HospitalInspections.org

Based on observation, interview, documentation in 1 of 1 medical record reviewed of a GPU patient who sustained multiple injures during the hospitalization (Patient 8), and review of policies and procedures and other documentation, it was determined that the hospital failed to ensure the patient's right to receive care in a safe setting. The hospital failed to investigate all incidents and injuries to identify causes and take appropriate actions to prevent further injuries from occurring.

Findings include:

1. During tour of the GPU on 05/06/2015 at 1040 Patient 8 was observed in a group activity room. A laceration surrounded by bruising was observed on the patient's right forehead.

2. The medical record of Patient 8 reflected he/she was admitted to the GPU on 04/09/2015 at 1800 and had a diagnosis of dementia with behavioral disturbances. Documentation on the 04/09/2015 "24 HR Nursing Assessment" reflected that the patient had bruising on his/her hands upon admission. There was no documentation of other skin alterations at that time.

Documentation on the skin assessment records reflected that the patient sustained the following injuries and skin alterations after admission:
* Second right toe skin tear identified on 04/11/2015 at 2349;
* Redness lower back identified on 04/11/2015 at 2349;
* Blister inner right heel identified on 04/11/2015 at 2349;
* Bump/swollen area on right forehead near brow identified on 04/12/2015 at 1830;
* Bruising of left side above waist identified on 04/20/2015; and
* 3 cm. laceration requiring 8 stitches on right side of forehead identified on 04/30/2015.

An X-ray report dated 04/15/2015 reflected that X-rays performed on that date revealed three fractures on the patient's left 10th and 11th ribs.

The progress notes reflected the following documentation related to incidents and injuries:
* On 04/12/2015 at 2024 an RN recorded "at 1815 pt was found on the floor apparently due to a fall...pt sustained a bump on the right side of [his/her] forehead close to the brow; site is tender to touch....no other injuries were apparent."
* On 04/12/2015 at 2204 an RN recorded "Pt c/o pain to upper left ribcage, grimacing and saying [he/she] had fallen...Pt. had unwitnessed fall at 1815 today."
* On 04/15/2015 at 0429 an RN recorded "continues with stiff movements. Gasped with pain holding left lower rib back when from sitting to supine. Tender to light touch on lowest rib."
* On 04/15/2015 at 1427 an RN recorded "cooperative of chest X-ray...", but the note contained no other information about the purpose or result of the X-rays.
* On 04/29/2015 at 1827 an RN recorded "found on floor of the seclusion hallway at 1813 told staff that [he/she] banged the floor. Security called and asked to review the tape and saw [patient] look for a place to sit then reach for the floor with [his/her] hands and lower [him/herself] to a sitting position with no fall noted by [security]."
* On 04/30/2015 at 0105 an RN recorded "At 2017, Med RN noticied (sic) patient lying on [his/her] right side on floor, and called for assitance (sic) to help. RN noticed large laceration to patient's forehead, with blood pooling on floor." The RN documented that the MD was called and the patient was sent to the ED. "Security called and reported that patient was seen on tape at 2017, holding onto wheelchair, lost [his/her] balance and fell to the ground. Pt was returned to the unit...with RN reporting...8 sutures in forehead."
* There was no documentation in the RN progress notes related to the second right toe skin tear, redness lower back, and the blister inner right heel all identified on the skin assessment on 04/11/2015 at 2349.
* There was no documentation in the RN progress notes related to the bruising of left side above waist identified on the skin assessment on 04/20/2015.

The "Observation and Monitoring" record reflected that the patient was "[Outside]" on 04/15/2015 from 1130 to 1200, and was "[Off Unit]" on 04/15/2015 from 1645 to 1730. There was no documentation on that record or in progress notes to explain the patient's location off the unit at those times.

3. The policy and procedure titled "Confidential Occurrence Reporting System", dated as revised "January, 2015", was reviewed. The policy reflected that "A Confidential Occurrence Report (COR) is used to document/report an occurrence or incident that is not consistent with the routine operations of the facility or the routine care of a particular patient." It stipulated that "All [CORS] will be initiated by the employee(s) or provider directly involved in, witnesses of, or first responders to the occurrence...should be completed as soon as possible after the event or not later than the end of the individual's shift...is to be completed, in its entirety, as described in the section 'Guidelines for [COR] Completion'...Once the form is completed it is electronically routed to the Department Director/Manager or their delegate...completes an initial investigation and documents the results...The Director/Manager or their delegate will...review COR's (sic) within 5 business days and then choose one of three 'dispositions': Complete (they have finished their review)...Investigating (they have not completed their review)...Additional referral (they have referred the COR to another staff member...)."

