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Based on interview and document review, the facility failed to provide timely written response to the patient and/or patient representative once a resolution to a patient grievance had been determined for 5 of 6 patients (P31, P32, P34, P35, P36) grievances reviewed.

Findings include:


P31's patient representative filed a grievance dated 6/10/14, which alleged that P31, who had been seen in the emergency room (ER), indicated "I believe she was not properly cared for during the first ER visit... and was sent home." An acknowledgement letter, of the grievance was sent to P31 on 6/20/14. A response letter was sent to P31 on 7/29/14.

P32 filed a grievance dated 4/1/14, alleged P32 received "unnecessary emotional grief and financial expense that could have been prevented by more pictures." A response letter was sent to P32 on 2/24/15.

P34 filed a grievance dated 8/9/14, alleged a physicians lack of knowledge and neglect. An acknowledgement letter, of the grievance, was sent to P34 on 8/18/14. A response letter was sent to P34 on 9/5/14.

P35 filed a grievance dated 4/7/14, indicated P35 being unhappy with the scheduling process at the Sanford Eye Clinic. Patient relations (PR)-A stated no response letter was sent to the P35.

P36 filed a grievance for alleged poor nursing care. An acknowledgement letter of the grievance was sent to P36 on 9/4/14. A response letter was sent to P36 on 9/10/14.

On 3/4/15, at 10:00 a.m. the chief medical officer (CMO) stated he had not been receiving or reviewing the grievance data.

When interviewed at 3/5/15, at 1:15 p.m. PR-A stated the grievances did not go to quality review, rather each unit was in charge of trending and improving their grievances.

The facility's policy, on Complaint/Grievance Process, revised on 6/14, indicated "A written complaint is always considered a grievance" and "...an appropriate time frame of response will be 7 business days."

Based on observation, interview, and document review, the hospital failed to ensure procedures had been implemented for choosing the most appropriate dialysate bath when providing inpatient hemodialysis for 1 of 1 patient (ESRD P1) in the sample who was observed during hemodialysis.

Findings include:

ESRD P1 was admitted to the hospital on 3/2/15, and had diagnoses that included, but were not limited to: end stage renal disease, and fever of unknown etiology.

Review of the Physician Orders dated 3/2/15, for ESRD P1's dialysis revealed directions if dialysate was ordered. A Modified Order/ standing order identified a choice of dialysate bath 3/4/15, based upon the value of serum potassium the patient had in his/her blood. The standing order included the following:

-"Serum K+ [potassium] less than or equal to 3.5-Use K+ 4 mEq/L [millieqivalent per liter], Ca++ [calcium] 2.25 mEq/L

-Serum K+ 3.6 to 4.7 -Use K+ 3 mEq/L, Ca++ 2.25 mEq/L

-Serum K+ greater than or equal to 4.8 -Use K+ 1.5 mEq/L, Ca++ 2.5 mEq/L"

Registered nurse (RN)-A who was the dialysis coordinator for the inpatient dialysis unit was interviewed on 3/4/15, at 8:45 a.m. during which she stated that a STAT (a medical term meaning immediately) serum potassium lab had been ordered for ESRD P1 at 8:07 a.m. on 3/4/15. RN-A stated that as of 8:45 a.m. the lab had not been drawn or processed for ESRD P1 and stated that she was going to start ESRD P1 on the same dialysate bath that was used during the first hemodialysis run upon admission. RN-A stated that using the same dialysate bath was an acceptable procedure and provided the standing order for review.

