laboratory result received to time results were distributed:

Patient #5's STAT PT and PTT results were received at 1400 at 09/20/12 and distributed at 1900 on 09/20/12. There was a 5 hour delay between receiving the lab results and distribution.

Patient #7's STAT PT result was received at 1400 at 09/20/12 and distributed at 1900 on 09/20/12. There was a 5 hour delay between receiving the lab result and distribution.

A review of STAT Coagulation studies (PT, PTT, and Fibrinogen) collected between 09/20/12 and 09/22/12, revealed 5 out of 5 patient results took over 1 hour from collection to result.

Patient # 5's STAT PT and PTT specimens were collected at 1200 at 09/20/12 and the results received at 1900 on 09/20/12. There was a 2 hour delay from collection until the results were received.

Patient # 6's STAT PT specimen was collected at 1155 at 09/20/12 and the results received at 1945 on 09/20/12. There was a 7 hour and 50 minute delay from collection until the results were received.

Patient # 7's STAT PT specimen was collected at 0941 at 09/20/12 and the results received at 1400 on 09/20/12. There was a 4 hour and 19 minute delay from collection until the results were received.

Patient # 8's STAT PT specimen was collected at 1032 at 09/21/12 and the results received at 1600 on 09/21/12. There was a 5 hour and 28 minute delay from collection until the results were received.

Patient # 9's STAT Fibrinogen specimen was collected at 1215 at 09/22/12 and the results received at 1700 on 09/20/12. There was a 4 hour and 45 minute delay from collection until the results were received.

The average turnaround time for the STAT samples sent out to the laboratory was approximately 5 hours and 30 minutes.

The delay in obtaining Coagulation study results on patients in a timely manner, limits the facility's ability to provide emergency services that meets the needs of the community they serve.

Review of the record for Patient #1 revealed an Emergency Department Note of 8/20/12 at 13:27 which stated the patient had "no laboratory abnormalities of acute significance, except elevated WBC, elevated CPK, elevated liver function tests." Review of patient lab results on 8/20/2012 at 11:57 revealed the following:
Hemoglobin 13.3 [12.0-16.0 g/dL]
Potassium 3.5 [3.5-5.1 mmol/L]
Calcium 9.4 [8.6-10.2 mg/dL]
Creatinine 0.9 [0.5-0.9 mg/dL]

Review of patient lab results on 8/21/2012 at 04:10 revealed the following highly abnormal lab results, only 16 hours and 12 minutes after the previous lab report:
Hemoglobin 7.5 [12.0-16.0 g/dL]
Potassium 1.78 [3.5-5.1 mmol/L]
Calcium 4.4 [8.6-10.2 mg/dL]
Creatinine 0.16 [0.5-0.9 mg/dL]

Nursing note for Patient #1 on 8-21-12 by Staff #6, RN revealed the following: "0540: Phone call to on-call physician, Staff #8, lab results significantly lower than yesterday. Orders to type and cross, transfuse 2 units PRBC and give Lasix 20 mg IV x 1 between units."

The RN responsible for the patient failed to properly assess the patient as there was no documented evidence in the record by Staff #6 RN of an assessment of Patient #1 to determine why the patient's hemoglobin dropped so dramatically or to determine the source of such a rapid loss of a high percentage of the blood or any signs and symptoms of hemorrhaging. There was no documented evidence that the nurse interviewed the patient about any signs or symptoms of blood loss. There was no documentation that the patient had verbalized any complaints of weakness, lightheadedness, blood in stool, excessive vaginal bleeding, or other symptoms normally associated with a rapid decline in hemoglobin. There was no documented evidence that Staff #6 RN called the lab to question or verify the critical result from the lab.

Nursing note for Patient #1 on 8-21-12 by Staff #12 RN revealed the following: "1025- unit 1 of PRBC's up. VSS 97. 1-93-138/79- 18. 1040- vss- 128/73-82-98.0, pt tol well."

The day shift RN responsible for the patient also neglected to properly assess the patient as there was also no documented evidence in the record by Staff #12 RN of an assessment of Patient #1 to determine why the patient's hemoglobin dropped so dramatically or to determine or monitor the source of such a rapid loss of a high percentage of the blood, or an assessment of any signs or symptoms of hemorrhaging.

The MD responsible for the patient failed to properly assess the patient as there was no documented evidence in the record by Staff #6 MD of an assessment of Patient #1 or any orders for testing to determine why the patient's hemoglobin dropped so dramatically or to determine the source of such a rapid loss of a high percentage of the blood or any signs and symptoms of hemorrhaging. There was no documented evidence that the physician interviewed the patient about any signs or symptoms of blood loss. There was no documentation that the patient had verbalized any complaints of weakness, lightheadedness, blood in stool, excessive vaginal bleeding, or other symptoms normally associated with a rapid decline in hemoglobin. There was no documented evidence that the physician Staff #6 contacted the lab to question or verify the critical result from the lab.

Review of a facility "Patient Safety Event/Incident Report" dated 8/21/12 at 2030 stated, in part, "AM labs drawn showed a [decrease] in Hgb from 13 to 7. On call MD ...ordered 2 units PRBC. Pt type + screen. 1st unit of blood [up] at ~ 1030. RN rec'd call from blood bank at approx. [1100 and 1200 both written] questioning results as everything appeared low. Dr. ...notified, he stated he ordered STAT redraws @ 0730 but did not call the floor to update RN. Labs collected and sent @ ~ 1100. HGB found to be 10, pt has been receiving IVF @ 150 ml/hr. Blood transfusion stopped at ~1200 ..."

Review of facility document, handwritten on blank piece of paper, stated, "13.3 on 8/20 @ 1200 - 7.5 on 8/21 @ 0512. Night shift nurse called the physician with the results. He said to transfuse. Per [Staff #12, RN] @ 1115. So the problem hits all areas. 1st the sample was not collected properly, 2nd the lab tech screwed up and will be terminated before her next shift. 3rd nurse did not question results and question where the pt is bleeding from and where the blood is going to. 4th doctor did not question results from a 13.3 Hgb to a 7.5 Hgb in less than 18 hrs. "

On 8-21-12, Staff #9, physician for Patient #1 documented in the record for Patient #1, "pt had reported Hgb of 7.7. 1 unit PRBC ordered and started. repeat CBC ordered stat, shows Hgb 10.9. discussed with lab, prior am lab with Hgb 7.7 also had abnormal calcium/potassium levels that were an error, thus Hgb 7.7 was likely an error. Transfusion discontinued, and pt and husband counseled (sic) of these findings, and that transfusion to be discontinued. no evidence of occult bleeding, except to shoulder injury."

