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624 WEST MAIN ST

YADKINVILLE, NC null

QUALITY ASSURANCE

Tag No.: C0336

Based on review of the hospital's Performance Improvement Plan policy, Quality Improvement review, and staff interview, the laboratory failed to monitor and track the collection of blood cultures with contracted laboratories.

Review of the facility's, "Performance Improvement Plan", revised on 08/2012 revealed, "PURPOSE: The purpose of this plan is to establish a framework for a hospital wide approach to improve patient care... KEY FUNCTIONS OF THE ORGANIZATION: ...Surveillance, prevention and control of infection... CATEGORIES OF KEY MEASURES: ... will monitor its commitment to quality utilizing specific key measures of performance... MODEL FOR PERFORMANCE IMPROVEMENT: ... Measure-... Data is collected on an ongoing, concurrent and / or retrospective basis by each department to identify trends, patterns of care, specific problems/issues, and to evaluate effectiveness of corrective actions previously implemented."

Interview with the laboratory manager on December 12, 2012 at 1000 revealed the laboratory is contracted with three laboratories for blood culture processiong. Interview revealed the laboratory is not monitoring the collection process to ensure no contamination during collection and is not tracking blood culture reporting.

Review of the Performance Improvement Meeting Minutes from October 2011 through November 2012 revealed no monitoring and tracking of the blood culture collection process by the laboratory staff.

Interview with Quality Director on December 12, 2012 at 1340 revealed the laboratory is not monitoring and tracking the blood culture collection process.

No Description Available

Tag No.: C0191

Based on review of the hospital's contracts for laboratory services, and staff interviews, the hospital failed to establish a contract agreement for pathology services.

The findings include:

Review of hospital contracts for laboratory services revealed 1 out of 3 (Laboratory #1)contracted services did not have an agreement for pathology services (tissue and specimen).

Interview on 12/12/2012 at 0915 with the Surgical Services Manager (RN#1) revealed that specimens obtained during surgical procedures are forwarded to Laboratory #1. The Surgical Services Manager also stated that she forwarded specimens obtained in surgery directly to Laboratory #1 per physicians preference without routing the specimens to the onsite Laboratory Manager.

Interview on 12/12/2012 at 1000 with the Laboratory Manager revealed that he was not aware of Surgical Services bypassing the hospital onsite laboratory services for specimen collection. The Laboratory Manager also stated that he is not aware of a contractual agreement between the facility and Laboratory #1.

No Description Available

Tag No.: C0202

Based on review of hospital policy and procedure, Malignant Hyperthermia Association of the United States guidelines (MHAUS), the United States Department of Health and Human Services Agency for Healthcare Research and Quality evidence-based patient safety guidelines, and the Malignant Hyperthermia Investigative Unit of Perioperative Interactive Education guidelines, observations during tours, and interviews, the hospital failed to ensure 36 vials of Dantrolene (a medication used in treating emergency cases caused by anesthesia) is kept at the hospital and readily available for treating Malignant Hyperthermia.

The findings include:

Review of the hospital's surgery policy and procedure manual, reviewed 08/01/2012, revealed the purpose of the Malignant Hyperthermia Emergency Procedure was to "assist in prevention or control of a malignant hyperthermia (rare, life threatening disorder triggered by anesthesia) crisis. Treatment of Malignant Hyperthermia (MH) is immediately available for any patient undergoing general anesthesia." Review of MH emergency procedure revealed "if an MH crisis occurs assist Anesthesia as directed including preparing Dantrolene Sodium ( muscle relaxant that is the only specific and effective treatment for malignant hyperthermia)". Review of the Anesthesia Policy and Procedure manual revealed the scope of the policy is to "outline care of patient with inability to maintain stable body temperatures" and further revealed treatment for malignant hyperthermia is to "include administration of Dantrolene 5 to 7 milligrams per kilogram intravenously over 5 minutes."

Review of the Malignant Hyperthermia Association of the United States guidelines, dated 04/2009, revealed the recommendation that "all facilities, including ambulatory surgery centers and offices where MH triggering anesthetics are administered, should stock a minimum of 36 vials of dantrolene, along with the other drugs and devices necessary to treat an MH reaction."

