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Based on observation, interviews, and preventive maintenance documentation it was determined that the CAH failed to ensure that facilities and equipment were maintained in good repair and in safe and appropriate operating condition. Floor, sink, and equipment surfaces in the surgical services and obstetrical services areas were in need of repair to ensure sanitary conditions; and patient care equipment used under arrangement and brought into the CAH periodically for surgical cases had not been incorporated into the preventive maintenance program in accordance with its policies and procedures and a written contract.

Findings include:

1. a. A tour of the decontamination area of the surgical services department was conducted on 02/06/2014 at 1340. Two washers used to pre-clean surgical instruments, and a portable vacuum unit used during surgical procedures were observed. The vacuum unit was positioned on a docking station on the floor between the two washers. The tile flooring around the base of both washers and the vacuum unit docking station had areas of brown staining. The flooring between the two washers behind the vacuum unit had loose dirt, lifting tiles and brown staining. The front surfaces of both washers had heavy drip marks and water scaling.

b. A policy and procedure titled "Cleaning of Surgery Dept. including C-Section Room," dated as effective "1-1-01" required nightly mopping of all floors in the decontamination room. However, the observation identified in finding 1 above reflected the policy had not been implemented.

c. During an interview conducted on 02/06/2014 at 1345 the central supply aid stated there was no regular cleaning schedule or procedure for cleaning the inside or outside of the instrument washers.

d. During an interview conducted on 02/06/2014 at 1550 the director of the CAH's physical plant services stated he/she was aware of the poor condition of the flooring in the decontamination area but had no plans to repair the floor because that area was going to be moved to a remodeled space "soon". He/she further indicated being unaware that there were housekeeping difficulties in that area.

2. A tour of the obstetrical services unit was conducted on 02/06/2014 at 1030. Observations on the unit reflected a handwashing sink behind the nurses station in dis-repair. The counter surface around the sink basin was significantly discolored and the back-splash on the wall behind the sink was separating from the counter surface and the wall.

3. a. A contract titled "Shared Transportable Lithotripter/Laser Service Agreement" dated by the CAH on 01/20/2007 was reviewed. It reflected arrangements for the use of a "Transportable Lithotripter...Transportable HO: YAG Laser...Transportable PVP Laser...for inpatients and outpatients..." The contract specified that "Equipment provided...will be inspected by Facilities biomedical department each time it comes into the hospital, and copies of routine preventative maintenance will be sent to Facility." A contract attachment reflected "The unit will arrive at the facility 1 hour before scheduled start-time. It is removed from the...vehicle...via hydraulic lift gate and transported into the [operating room] via jack...Lithotripter is accompanied by the Odyssey 30 Holmium Laser System on all cases, for any unanticipated ancillary procedures."

b. Review of a document titled "MR OR Procedures by Rev Code 360, 361" reflected that the lithotripter/laser had been used on five surgical cases between 06/26/2013 and 11/21/2013: three cases on 06/26/2013, one case on 08/28/2013, and one case on 11/21/2013.

c. Review of a policy and procedure titled "Medical Equipment Management Plan" dated as last reviewed "4/13" reflected that the equipment management plan "is to support a safe patient care and treatment environment by managing risks associated with the use of clinical equipment". The plan specifies that "Upon notification of arrival of a piece of equipment on loan or lease to be used or evaluated, a [biomedical equipment technologist] will inspect the device for the following...Presence of all operations manuals...Perform Electrical Safety Testing to assure compliance with current standards...Evidence of current operational testing based on the device's performance specifications formulated by the owner/manufacturer...After completion of the above processes all documentation will be filed in the 'Demo/Rental Equipment" file, #.B0001, in the Bio-medical Engineering file."

d. On 02/07/2013 at 1600 an interview was conducted with the director of the CAH's physical plant services. He/she stated that when a lithotripter is needed for a case, staff from that company transport it to the CAH early in the morning and leave it in front of the physical plant offices. He/she indicated an electrical safety check is conducted before the equipment is transported to surgery. He/she further confirmed that although there were multiple lithotripters and lasers brought in by the company, the CAH maintained no records of the checks for any of the equipment. During the interview a biomedical technologist joined over the telephone. He/she confirmed that an electrical safety check is conducted and if it passes a sticker is placed on it so that surgical staff know it passed. He/she further confirmed that there was no documentation of these activities and that the equipment was not in the CAH's equipment database. During the interview the Quality/Patient Safety Manager stated that surgical staff confirmed that surgical services did not track which specific lithotripter or laser was used for each surgical case.





29708

29708

Based on interview and review of humidity records, it was determined that the CAH failed to develop and implement policies and procedures to ensure humidity was controlled in the surgical services department and the C-section procedure room. Humidity levels in these areas were not monitored and maintained in accordance with professional standards of practice to inhibit bacterial growth, to ensure the integrity of wrapped sterile instruments and supplies, and to prevent patient infections.

Findings included:
1. Standards published by the Association of periOperative Registered Nurses reflects the current standard of practice related to humidity levels in operating rooms: "The recommended humidity range in an operating room is 20% to 60% based upon addendum d to ANSI/ASHRAE/ASHE Standard 170-2008. Each facility should determine acceptable ranges for humidity in accordance with regulatory and accrediting agencies and local regulations. The center for Medicaid and Medicare systems has modified their requirements to allow for the 20% lower limit effective June 2013. Temperature and humidity should be monitored and recorded daily using a log or electronic documentation of the heating, ventilation, and air conditioning (HVAC) system."

2. Humidity records for the ORs and C-section room were reviewed:

* There were no humidity monitoring records available for OR #s 1, 2, 3, or 4.

* A document titled "OR5 Humidity" reflected humidity monitoring for OR #5 for 01/31/2014 through 02/05/2014. There were no other humidity monitoring records available for OR #5.

* A document titled "OR6 Humidity" reflected humidity monitoring for OR #6 for the month of August 2013. On 11 days the humidity exceeded "80.4." The next documented humidity monitoring for OR #6 was 01/31/2014 through 02/05/2014. There were no further humidity monitoring records for OR #6.