Review of facility policy PC.004.01 entitled, "Assessment and Re-assessment" stated, in part, "Re-Assessment
1. Each patient is reassessed:
a. To determine the patient's response to care, treatment and services and progress toward or variance from treatment outcomes;
b. To determine when there is significant change in the patient's condition and/or diagnosis and communicate changes to the physician ...

DOCUMENTATION A. USAGE Assessment, reassessment, and the care planning process is to be documented on approved electronic forms as appropriate to the needs of the patient.
Documentation will be used to show evidence of: ...
3. Screening to identify high-risk patients who may need referral for specialized assessments...
6. Reassessment to determine response to interventions and progress toward achievement of desired outcomes "

The above findings were confirmed in an interview in the conference room the afternoon of 9/27/12 with the Nurse Manager, Staff #4.
VIOLATION: ORGANIZATION OF NURSING SERVICES Tag No: A0386
Based on a review of facility policies and staff interviews, the facility failed to ensure that the director of nursing service established a Nursing Peer Review Committee as required by facility policy and state law.

Findings were:

Review of Texas Administrative Code, Texas Board of Nursing, Section 217.19 (c) Applicability of Incident-Based Peer Review. TOC ?303.0015 (NPR Law) requires a person who regularly employs, hires or contracts for the services of ten (10) or more nurses (for peer review of an RN, at least 5 of the 10 must be RNs) to conduct nursing peer review for purposes of TOC ?301.401(1) and ?301.402(e) (NPA) (relating to alternate reporting by nurses to nursing peer review when a nurse engages in conduct subject to reporting), ?301.403 (relating to nursing peer review committee reporting), ?301.405(c) (relating to nursing peer review of external factors as part of employer reporting), and ?301.407(b) (relating to alternate reporting by state agencies to peer review).

Review of Texas Occupations Code, Sec. 303.0015. REQUIRED ESTABLISHMENT OF NURSING PEER REVIEW COMMITTEE. (a) A person shall establish a nursing peer review committee to conduct nursing peer review under this chapter and Chapter 301 ...(2) for professional nurses, if the person regularly employs, hires, or contracts for the services of 10 or more nurses, at least five of whom are registered nurses.

Review of facility policy, "Incident-Based Nursing Peer Review" stated in part, "A. The Peer Review Committee (PRC) shall operate in accordance with policy and the requirements of the Peer Review (PR) Code 303.002(e) and Board of Nurse Examiner (BNE) rule relating to minimum due process during incident-based peer review ...a. The PRC is established under the authority of the governing body of the LRMC ... "

In an interview with Staff #2, Risk Management Director on 9/27/12, she stated that the hospital had a policy requiring a hospital nursing peer review committee, but that the hospital did not have a nursing peer review committee. Staff #2 was unable to provide documented evidence of an established nursing peer review committee.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a review of facility policies and documentation, personnel records, patient records, and staff interviews, the facility failed to ensure that nursing care for patients was properly supervised, implemented and evaluated for each patient based on their presentation and assessment.

Findings were:

Review of the record for Patient #1 revealed an Emergency Department Note of 8/20/12 at 13:27 which stated the patient had "no laboratory abnormalities of acute significance, except elevated WBC, elevated CPK, elevated liver function tests. "

Review of patient lab results on 8/20/2012 at 11:57 revealed the following:
Hemoglobin 13.3 [12.0-16.0 g/dL]
Potassium 3.5 [3.5-5.1 mmol/L]
Calcium 9.4 [8.6-10.2 mg/dL]
Creatinine 0.9 [0.5-0.9 mg/dL]

Review of patient lab results on 8/21/2012 at 04:10 revealed the following highly abnormal lab results, only 16 hours and 12 minutes after the previous lab report:
Hemoglobin 7.5 [12.0-16.0 g/dL]
Potassium 1.78 [3.5-5.1 mmol/L]
Calcium 4.4 [8.6-10.2 mg/dL]
Creatinine 0.16 [0.5-0.9 mg/dL]

Nursing note for Patient #1 on 8-21-12 by Staff #6, RN revealed the following:
"0540: Phone call to on-call physician, Staff #8, lab results significantly lower than yesterday. Orders to type and cross, transfuse 2 units PRBC and give Lasix 20 mg IV x 1 between units."

The RN responsible for the patient failed to properly assess the patient as there was no documented evidence in the record by Staff #6 RN of an assessment of Patient #1 to determine why the patient's hemoglobin dropped so dramatically or to determine the source of such a rapid loss of a high percentage of the blood or any signs and symptoms of [DIAGNOSES REDACTED]#6 RN called the lab to question or verify the critical result from the lab.

Nursing note for Patient #1 on 8-21-12 by Staff #12 RN revealed the following:
"1025- unit 1 of PRBC ' s up. VSS 97. 1-93-138/79- 18. 1040- vss- 128/73-82-98.0, pt tol well."

The day shift RN responsible for the patient also neglected to properly assess the patient as there was also no documented evidence in the record by Staff #12 RN of an assessment of Patient #1 to determine why the patient ' s hemoglobin dropped so dramatically or to determine or monitor the source of such a rapid loss of a high percentage of the blood, or an assessment of any signs or symptoms of [DIAGNOSES REDACTED]

Nursing note for Patient #1 on 8-21-12 by Staff # 12 RN revealed the following:
"1130-labs redrawn as lab thinks am contaminated. awaiting results. 1205- blood transfusion stopped as per Dr's order. Pt received (sic) approx. 150cc of blood. no sign of distress."

Review of patient lab results on 8/21/2012 at 11:30 revealed the following:
Hemoglobin 10/9 [12.0-16.0 g/dL]
Potassium 3.2 [3.5-5.1 mmol/L]
Calcium 7.9 [8.6-10.2 mg/dL]
Creatinine 0.4 [0.5-0.9 mg/dL]

In an interview with Staff #4, Nurse Manager, she confirmed that Staff #6 incorrectly obtained the lab specimen from the IV of Patient #6, thereby diluting the specimen which resulted in inaccurate lab results. This was not determined until after the patient received 150 ccs of packed red blood cells.

Review of facility policy PC.004.01 entitled, "Assessment and Re-assessment" stated, in part, "Re-Assessment
1. Each patient is reassessed:
a. To determine the patient's response to care, treatment and services and progress toward or variance from treatment outcomes;
b. To determine when there is significant change in the patient's condition and/or diagnosis and communicate changes to the physician ...

DOCUMENTATION A. USAGE Assessment, reassessment, and the care planning process is to be documented on approved electronic forms as appropriate to the needs of the patient.
Documentation will be used to show evidence of: ...
3. Screening to identify high-risk patients who may need referral for specialized assessments ...
6. Reassessment to determine response to interventions and progress toward achievement of desired outcomes."