Review of the Malignant Hyperthermia Investigative Unit of Perioperative Interactive Education guidelines ,dated 02/2008, revealed "... for treatment of Malignant Hyperthermia administer dantrolene. Immediately begin dantrolene sodium 2.5 milligrams per kilogram. Rapidly administer the initial bolus intravenously with supplemental increments up to 10 milligrams per kilogram. Continue to administer dantrolene until signs of MH are controlled." Further review of the guidelines revealed the number of dantrolene vials to be available for treatment of malignant hyperthermia is "a minimum of 36 vials of Dantrolene should be available." The guidelines revealed "the initial dose is 2.5 milligrams per kilogram with a suggested upper limit of 10 milligrams per kilogram; for a 70 kilogram patient this would be 36 vials."

Review of the 2012 Perioperative Standards and Recommended Practices, dated 04/2012, revealed "Dantrium (Dantrolene) should be administered by continuous rapid intravenous push beginning at a minimum dose of 1 milligram per kilogram, and continuing until symptoms or the maximum cumulative dose of 10 milligrams per kilogram has been reached." Further review of the recommended practice revealed "It is important to note that administration of Dantrium (Dantrolene) intravenous should be continuous until symptoms subside."

An observation during tour on 12/11/2012 at 1456 revealed 16, 20 milligram vials of Dantrolene with an expiration date of 02/2014 on the crash cart in the preoperative area immediately adjacent to the operating room.

Interview on 12/11/2012 at 1456with RN # 1 stated, "we (the hospital) keep at least 16 vials of Dantrium on hand all the time and get pharmacy to order when the supply is less than 16 vials."

Observation on 12/12/2012 at 1502, after being called by RN #1 stating she had found more "Dantrium", revealed 30, 20 milligram vials of Dantrolene with an expiration date of 04/2012 on the crash cart in the preoperative area immediately adjacent to the operating room.

Interview on 12/12/2012 at 1502 with RN # 1 stated, " I know there should be 36 vials of Dantrium on hand prior to surgery but there are 30 vials here now." Interview confirmed the hospital failed to have 36 vials of dantrolene available for the treatment of Malignant Hyperthermia as per recommended practice guidelines.

No Description Available

Tag No.: C0204

Based on the review of the hospital's Crash Carts Policy and Procedure, review of the Daily Defibrillator Crash Cart Check Log, and staff interviews, the facility failed to ensure the defibrillators, commonly used in life-saving procedures, are verified daily for functionality.

The findings include:

Review of the Yadkin Valley Community Hospital Crash Cart Policy and Procedure revised on 08/30/2012 revealed "...the carts will be monitored for security of those contents on a daily basis using a checklist verification process which includes ; defibrillator checked (plugged and unplugged)". Review of the Yadkin Valley Community Hospital procedure for checking the crash cart defibrillators revealed"...The Crash Cart will be checked daily by a nurse working on the unit where the cart is housed. The nurse responsible for checking will ensure that the defibrillator/monitor is checked both plugged and unplugged using the user option test mode, as per monitor instructions."

Review of the daily defibrillator and crash cart check log for the past six months revealed the defibrillator on the Operating Room (OR) crash cart was checked weekly (not daily) from 06/05/2012 until 12/10/2012. Review of the crash cart check log included a total of 18 entries for the six month period from 06/05/2012 until 12/10/2012.

Interview with RN # 1 (Operating room manager) on 12/11/2012 at 1450, interview revealed "We check the defibrillator on the OR crash cart every day before surgery." Interview further revealed the fibrillator on the OR crash cart was checked daily before surgery and the outcome was noted on the Daily PACU (post anesthesia care unit) and Endoscopy Suite Defibrillator and Crash Cart Check Log. Interview revealed the crash cart defibrillator should be checked daily but on most occasions the other nurse (RN # 2) checked the defibrillator.

Interview with RN # 2 on 12/11/2012 at 1500 revealed, "The defibrillator on the crash cart should be checked daily but we have been checking it once a week." RN # 2 said she performed the test on the defibrillator most of the time and entered the testing date on the crash cart log. Interview revealed the defibrillator was not being checked daily per policy.