Review of the standing order dated 3/2/15, revealed the physician director of nephrology for the hospital had developed a standing order which included the following: If no potassium level available at start of subsequent acute dialysis treatments, draw potassium level STAT and start with K+ bath used during previous treatment until results back." RN-A confirmed hemodialsysis was only provided every other day in most cases to hospital inpatient's and there was a gap of approximately 36 hours post dialysis treatment for a potassium to be drawn prior to the next treatment, and there was more than enough time to ensure that a serum potassium level was checked between dialysis treatments. RN-A stated there were often times when a STAT potassium lab may not have been drawn and analyzed for over two hours. RN-A stated that she had not reported that long STAT lab timing to the laboratory director. RN-A further stated the risk of using the same strength potassium dialysate as the previous treatments without checking a patients serum potassium level would be a significant electrolyte imbalance affecting patients heart functioning. RN-A stated she was not sure of the logic behind using the same dialysate as previous dialysis runs rather than waiting for a serum potassium level to start dialysis. RN-A stated that having an automatic potassium level drawn post dialysis had not been initiated but that it was a good idea so that patients got the correct dialysate for their serum potassium level.

The nephrologist who developed the standing order "If no potassium level available at start of subsequent acute dialysis treatments, draw potassium level STAT and start with K+ bath used during previous treatment until results back" was not available for comment during the survey.

Further observation of ESRD P1 during dialysis on 3/4/15, at 9:00 a.m. revealed at the start of dialysis ESRD P1 had been provided K+ 1.5 mEq/L, Ca++ 2.25 mEq/L dialysate because it had been used during the hemodialysis run on 3/2/15, however, when the STAT serum potassium lab was drawn and analyzed on 3/4/15, at 10:38 a.m. (two hours and 31 minutes later) the result revealed that ESRD P1's serum potassium was 4.4 and the most appropriate dialysate was K+ 3 mEq/L, Ca++ 2.25 mEq/L and not K+ 1.5 mEq/L, Ca++ 2.5 mEq/L.

Based on observation and interview, the hospital failed to ensure ongoing quality assurance projects had been developed and implemented for laboratory services, organ procurement and medical records. This deficient practice had the potential to affect all current inpatients and outpatients of the hospital.

Findings include:

LABORATORY
Observation of ESRD P1 during dialysis on 3/4/15, at 9:00 a.m. revealed at the start of dialysis ESRD P1 had been provided K+ 1.5 mEq/L, Ca++ 2.25 mEq/L dialysate because it had been used during the hemodialysis run on 3/2/15. However, when the STAT (a medical term meaning immediately) serum potassium lab was drawn and analyzed on 3/4/15, at 10:38 a.m. (two hours and 31 minutes later) the result revealed that ESRD P1's serum potassium was 4.4 and the most appropriate dialysate was K+ 3 mEq/L, Ca++ 2.25 mEq/L and not K+ 1.5 mEq/L, Ca++ 2.5 mEq/L.

Registered nurse (RN)-A who was the dialysis coordinator for the inpatient dialysis unit was interviewed on 3/4/15, at 8:45 a.m. during which she stated that a STAT serum potassium lab had been ordered for ESRD P1 at 8:07 a.m. At 9:15 a.m. the RN-A checked on the status of the STAT lab and it still had not been collected. At 9:20 a.m. by chance a laboratory technician was seen in the common corridor and RN-A asked the lab tech to check on the STAT lab and draw the sample. The sample was finally drawn after intervention by RN-A. During further interview with RN-A on 3/4/15, at 9:15 a.m. she stated that it was not uncommon for STAT labs to take longer than two hours to complete and she had not reported that time delay to the director of the laboratory. The laboratory result for the serum potassium of ESRD P1 was not available until 10:38 a.m. when it was recorded in the medical record.

The director of laboratory services was interviewed on 3/4/15, at 12:35 p.m. during which he stated he was unaware that there was an issue with the laboratory turn around times for STAT labs. The director of laboratory services stated the department had not monitored quality standards for STAT lab turnaround times and confirmed that a STAT lab which took longer than two hours and 31 minutes was not considered timely according to the hospital policy for STAT labs.


18622

On 3/3/15, at 2:00 p.m. a tour of the facility's Laboratory Services was conducted with the director of laboratory services. When asked about a quality assurance program, the director of laboratory services stated the lab monitored the blood products for expiration dates, temperature and quality of the blood received. The director of laboratory services was asked about additional monitoring of laboratory services and he did not have any additional documentation. The director of lab was then asked if there were any quality projects that the lab was monitoring and trying to improve. The director of laboratory services confirmed the lab was not collecting any data on quality measures to include correct specimen collections and accuracy of specimen results.