Review of facility document, handwritten note on blank piece of paper, stated, "13.3 on 8/20 @ 1200 - 7.5 on 8/21 @ 0512. Night shift nurse called the physician with the results. He said to transfuse...1st the sample was not collected properly ... 3rd nurse did not question results and question where the pt is bleeding from and where the blood is going to."

Review of the personnel record for Staff #6 RN revealed an entry dated 9/12/12 written and signed by the Nurse Manager which stated "We revisited the incident from 8/26/12 and discussed that there were no signs and symptoms of [DIAGNOSES REDACTED]"

Ultimately, the patient received a blood transfusion which was not medically indicated, which exposed the patient to risks such as an allergic reaction, febrile reaction, acute or delayed [DIAGNOSES REDACTED] reaction, blood borne infections, and iron overload, which could damage the heart or liver.

Review of the medical record for Patient #1 revealed concurrent active and conflicting vital signs orders, as vital signs orders were not discontinued when new orders were entered. There were three active orders for hourly vital signs for Patient #1 that were active until her discharge. The vital signs orders are as follows:

? Vital Signs hourly, STAT on arrival. Ordered at 11:37 on 8/20/12; the order was not discontinued until 8/28/12 at 14:54 at the patient's discharge.

? Vital Signs Routine every 8 hours. Ordered at 14:03 on 8/20/12; discontinued on 8/28/12 at 14:54 at discharge.

? Vital Signs q15 x 4, then q30 x 2 then 1 hour. Ordered at 19:44 on 8/24/12; the order was not discontinued until 8/28/12 at 14:54 at the patient's discharge.

? Vital Signs every 15 minutes for 4 times, 15 x 4 then 30 x 2 then q1 hour. Ordered at 19:44 on 8/24/12; the order was not discontinued until 8/28/12 at 14:54 at the patient's discharge.

? Vital Signs every 4 hours per protocol. Ordered at 23:34 on 8/24/12; the order was not discontinued until 8/28/12 at 14:54 at the patient's discharge.

Review of the Vital Signs Measurements as provided by Staff #4 for Patient #1 revealed that vital signs were documented at the follow times:

? 8/20/12 at 1143, 1226, 1304, 1449, 1713, and 1926;

? 8/21/12 at 0457, 0857, 1134, 1753, and 193;

? 8/22/12 at 0027, 0759, 1143, 1626, 2038, and 2058;

Vital signs failed to be documented hourly as ordered throughout the rest of the hospitalization for Patient #1, including the post-operative period. Monitoring or documenting vital signs as ordered after surgery allows for early detection and intervention of physiologic abnormalities that could develop, such as a change in temperature indicating infection, change in heart rate or blood pressure indicating hemorrhage or blood loss or a precursor to a cardiac event. In an interview with the nurse manager the afternoon of 9/27/12 in the conference room, she confirmed that the patient had active conflicting vital signs orders.

The above findings were confirmed in the conference room the afternoon of 9/27/12 with Staff #4.
VIOLATION: PATIENT CARE ASSIGMENTS Tag No: A0397
Based on review of patient records, facility policies, personnel records, and staff interviews, the facility failed to ensure that the nursing care of patients was assigned based on verified nursing competency in accordance with each patient's individualized needs.

Findings were:

Review of the personnel records for the nurse assigned to Patient #1 and the medical record for Patient #1 revealed that the nurse's competency in collecting lab specimens and in phlebotomy had not been verified or documented at the time of the specimen collection. The nurse assigned to Patient #1 incorrectly collected a lab specimen from an IV, resulting in erroneous results and, based on those results, exposed the patient to a blood transfusion that was not clinically indicated.

Review of the facility "Patient Safety Event/Incident Report" dated 8/21/12 at 1230 stated, in part, "pt came in w/hgb 13.1 on 8/20 1200. 7.5 Hgb was reported out on 8/21 @ 0512. Sample was contaminated w/IV fluid. 2 units crossmacth (sic) was ordered and one unit was started before the results were questioned by [Staff #11, General Lab Supervisor] due to the fact that some chemistry results were still on the pending list ...realized that the sample was contaminated with IV fluid."

Review of facility document, handwritten on blank piece of paper, stated, "13.3 on 8/20 @ 1200 - 7.5 on 8/21 @ 0512. Night shift nurse called the physician with the results. He said to transfuse...1st the sample was not collected properly ... 3rd nurse did not question results and question where the pt is bleeding from and where the blood is going to."

Review of the personnel record for Staff #6 RN revealed she was hired by the facility on 7/11/12. Per the general nursing "INITIAL Competency Validation Summary" for Staff #6 RN, the competency assessment for "Specimen Collection " was not documented or competency validated until 9/13/12, which was 24 days after Staff #6 RN incorrectly obtained a lab specimen from Patient #1 (8/21/12) resulting in a blood transfusion that was not medically indicated.

Review of the personnel record for Staff #6 RN also revealed that the specific "Competency Checklist Phlebotomy and Labeling and Labeling of Specimens" was not initiated or competency documented with Staff #6 RN until 8/26, which was 6 days after the lab specimen was incorrectly obtained by Staff #6 RN from Patient #1 resulting in a blood transfusion that was ordered and administered based on erroneous results and was not medically indicated.

Review of facility document, "Competency Checklist Phlebotomy and Labeling of Specimens" stated, in part "Washes hands, dons gloves, pauses all IV fluids being administered into the same limb being used for phlebotomy, and applies tourniquet. Veins palpated for potential draws."

Review of the personnel record for Staff #6 RN revealed an entry dated 8/26/12 written by the Nurse Manager which stated, in part, "The blood draw and orders for transfusion on 8/21/12 have been discussed with [Staff #6 RN] ...She should have redrawn that sample to check for accuracy given that it was a substantial drop and there were no signs or symptoms of bleeding. She is still struggling with difficult sticks ...we do not have a phlebotomist at this time ...She has been instructed not to ever draw blood from an IV for a type and cross or screen. She will require further monitoring and education to assist with her knowledge."

The above findings were confirmed in an interview with the Nurse Manager, Staff #4 in the conference room the afternoon of 9/27/12.
VIOLATION: QAPI Tag No: A0263
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


The surveyors were provided with the QAPI reports for the months in which meetings of the QAPI committee had been held. It was noted that there was only one patient-care related complaint included in the minutes for the six months that the facility has been operational. However, review of a medical record (Patient #1) revealed that the spouse of the patient complained and was upset over a surgery that had been canceled and an unnecessary blood transfusion. This was not included as a complaint in the facility's QAPI data. The only complaint that was included was that of a family member that complained that a patient had been treated rudely by a staff member.

