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HENDERSONVILLE, NC 28791

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on hospital policy reviews, medical record reviews, and staff interview, the hospital's staff failed to promote a patient's right to make informed decisions by failing to obtain written surgical consents that were provided and explained in a language or manner that the patient (or the patient ' s representative) can understand for 1 of 2 patients (Patient #7) requiring a surgical procedure.

Findings included:

Review on 06/15/2017 of hospital policy, "Consent Forms", last revision date 03/23/3016, revealed, "...Prior to any medical or surgical treatment, the attending physician is responsible for obtaining informed consent from the patient for specific proposed medical or surgical treatment..."

Review on 06/15/2017 of hospital policy, "Abbreviations", last revision date: 07/28/2015, revealed, "POLICY: It is the policy of (Named hosptial) to maintain a listing of approved abbreviations... PROCEDURE: ·The abbreviations... used throughout the organization will be standardized to reduce the potential for confusion, misunderstanding, and misinterpretation. This applies to all clinical documentation... ·A list of acceptable abbreviations will be reviewed and approved by the Health Information Management Committee and the Medical Executive Committee at least every three years..."

Closed medical record review on 06/14/2017 for Patient #7, revealed a 68-year-old female admitted to the facility on 06/08/2017 with a diagnosis of "Septic (infection) arthritis of knee, right", and required an above the knee amputation of her right leg. Review of the "REQUEST AND CONSENT FOR OPERATION OR PROCEDURE", signed by Patient #7 on 06/09/2017 at 1350 revealed, "...I authorize... to perform the following Procedure(s) (LRB): AMPUTA THIGH THRU FEMUR ANY LEVEL; OPEN CIRCULAR (Right) NEG PRESS WOUND TX (VAC ASSIST) INCL TOPICALS, PER SESSION, TSA LESS THAN/= 50 CM SQUARED (Right)..." Review revealed the surgical procedure consent form was not provided and explained in a language or manner that the patient (or the patient ' s representative) can understand and used unapproved abbreviations.

Review of the hosptial's "Officially Accepted Abbreviations" list, approved on 12/19/2016, revealed the following abbreviations utilized on Patient #7's "REQUEST AND CONSENT FOR OPERATION OR PROCEDURE" were not approved: AMPUTA, THRU, VAC, INCL, and TSA.

Interview on 06/15/2017 at 1057 with Director #1 revealed the hosptial's electronic documentation system generates the surgical consent forms by pulling the "CPT Code" (Current Procedural Terminology Code - a billing code for the procedure being performed) from the operating room schedule. The hosptial has been working toward having the procedure "named word for word" on the surgical consent forms. Interview revealed abbreviations are not approved for use on surgical consent forms, and this has been identified as a problem. Interview confirmed the medical record review finding.

QAPI GOVERNING BODY, STANDARD TAG

Tag No.: A0308

Based on policy and procedure review, quality data review, Performance Improvement (PI) Committee minute review, and staff interview, the hospital's staff failed to ensure the quality program reflected the complexity of the organization and services by failing to provide evidence of integration of hospital owned off-site physician practices under the hospital's Medicare certification number, into Hospital Quality for 24 of 24 off-site physician office practices/clinics and failing to provide evidence of clinical quality monitoring for 17 of 24 off-site physician office practices.

Finding included:

Review on 06/15/2017 of Quality Management policy titled "Quality Policy", last revised 01/21/2015, revealed "...SCOPE OF SERVICES:....Inpatient services include acute medical, surgical, obstetrical, psychiatric/medical detoxification, pediatric and normal newborn care. Outpatient services include diagnostic, therapeutic and rehabilitative care....(Hospital Name) physician practices include neurological, urological, internal medicine, primary care, obstetrical and midwifery services. Primary care for adults and children is provided by (Hospital Name) owned physician office practices.... QUALITY MANAGEMENT SYSTEM: The organization develops, implements, and maintains an ongoing system for managing quality and patient safety. The system includes all departments and services and performance improvement efforts address priorities for improved quality of care and patient safety. ..."

1. Review on 06/15/2017 of quality data and PI Committee Meeting minutes with Director #3, did not reveal any evidence of clinical quality data reporting to the Quality Department or the PI Committee from any off-site physician office practice/clinic.

Interview on 06/14/2017 at 1545, with Director #4, revealed pneumonia vaccines and colorectal and breast cancer screening data were collected in the primary care physician offices practices, but were not currently reported to the hospital Quality Department or through the PI Committee.

Interview on 06/15/2017 at 1345 with Director #3, revealed no off-site physician office practice/ clinic data was reported to Quality. Interview revealed there was a strong hospital focused quality program, but it had not expanded out into the physician network. Interview confirmed no data were available for review.

Interview on 06/15/2017 at 1615 with the hospital's Chief Administrative Officer, revealed there were 24 off-site locations of physician office practices and clinics associated with the hospital and under the hospital's Medicare provider number.

2. Review of quality data, on 06/14-15/2017, did not reveal any evidence that any clinical quality data were being collected or trended for the specialty off-site physician practices and clinic locations under the hospital's Medicare provider number.

Interview on 06/14/2017 at 1545, with Director #4, revealed no clinical quality data were currently being collected for the specialty physician practices. Interview revealed there was a plan to incorporate data collection into these practices.

Interview on 06/15/2017 at 1335, with Manager #1, who managed orthopedic clinics revealed there were no clinical quality data being collected and trended. Interview revealed "the only thing we do is informal."

