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Based on observation and interviews, the facility failed to ensure supplies used in treating emergency cases were readily available and not beyond their expiration date.

This failure created the potential for supplies and equipment to lose both sterility and effectiveness leading to avoidable infection or the inability to emergently treat patients timely and efficiently.

FINDINGS

POLICY

According to Emergency Medications Policy, the hospital maintains supplies of emergency equipment and medications located in crash carts and portable emergency medication boxes in patient care areas of the hospital. The Pharmacy and Therapeutics Committee determines which medications will be stocked in these carts and portable boxes in unit dose, age-specific and ready -to-administer forms, whenever possible per hospital policy. The Pharmacy Department is responsible for the overall integrity and security of medications contained in the crash carts and portable boxes.

According to Floor Stock Policy, responsibility for control of floor stock medications within the facility rests with the Pharmacy Department. Medications contained in floor stock are stored under the conditions listed by the medication manufacturer to ensure stability.

1. The facility failed to ensure medications and supplies readily available for use in emergency situations were safe and not expired.

a) On 08/15/16 at 2:40 p.m., a tour of the Emergency Department (ED), including Treatment and Trauma rooms, was conducted with the Chief Nursing Officer (CNO).

Several emergency supplies and medications were past the expiration date. As example:

1 Bard 16 Fr Foley Catheter (09/15) Trauma Room Adult Code Cart (TRACC)
3 Kendall Monoject Magellan Safety needles (12/15 and 04/16) TRACC
1 Nutrake Bivona Emergency Cricothyrotomy device (05/07) TRACC
2 BD Insyte Autoguard 18 gauge 1.16 inches (06/16) Trauma Room Pediatric Code Cart (TRPCC)
1 BD Insyte Autoguard 24 gauge x 0.75 inches (07/15) TRPCC
1 Mallinckrodt intubating sty let (07/16) in inpatient code cart
3 prefilled normal saline (NS) 10 cc syringes (07/16) Treatment Room adult code cart
2 1 liter bags of NS (03/16) adult code cart in Treatment Room #1 adult Treatment Room adult code cart
3 1 liter bottles of Baxter NS Irrigation Solution (02/15) ante room
2 Adenosine injection 3 milligrams/milliliter prefilled syringes (05/16) TRPCC
3 prefilled NS 10 cc syringes (07/16) TRACC

Trauma Room's Broselow Emergency Pack System, (Pediatric Trauma System-supplies, information and equipment used in pediatric emergency resuscitation)

Yellow Section

1 Oxygen delivery system (01/16 and 06/16)
1 Size 4 Endotrachael Tube (08/08)
1 Silicone Salem Sump catheter (03/11)
1 10 Fr. Foley Catheter (08/15)
1 Endotrachael guide (12/00)

Red System

1 intravenous (IV) delivery module (05/14)
1 Oxygen delivery system (06/16)
1 8 Fr. Salem Sump tube (03/15)
Intubation module (11/15)

Purple System

1 8 Fr. Salem Sump tube (03/15)
1 Intubation Module (01/16)
1 Oxygen delivery module (06/16)
1 IV delivery module (07/14)
1 10 Fr. Foley catheter

White System

1 Intubation module (01/16)
1 IV delivery module (05/14)
1 Oxygen delivery module (06/16)
1 10 Fr. Foley catheter (08/15)
1 12 Fr. Silicone Salem Sump tube (03/14)

Blue System

1 Oxygen delivery module (06/16)
1 IV delivery module (05/14)
1 Intubation module (01/16)
1 12 Fr. Silicone Salem Sump tube (03/14)

Green System

1 IV delivery module (05/14)
1 Intubation module (01/16)
1 12 Fr. Foley Catheter (06/14)
1 Silicone Salem Sump tube (07/13)