* The "OB Humidity" records for the cesarean procedure room for the month of August 2013 reflected the humidity exceeded 60% every day, and additionally exceeded "72.9" on 08/05/2013, 08/06/2013, 08/08/2013, 08/16/2013 and 08/25/2013. Humidity records for the month of September 2013 reflected approximately 27 days when the humidity was recorded between "61.3" and "81.0". The humidity was recorded as "63.5" on 10/12/2013 and "63.5" on 11/01/2013. Similar findings were identified for the months of March 2013, April 2013, May 2013, June 2013 and July 2013.

3. An interview was conducted on 02/06/2014 at 1305 with the surgical services director. He/she stated the CAH had 6 ORs and an additional "OB" room for performing C-sections. The director stated that the humidity in these areas should be monitored and maintained between 30-60%. The director stated that he/she recently learned that humidity levels in these areas had been outside the 30-60% range "for the last couple months." The director indicated that the CAH had no policy or procedure for monitoring or maintaining the humidity levels, or a process for addressing the humidity levels when they were outside the acceptable range.

4. During an interview conducted on 02/07/2014 at 1620 the VP of Nursing acknowledged the lack of documented humidity records.

Based on observation, interview, and review of policies and procedures it was determined that the CAH failed to ensure pharmacy control and management of drugs used in all departments. Drugs observed in outpatient cardiopulmonary, outpatient infusion, the obstetrics unit and the radiology department had not been controlled and managed to ensure that outdated or otherwise unusable drugs were not available for patient use.

Findings include:

1. a. During tour of the outpatient cardiopulmonary department on 02/05/2014 at 1215, a bottle of Nitrostat 0.4 mg tablets was observed within a wall mounted storage cabinet. The label on the medication bottle reflected an expiration date of 05/2013.

b. During interview on 02/05/2014 at 1220 the RN in the outpatient cardiopulmonary department acknowledged that the Nitrostat medication was expired and stated during the interview that there was no process for monitoring the expiration of the medication.

2. a. During tour of "Unit A", the OB unit, on 02/06/2014 at 1040 a locked "anesthesia cart" was observed in a supply storage room. There was no identification of the contents of the cart visible on the outside of the cart.

The following outdated drugs were observed in the cart:
* Three vials .9% sodium chloride, expiration date 02/01/2014.

In addition, the following drugs were observed:
* Nine doses sodium chloride for injection;
* Seven vials .9% sodium chloride;
* Four 10 ml. ampules sodium chloride for injection;
* Three vials phenylephrine 1%;
* Thee vials ephedrine sulfate;
* Three vials lidocaine; and
* One vial bupivacaine .25%.

b. During interview with the OB nurse manager on 02/06/2014 during the tour he/she stated being unaware that drugs were in the cart stored in the supply room.

During interview with the CRNA on duty on 02/06/2014 at approximately 1050 he/she stated that he/she had removed the drugs from the Pyxis machines (automated, secure medication dispensing system) and put them in the anesthesia cart for use.

3. During tour of "Unit C", for outpatient infusion and observation patients, on 02/06/2014 at 1145 a "PICC cart" was observed in a supply storage room. There was no identification of the contents of the cart visible on the outside of the cart.

Outdates observed in the cart included:
* Chlorascrub, expiration date "10/2012";
* Chlorascrub, expiration date "11/2013";
* Two Medichoice lubricating jelly, expiration date "Dec 08"

4. a. During tour of the Radiology Department on 02/06/2014 at 1710 the following observations were made:
* Sterile water with an expiration date of 09/01/2012 was observed in a cabinet labeled as the "PM" cabinet.
* Five 50 ml. bottles of Isovue-300 for intravenous use were observed in a "warmer". Each bottle had a manufacturer's expiration date on the manufacturer's label, and in addition had a handwritten date on the bottle itself. The handwritten date was "1/4/14".

b. During interview at the time of the tour on 02/06/2014, a radiology technologist explained the handwritten date on the Isovue contract media bottles. He/she stated that the date indicated the date the bottle was placed in the warmer and the bottle was only good for use within 30 days of being placed in the warmer. He/she confirmed that the bottles dated "1/4/14" were beyond the 30 days allowed by the procedure.

c. The policy and procedure titled "Contrast Administration Process" dated as last revised on "5/2013" was reviewed. It reflected that "Contrast agents are ordered and stored long term in Pharmacy. Short term storage is kept in locked containers located in CT and MRI departments. CT contrast warmer is monitored daily for correct heat settings." The policy and procedure did not include the process or practice described by the radiology staff during the tour and interview, it did not identify "correct heat settings", nor was there any further description for the management of the contrast bottles.

4. The policy and procedure titled "Medication Management Program" last reviewed "09/30/2013", reflected that the pharmacy department "provides fundamental functions as well as key oversight responsibilities and activities in the system of medication management...". The list of functions and activities included: "Storage of medications...Drug floor stock distribution..."



29708

29708

Based on observation, interview, and policy review it was determined the CAH failed to fully develop or implement policies and procedures for infection prevention related to isolation precautions, disinfection of glucose meters used throughout the CAH, and disinfection of ultrasound probes used in the radiology department.

