HospitalInspections.org

Based on document review, record review, observation and interview, the hospital failed to have an effective Governing Body that was legally responsible for the conduct of the hospital as an institution. The Governing Body failed to ensure that the hospital was in compliance with acute care hospital regulations, and this failure has the
likelihood to compromise patient care. The findings are:

A. Based on interview and document review, the hospital failed to ensure that the facility was in compliance with the Condition of Participation for Quality Assessment & Performance Improvement (QAPI). The hospital's QAPI program was not hospital-wide and did not include 4 Conditions of Participation. The failure to include 4 Conditions of Participation did not allow the hospital to improve patient care and reduce medical errors hospital wide. (Refer to A 0263)

B. Based on document request and interviews the hospital failed to ensure that the Infection Control Program was integrated into the QAPI program.
The hospital failed to integrate the Infection Control Program into QAPI program from some unknown time in the past until February 2011. It should be noted that at the time of survey, QI minutes still did not show any Infection Control Data being reported. On 04/13/11 at 10:15 am, the Director of Nursing and Director of Quality were asked, "In 2010, what infection control interventions were instituted to address issues identified through IC activities and was there evidence that these interventions were discovered from data collection and analysis?" Both stated that they could not think of anything. (Refer to A 0747)

C. Based on record review, staff interviews and facility policy, nursing services and the hospital failed to ensure that: (1) a qualified individual was appointed to direct the psychiatric nursing services of the psychiatric unit (Refer to A 386); (2) clinical activities of the non-employee nursing personnel were adhering to the hospital's policy and procedures and that the Director of Nursing service provided adequate supervision and evaluation of the non-employee nursing personnel (Refer to A 398); (3) orders for drugs and biologicals were signed by a practitioner in accordance with hospital policy and State law (Refer to A 406); and (4) hospital staff completed the blood transfusion records in accordance with the hospital facility policy (Refer to A 409). The cumulative effect of these systemic practices resulted in the hospital nursing services' inability to ensure that patients' needs could be met.

D. Based on document review and interview the Governing Body (GB) failed to ensure that all patient care related contracts were being evaluated through the hospital's Quality Assessment & Performance Improvement (QAPI) program to: assess the services provided under contract, identify quality and performance problems, implement appropriate corrective or improvement activities, and ensure the monitoring and sustainability of those corrective or improvement activities. This failure to evaluate all patient care contract services prohibited the GB from ensuring that all contract services were in compliance with the Conditions of Participation for hospitals. (Refer to A 0084)

E. Based on record review and interviews, the hospital's leadership, including the chief executive officer (CEO), medical staff and director of nursing (DON), failed to ensure that the hospital-wide quality assurance program addressed problems that were identified by the infection control (IC) officer. (Refer to A 0310)

Based on document request and interview, the Governing Body (GB) failed to ensure that the medical staff was accountable to the GB for the quality of care provided to patients. The GB failed to ensure that the medical staff provided the GB with a periodic evaluation of patient care services being provided hospital-wide, at every patient care location of the hospital. The hospital was unable to provide any evidence that this patient care evaluation had been done within the last year. The periodic patient care evaluation performed by the medical staff would have provided the GB with a professional evaluation of the quality of patient care. The findings are:

A. On 04/04/11 at 3:30 pm, the hospital was given a Request for Information list which included a request for "evidence that the Governing Body has been apprised of the medical staff evaluation of patient care services provided hospital-wide, at every patient care location of the hospital within the last twelve (12) months." When the Request for Information list was returned by the hospital staff with the requested information, there was a question mark next to the above request and no documentation was provided.
B. During interview on 04/12/11 at 9:10 am, the Director of Quality confirmed that the hospital did not have the medical staff do an evaluation of all patient care areas within the last year.
C. During interview on 04/15/11 at 9:45 am, the Chief Executive Officer confirmed that the hospital did not have the medical staff do an evaluation of all patient care areas within the last year.

Based on document request and interview, the Governing Body (GB) failed to appoint a Chief Executive Officer (CEO) who is responsible for managing the hospital. The findings are:

A. On 04/04/11 at 3:30 pm, the hospital was given a Request for Information list which included a request for "evidence that the Governing Body has appointed the CEO." When the Request for Information list was returned by the hospital staff with the requested information, there was a comment, "Have not been able to find this," next to the above request and no documentation was provided.
B. On 04/12/11 at 9:10 am, the Director of Quality stated, "We have been unable to find any documentation in Governing Body minutes that the CEO was appointed. He has been here for some time and the documentation might be in stored files." By the end of the survey, no documentation was ever provided.

Based on document review and interview, the Governing Body (GB) failed to ensure that all patient care related to contracts were being evaluated through the hospital's Quality Assessment & Performance Improvement (QAPI) program to: assess the services provided under contract, identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities. This failure to evaluate all patient care contract services prevented the GB from ensuring that all contracted services were in compliance with the Conditions of Participation for hospitals. The findings are:

A. On 04/04/11 at 3:30 pm, the hospital was given a Request for Information list which included a request for "evidence that every patient care contracted service is evaluated as part of the hospital wide QAPI program."

B. On 04/05/11, the hospital provided a master list of contracted services utilized by the hospital. Included was a list entitled "Lea Regional Medical Center - Physician Contract Summary - Employment and Professional Services Agreements (PSA)," dated 04/04/2011. This list included the following: (1) Twenty-seven (27) practitioners with employment contracts; (2) Six (6) PSA's with practitioners; and (3) Five (5) PSA's with companies providing patient care or evaluation services. Of all of the providers and companies on the list, the hospital only provided evidence that one (1) company with a PSA and no practitioners had been evaluated.

C. The hospital also provided a ist that was entitled "Lea Regional Medical Center - Equipment & Service Agreement." Review of the list indicated that there were fifty-two (52) patient care related contracts. The hospital also provided a document entitled "Lea Regional Medical Center - Contract Services Scope and Evaluation - Patient Care Services." This document indicated that nineteen (19) of the fifty-two (52) patient care contracts had been evaluated in May 2010. There was no documentation provided by the hospital that the remaining thirty-three (33) contracts had ever been evaluated.

D. During interview on 04/15/11 at 9:45 am, the Chief Executive Officer confirmed that the hospital had not evaluated all of the patient care related contracted services through the Quality Assessment & Performance Improvement program.

Based on observation, staff and patient interview, and record review, it was determined that the hospital failed to ensure patients were provided services in a safe environment and setting (A 0144). The hospital further failed to ensure patients coming in for outpatient services were being advised of their Patient Rights prior to receiving treatment. Failure could result in the people receiving care at the hospital not being fully informed (A 0117). The hospital failed to ensure a patient's decision was enforced after the patient (#16) had refused blood for 1 of 36 sampled patients. The doctor infused two units of packed red blood cells (RBCs) even after the doctor knew that Patient #16 had refused to sign the consent for blood products and verbally told the doctor that she did not want the blood products. Failure of not following the patients informed decisions could lead to medical errors and unnecessary medical treatments (A 0131). The hospital failed to ensure 1 of 36 sampled patients (#16) was free from harassment when she chose not to receive blood products during her hospital stay. She signed a refusal for blood transfusions and the doctor knew this but bullied her into signing a consent after the doctor had transfused two units of packed red blood cells (RBCs). Failure to protect a patient from abuse and harassment from a doctor could lead to other patients being forced into treatments or procedures against their will (A 0145). The cumulative effect of these systemic practices resulted in the hospital's inability to ensure that the patients were fully informed of their right of refusal and that the patients received care in a safe environment.

Based on review of the admission packet for outpatient services and staff interview, the hospital failed to ensure patients coming in for outpatient services were being advised of their Patient Rights prior to receiving treatment. Failure could result in the people receiving care at the hospital not being fully informed. The findings are:

A. Review of the admission packet for outpatient services revealed no copy of Patient Rights in the packet.

B. On 04/07/11 at 2:00 pm, during an interview, Registrar #1 at the off-site therapies unit confirmed Patient Rights were not given to the patients when they are admitted.

C. On 04/07/11 at 3:10 pm, during an interview, Registrar #2 in the laboratory unit confirmed Patient Rights were not given to the patients when they are admitted.

D. On 04/07/11 at 3:15 pm, during an interview, Registrar #3 in the radiology unit confirmed Patient Rights were not given to the patients when they are admitted.

Based on medical record review and interview, the hospital failed to ensure a patient's decision was enforced after the patient (#16) had refused blood for 1 of 36 sampled patients. The doctor infused two units of packed red blood cells (RBCs) even after the doctor knew that Patient #16 had refused to sign the consent for blood products and verbally told the doctor that she did not want the blood products. Failure of not following the patients informed decisions could lead to medical errors and unnecessary medical treatments. The findings are:

A. Review of Patient #16's clinical record revealed a Refusal to Permit Blood Transfusion dated 02/01/11 at 4:30 pm, that was signed by Patient #16 and witnessed by two hospital employees.

B. Review of Patient #16's Progress Notes revealed a late entry for 02/02/11. Review of the document revealed that the doctor knew of the patient's decision not to receive blood products, but infused 2 units of packed RBCs. The patient had just gone through surgery with anesthesia and was still under the influence of the anesthesia. The doctor again asked the patient about getting the blood product and the patient again refused. Further review of the document revealed that the Chief Executive Officer also was involved in the case and counseled the doctor to "get a consent from the patient as soon as she woke up."

C. Review of the patient's nurses' notes for 02/02/11 revealed the following entries:
1. At 4:27 pm that read, "Consent for blood transfusion discussed... Pt. [patient] refused. Consent for refusal signed and witnessed."
2. At 7:18 pm that read, "[Doctor at] bedside. Discussing blood and transfusion and risk of life if blood not infused. Pt. verbalized understanding and refusal of blood transfusion."
3. At 9:42 pm, that read, "[Doctor] at bedside discussing blood transfusion with pt. [Doctor] asks the pt to sign blood transfusion consent as a personal favor to her. Discussed follow up and lab work and possible need for more blood. Pt states she does not want to receive any more blood."

D. On 04/13/11 at 5:15 pm, during a telephone interview, Patient #16 confirmed that she received blood products and did not want them. She felt that she was bullied by the doctor into signing the form while she was still under the influence of medications, but did not want the doctor to get into trouble.

This is a repeat deficiency from a complaint survey completed on 12/17/10.

Based on observation, record review, and interview, the hospital failed to ensure patients received care in a safe setting by not having the following;
1. A hospital-wide quality assessment and performance improvement (QAPI) program,
2. An active infection control (IC) program,
3. Enough staff on the Medical/Surgical floor for Patients #8 and 40, in the emergency room for Patient #39, and respiratory therapists to provide care for Patient #7,
4. Staff properly trained in blood transfusion monitoring for Patient #15,
5. Sterile processing unit that was physically set up to ensure the sterility of the instrument packets,
6. Four operating rooms that had a floor that would ensure the hospital's ability to sterilize the floor,
7. Trained staff that utilized the proper sterilizing agent and follow the directions for use, and
8. Readily available emergency tracheotomy kits where invasive and surgical procedures were being done. This information was collected from a universe of 41 sampled patients. The cumulative effect of these failed practices resulted in the hospital's inability to endure that the patient's needs could be met in a safe environment and setting. The findings are:

A. The hospital's Governing Body, medical staff, and administrative officials failed to ensure that the hospital had an ongoing program for Quality Assessment & Performance Improvement (QAPI) which was defined, implemented, and maintained. (Refer to A 0310)

B. The hospital failed to ensure that Anesthesia Services were integrated into the hospital-wide Quality Assessment & Performance Improvement (QAPI) program for the provision of safe care to patients. (Refer to A 1000)

C. The hospital failed to ensure that the Nuclear Medicine Services were integrated into its hospital-wide QAPI program for the provision of safe care to patients. (Refer to A 1026)

D. The hospital failed to ensure that Outpatient Services were integrated into the hospital-wide QAPI program. (Refer to A 1077)

E. On 04/13/11 at 9:45 am, during interview, the Infection Control Officer was asked if the Infection Control Program of the hospital was incorporated into the Quality Improvement program. She stated, "No it is not."

F. On 04/04/11, the hospital was given a Request for Information to provide a list of all performance improvement indicators for all services. On 04/05/11, a document titled "[Name of hospital] 2011 Performance Indicators by Department" was provided to the surveyors. The Director of Quality verified that it was valid as of 01/01/11. Among the supporting documentation attached was a document titled "[Name of hospital] - Blood Culture Contamination Rate - Year 2010." This document contained a chart indicating the level of blood culture contaminations each month from January 2010 through December 2010. The chart indicated that a benchmark of 3% had been set by the hospital as an acceptable level of blood culture contamination. The chart indicated that this benchmark had been exceeded for each of the seven consecutive months beginning in June 2010 through December 2010. The rates of blood culture contamination were as follows: June 8%, July 6%, August 8%, September 5%, October 7%, November 4% and December 4%. The blood culture contamination rate continues to exceed the hospital's benchmark for 2011. In January 2011 - 4% and February 2011 - 5%. Thus for a period of nine months the QAPI data indicated that the blood culture contamination rates were continuously above the hospital's benchmark.

G. The document titled, "[Name of hospital] - Blood Culture Contamination Rate - Year 2010," had a section entitled "Summary of findings - Analysis of Data" for each quarter of 2010. The second quarter, the summary of findings indicates, "Monitor contamination rate on a monthly basis. Now using BacT/ALERT analyzer. Contamination rate increased. ER assigned CHS blood culture collection online in-service and BacT/Alert instructional DVD." The third quarter, the summary of findings indicates, "Monitor contamination rate on a monthly basis. Now using BacT/ALERT analyzer. Contamination rate increased. ER assigned CHS blood culture collection online in-service and BacT/Alert instructional DVD." The fourth quarter, the summary of findings indicates, "Monitor contamination rate on a monthly basis. Contamination rate increased. % [The percentage]decreasing in Nov. & Dec."
Thus over a seven-month period with the blood culture contamination rates consistently exceeding the hospital's own benchmark, the only action taken was to ask staff to look at an on-line in-service and an instructional DVD. No other action was taken to determine why the blood culture contamination rates had reached almost three times the hospital benchmark in June, August and October 2010.

H. On 04/14/11 at 10:40 am, the Quality Director was asked, "Given that your QI data was exceeding your own benchmark for seven months, what did the Quality Improvement program do to resolve the problem?" She stated that nothing had been done, other than education.

I. On 04/07/11 at 10:00 am, during interview, the acting Infection Control Officer and the Director of Quality were asked if anything was reported to the Quality Improvement program concerning the information from the hospital's "Nosocomial Infection Report 2010" for the month of October. The report indicated that there were nine (9) nosocomial infections (the highest number for the year), broken down there were two (2) SSI (Surgical Site Infections) and seven (7) non-surgical hospital acquired infections (the highest number for the year), which would include urinary tract infections. The Director of Quality stated, "No, this was not taken to the quality assurance committee."