Orange System

1 IV delivery module (07/14)
1 Intubation module (01/16)
1 Foley Catheter (06/14)
1 Silicone Salem Sump tube (06/13)
1 Intubation Module (01/16)

b) On 08/15/16 at 3:42 p.m., an interview was conducted with CNO #1 who stated it was the expectation of RN's to verify medications and supplies were not outdated prior to use. CNO #1 was unable to ensure the expired medications and supplies would not be used during emergency situations.

c) On 08/15/16 at 3:53 p.m., an interview was conducted with Registered Nurse #8 (RN) who stated it was important to check expiration dates on supplies in the Pediatric Trauma System prior to them being used. S/he further stated it was difficult to verify the integrity of items once they had expired.

d) On 08/16/16 at 8:00 a.m., an interview was conducted with Pharmacist #6 who stated any expired medications should have been removed from stock.

Based on the onsite recertification completed on September 6 and 7, 2016, the facility failed to comply with the regulations set forth for Life Safety and, therefore were cited under Life Safety Code tags K29, K52, K56, K62, K69, K70, K72, K144, and K147,. See Survey ID# RNY721 For full details of the cited deficiencies.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §485.635, PROVISION OF SERVICES, was out of compliance.

C-0276-Standard-Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. The facility failed to maintain accurate medication record keeping which showed disposition of controlled medications. Additionally, the facility failed to ensure outdated medications were removed from stock according to manufacturer's expiration. This failure created the potential for medications to be unavailable for patient use. Additionally, this failure created the potential for patients to receive compromised or expired medications.

C-0278-Standard-A system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel. The facility failed to ensure reusable patient care equipment was cleaned and reprocessed correctly before use on another patient. Specifically, radiology staff were not appropriately trained in the process of high level disinfection of vaginal ultrasound probes and failed to follow the manufacturer's instructions in the use of disinfection supplies. This failure created the potential for the transmission of infections and communicable diseases amongst patients who received diagnostic tests for medical conditions.

C-0292-Standard-The person principally responsible for the operation of the CAH under§485.627(b)(2) of this chapter is also responsible for the following:
Ensuring that a contractor of services (including one for shared services and joint ventures) furnishes services that enable the CAH to comply with all applicable conditions of participation and standards for the contracted services. The facility failed to ensure services provided through a contractor complied with the conditions of participation. Specifically, the chief executive officer did not assess services provided by the contracted pharmacist and did not provide essential oversight to ensure pharmacy department records were accurately maintained. This failure resulted in pharmacy services' vulnerability to the diversion of medications within the facility.

Based on observation, interviews and document review, the facility failed to maintain accurate medication record keeping which showed disposition of controlled medications. Additionally, the facility failed to ensure outdated medications were removed from stock according to manufacturer's expiration.

This failure created the potential for medications to be unavailable for patient use. Additionally, this failure created the potential for patients to receive compromised or expired medications.

FINDINGS

POLICY

According to Floor Stock, responsibility for control of floor stock medications within the facility rests with the Pharmacy Department. Medications contained in floor stock are stored under the conditions listed by the medication manufacturer to ensure stability.

According to Labeling Standards, all drug containers shall be labeled and drug labels must be clear, consistent, legible and in compliance in state and federal requirements.

According to Drug Procurement/Inventory Control, medications are stored under proper conditions as stated by the medication manufacturer to assure stability of that medication. All drug areas within the facility will be inspected monthly by the Pharmacy Department. Reports of discrepancies will be shared with the supervising professional of the unit involved. Expired, damaged and/or contaminated medications will be removed from drug storage areas within the facility during the Pharmacy inspection and will be returned to the Pharmacy Department for proper disposal.

According to IV Solutions Stored in the Fluid Warmer, all intravenous (IV) solutions shall be dated with an indelible marker on the exterior wrap when placed in the warmer.

According to Controlled Drug Distribution, a transaction record for all controlled substances in schedules II, III and IV (C-II, C-III, C-IV) will be maintained by the hospital. All C-II, C-III, and C-IV drugs are dispensed as floor stock. All controlled drug records will be maintained for the period required by law and be readily retrievable. A perpetual inventory record of all C-II drugs stored in the main Pharmacy will be maintained.