Findings included:

1. a. During tour of "Unit B", the medical/surgical unit, on 02/05/2014 at 1040 the outside of patient room B214 was observed. PPEs were observed stored in a multi-compartment, cloth-like organizer hanging on the room door. A "Droplet Precautions" sign was observed hanging on the organizer. However, the door opened inward to the room and therefore the PPEs were not clearly evident prior to entering the room and the sign could not be read until one was in the room. There were no PPEs and no signage observed outside of the patient room.

b. During tour of "Unit B", the medical/surgical unit, on 02/06/2014 at 1020 the outside of patient room B213 was observed. PPEs were observed stored in a previously described organizer hanging on the room door. However, the door opened inward to the room and therefore the PPEs were not clearly evident to prior to entering the room. A standard size, white piece of typing paper was observed taped 3/4 of the way up the height of the vertical door jamb. Staff present during the tour lifted the white paper up to reveal a red "STOP" sign located underneath.

c. During tour of "Unit B", the medical/surgical unit, on 02/07/2014 at 1545 the following observations were made:
* The outside of patient room B210 was observed. PPEs were observed stored in a previously described organizer hanging on the room door. An "Enteric Precautions" sign was observed hanging on the organizer. As the door to the room was closed at the time of the observation the precautions sign was clearly visible. However, there was no "STOP" sign nor other related signage observed outside of the patient room for the occasions when the door would be open.
* The outside of patient room B216 was observed and the door was opened inward to the room. A "Computer on Wheels" was observed in the doorway. Through and behind the computer, PPEs were observed stored in a previously described organizer hanging on the room door. A "Droplet Precautions" sign was observed hanging on the organizer. However, the PPEs were significantly obscured by the computer and the sign could not be read. There were no PPEs and no signage observed outside of the patient room.
* The outside of patient room B226 was observed. PPEs were observed stored in a previously described organizer hanging on the room door. A "Droplets Precautions" sign was observed hanging on the organizer. As the door to the room was closed at the time of the observation the precautions sign was clearly visible. However, there was no "STOP" sign nor other related signage observed outside of the patient room for the occasions when the door would be open.

d. A policy titled "Isolation Precautions Guidelines", dated as last reviewed by the CAH on "11/9/11" was reviewed. The policy reflected procedures to be used for patients with conditions that required isolation precautions. The procedure required that for "Signage...Use precautions signs to alert health care workers and visitors when additional infection control precautions are required. Signage must be posted outside a patient's room." The procedure additionally required under the "Procedures For Isolation" section that "Appropriate color-coded signage is posted outside the patient's room...Isolation equipment should be outside the room or in anteroom if available."

e. During interview on 02/05/2014 at 1040 the observations of the tour of Unit B were discussed with the Quality/Patient Safety Manager. In regards to the unclear signage and how visitors would know there were precautions in place he/she stated "I hope someone would stop them". During further interview on 02/07/2014 at 1545 the Quality/Patient Safety Manager confirmed that the isolation signs on Unit B could not be clearly seen from outside patient rooms when doors were open.

2. a. During tour of "Unit A", the OB unit, on 02/06/2014 at 1030 a glucose meter was observed. During interview at the time of the observation, unit staff stated that the multi-patient use meter was cleaned with Asepti-wipe II disinfectant wipes between each patient.

b. During tour of "Unit C", for outpatient infusion and observation patients, on 02/06/2014 at 1230 the glucose meter was observed at the nurses station. During interview at the time of the observation, unit staff stated that the multi-patient use meter was cleaned with Brawny towels soaked in a bucket of Hepastat 256 at the change of shift. The bucket of Brawny soaked towels was observed at the nurses station.

c. During tour of "Unit D", the intensive care unit, on 02/06/2014 at 1345 the glucose meter was observed at the nurses station. A Brawny bucket filled with solution and towels was observed at end of the nurses station counter. During interview at the time of the observation, unit staff stated that the multi-patient meter was cleaned between patients with Asepti-wipe II disinfectant wipes. He/she indicated that the Hepastat 256 couldn't be used on everything.

d. During tour of the outpatient cardiopulmonary department on 02/05/2014 at 1200 a glucose meter was observed. During interview at the time of the observation, an RN indicated that patient blood sugars were checked using the multi-patient glucose meter. The RN stated he/she cleaned the meter by wiping it down with Asepti-wipe II disposable wipes "daily or if it had visible blood or soiling".

e. During the tour of the ED on 02/05/2014 at 1400 an RN stated that a multi-patient glucose meter was used to check patient blood sugars and Asepti-wipe II disposable wipes were used to clean the meter.

f. A policy titled "Hospital approved Disinfectants," dated as approved 02/15/2012 was reviewed. The policy reflected "On January 25, 2005, the Infection Control Committee at GSHCS approved Coastwide Hepastat 256 as it's approved general disinfectant."

A policy titled "Inform II Meter Guide" revised 10/28/2013 was reviewed. The policy described procedures for cleaning and disinfecting blood glucose meters. The policy reflected "...The FDA recommends that Point of Care testing devices, such as blood glucose meters, should be used only on one patient and not shared. If dedicating blood glucose meters to a single patient is not possible, the meters must be properly cleaned and disinfected after every use following the guidelines given in this manual...Cleaning and disinfecting are companion procedures that are generally performed together at the same time." The "Disinfecting Procedure" reflected "...Use an approved wipe...Allow the surfaces of the meter to remain damp with the disinfecting solution for...one full minute if using Clorox Germicidal Wipes or two full minutes if using Super Sani-Cloth wipes..."

g. During an interview on 02/06/2014 at 1430 the Quality/Patient Safety Manager stated that multi-patient glucose meters should be disinfected with the CAH approved Coastwide Hepastat 256 as indicated in the policy above.

The policies and procedures had not been effective and monitored as they contained discrepant information related to the required product to be used and actual practices related to product use and frequency of disinfection were further inconsistent.

3. a. During tour of the Radiology Department on 02/06/2014 at 1710 the following observations were made:
* In the first of two ultrasound rooms, a bottle of Cidex OPA Test Strips was observed with a manufacturer's expiration date of "8/2013".
* In the second of two ultrasound rooms, a bottle of Cidex OPA Test Strips was observed with a manufacturer's expiration date of "8/2013".

b. An Ultrasound Endocavity Probe Disinfectant Log posted for "Room: [ultrasound] 2" dated for the month of February 2014 was reviewed. There were no entries for 02/01/2014 and 02/02/2014. Entries for 02/03, 02/04, 02/05, and 02/06/2014 under the column labeled "Test Strip Pass/Fail?" reflected "pass". Entries on those dates under the column labeled "Test Strip [expiration] date (90 days)" lacked a date and instead contained the initials of a person.

c. The policy and procedure titled "Infection Control-Sterilization Procedure for Endocavity Probe" dated as last revised "10/11" was reviewed. It indicated that "Log sheets are kept at all disinfection stations...There is a 90 day expiration date from when the test strip container is opened...to when they need to be disposed. These dates will be logged on the documentation sheet." The policy did not address the test strip manufacturer's expiration date and the relationship of that date to the "90 day expiration date from when the test strip container is opened".