J. On 04/13/11 at 9:45 am, during interview, the Infection Control Officer of the hospital was asked if she was aware of the elevated blood culture contamination rates for the last seven months of 2010. She stated that she had only been in the position of Infection Control Officer for the past four months but that she was not aware of the problem and no one in the hospital had brought it to her attention.

K. On 04/13/11 at 11:00 am, the Quality Director was asked if the Infection Control Program was integrated into the hospital-wide QAPI program. She stated that it was not.

L. The hospital failed to ensure that the Quality Assessment & Performance Improvement (QAPI) program conducted performance improvement projects. (Refer to A 0297)

M. The hospital failed to ensure that the infection control officer had been designated in writing as the appointed infection control officer (Refer to A 0748)

N. The hospital failed to ensure there was a system in place for identifying, reporting, preventing, investigating, and controlling infections and that there was an active infection control surveillance program. (Refer to A 0749)

O. The hospital's leadership including the chief executive officer (CEO), medical staff and director of nursing (DON) failed to ensure that the hospital-wide quality assurance program addressed problems that were identified by the infection control (IC) officer. (Refer to A 0756)

P. Record review of the discharge summary dated 08/14/10 for Patient #8 (Refer to A 0396) revealed her discharge diagnosis as menometrorrhagia (excessive menstrual and uterine bleeding). On postoperative day #1 Patient #8 had a critical drop in hemoglobin of 5.7 (normal is 12.0-16.0) and hematocrit of 17 (normal is 38-47) at 7:09 am, on 08/12/11. This resulted in a return to surgery for post operative bleed and Patient #8 received 4 units of blood and 1 unit of packed red blood cells.
Record review of a care plan dated 08/11/10 for Patient #8 revealed in the problem for "Standards of Care," was an intervention for hourly rounds, and was assigned on 08/12/10, no time listed.
1. The "Patient Care Activities" section of the chart revealed that hourly rounds on 08/12/10 were conducted at 19:45 (7:45 pm) and 21:29 (9:29 pm). This was 1 hour and 25 minutes after the rounds at 19:45 (7:45 pm).
2. On 08/12/10 the last hourly rounds were charted at 22:15 (10:15 pm), and the next charted hourly round was on 08/13/10 at 00:10 (12:10 am). This was 1 hour and 55 minutes after the last rounds. Other hourly rounds for 08/13/10 were at 1:50 am, 1 hour and 40 minutes apart; 4:00 am, 2 hours and 10 minutes apart; 6:00 am, 2 hours apart; 7:40 am, 1 hour and 40 minutes apart; 10:00 am, 2 hours 20 minutes; and 11:30 am, 1 hour and 30 minutes.

Q. Review of Patient #40's medical record (Refer to A 0392), who was admitted on 01/12/11 and discharged 01/24/11, revealed the following:
1. Review of the physician documentation dated 01/12/11 indicated that Patient #40 fell at home, from a standing position after becoming unsteady on feet. She complains of right upper thigh leg discomfort and rates the pain as 10 on a one-to-ten scale with ten as the worst pain. Patient #40's past medical history includes: hypertension, ejection fraction of 30% (a measurement of how well your heart is pumping throughout your body. Normal is 100%), uncontrolled diabetes mellitus, the patient has been strongly advised to begin insulin therapy, which she has consistently refused (her glucose in the emergency room is 412, normal is 75 - 103), and she has renal failure which she recently had an arteriovenous fistula created in anticipation of dialysis. Her vital signs at 1820 (6:20 pm) were as follows: blood pressure 82/64, temperature 98.2, pulse 112 and is regular, respirations 20 and unlabored, oxygen saturation of 96% on room air. Her pain at time of transfer to floor is 0 on a 1-10 scale.
2. Review of the admitting physician's orders dated 01/12/11 at 6:10 pm revealed the following: "Admit to Tele [telemetry], vitals as per protocol [vital signs should be taken every 4 hours], condition: guarded..."
3. Review of the patient chart including vital signs revealed the following: 01/12/11 vital signs taken at 2120 (9:20 pm). The next recorded set of vital signs were documented on 01/13/11 at 5:00 am, this is 8 hours later.

R. Record review for Patient #39 (Refer to A-1103) revealed she presented to the ED on 02/20/11 at 13:00 (1:00 pm). Patient (pt) #39's data sheet revealed the following:
1. Review of the "Initial Assessment Form" dated 02/20/11 at 13:24 (1:24 pm) revealed "Priority 3 Urgent, Chief Complaint: Fall--Injury/Pain, Brief Assessment: pt fell from standing position this morning getting up from bed, fell last Thursday, as per pt's son pt getting confused x 4 days, denies ALOC [acute loss of consciousness], c/o [complains of] bilateral knee pain, Vital Signs [VS] T [temperature]: 97.9, P [Pulse]: 56 regular, R [Respirations]: 20 unlabored, BP: 72/39, Oxygen: 94% on RA [room air], Pain Intensity Scale: 8/10, Pain Location: multiple areas, placed in room 15:02 [3:02 pm]."
2. Review of the Adult Assessment dated 02/20/11 at 15:39 (3:39 pm) revealed she was placed in room 6, and her pain level was "'0' radiates to the left, is intermittent."
3. Ongoing assessments were as follows:
a. Reassessment was conducted at 15:40 (3:40 pm) and revealed "blood drawn and IV hep lock est [established] to left ac [antecubital (at the bend of the elbow)] 20 gauge angio [size of needle], MD [medical doctor] in to see pt."
b. Reassessment was conducted at 15:53 (3:53 pm) and revealed "Specimen collected at 15:45 [3:45 pm], by nurse. Type of specimen collected was blood. Specimen was sent to lab [laboratory]. Physician was at the bedside at 15:45 [3:45 pm]."
c. Reassessment was conducted at 16:42 (4:42 pm), 49 minutes later, and revealed, "Patient was transported to radiology at 02/20/11 at 16:42 [4:42 pm], for CT [computerized tomography] Scan."
d. Reassessment was conducted at 17:12 (9:12 pm) and revealed a report from the lab, "Critical Values: Physician notified at 17:07 [9:07 pm]; Troponin 7.70 [normal range 0.00 - 0.09] and CK [creatinine kinase] 3029 [normal range 21 - 215, the results of the elevated cardiac enzymes indicate cardiac muscle damage], returned from radiology at 17:00 [9:00 pm], pts condition was unchanged upon return from radiology. 17:14 [9:14], pt sleeping with eyes closed and respirations even and unlabored."
e. Reassessment was conducted at 18:01 (6:01 pm), 45 minutes later.
f. Reassessment was conducted at 19:03 (7:03 pm), 1 hour and 2 minutes later.
4. Review of the ED treatment sheet revealed the following treatments were administered.
a. "Normal Saline 500 cc (cubic centimeters) bolus at 999 cc/hr in the left arm, given for hydration reasons initiated at 02/20/11 at 15:51[3:51 pm], 17:15 [5:15 pm] - infusing without signs of infiltration, 19:40 [7:40 pm] - IV infusion stopped at 02/20/11 19:40." This infusion should have finished within 30 minutes.
b. "IV Heparin bolus of 3138 (units) and drip per protocol for low intensity initiated at 02/20/11 18:01."
c. "Disposition: Transfer; Patient left the department at 02/20/11 19:42 [7:42 pm]. Transfer was initiated for: Specialized care - cardiac. Discharge Diagnosis: Non ST Segment Elevation Acute MI."
5. The ED report dated 02/20/11 at 17:21 (5:21 pm) revealed in the section titled "Chief Complaint/History of Present Illness," "[Name of patient] is a 86 year old F [female] that presented to the ED at 13:08 [1:08 pm] by w/c [wheel chair]. The patient was triaged at 13:24 [1:34 pm] with the following vital signs: T: 97.9, P: 56 regular, R: 20, unlabored, BP: 072/039, SPO2 [oxygen saturation]: 94 Amt: RA [room air], Pain: 8 multiple areas." This was documented by the attending physician at 17:21 (5:21 pm).
6. The ED report dated 02/20/11 at 17:21 (5:21 pm) revealed in the section titled "Chief Complaint --Fall--Injury/Pain," "86 yo female with HTN [hypertension], DM [diabetes mellitus] who felt weak and left body weakness two days ago with slurred speech and facial droop lasting two hours, she reports profound weakness and continued facial droop with speech difficulty since then. ... she fell twice on attempts to get out of bed and was brought in for evaluation where she is found to be hypotensive w/SBP 70 [systolic blood pressure].
7. The ED record revealed documentation for only 2 sets of vital signs. Triage vs were taken at 13:24 (1:24 pm) and revealed a BP of 72/39, P 56. Discharge vs were taken at 19:42 (7:42 pm) and revealed P 65, BP 128/69.

S. The facility policy and procedure titled "Triage Assessment of Patients (5 tier)," effective date of 06/2010, revealed on page 4 of 5, "B. High risk situation is a patient you would put in your last open bed. Severe pain/distress is determined by clinical observation and/or patient rating of greater than or equal to 7 on 0-10 pain scale. C. Danger Zone Vital Signs. Consider up triage to ESI [emergency services index] 2 if any vital sign criterion is exceeded." (Pt triage BP was 72/39.)

T. Record review for Patient #7 revealed in the "Patient Care Activities" documentation in the skilled nurses' notes as follows:
1. On 02/07/11 at "1948 [7:48 pm] - received report, care assumed, initial assessment started, 2022 [8:22 pm] - pt's [patient] resp [respiratory] rate noted to be 43 at this time. Dr. [doctor] notified, no new orders received. MD [medical doctor] states she does not want to be notified of increased resp rate unless oxygen saturation decreases. Will continue to monitor. 2333 [11:33 pm] - RT [respiratory therapy] currently on unit. pt is on 5 L [liters] via nc [nasal canula] with no humidification, notified RT of need, [name of staff] states 'I know' when informed. Reiterated need for humidifications conveyed to RT."
2. On 02/08/11 at "1945 [7:45 pm] - pt already showing signs of agitation AEB [as evident by] pulling at mask, Foley, kicking legs, grabbing for invisible objects. [Name of physician] notified, new orders received to increase Haldol to 1 mg [milligram] IV [intervenes] q [every] 6 hours PRN [as needed]."
a. At "2330 [11:30 pm] - pt's oxygen saturation steadily decreasing, now in mid 80's. RT [respiratory therapy] paged at this time with no answer."
b. At "2334 [11:34 pm] - Oral care performed, throat suctioned via catheter, large amount of blood tinged mucous removed. Pt exhibited good cough and gag reflex, pt would cough upon command. O2 [oxygen] sats [saturations] remain mid 80's with no improvement."
c. At "2342 [11:42 pm] - RT paged again, no answer. Attempting to track RT down on third floor, [Name of staff] states RT is in L & D [labor and delivery] for an emergency delivery at this time. Will continue to attempt to reach them."
d. At "2345 [11:45 pm] - Pt given chest PT [percussion therapy] via manual manipulation by [name of registered nurse], turned pt and performed PT on both sides of chest, pt coughing on command. 02 sats remain low. Suctioning performed again, more blood tinged mucous removed. Pt's throat is raw, red, excoriated and weeping serous fluid. Pt had complained of sore throat previously."
e. At "0004 [12:04 am] - Pt's sats remain low despite attempted nursing interventions. RT paged again, no answer at this time."
f. At "0020 [12:20 am] - [Name of doctor] notified of pt's continued status of oxygen saturations in the mid 80's, states to increase [oxygen] to 60% and call pt's wife to discuss possible intubation."
g. At "0021 [12:21 am] - [Name of pts wife] notified of pt's condition, possible impending intubation and states she will arrive in unit within the hour to discuss options for patient."
h. At "0107 [1:07 am] - RT paged again, no answer. [Oxygen] still needing to be increased to 60%. Pt's O2 sats now at 86-87%."

U. Review of the discharge summary dictated on 02/10/11 at 6:25 am, revealed, "He became more short of breath with waxing and waning mental status and developed respiratory failure. He was treated with BiPap. His wife had requested that he not be intubated. Echocardiogram showed a normal ejection fraction. He did have a right pleural effusion which layered out. He was suspected to have pneumonia. He was treated with broad-spectrum antibiotics with continuing worsening of his condition. Due to his worsening condition despite adequate treatment and he has multiple comorbidities, his wife requested that treatment be withdrawn, and he will be treated for comfort measures only. This was done. He was kept comfortable, and he was pronounced dead at 05:30 hours on the morning of February 10, 2011."

V. Review of Patient #15's medical record revealed that following the delivery of her twins, she developed mild uterine atony (lack of normal uterine muscle tone or strength). Patient #15 also had pre-existing severe anemia throughout the pregnancy. After the delivery of her twins, Patient #15 required blood transfusions due to having a low hemoglobin of 7.7 (normal is 12 -16). Patient #15 received 4 units of packed red blood cells and 2 units of fresh frozen plasma. The blood transfusion record documentation revealed the following information:
1. The blood transfusion record dated 01/28/11, and issued at 2020 (8:20 pm), were missing the following documentation: Temperatures were not documented for the 15-minute and 30-minute intervals. The signature was also not documented for the post-transfusion vital signs.
2. The blood transfusion record dated 01/28/11, and issued at 2200 (10:00 pm), was missing the post-transfusion blood pressure, pulse, temperature, respirations and nurse's signature.
3. The blood transfusion record for the unit of blood #W041511002687, dated 01/29/11, and issued at 1320 (1:20 pm), indicated that the transfusion was started at 1800 (6:00 pm) and stopped at 1800 with the date missing on the document. This would indicate that from the time the blood was issued at 1320 until the blood was started at 1800, 4 hours and 40 minutes had elapsed. The Blood transfusion record indicates "Transfusion MUST begin within 30 min of removal from Blood Bank. Blood Products EXPIRE 4 hrs after removal from Blood Bank." Further review of the blood transfusion record indicated that a Licensed Practical Nurse (LPN) administered the blood transfusion.
a. On 04/12/11 at 10:45 am, during interview, the Director of the Medical/Surgical floor, when asked to see the LPN's blood transfusion competency test, stated that she could not find it. She also stated that she could not find a "Cascade Learning Kit" written test on the LPN. She further stated that the hospital usually does the LPN's competencies on a yearly basis. The Director of the Medical/Surgical floor confirmed that the blood transfusion record "looks like" the blood was started and stopped at 1800.
b. On 04/13/11 at 11:00 am, when the Laboratory Director retrieved her copy of the blood transfusion record, it revealed that the time, date and initials were missing as to when the blood was started and when the blood was stopped.
c. On 04/14/11 at 10:00 am, during interview, when the Laboratory Director was shown the blood transfusion record that was in the chart, she verified that the time the blood was started and stopped was documented as 1800.
4. The blood transfusion record dated 01/30/11 and issued at 10:30 am was missing the post-transfusion blood pressure, pulse, temperature, respirations and nurse's signature.