ORGAN/TISSUE AND EYE PROCUREMENT
On 3/5/15, at 11:15 a.m. the director of Organ, Tissue, and Eye Procurement was interviewed. At the time of the interview, the director confirmed LifeSource kept statistics on the number of referrals and the number of viable and nonviable candidates for donation. The director confirmed the facility did not collect statistic on the program and did not have quality measures in place. Although LifeSource gathered the statistics the information was not not brought forward to the quality assurance meeting.


31220

MEDICAL RECORDS
During interview on 3/3/15, at 1:00 p.m. the health information operation manager (HIM) stated the medical records department had been in the process of creating a quality improvement project related to transcription for the last year, however, the process had not yet been implemented.

Based on observation, interview and document review, the facility failed to ensure 1 of 2 medical record storage buildings stored records in a manner to protect from fire.

Findings include:

During interview on 3/3/15, at 1:00 p.m. the health information operation manager (HIM) stated medical records were stored in two offsite locations. The first location was the Release of Information Building and the second offsite location was a garage which stored some death records. HIM stated the Release of Information Building had a fire alarm system and fire extinguishers in place for protection from fire but was unsure of any fire protection at the garage location.

During tour of the offsite record storage areas on 3/5/15, at 8:00 a.m. it was observed that the only fire protection equipment in place at the garage location was a single fire extinguisher near the door. HIM confirmed the building was not sprinkled and did not have a fire detection system in place.

Review of the facility policy entitled Records Retention and Destruction dated 2/14, revealed off-site medical record storage areas were to be safeguarded from ordinary hazards such as fire.

Based on interview and document review, the facility failed to ensure radiation exposure had been checked periodically by the use of exposure meters or badge tests for 1 of 1 outpatient clinic whose workers utilized X-ray equipment and was exposed to radiation daily.

Findings include:

Medical lab technician (MLT-A) who was responsible for taking the X-rays at the outpatient Blackduck Clinic was interviewed on 3/5/15, at 9:00 a.m. during which she stated she performed X-rays daily. MLT-A further stated she did not wear a badge or meter that detected the amount of radiation exposure because she had been told by the physicist that she did not need one. MLT-A stated she would feel better if she wore an exposure meter to know for sure she was not getting exposed to a high amount of radiation.

The outpatient branch manager (OBM) for the Blackduck Clinic was interviewed on 3/5/15, at 9:30 a.m. during which she stated from July 2013 through July 2014, a total of 225 X-rays had been taken by MLT-A at the Blackduck Clinic and from July 2014 through March 4, 2015, MLT-A had taken a total of 343 X-rays. The OBM further stated the reason MLT-A had not worn a radiation exposure badge was because MLT-A was not being exposed to an excess of 10% of the maximum permissible dose of radiation. When OBM was asked how she knew how much radiation exposure MLT-A was getting OBM stated the physicist had completed an assessment of the radiation exposure at the Blackduck Clinic. OBM was asked to provide the physicist assessment, however, it had not been provided.

The policy for Radiation Personnel External Radiation Exposure Monitoring Program dated and reviewed on 2/14, indicated the following: Radiation workers will be evaluated by the Medical Physicist for their potential for exposure and other working conditions according to the criteria below to determine who will be issued a radiation monitor. Routine monitoring of the radiation environment was an essential part of an effective radiation safety program. The personnel external radiation exposure monitoring program was designed to measure the radiation environment for employees. All individuals who are likely to be occupationally exposed to ionizing radiation in excess of 10% of the maximum permissible dose will be issued a film or thermoluminescent dosimeter (TLD) whole body monitor that will be processed on a monthly or quarterly basis. The film badge must be worn at approximately the collar level outside of the protective clothing that the employee wears. All individuals who are occupationally exposed to radiation on an occasional basis, such as nurses caring for radiopharmaceutical therapy or implant patients, will be issued a whole body monitor.