4. During interview on 05/08/2015 at 1020 a SPI Representative provided two "Complaint" event reports for Patient 8.

The first "Complaint" was a "Scalp [Laceration]" and was dated as received on 04/12/2015 with an event or incident date of 04/12/2015. The report reflected two "referral" dates of 04/24/2015 and 05/06/2015 and neither of those referral sections were complete. Numerous fields on the report were blank including "Status...Date...Closed...Action...Disposition...", and 10 questions under the "Falls" section of the report. During the interview the SPI Representative stated that those fields were to be completed by the manager if they had not been completed by the staff person who initiated the report in the electronic reporting system. He/she stated the report should have been completed by now.

The second "Complaint" was a "Scalp [Laceration]" and was dated as received on 05/01/2015 with an event or incident date of 04/30/2015. The report reflected two "referral" dates of 05/01/2015 and 05/06/2015 and neither of those referral sections were complete. Fields on the electronic report were not completed and were blank including "Status...Date Closed...Action...Disposition..."

During the interview the SPI Representative confirmed that there were no event or incident reports that addressed the findings of second right toe skin tear, redness lower back, blister inner right heel, bruising of left side above waist, and fractured ribs.

There was also no documentation provided reflecting a report of the patient having been found on the floor on 04/29/2015.

Based on interview, review of documentation in 5 of 5 medical records of patients who had blood transfusions (Patients 17, 18, 19, 20, and 21), and review of policies and procedures, it was determined that the hospital failed to ensure that 18 of 19 blood units dispensed from the laboratory blood bank were managed and transfused in accordance with policies and procedures:
* The disposition of blood dispensed from the blood bank was not clearly documented;
* Transfusion start and stop times were not documented; and
* Vital sign monitoring per required intervals was not documented.

Findings include:

1. Review of the medical record of Patient 17 revealed the patient arrived at the ED by ambulance on 04/19/2015 at 1902 after having been found unresponsive in a car.

The Batch Transfusion Report reflected two units of blood associated with this patient on 04/19/2015. The electronic blood bank documentation reflected that two units of blood, unit #s W202115436661 and W202115441558, were dispensed from the blood bank on 04/19/2015 at 1915.

The Emergency DC Documentation note recorded by the MD contained the following entry under "Medical Decision Making...Rationale": "Emperic (sic) O neg blood given melena...CPR, fliuds (sic), blood...I and team felt efforts are futile and code called at 1925."

The Code Blue Data Summary reflected the resuscitation efforts, drugs, IV, and other interventions attempted during the code. In relation to blood, the summary included one entry at 1909 that was written as "Blood sent". There was no other documentation of transfusion on the code summary. The summary reflected the code was stopped and the time of death was 1925.

The physician orders reflected that the order start date/time for ABO/Rh type and "retype-confirmation" was 04/19/2015 at 1945, after the patient's death.

The Crossmatch Summary reflected that blood was "collected" for crossmatch for the two units on 04/19/2015 at 1945.

A Transfusion Summary reflected that the "product status" for the two units was "transfused" on 04/19/2015 at 1945, after the patient's death.

The Visit Summary included an entry for "Blood Bank 04/19/2015 1945 Transfused", after the patient's death.

The record did not clearly reflect the disposition of the two units of blood that were dispensed from the blood bank. There was no documentation in the record to explain the discrepancies related to the recorded time of transfusion in relation to the time of the patient's death.

2. Review of the medical record of Patient 18 reflected that the patient was admitted on 04/23/2015 at 0836 as result of a fractured right hip.

The electronic blood bank documentation reflected that blood unit # W202115409186 was dispensed from the blood bank on 04/26/2015 at 1236. The Blood Transfusion Procedures record completed by RNs did not reflect the time the transfusion was started, nor the time the transfusion was stopped. Those fields on the EMR were blank. As those times were lacking there was no way to evaluate if the transfusion was initiated within the required time after being dispensed from the lab; or if documented vital signs taken at 1300, 1315, 1425, 1548, and 1755 were taken before and after transfusion and at the required intervals during the transfusion.

The electronic blood bank documentation reflected that unit # W202115438901 was dispensed from the blood bank on 04/27/2015 at 1318. The Blood Transfusion Procedures record completed by RNs reflected that the transfusion was stopped on 04/27/2015 at 1610. Vital sign documentation reflected that vital signs were taken at 1530, 40 minutes prior to the end of transfusion, and not again until 1740, one hour and 30 minutes after the completion of the transfusion.

3. Review of the medical record of Patient 19 reflected that the patient was admitted on 04/28/2015 at 1306 as result of a fractured left hip.