W. The hospital and its infection control program failed to ensure that sterilized materials were stored in a manner that ensured continued sterility. The room in which sterilized materials and instruments were stored had a pass-through window to the dirty instrument cleaning room. This pass-through window remained open even after two surveyors advised the Operating Room and sterile processing staff that the pass-through window could not remain open. The open pass-through window allowed air contaminated from the cleaning of dirty instruments to pass into the room where cleaned instruments were being packaged for sterilization and being stored after sterilization. The failure to maintain separation between the dirty instrument processing area and the room where cleaned instruments were being packaged for sterilization and stored after sterilization had the potential to contaminate the sterilized materials and instruments.

X. On 04/06/11, at 6:00, am the health and life safety surveyors began their inspection of the operating rooms. It was immediately noticed that operating rooms floors had the following sanitation issues: (1) Operating rooms #2, #3, & #5 had floors composed of ceramic tiles with aggregate grout rather than the required monolithic flooring; (2) operating rooms #2, #3, & #5 each had cracked tiles in the floor; (3) in operating room #2, the tiles used to make the baseboard where the floor joins the walls had places where the tiles had either come loose or had separation between the tiles. It should also be noted that operating room #4 was being used as a storage room, but it also had the tile and grout floor.

Y. On 04/06/11 at 2:43 pm, the surveyor observed the terminal cleaning of Operating Room #4 in the main surgical area. Two housekeepers, HK#1 and HK #2 were doing the terminal cleaning. After damp mopping the ceiling and walls, HK#1 took a mop bucket from the housekeeping cart that was filled with clean water and began to pour a 3M product called #3 into the mop bucket. Both HK#1 & HK#2 began mopping the operating room floor at 3:12 pm. At 3:15 pm, the mopping was completed. At 3:16 pm, a floor vacuum was employed to begin removing the mop water from the floor. By 3:25 pm, the vacuuming was completed and no more water could be seen on the floor. It should be noted that the mop water containing the cleaning product was only on the floor for 3 minutes before the vacuuming began. At 3:32 pm, the surveyor asked HK#1 how long the cleaning product had to remain on the floor to disinfect, she replied, " It needs to stay on for 10 minutes." The surveyor pointed out that they had only left the mop water on the floor for 3 minutes before they started removing it. She had no response.

Z. The hospital failed to ensure that a tracheotomy set was readily available in two locations where surgical procedures were being performed. The Labor & Delivery (L&D) Charge Nurse was unaware of the location of the tracheotomy set in the Labor & Delivery Suite and no tracheotomy set was present in the Endoscopy Suite. The failure of the Surgical Services to readily find or have available a tracheotomy set could prevent the surgical team from performing an emergency tracheotomy to restore breathing to a patient.

Based on medical record review and interview, the hospital failed to ensure 1 of 36 sampled patients (#16) was free from harassment when she chose not to receive blood products during her hospital stay. She signed a refusal for blood transfusions and the doctor knew this but bullied her into signing a consent after the doctor had transfused two units of packed red blood cells (RBCs). Failure to protect a patient from abuse and harassment from a doctor could lead to other patients being forced into treatments or procedures against their will. The findings are:

A. Review of Patient #16's clinical record revealed a Refusal to Permit Blood Transfusion dated 02/01/11 at 4:30 pm, that was signed by Patient #16 and witnessed by two hospital employees.

B. Review of Patient #16's Progress Notes indicated a late entry for 02/02/11. Review of the document revealed that the doctor knew of the patient's decision not to receive blood products, but infused 2 units of packed RBCs. The patient had just gone through surgery with anesthesia and was still under the influence of the anesthesia. The doctor again asked the patient about getting the blood product and the patient again refused. Further review of the document revealed that the Chief Executive Officer also was involved in the case and counseled the doctor to "get a consent from the patient as soon as she woke up."

C. Review of the patient's nurses' notes for 02/02/11 revealed the following entries:
1. At 4:27 pm, "Consent for blood transfusion discussed...Pt. [patient] refused. Consent for refusal signed and witnessed."
2. At 7:18 pm, "[Doctor at] bedside. Discussing blood and transfusion and risk of life if blood not infused. Pt. verbalized understanding and refusal of blood transfusion."
3. At 9:42 pm, "[Doctor] at bedside discussing blood transfusion with pt. [Doctor] asks the pt to sign blood transfusion consent as a personal favor to her. Discussed follow up and lab work and possible need for more blood. Pt. states she does not want to receive any more blood."

D. On 04/13/11 at 5:15 pm, during a telephone interview, Patient #16 confirmed that she received blood products and did not want them. She felt that she was bullied by the doctor into signing the form while she was still under the influence of medications, but did not want the doctor to get into trouble.

Based on interview and document review, the hospital failed to ensure that the facility was in compliance with the Condition of Participation for Quality Assessment & Performance Improvement (QAPI). The hospital's Quality Improvement (QI) program was not hospital-wide and did not include four (4) Conditions of Participation. The hospital failed to ensure that there was an effective hospital-wide, data-driven QAPI program from all patient care areas. The hospital's QI program did not include the participation of Anesthesia Services, Nuclear Medicine Services, Outpatient Services, and Infection Control Services, and the hospital contractors that provide patient care were not being evaluated. This failure has the likelihood to diminish patient care and increase medical errors hospital-wide. The findings are:

A. Based on document review and interview, the hospital failed to ensure that Anesthesia Services were being integrated into the hospital-wide Quality Assessment & Performance Improvement (QAPI) program for the provision of safe care to patients. (Refer to A 1000)

B. Based on interview and document review, the hospital failed to ensure that Nuclear Medicine Services were being integrated into the hospital-wide QAPI program for the provision of safe care to patients. (Refer to A 1026)

C. During interview on 04/15/11 at 9:45 am, the Chief Executive Officer confirmed that the hospital had not evaluated all of the patient care related contracted services through the QAPI program. (Refer to A 0083)

D. Based on document request and interviews, the hospital failed to ensure that the Infection Control Program was integrated into the QAPI program from some unknown time in the past until March 2011. It should be noted that at the time of survey QI minutes did not show any Infection Control Data being reported. On 04/13/11 at 10:15 am, the Director of Nursing and the Director of Quality were asked, "In 2010, what Infection Control (IC)interventions were instituted to address issues identified through IC activities and was there evidence that these interventions were discovered from data collection and analysis?" They both stated that they could not think of anything. (Refer to A 0747)

Based on document review and interview, the hospital failed to ensure that the Quality Assessment & Performance Improvement (QAPI) program showed measurable improvement in indicators that could improve health outcomes. The findings are:

A. On 04/04/11, the hospital was given a Request for Information to provide a list of all performance improvement indicators for all services. On 04/05/11, a document titled "[Name of hospital] 2011 Performance Indicators by Department" was provided to surveyors. The Director of Quality verified that it was valid as of 01/01/11. Among the supporting documentation attached was a document titled "[Name of hospital]- Blood Culture Contamination Rate - Year 2010." This document contained a chart showing the level of blood culture contaminations each month from January 2010 through December 2010. The chart indicated that a benchmark of 3% had been set by the hospital as an acceptable level of blood culture contaminations. The chart indicated that this benchmark had been exceeded for each of seven consecutive months beginning in June 2010 through December 2010. The rates of blood culture contaminations were as follows: June 8%, July 6%, August 8%, September 5%, October 7%, November 4% and December 4%. The blood culture contamination rates continue to exceed the hospital's benchmark as follows: January 2011- 4% and February 2011- 5%. Thus for a period of nine months the QAPI data indicated that the blood culture contamination rates were continuously above the hospital's benchmark.

B. The document titled "[Name of hospital]- Blood Culture Contamination Rate - Year 2010," had a section entitled "Summary of findings - Analysis of Data" for each quarter of 2010. For the second quarter, the summary of findings indicates, "Monitor contamination rate on a monthly basis. Now using BacT/ALERT analyzer. Contamination rate increased. ER assigned CHS blood culture collection online in-service and BacT/Alert instructional DVD. For the third quarter, the summary of findings indicates, "Monitor contamination rate on a monthly basis. Now using BacT/ALERT analyzer. Contamination rate increased. ER assigned CHS blood culture collection online in-service and BacT/Alert instructional DVD." For the fourth quarter, the summary of findings indicates, "Monitor contamination rate on a monthly basis. Contamination rate increased. % [the percentage] decreasing in Nov. & Dec."
Thus over a seven-month period with the blood culture contamination rate consistently exceeding the hospital's own benchmark, the only action taken was to ask staff to look at an on-line in-service and an instructional DVD. No other action was taken to determine why the blood culture contamination rates had reached almost three times the hospital benchmark in June, August and October 2010.

C. On 04/14/11 at 10:40 am, the Quality Director was asked "Given that your QI data was exceeding your own benchmark for seven months, what did the Quality Improvement program do to resolve the problem?" She stated that nothing had been done, other than education.

D. On 04/13/11 at 9:45 am, during interview, the Infection Control Officer of the hospital was asked if she was aware of the elevated blood culture contamination rates for the last seven months of 2010. She stated that she had only been in the position of Infection Control Officer for the past four months but that she was not aware of the problem and no one in hospital had brought it to her attention.

E. On 04/13/11 at 9:45 am, during interview, the Infection Control Officer was asked if the Infection Control Program of the hospital was incorporated into the Quality Improvement program. She stated, "No it is not."

This is a repeat deficiency from a complaint survey completed on 12/17/10.

Based on document review and interview the hospital failed to ensure that the Quality Assessment & Performance Improvement (QAPI) program measured, analyzed and tracked quality indicators, including adverse patient events and other aspects of performance that assessed processes of care, hospital services and operations (for all hospital departments and patient care contractors). The findings are:

A. Based on document review and interview, the hospital failed to ensure that the Anesthesia Services were integrated into the hospital-wide Quality Assessment & Performance Improvement (QAPI) program for the provision of safe care to patients. (Refer to A 1000)

B. Based on interview and document review, the hospital failed to ensure that the Nuclear Medicine Services were integrated into its hospital-wide QAPI program for the provision of safe care to patients. (Refer to A 1026)

C. Based on observation, record review, and staff interview, it was determined the hospital failed to ensure that Outpatient Services were integrated into the hospital-wide QAPI program.

D. On 04/13/11 at 9:45 am, during interview, the Infection Control Officer was asked if the Infection Control Program of the hospital was incorporated into the Quality Improvement program. She stated, "No it is not."

E. On 04/04/11, the hospital was given a Request for Information to provide a list of all performance improvement indicators for all services. On 04/05/11, a document titled "[Name of hospital] 2011 Performance Indicators by Department" was provided to the surveyors. The Director of Quality verified that it was valid as of 01/01/11. Among the supporting documentation attached, was a document titled "[Name of hospital] - Blood Culture Contamination Rate - Year 2010." This document contained a chart indicating the level of blood culture contaminations each month from January 2010 through December 2010. The chart indicated that a benchmark of 3% had been set by the hospital as an acceptable level of blood culture contamination. The chart indicated that this benchmark had been exceeded for each of the seven consecutive months beginning in June 2010 through December 2010. The rates of blood culture contamination were as follows: June 8%, July 6%, August 8%, September 5%, October 7%, November 4% and December 4%. The blood culture contamination rate continues to exceed the hospital's benchmark for 2011. In January 2011 - 4% and February 2011 - 5%. Thus for a period of nine months the QAPI data indicated that the blood culture contamination rates were continuously above the hospital's benchmark.

F. The document titled, "[Name of hospital] - Blood Culture Contamination Rate - Year 2010," had a section entitled "Summary of findings - Analysis of Data" for each quarter of 2010. The second quarter, the summary of findings indicates, "Monitor contamination rate on a monthly basis. Now using BacT/ALERT analyzer. Contamination rate increased. ER assigned CHS blood culture collection online in-service and BacT/Alert instructional DVD." The third quarter, the summary of findings indicates, "Monitor contamination rate on a monthly basis. Now using BacT/ALERT analyzer. Contamination rate increased. ER assigned CHS blood culture collection online in-service and BacT/Alert instructional DVD." The fourth quarter, the summary of findings indicates, "Monitor contamination rate on a monthly basis. Contamination rate increased. % [The percentage]decreasing in Nov. & Dec."
Thus over a seven-month period with the blood culture contamination rates consistently exceeding the hospital's own benchmark, the only action taken was to ask staff to look at an on-line in-service and an instructional DVD. No other action was taken to determine why the blood culture contamination rates had reached almost three times the hospital benchmark in June, August and October 2010.

G. On 04/14/11 at 10:40 am, the Quality Director was asked, "Given that your QI data was exceeding your own benchmark for seven months, what did the Quality Improvement program do to resolve the problem?" She stated that nothing had been done, other than education.

H. On 04/07/11 at 10:00 am, during interview, the acting Infection Control Officer and the Director of Quality were asked if anything was reported to the Quality Improvement program concerning the information from the hospital's "Nosocomial Infection Report 2010" for the month of October. The report indicated that there were nine (9) nosocomial infections (the highest number for the year), broken down there were two (2) SSI (Surgical Site Infections) and seven (7) non-surgical hospital acquired infections (the highest number for the year), which would include urinary tract infections. The Director of Quality stated, "No, this was not taken to the quality assurance committee."

I. On 04/13/11 at 9:45 am, during interview, the Infection Control Officer of the hospital was asked if she was aware of the elevated blood culture contamination rates for the last seven months of 2010. She stated that she had only been in the position of Infection Control Officer for the past four months but that she was not aware of the problem and no one in the hospital had brought it to her attention.

J. On 04/13/11 at 11:00 am, the Quality Director was asked if the Infection Control Program was integrated into the hospital-wide QAPI program. She stated that it was not.

Based on document request and interview the hospital failed to ensure that the Quality Assessment & Performance Improvement (QAPI) program conducted performance improvement projects. The findings are:

A. On 04/04/11 at 3:30 pm the hospital was given a Request for Information, including a request for documentation of performance improvement project that the hospital was conducting. A review of the submitted documents revealed that they did not contain any information or documentation of performance improvement projects that met the requirements of this regulation.

B. On 04/12/11 at 9:10 am, during interview, the Quality Director confirned that the hospital had not done any performance improvement projects in the recent past.