Based on interview and document review, the hospital failed to ensure STAT labs were collected and analyzed in a timely manner according to the facility policy for 2 of 2 patients diagnosed with kidney disease (ERSD P1, P3).

Findings include:

ESRD P1 was admitted to the hospital on 3/2/15, and had diagnoses that included, but were not limited to: end stage renal disease, and fever of unknown etiology.

Registered nurse (RN)-A who was the dialysis coordinator for the inpatient dialysis unit was interviewed on 3/4/15, at 8:45 a.m. during which she stated that a STAT (a medical term meaning immediately) serum potassium lab had been ordered for ESRD P1 at 8:07 a.m. At 9:15 a.m. the RN-A checked on the status of the STAT lab and it still had not been collected. At 9:20 a.m. by chance a laboratory technician was seen in the common corridor and RN-A asked the lab tech to check on the STAT lab and draw the sample. The sample was finally drawn after intervention by RN-A. During further interview with RN-A on 3/4/15, at 9:15 a.m. she stated that it was not uncommon for STAT labs to take longer than two hours to complete and she had not reported that time delay to the director of the laboratory. The laboratory result for the serum potassium of ESRD P1 was not available until 10:38 a.m. when it was recorded in the medical record.


31593

P3 was admitted to the hospital on 2/21/15, at 9:00 a.m. Upon admission to the emergency department (ED), P3 complained of increasing redness and swelling with drainage from the right great toe. P3's ED physician notes dated 2/21/15, at 9:00 a.m. identified a large ulcer with draining pus from the right great toe, with a history of amputation of the right third toe, anticoagulation use (blood thinning medication use), and stage 4 chronic kidney disease (advanced kidney damage). The ED notes further identified a concern for the possible need for amputation of the toe. Surgeon consult notes dated 2/22/15, at 3:27 p.m. identified P3 had an abscess in the toe with cellulitis (skin infection) extending from the foot and heel, up to the shin bone, with a plan to open the area in surgery and drain the infection.

On 2/21/15, at 9:15 a.m. the ED physician ordered STAT (immediate) blood tests for the following:
-complete blood count (includes a hemoglobin and white blood count which identified infection),
-blood gases (identifies a patient's lung function),
-protime/INR (identifies thinness of a patient's blood, necessary to know prior to performance of surgery),
-basic metabolic panel (includes results of patient's blood chemistry to identify kidney function and identify safe levels to perform surgery),
-c-reactive protein (indicator of level of inflammation and/or infection in the body), and
-lactic acid (can indicate level of infection or sepsis, and/or heart failure).

On 2/21/15, at 10:35 a.m. blood for the 9:15 a.m. STAT tests were drawn (one hour and twenty minutes after the STAT order was given).

The director of laboratory services was interviewed on 3/4/15, at 12:35 p.m. during which he stated that he was unaware there was an issue with the laboratory turnaround times for STAT labs. The director of laboratory services stated that the department had not monitored quality standards for STAT lab turnaround times and confirmed that a STAT lab which took longer than 2 hours and 31 minutes was not considered timely according to the hospital policy for STAT labs.

Review of the hospital policy Laboratory Pathology Services Manual Turnaround times for Laboratory and Pathology dated as last revised 9/14, revealed the following procedure for STAT Orders: "Patient is in a life-threatening situation so diagnostic tests are completed. For Laboratory testing this means the specimen will be collected within 5-10 minutes of receiving the orders and the test will be completed within an hour of collection..."

Based on observation and interview, the hospital was found to be out of compliance with Life Safety Code requirements. These findings had the potential to affect all patients in the hospital.

Findings include:

Please refer to Life Safety Code inspection tags: K-0052, K-0073, and K-0146.