The policy and procedure was not effective and had not been monitored as test strips in use were expired and the disinfectant log posted in the ultrasound room was not completed as required.

Based on interview, policy review and review of other documentation, it was determined that the CAH failed to fully develop and implement policies and procedures to ensure the nutritional needs of patients were in accordance with recognized dietary practices. Policies and procedures were not fully developed and implemented to ensure refrigerator, freezer and dishwasher temperatures were monitored, maintained and addressed.

Findings included:

1. a. A policy and procedure titled "Temperature Control," dated as last reviewed "8/11" reflected "...A log of temperatures is recorded daily for freezers, refrigerators and dishwashing machine...Deviations outside the acceptable range must be corrected...Upon arrival, the cook records all freezer and refrigerator temperatures on the temperature log daily...The am dishwasher person records dish machine wash and rinse temperatures before the first load of dishes...Corrective action is taken immediately by the person recording an unacceptable temperature log...Follow up and subsequent actions by other people, such as the supervisorr [sic] or maintenance, is documented on the temperature log." Although the policy reflected that unacceptable temperatures must be addressed, the policy was not fully developed to describe what the acceptable temperature ranges were for the freezers, refrigerators or dishwashing machine.

b. A document titled "Daily Refrigerator/Freezer Temperature Log" for the "Drawers Refrigerator" was reviewed. The document was not dated. The dietary manager identified the document as a log of refrigerator temperatures for January 2014. The instructions on the top of the form reflected "This log will be maintained for each refrigerator and freezer (both walk-in and reach-in units) in the facility. A designated food service employee will record the time, air temperature and their initials (preferably upon arrival) once in the morning and once (preferably just before leaving the facility) in the afternoon...The food service supervisor for each facility will verify that food service employees have taken the required temperatures by visually monitoring food service employees and reviewing, initialing, and dating a sample of logs each month. The instructions additionally reflected that refrigerator temperatures should be between 36 and 41 degrees, and freezer temperatures should be between -10 and 0 degrees, and "If corrective action is required on any day, circle the date in the first column and explain the action taken on the back of the chart or on an attached sheet of paper."

No temperatures were recorded on the log for 01/04/2014, 01/18/2014 and 01/19/2014. No temperatures were recorded in the "AM" for 01/05/2014, 01/11/2014, 01/12/2014, 01/26/2014 and 01/30/2014. No temperature was recorded in the "PM" for 01/17/2014. The area at the bottom of the form for the "Supervisory Employee's Initials and Date" was blank, and there was no documentation to reflect that the supervisor had verified that the temperatures had been checked in accordance with the instructions identified on the form above.

c. Review of the "Walk In Refrigerator" log dated "Month/Year: Jan 2014" reflected that no temperatures were recorded for 01/04/2014, 01/18/2014 and 01/19/2014. No temperatures were recorded in the "AM" for 01/05/2014, 01/11/2014, 01/12/2014 and 01/30/2014. Additionally, the "AM" temperatures for 01/02/2014 and 01/07/2014 were recorded as "35", below the temperature range identified in finding b. above. There were no documented actions taken to address the temperatures and the area at the bottom of the log for the "Supervisory Employee's Initials and Date" was blank.

d. Review of the "Walk In Freezer" log dated "Month/Year: 1-14" reflected that no temperatures were recorded for 01/04/2014, 01/18/2014 and 01/19/2014. No temperatures were recorded in the "AM" for 01/05/2014, 01/11/2014, 01/12/2014 and 01/26/2014. The area at the bottom of the log for the "Supervisory Employee's Initials and Date" was blank.

Similar findings were identified during review of the following additional refrigerator and freezer temperature logs: "Walk In Protein Refrigerator" dated "Month/Year: 1-14", "Prep Freezer" dated "Month/Year: "1-14", "Prep Refrigerator" dated "Month/Year: 1-14", "Line Prep Table" dated "Month/Year: 1-14", "Walk In Protein Refrigerator" dated "Month/Year: Dec 2013", and "Walk In Refrigerator" dated "Month/Year: 12-13". Similar findings were also identified during review of the following undated refrigerator and freezer temperature logs: "Walk In Freezer", "Prep Freezer", "Prep Refrigerator" and "Line Prep Table". The area at the bottom of all of these logs that reflected "Supervisory Employee's Initials and Date" was blank.

e. Dishwasher temperatures for December 2013 recorded on a document titled "Dec. 2013 Dishwasher Temp" were reviewed. No dishwasher temperatures were recorded for the following dates: 12/02/2013, 12/13/2013, 12/22/2013, 12/28/2013 and 12/29/2013.

Dishwasher temperatures recorded on a January 2014 monthly calendar were reviewed. No dishwasher temperatures were recorded for 01/13/2014 and 01/27/2014.

f. During an interview on 02/05/2014 at 1110 the dietary services manager acknowledged there were "gaps" in temperature monitoring for the dishwasher, refrigerators and freezers and stated during the interview he/she identified the problem at the end of December.

Based on interview, documentation for 8 of 15 blood transfusions in 6 of 7 medical records reviewed (Patient #s 1, 2, 4, 5, 6, and 30) and review of policies and procedures it was determined that the CAH failed to fully develop and implement its policies and procedures related to the length of time blood transfusions were to be started and completed after the blood had been issued by the blood bank. In addition, transfusion records, which included patient's vital signs, were not always complete and legible.

Findings include:

1. Review of transfusion records for Patient 1 revealed a blood "Unit Issue Card" which reflected that a unit of blood was issued from the blood bank on 09/26/2013 at 1947. The Blood Transfusion Record reflected that the transfusion of that unit started on 09/26/2013 at 2100, one hour and 13 minutes after the unit left the blood bank. The transfusion ended at 2350, four hours and 3 minutes after the unit left the blood bank.