The electronic blood bank documentation reflected that blood unit # W202115431724 was dispensed from the blood bank on 04/29/2015 at 1011. The Blood Transfusion Procedures record completed by RNs reflected the transfusion was started at 1018, but did not reflect the time the transfusion was stopped. That field on the EMR was blank.

The electronic blood bank documentation reflected that unit # W202115451236 was dispensed from the blood bank on 04/29/2015 at 1258. The Blood Transfusion Procedures record completed by RNs reflected the transfusion was started at 1303, but did not reflect the time the transfusion was stopped. That field on the EMR was blank. Therefore, it was not clear if documented vital signs taken at 1310, 1320, 1400, 1600, and 1800 were at the required intervals during, and after the transfusion.

4. Review of the medical record of Patient 20 reflected that the patient was admitted on 04/21/2015 at 1433 as result for anemia and difficulty breathing.

The electronic blood bank documentation reflected that unit # W202115385329 was dispensed from the blood bank on 04/21/2015 at 2007. The Blood Transfusion Procedures record completed by RNs reflected that the transfusion was started at 2015 and stopped on at 2209. Vital sign documentation reflected that vital signs were taken on 04/21/2015 after the transfusion stated at 2030 and 2201. The second set of vitals were taken one hour and 54 minutes after the transfusion began.

The electronic blood bank documentation reflected that unit # W202115456213 was dispensed from the blood bank on 04/21/2015 at 2231. The Blood Transfusion Procedures record completed by RNs reflected that the transfusion was started at 2242 and stopped on 04/22/2015 at 0040. Vital sign documentation reflected that vital signs were taken on 04/22/2015 at 0030, ten minutes before the transfusion was stopped, and were not taken again until 0310, two hours and thirty minutes after the transfusion was stopped.

5. Review of the medical record of Patient 21 reflected that the patient was admitted on 04/13/2015 at 1817 with an admission diagnosis of pericardial effusion.

The electronic blood bank documentation reflected that 10 units of blood and blood products were transfused between 04/14/2015 at 1244 and 04/15/2015 at 0129. The Blood Transfusion Procedures record completed by RNs reflected the times each unit was started, but did not reflect the time any of the transfusions were stopped. Those fields on the EMR were blank. Intervals between the transfusion start times varied. For example: On 04/14/2015 at 1408 the transfusion of one unit was started and on 04/14/2015 at 1533, the next unit transfusion was started, an interval of one hour and 25 minutes. On 04/14/2015 at 2030 the transfusion of the next unit was started, an interval of four hours and 57 minutes.

6. The hospital policy and procedures titled "Transfusion Therapy - Blood Products Administration", with a revised date of "August 2010", was reviewed. It included the following requirements: "Blood administration should be started within 30 minutes after removal from the Blood Bank Refrigerator." The procedure portion of the policy required the following in chronological order "...Obtain unit from Blood Bank...Take and record baseline vitals...Prior to transfusion, a [RN] and one other trained professional must verify at the patient's bedside the following...Set up blood...Establish slow rate of infusion...Stay with the patient for the first fifteen minutes and observe for transfusion reaction, then every hour during the transfusion...Patient monitoring and vital signs will be recorded: Prior to the beginning of the transfusion...After the first 15 minutes...Every hour during the transfusion...At the conclusion of the transfusion." Item "XV" on the procedure stipulated "Repeat steps 3-10 if additional units are required." However, there were no items in the procedure that were numbered in that manner, there were no "steps 3-10." The documentation portion of the policy reflected only "Electronic Medical Record" and "Informed Consent."

7. During interview with the BBS on 05/07/2015 at 1410 he/she confirmed that for Patient 17 there was no record that the blood units dispensed from the blood bank had been returned to the blood bank after the patient's death. He/she confirmed that the blood bank documentation system reflected the two units had been transfused.

8. The EMR reviews were conducted with the DSPI, the DOP, the M/S Manager, the ICU Manager, and an analytics RN present during some or all of the reviews on 05/07/2015 in the afternoon and on 05/08/2015 in the morning. During interviews at those times staff present confirmed the incomplete blood transfusion documentation.

Based on observation, interview, review of policies and procedures and other documentation, it was determined that the hospital failed to fully develop and implement its policies and procedures to ensure that drugs and biologicals were appropriately controlled, distributed, and stored; and that "guidelines" for drug therapy were reviewed and approved:
* Emergency drug carts and kits containing emergency drugs were not managed and maintained throughout the hospital to ensure the security and integrity of the contents;
* Drugs in all departments were not under the control of the pharmacy;
* Outdated or otherwise unusable drugs were observed; and
* Written chemotherapy drug "guidelines" available to staff had not been reviewed and approved.