Although there were numerous incidents of inaccurate and late STAT labs, there was no mention of these found in the QAPI minutes. Survey staff was informed that these types of issues were discussed during the daily "huddles" held each weekday morning with administrative staff; however, there was no documentation of what occurred in these "huddles," that were available for review.

A [AGE] year old female patient was in the facility's Intensive Care Unit on 7/20/12, and her physician ordered a blood transfusion and an antibody screen at 1420. However, the phlebotomist, a registered nurse on the unit, failed to place her initials on the tube containing the blood, signifying that she, the nurse, had drawn the patient's blood. Due to the fact that the initials were not on the tube, the lab did not process this blood sample. A second blood sample on this patient had to be drawn at 1700, thus delaying the care of this patient. The laboratory did not communicate the missing initials to the nursing staff nor did they communicate the fact that the laboratory chose not to process the blood sample. This incident was not included in the QAPI findings; although it was found in an incident report.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on review of data, review of records, policies and procedures, and interviews, it was determined that the facility failed to use the data collected in their QAPI program to affect changes that could result in improvement in the communications between the laboratory and nursing staff to ensure the quality of care provided to patients. Findings included:

1. On 09/27/12, in an interview, the Laboratory Director acknowledged that there is no current policy to issue corrected lab reports or to notify physicians or floor nursing staff of incorrect and/or corrected lab values.

2. The facility has a policy regarding laboratory services, entitled Communicating Critical Patient Results , which stated, in part,

"Laboratory
Critical test results will be communicated to the responsible licensed caregiver within 1 hour from the time the result if verified in the laboratory. The 1 hour turnaround time is divided into: 10 minutes for the laboratory turnaround time from when the test result is verified as critical to the time when the patient care nurse receives the result ... "

A review of facility provided laboratory data revealed the following turnaround times from laboratory result received to time results were distributed:

Patient #5's STAT PT and PTT results were received at 1400 at 09/20/12 and distributed at 1900 on 09/20/12. There was a 5 hour delay between receiving the lab results and distribution.

Patient #7's STAT PT result was received at 1400 at 09/20/12 and distributed at 1900 on 09/20/12. There was a 5 hour delay between receiving the lab result and distribution.

On 7/12/2012, a female patient was seen in the emergency room , and a Troponin level was required to be done STAT; however, the level took well over an hour to be communicated to the emergency room from the laboratory. This same patient presented again to the emergency room on [DATE], again required a STAT Troponin level, and it again was over an hour for the results to be communicated to the emergency department, outside of the time frame listed in the laboratory policy regarding STAT labs.

3. The facility had this data available to them; however, there was no documented evidence of activities designed to affect improvement in the area of communication between the laboratory and the nursing staff that would enhance patient care.
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0450
Based on a review of patient records and staff interviews, the facility failed to ensure that all patient medical record entries were accurately timed to ensure integrity of the medical record.

Findings were:

Review of the record for Patient #1 revealed that Staff #9, MD began a "Daily Progress Note" electronic medical record entry on 08-21-2012 at 07:36. However, the Daily Progress Note was also "Last Updated: 08-21-2012 12:17 by [Staff #9]" The progress note, initiated at 07:36, included documentation of an event that occurred at approximately 11:15 on 8/21/12.

The Daily Progress Note from 8/21/12 is as follows:

"h/p x 3

pt had reported hgb of 7.7. 1 unit prbcs ordered and started. repeat cbc ordered stat, shows hgb 10.9. discussed with lab, prior am lab with hgb 7.7 also had abnormal calcium/potassium levels that were an error, thus hgb 7.7 was likely an error. Transfusion discontinued, and pt and husband counselled (sic) of these findings, and that transfusion to be discontinued. no evidence of occult bleeding, except to shoulder injury."

In an interview the afternoon of 9/27/12 with Staff #4, Nurse Manager, she confirmed the above. Staff #4 stated that Staff #9, MD, always makes an electronic medical record entry "just like the 'h/p 3' entry when he dictates a note " for the medical record. Staff #4 stated that the entry of " h/p 3 " was "probably made" at 07:36. She stated the information about lab error and inappropriate blood transfusion for Patient #1 was probably added later, presumably during the entry at 12:17.

When asked about documentation of timing of the entries, Staff #4 stated she was not sure of the time each of the entries was actually made. Staff #4 was unable to determine from the electronic medical record the exact time each of the entries was actually made into or amended in the medical record. Staff #4 stated that the electronic medical does not include a system of timing entries or corrections, amendments or deletions made in the electronic medical record. Timing of medical record entries protects the security of the medical record and establishes a time frame within which a patient care activity occurred. Timing of entries is necessary for patient safety by establishing a baseline for future actions, such as assessments, risk management, or quality activities. Staff #4 was unable to discuss or demonstrate how the facility prevents or tracks alterations or additions to record entries after the record has been authenticated.
VIOLATION: CONTENT OF RECORD - OTHER INFORMATION Tag No: A0467
Based on a review of facility policies and documents, medical records, and staff interviews, the facility failed to ensure medical records contained adequate information necessary to monitor patient conditions as there was no documented evidence of an assessment of a patient with critical lab results and active patient monitoring orders were conflicting. The facility also failed to ensure that lab reports were corrected in the medical record.

Findings were:

3 of 3 patient records reviewed revealed incorrect Troponin lab values were documented in the medical record on 08/09/12.

Patient # 2 had three elevated Troponin levels, documented as 0.052 on 08/09/12 at 12:02 AM, 0.052 on 08/09/12 at 05:50 AM, and 0.053 on 08/09/12 at 11:50 AM in the medical record. According to documentation, the laboratory retested these three specimens on 08/09/12 at 06:28 PM with resulting corrected Troponin levels of 0.010, all within normal limits.

Patient # 3 had one elevated Troponin level documented as 0.054 on 08/09/12 at 12:36 PM, in the medical record. According to documentation, the laboratory retested this specimen on 08/09/12 at 06:28 PM with a resulting correct Troponin level of 0.010, within normal limits.

Patient # 4 had one elevated Troponin level documented as 0.052 on 08/09/12 at 02:20 PM, in the medical record. According to documentation, the laboratory retested this specimen on 08/09/12 at 06:28 PM with a resulting correct Troponin level of 0.010, within normal limits.

The corrected Troponin levels were not found in 3 of the 3 patient medical records (Patients # 2, 3, and 4), nor is there documented evidence that nursing staff caring for these patients were made aware of the corrected Troponin levels.