2. Review of transfusion records for Patient 1 revealed a blood "Unit Issue Card" which reflected that a unit of blood was issued from the blood bank on 09/26/2013 at 2339. The Blood Transfusion Record reflected that the transfusion of that unit started on 09/26/2013 at 2355 and ended at 0400 on 09/27/2013, four hours and 21 minutes after the unit left the blood bank.

3. Review of transfusion records for Patient 2 revealed a blood "Unit Issue Card" which reflected that a unit of blood was issued from the blood bank on 11/12/2013 at 2013. The Blood Transfusion Record reflected the transfusion of a unit for which the blood unit number was not recorded. An unidentified unit was started on 11/12/2013 at 2045, 32 minutes after the unit left the blood bank. The time the transfusion of the unidentified unit ended was not recorded.

4. Review of transfusion records for Patient 4 revealed a blood "Unit Issue Card" which reflected that a unit of blood was issued from the blood bank on 12/25/2013 at 1118. The Blood Transfusion Record reflected that the transfusion of that unit started on 12/25/2013 at either 1153 or 1253. The time was unclear as the two times were written over each other. If the time was 1153, the transfusion started 35 minutes after the unit left the blood bank. If the time was 1253, the transfusion started one hour and 35 minutes after the unit left the blood bank. The transfusion ended at 1556, four hours and 38 minutes after the unit left the blood bank.

5. Review of transfusion records for Patient 4 revealed a blood "Unit Issue Card" which reflected that a unit of blood was issued from the blood bank on 12/25/2013 at 1624. The Blood Transfusion Record reflected that the transfusion of that unit started on 12/25/2013 at 1630 and ended at 2044, four hours and 20 minutes after the unit left the blood bank.

6. Review of transfusion records for Patient 5 revealed a blood "Unit Issue Card" which reflected that a unit of blood was issued from the blood bank on 10/15/2013 at 0850. The Blood Transfusion Record reflected that the transfusion of that unit started on 10/15/2013 at 0927, 37 minutes after the unit left the blood bank.

7. Review of transfusion records for Patient 6 revealed a blood "Unit Issue Card" which reflected that a unit of blood was issued from the blood bank on 09/15/2013 at 1822. The Blood Transfusion Record reflected that the transfusion of that unit started on 09/15/2013 at 1926, one hour and 4 minutes after the unit left the blood bank.

8. Review of transfusion records for Patient 30 revealed a blood "Unit Issue Card" which reflected that a unit of blood was issued from the blood bank on 08/03/2013 at 0938. The Blood Transfusion Record reflected that the transfusion of that unit started on 08/03/2013 at 1000 and ended at 1340, four hours and 2 minutes after the unit left the blood bank.

9. Refer also to findings under the deficiency cited at CFR 485.638(a), Tags C302 and C307, which contain examples from transfusion records that reflect entries, including patient vital signs, were not always complete, accurate, legible, dated, timed, or signed.

10. The CAH policy and procedure titled " Blood and Blood Products Transfusion Therapy" dated as last revised "2/11",was reviewed. It contained the requirement that: "A unit of blood must be transfused within 4 hours." Although the time transfusions were started after blood was issued from the blood bank varied from 6 minutes up to one hour and 13 minutes, the policy and procedure did not provide direction related to transfusion start time.

11. During interview on 02/07/2013 at 1645 the VP of Nursing stated that the policy and procedure did not specify the timeframe a transfusion was to begin relative to the time the blood left the blood bank.

Based on interview, documentation in 27 of 30 medical records reviewed (Patient #s 1 through 6, 8, 9, 11, and 13 through 30), and review of CAH policies it was determined that the CAH failed to ensure that all entries in the medical record, including those on physician progress notes, blood transfusion records, critical care and medical/surgical flow sheets, admissions and consent forms, physician orders, pre-operative checklists, anesthesia records, imaging reports, ED records, discharge instructions were legible, complete, and accurately documented. Further, the records were not complete as the provision of patient's rights information was not reflected in accordance with the CAHs policies and procedures.

Findings include:

1. The medical record for Patient 1 reflected the patient was admitted to the CAH on 09/26/2013.
* Entries on physician progress notes dated 09/27/2013 at 0835 and on 09/28/2013 at 0905 had been altered and were not legible as the original entry had been scribbled out.
* An entry of a blood pressure recorded on a blood transfusion record dated 09/26/2013 had been altered and was not legible as the original entry had been written over.
* There was no documentation to reflect that the patient had received patient's rights information.

2. The medical record for Patient 2 reflected the patient was admitted to the CAH on 11/12/2013.
* Entries on the "Critical Care Flow Sheet" dated 11/14/2013 had been altered and were not legible as the original entries had been written over.
* An entry of the patient's pulse recorded on a blood transfusion record dated 11/12/2013 had been altered and was not legible as the original entry had been scribbled out.
* There was no documentation to reflect that the patient had received patient's rights information.

3. The medical record for Patient 3 reflected the patient was admitted to the CAH on 11/27/2013.
* The advance directive section on the "Conditions of Admissions" form dated 11/26/2013 was blank and had not been completed..
* The time recorded for an order dated 11/27/2013 on the "Physicians Orders" was not legible.
* Entries on physician's order dated 11/27/2013 and 11/29/2013 had been altered and were not legible as the original entries had been scribbled out.
* Entries on "24-Hour Medical/Surgical Record" forms dated 11/28/2013, 11/29/2013, and 11/30/2013 had been altered and were not legible as the original entries had been written over.
* Entries for two blood pressures recorded on a blood transfusion record dated 11/28/2013 had been altered and were not legible as the original entries had been written over.
* An "Anesthesia Record" for a lower extremity amputation performed on 11/27/2013 contained illegible entries as entries had been scribbled out or written over. In addition, the record contained the signatures of two anesthesia providers, however it was not clear which provider was responsible for all entries, including the illegible ones.
* There was no documentation to reflect that the patient had received patient's rights information.