Based on document review and interview, the hospital's Governing Body, medical staff, and administrative officials failed to ensure that the hospital had an ongoing program for Quality Assessment & Performance Improvement (QAPI) which was defined, implemented, and maintained. This failure prevented the hospital from improving patient care and reducing medical errors hospital-wide. The findings are:


A. The hospital failed to ensure that Infection Control, Anesthesia, Nuclear Medicine and Outpatient Services were participating in the hospital-wide QAPI program and that data from these services was being consistently collected, analyzed, and acted upon by the QI committee.


B. The hospital failed to integrate the Infection Control Program into QAPI program from some unknown time in the past until March 2011. On 04/13/11 at 10:45 am, during interview, the Director of Nursing and the Director of Quality were both asked to explain how the hospital's Infection Control (IC) program is integrated into the hospital-wide QAPI program. The Director of Quality stated, "We realized that we had a lot of information that was not going to the infection control officer. For a while, the nursing units would gather surveillance information, such as handwashing, the units would then present that information to the quality assurance program, but we realized this information was bypassing the infection control officer. Since last month [March 2011], we have rerouted that information, so now, the nursing units gather their surveillance information, take the information to the IC officer and then the information is passed through to quality." The DON stated, "There have been things that we have been working on, but due to problems or events, I will say that we have not done a very good job of documenting and carrying that information up through [the quality assurance program]." When they were both asked if there had been any infection control problems or information integrated into the hospital-wide QAPI program, they both replied that nothing had been identified in the past twelve months.
It should be noted that at the time of survey QI minutes from September 2010 through February 2011 still did not show any Infection Control Data being reported.

C. On 04/13/11 at 10:15 am, the Director of Nursing and Director of Quality were asked, "In 2010, what infection control interventions were instituted to address issues identified through IC activities and was there evidence that these interventions were discovered from data collection and analysis?" Both stated that they could not think of anything.

Based on record review, staff interviews and facility policy, nursing services and the hospital failed to ensure that: (1) a qualified individual was appointed to direct the psychiatric nursing services of the psychiatric unit (Refer to A 386); nursing personnel with the appropriate education, experience, licensure, competence and specialized qualifications were assigned to provide nursing care for each patient in accordance with the individual needs of each patient throughout the facility (Refer to A 397); (2) clinical activities of the non-employee nursing personnel were adhering to the hospital's policies and procedures and that the Director of Nursing provided adequate supervision and evaluation of the non-employee nursing personnel (Refer to A 398); (3) orders for drugs and biologicals were signed by a practitioner in accordance with hospital policy and State law (Refer to A 406); and (4) the hospital staff completed blood transfusion records that were in accordance with the hospital facility policy (Refer to A 409). The cumulative effect of these systemic practices resulted in the hospital nursing services' inability to ensure that patients' needs could be met.

042 CFR 412.27 Excluded Psychiatric Units: Additional Requirements:
412.27(d)(3)(i) The director of psychiatric nursing services must be a registered nurse who has a master's degree in psychiatric or mental health nursing, or its equivalent, from a school of nursing accredited by the National League for Nursing, or be qualified by education and experience in the care of the mentally ill. The director must demonstrate competence to participate in interdisciplinary formulation of individual treatment plans; to give skilled nursing care and therapy; and to direct, monitor, and evaluate the nursing care furnished.
Based on staff interviews, the hospital failed to ensure a qualified individual was appointed to direct the psychiatric nursing services of the psychiatric unit. This failure could result in the hospital's inability to ensure that the patient's psychiatric needs were being met. The findings are:
A. On 04/06/11 at 2:30 pm, the Director of the Psychiatric Unit stated there was no individual designated as the director of psychiatric nursing services. When asked, she stated that no nurse on the unit held a master's degree. She further stated that she was not a nurse.
B. On 04/06/11 at 2:45 pm, Counselor #12 confirmed there was no director of psychiatric nursing on the psychiatric unit.

Based on record review, and staff interview, the hospital failed to ensure adequate staffing to implement physician orders for 1of 41 sampled patients (Patient #40), whose condition was considered "guarded" from the emergency unit and admitted to the Medical/Surgical unit, requiring vital signs to be taken every 4 hours as per protocol. This failed practice was likely to put patients at an increased risk for not being reassessed. The findings are:

A. Review of Patient #40's medical record, who was admitted on 01/12/11 and discharged 01/24/11 revealed the following:
1. Review of the Physician Documentation dated 01/12/11 indicated that Patient #40 fell at home, from a standing position after becoming unsteady on feet. She complains of right upper thigh leg discomfort and rates the pain as 10 on a one-to-ten scale with ten as the worst pain. Patient #40's past medical history includes: hypertension, ejection fraction of 30% (a measurement of cardiac function; normal is 100%), uncontrolled diabetes mellitus for which the patient has been strongly advised to begin insulin therapy (but which she has consistently refused), and renal failure for which she recently had an arteriovenous fistula created in anticipation of dialysis. Her vital signs at 1820 (6:20 pm) were as follows: blood pressure 82/64, temperature 98.2, pulse 112 and regular, respirations 20 and unlabored, oxygen saturation of 96% on room air. Her pain at time of transfer to floor is 0 on a 1-10 scale.
2. Review of the admitting Physician's orders dated 01/12/11 at 6:10 pm revealed the following: "Admit to Tele [telemetry], vitals as per protocol [vital signs should be taken every 4 hours], condition: guarded..."
3. Review of the Patient Chart including vital signs revealed the following: 01/12/11 vital signs taken at 2120 (9:20 pm). The next recorded set of vital signs were documented on 01/13/11 at 5:00 am (8 hours later).
4. On 04/13/11 at 2:30 pm, during interview, the Director of the Medical/Surgical unit was asked what taking vitals per protocol meant. She replied that the vital signs should be taken every 4 hours.





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Based on record review and interview, the facility failed to initiate treatment for wound care for 1 of 41 (#9) sampled patients. Patient #9 was admitted with redness to the perineum and had a laceration to the buttocks. This failed practice was likely to cause the areas to worsen or become infected without treatment. All patients could be affected due to failure to initiate care. The findings are:

A. Record review for Patient #9 revealed her diagnosis to be diarrhea with clostridium difficile-associated diarrhea, urinary tract infection, and acute kidney injury.
1. Record review for Patient #9 revealed on the emergency department (ED) "Adult Assessment" form dated 03/16/11 in the integumentary section, "Increased redness to peri area [perineum] due to freq [frequent] diarrhea."
2. Record review of the "Nursing Assessment" dated 03/16/11 revealed in section "Skin Appearance," "Pt [patient] has small laceration to right buttock that appears to be a scratch." There was no documentation for the measurement of the area, if the area was open or scabbed over, and the color of the wound and surrounding tissue.

B. Review of the care plan revealed an outcome for "Adequate hydration (active): 03/16/11." An intervention was listed to "assess skin turgor (active) assigned: 03/16/11." No other interventions were listed to care for the perineal area or the small laceration.

C. On 04/16/11 at 9:40 am, an interview was conducted with the Medical Floor Nurse Director. When she was asked if a treatment should have been ordered, she stated, "No wound care was implemented. The wound care for incontinence of stool and excoriation should have been implemented." When asked why there was no documentation about the care of the areas, she stated, "I can't tell you what the nurses reasons were for not treating the area. I would have measured it and start treatment."



Based on record review and interview, the facility failed to ensure that enough supportive staff were on duty to delivery the oxygen therapy needed for 1 of 41 (#7) sampled patients. This failed practice was likely to be the reason the family had to make a decision about possible impending intubation. All patients receiving oxygen were at risk. The findings are:

A. Record review for Patient #7 of the History and Physical dated 01/31/11 revealed "Chief Complaint" to be "Mental status changes." His medical history revealed other diagnoses were positive for hypertension, hyperlipidemia, coronary artery disease, normal pressure hydrocephalus, controlled rate atrial fibrillation, benign prostatic hypertrophy with obstruction, rectal bleeding, urinary retention, hypothyroidism, and urethral stricture, and were negative for any diabetes or cancer.

B. Record review for Patient #7 revealed in the "Patient Care Activities" documentation in the skilled nurses' notes as follows:
1. On 02/07/11 at "1948 [7:48 pm] - received report, care assumed, initial assessment started, 2022 [8:22 pm] - pt's [patient] resp [respiratory] rate noted to be 43 at this time. Dr. notified, no new orders received. MD states she does not want to be notified of increased resp rate unless oxygen saturation decreases. Will continue to monitor. 2333 [11:33 pm] - RT [respiratory therapy] currently on unit. Patient is on 5 L [liters] via nc [nasal canula] with no humidification, notified RT of need, [name of staff] states 'I know' when informed. Reiterated need for humidifications conveyed to RT."
2. On 02/08/11 at "1945 [7:45 pm] - pt already showing signs of agitation AEB [as evident by] pulling at mask, Foley, kicking legs, grabbing for invisible objects. [Name of physician] notified, new orders received to increase Haldol to 1 mg [milligram] IV [intervenous] q [every] 6 hours PRN [as needed]."
a. At "2330 [11:30 pm] - pt's oxygen saturation steadily decreasing, now in mid 80's. RT [respiratory therapy] paged at this time with no answer."
b. At "2334 [11:34 pm] - Oral care performed, throat suctioned via catheter, large amount of blood tinged mucous removed. Pt exhibited good cough and gag reflex, pt would cough upon command. O2 [oxygen] sats [saturations] remain mid 80's with no improvement."
c. At "2342 [11:42 pm] - RT paged again, no answer. Attempting to track RT down on third floor, [Name of staff] states RT is in L & D [labor and delivery] for an emergency delivery at this time. Will continue to attempt to reach them."
d. At "2345 [11:45 pm] - Pt given chest PT [percussion therapy] via manual manipulation by [name of registered nurse], turned pt and performed PT on both sides of chest, pt coughing on command. 02 sats remain low. Suctioning performed again, more blood tinged mucous removed. Pt's throat is raw, red, excoriated and weeping serous fluid. Pt had complained of sore throat previously."
e. At "0004 [12:04 am] - Pt's sats remain low despite attempted nursing interventions. RT paged again, no answer at this time."
f. At "0020 [12:20 am] - [Name of doctor] notified of pt's continued status of oxygen saturations in the mid 80's, states to increase Fi02 [amount of oxygen] to 60% and call pt's wife to discuss possible intubation."
g. At "0021 [12:21 am] - [Name of pts wife] notified of pt's condition, possible impending intubation and states she will arrive in unit within the hour to discuss options for patient."
h. At "0107 [1:07 am] - RT paged again, no answer. Fi02 still needing to be increased to 60%. Pt's O2 sats now at 86-87%."

C. Review of the discharge summary dictated on 02/10/11 at 6:25 am, revealed, "He became more short of breath with waxing and waning mental status and developed respiratory failure. He was treated with BiPap. His wife had requested that he not be intubated. Echocardiogram showed a normal ejection fraction. He did have a right pleural effusion which layered out. He was suspected to have pneumonia. He was treated with broad-spectrum antibiotics with continuing worsening of his condition. Due to his worsening condition despite adequate treatment and he has multiple comorbidities, his wife requested that treatment be withdrawn, and he will be treated for comfort measures only. This was done. He was kept comfortable, and he was pronounced dead at 5:30 am on the morning of February 10, 2011."

D. On 04/12/11 at 10:00 am, an interview was conducted with the Respiratory Manager. When he was asked about the repeated attempts to call RT he stated, "She should have only had to page once. They were in the delivery room. We send both therapists if the physician requests them." When asked if they have backup or someone on call, he stated that they do, and the house supervisor could have been involved. He further stated that there were dead spots and that they now have cellular phones.

Based on record review and interview, the facility failed to ensure nursing staff executed listed interventions, individualized, and revised the nursing care plan as needed for 2 of 41 (#8 and 9) sampled patients. This failed practice was likely to affect the patients outcome by not assessing the patient in a timely manner, and by not providing treatment consistent with the needs of the patient. The findings are:

A. Record review of the discharge summary dated 08/14/10 for Patient #8 revealed her discharge diagnosis as menometrorrhagia (excessive menstrual and uterine bleeding). On the first postoperative day Patient #8 had a critical drop in hemoglobin of 5.7 (normal is 12.0-16.0) and hematocrit of 17 (normal is 38-47) at 7:09 am, on 08/12/11. This resulted in a return to surgery for post operative bleed and Patient #8 received 4 units of blood and 1 unit of packed red blood cells.

B. Record review of a care plan dated 08/11/10 for Patient #8 revealed an intervention for hourly rounds, assigned on 08/12/10, with no time listed.
1. The "Patient Care Activities" section of the chart revealed that hourly rounds on 08/12/10 were conducted at 19:45 (7:45 pm), and 21:29 (9:29 pm). This was 1 hour and 25 minutes after the rounds at 19:45 (7:45 pm).
2. On 08/12/10 the last hourly rounds were charted at 22:15 (10:15 pm), and the next charted hourly round was on 08/13/10 at 00:10 (12:10 am). This was 1 hour and 55 minutes after the last rounds. Other hourly rounds for 08/13/10 were at 1:50 am, 1 hour and 40 minutes apart; 4:00 am, 2 hours and 10 minutes apart; 6:00 am, 2 hours apart; 7:40 am, 1 hour and 40 minutes apart; 10:00 am, 2 hours 20 minutes apart; and 11:30 am, 1 hour and 30 minutes apart.

C. On 04/07/11 at 4:10 pm, an interview was conducted with the Chief Nursing Office. When asked about the monitoring, she stated that she talked to the nurse about the rounds and the nurse felt the patient was asymptomatic.

D. Record review for Patient #9 revealed her diagnosis to be diarrhea with clostridium difficile-associated diarrhea, urinary tract infection, and acute kidney injury.
1. Record review for Patient #9 revealed on the emergency department (ED) "Adult Assessment" form dated 03/16/11, in the integumentary section, "Increased redness to peri area due to freq [frequent] diarrhea."
2. Record review of the nursing assessment dated 03/16/11 revealed in the section "Skin Appearance," "Pt [patient] has small laceration to right buttock that appears to be a scratch."
3. Review of the history and physical dated 03/16/11 revealed no documentation that Patient #9 had an ostomy appliance, was on dialysis or had a fluid restriction.