According to interviews with laboratory personnel, the incorrect elevated Troponin levels on 08/09/12 were the result of one chemical analyzer malfunctioning in the laboratory. There were no corrected lab values for the Troponin levels entered into these patients ' medical charts. The incorrect elevated Troponin levels remained on the medical records. The laboratory did not contact or document contacting these patients' physicians regarding the elevated Troponin levels reported in error on 08/09/12.

1 of 1 patient records reviewed revealed incorrect hematology and chemistry lab values were documented in the medical record on 8/21/12.

Patient #1 had critical hematology lab results, documented as a hemoglobin of 7.5, hematocrit of 22.3, sodium as "Pending" and potassium as "Pending" reported on 8/21/12 at 05:12 AM. The hemoglobin was an erroneous result due to an incorrectly collected specimen; however there was no documented evidence in the record that the lab report was corrected. The "Pending" results were not reported and not discovered until 11:15 AM when the laboratory manager noticed and called the nurse.

Review of the facility "Patient Safety Event/Incident Report" regarding Patient #1 dated 8/21/12 at 1230 from the Laboratory stated, in part, "pt came in w/hgb 13.1 on 8/20 1200. 7.5 Hgb was reported out on 8/21 @ 0512. Sample was contaminated w/IV fluid. 2 units crossmacth (sic) was ordered and one unit was started before the results were questioned by [Staff #11, General Lab Supervisor] due to the fact that some chemistry results were still on the pending list looked at the results on the [lab specimen analyzer] an (sic) realized that the sample was contaminated with IV fluid. Called to [Staff #12, RN] @1115 to redraw and to have the physician notified and to have the Dr. call the lab."

2 of the 3 patients (Patients # 2 and 3) had cardiac catheterizations performed based partially on the incorrect Troponin lab values.

Review of patient # 4's medical record revealed, two concurrent, active, and conflicting orders for vital signs. One order was for vital signs hourly entered at 1237 on 08/09/12 and was discontinued upon discharge at 1312 on 08/10/12. The second order indicated vital signs every eight hours entered on 08/09/12 and was discontinued upon discharge at 1312 on 08/10/12

Patient # 4's vitals were monitored hourly until 08/09/12 at 2345. The patient ' s vitals were then monitored on 08/10/12 at 0447 an 0815.

Patient # 4 did not have his vitals properly monitored hourly per physician orders on the date of 08/10/12.

The lack of information necessary to monitor patient condition in the medical record was confirm in an interview with lab personnel on 09/26/12 and the director of quality management on 09/27/12.


Review of the record for Patient #1 revealed an Emergency Department Note of 8/20/12 at 13:27 which stated the patient had "no laboratory abnormalities of acute significance, except elevated WBC, elevated CPK, elevated liver function tests."

Review of patient lab results on 8/20/2012 at 11:57 revealed the following:
Hemoglobin 13.3 [12.0-16.0 g/dL]
Potassium 3.5 [3.5-5.1 mmol/L]
Calcium 9.4 [8.6-10.2 mg/dL]
Creatinine 0.9 [0.5-0.9 mg/dL]

Review of patient lab results on 8/21/2012 at 04:10 revealed the following highly abnormal lab results, only 16 hours and 12 minutes after the previous lab report:
Hemoglobin 7.5 [12.0-16.0 g/dL]
Potassium 1.78 [3.5-5.1 mmol/L]
Calcium 4.4 [8.6-10.2 mg/dL]
Creatinine 0.16 [0.5-0.9 mg/dL]

07:36; however an amendment was made to the above progress note at 12:17. In an interview with Staff #4 the afternoon of 9/27/12 in the conference room, she confirmed that medical records progress notes can be amended, but the electronic medical record system does not indicate specifically what content was amended and when.

Review of the medical record for Patient #1 revealed concurrent active and conflicting vital signs orders, as vital signs orders were not discontinued when new orders were entered:

? Vital Signs hourly, STAT on arrival. Ordered at 11:37 on 8/20/12; the order was not discontinued until 8/28/12 at 14:54 at the patient ' s discharge.

? Vital Signs Routine every 8 hours. Ordered at 14:03 on 8/20/12; discontinued on 8/28/12 at 14:54 at discharge.

? Vital Signs q15 x4, then q30 x 2 then 1 hour. Ordered at 19:44 on 8/24/12; the order was not discontinued until 8/28/12 at 14:54 at the patient ' s discharge.

? Vital Signs every 15 minutes for 4 times, 15 x 4 then q30 x 2 then q1 hour. Ordered at 19:44 on 8/24/12; the order was not discontinued until 8/28/12 at 14:54 at the patient ' s discharge.

? Vital Signs every 4 hours per protocol. Ordered at 23:34 on 8/24/12; the order was not discontinued until 8/28/12 at 14:54 at the patient ' s discharge.

In an interview with the nurse manager the afternoon of 9/27/12 in the conference room, she confirmed that the patient had active conflicting vital signs orders.

The above findings were confirmed in the conference room the afternoon of 9/27/12 with the nurse manager and the Director of Risk Management.
VIOLATION: CONTENT OF RECORD - DISCHARGE SUMMARY Tag No: A0468
Based on a review of records, the facility failed to ensure that medical records contained a discharge summary.

Findings were:

A review of medical records on 09/26/12, revealed 1 out of 3 patients (Patient # 4) did not have a discharge summary in his medical record. Patient # 4 was discharged from this facility on 08/10/12.

Facility Medical Staff Rules and Regulations stated in part,

"11.3.3 Medical records must be completed promptly and all reports that require authentication must be authenticated by a physician within fourteen 914) days following the patient discharge.

11.3.4 If a patient ' s medical record remains incomplete more than thirty (30) days after discharge for any reason, it is delinquent ...

11.8.9 Discharge Summary: A discharge clinical summary shall be entered promptly into the medical record and include the following: reason for hospitalization , significant findings, procedures performed and treatment rendered, condition of patient on discharge relating to diet, medication, activity, and follow-up care."
VIOLATION: LABORATORY SERVICES Tag No: A0576
Based on a review of medical records, facility documents, and staff interviews, the facility failed to ensure that adequate laboratory services were available or utilized to meet the needs of its patient population as a contaminated specimen was received by the lab, but the lab technician failed to communicate or take action in a timely manner; lab values were incorrectly documented in the medical record; and corrected lab values were not updated.

An Immediate Jeopardy exists due to the fact that two of thee patient with incorrect and non-updated lab values, specifically Troponin levels, had cardiac catheterizations performed on an emergently based partially on erroneous lab values. Not having corrected lab values available to treating physicians jeopardizes the safety and well-being of all patients served by or seeking services at the facility.