According to Controlled Drug Management on Patient Care, controlled substance drugs will be taken from the narcotic cabinet in the Pharmacy Department by the Pharmacist and the Pharmacist will note in the Controlled Substance (Class II) Disposition Logbook; the date, patient care unit, number of units dispensed; indicate the balance of drug remaining; check to see that the inventory is correct and initial the entry.

Pharmacy will check the Controlled Substance Disposition Records on a routine basis.

According to Authorized Access to the Pharmacy, the person who removes a medication from the pharmacy shall make a record of the removal. This record shall contain:

Time and date of removal or verification
Location and name of the patient and medical record number
Drug name, strength and dosage form
Quantity taken (amount removed)
Signature of person making the removal

1. The facility failed to ensure current and accurate records were kept of the receipt and disposition of all scheduled drugs.

a) A review of the pharmacy's checklist used to monitor the medications distributed to staff for patient use (Drug Room Checklist), from 02/02/16 through 08/16/16, revealed 29 of 560 medications were issued to staff with no documentation of signature or initials indicating who the medications were distributed to.

b) A review of the pharmacy's inventory tracking list of (Tracking List)Class II and Class III medications (controlled substances used for sedation and management of pain and anxiety) revealed several entries missing dates and initials indicating which staff were responsible for the removal and receipt medications from the pharmacy. For example:

Oxycodone IR 5 mg, 28/31 entries without documentation of complete date, 31/31 entries without issued by initials and last dates inventoried 07/20 (year not documented).

In addition, out of the 3604 medications being tracked from the Tracking List, 3103 did not have a documented inventory conducted within the last 6 months in accordance with facility expectations, 1711 had no evidence of being initialed upon removal, 60 were outdated, and 88 were missing the date of removal. This resulted in the facility being unaware of the current inventory of medications available for patient use and not being aware of who was handling the medications in the facility.

c) On 08/17/16 at 9:30 a.m., an interview was conducted with RN #10 who stated medication inventory was completed on a biannual basis, the last one performed in 2015. RN #10 stated when staff retrieved medications from the pharmacy, they were expected to document their signature on the log. S/he further stated anesthesiologists had access to the pharmacy and don't usually sign (initial) the medication log.

d) On 08/18/16 at 10:30 a.m., an interview was conducted with the Chief Nursing Officer (CNO #1) who stated it was the facility's expectation for the pharmacy to maintain current and accurate medication logs. CNO #1 stated it was his/her expectation that anyone removing medications from the pharmacy after hours would sign and initial the log for tracking purposes.

e) On 08/17/16 at 7:10 a.m., an interview was conducted with Pharmacist #6 who stated s/he expected staff to have signed medications out in the log book upon removal from the pharmacy.

On 08/18/16 at 11:19 a.m., an additional interview was conducted with Pharmacist #6 who stated s/he was unaware as to when the last inventory of schedule III and IV medications had occurred. Pharmacist #6 stated s/he didn't sign her/his name on the Tracking List when removing medications because Pharmacist #6 was familiar with his/her handwriting if s/he ever had to review the document .

On 08/18/16 at 12:26 p.m., a third interview was conducted with Pharmacist #6 who stated s/he hadn't kept a running inventory of III, IV and V scheduled medications since the facility moved to a different location in July of 2015. Pharmacist #6 then stated the last time s/he physically counted all of the medications in pharmacy was in May of 2015.

f) On 08/18/16 at 11:00 a.m., an interview was conducted with the Chief Executive Officer (CEO #7) who stated it was the expectation for the pharmacist to maintain current medication inventory logs.

2. The facility failed to ensure outdated medications were removed from the Pharmacy and not available for patient use.

a) On 08/16/16 at 8:00 a.m., a tour of the Pharmacy with Pharmacist #6 revealed several medications were past the expiration date. As example:

60 Dexamethasone tablets 5 mg expired on 07/2016
15 Cefdinir 300 mg capsules expired on 03/16
1 bottle Vitamin B Supplement Natures Blend expired on 05/16
1 bottle Vitamin B 12 1000 mg tablets expired on 06/15
17 Ampicillin 250 mg vials expired on 07/13

During the same tour, Pharmacist #6 stated expired medications should have been removed from stock.