Findings include:

1. During tour of the ED on 05/06/2015 at 1530 an emergency code cart tabled "ER7" was observed in an ED corridor. A red, breakaway "lock" (also referred to as a seal) with number 6263201 was observed in place in a locking mechanism on the cart. In addition a yellow, breakaway "lock" was observed in a second locking mechanism on the cart with number 450242.

The "Code Cart Checklist" for May 2015 observed on the cart included a column titled "lock". The daily entries in that column consisted of a checkmark. The numbers of the two "locks" in place on that cart were not recorded and there was no way to determine if the "lock" numbers in place at that time were in fact the last "locks" placed on the cart after the cart's last use. Therefore, there was no way to determine if tampering had occurred and to ensure the security and integrity of the contents.

The "Code Cart" notebook maintained in the pharmacy department was reviewed on 05/08/2015 at 1420. It contained a "Code Cart Expiration Dates" record that consisted of a list of all code carts in the hospital and the corresponding next or first drug expiration date in each cart. For the "ER7" cart that record reflected the next expiration date was "9/15", although the original entry had been altered and written over and was not entirely legible.

The notebook also contained a "Code Cart Trays" record for each code cart in the facility. That record reflected that the next or first expiration date in the "ER7" cart was "7/15".

Further, the "Code Cart Trays" record for the "ER7" code cart reflected that the last "lock" placed on that cart was number 6264013. Although that number did match the "lock" number observed on 05/06/2015 there was no date associated with the change in that "lock". The previous "lock" number listed was 6263201 and the record reflected that "lock" number had been placed on 04/21/2015. That was the last dated entry on the record.

There was no record for the numbered yellow "lock" in place on the cart.

2. During tour of the ED on 05/06/2015 at 1530 an emergency code cart tabled "Ped Cart 2" was observed in an ED corridor. A red, breakaway "lock" with number 6263860 was observed in place in a locking mechanism on the bottom drawer of the nine drawer cart. In addition each of the remaining eight drawers had different colored, breakaway, numbered "locks" as follows:
* Drawer 1 - Yellow "lock" numbered 450276;
* Drawer 2 - Red "lock", numbered 681417;
* Drawer 3 - Blue "lock", numbered 625907;
* Drawer 4 - Yellow "lock", numbered 450293;
* Drawer 5 - Yellow "lock", numbered 5141828;
* Drawer 6 - Blue "lock", numbered 625981;
* Drawer 7 - Yellow "lock", numbered 5141834; and
* Drawer 8 - Green "lock", numbered 705703.

A label on the outside of the cart reflected "Code Cart 1st item to expire 06/15." However, the space to specify the item first to expire had not been completed. Additionally, the "Pediatric Code Blue Cart Content List" on the outside of the cart was observed. It consisted of five pages of a listing of the drugs and supplies contained in that cart. In the space on the form labeled "Outdates" the entry "06/15" was written. However, there was no indication on the list of contents of the cart which items, drugs or supplies, were to expire on that date.

The "Code Cart Checklist" for April and May 2015 observed on the cart included a column titled "lock". The daily entries in that column consisted of a checkmark. The numbers of the nine "locks" in place on that cart were not recorded and there was no way to determine if the "lock" numbers in place at that time were in fact the last "locks" placed on the cart after the cart's last use.

In addition, the entire rows on the April checklist for the daily entries for 04/11/2015 and 04/17/2015 were blank, including the "lock" column; and the entries for 04/12/2015 had been altered by crossing them out, with no explanation.

The "Code Cart" notebook maintained in the pharmacy department was reviewed on 05/08/2015 at 1420. The "Code Cart Trays" record for the "Ped #2" cart reflected that the last "lock" placed on that cart was number 6263860 and that "lock" was attached on 03/22/2015. That "lock" number did match the one observed on drawer 9 of the cart on 05/06/2015. However, there was no record of the "lock" #s for the other eight drawers.

3. During tour of the radiology department on 05/06/2015 at 1630 a code cart labled "CT" was observed. A red, breakaway "lock" was observed in place on the locking mechanism. The number on the "lock" was 0893919.

The "Code Cart Checklist" for April and May 2015 observed on the cart included a column titled "lock". The daily entries in that column consisted of a checkmark. The number of the "lock" was not recorded and there was no way to determine if the "lock" number in place was in fact the last "lock" placed on the cart after the cart's last use.

In addition, the entire rows on the April and May checklists for the daily entries for 04/08/2015, 04/22/2015, 05/03/2015 and 05/04/2015 were blank, including the "lock" column.