Findings were:

3 of 3 patient records reviewed revealed incorrect Troponin lab values were documented in the medical record on 08/09/12.

Patient # 2 had three elevated Troponin levels, documented as 0.052 on 08/09/12 at 12:02 AM, 0.052 on 08/09/12 at 05:50 AM, and 0.053 on 08/09/12 at 11:50 AM in the medical record. According to documentation, the laboratory retested these three specimens on 08/09/12 at 06:28 PM with resulting corrected Troponin levels of 0.010, all within normal limits.

Patient # 3 had one elevated Troponin level documented as 0.054 on 08/09/12 at 12:36 PM, in the medical record. According to documentation, the laboratory retested this specimen on 08/09/12 at 06:28 PM with a resulting correct Troponin level of 0.010, within normal limits.

Patient # 4 had one elevated Troponin level documented as 0.052 on 08/09/12 at 02:20 PM, in the medical record. According to documentation, the laboratory retested this specimen on 08/09/12 at 06:28 PM with a resulting correct Troponin level of 0.010, within normal limits.

The corrected Troponin levels were not found in 3 of the 3 patient medical records (Patients # 2, 3, and 4), nor is there documented evidence that nursing staff caring for these patients were made aware of the corrected troponin levels.

According interviews with laboratory personnel, the incorrect elevated troponin levels on 08/09/12 were the result of one chemical analyzer malfunctioning in the laboratory. There were no corrected lab values for the troponin levels entered into these patients' medical charts. The incorrect elevated troponin levels remained on the medical records. The laboratory did not contact or document contacting these patients' physicians regarding the elevated troponin levels reported in error on 08/09/12.

On 09/27/12, in an interview, the Laboratory Director acknowledged that there is currently no policy to issue corrected lab reports or to notify physicians or floor nursing staff of incorrect and/or corrected lab values.

2 of the 3 patients (Patients # 2 and 3) had cardiac catheterizations performed based partially on the incorrect troponin lab values.

Facility policy & procedure titled Communicating Critical Patient Results stated, in part,

"Laboratory
Critical test results will be communicated to the responsible licensed caregiver within 1 hour from the time the result is verified in the laboratory. The 1 hour turnaround time is divided into; 10 minutes for the laboratory turnaround time from when the test result is verified as critical to the time when the patient care nurse receives the result ... "

"Laboratory Critical Limits" included Coagulation with the following critical limits: PT low >4 and high >25.0 and PTT low 18.0 and high 70.0.

A review of facility provided laboratory date revealed the following turnaround times from laboratory result received to time results were distributed:

Patient #5's STAT PT and PTT results were received at 1400 at 09/20/12 and distributed at 1900 on 09/20/12. There was a 5 hour delay between receiving the lab results and distribution.

Patient #7's STAT PT result was received at 1400 at 09/20/12 and distributed at 1900 on 09/20/12. There was a 5 hour delay between receiving the lab result and distribution.

A review of STAT Coagulation studies (PT, PTT, and Fibrinogen) collected between 09/20/12 and 09/22/12, revealed 5 out of 5 patient results took over 1 hour from collection to result.

Patient # 5's STAT PT and PTT specimens were collected at 1200 at 09/20/12 and the results received at 1900 on 09/20/12. There was a 2 hour delay from collection until the results were received.

Patient # 6's STAT PT specimen was collected at 1155 at 09/20/12 and the results received at 1945 on 09/20/12. There was a 7 hour and 50 minute delay from collection until the results were received.

Patient # 7's STAT PT specimen was collected at 0941 at 09/20/12 and the results received at 1400 on 09/20/12. There was a 4 hour and 19 minute delay from collection until the results were received.

Patient # 8's STAT PT specimen was collected at 1032 at 09/21/12 and the results received at 1600 on 09/21/12. There was a 5 hour and 28 minute delay from collection until the results were received.

Patient # 9's STAT Fibrinogen specimen was collected at 1215 at 09/22/12 and the results received at 1700 on 09/20/12. There was a 4 hour and 45 minute delay from collection until the results were received.

The average turnaround time for the STAT samples sent out to the laboratory was approximately 5 hours and 30 minutes.

The delay in obtaining Coagulation study results on patients in a timely manner, limits the facilities ability to provide adequate emergency services to the community.

On 8/21/12, the laboratory received a blood specimen for Patient #1, which had been incorrectly drawn from her IV at 04:10. The blood specimen was diluted and contaminated with the IV fluid and was not a valid sample, resulting incorrect lab values. However the inaccurate results were reported as actual and accurate results on 8/21/12 at 05:12. The incorrect lab results included a critically low hemoglobin of 7.5 [12.0-16.0 g/Dl]. In addition, the potassium and calcium results from the same specimen were reported as "Pending" and accurate results were never reported. Based on the inaccurate results, the physician ordered a blood transfusion. The error was not realized until 11:15 AM when the day shift laboratory supervisor notified the nurse and the transfusion was discontinued. The night shift lab tech failed to retest or validate specimens that were obviously contaminated, failed to notify the physician or nurse that the specimens were contaminated, failed to issue lab reports for the "pending" specimens, and failed to issue corrected reports.

Review of facility document, handwritten on blank piece of paper, referring to the incident with Patient #1, stated, "13.3 on 8/20 @ 1200 - 7.5 on 8/21 @ 0512. Night shift nurse called the physician with the results. He said to transfuse. Per [Staff #12, RN] @ 1115. So the problem hits all areas. 1st the sample was not collected properly 2nd the lab tech screwed up and will be terminated before her next shift."

Review of print out of lab results for Patient #1 on 8/21/12 included CA 4.4L; Crea 0.16 <Test; K 1.78L; and handwritten on the print out was "results that were still pending big clue that the sample was contaminated with IV fluid" indicating that the lab technician should have been aware that the sample was contaminated.

Review of the facility "Patient Safety Event/Incident Report" regarding Patient #1 dated 8/21/12 at 1230 from the Laboratory stated, in part, "pt came in w/hgb 13.1 on 8/20 1200. 7.5 Hgb was reported out on 8/21 @ 0512. Sample was contaminated w/IV fluid. 2 units crossmacth (sic) was ordered and one unit was started before the results were questioned by [Staff #11, General Lab Supervisor] due to the fact that some chemistry results were still on the pending list looked at the results on the [lab specimen analyzer] an (sic) realized that the sample was contaminated with IV fluid. Called to [Staff #12, RN] @1115 to redraw and to have the physician notified and to have the Dr. call the lab."