On 08/17/16 at 9:15 a.m., a second tour of the Pharmacy with Pharmacist #6 and Registered Nurse (RN) #10 revealed a bag containing 10 filled syringes (1 ml) of Roxanol 20 milligrams/milliliter labeled without date or time the medication was drawn into the syringes. Pharmacist #6 stated the bag of Roxanol syringes had been made for a previous patient and the syringes should have been timed, dated and disposed of per policy.

b)On 08/17/16 at 1:32 p.m., and interview with the CNO #1 was conducted who stated the facility's practice was to not use pre-filled syringes CNO #1 then stated medication were expected to be kept in the original vial until needed and that it would be concerning to find Roxinal or any other type of controlled substance pre-drawn in the facility.

c) On 08/18/16 at 11:00 a.m., an interview was conducted with CEO #7 who stated s/he was mortified that Pharmacist #6 had not been keeping the records s/he was supposed to; the facility trusted Pharmacist #6 was doing what was expected.

3. The facility failed to ensure intravenous fluids (IVF) were dated when placed in the fluid warmer to ensure they were safe for patient use.

a) On 08/15/16 at 4:26 p.m., a tour of the Imaging Department with Radiology Technologist #9 revealed 4 Normal Saline (NS) IV bags (100 ml) which lacked a date indicating when they were placed into the fluid warmer.

b) During the same tour, CNO #1 stated fluids that were placed in the fluid warmer should have been dated and removed after 14 days.

Based on observations, interviews and record review, the facility failed to ensure reusable patient care equipment was cleaned and reprocessed correctly before use on another patient. Specifically, radiology staff were not appropriately trained in the process of high level disinfection of vaginal ultrasound probes and failed to follow the manufacturer's instructions in the use of disinfection supplies.

This failure created the potential for the transmission of infections and communicable diseases amongst patients who received diagnostic tests for medical conditions.

FINDINGS

POLICY

According to the Infection Control Scope of Service, nosocomial infections are potential hazards for all persons having contact with the facility. A system of surveillance of infections will be adopted and maintained to prevent, identify, and control such infections.

The Infection Control Department (ICD) follows facility policies, procedures and guidelines. The department recognizes and adheres to the Centers for Disease Control (CDC) Hospital Infections Program.

REFERENCES

The CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 states items which come into contact with mucous membranes or nonintact skin should be free from all microorganisms (p. 10). Because condoms/probe covers can fail, the vaginal probe should be high-level disinfected between each patient (p. 19).

According to PCI Medical, GUS Model G 10VPL Wall-Mounted Vapor Control System for Transvaginal and Transrectal Ultrasound Probes Instruction Manual, the cleaning process consist of:
-removing sheath or condom from probe, wipe off gel and wash probe with enzymatic cleaner prior to disinfection
-soak probes in disinfectant solution for 8-20 minutes
-rinse disinfectant off probe in the rinse container and wipe dry with paper towel
-final rinse occurs at a sink under running water
-remove rinse water from container, wash both the container and cap using mild detergent solution or cloth
-once dry, replace rinse water in container

According to Cidex Activated Dialdehyde Solution Reusable Sterilizing and Disinfecting Solution directions for use, Cidex solution is used as a High Level Disinfectant for up to a maximum of 14 days at 25 degrees Celsius with an immersion time of at least 45 minutes.

Cidex Solution Test Strips are chemical indicators for use in determining whether the concentration of the active ingredient gluteraldehyde is above or below the minimum effective concentration (MEC) established for Cidex Activated Dialdehyde Solution. It is recommended that activated solution be tested daily before each usage to guard against dilution which may lower the gluteraldehyde level of the solution.