The "Code Cart" notebook maintained in the pharmacy department was reviewed on 05/08/2015 at 1420. The "Code Cart Trays"
record for the CT code cart reflected that the last "lock" placed on that cart was number 089413. That number did not match the number of the "lock" observed in place on that cart on 5/06/2015. There was no date associated with that "lock" change. The previous "lock" number listed was 0894003 and the record reflected that "lock" number had been placed on 01/12/2015. That was the last dated entry on the record.

4. Similar findings were observed in relation to the code carts observed during tour of the 5W M/S unit on 05/05/2015 at 1400, and during tour of the 4E M/S unit on 05/05/2015 at 1550.

5. Review of the "Code Cart Trays" record for "ER15" cart included an entry dated 01/26/2015 which reflected "lock" number 0894040 was placed on the cart. However, that number had been crossed out and number 6263593 had been written in that space by a second person with different initials. There was no explanation for the altered entry and the date that entry was made was not documented.

6. During tour of Surgical Services on 05/07/2015 at 1200 the MH Cart was observed. A yellow, breakaway "lock" was observed in place on the locking mechanism.

A two page "Inventory Form" located with the cart was reviewed. It contained numerous items to be stored in the cart, including drugs. Among those it reflected the cart should contain the following which were not observed in the cart and/or were not observed in the designated drawer:
* 5 "Prep Pad Betadine" was observed in Drawer 1 and the inventory form reflected it should be in drawer 2.
* "IV Sterile Water 1000 ML"; "IV 0.9 [percent] Sodium Chloride 1000 ML"; "IV 5 [percent] Dextrose 500 ML"; and "IV Heparin NACL 2 Units/ML 500 ML" were not observed in the cart.

During an interview conducted 05/07/2015 at 1200, the OR Manager stated that the process for monitoring the inventory within the MH cart was to compare the contents of the cart to the inventory sheet monthly and after the cart was used. However, observation of the cart reflected the stated process was not effective as all items on the inventory sheet were not available within the cart.

7. During a tour of the M/S unit on 05/05/2015 at 1615 the "Chemo Cart" was observed in a utility room. During an interview conducted at the time of the observation, the Chemo RN stated that Chemo nurses and unit managers had access to the cart. Although no drugs were observed, inside the cart was an undated, unauthenticated, hand-written notecard titled "Treatment Guidelines For Extravasation of Antineoplastics" which included the following: "Etoposide Vinblastin Vincristine Navelbine...Stop infusion - Do Not remove needle...Aspirate 3-5 ml blood...Aspirate sub q drug [with] 25 gauge needle...give 150 units Hyaluronidase - IV in 3 ml NS...Cisplatin...10 ml Thiosulfate 1.6 ml thiosulfate 25 [percent] diluted with 8.4 ml sterile water..."
There was no documentation to reflect pharmacy or other professional review and approval of the "guidelines", who wrote the "guidelines", and under what circumstances they should be used.

During an interview with the RN CIC at the time of observation, he/she acknowledged that there was no way to determine who wrote the "guidelines", who approved the "guidelines", and whether or not the "guidelines reflected current practice."

8. During tour of the GPU on 05/05/2015 at 1540 the following observations were made in the medication room:
* A Curad Enema was observed with an expiration date of "02/15";
* A MDV of TB Purified Protein Derivative was labeled with a yellow sticker that reflected an expiration date of 05/03/2015 secondary to its opened date; and
* A vial of Pneumovac reflected it was dispensed by the pharmacy on 04/03/2015 for Patient 28 who had been discharged from the hospital in April 2015.

9. During a tour of the TOPS on 05/07/2015 at 1100 with the OR Director the following observations were made in OR2:
* A bottle of Isopto Hyoscine 0.25 [percent] drops with an expiration date of "01/2015" located in the "Eye Cart"; and
* Three vials of 0.9 [percent] normal saline with an expiration date of "01/2015."

10. The following policies and procedures were reviewed:
* "Code Cart Processing", undated;
* "Checking Code Cart", revised "December 2011";
* "Cardiopulmonary Resuscitation (Code Blue)", revised "January 2011; and
* "Code Blue (Cardiopulmonary arrest)", approved "April 2011".

None of the policies and procedures clearly reflected the specific disposition of the drug drawers and contents after a code to ensure the security and integrity of the remaining, unused drugs. The "Code Cart Processing" policy reflected that the cart was transported to Sterile Processing before going to the pharmacy.