E. Review of the care plan dated 03/16/11 for Patient #9 revealed problems as follows:
1. "Elimination-fluid balance altered (includes nursing diagnosis for fluid volume excess-deficit, nausea, constipation, diarrhea, bowel elimination, bowel incontinence, urinary elimination-impaired, urinary retention) (active) assigned: 03/16/11."
a. An outcome was listed for "Ostomy appliance fitted assigned 03/16/11. Ostomy care-education (Active) assigned: 03/16/11 and Referral to wound continent ostomy nurse (active) assigned: 03/16/11."
b. An outcome was listed for "Optimal fluid and electrolyte balance (active) assigned: 03/16/11. Dialysis (active) assigned: 03/16/11, Fluid Restriction as ordered (active) assigned: 03/16/11."
c. Review of the care plan revealed an outcome for "Adequate hydration (active): 03/16/11." An intervention was listed to "assess skin turgor (active) assigned: 03/16/11." No other interventions were listed to care for the perineal area or the small laceration.

F. Review of the hospital's "Skin Care Protocol" revealed a protocol for excoriation and incontinence (of feces) care. This protocol was not in the care plan or initiated for Patient #9.
1. Listed treatments for excoriation were: "1. Gently clean area with soap and water, normal saline or sterile water. 2. Apply Calmoseptine to entire area of breakdown. 3. If there are areas of skin where the Calmoseptine is not adhering to the skin due to moisture, apply small amounts of stomahesive powder, dust off the excess and reapply the Calmoseptine. 4. Each time the patient requires cleaning, do not attempt to rub the Calmoseptine completely off. It is intended to be used as a barrier cream. therefore only wipe off the outer soiled layer. 5. Reapply more layers of Calmoseptine as needed. 6. Try to limit use of adult brief on patients with excoriation due to lack of air circulation th the area. 7. Look for signs of Candida and notify MD if present."
2. Listed treatments for incontinence (of feces) care were: "1. For frequent loose stools consider applying fecal incontinence pouch to dry intact skin ... . 2. If stool incontinence persists, obtain an order, if applicable, for the use of a Fecal Management System. ..." 3. Place and frequently change underpads as they become soiled. 4. Absorbent adult briefs or peripads as they become soiled. 4. Absorbent adult briefs or peripads with the mesh undergarment should be used only when active; i.e. walking in the hall... Use briefs only when necessary."

G. On 04/16/11 at 9:40 am, an interview was conducted with the Medical Floor Nurse Director. When she was asked if the care plan should have included wound care or been revised for wound care, she stated, "No wound care was implemented. The wound care for incontinence of stool and excoriation should have been implemented." The Medical Floor Nurse Director conceded that their (hospital) care plans needed improvement.

Based on record review, hospital policy and interview, the hospital failed to ensure that clinical activities of the non-employee nursing personnel were adhering to the hospital's policy and procedures and that the Director of Nursing service provided adequate supervision and evaluation of the non-employee nursing personnel for 1 of 41 sampled patients (Patient # 15). This is a repeat deficiency from a complaint survey completed on 12/17/10. The findings are:

A. Review of Patient #15's medical record revealed that following the delivery of her twins, she developed mild uterine atony. Patient #15 also had pre-existing severe anemia throughout the pregnancy. After the delivery of her twins, Patient #15 required blood transfusions due to having a low hemoglobin of 7.7 (normal is 12 -16). Patient #15 received 4 units of packed red blood cells and 2 units of fresh frozen plasma. The blood transfusion record documentation revealed the following:
1. The blood transfusion record for a unit of blood that was dated 01/29/11 and issued at 1320 (1:20 pm) indicated that the transfusion was started at 1800 (6:00 pm) and stopped at 1800 with the date of administration missing on the document. This would indicate that from the time the blood was issued at 1320 until the blood was started at 1800, 4 hours and 40 minutes had elapsed. The blood transfusion record indicates "Transfusion MUST begin within 30 min of removal from Blood Bank. Blood Products EXPIRE 4 hrs after removal from Blood Bank." Further review of the blood transfusion record indicated that a non-employee Licensed Practical Nurse (LPN) administered the blood transfusion.
a. On 04/12/11 at 10:45 am, during interview, the Director of the Medical/Surgical floor, when asked to see the LPN's blood transfusion competency test, stated that she could not find it. She also stated that she could not find a "Cascade Learning Kit" written test on the LPN. She further stated that the hospital usually does the competencies of the employed LPN's on a yearly basis and that the hospital receives the competencies of non-employed LPN's from each LPN's agency. The Director of the Medical/Surgical floor confirmed that the blood transfusion record "looks like" the blood was started and stopped at 1800.
b. On 04/13/11 at 11:00 am, during interview, when the Laboratory Director retrieved her copy of the blood transfusion record, the time, date and initials were missing as to when the blood was started and when the blood was stopped.
c. On 04/14/11 at 10:00 am, during interview, when the Laboratory Director was shown the blood transfusion record that was in the chart, she verified that the time the blood was started and was stopped indicated as 1800. She further stated that it appeared that the non-employee nurse may have realized that she did not complete the blood transfusion record, but then inadvertently documented the wrong times the transfusion was hung and stopped.

Based on record review, hospital policy, and interviews, the hospital failed to ensure that hospital staff complete the blood transfusion records were in accordance with the hospital policy for 4 of 41 sampled patients (Patient #8, 15, 16 and 38). This is a repeat deficiency from a complaint survey completed on 12/17/10. The findings are:

A. Review of Patient #8's medical record revealed that on 08/11/10 she underwent a total vaginal hysterectomy without complications. On 08/12/10, she returned to surgery for postoperative blood loss. Patient #8 was given 4 units of packed red blood cells and one unit of fresh frozen plasma. The blood transfusion record documentation revealed the following information:
1. The blood transfusion record dated 08/12/10, at 10:58 am, was missing the signature for the 1st verifier for this unit of blood. There was only a signature for the 2nd verifier. There were no times listed for the vital signs (VS) recorded and no documented VS for the 30-minute interval. The 1 hour 30 minute and post transfusion documentation for respirations only listed "vent."
2. The blood transfusion record dated 08/12/10, at 13:01 (1:01 pm), revealed the documentation for respirations during the infusion only listed "vent."
3. The blood transfusion record dated 08/12/10, at 13:49 (1:49 pm), revealed the documentation for respirations during the infusion only listed "vent."
4. The blood transfusion record dated 08/12/10, at 14:52 (2:52 pm), revealed the transfusion was started at 15:07 (3:07 pm). Vital signs were taken from 15:07 (3:07 pm) and continued until 18:07 (6:07 pm) for a total infusion time of 3 hours. The documentation also revealed that the transfusion stopped at 16:00 (4:00 pm).
5. The blood transfusion record dated 08/12/10, at 18:20 (6:20 pm), revealed no vital signs were taken for the 30-minute interval.
6. On 04/14/11 at 09:20 am, an interview was conducted with the Staff Educator. When she was shown the above issues on the blood documentation sheets and asked if the documentation had a problem she stated, "Of course." She was then asked if two registered nurses were required to sign off on the form before starting the transfusion, and she stated, "Yes."

B. Review of Patient #15's medical record revealed that following the delivery of her twins, she developed mild uterine atony (lack of normal uterine tone or strength). Patient #15 also had pre-existing severe anemia throughout the pregnancy. After the delivery of her twins, Patient #15 required blood transfusions due to having a low hemoglobin of 7.7 (normal is 12 -16). Patient #15 received 4 units of packed red blood cells and 2 units of fresh frozen plasma. The blood transfusion record documentation revealed the following:
1. The blood transfusion record dated 01/28/11, and issued at 2020 (8:20 pm), was missing documentation of temperatures for the 15-minute and 30-minute intervals. A signature was also missing for the post-transfusion vital signs.
2. The blood transfusion record dated 01/28/11, and issued at 2200 (10:00 pm), was missing the post-transfusion blood pressure, pulse, temperature, respirations and nurse's signature.
3. The blood transfusion record for the unit of blood #W041511002687, dated 01/29/11, and issued at 1320 (1:20 pm), indicated that the transfusion was started at 1800 (6:00 pm) and stopped at 1800 with the date missing on the document. This would indicate that from the time the blood was issued at 1320 until the blood was started at 1800, 4 hours and 40 minutes had elapsed. The blood transfusion record indicates "Transfusion MUST begin within 30 min of removal from Blood Bank. Blood Products EXPIRE 4 hrs after removal from Blood Bank." Further review of the blood transfusion record indicated that a non-employee Licensed Practical Nurse (LPN) administered the blood transfusion.
a. On 04/12/11 at 10:45 am, during interview, the Director of the Medical/Surgical floor, when asked to see the LPN's blood transfusion competency test, stated that she could not find it. She also stated that she could not find a "Cascade Learning Kit" written test on the LPN. She further stated that the hospital usually does the competencies of the employed LPN's on a yearly basis and that the hospital receives the competencies of non-employed LPN's from each LPN's agency. The Director of the Medical/Surgical floor confirmed that the blood transfusion record "looks like" the blood was started and stopped at 1800.
b. On 04/13/11 at 11:00 am, during interview, when the Laboratory Director retrieved her copy of the blood transfusion record, the time, date and initials were missing as to when the blood was started and when the blood was stopped.
c. On 04/14/11 at 10:00 am, during interview, when the Laboratory Director was shown the blood transfusion record that was in the chart, she verified that the time the blood was started and stopped was documented as 1800.
4. The blood transfusion record dated 01/30/11, and issued at 10:30 am, was missing the post-transfusion blood pressure, pulse, temperature, respirations and nurse's signature.

C. Review of Patient #16's medical record indicated that the patient received 2 units of blood following the birth of her baby. The blood transfusion record documentation revealed the following:
1. Review of the document titled "Refusal to Permit Blood Transfusion" was dated 02/01/11, timed at 1630 (4:30 pm) and signed by the patient.
2. Review of the document titled "Agreement for Blood Transfusion" was dated 02/01/11, but no signature of the patient was in evidence.
3. Review of the document titled "Agreement for Blood Transfusion" was dated on 02/02/11, timed at 1832 (6:32 pm) and signed by the patient's significant other.
4. The document titled "Emergency Transfusion Request" was dated 02/02/11 at 2030 (8:30 pm) and signed by Patient #16's attending physician. The physician was requisitioned 3 units of blood. The document, under the "Reason for Request" indicated "unable to obtain proper consent."
5. An undated Progress Note indicates a time when 2 units of blood (of the 3 that were requisitioned) were hung and when the 2 units were administered to Patient #16 by the attending physician.
6. Review of the document titled "Agreement for Blood Transfusion" revealed that the document was dated 02/03/11 at 9:40 am and was signed by Patient #16, after 2 units of blood had been given on 02/02/11.

D. Review of Patient #38's medical record indicated that the patient received 2 units of blood during her hospitalization. The blood transfusion record documentation revealed the following:
1. The blood transfusion record dated 12/27/10, issued at 11:41 am, was missing the post-transfusion blood pressure, pulse, temperature, respirations and nurse's signature.
2. The blood transfusion record dated 12/27/10, issued at 1340 (1:40 pm), was missing the nurse's signature on the post-transfusion line.

E. Review of the facility policy titled "Blood Transfusion: General Nursing Procedures," last revised on 02/10, revealed the following:
"In accordance with the policy and intravenous administration, only RN's and I.V. competent LPN's may administer or discontinue blood transfusions or blood components...Take vital signs, pre transfusion, and record on the patient's clinical record: temperature, pulse, respiration, blood pressure...Check vital signs at first 15 minutes, then 30 minutes, then at 1 hour and post transfusion..."

F. On 04/14/11 at 10:30 am, during interview, both the Laboratory Director and the nurse educator confirmed that the above blood transfusion records were not completed as required by hospital policy.

Based on record review and staff interview, the hospital failed to ensure that all patient medical record entries were legible, complete, and that physician order entries were either dated, timed or authenticated in written form for 1 of 41 sampled patients (Patient # 40). This is a repeat deficiency from a complaint survey completed on 12/17/10. The findings are:

A. Review of the medical record for Patient #40, who was admitted on 01/12/11 and discharged on 01/24/11, revealed the following:
1. Nursing Narrative Notes dated 01/12/11, timed from 2130 (9:30 pm) to 0457 (4:57 am), were illegible.
2. Progress Notes dated 01/12/11, timed from 0457 (4:57 am) to 0540 (5:40 am), were not dated or signed by the nurse.
3. On 04/07/11 at 3:00 pm, during interview, the Director of the Medical/Surgical floor, when asked if she was able to read back the nursing narrative notes dated 01/12/11, stated that she was unable to do so. When she was also asked if she observed a time or signature on the Progress Notes, she confirmed that there was no date or signature on the Progress Notes.
4. Review of the physician orders revealed that 23 out of 51 physician entries were neither signed nor timed by the physician in a timely manner.

B. On 04/07/11 at 3:30 pm, during interview, the Director of the Medical/Surgical floor confirmed that the physician orders were neither signed nor timed by the physicians in a timely manner.

Based on record review, hospital policy, medical staff bylaws and interview, the hospital failed to ensure that verbal orders were signed by a practitioner in accordance with hospital policy and State law for 1 of 41 sampled patients (Patient #40). The findings are:

A. The State law of New Mexico requires that all verbal and telephone orders be authenticated by the prescribing practitioner, or a practitioner authorized to sign on behalf of the prescribing physician, in writing within 72 hours. Review of the medical record of Patient #40, who was admitted on 01/12/11 and discharged 01/24/11, revealed the following information:
1. The Physician's Orders dated 01/12/11 indicated a telephone order from the physician to the nurse for Vicodin 5/500 1 tablet by mouth every 6 hours as needed. The order was signed by the physician on 02/05/11, which is 24 days after the verbal order was written by the nurse.
2. The Physician's Orders dated 01/12/11 indicated a telephone order from the physician to the nurse for Blood Sugars AC (before meals) & HS (hour of sleep), along with a sliding scale of Novolog Insulin. The order was signed by the physician on 02/05/11, which is 24 days after the verbal order was written by the nurse.
3. The Physician's Orders dated 01/13/11 indicated a telephone order from the physician to the nurse for a Propofol drip, Lasix 100 mg IV times 1 and an oxygen titration order. The orders were signed by the physician on 03/28/11, which is 74 days after the verbal orders were written by the nurse.
4. The Physician's Orders dated 01/14/11 indicated an order written by the pharmacist to change a Levaquin order. The order was signed by the physician on 02/05/11, which is 22 days after the verbal order was written.
5. The Physician's Orders dated 01/15/11 indicated a telephone order from the physician to the nurse for Primaxin 500 mg IV every 12 hours. Later that same day the Primaxin order was discontinued. The orders were signed by the physician on 03/28/11, which is 72 days after the verbal order was written by the nurse.
6. The Physician's Orders dated 01/16/11 indicated a telephone order from the physician to the nurse for Tylenol 650 mg by mouth every 4 hours as needed. The order was signed by the physician on 02/08/11, which is 23 days after the verbal order was written by the nurse.
7. The Physician's Orders dated 01/16/11 indicated a telephone order from the physician to the nurse for Flagyl 500 mg by mouth three times a day. The order was signed by the physician on 02/08/11, which is 23 days after the verbal order was written by the nurse.
8. The Physician's Orders dated 01/17/11 indicated a telephone order from the physician to the nurse for Ativan 0.25 - 0.50 mg by mouth times 1 now and to change all medications to the oral route. The order was signed by the physician on 02/08/11, which is 22 days after the verbal order was written by the nurse.
9. The Physician's Orders dated 01/18/11 indicated an order written by the pharmacist to continue Vancomycin 500 mg every 24 hours. The order was signed by the physician on 02/07/11, which is 20 days after the order was written by the pharmacist.
10. The Physician's Orders dated 01/22/11 indicated a telephone order from the physician to the nurse for Regular insulin 10 units sq (subcutaneous) times 1 now and Lantus 10 units sq every hs. The orders were signed by the physician on 01/31/11, which is 9 days after the verbal order was written by the nurse.
11. The Physician's Orders dated 01/23/11 indicated a telephone order from the physician to the nurse for Ambien 5 mg by mouth times 1 now. The order was signed by the physician on 02/05/11, which is 13 days after the verbal order was written by the nurse.