4. The medical record for Patient 4 reflected the patient was admitted on 12/25/2013.
* The advance directive section on the "Condiciones Para La Admision Del Paciente" (Conditions of Admissions) form dated 12/25/2013 at 0813 was blank and had not been completed.
* There was no documentation to reflect that the patient had received patient's rights information.

5. The medical record for Patient 5 reflected the patient was admitted to the CAH on 10/12/2013.
* The "Physicians Orders" contained a telephone order from a physician taken by an RN dated 10/14/2013. The time the RN took the order had been altered as the original entry had been written over.
* Orders for intravenous Morphine (narcotic pain medication) on the "Post Anesthesia Orders" had been altered as the original entry had been scribbled out.
* A blood transfusion record for two transfusions dated 10/15/2013 contained entries for the patient's blood pressure and temperature, and times that had been altered as the original entries had been written over.
* The patient's weight on a "Pre-Operative Check List" for a hip surgery performed on 10/12/2013 had been altered as the original entry had been scribbled out.
* The "Pre-Operative Check List" for a hip surgery performed on 10/12/2013 contained blank spaces for the following information required on the form: "Supervisor notified...Time:"; "Output...Time:...Amount:"; "Chart Preparation (sic)...Nurse:"; "CRNA notified Time: By:"; "H&P...and attestation...or recent progress note".
* The "Anesthesia Record" for a hip surgery performed on 10/12/2013 reflected the time the anesthesia was stopped. However, that entry had been altered as the original entry had been scribbled out.
* There was no documentation to reflect that the patient had received patient's rights information.

6. The medical record for Patient 6 reflected that the patient was admitted to the CAH on 09/15/2013.
* The "Pre-Operative Check List" for a endoscopy and colonoscopy performed on 09/06/2013 contained blank spaces for the following information required on the form: "Nurse"; "Operative Area"; "Oral Hygiene Given"; "Glasses/Contact Lenses Removed"; Metal Removed/Taped"; "Valuables Secured"; "Time: Amount:" the patient voided"; "Chart Preparation (sic)...Nurse:"; "CRNA notified Time: By:"; "H&P...and attestation...or recent progress note".

7. The record of Patient 8 reflected the patient was admitted on 02/05/2014.
* Documentation on the "Conditions of Admissions" form dated 02/05/2014 at 1612 reflected that the patient did have an advance directive and described the location of the document as being on file at a family member's office and additionally at an attorney's office. However, documentation on the admission assessment to the patient care unit dated 02/05/2014 at 2135 reflected that the patient did not have an advance directive formulated.
* There was no documentation to reflect that the patient had received patient's rights information.

8. The medical records for Patient 13 reflected the patient was admitted to the CAH on 11/12/2013.
* The date and time the physician signed the Heparin Dosing Orders and Monitoring Protocol were altered as the original entries had been scribbled over.
* An electronically generated Echocardiogram Report reflected the date of exam to be 07/03/2013. Five entries related to the clinical findings and severity of the findings had been altered and new entries added by hand. For example: ""Moderate" and "Mild" had been crossed out and "now severe" had been handwritten on the report. The author of those altered and added entries was not identified, nor the date and time the handwritten entries were made.

9. The medical records for Patient 15 reflected the patient was admitted for emergency services on 08/09/2013.
* There was no documentation to reflect that the patient had received patient's rights information.

10. The medical record for Patient 19 reflected the patient was admitted for emergency services on 09/05/2013.
* There was no documentation to reflect that the patient had received patient's rights information.

11. The record for Patient 30 reflected the patient received an outpatient blood transfusion on 08/03/2013. * The advance directive section on the "Conditions of Admissions" form dated 08/03/2013 was blank and had not been completed.
* There was no documentation to reflect that the patient had received patient's rights information.

12. Similar findings were identified in records for Patient #s 9, 11, 14, 16, 17, 18, and 20 through 29.

13. The policy and procedures titled "Medical Record Guidelines for Physicians", dated as last revised "12/10", was reviewed. It required that "All entries must be authenticated by signing, dating and timing the entry...All progress notes shall be dated, timed and signed...Written orders must be signed, dated and timed when written...orders must be written clearly, legibly and completely...No entry in a patient records shall be removed from the record once placed there. All corrections shall be made by drawing a single line through the entry, but not obliterating any incorrect information, writing the correct entry, indicating the date and time of the correction, and the initials of the person making the change."

14. The policy and procedure titled "Surgical Checklist", dated as last revised "09/11", was reviewed. It required that a surgical checklist be completed prior to surgery and that "Patient Preparation and Chart Preparation sections are completed and a checkmark is placed by each item...The RN responsible for the patient is to sign, date and time the form."

15. The policy and procedures titled "Patient's Bill of Rights Responsibilities", dated as last reviewed "7/11", required that the CAH "as part of maintaining patient's rights, will provide the Patient's Rights & Responsibilities brochure to all patients on admission." The policy and procedure directed that "All patients (inpatient and/or outpatient will receive, upon registration, a copy of the Patient's Rights and Responsibilities brochure...When written communication is not effective, the brochure can be read to the patient...For inpatients and outpatients, documentation that the patients have had their rights explained will occur on the Advance Directive form (6251006)."

16. The Quality/Patient Safety Manager indicated during interview on 02/05/2014 at 1645 that CAH staff gives patients the patient's right information during the registration process but it's not documented anywhere.






29708

Based on documentation in 17 of 30 medical records reviewed (Patient #s 1 through 6, 8, 11, 13, 14, 15, 19, 20, 22, 23, 24, and 30), and review of CAH policies, it was determined that the CAH failed to ensure that all entries in the medical records, including those on physician progress notes, blood transfusion records, admissions and consent forms, physician orders, pre-operative checklists, anesthesia records, ED records, discharge instructions, were dated, timed, or authenticated by the authors of the entries, and maintained in accordance with its own policies and procedures.