Further, Cidex Solution Test Strips should be stored in their original container with the cap tightly closed. When opening the bottle for the first time, record the date opened in the space provided on the label. Do not use test strips 90 days after opening the bottle. Improper storage of test strips may result in false readings.

1. The facility failed to ensure supplies for the process of High Level Disinfection (HLD) were stored according to the manufacturer's instructions. In addition, the facility failed to adhere to the manufacturer's directions for use of HLD solutions.

a) On 08/15/16 at 4:34 p.m. a tour of the radiology department was conducted. In the ultrasound examination room an opened bottle of Cidex Solution Test Strips was observed. There was no date written on the bottle label to show when the bottle had been opened. The manufacturer expiration date stamped on the bottom of the bottle was 05/2015.

During the same tour, review of the Ultrasound Cidex Probe Cleaner PH Test log revealed the Cidex Activated Dialdehyde Solution was changed on 11/02/15 and again on 03/03/16, 05/12/16, and 08/12/16, intervals of 3-4 months which was in contrast to the 14 day interval stated in the directions for use.

b) An interview was conducted with ultrasound technician #3 (UT #3) on 08/15/16 at 4:34 p.m. UT #3 confirmed the test strips were expired and stated s/he had not been instructed to date the Cidex Solution Test Strips bottle upon opening and had not read the manufacturer's instructions attached to the side of the bottle. UT #3 additionally stated the Cidex Solution was changed every 30 days.

c) On 08/16/16 at 4:25 p.m., an interview was conducted with UT #4. UT #4 stated the dates on the Ultrasound Cidex Probe Cleaner PH Test log represented the dates of the minimum effective concentration (MEC) testing and the dates the solution was changed. UT #4 stated the Cidex Activated Dialdehyde Solution was changed every 3 months or when the MEC test fails.

d) The Director of Radiology (Director #5) was present during the same interview on 08/16/16. Director #5 confirmed the Cidex Solution Test Strips were beyond the expiration dates for use and stated the discovery of containers of the Cidex Activated Dialdehyde Solution had expired and been discarded during the survey.

Director #5 stated the GUS Wall-Mounted Vapor Control System for Transvaginal and Transrectal Ultrasound Probes had just been placed into use 2 months ago by the facility and no training had been provided. Director #5 further stated no policy existed for the reprocessing of vaginal ultrasound probes.

Based on interviews and record review the facility failed to ensure services provided through a contractor complied with the Conditions of Participation. Specifically, the chief executive officer did not assess services provided by the contracted pharmacist and did not provide essential oversight to ensure pharmacy department records were accurately maintained.

This failure resulted in pharmacy services' vulnerability to the diversion of medications within the facility.

FINDINGS

REFERENCE

According to the Bylaws the Board of Directors (Board) shall select and employ a Chief Executive Officer (CEO) with the necessary authority to manage the facility in all its activities and shall act as the agent of the Board. The authority and duties of the CEO shall include the responsibility for assuring the facility conforms to the requirements of authorized planning, regulatory, and inspecting agencies. The CEO is further responsible for overseeing facility compliance with the laws and regulations of federal, state and local governmental agencies and with the standards, rules and regulations of the various accrediting and approval agencies.

1. The CEO failed to ensure contracted pharmacy services provided services in a manner which complied with applicable federal and state regulations.

a) On 08/18/16 a survey of all services rendered by the facility were reviewed. Documentation within the pharmacy department revealed expired medications available for patient use and a lack of accurate accountability of all scheduled medications within the facility for greater than a year.

b) An interview was conducted with the Pharmacist (Pharmacist #6) on 08/17/16 at 7:20 a.m. Pharmacist #6 stated staff in the facility who had access to the pharmacy when s/he was not present included the Chief Nursing Officer (CNO #1) and all nurses. Pharmacist #6 stated there was no set process to investigate the diversion of medications since it had never happened and if it were to occur the facility would figure out how to investigate the diversion at that time.