B. Review of the hospital policy entitled "Verbal Orders" reviewed on 02/11 and revised on 06/10, revealed the following: "...Verbal/telephone orders shall indicate the name of ordering physician and be signed by the person receiving the order. The ordering physician shall be responsible for signing such orders...Orders that are not written by the prescriber will be subsequently authenticated and countersigned by the prescribing practitioner or other responsible practitioner within 72 hours of receipt."

C. Review of the Medical Staff Bylaws MS.5-1, revealed the following:
"Physician's orders may only be given to licensed staff members; however, verbal/telephone orders are to be used infrequently... After the issuance of a verbal or telephone order, the ordering physician or another physician within his practice group or providing coverage, shall be responsible for authenticating verbal or telephone orders, along with the date and time of the authentication, within 72 hours of issuance of the order."

D. On 04/13/11 at 2:30 pm, during interview, the Director of Quality confirmed that the physician orders were not authenticated within the 72 hours in accordance with hospital policy.

Based on observation and interview, the facility failed to ensure that the temporary dishwasher had adequate sanitizer and/or the rinse cycle was able to maintain a temperature of 180 degrees. One meal was served on unsanitized dishes before the facility was able to demonstrate adequate sanitation. This violation of sanitation practice had the potential to affect staff, visitors and patients . The findings are:

A. On 04/05/11 at 11:50 am, a tour of the temporary kitchen and dishwasher area was conducted with the Dietary Manager (DM). The procedure of the dish washing was discussed and the DM stated that the dishwasher was currently down due to a solenoid and it should be fixed on the evening of 04/05/11. He was asked about the type of the machine. He stated it was a high temperature machine but they had also added chemicals for the rinse cycle. The DM stated he was planning to use disposable dishes until the machine was repaired.

B. Observation of the labeled information on the dishwasher revealed it was a low temperature machine, as evidenced by the markings on the machine: "Wash temp 120 recommend 140; Rinse temp 120-140, required chlorine 50 ppm [parts per million], Machine CMA 44L."

C. On 04/06/11 10:15 am, a 2nd observation of the temporary kitchen was conducted with the DM. There were dirty dishes in the area from breakfast. The DM stated that the machine had been fixed and they had served breakfast on the dishes. Review of the dishwasher temperature log revealed on 04/05/11 at 6:40 pm, after the repair by [company name], results were "wash 154, rinse 184." These results were from the gauges on the machine. When requested, the DM checked the rinse temperature with a water thermometer and a multi meter reader with results ranging from 155 to 168. The DM was asked to do a chemical test and he performed a Ph test using litmus paper. The result verified a Ph change but could not indicate how much chlorine was in the water. The DM decided at this time he would continue to serve meals on disposable ware.

D. On 04/07/11 at 11:40 pm, interview and observation were conducted with the [name of company] representative and the DM. The representative tested the chlorine level with test strip QT 10 and the reading was 100 ppm. The [name of company] representative was asked if he does a verification of the water temperature gauges on the machine. He stated that he does not do any tests of the machine because it is not his company's machine. He was also asked if he does any testing on the hospital's main dishwasher. He stated that it is not their machine so he does not do testing, just relies on the gauges. When the DM was asked why he used the wrong chemical test paper the day before, he stated, "I don't know, the main kitchen machine is a high temp [temperature]."

E. On 04/07/11 at 11:45 pm, the DM was asked how often monitoring/service was performed from the dishwasher representative, he stated, "only when there is a problem." The DM was asked how he monitors the gauges and he stated that he only reads the gauges and has no follow-up procedure for verifying that the gauges are working properly.

Based on the request of documents and interviews, the hospital failed to ensure that the infection control officer had been designated in writing as the appointed infection control officer (Refer to A0748); that there was a system in place for identifying, reporting, preventing, investigating, and controlling infections; and that there was an active infection control surveillance program (Refer to A0749). The cumulative effect of these systemic practices resulted in an increased potential for patients to be subject to infection. The findings are:

A. Based on document request and interviews the hospital failed to ensure that the Infection Control Program was integrated into the Quality Assessment & Performance Improvement (QAPI) program.
The hospital failed to integrate the Infection Control Program into QAPI program from some unknown time in the past until March 2011. It should be noted that at the time of survey QI minutes still did not show any Infection Control Data being reported. On 04/13/11 at 10:15 am, the Director of Nursing and Director of Quality were asked, "In 2010, what infection control interventions were instituted to address issues identified through IC activities and was there evidence that these interventions were discovered from data collection and analysis?" Both stated that they could not think of anything.

Based on document review and interviews, the hospital failed to ensure that the infection control officer had been designated in writing as the appointed infection control officer. The findings are:

A. Review of the infection control program did not indicate that the acting infection control officer had been designated in writing as the appointed infection control officer.

B. On 04/13/11 at 9:45 am, during interview, the Acting Infection Control Officer was asked if she had been designated in writing as the appointed infection control officer for the hospital. She replied that she did not know that it needed to be in writing.

C. On 04/13/11 at 10:45 am, during interview, the Director of Nursing and the Director of Quality were asked if the Infection Control Officer had been designated in writing as the appointed infection control officer for the hospital. They replied that the Acting Infection Control Officer signed a job description for the infection control officer.

D. Review of the job description document revealed no evidence to indicate that the Acting Infection Control Officer had received an appointment by the hospital as the infection control officer or had accepted the duties of infection control officer.

Based on the request of documents and interviews, the hospital failed to ensure that there was an ongoing system in place for identifying, reporting, preventing, investigating, and controlling infections which included the following issues:
Failure to conduct ongoing active surveillance.
Failure to perform program evaluation and revision.
Failure to maintain a sanitary hospital environment.
Failure to maintain safe air handling in sterile processing.
Failure to practice safe food handling and sanitation techniques.
Failure to clean and disinfect environmental surfaces.
Failure to use disinfectants, antiseptics and germicides in accordance with manufacturers' guidelines.
The findings are:

A. Review of the Infection Control Program Manual did not indicate that the hospital had an active infection control surveillance program. In interview on 04/13/11 at 9:45 am, the Acting Infection Control Officer (ICO) stated that she walks around the hospital campus, takes notes and asks questions. However, review of the Infection Control Log revealed that none of her findings are recorded in that document.


B. On 04/13/11 at 9:45 am, during interview, the acting Infection Control Officer (ICO) was asked several questions regarding her knowledge and understanding of the hospital's infection control program. She made the following admissions:
· That she had not been to all parts of the hospital during her rounds as the ICO.
· That she did not document entries in an infection control log, but instead only sent e-mails to the Director of Quality (DOQ).
· That no collection of infection control data had been done. She stated, "I probably would not have anything [infection control data] to show you at this time."
· That no analysis of infection control data had been done.
· That she had not monitored any negative trends identified from infection control data.
· That she does not have a full understanding of how the infection control program is integrated into the hospital-wide QAPI. She stated, "I have not had an orientation to how the Infection Control program works with the Quality Assurance committee."
· That she identifies and manages the Multi-Drug Resistant Organisms (MDRO), but just for the purpose of "seeing what is growing."
· That she is unaware of how the operating rooms, intensive care units and isolation rooms' air handling system works.
· That she had not observed a terminal cleaning of the operating rooms.
· That she had not observed any aseptic technique practices used in the operating rooms while surgery was being performed; neither had she observed any aseptic technique employed outside of the operating rooms.
· That she has not observed the sterilization process of surgical instruments. She admitted that she only knows where sterilization of the instruments is done.
· That she was not able to ensure that disinfectants, antiseptics and germicides were being used according to manufacturers' instructions.
· That her orientation to the infection control process has been inadequate.
C. Review of the Infection Control Preceptor Checklist indicated by dates of completion that as the acting Infection Control Officer she had a good understanding of the different topics relating to Infection Control, when in fact, by her own admission during the interview on 04/13/11 (as noted above), she did not. The checklist included the the following areas, as quoted:

· Surveillance: targeted, comprehensive and reportables;

· The Infection Control Program including: prioritized risks, measurable goals, strategies & interventions and annual evaluation;

· Infection Control Orientation & Training, including: APIC Basic Course and Infection Control conference on disease prevention;

· Statistics & Data Analysis including: how to display data and data analysis;

· Policies and Procedures including: periodic review, bioterrorism, plan for influx of infected patients, pet therapy and exposures/outbreak procedures;

· Practices including: aseptic technique, handwashing, isolation, devise [sic] related infections, Ventilation Acquired Pneumonia, Blood Stream Infections, Urinary Tract Infections, pressure ulcer, Infection in neonates and Antibiotic resistant infections (MRSA, VRE and C-Diff);

· Coordination with Employee Health including: PPD compliance, influenza program and exposure plan;

· Facilities Management including: Construction & Renovation Risk Assessment, Environmental Services in cleaning agents approval, linen service and regulated waste, Ventilation and Water Issues;

· Support Services including: Cleaning, Disinfection & Sterilization, Flash Sterilization, Single-use devises [sic] and Volunteers;

· Diagnostic & Therapeutic Services including: Antimicrobial use and development of resistance and Cardiac Catheterization;

· Diagnostic & Therapeutic Services including: IC & laboratories, IC & endoscopy, pharmacy, antibiotic usage, physical therapy, respiratory therapy, dialysis, and patient immunizations including: Pneumococcal and Influenza.

The Director of Quality Management commented on 03/29/11 that the acting Infection Control officer "has caught on to the IC program very quickly and is doing a great job."

D. On 04/13/11 at 10:45 am, during interview, the Director of Nursing (DON) and the Director of Quality (DOQ), when asked several questions regarding the hospital's infection control program, made the following admissions:
· That there has not been any documentation of surveillance rounds.
· That they could not think of any interventions that have been instituted in the past year that would address issues identified through IC activities.
· That the DOQ was more familiar with negative pressure rooms than positive pressure rooms, while the DON was not familiar with either.
· That the acting ICO had not observed a terminal cleaning of the operating rooms as of yet.
· That they could not recall if there had been any active surveillance activities being performed in the area of regulated (biohazard) and regular waste at this time.

· The DON and DOQ could not recall if there had been any identified problems by the Infection Control program that would have been reported to the Quality Assurance committee.

Based on record review and interviews, the hospital's leadership including the Chief Executive Officer (CEO), Medical staff and Director of Nursing (DON) failed to ensure that the hospital-wide quality assurance program addressed problems that were identified by the Infection Control (IC) officer. This failure prevented the hospital from improving patient care hospital-wide. The findings are:

A. During record review of the hospital's Quality Assessment and Performance Improvement (QAPI) committee minutes, there was no evidence that the Infection Control program information was being addressed in the hospital-wide QAPI program.

B. On 04/15/11 at 9:45 am, during interview, the CEO was asked if the hospital-wide quality assurance program was addressing problems that have been identified by the IC officer. He replied that he thought the IC information was addressed. He then stated, "Obviously not."

C. On 04/13/11 at 10:45 am, during interview, the Director of Nursing (DON) and the Director of Quality (DOQ) were asked to explain how the hospital's IC program was integrated into the hospital-wide QAPI program. The DOQ replied, "We realized that we had a lot of information that was not going to the IC officer. For a while, the nursing units would gather surveillance information, such as handwashing. The units would then present that information to the quality assurance program, but we realized this information was bypassing the IC officer. Since last month [March 2011], we have rerouted that information, so now, the nursing units gather their surveillance information, take the information to the IC officer and then the information is passed through to the quality assurance program." The DON stated, "There have been things that we have been working on, but due to problems or events, I will say that we have not done a very good job of documenting and carrying that information up through [to the quality assurance program]." The DOQ and the DON were asked if there has been any infection control problems or information integrated into the hospital-wide QAPI program. They both replied that nothing has been identified in the past twelve months.

Based on observation and interview, the hospital and its infection control program failed to ensure that sterilized materials were stored in a manner that ensured continued sterility. The room in which sterilized materials and instruments were stored had a pass-through window to the dirty instrument cleaning room. This pass-through window remained open even after two surveyors advised the Operating Room and sterile processing staff that the pass-through window could not remain open. The open pass-through window allowed air contaminated from the cleaning of dirty instruments to pass into the room where cleaned instruments were being packaged for sterilization and being stored after sterilization. The failure to keep separation between dirty instrument processing area and the room where cleaned instruments were being packaged for sterilization and stored after sterilization had the potential to contaminate the sterilized materials and instruments. The findings are:

A. On 04/06/11, at 7:45 am, the surveyor observed the "clean" room of the sterile processing area. This room was used to package instruments for sterilization and storage after sterilization. The surveyor observed a pass-through window that was approximately 4' x 4' that opened into the room where the dirty or gross cleaning of dirty instruments was done. This open window not only allowed potentially contaminated air from the dirty instrument room to flow into the "clean" room, it also defeated the need to have positive air pressure in the "clean" room. The surveyor advised the Operating Room Manager and a sterile processing staff person that the pass-through window had to be closed immediately. The Operating Room Manager acknowledged that the pass-through should be closed.

B. On 04/07/11, at 10:30 am, the surveyor returned to the sterile processing area to inspect the sterilization and storage of sterile instruments and materials. Upon entering the "clean" room, the surveyor again observed that the pass-through window which opened into the room where the dirty or gross cleaning of dirty instruments was done continued to be open. The surveyor told the Sterile Processing manager that the window needed to be closed. At first she protested that they wouldn't be able to pass materials and instruments into the clean room, but finally acknowledged that the pass-through window had to be closed to maintain a sterile environment and positive air pressure.