In addition, although the policies did reflect that the pharmacy would record the "lock" numbers in the pharmacy, none of the policies and procedures addressed a system for staff monitoring of the "locked" drug drawers of the carts in a way to ensure the security and integrity of the contents on a continual basis and in a way that would identify any possible tampering or unauthorized access within a timely manner.

11. During tour of the ED on 05/06/2015 at approximately 1545, a SPT was interviewed in regards to the process for code cart exchange and "lock" number application. He/she stated that the SP department maintained a stock of all the numbered "locks", including the red pharmacy drawer "locks". He/she stated that after a code cart is used, including the nine drawer pediatric cart, SP staff replace the "locks" from the stock in that department. He/she further stated that the cart is then sent to the pharmacy for medications and the pharmacy records all the "lock" numbers associated with that cart.

12. During interview with the DOP on 05/07/2015 at 1645 he/she stated that the pharmacy does not keep records of any numbered "locks" other than the red ones on the medication drawers.

Based on observation and interview it was determined that the hospital failed to ensure all areas were maintained to be clean and in good repair in a manner to ensure the safety and well-being of patients and staff. Cabinets, shelves, a door, shower tiles and other surfaces in the GPU were not clean or were in disrepair; and tiles in the SP department were not clean and were in disrepair.

Findings include:

1. During tour of the GPU on 05/05/2015 beginning at 1420 the following observations were made:

* The "kitchen" area inside the patient dining room was observed. Multiple cabinet doors were observed in disrepair, with layers of laminate separating from each other and causing the doors to be soft and pliable to the touch, including the cabinet doors under the ice machine counter.

* In the "kitchen" under the microwave counter a large open cabinet was observed which had no doors. A garbage can and a toilet plunger were observed in that space. The garbage can was removed and revealed a large hole in the bottom of the cabinet with an approximately 4 -5 inch space below the cabinet floor surface and the bottom of the room floor. That space was observed to be filled with an accumulation of paper, dust, and other debris. Overall, the surface of that entire cabinet was rough and unfinished wood.

* In addition, in the "kitchen" cabinet floor surfaces covered with peeling contact paper under the sink and toaster counter were covered with layers of dried spills and debris.

* The door to a shower room, room 134, was observed to be out of alignment, causing the door to not close completely without effort. Bottles of personal care supplies were observed in the room causing a potential hazard to the GP patients with dementia and wandering behaviors. (Observation again on 05/06/2015 at approximately 1030 reflected that the shower room door, room 134, was again ajar and not closed completely. Bottles of personal care supplies were observed in the room.)

* Observations at the nurses station revealed two separate handwashing sinks along the same counter space. Each of those sinks had an undersink cabinet with a cabinet door. The doors of both cabinets were opened and revealed that the floor of each cabinet was covered with an extensive buildup of brown and black textured residue and substance in the shapes of dried water or fluid spills. When the cabinet door of the sink on the left side of the counter was opened an immediate and strong mold or mildew odor permeated the room which was acknowledged by multiple staff present at the nurses station at that time.

* The surfaces of the refrigerator at the nurses station were observed to be covered with dried spills and other residues and matter.

* Observations of the shower room, room 134, revealed a build-up of black residue on the grout between the tiles in the shower area.

2. An observation of the surgical cart cleaning room in the SP area was conducted on 05/07/2015 at 1220 with the OR Director. Observation revealed chipped, cracked and missing tiles; and tiles with a rust stained appearance on the wall and floor.

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Based on observation, interview, and review of policies and procedures, it was determined the hospital failed to fully develop and implement policies and procedures for infection prevention in the following areas:
* Isolation precautions;
* Hand hygiene practices;
* Injectable medication practices and supplies;
* Humidity and temperature levels in ORs and other areas;
* Sterile processing supplies and processes; and
* Storage and management of personal care supplies and linens in the GPU.

Findings included:

1. The following observations were made during tour of the M/S unit:

* The outside of patient room 5525 was observed on 05/06/2015 at 1540 with the IP RN and the Manager of the M/S unit. The door to the room was open. A "Contact Enteric Precautions" sign was attached to the door and included the following instructions: "STOP" and "Families and Visitors follow instructions from information sheet." However, with the door in the open position, the sign was not readily visible from all angles of the hallway. During an interview conducted just after the observation, the IP RN acknowledged that the sign was not readily visible.

* An RN was observed to provide patient care on 05/05/2015 at 1630. The RN handled/touched the patient and the patient's indwelling urinary catheter tubing with gloved hands. The RN then removed the gloves, donned another pair of gloves, and assisted the patient with oral/denture care. The RN did not perform hand hygiene during this observation.