Findings include:

1. The medical record for Patient 1 reflected the patient was admitted to the CAH on 09/26/2013.
* Twelve sets of vital signs recorded on the blood transfusion record for two transfusions administered on 09/26/2013 did not reflect the specific times the vital signs were taken and recorded. The documentation reflected only "Before", "15 min", "30 min", "1 hr", "2 hr", "3 hr", and "After".
* Twelve sets of vital signs recorded on the blood transfusion record for two transfusions administered on 09/26/2013 did not clearly reflect authentication by the individual(s) who took and recorded the vital signs. The record also contained an entry that reflected "This unit was started in ER" but the form did not reflect any entries authenticated or timed by ER staff.

2. The medical record for Patient 2 reflected the patient was admitted to the CAH on 11/12/2013.
* Ten sets of handwritten physician orders recorded on "Physician Orders" forms did not reflect the date and time the orders were written by the physician.
* Five of ten sets of vital signs recorded on the blood transfusion record for two transfusions administered on 11/12/2013 did not reflect the specific times the vital signs were taken and recorded. The documentation for those vital signs reflected only "Before", "15 min", "30 min", "1 hr", "2 hr", "3 hr", and "After".
* Ten sets of vital signs recorded on the blood transfusion record for two transfusions administered on 11/12/2013 did not clearly reflect authentication by the individual(s) who took and recorded the vital signs.

3. The medical record for Patient 3 reflected the patient was admitted to the CAH on 11/27/2013.
* An entry on the physician progress notes dated 12/01/2013 was not timed.
* The time recorded for an order dated 11/27/2013 on the "Physicians Orders" was not legible.
* "Post Anesthesia Orders" initialed by the "Anesthesia Provider" were not dated and timed.
* "Diabetes Care Physician Order Set" orders dated 11/27/2013 were not timed.
* Fourteen sets of vital signs recorded on the blood transfusion record for two transfusions administered on 11/28/2013 did not reflect the specific times the vital signs were taken and recorded. The documentation reflected only "Before", "15 min", "30 min", "1 hr", "2 hr", "3 hr", and "After".
* Fourteen sets of vital signs recorded on the blood transfusion record for two transfusions administered on 11/28/2013 did not clearly reflect authentication by the individual(s) who took and recorded the vital signs.
* The signatures of two RNs who recorded entries on the "Pre-operation Check List" were not dated and timed.
* A "Preop Check List" electronically completed and dated on 11/26/2013 additionally contained numerous handwritten entries that were not dated, timed, or authenticated.
* An "Anesthesia Record" for a lower extremity amputation performed on 11/27/2013 contained the signatures of two anesthesia providers, however it was not clear which provider was responsible for all entries, including the illegible ones.
* The time the patient signed the "Consent for Anesthesia Services" on 11/27/2013 had been altered as the original entry had been written over.
* The "Conditions of Admissions" form dated 11/26/2013 lacked the time the patient signed the consent.

4. The medical record for Patient 5 reflected the patient was admitted to the CAH on 10/12/2013.
* Notes recorded on physician progress notes dated "10-12", "10-13", "10-15", and 10-16" did not include the year. Three of those entries additionally lacked the time of the note.
* The "Physicians Orders" contained orders dated "10-15" and "10-16". Both dates did not include the year and the order dated "10-15" did not include the time.
* "Post Anesthesia Orders" initialed by the "Anesthesia Provider" were not dated and timed.
* The "Immediate Post Operative Progress Note" was dated "10/12", did not include the year, and was not timed.
* The "Pre-Operative Check List" for a hip surgery performed on 10/12/2013 was not authenticated, dated and timed by the individual who completed it.
* A "Consent to Surgery, Recovery, Anesthesia, Medical Treatment or Other Procedure" lacked the date and time the patient signed the consent form.
* A "Consent to Surgery, Recovery, Anesthesia, Medical Treatment or Other Procedure" was dated by the physician on "10/12". The date lacked the year.

5. The medical record for Patient 6 reflected that the patient was admitted to the CAH on 09/15/2013.
* The "Pre-Operative Check List" for a endoscopy and colonoscopy performed on 09/06/2013 was not authenticated, dated, or timed by the individual who completed it.
* The time the anesthesia provider signed the "Consent for Anesthesia Services" dated 09/15/2013 was blank.

6. The medical records for Patient 13 reflected the patient was admitted to the CAH on 11/12/2013.
* The date and time the physician signed the Heparin Dosing Orders and Monitoring Protocol were altered as the original entries had been scribbled over.
* A Preliminary Echo Report was signed by the technologist with the first name only and was not dated or timed.
* An electronically generated Echocardiogram Report reflected the date of exam to be 07/03/2013. Five entries related to the clinical findings and severity of the findings had been altered and new entries added by hand. For example: ""Moderate" and "Mild" had been crossed out and "now severe" had been handwritten on the report. The author of those altered and added entries was not identified. Those entries had not been authenticated, dated or timed.

7. The medical records for Patient 15 reflected the patient was admitted for emergency services on 08/09/2013.
* Discharge instructions to the patient were not dated and not clearly timed.

8. The medical record for Patient 19 reflected the patient was admitted for emergency services on 09/05/2013.
* Discharge instructions to the patient were not signed, dated, or timed.

9. Similar findings were identified in records for Patient #s 4, 8, 11, 14, 20, 22, 23, 24, and 30.

10. The policy and procedures titled "Medical Record Guidelines for Physicians", dated as last revised "12/10", was reviewed. It required that "All entries must be authenticated by signing, dating and timing the entry...All progress notes shall be dated, timed and signed...Written orders must be signed, dated and timed when written...orders must be written clearly, legibly and completely...No entry in a patient records shall be removed from the record once placed there. All corrections shall be made by drawing a single line through the entry, but not obliterating any incorrect information, writing the correct entry, indicating the date and time of the correction, and the initials of the person making the change."

11. The policy and procedure titled "Surgical Checklist", dated as last revised "09/11", was reviewed. It required that a surgical checklist be completed prior to surgery and that "Patient Preparation and Chart Preparation sections are completed and a checkmark is placed by each item...The RN responsible for the patient is to sign, date and time the form."
