Based on observation the hospital failed to ensure that three of three operating rooms in use -- #2, #3, & #5 in the main operating suite -- had monolithic flooring that would permit adequate sanitation during surgical cases and between surgical cases, as well as during terminal cleaning. The grout and damaged tile floors in operating rooms #2, #3, & #5 could not be sanitized and would thus expose all patients to potential infections. The findings are:

A. On 04/06/11 at 6:00 am,the health and life safety surveyors began their inspection of the operating rooms. It was immediately noticed that operating room floors had the following sanitation issues: (1) operating rooms #2, #3, & #5 had floors composed of ceramic tiles with aggregate grout rather than the required monolithic flooring; (2) operating rooms #2, #3, & #5 each had cracked tiles in the floor; (3) in operating room #2, the tiles used to make the baseboard where the floor joins the walls had places where the tiles had either come loose or had separation between the tiles. It should also be noted that operating room #4 was being used as a storage room, but it also had the tile and grout floor.

B. On 04/06/11 at 6:00 am, the health and life safety surveyors began their inspection of the operating rooms. In operating room #2, surveyors noticed that a recessed fluorescent light fixture in the ceiling had places where it had rusted and paint was flaking from the lens cover frame. In operating room #4, paint was peeling off of a ceiling access panel very close to the operating table and there was rust on the air louvers vent covers located in the wall. Operating room #5 had paint flaking off the arm of the surgical overhead light located directly over the surgical table.

C. On 04/06/11, at 7:45 am, the surveyor observed during a tour with the Facility Manager and the Maintenance Supervisor that the "Flash Hallway" was missing base tile and there was wall damage located behind supply carts and wall damage at (under) the scrub sinks, and an electrical cover plate that was smaller than the opening.

D. On 04/06/11 at 7:45 am, the surveyor observed during a tour with the Facility Manager and the Maintenance Supervisor that the "Sterilizer Room" had damage at the bottom of 2 walls.

Based on observation and interview the hospital failed to ensure that the floors in all areas of the operating suites were being disinfected between surgical case and during the terminal cleaning. The housekeeping staff was using a general cleaner rather than a disinfectant to clean all of the floors in operating areas. The failure to disinfect the operating room and adjacent area floor resulted in operating area floors that were not sanitary and had the likelihood to impact infection control efforts. The findings are:

A. On 04/06/11 at 2:43 pm, the surveyor observed the terminal cleaning of Operating Room #4 in the main surgical area. Two housekeepers, HK#1 and HK #2, were doing the terminal cleaning. After damp mopping the ceiling and walls, HK#1 took a mop bucket from the housekeeping cart that was filled with clean water and began to pour a (company name) product called #3 into the mop bucket. Both HK#1 & HK#2 began mopping the operating room floor at 3:12 pm. At 3:15 pm, the mopping was completed. At 3:16 pm, a floor vacuum was employed to begin removing the mop water from the floor. By 3:25 pm, the vacuuming was completed and no more water could be seen on the floor. It should be noted that the mop water containing the cleaning product was only on the floor for 3 minutes before the vacuuming began. At 3:32 pm, when the surveyor asked HK#1 how long the cleaning product had to remain on the floor to disinfect, she replied, " It needs to stay on for 10 minutes." The surveyor pointed out that they had only left the mop water on the floor for 3 minutes before they started removing it. She had no response. HK#1 was then asked for the technical information for (company name) product #3. She stated that she did not have the instructions or technical information. She went to a supply closet but was unable to find the requested information. The surveyor asked the OR Manager to have a copy of the instructions brought to the surveyor. Later that afternoon the Physical Plant Manager brought a page of instructions for using (company name) Product #3. The page mentioned nothing about Product #3 being a disinfectant. The Physical Plant Manager said that there must be another technical data sheet that gave information about the disinfectant qualities of Product #3 and he would bring it to the surveyor on 04/07/11. At 9:15 on 04/07/11, the Physical Plant Manager brought another copy of the same sheet he presented on 04/06/11 and said that this was all he could find. A review of this technical data sheet for (company name) Product #3 revealed that it was a "Neutral Cleaner," and did not have any disinfecting properties. In response to a question from the surveyor, the Physical Plant Manager confirmed that the housekeepers were doing the terminal and between-case cleaning of all the operating rooms, OR halls and sterile processing area with a mild cleaner rather than a disinfecting cleaner.

Based on observation and interview, the hospital failed to ensure that a tracheotomy set was readily available in two locations where surgical procedures were being performed. The Labor & Delivery (L&D) Charge Nurse was unaware of the location of the tracheotomy set in the Labor & Delivery Suite and no tracheotomy set was present in the Endoscopy Suite. The failure of the Surgical Services to readily find or have available a tracheotomy set could prevent the surgical team from performing an emergency tracheotomy to restore breathing to a patient. The findings are:

A. On 04/06/11, at 7:00 am, the surveyor asked L&D Charge Nurse #1 to show where the tracheotomy set for the L&D operating suite was located. She stated that it was in an instrument cart in a recovery room. At 7:05 am, L&D Charge Nurse #1 tried the drawers to the cart and discovered that they were locked. She then left the room to look for the keys to the cart. The L&D Nursing Manager stated to the surveyor that as the L&D Charge Nurse, L&D Charge Nurse #1 should know where the keys to the cart were located. During the next 6 minutes the L&D Charge Nurse #1 brought 3 different sets of keys, none of which would open the instrument cart. During this 6-minute period the L&D Nursing Manager stated to the surveyor, "There are two tracheotomy sets, one in the instrument cart and one in the bottom section of the emergency cart." At 7:11 am, L&D Charge Nurse #1 finally found the right key and was able to open the instrument cart, but there was no tracheotomy set in the cart. The L&D Nursing Manager had to prompt L&D Charge Nurse #1 that she should look in the bottom section of the emergency cart, sitting next to the instrument cart. L&D Charge Nurse #1 broke the seal on the bottom section of the emergency cart and found the tracheotomy set. Had a patient emergency occurred requiring the use of the tracheotomy set, L&D Charge Nurse #1 would not have been able to find the tracheotomy set in a timely manner.

B. On 04/06/11, at 4:15 pm, during an inspection of the Endoscopy Suite procedure rooms, the surveyor asked the OR Manager to show where the tracheotomy set was kept for these procedure rooms. She stated that there was no tracheotomy set in the Endoscopy Suite. The surveyor asked, "What would you do if a tracheotomy set was needed?" The OR Manager stated, "Someone would have to go over to the main OR and bring the tracheotomy set over." It should be noted that the OR Manager had previously stated that the anesthesia for many of the procedures in the Endoscopy Suite were done by injecting drugs through an intravenous line. This method of administering drugs increases the potential that an adverse drug reaction could occur, which might in turn require the use of a tracheotomy set.

Based on document review and interview, the hospital failed to ensure that the Anesthesia Services were integrated into the hospital-wide Quality Assessment & Performance Improvement (QAPI) program. The failure to include Anesthesia Services in the QAPI reduced the ability of the hospital to improve patient care and reduce medical errors. The finding are:

A. On 04/04/11 the hospital was given a Request for Information to provide a list of all performance improvement indicators for all services.
On 04/05/11 a document titled "[Name of Hospital] 2011 Performance Indicators by Department" was provided to surveyors. A review of this document found no data that was specific to Anesthesia Services and that would help the hospital to evaluate the quality of care being provided to patients receiving anesthesia.

B. On 04/12/11 at 10:00 am the Quality Improvement Director was asked to explain which of the five general indicators under the heading of "Surgical Svcs/Anesthesiology" were being collected for Anesthesia. She stated, "The hospital is not collecting any Quality Improvement data on Anesthesiology, and Anesthesiology is not included in the Quality Improvement program."

Based on interview and document review the hospital failed to ensure that the Nuclear Medicine Services were integrated into its hospital-wide Quality Assurance & Performance Improvement (QAPI) program. The failure to include Nuclear Medicine in the QAPI reduced the ability of the hospital to improve patient care and reduce medical errors The findings are:

A. On 04/04/11 the hospital was given a Request for Information to provide a list of all performance improvement indicators for all services.
On 04/05/11 a document titled "[Name of Hospital] 2011 Performance Indicators by Department" was provided to surveyors. A review of this document found no data for the Nuclear Medicine Services.

B. On 04/07/11 at 11:35 am the Director of Quality was interviewed about the lack of performance indicators and data for the Nuclear Medicine Services. She stated that the hospital had decided in late 2010 to add an indicator for Nuclear Medicine. She produced a document titled " Nuclear Medicine/[Name of Hospital] /2011." The document listed three indicators, (1) Compliance - Scheduled vs. No-Shows, (2) Number of no shows - no calls (numerator) and (3) Total number of exams scheduled (denominator). The document only contained data for the month of March 2011. When the QI Director was asked to explain how monitoring the number of no-shows would help to improve patient safety and reduce medical errors, she stated that she could could not provide such an explanation.

C. On 04/05/11 the hospital provided a policy/procedure from the Nuclear Medicine department titled "Medicare Guidelines." The stated purpose of the policy/procedure was "To address Medicare Interpretative Guidelines." The policy/procedure contained the following paragraph: "The Nuclear Medicine Department is participating in the QAPI program. Monitoring the patients scheduled for nuclear medicine exams, which do not show for the exams. Items monitored are Date/Time, Doctor, Study, Isotope, were we informed? Bullet #1: This may improve lost revenue due to isotopes ordered and not being used. Bullet #2: Improve the amount of down time for the department. Determine if we may need to further educate physicians/Offices, on procedures and/or protocols."

Based on observation, record review, and staff interview, the hospital failed to ensure outpatient services were appropriately organized by not having outpatient services participate in the the hospital-wide Quality Assessment & Performance Improvement (QAPI) program. Failing to participate in the hospital's QAPI program increases the likelihood of medical errors (Refer to A 1077). The hospital further failed to ensure that outpatient medical records were integrated into the hospital's comprehensive medical records until the patients receiving the outpatient care were discharged from outpatient care. Lack of communication of patient treatment increases the likelihood of medical error (Refer to A 1077). The hospital further failed to to assign an individual to be responsible for outpatient services. This failure of the hospital resulted in a lack of coordination between the outpatient departments and other departments of the hospital (Refer to A 1079). The cumulative effect of these systemic practices resulted in the agency's inability to ensure that the patient's needs would be met in a safe manner.

Based on record review and staff interview, the hospital failed to ensure outpatient services were appropriately organized by not having outpatient services participate in the hospital-wide QAPI program. Failing to participate in the hospital's QAPI program increases the likelihood of medical errors. The findings are:

A. Review of the hospital's QI meeting minutes for the past six months revealed no data for outpatient services.

B. On 04/05/11 at 10:45 am, during an interview, the Director of Quality confirmed that the departments providing outpatient services are not collecting data with outpatient services as the focus.


Based on observation and staff interview. the hospital failed to ensure that patient medical records from the hospital's off-site outpatient treatment facility were integrated into the hospital's comprehensive medical records until patients receiving the outpatient care were discharged from outpatient care. This absence of information in the comprehensive record during patients' treatment increases the likelihood of medical error. The findings are:

A. On 04/07/11 at 1:15 pm, during an observation at the outpatient therapy clinic, it was noted that the clinical records for the patients being treated at this site were being kept in a filing cabinet.

B. On 04/07/11 at 1:30 pm, during an interview, the Director of Outpatient Therapies stated that the medical records at the outpatient treatment unit are only kept on the unit until the patient is discharged from the unit and he takes the record to the hospital medical records department. When he was asked about the hospital needing the record before the patient's discharge, he stated that if the hospital calls during his office hours, he can get the information to the hospital, but he cannot do so during non-office hours.

Based on record review and staff interview, the hospital failed to assign an individual to be responsible for outpatient services. This failure of the hospital resulted in a lack of coordination between the outpatient departments and other departments of the hospital. The findings are:

A. Review of the hospital's organizational chart revealed no individual assigned as the Director of Outpatient Services.

B. On 04/05/11 at 10:45 am, during an interview, the Chief Nursing Officer confirmed there was no individual assigned to direct outpatient services. She further stated that she just oversees administratively the departments that provide outpatient services.

Based on record review and interview, the hospital's emergency department (ED) failed to properly assess and initiate necessary medical services causing one patient (#5) to be prematurely discharged from the ED only to return to the ED by an ambulance in full respiratory arrest. A second patient (#39) who presented to the ED with a pain level of 8, a low BP of 72/39, and who reported that she had fallen earlier in the day, sat in the waiting area following triage for for an additional 2- 1/2 hours before being seen. These failed practices were likely to have been the cause for these patients to be transferred to other facilities providing a higher level of care. The findings are:

A. Review of the medical record for Patient #5 revealed the following:
1. Patient #5 is a 15-year-old male. He presented to the Emergency Department (ED) on 01/21/11 at 2:18 am by ambulance, accompanied by his mother. His chief complaint was shortness of breath. Past medical history was positive for congenital myasthenic syndrome (excessive muscular weakness and fatigability of muscle function), positive history of pneumonia, bronchitis and positive RSV (respiratory syncytial virus - an infection of the lungs and breathing passages). He is using a Bi-Pap respiratory machine.
2. Nurse Documentation indicated at 2:32 am, Patient #5's respiratory assessment is as follows: "Airway is patent. Respiratory effort is noted to be moderately labored. Lung sounds by auscultation reveal clear breath sounds in the left upper lobe, crackles in the right upper lobe and right middle, diminished sounds in the left base and right base. Pulse oximetry attached to patient with reading of 95. Patient on his BiPAP machine."
3. A chest x-ray performed at 2:55 am, and results revealed that Patient #5 had a right lower lobe infiltrate (bronchitis).
4. Patient #5's intravenous (IV) was started at 3:55 am, normal saline was started at 125 cc/hour and Rocephin ( IV antibiotic) was given at 4:02 am. Breathing treatment of Albuterol and Atrovent was given at 4:20 am.
5. Patient #5 was reassessed by nursing at 4:11 am, which indicated: "Patient is alert and oriented x 3. Respirations are regular and unlabored. Skin is warm and dry."
6. Patient #5 was reassessed at 4:20 am, indicating: "Patient is alert and oriented x 3. Respirations are labored. Refer to respiratory assessment. Skin is warm and dry, vascular status intact. Patient with his BiPAP on. Respiratory therapist to do breathing treatment."
7. Physician documentation revealed at 4:38 am, the following: "Case discussed with [name of pediatrician]. He feels patient may be appropriately discharged with an office follow-up. All physical findings explained, agree with antibiotic, will see patient in office."
8. Patient #5 was reassessed by nursing at 5:22 am, which indicated: "Patient is alert and oriented x 3. Skin is warm and dry, vascular status intact. Respiration are labored. Refer to respiratory assessment. Patient is sleeping but on his BiPAP machine. IV discontinued due to patient's mother thinking the family was here to pick them up. Patient's mother stated afterwards that the family called and are just now leaving to come pick them up. Continue to monitor."
9. Nurse documentation revealed the following: "Patient left the department at 01/21/2011 5:53 am. Patient's disposition is home. Discharge instructions were given to the patient and given to the parent. The family member with patient verbalizes understanding of the discharge instructions. The condition at discharge is stable. Belongings were taken by a family member. Vital signs taken at 5:54 were T: 97.8 AX, P: 79 and is regular, R: 23 and patient is on BiPAP machine, O2 Sat: 97, O2 delivered by BiPAP, pain level is 0 on a 1-10 scale."