Review of a facility "Patient Safety Event/Incident Report" regarding Patient #1 dated 8/21/12 at 2030 stated, in part, "AM labs drawn showed a [decrease] in Hgb from 13 to 7. On call MD ...ordered 2 units PRBC. Pt type + screen. 1st unit of blood [up] at ~ 1030. RN rec'd call from blood bank at approx. [1100 and 1200 both written] questioning results as everything appeared low. [Staff #9, Physician for Patient #1] notified, he stated he ordered STAT redraws @ 0730 but did not call the floor to update RN. Labs collected and sent @ ~ 1100. HGB found to be 10, pt has been receiving IVF @ 150 ml/hr. Blood transfusion stopped at ~1200 ..."

Review of medical record for Patient #1 revealed the following lab results:
8/20/2012 11:57
Hemoglobin 13.3 [12.0-16.0 g/dL]
Potassium 3.5 [3.5-5.1 mmol/L]
Calcium 9.4 [8.6-10.2 mg/dL]
Creatinine 0.9 [0.5-0.9 mg/dL]

8/21/2012 04:10
Hemoglobin 7.5 [12.0-16.0 g/dL]
Potassium 1.78 [3.5-5.1 mmol/L]
Calcium 4.4 [8.6-10.2 mg/dL]
Creatinine 0.16 [0.5-0.9 mg/dL]

Review of the medical record for Patient #1 revealed that the patient did receive a blood transfusion that was not medically indicated due to erroneous lab results. The erroneous lab results were reported on 8/21/12 at 04:10; the lab did not take action or notify the nursing floor until around 11:30.

Nursing note on Patient #1 on 8-21-12 by Staff #6, RN revealed the following:
0540: "Phone call to [Staff #8, on-call MD], lab results significantly lower than yesterday. Orders to type and cross, transfuse 2 units PRBC and give Lasix 20 mg IV x 1 between units."

Nursing note on Patient #1 on 8/21/12 by Staff #12, RN revealed the following:
1025- unit 1 of prbc's up. Vss 97. 1-93-138/79- 18.
1040- vss- 128/73-82-98.0, pt tol well.
1130-lab redrawn as lab thinks am contaminated. awaiting results.
1205- blood transfusion stopped as per dr.s order. Pt received (sic) approx. 150cc of blood. no sign of distress.

On 8-21-12, Staff #9, MD documented in a progress note for Patient #1 the following:
"pt had reported hgb of 7.7. 1 unit prbcs ordered and started. repeat cbc ordered stat, shows hgb 10.9. discussed with lab, prior am lab with hgb 7.7 also had abnormal calcium/potassium levels that were an error, thus hgb 7.7 was likely an error. Transfusion discontinued, and pt and husband counseled (sic) of these findings, and that transfusion to be discontinued. no evidence of occult bleeding, except to shoulder injury."

8-22-12 at 1739 Staff #9, MD documented that Patient #1 was cleared for surgery for the right humerus fracture and documented "Anemia acute blood loss: mild. erroneous lab led to inadvertent blood transfusion exposure. pt and family were counseled (sic)."

On 09/27/12, in an interview, the Laboratory Director acknowledged that there is currently no policy to issue corrected lab reports or to notify physicians or floor nursing staff of incorrect and/or corrected lab values.

There was no documented evidence in the record for Patient #1 that the lab notified the nursing staff of the corrected lab results.

The above findings were confirmed in an interview with Staff #2 and 4 in the conference room the afternoon of 9/27/12.
VIOLATION: WRITTEN DESCRIPTION OF SERVICES Tag No: A0584
Based on a review of available documentation and interview, the facility laboratory failed to have written description of the services provided that were available to the medical staff.

Findings were:


The facility laboratory did not have a policy in place to define turnaround time parameters for STAT lab values from time of collection to confirming results. The only policy addressing STAT lab turnaround time referenced communication of critical test result to responsible licensed caregiver within 1 hour from the time the test is verified in the lab.

On 09/27/12, in an interview, the Laboratory Director acknowledged that there is currently no policy to issue corrected lab reports or to notify physicians of incorrect and/or corrected lab values.
VIOLATION: THERAPEUTIC DIETS Tag No: A0629
Based on a review of medical records, facility documents, and staff interviews, the facility failed to ensure that therapeutic diet orders were prescribed for a patient based on assessed and identified need.

Findings were:

Review of the medical record for Patient #1 revealed the following:

? 8/21/12: a swallow study was ordered based on "wet coughing upon drinking water."

? 8/21/12 at 1801: Rehab evaluation documented "Nursing observed wet cough and throat clearing on thin liquids: husband reported pt has been doing this for the last few months and pt stated it has been worsening. Husband stated pt had a choking episode a few months ago on a solid food when patient couldn ' t talk and pt attempted Heimlich maneuver. Diagnosis: suspected dysphagia with thin liquids ...Recommended Diet: Regular with nectar thick liquids. Special Training: Patient and husband were present and educated and trained in risk of aspiration and benefits of thickening liquids."

? 8/23/12: Speech Therapy progress note stated, "Order for nectar liquids per Bedside assessment not made. Discussed with [Staff #9, MD] the recommendation for nectar liquids. He said it would be ordered when her diet is reinitiated after her procedure ... Based upon discussions with husband, patient continues to have occasional difficulty with swallowing. P: change diet to mechanical soft with nectar thick liquids following procedure."

? 8/24/12 Daily physician progress note revealed the following:

? "protein cal malnutrition: pt requiring NPO for surgery, advance diet if not done today, of post op. provide supplements."

? 8/25/12 Physician progress note revealed the following:

? "Patient case discussed with Staff #9, MD. Case is also discussed with the patient's nurse and ... recommendations for mechanical soft diet with nectar - thick liquids and will change the diet this. Patient is to be followed by speech therapy for dysphagia issues. Patient husband does state that every once in a while his wife will "cough or choke" on food.

? Assessment: 3. Dysphagia. Patient is on a modified diet. Will start her on, per Speech Therapy recommendations, mechanical soft and nectar thick liquids.

? Protein - calorie malnutrition with low albumin. Will await nutrition input. Consider adding protein supplementation. This may be alcohol - related as well."

? 8/27/12 Speech Therapy progress note revealed the following:

? "Pt reportedly tolerating nectar thick liquid diet well with no reports of choking episodes. Patient self - reported she is doing well on the nectar thick liquids... Recommend continue on nectar thick liquids with re-check tomorrow (8/28) and if pt continues to exhibit improved swallow on thin liquids consider returning to thin liquids as tolerated.