ORDERS FOR DRUGS AND BIOLOGICALS

Tag No.: A0409

Based on hospital policy review, Lippincott textbook review, medical record review, and staff interview, the hospital's staff failed to administer blood transfusions in accordance with hospital policy by failing to monitor patient's vital signs in 3 of 3 patients (Patients #3, #7, and #4) receiving blood transfusions.

Findings included:

Review on 06/14/2017 of hospital policy, "Blood Administration", last revision 04/09/2015, revealed "...OBJECTIVE: To safely administer blood and blood components utilizing a defined process. PROCEDURE: ...Administering Blood and Blood Components (Lippincott 10th Edition - Procedure Guidelines 27-1 p. [pages] 1005-1009)..."

Review on 06/14/2017 of Lippincott 10th Edition - Procedure Guidelines 27-1 p. 1005-1009, revealed "...Obtain and record baseline vital signs... Remain at bedside 15-30 minutes... Observe the patient closely and check vital signs at least hourly until 1 hour after the transfusion... Facts relating to the transfusion should be charted exactly..."

1. Open medical record review on 06/14/2017, revealed Patient #3 was a 67-year-old female who received Packed Red Blood Cells (PRBC) on 06/13/2017. Review revealed the PRBC were initiated at 0845, with baseline vital signs documented at 0800 (45 minutes prior to the initiation of the PRBC) as follows: Temperature (T) 99.7 ° (degrees) F (Fahrenheit), Pulse (P) 75, Respirations (Resp) 12, Blood Pressure (BP) 122/72, and Pulse Oximetry (SpO2) 100 % (percent). Subsequent vital signs were documented as follows: 0910 (25 minutes after initiation of the PRBC), T (no value), P 82, Resp 14, BP 136/76, and SpO2 (no value); 0925 (40 minutes after initiation of the PRBC), T 99.7°F, P 82, Resp 14, BP 136/76, and SpO2 (no value); 1023 (1 hour and 38 minutes after initiation of the PRBC), T (no value), P 80, Resp 13, BP 140/76, and SpO2 99%; 1105 (2 hours and 20 minutes after initiation of the PRBC), T 98.9°F, P (no value), Resp (no value), BP (no value), and SpO2 (no value); 1115 (2 hours and 30 minutes after initiation of the PRBC), T (no value), P 106, R 22, BP 128/77, and SpO2 99%. The PRBC infusion ended on 06/13/2017 at 1150. Vital signs documented at 1237 (47 minutes after the PRBC infusion ended) were T 99.6°F, P 81, Resp 12, BP 122/74, and SpO2 99%. No vital signs were documented at 1250, one hour after the transfusion ended.

Interview on 06/14/2017 at 1555 with the hospital's CNO (Chief Nursing Officer), revealed baseline vital signs should be taken close to the time a PRBC infusion is started. Interview revealed 45 minutes is "too long." Interview revealed the expectation is for each set of vital signs should be a full set of vital signs, consisting of temperature, pulse, respirations, blood pressure, and pulse oximetry, especially noting temperature, as it is "the number one indicator of a blood transfusion reaction." Interview revealed vital signs should have been obtained 15 minutes after the PRBC were initiated, and one hour after the PRBC transfusion had ended. Interview revealed hospital policy was not followed.

2. Open medical record review on 06/14/2017, revealed Patient #7 was a 68-year-old female who received PRBC on 06/11/2017. Review revealed the PRBC were initiated at 1632, with vital signs documented at 1613 (19 minutes prior to the initiation of the PRBC) as follows: T 98.4°F, P 85, Resp 16, BP 104/66, and SpO2 92%. Subsequent vital signs were documented as follows: 1650 (18 minutes after the initiation of the PRBC), T (no value), P 84, Resp (no value), BP 96/61, and SpO2 97%; 1710 (38 minutes after the initiation of the PRBC), T 97.9°F, P 91, Resp (no value), BP (116/59, and SpO2 97%; 1736 (54 minutes after the initiation of the PRBC), T (no value), P 97, Resp (no value), BP 120/72, and SpO2 96%; and 1915 (2 hours and 43 minutes after the initiation of the PRBC), T 98.0°F, P 88, Resp (no value), BP 105/63, and SpO2 93%. The PBRC transfusion ended at 1916. No evidence was documented that vital signs were obtained at 1832 (2 hours after the initiation of the PRBC).

Interview conducted on 06/14/2017 at 1555 with the hospital's CNO revealed the expectation is for each set of vital signs should be a full set of vital signs, consisting of temperature, pulse, respirations, blood pressure, and pulse oximetry, especially noting temperature, as it is "the number one indicator of a blood transfusion reaction." Interview revealed vital signs should be checked hourly while PRBC are infusing. Interview revealed hospital policy was not followed.

3. Closed medical record review on 06/14/2017, revealed Patient #4 was a 50-year-old female who received PRBC on 03/08/2017. Review revealed the PRBC were initiated at 1800, with vital signs documented at 1130 (6 hours and 30 minutes prior to the initiation of the PRBC) as follows: T 98.4°F, P 97, Resp 18, BP 134/65, and SpO2 (no value). Vital signs were next documented at 1630 (1 hour and thirty minutes prior to the initiation of the PRBC) as follows: T (no value), P 88, Resp, 15, BP 155/84, and SpO2 99%.

Interview conducted on 06/14/2017 at 1555 with the hospital's CNO revealed baseline vital signs should be taken close to the time a PRBC infusion is started. Interview revealed 6 hours and 30 minutes is "too long." Interview revealed the expectation is for each set of vital signs should be a full set of vital signs, consisting of temperature, pulse, respirations, blood pressure, and pulse oximetry, especially noting temperature, as it is "the number one indicator of a blood transfusion reaction." Interview revealed hospital policy was not followed.