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2. Review on 12/13/2012 of the hospital's policy, "Crash Carts", revised 08/01/2012, Applicable to: Hospital Wide revealed "the crash cart will be checked daily by a nurse working on the unit where the cart is housed".

Observation on 12/10/2012 at 1505 of the medical-surgical unit revealed a crash/emergency cart in a recessed hall cubicle by the nurse's station. On top of the cart was the cardiac monitor/defibrillator. The "daily defibrillation check" sheet was on a clipboard on top of the cart. Review of the daily check list revealed no date or signature that the cart had been checked 4 of 10 days in December 2012 (December 4, 5, 6, & 7). Further review revealed the crash cart had not been checked 10 of 30 days in November 2012 (November 1, 7, 8, 15, 16, 19, 20, 26, 27 & 29).

Interview on12/10/2012 at 1505 during the tour of the medical/surgical unit with the RN staffing the unit (RN #9) revealed the crash cart checks are to be done daily and documented on the "daily defibrillation check" sheet. Interview with the RN confirmed that the crash cart was not checked per hospital policy on November 1, 7, 8, 15, 16, 19, 20, 26, 27 & 29, December 4, 5, 6, & 7.

No Description Available

Tag No.: C0220

Based on observations as referenced in the Life Safety Report of survey completed on 12/11/2012, the hospital failed to develop and maintain the facilities in a manner to ensure the safety of patients.

The findings include:

1. The facility failed to ensure all preventive maintance programs (mechanical, electrical, and patient-care equipment) are maintained in a safe operating manner.

~cross refer to 485.623(b)(1) - Maintenance Standard Tag C0222

2. The facility failed to ensure proper ventilation, lighting, and temperature control in all pharmaceutical, patient care, and food preparation areas.

~cross refer to 485.623(b)(5) - Maintenance Standard Tag C0226

3. The hospital failed ensure the safety and well-being of patients by failing to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association (NFPA).

~cross refer to 485.623(d)(1) & (3) - Life Safety from Fire Standard Tag C0231

No Description Available

Tag No.: C0222

Based on observations as referenced in the Life Safety Report of Survey completed December 11, 2012, the facility failed to ensure all preventive maintance programs (mechanical, electrical, and patient-care equipment) are maintained in a safe operating manner.

This standard is not met as evidenced by:

1. Documentation on December 11, 2012 at approximately 8:30am onward revealed the emergency generator is not exercised under load for thirty minutes per month.

~cross-refer to Life Safety Code Standard- NFPA 101, Tag K144.

2. Observations from December 11, 2012 at approximately 8:30am onward, the facility is noncompliant with the National Electrical Code due to the following:

a. ground fault interrupter receptacle is not functioning properly in resident room 101 - located beside lavatory.

b. use of improperly listed multioutlet power tap in operating room - tap provided was not mounted to a mobile IV pole.

c. surgical light in operating room is not properly grounded by metal raceway terminating in an approved junction box; and connected to the base of fixture.

~cross-refer to Life Safety Code Standard-NFPA 101, Tag K147.

3. Observation from December 11, 2012 revealed, a barrel-bolt latch used on the exit access door from the toilet between linen rooms #1, and #2. Doors may not be locked against egress from inside the room. Linen rooms, formerly patient rooms, are located on north corridor near med - surg nurse's station.

~cross-refer to Life Safety Code Standard-NFPA 101, Tag K38.

4. Observation from December 11, 2012 revealed the exit access door between eight feet corridor and surgery waiting room is less than forty-one and a half inch opening width. The exit is required to prevent a dead-end corridor at entry to surgery suite. The existing level of life safety is reduced below standards required at time of area renovations; all other exit access doors used by patients in patient care areas are minimum 41.5 inch openings.

~cross-refer to Life Safety Code Standard-NFPA 101, Tag K40.

5. Observation from December 11, 2012 revealed the means of egress is noncompliant due to the following:

a. door to office beside med-surg desk protrudes greater than seven inches into the corridor.

b. surgery waiting room and lobby - a minimum eight feet width is not maintained through lobby area.

~cross-refer to Life Safety Code Standard-NFPA 101, Tag K72.

No Description Available

Tag No.: C0226

Based on observations as referenced in the Life Safety Report of Survey completed December 11, 2012, the facility failed to ensure proper ventilation, lighting, and temperature control in all pharmaceutical, patient care, and food preparation areas.