? 8/27/12 Nutrition Evaluation note revealed the following:

? "Tolerating current diet order well, we wanted to try the fish for lunch to see if she would like it as she's been pretty much eating the same thing each day. Mechanical soft with nectar thick liquids."

Review of the diet orders for Patient #1 revealed no documented evidence that an order was ever entered for "nectar thick liquids." There were several conflicting concurrent active orders, as orders were not discontinued; the patient had two active orders for NPO except for meds from 8/23/12 until her discharge on 8/28/12. On 8/24/12, after the documented recommendation of nectar thick liquids due to choking on thin liquids on 8/21/12, a clear liquid diet was ordered. Diet orders were as follows:

? 8/22/12 at 11:37: NPO. Order discontinued on 8/23/12 at 02:01

? 8/22/12 at 14:03: Regular Diet. Order discontinued on 8/23/12 at 02:01

? 8/22/12 at 20:49: NPO after midnight except for meds. Order discontinued on 8/28/12 at 14:54

? 8/23/12 at 20:35: NPO after 0700 am, except for meds. Order discontinued on 8/28/12 at 14:54

? 8/24/12 at 23:23: Diabetic Diet, Low Lactose, Clear Liquid. Order discontinued on 8/28/12 at 14:54

? 8/25/12 at 13:18: Mechanical Soft Diet. Order discontinued on 8/28/12 at 14:54

The above findings were confirmed in an interview with the Nurse Manager, Staff #4 the afternoon of 9/27/12 in the conference room.
VIOLATION: DIETS Tag No: A0630
Based on a review of medical records, facility documents, and staff interviews, the facility failed to ensure that a timely nutritional needs assessment was completed in a compromised patient.

Findings were:

Review of facility document, "Plan for the Provision of Care and Statement of Operations 2012" stated, in part, "Assessment of Patients. Patient care is based on the unique needs of the individual and family as assessed by the interdisciplinary care team ... Nutritional Services. Timeframe for completion of initial assessment: based upon nursing screen: or physician order. High risk: within 24 hours, moderate risk: within 48 hours.
... Food and nutrition services ... Registered dietitians provide ongoing nutritional assessment and counseling for patients and make recommendations for changes to members of the medical staff. Dietitians will also work in collaboration with food preparation personnel in the design and template integration of all therapeutic. Diets ... Key functions: ...Nutrition assessment/reassessment, nutrition counseling and education."

Review of the record for Patient #1 revealed she was admitted with risk factors for nutritional needs, including Alcohol Abuse. Patient #1 subsequently had a speech therapy consult on 8/21/12 revealing a risk for aspiration and choking with thin liquids; she was NPO for 2 days (8/22/12 - 8/24/12), and she subsequently was diagnosed with malnutrition.
? On 8/23/12, the speech therapist documented "
? On 8/24/12, the physician documented, " protein cal malnutrition: pt requiring npo for surgery, advance diet if not done today, of post op. provide supplements. "
? On 8/25/12, the physician documented, " Protein - calorie malnutrition with low albumin. Will await nutrition input. Consider adding protein supplementation. This may be alcohol - related as well."
There was no nutrition evaluation until 8/27/12, just prior to the patient ' s discharge after being in the hospital for 7 days, despite the above nutritional risk factors.
? On 8/27/12, a Nutrition Evaluation was conducted, and a note revealed the following: "Tolerating current diet order well, we wanted to try the fish for lunch to see if she would like it as she's been pretty much eating the same thing each day. Mechanical soft with nectar thick liquids."

The above findings were confirmed in an interview with the Nurse Manager, Staff #4 the afternoon of 9/27/12 in the conference room.
VIOLATION: EMERGENCY SERVICES Tag No: A1100
Based on a review of available documentation and interview, the facility failed to meet the emergency needs of patients in accordance with acceptable standards of practice.

An Immediate Jeopardy exists due to the fact that the facility is currently unable to provide STAT labs for coagulation levels, with turnaround times from collection to result distribution taking as long as seven hours. Not having correct critical lab values or STAT lab values exceedingly delayed and available to treating physicians jeopardizes the health and well-being of all patients being served by or seeking services from the facility.

Findings were:

A review of facility policies revealed there was no written stroke or chest pain protocol policy in place. The only emergency department documentation related to chest pain was a checklist, group order sheet, and code activation list.

In an interview on 09/27/12, the emergency room Nurse confirmed the facility does not have stroke policy in place to direct patient assessment, care, and treatment.

Facility policy & procedure titled Communicating Critical Patient Results stated, in part,

"Laboratory
Critical test results will be communicated to the responsible licensed caregiver within 1 hour from the time the result is verified in the laboratory. The 1 hour turnaround time is divided into; 10 minutes for the laboratory turnaround time from when the test result is verified as critical to the time when the patient care nurse receives the result ..."

"Laboratory Critical Limits" included Coagulation with the following critical limits: PT low >4 and high >25.0 and PTT low 18.0 and high 70.0.

A review of facility provided laboratory date revealed the following turnaround times from laboratory result received to time results were distributed:

Patient #5's STAT PT and PTT results were received at 1400 at 09/20/12 and distributed at 1900 on 09/20/12. There was a 5 hour delay between receiving the lab results and distribution.

Patient #7's STAT PT result was received at 1400 at 09/20/12 and distributed at 1900 on 09/20/12. There was a 5 hour delay between receiving the lab result and distribution.

A review of STAT Coagulation studies (PT, PTT, and Fibrinogen) collected between 09/20/12 and 09/22/12, revealed 5 out of 5 patient results took over 1 hour from collection to result.

Patient # 5's STAT PT and PTT specimens were collected at 1200 at 09/20/12 and the results received at 1900 on 09/20/12. There was a 2 hour delay from collection until the results were received.

Patient # 6's STAT PT specimen was collected at 1155 at 09/20/12 and the results received at 1945 on 09/20/12. There was a 7 hour and 50 minute delay from collection until the results were received.

Patient # 7's STAT PT specimen was collected at 0941 at 09/20/12 and the results received at 1400 on 09/20/12. There was a 4 hour and 19 minute delay from collection until the results were received.

Patient # 8's STAT PT specimen was collected at 1032 at 09/21/12 and the results received at 1600 on 09/21/12. There was a 5 hour and 28 minute delay from collection until the results were received.

Patient # 9's STAT Fibrinogen specimen was collected at 1215 at 09/22/12 and the results received at 1700 on 09/20/12. There was a 4 hour and 45 minute delay from collection until the results were received.

The average turnaround time for the STAT samples sent out to the laboratory was approximately 5 hours and 30 minutes.

The delay in obtaining Coagulation study results on patients in a timely manner, limits the facilities ability to provide adequate emergency services to the community.