* A graduated cylinder containing multiple unwrapped Carpuject Holder devices was observed with the IP RN in the medication room on 05/06/2015 at 1540. The cylinder was positioned partially over the edge of the sink and it was unclear whether the devices had been used. During an interview with the IP RN at the time of observation, he/she stated that no supplies should be stored at the sink area.

2. The following observations were made during tour of the TOPS department with the OR Director and the IP RN on 05/07/2015 beginning at 1010:

* During observation in OR 2 at 1020, an RN was observed to reach into the middle of a draped sterile field with a bare hand and pour a liquid medication from its original container into a secondary container.
During an interview conducted 05/07/2015 at 1100 the OR Director acknowledged that it was not acceptable for the RN to reach into the sterile field with a bare hand.

* During observation in OR 2 at 1040, an anesthesiologist was observed removing a syringe from his/her pocket. The syringe was observed to contain a liquid and was labeled "Midazolam" and had a hand-written label "5/7/15 1200." The syringe had no date or time the medication was prepared in the syringe. During an interview conducted at the time of observation, the anesthesiologist indicated that the "5/7/15 1200" date observed on the label represented the expiration of the medication.

* Review of the policy titled "Safe Medication Practices and Labeling in Perioperative and Procedural Areas," dated "10/10" stipulated the following: "...All medications, medication containers, and solutions on and off the sterile field will be labeled...Labeling will occur when any solution or medication is transferred from the original packaging to another container...Deliver medications to the sterile field in an aseptic manner...Label all medications...including syringes...Label each medication or solution as soon as it is prepared or received, unless immediately administered..."

3. The following observation was made during tour of SP with the SPT and the OR Director on 05/07/2015 beginning at 1220:

* An unmarked, unlabeled container of indicator strips was observed. During an interview with the SPT at the time of the observation, he/she indicated that the strips were used to monitor the surgical instrument sterilizer. He/she acknowledged that the expiration of the strips could not be determined because the strips had been removed from their original container and transferred to the unmarked bin.

4. During an interview conducted on 05/06/2015 beginning at 1000 the IP RN stated that the hospital had seven AIIRs. He/she indicated that engineering staff monitored the air pressure daily using a tissue test when the rooms were in use for a patient on airborne precautions.

* Review of the policy and procedure titled "General Environmental (Engineering) Controls" dated "04/09" reflected the following: "...Smoke tube testing will be done on TB rooms annually. Smoke flowing into the room is at negative pressure relative to the corridor...When TB isolation precautions are implemented, Engineering will do daily monitoring and recording that negative airflow is functioning properly." The policy and procedure was not clear related to how daily monitoring would be conducted, and did not provide assurance that a visual indicator would be used for daily checks of the air pressure when AIIRs were in use for a patient on airborne precautions.

5. During an interview conducted on 05/07/2015 at 1045, the OR Director stated that humidity levels were monitored by the hospital's biomedical staff and he/she had no logs or other documentation of humidity levels for the ORs. The director stated he/she was unsure what the acceptable humidity range was, but thought it may be 20-80 percent.

6. During an interview conducted on 05/07/2015 at 1410, the EM stated that he/she was not able to provide documentation of the electronic continuous humidity monitoring of the ORs for more than the past one and 1/2 weeks.

Therefore, handwritten "Monthly Temperature and Humidity Logs" for ORs 1, 2, 3, 4, 6 and 7 were provided and reviewed for December 2014, January 2015, February 2015, March 2015, April 2015 and May 2015. The instructions on the log stipulated "Record room temperature and humidity. Temps should be between 55 [degree] and 65 [degree]. Humidity between 30 [percent] and 70 [percent]." Documentation on the logs reflected one humidity and one temperature reading recorded daily, Monday through Friday for each OR. There were no readings recorded for Saturdays or Sundays, and no documentation to reflect why there were no readings on those days. There was no documentation to reflect the time the temperature and humidity readings were taken or the individual who recorded the readings.

Review of an undated document provided titled "Tuality Perioperative Services Guidelines: Humidity Watch for Readings [greater than] 70 [percent]" reflected the following: "The quality of air entering the suites will be monitored daily for humidity and temperature levels...Low humidity may increase the risk of electrostatic charges, and increases the potential for dust. High humidity increases the risk of microbial growth...Relative humidity should be maintained between 20-70 [percent] within the individual perioperative suites..."

Although the guidelines referred to monitoring temperature levels they did not specify an acceptable temperature range. Further, the humidity levels referred to in the guidelines were inconsistent with the instructions on the logs which reflected an acceptable humidity level of 30-70 percent.

During an interview on 05/06/2015 at 1000 the IP RN stated that the ideal humidity levels in the OR would be 60 to 70 percent.