This standard is not met as evidenced by:

1. Observation from December 11, 2012 revealed there is a single bulb light fixture located at the exit discharge near the Endoscopy procedure room.

~cross-refer to Life Safety Standard Code-NFPA 101, Tag K45.

2. Observation from December 11, 2012 revealed the emergency lighting is incomplete in the following areas:

a. med-surg exit discharge - there is no emergency lighting provided from exit discharge to publicway.

b. palliative care suite - circuits supplying emergency power and normal power could not be distinguished by labeling of panelboard circuit directories. Life Safety branch lighting could not be identified.

c. exit discharge to publicway near Endoscopy procedure room - no emergency lighting to cover complete egress path.

~cross-refer to Life Safety Code Standard-NFPA 101, Tag K46.

3. Observation from December 11, 2012 revealed the EES is incomplete due to the following:

a. medication preparation room near med-surg - lighting in room is not identified as connected to the critical branch of the essential electrical system.

b. visual indicators for normal power are not functioning on automatic transfer switches QB, and E - located in the generator room.

~cross-refer to Life Safety Code Standard-NFPA 101, Tag K145.

No Description Available

Tag No.: C0231

Based on observations as referenced in the Life Safety Report of survey completed 12/11/2012, the hospital failed ensure the safety and well-being of patients by failing to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association (NFPA).

The findings include:

1. Observations from December 11, 2012 revealed there are unsealed penetrations in the two hour fire barrier separating the EMS building from the hospital.

~cross-refer to Life Safety Code Standard-NFPA 101, Tag K11.

2. Observations from December 11, 2012 revealed the building construction type is incomplete in the following area:

a. north corridor, near med-surg nurse's station, roof/ceiling assembly is not a minimum one hour rated; recessed light fixtures are not equipped with fire protective enclosures as necessary to protect open-web bar joist from fire exposure.

b. operating room suite - holes in suspended roof/ceiling assembly of hallway between operating room and old delivery room. The open-web steel bar joist are not protected from fire exposure.

c. operating room suite - lack of fire protective enclosures for recessed lights in suspended roof/ceiling assembly. Roof/ceiling assembly must meet design assembly specified by original construction documents

d. operating room suite - lack of listed fire damper assemblies in mechanical outlets/inlets in suspended roof/ceiling assembly. Roof/ceiling assembly must meet design assembly specified by original construction documents.

~cross-refer to Life Safety Code Standard-NFPA 101, Tag K12.


3. Observations from December 11, 2012 revealed, there is wood paneling used as a wainscot in the following rooms:

a. patient rooms 101, 102, 105,106, 108, 109, 110, 111, and 112.

b. radiology waiting room.

~cross-refer to Life Safety Code Standard-NFPA 101, Tag K15.


4. Observations from December 11, 2012 revealed the one hour rated corridor wall is incomplete in the following area:

a. entry to palliative care suite - duct penetration is not equipped with fire damper. Damper must be installed in accordance with the manufacturer's installation instructions.

~cross-refer to Life Safety Code Standard-NFPA 101, Tag K17.

5. Observations from December 11, 2012 revealed the hazardous areas in the following rooms are incomplete due to the following:

a. soiled utility/soiled linen room is not equipped with minimum c-labeled door and sprinkler(s) - located near med-surg nurse's station.

b. linen room #1 - formerly a patient room, is not equipped with a one hour enclosure and sprinkler(s).

c. generator room - lack of a complete two hour fire door assembly between maintenance office and fuel driven generator room.

~cross-refer to Life Safety Code Standard-NFPA 101, Tag K29.

6. Observations from December 11, 2012 at approximately 8:30am onward, the fire alarm system would not function on the alternate power(batteries) supply.

~cross-refer to Life Safety code Standard-NFPA 101, Tag K51.

7. Observation from December 11, 2012 revealed the exit access doors in the following areas are noncompliant due to the following:

a. lack of latching hardware on door to office near med-surg nurse's station.

b. lack of minimum twenty-minute rated doors or equivalent rating in door openings to palliative care suite.

c. chapel - hollow core door of less than required fire rating in door opening.

d. door to chapel - hardware set is non-passage type from inside chapel.