Based on observation, interview and document review, the facility failed to ensure patient sterile supplies were not expired in 2 of 10 nursing unit supply rooms observed. In addition, the facility failed to ensure patient equipment received timely preventive maintenance checks, as required, for 4 of 10 intravenous (IV) pumps and 1 of 3 suction heads located in trauma room nine.

Findings include:

On 3/2/15, from 8:40 a.m. to 10:40 a.m. a tour of the second and third floor supply and storage rooms was performed with the facility chief nursing officer (CNO). During the tour, the following was observed:

Second floor north patient equipment storage room:
-One Hospira Plum-A intravenous (IV) pump, used for administration of IV fluids and/or medication to patients, was past due for preventive maintenance (PM). A bright yellow sticker on the side of the device indicated the pump was due for maintenance 1/2015.

Second floor west patient equipment storage room:
-Three Hospira Plum-A IV pumps, with bright yellow stickers on the side which indicated the devices were due for PM 1/2015.

Third floor patient supply room:
-One sterile Pleura-guide chest tube kit (utilized to drain fluid from a patient's chest cavity) labeled expired 12/2014, 61 days past expiration.
-One sterile Arrow epidural catheter kit (utilized to access the outer portion of the patient's spinal canal to deliver medication) labeled expired 1/2015, 30 days past expiration.
-One 1000 milliliter plastic bottle of sterile saline labeled expired 12/1/14, 91 days past expiration.

During the above observations the facility CNO confirmed the aforementioned patient supplies were expired and should not be available for patient use, and the IV pumps were past due for preventive maintenance. The CNO removed the expired supplies from the rooms.

On 3/5/15, at 8:45 a.m. the facility director of biomedical maintenance (DBM) verified the IV pumps were past due for preventive maintenance. DBM confirmed the usual practice was to perform the PM within the month indicated on the sticker.

On 3/5/15, at 8:47 a.m., the facility supply chain director verified the sterile supplies were past the expiration date and stated usual practice was for materials staff to replace expired patient supplies. The director further confirmed expired sterile supplies were not to be available for patient use and these were.

On 3/5/15, a typed note was provided which directed the following:
The policy at the facility for scheduled PM was that it would be 90% complete by the end of the month it was due.

Review of facility policy titled, Sterile Supply Outdate Checks, reviewed 8/14, was provided.
The policy identified it served as a guideline to aid in infection prevention. In addition, sterile supplies would be checked routinely for expiration dates. The policy further directed that outdated supplies and/or equipment must be removed from stock and replaced with current dated sterile supplies.

Based on interview and document review, the hospital failed to maintain a current contractual agreement with the Minnesota Lions Eye Bank, an organ procurement organization. This had the potential to affect all 11 patients who had expired in the facility during the time period no agreement was in place.

Findings include:

During interview on 3/3/15, at 12:30 p.m. the director of the facility's Organ, Tissue, and Eye Procurement stated the contract with the Minnesota Lions eye bank had expired on 1/31/15, and the facility continued to work with LifeSource who would then contact the eye bank.

Documentation reviewed on patients who had expired after 1/31/15, indicated there were 11 deaths from 2/1/15, through 3/2/15.

During interview on 3/5/15, at 11:15 a.m. the director of the facility's Organ, Tissue, and Eye Procurement stated the facility renewed the contract with the MN Lions Eye Bank dated 4/1/15, through 3/31/20. The contract was only signed by the president of the facility, which was signed and dated 3/4/15, which was after the survey started and it was brought to the facility attention on 3/3/15.

Based on interview and document review, the facility failed to ensure only a trained designated requestor spoke to family of potential donors when requesting organ donation for 2 of 2 patients (P52, P53) reviewed when untrained hospital staff members talked to the family's about organ donation.

Findings include:

There were two documented incidents when the facility staff approached family members of patients (P52, P53) who had a brain death exam and met the criteria for brain death and the family said they did not want donation on both of these patients.