7. During tour of the GPU on 05/05/2015 beginning at 1420 the following observations were made:

* In patient room 118 three toothbrushes, labeled with the names of two different patients, were lying uncovered and unprotected on the surfaces of the sinks in the room. Similar observations were made in rooms 119 and 120 and included commingling with hairbrushes. This also created the potential for GP patients with dementia and wandering behaviors to use other patient's toothbrushes.

* Shower room, room 134, was observed. A household laundry basket completely full with folded linens and towels was observed to be placed on the handwashing sink in the room. (This observation was made again on 05/06/2015 at 1030 and during interview at that time, staff stated that those were clean linens and kept in that location to have available during patient showers.)

* Observations at the nurses station revealed a container which held numerous co-mingled fingernail clippers and toenail clippers. During interview with multiple staff at that time it was confirmed that those were used for multiple patients. None of the staff present was knowledgeable about what disinfection procedures were in place between patients.

Based on interview, documentation reviewed in 1 of 2 medical records reviewed of patients who were discharged to a SNF (Patient 2), and review of policies and procedures, it was determined the hospital failed to implement its discharge planning policies and procedures to ensure patients who were discharged to a SNF were presented a list of Medicare participating SNFs.

Findings include:

1. Review of the record for Patient 2 reflected he/she was admitted to the hospital on 05/01/2015 for a left hip and a left clavicle fracture and was discharged to a SNF on 05/05/2015.

The RN notes on the "Discharge Planning Assessment -Text" dated 05/04/2015 at 1316 reflected "Discharge To, Anticipated: Skilled nursing unit."

The RN notes on the "Discharge Planning Ongoing Assess -Text" dated 05/05/2015 at 1638 reflected "Phoned pt's [family member]...to advise of fact transportation arranged for: 1800, as well as fact [SNF] is aware and ready to accept pt for admission...No further RN CM needs at this time..."

There was no documentation in the record to reflect that the patient was presented with a list of Medicare participating SNFs available in the geographic area requested by the patient.

* The policy and procedure titled "Placement of Patient in Skilled or Intermediate Care Facility," dated "02/15" reflected "Provide the family with a list of all skilled nursing facilities in the community...CM/MSW...documents in the medical record the details of the patient discharge arrangements."

Based on interview, documentation in 2 of 6 medical records reviewed for anesthesia services (Patients 1 and 18), and review of medical staff rules and regulations, it was determined that the hospital failed to fully develop and implement medical staff rules and regulations to ensure that a pre-anesthesia evaluation was completed and documented by the qualified anesthetist prior to the surgery or procedure, before the delivery of the first dose of medication(s) administered for the purpose of inducing anesthesia.

Findings include:

1. The record of Patient 1 reflected that he/she was admitted to the hospital on 05/05/2015 at 0531. The Anesthesia Record reflected the patient's pre-op diagnosis was "Stress urinary incontinence" and the procedure performed was "Artificial Urinary Sphincter" under general anesthesia.

The Anesthesia Record reflected that the anesthesia start time on 05/05/2015 was 0741. The surgery start time was recorded as 0832 and surgery stop time was 1105.

The Anesthesia Preop Note reflected that the anesthesiologist "performed" the evaluation on 05/05/2015 at 1041, three hours after anesthesia was started, and completed the evaluation when he/she "signed" and "authenticated" it on 05/05/2015 at 1659, 9 hours and 18 minutes after anesthesia start and after the surgery was over.

2. The record of Patient 18 reflected that he/she was admitted to the hospital on 04/23/2015 at 0837. The anesthesia record reflected the patient underwent surgery secondary to a right hip fracture under general anesthesia.

The Anesthesia Record reflected that the anesthesia start time on 04/24/2015 was 1655 and the surgery start time was 1739.

The Anesthesia Preop Note reflected that the anesthesiologist "performed", "signed", and "authenticated" the evaluation on 04/24/2015 at 1804, one hour and nine minutes after anesthesia was started.

3. The "Rules and Regulations of the Medical Staff of Tuality Community Hospital", dated 04/30/2015, were reviewed. Under "Section IX. Medical Records" was the following stipulation: "When a general or regional anesthetic is anticipated there must be a preanesthesia note in the medical record." There were no other requirements related to preanesthesia evaluations.

4. The EMR reviews were conducted with the DSPI, the DOP, the M/S Manager, the ICU Manager, and an analytics RN present during some or all of the reviews on 05/07/2015 in the afternoon and on 05/08/2015 in the morning. During interviews at those times staff present confirmed the lack of timely preanesthesia evaluations.