~cross-refer to Life Safety Code Standard-NFPA 101, Tag K18.

No Description Available

Tag No.: C0240

Based on observations as referenced in the Life Safety Report of survey completed on 12/11/2012, the hospital failed to ensure an effective organizational structure by failing to develop and maintain the facilities in a manner to ensure the safety of patients.

The findings include:

1. The hospital failed to develop and maintain the facilities in a manner to ensure the safety of patients.

~ cross refer to 485.623 Physical Plant and Environment - Condition Tag C0220

No Description Available

Tag No.: C0253

Based on observation during tours, staff interviews, and personnel file review, the hospital failed to provide qualified personnel for laboratory testing.

This standard is not met as evidence by:

Observation during tours conducted on December 11, 2012 at 0930 revealed the hospital Laboratory Services hours of operation are 0630-2359. Interview with the Laboratory Manager (LM) while on tour revealed an after hours cart is delivered to the Emergency Services department for personnel (Registered Nurses) to perform waived and non-waived testing. Interview revealed the Emergency Services personnel performs non-waived D-Dimer and Cardiac panel (which include CPK, CKMB and Triponin I) using the Biosite (Alere) Triage Meter Plus.

Review of personnel files (Registered Nurses: #4,#5,#6,#7 and #8) on December 12, 2012 revealed five out of five Emergency Services personnel (registered nurses) had no documentation of initial training and six months competencies for the non-waived D-Dimer and Cardiac Panel tests.

Interview with LM on December 12, 2012 revealed no documentation and competencies were on file for RNs #4, #5, #6, #7 and #8 for the nurses to perform non-waived D-Dimer and Cardiac panel (which include CPK, CKMB and Triponin I) using the Biosite (Alere) Triage Meter Plus.

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No Description Available

Tag No.: C0276

Based on review of policies and procedures, observations, and staff interviews the facility failed to label , date, and time open, multi-dose vials per policy.

The findings include:

A review of the Management of Multi-Dose Vials policy last revised on 11/15/2010 revealed the purpose of the policy is to "maintain sterility of injectable/parenteral solutions used in sterile product preparation and medications utilized in patient care." Further review of the policy revealed the procedure for multi-dose vial use is "when a multi-dose vial is opened, it should be labeled with the date it is entered. " Continued review of the policy further revealed "once opened, multi-dose vials should be labeled with a 28-day beyond use date..."

A review of the Pharmacy Medication Use Process Policy last revised in 01/2012 revealed the medication use process policy was instituted to "provide a safe medication use process consistent with all applicable state and federal laws, rules, and regulations and consistent with accepted professional standards and regulatory expectations." Further review revealed the purpose is "to describe the required elements and procedures necessary to maintain a safe and effective medication use process." Review of the policy section entitled medications are labeled revealed "any time one or more medications are prepared but are not administered immediately, the medication container must be appropriately labeled."

An observation on 12/12/2012 at 1442 revealed an open, unlabeled, undated, and untimed, vial of Depo-Medrol (an anti-inflammatory medication ) 40 milligrams per milliliter with 5 milliliters remaining in the opened vial, an open, unlabeled, undated, and untimed vial of Bupivicaine (local anesthetic) 2.5 milligrams per milliliter with 30 milliliters remaining in the vial, and two open, unlabeled, undated, and untimed, vials of Lidocaine (local anesthetic) 20 milligrams per milliliter with 50 milliters remaining in each vial.

In an interview with the Certified Medical Assistant (CMA#1) on 12/12/2012 at 1442 revealed "I opened the vial of Depo-Medrol yesterday !2/11/2012) and it (open vial of Depo-Medrol) would be discarded if not used in one week."The interview with CMA # 1 further revealed she didn't know who opened the Bupivicaine or the Lidocaine. In an interview CMA # 1 stated, "They (the multi-dose open vials) should be labeled with date, time, and expiration date after opening."

In an interview with RN # 3 on 12/11/2012 at 1123 stated, " Multi-dose vials should be labeled with the date, time, and expiration date when opened." Interview confirmed the hospital's policy for labeling multi-dose vials when opened was not followed.