P52's medical record indicated on 5/20/14, P52 had been pronounced brain dead two days ago and was on a vent. P52's progress notes indicated LifeSource was not contacted because hospital staff had approached the family and family indicated they were not interested in donating P52's organs. The documentation was not clear on which staff member in the intensive care unit had talked to the family regarding organ donation. An e-mail memo went out to the intensive care unit with the following information: "We don't have any staff that were trained to approach the family/significant others regarding organ donation. Contact the Life Source staff; they will take care of speaking to the family/significant others. If the family approaches you about organ donation, place a call to Life Source, again they will assist the family/significant other."

P53's LifeSource referral email dated 1/3/15, indicated a referral had been made from the intensive care unit on a 61 year old female. The physician had completed a brain death exam, and it appeared the patient, P53, had met the criteria of brain death. According to the email, a representative from Life Source paged the physician and the physician indicated it would not be acceptable for LifeSource to have the conversation of organ donation over the phone, and the physician would speak to the family regarding donation options. The family declined potential organ donation to the physician, and LifeSource was not given the opportunity to speak to the family.

Life Source sent an email to the director for organ, tissue, eye procurement on 1/29/15, and indicated, "Whenever we have a hospital approach, it's a pretty big deal because we're really trying to move past those with educational efforts. Most of the time we are required to do a Root Cause Analysis as we call it a missed donation opportunity." This one was a little unique in that we didn't have enough information to rule patient in, or out, without speaking to the family or reviewing the chart."

During interview on 3/5/15, at 10:55 a.m. the quality director (QD)-C stated the only personnel trained in organ procurement/donation were direct care nurses.

During interview on 3/5/15, at 11:15 a.m. the director of organ, tissue, and eye procurement stated the two instances with P52 and P53 were considered missed opportunities for possible organ donation, and the physician who spoke with the family regarding donation for P53 had not been trained on organ, tissue and eye procurement.

A organ procurement organization policy was requested but not received.

Based on observation, interview, and document review, the hospital failed to ensure the anesthesia surgical consent was signed for 1 of 6 records reviewed (P8). In addition, the facility failed to ensure expired medications and supplies were removed from carts located in the surgical area. This had the potential to affect all patients who may have surgery in the future.

Findings include:

Consents:
P8's medical record indicated the resident was admitted 3/3/15, for resection of the low anterior colon, and insertion of bilateral urethral stents. The consent for surgery and/or Medical Treatment and Anesthesia was signed by the patient on 3/3/15, however, there was no physician signature. The Informed Consent for Anesthesia Services, which identified and explained the types of anesthesia and the risks was located in the patients medical record, however, the form was not signed by either the patient or the anesthesiologist to indicate this was reviewed with the patient prior to surgery.

During interview on 3/5/15, at 1:45 p.m. registered nurse (RN)-K and anesthesiologist (A)-B stated the anesthesia consent was not signed for P8, however, he was unsure how that got missed. RN-K stated the contracted anesthesiologists had their own consent for the patients to sign, and the anesthesiologists were responsible for having it signed by the patient.

The facility policy and procedure titled Obtaining General Consents dated 6/14, indicated components of an informed consent included the nature and purpose of the proposed surgery or treatment including the anesthesia to be used, and the risks and benefits of the recommended treatment and potential problems. Consents must be obtained. All documentation should be completed prior to completion of a written consent form for surgical patients, and a written and signed consent form must be completed for all major surgery requiring general anesthetic.

Expired medications:
During tour of the surgical suites with registered nurse (RN)-K who was the director of surgery, on 3/3/15, at approximately 1:30 p.m. the anesthesia airway cart in the storage room contained Lidocaine liquid (local anesthetic) with an expiration date of 9/14, a Hurricane spray (used to relieve pain and irritation) labeled with a patient name which was dated 12/12/13, Lidocaine jelly with an expiration date of 7/07, and a tracheal tube with a use by date of 12/05. RN-K stated the cart was used by anesthesia, and the dates of medications and supplies was the responsibility of the anesthesia department. RN-K stated anesthesia completed a checklist when checking for outdated drugs and supplies, however, the checklist provided was outdated and was only through March 2014, through December 2014.