29708

Based on documentation in 2 of 2 medical records reviewed of patients (Patients 13 and 14) who expired at the CAH, review of policies and procedures, and contract review, it was determined that the CAH failed to ensure the OPO was notified timely of the patient's death in accordance with the CAH's policies and procedures. Additionally, the CAH's contract with the OPO was not dated when it was signed by the CAH to reflect when the contract was effective.

Findings included:

1. A "Contract For Pacific Northwest Transplant Bank Organ Procurement Services" was reviewed. The contract was between OHSU and Good Shepherd Medical Center (ENTITY). The contract reflected "...ENTITY shall refer all ventilated patients for which death is imminent to the donor referral line...ENTITY must make the referral in a timely manner...A timely referral is one that occurs as soon as the patient meets the mutually agreed clinical trigger/imminent death criteria and prior to the withdrawal or deceleration of life sustaining therapies, as set forth in more specific detail in ENTITY policy." The term of the contract reflected "This Contract shall be effective upon the date of the last signature..." The "OHSU Departmental Approval Signature & Date" line had a signature and was dated "2/8/2013". The contract additionally reflected a signature by a CAH representative. However, it was not dated when it was signed by the CAH representative to reflect when it was effective.

2. A policy titled "Organ and Tissue Donation (Required Request)", dated as last reviewed "12/12" reflected "1. Nurse will complete the 'donor line referral' worksheet and then call Donor Referral Line...when a patient reaches impending death or the clinical trigger for brain death or a plan is made to withdraw support...2. Any nurse can call the Donor Referral Line...within one hour of cardiac death to determine medical suitability for eye and tissue donation..."

3. Review of the medical record for Patient 13 reflected that the patient expired on 11/17/2013 at 0020. Documentation on a form titled "Donor Referral Line 800-344-8916" reflected "...Lion's Vision Gift Declines Donation 11/17/2013 [at] 0150". However, there was no documentation in the record that the OPO had been notified within one hour of the patient's expiration.

Review of the medical record for Patient 14 reflected that the patient expired on 01/14/2014 at 1945. The 2114 nurse progress notes reflected "Have contacted donor line and am waiting for a return call." However, there was no documentation in the record that the OPO had been notified within one hour of the patient's expiration.

4. During an interview conducted on 02/07/2014 at 1300 the VP of Nursing acknowledged the contract in finding 1. above was not dated when signed by the CAH representative.

5. During an interview with the VP of Nursing conducted on 02/07/2014 at 1415, he/she acknowledged that the medical records for Patients 13 and 14 lacked documentation of OPO notification in accordance with the CAH policy in finding 2. above.

29708

Based on interview, documentation in 27 of 30 medical records reviewed (Patient #s 1 through 6, 8, 9, 11, and 13 through 30), and review of CAH policies it was determined that the CAH policies and procedures and other documents, it was determined the CAH failed to develop and implement policies and procedures to ensure patients were fully informed of their visitation rights and that documentation of that was maintained. These rights included any clinical restriction or limitation imposed on patient visitation; and the right, to receive or deny visitors that the patient designates, including, but not limited to, a spouse, a domestic partner (including a same-sex partner), another family member, or a friend.

Findings included:

1. The medical records for Patient #s 1 through 6, 8, 9, 11, and 13 through 30 were reviewed and contained no documentation that patients had received patient rights information, including their rights related to visitation. Refer to findings under the deficiency cited at CFR 485.638(a), Tag C302, which reflects that medical records were not complete as they did not contain documentation of patient rights information provided to patients.

2. a. A policy and procedure titled "Patient's Bill of Rights [sic] Responsibilities", dated as last reviewed by the CAH on "7/11" was reviewed. Page 3 of the policy reflected "...The patient has the right to visit with his/her pastor or spiritual advisor." This was the only mention of visitors or visitation in the document.

b. A policy and procedure titled "Visiting Guidelines/Therapeutic Environment" dated as last reviewed by the CAH on "7/11" was reviewed. Although the policy and procedure stated that the CAH "...recognizes that visitation by family and friends can be an important therapeutic tool..." it did not include specific language about patient's rights for visitation, including the right, subject to his or her consent, to receive the visitors whom he or she designates, including, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend, and his or her right to withdraw or deny such consent at any time. Further, the policy and procedure did not specify how patients would be informed of their rights and how that would be documented.

c. A policy and procedure titled "Visitation in Unit A" dated as last reviewed by the CAH on "1/14" was reviewed. It indicated the purpose was to "Provide guidelines for visitation in the OB unit." However, it did not include specific language about patient's rights for visitation, including the right, subject to his or her consent, to receive the visitors whom he or she designates, including, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend, and his or her right to withdraw or deny such consent at any time. Further, the policy and procedure did not specify how patients would be informed of their rights and how that would be documented.


d. A brochure titled "Patient Rights and Responsibilities" dated "(09/06)" was reviewed and reflected "...The patient has the right to visit with his/her pastor or spiritual advisor." This was the only mention of visitors or visitation in the brochure.

e. The patient's rights and visitation policies and procedures and brochure reviewed above all failed to specify the following:
* Language which informed each patient (or support person, where appropriate) of his or her visitation rights, including any clinical restriction or limitation on such rights, in advance of furnishing patient care whenever possible
* Language which informed each patient (or support person, where appropriate) of the right, subject to his or her consent, to receive the visitors whom he or she designates, including, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend, and his or her right to withdraw or deny such consent at any time.
* Language which informed each patient that not only may the support person visit the patient, but he or she may also exercise a patient's visitation rights on behalf of the patient with respect to other visitors, when the patient is unable to do so. CAHs must accept a patient's designation, orally or in writing, of an individual as the patient's support person.
* The notice to patients must be in writing in a language or manner that the patient (or the patient's support person) can understand.

3. During an interview conducted on 02/06/2014 at 1430 the Quality/Patient Safety Manager indicated that the brochure identified in finding d. above was provided to patients to inform them of their rights, and acknowledged during the interview that the brochure did not include the information addressing the required visitation rights. He/she further acknowledged during the interview that the medical records had no documentation reflecting patients were informed of the required visitation rights.