B. Physician dDocumentation dated 01/21/11 at 7:03 am, 45 minutes after discharge, revealed the following incident: "Patient brought to ED in "near-arrest" condition. Arrest was witnessed by family member. Prior to arrest patient had been complaining of shortness of breath. Downtime prior to initiation of CPR [cardiopulmonary resuscitation] estimated at approximately 10 minutes. CPR in progress for approximately 20 minutes prior to arrival in ED. Intubated in field and administered 100% O2 via bag-valve en route to ED. CPR administered prior to arrival in ED. Peripheral venous access established. Patient received the following medications prior to arrival in ED: epinephrine, atropine x 2. This patient has a muscular dystrophic disease and is well known at [local university hospital's name]."
1. Nurse documentation revealed the following assessment at 6:49 am: "The child is unarousable. Right pupil is 6-7 mm. Left pupil is 6-7 mm. Left pupil response is dilated, fixed. Right pupil response is dilated, fixed (could possibly indicate lack of oxygen to the brain). Will not communicate with those involved in care. The patient has a flat affect. Pediatric Glasgow Coma Scale (GCS) - Eye Opening: None-1, Best Verbal: None-1, Best Motor: None-1, Total GCS: 3 (normal GCS is 15). The pulse is weak. Capillary refill is 6 seconds. Heart rate is 152. Cardiac monitor is attached to patient. Electronic non-invasive blood pressure monitor attached to patient. Monitor shows sinus tachycardia. The skin appears cold, pale. Skin turgor shows decreased elasticity. Mucous membranes appear pale. Airway is maintained mechanically. Pulse oximetry attached to patient with a reading of 100."
2. At 7:02 am, "EKG (electrocardiogram) was performed at bedside."
3. At 7:15 am, "Patient taken for CT (computerized axial tomography scan). Lung sounds audible and crackles heard bilaterally post transfer from stretcher to CT table. Vital signs within normal limits."
4. At 7:20 am, "CT head and chest in progress. Vital signs stable."
5. At 7:25 am, "Lung sounds audible with crackles heard bilaterally post transfer from CT table to stretcher. Vital signs stable.
6. At 7:38 am, "laboratory called, glucose level of 428 [normal is 75 - 103] and AST is 1116 [normal is 10 - 34]."
7. Nurse reassessment at 8:00 am indicated the following: "The pulse is strong and regular. Capillary refill is less than 2 seconds. Heart rate is 156. Monitor shows sinus tachycardia. Cardiac monitor is attached to patient. Electronic non-invasive blood pressure monitor attached to patient. The skin appears normal, warm and dry. Skin turgor is normal. Edema is not present. Mucous membranes appear pink, moist. Airway is mechanically supported by a ventilator. Respiratory effort is absent. Lung sound by auscultation reveal crackles in the left upper lobe and right upper lobe and right middle and left base and right base."
8. "Doctor at the local university hospital was consulted at 8:58 am, she recommends transferring the patient to a higher level of care hospital."
9. A chest x-ray performed at 10:00 am indicated the following impression: bilateral upper lobe atelectasis [a collapsed or airless condition of the lung] versus developing acute respiratory distress syndrome. These are not conspicuous on previous study from earlier at 2:55 am."
10. Nurse reassessment at 10:00 am indicated the following: "All pulses are palpable, strong and intact. The skin appears normal, warm and dry. Edema is not present. Chest wall is non-tender to touch, observed as symmetrical, no abnormalities noted. Physician notified of continued elevated heart rate of 158."
11. "Patient left the department at 01/20/2011 at 1:00 pm. Transferred to the local university hospital via fixed wing. Vital signs taken at 11:50 am were: T: 96.9, P: 148 and regular, R: 12 and assisted, BP: 115/92, O2 Sat: 100, cardiac monitor shows: sinus tachycardia, pain level is 0 on a 1 -10 scale in the Wong-Baker on 100% FiO2. Belongings were taken by a family member. Report given and patient care handed over to Lifeguard flight crew at 12:00 pm."

C. On 04/07/11 at 3:30 pm, during interview, the Director of Quality confirmed that this patient had been discharged from the ED at 5:53 am and came back into the ED 45 minutes later in full respiratory arrest. When she was asked if this case went through the Mortality Review committee, she stated that the patient did not die in the hospital and that he had died at another hospital. She was also asked if this case was considered a sentinel event or a near miss event. She replied, "No."

D. Record review for Patient #39 revealed she presented to the ED on 02/20/11 at 13:00 (1:00 pm). Patient (pt) #39's data sheet revealed the following:
1. Review of the "Initial Assessment Form" dated 02/20/11 at 13:24 (1:24 pm) revealed "Priority 3 Urgent, Chief Complaint: Fall--Injury/Pain, Brief Assessment: pt fell from standing position this morning getting up from bed, fell last Thursday, as per pt's son pt getting confused x 4 days, denies ALOC [acute loss of consciousness], c/o [complains of] bilateral knee pain, Vital Signs [vs] T [temperature]: 97.9, P [Pulse]: 56 regular, R [Respirations]: 20 unlabored, BP: 72/39, Oxygen: 94% on RA [room air], Pain Intensity Scale: 8/10, Pain Location: multiple areas, placed in room at 15:39 [3:39 pm]."

2. It should be noted that the patient sat in the waiting room after triage from 1:24 pm to 3:02 pm, a total of two and one quarter hours, until being directed to a treatment room.
3. Review of the Adult Assessment dated 02/20/11 at 15:39 (3:39 pm) revealed she was placed in room 6, and her pain level was "'0' radiates to the left, is intermittent."
4. Ongoing assessments were as follows:
a. Reassessment was conducted at 15:40 (3:40 pm) and revealed "blood drawn and IV hep lock est [established] to left ac [antecubital (at the bend of the elbow)] 20 gauge angio [size of needle], MD [medical doctor] in to see pt."
b. Reassessment was conducted at 15:53 (3:53 pm) and revealed "Specimen collected at 15:45 [3:45 pm], by nurse. Type of specimen collected was blood. Specimen was sent to lab [laboratory]. Physician was at the bedside at 15:45 [3:45 pm]."
c. Reassessment was conducted at 16:42 (4:42 pm), 49 minutes later, and revealed, "Patient was transported to radiology at 02/20/11 at 16:42 [4:42 pm], for CT [computerized tomography] Scan."
d. Reassessment was conducted at 17:12 (9:12 pm) and revealed a report from the lab, "Critical Values: Physician notified at 17:07 [9:07 pm]; Troponin 7.70 [normal range 0.00 - 0.09] and CK [creatinine kinase] 3029 [normal range 21 - 215, the results of the elevated cardiac enzymes indicate cardiac muscle damage], returned from radiology at 17:00 [9:00 pm], pt's condition was unchanged upon return from radiology. 17:14 [9:14], pt sleeping with eyes closed and respirations even and unlabored."
e. Reassessment was conducted at 18:01 (6:01 pm), 45 minutes later.
f. Reassessment was conducted at 19:03 (7:03 pm), 1 hour and 2 minutes later.
5. Review of the ED treatment sheet revealed the following treatments were administered:
a. "Normal Saline 500 cc (cubic centimeters) bolus at 999 cc/hr in the left arm, given for hydration reasons initiated at 02/20/11 at 15:51[3:51 pm], 17:15 [5:15 pm] - infusing without signs of infiltration, 19:40 [7:40 pm] - IV infusion stopped at 02/20/11 19:40." This infusion, which should have been completed within 30 minutes, instead took three hours and 39 minutes.
b. "IV Heparin bolus of 3138 [units] and drip per protocol for low intensity initiated at 02/20/11 18:01."
c. "Disposition: Transfer; Patient left the department at 02/20/11 19:42 [7:42 pm]. Transfer was initiated for: Specialized care - cardiac. Discharge Diagnosis: Non ST Segment Elevation Acute MI [mycardial infarction]."
6. The ED report dated 02/20/11 at 17:21 (5:21 pm), revealed in the section titled "Chief Complaint/History of Present Illness," "[Name of patient] is a 86 year old F [female] that presented to the ED at 13:08 [1:08 pm] by w/c [wheel chair]. The patient was triaged at 13:24 [1:34 pm] with the following vital signs: T: 97.9, P: 56 regular, R: 20, unlabored, BP: 072/039, SPO2 [oxygen saturation]: 94 Amt: RA [room air], Pain: 8 multiple areas." This was documented by the attending physician at 17:21 [5:21 pm].
7. The ED report dated 02/20/11 at 17:21 (5:21 pm), revealed in the section titled "Chief Complaint -- Fall --Injury/Pain": "86 yo female with HTN [hypertension], DM [diabetes mellitus] who felt weak and left body weakness two days ago with slurred speech and facial droop lasting two hours, she reports profound weakness and continued facial droop with speech difficulty since then. ... she fell twice on attempts to get out of bed and was brought in for evaluation where she was found to be hypotensive w/SBP 70 [systolic blood pressure]."

E. The ED record revealed documentation for only 2 sets of vital signs (VS). Triage VS were taken at 1:24 pm and revealed a BP of 72/39, P 56. Discharge VS were taken at 7:42 pm and revealed P 65, BP 128/69.

F. The facility policy and procedure titled "Triage Assessment of Patients (5 tier)," effective date of 06/2010, revealed on page 4 of 5, "B. High risk situation is a patient you would put in your last open bed. Severe pain/distress is determined by clinical observation and/or patient rating of greater than or equal to 7 on 0-10 pain scale. C. Danger Zone Vital Signs. Consider up triage to ESI [emergency services index] 2 if any vital sign criterion is exceeded." (Pt triage BP was 72/39.)

G. On 04/06/11 at 2:30 pm, an interview was conducted with Registered Nurse #1. When asked about Patient #39's presentation to ED with a pain level of 8 and a low BP of 72/39, she stated, "The patient should have been monitored quicker and her full assessment should not have been 2 1/2 hours later."

Based on record review and interview, the hospital failed to ensure that enough respiratory staff were on duty to delivery the respiratory care needed for 1 of 41 (#7) sampled patients. This failed practice was likely to be the reason the family had to make a decision about possible impending intubation. All patients with respiratory problems were at risk. The findings are:

A. Record review for Patient #7 revealed in the "Patient Care Activities" documentation in the skilled nurses' notes as follows:
1. On 02/07/11 at "1948 [7:48 pm] - received report, care assumed, initial assessment started, 2022 [8:22 pm] - pt's [patient] resp [respiratory] rate noted to be 43 at this time. Dr. [doctor] notified, no new orders received. MD [medical doctor] states she does not want to be notified of increased resp rate unless oxygen saturation decreases. Will continue to monitor. 2333 [11:33 pm] - RT [respiratory therapy] currently on unit. pt is on 5 L [liters] via nc [nasal canula] with no humidification, notified RT of need, [name of staff] states 'I know' when informed. Reiterated need for humidifications conveyed to RT."
2. On 02/08/11 at "1945 [7:45 pm] - pt already showing signs of agitation AEB [as evident by] pulling at mask, Foley, kicking legs, grabbing for invisible objects. [Name of physician] notified, new orders received to increase Haldol to 1 mg [milligram] IV [intervenous] q [every] 6 hours PRN [as needed]."
a. At "2330 [11:30 pm] - pt's oxygen saturation steadily decreasing, now in mid 80's. RT [respiratory therapy] paged at this time with no answer."
b. At "2334 [11:34 pm] - Oral care performed, throat suctioned via catheter, large amount of blood tinged mucous removed. Pt exhibited good cough and gag reflex, pt would cough upon command. O2 [oxygen] sats [saturations] remain mid 80's with no improvement."
c. At "2342 [11:42 pm] - RT paged again, no answer. Attempting to track RT down on third floor, [Name of staff] states RT is in L & D [labor and delivery] for an emergency delivery at this time. Will continue to attempt to reach them."
d. At "2345 [11:45 pm] - Pt given chest PT [percussion therapy] via manual manipulation by [name of registered nurse], turned pt and performed PT on both sides of chest, pt coughing on command. 02 sats remain low. Suctioning performed again, more blood tinged mucous removed. Pt's throat is raw, red, excoriated and weeping serous fluid. Pt had complained of sore throat previously."
e. At "0004 [12:04 am] - Pt's sats remain low despite attempted nursing interventions. RT paged again, no answer at this time."
f. At "0020 [12:20 am] - [Name of doctor] notified of pt's continued status of oxygen saturations in the mid 80's, states to increase [oxygen] to 60% and call pt's wife to discuss possible intubation."
g. At "0021 [12:21 am] - [Name of pts wife] notified of pt's condition, possible impending intubation and states she will arrive in unit within the hour to discuss options for patient."
h. At "0107 [1:07 am] - RT paged again, no answer. [Oxygen] still needing to be increased to 60%. Pt's O2 sats now at 86-87%."

B. Review of the discharge summary dictated on 02/10/11 at 6:25 am revealed, "He became more short of breath with waxing and waning mental status and developed respiratory failure. He was treated with BiPap. His wife had requested that he not be intubated. Echocardiogram showed a normal ejection fraction. He did have a right pleural effusion which layered out. He was suspected to have pneumonia. He was treated with broad-spectrum antibiotics with continuing worsening of his condition. Due to his worsening condition despite adequate treatment and he has multiple comorbidities, his wife requested that treatment be withdrawn, and he will be treated for comfort measures only. This was done. He was kept comfortable, and he was pronounced dead at 05:30 hours on the morning of February 10, 2011."

C. On 04/12/11 at 10:00 am, an interview was conducted with the Respiratory Manager. When he was asked about the repeated attempts to call RT, he stated, "She should have only had to page once. They were in the delivery room. We send both therapists if the physician requests them." When asked if they have backup or someone on call he stated that they do, and the house supervisor could have been involved. He further stated that there were dead spots for pagers in the hospital and that they now have cellular phones.