During observation of the operating room crash cart with RN-K, the cart contained electrode pads with an expiration date of 10/6/14. RN-K stated the operating room personnel were responsible for checking the crash cart for outdated supplies. RN-K was unable to determine when the crash cart had last been checked for outdated supplies.

During interview on 3/3/15, at 1:45 p.m. anesthesiologist (A)-A stated the certified registered nurse anesthetists (CRNAs) were responsible for checking carts for outdated drugs and supplies, and the supplies and medications that were outdated should be removed and disposed of to ensure they are not used.

The hospital policy and procedure titled Sterile Supplies Outdate Checks dated 8/14, indicated sterile supplies shall be date checked routinely for expiration dates. The date check would be completed in all areas of the hospital, and outdated supplies would be removed from stock by the person doing the checking.

The policy and procedure titled Department of Anesthesiology, Position and Responsibilities, dated 8/13, indicated the CRNAs were responsible for checking for immediate availability of supplies and equipment.

Based on observation and interview, the hospital failed to ensure ongoing quality assurance projects had been developed and implemented for laboratory services, organ procurement and medical records. This deficient practice had the potential to affect all current inpatients and outpatients of the hospital.

Findings include:

LABORATORY
Observation of ESRD P1 during dialysis on 3/4/15, at 9:00 a.m. revealed at the start of dialysis ESRD P1 had been provided K+ 1.5 mEq/L, Ca++ 2.25 mEq/L dialysate because it had been used during the hemodialysis run on 3/2/15. However, when the STAT (a medical term meaning immediately) serum potassium lab was drawn and analyzed on 3/4/15, at 10:38 a.m. (two hours and 31 minutes later) the result revealed that ESRD P1's serum potassium was 4.4 and the most appropriate dialysate was K+ 3 mEq/L, Ca++ 2.25 mEq/L and not K+ 1.5 mEq/L, Ca++ 2.5 mEq/L.

Registered nurse (RN)-A who was the dialysis coordinator for the inpatient dialysis unit was interviewed on 3/4/15, at 8:45 a.m. during which she stated that a STAT serum potassium lab had been ordered for ESRD P1 at 8:07 a.m. At 9:15 a.m. the RN-A checked on the status of the STAT lab and it still had not been collected. At 9:20 a.m. by chance a laboratory technician was seen in the common corridor and RN-A asked the lab tech to check on the STAT lab and draw the sample. The sample was finally drawn after intervention by RN-A. During further interview with RN-A on 3/4/15, at 9:15 a.m. she stated that it was not uncommon for STAT labs to take longer than two hours to complete and she had not reported that time delay to the director of the laboratory. The laboratory result for the serum potassium of ESRD P1 was not available until 10:38 a.m. when it was recorded in the medical record.

The director of laboratory services was interviewed on 3/4/15, at 12:35 p.m. during which he stated he was unaware that there was an issue with the laboratory turn around times for STAT labs. The director of laboratory services stated the department had not monitored quality standards for STAT lab turnaround times and confirmed that a STAT lab which took longer than two hours and 31 minutes was not considered timely according to the hospital policy for STAT labs.


18622

On 3/3/15, at 2:00 p.m. a tour of the facility's Laboratory Services was conducted with the director of laboratory services. When asked about a quality assurance program, the director of laboratory services stated the lab monitored the blood products for expiration dates, temperature and quality of the blood received. The director of laboratory services was asked about additional monitoring of laboratory services and he did not have any additional documentation. The director of lab was then asked if there were any quality projects that the lab was monitoring and trying to improve. The director of laboratory services confirmed the lab was not collecting any data on quality measures to include correct specimen collections and accuracy of specimen results.

ORGAN/TISSUE AND EYE PROCUREMENT
On 3/5/15, at 11:15 a.m. the director of Organ, Tissue, and Eye Procurement was interviewed. At the time of the interview, the director confirmed LifeSource kept statistics on the number of referrals and the number of viable and nonviable candidates for donation. The director confirmed the facility did not collect statistic on the program and did not have quality measures in place. Although LifeSource gathered the statistics the information was not not brought forward to the quality assurance meeting.


31220

MEDICAL RECORDS
During interview on 3/3/15, at 1:00 p.m. the health information operation manager (HIM) stated the medical records department had been in the process of creating a quality improvement project related to transcription for the last year, however, the process had not yet been implemented.

Based on interview and document review, the hospital failed to ensure STAT labs were collected and analyzed in a timely manner according to the facility policy for 2 of 2 patients diagnosed with kidney disease (ERSD P1, P3).

Findings include:

ESRD P1 was admitted to the hospital on 3/2/15, and had diagnoses that included, but were not limited to: end stage renal disease, and fever of unknown etiology.

Registered nurse (RN)-A who was the dialysis coordinator for the inpatient dialysis unit was interviewed on 3/4/15, at 8:45 a.m. during which she stated that a STAT (a medical term meaning immediately) serum potassium lab had been ordered for ESRD P1 at 8:07 a.m. At 9:15 a.m. the RN-A checked on the status of the STAT lab and it still had not been collected. At 9:20 a.m. by chance a laboratory technician was seen in the common corridor and RN-A asked the lab tech to check on the STAT lab and draw the sample. The sample was finally drawn after intervention by RN-A. During further interview with RN-A on 3/4/15, at 9:15 a.m. she stated that it was not uncommon for STAT labs to take longer than two hours to complete and she had not reported that time delay to the director of the laboratory. The laboratory result for the serum potassium of ESRD P1 was not available until 10:38 a.m. when it was recorded in the medical record.


31593

P3 was admitted to the hospital on 2/21/15, at 9:00 a.m. Upon admission to the emergency department (ED), P3 complained of increasing redness and swelling with drainage from the right great toe. P3's ED physician notes dated 2/21/15, at 9:00 a.m. identified a large ulcer with draining pus from the right great toe, with a history of amputation of the right third toe, anticoagulation use (blood thinning medication use), and stage 4 chronic kidney disease (advanced kidney damage). The ED notes further identified a concern for the possible need for amputation of the toe. Surgeon consult notes dated 2/22/15, at 3:27 p.m. identified P3 had an abscess in the toe with cellulitis (skin infection) extending from the foot and heel, up to the shin bone, with a plan to open the area in surgery and drain the infection.

On 2/21/15, at 9:15 a.m. the ED physician ordered STAT (immediate) blood tests for the following:
-complete blood count (includes a hemoglobin and white blood count which identified infection),
-blood gases (identifies a patient's lung function),
-protime/INR (identifies thinness of a patient's blood, necessary to know prior to performance of surgery),
-basic metabolic panel (includes results of patient's blood chemistry to identify kidney function and identify safe levels to perform surgery),
-c-reactive protein (indicator of level of inflammation and/or infection in the body), and
-lactic acid (can indicate level of infection or sepsis, and/or heart failure).

On 2/21/15, at 10:35 a.m. blood for the 9:15 a.m. STAT tests were drawn (one hour and twenty minutes after the STAT order was given).

The director of laboratory services was interviewed on 3/4/15, at 12:35 p.m. during which he stated that he was unaware there was an issue with the laboratory turnaround times for STAT labs. The director of laboratory services stated that the department had not monitored quality standards for STAT lab turnaround times and confirmed that a STAT lab which took longer than 2 hours and 31 minutes was not considered timely according to the hospital policy for STAT labs.

Review of the hospital policy Laboratory Pathology Services Manual Turnaround times for Laboratory and Pathology dated as last revised 9/14, revealed the following procedure for STAT Orders: "Patient is in a life-threatening situation so diagnostic tests are completed. For Laboratory testing this means the specimen will be collected within 5-10 minutes of receiving the orders and the test will be completed within an hour of collection..."