Pharmacist #6 further stated the Pharmacy and Therapeutics Committee met quarterly and was required to report to another committee but s/he did not know which committee since s/he was not required to attend.

During additional interviews with Pharmacist #6 on 08/18/16 by phone at 11:18 a.m. and in person at 12:26 p.m., s/he stated tracking of all scheduled medications had not occurred and the last time a full inventory of scheduled medications was completed was in May, 2015. Pharmacist #6 stated s/he could not be sure if a diversion had occurred.

c) On 08/17/16 at 1:32 p.m. an interview was conducted with CNO #1. CNO #1 confirmed pharmacy services was within the responsibility of the CNO at the executive level. CNO #1 additionally confirmed all staff nurses had access to the pharmacy when the pharmacist was not present. According to CNO #1 there was a limitation to access certain scheduled medications and anyone who removed medications from the pharmacy when the pharmacist was not present should have signed and initialed the log book kept in the pharmacy.

CNO #1 confirmed no other staff member audited the medications maintained in the facility except Pharmacist #6 and there was no written process for investigating the diversion of medications within the facility. CNO #1 stated the facility was responsible to ensure the services provided by the contracted pharmacist were completed as required by agreement.

d) An interview was conducted on 08/18/16 at 11:00 a.m. with CEO #7. CEO #7 stated s/he reviewed the pharmacy services contract annually through input from the medical staff and presented the contract to the Board for renewal. CEO #7 stated "I'm mortified" the pharmacist had not been maintaining accurate records of the medications in the facility as required by agreement. CEO #7 then stated s/he had trusted the pharmacist was performing duties as expected.

Based on interviews and record review the facility failed to maintain complete medical records for patients who received care. Specifically, there was incomplete or missing documentation in 3 out of 20 medical records reviewed (Patient #5, #10, and #13).

This failure resulted in incomplete patient medical information available to care staff and missing documentation to show transfer of care was agreed to by the patient.

FINDINGS

POLICY

According to Patient Transfer to Another Facility-Interfacility, the requirements of the interfacility transfer mechanism include an interfacility transfer report and discharge summary.

REFERENCE

According to Medical Staff Rules and Regulations, the attending physician shall be held responsible for the preparation of a complete medical record for each patient. Medical records shall be completed within thirty (30) days of patient discharge from the hospital. No medical record shall be filed until it is complete.

The medical record must contain information to justify the care provided from admission to discharge including, but not limited to: signed and dated progress notes, informed consents, and a discharge summary-which shall contain the discharge diagnoses and instructions.

All notes written in patient charts by non-physician health care providers must be countersigned by the responsible medical staff member.

1. The facility failed to ensure patient medical records were accurate and complete in content.

a) A review of 20 medical records revealed 3 patient records lacked required documentation and signatures from physicians as required by Medical Staff Rules and Regulations.

A review of Patient #13's medical record was completed on 08/18/16. Patient #13 entered the Emergency Department (ED) on 06/16/16 with chest pain and was kept for observation. Four hours and 20 minutes later the patient was transferred to an outside facility. Further review of the medical record revealed a lack of physician documentation on the Patient Transfer Form to show which outside facility the patient was transferred to, the mode and support treatment required during transport, or how any required accompanying documentation was sent to the outside facility. Additionally, there was no documentation by the physician to show the course of treatment provided to the patient. The medical record remained incomplete 62 days after discharge from the facility.

Patient #10's medical record was reviewed on 08/17/16, 75 days after discharge. Patient #10 was 16 years old and was seen in the ED on 06/02/16 for convulsions and tremors. There was no Patient Transfer Form to the show the patient or alternate decision maker had given consent for the transfer to an outside facility

The medical record of Patient #5, reviewed on 08/17/16, revealed the patient was hospitalized from 05/09/16 to 05/10/16 with a diagnosis of pancreatitis (inflammation of the pancreas organ involved in digestive functioning) which required intravenous narcotic pain management. There was no discharge summary within the medical record to show the course of care provided or instructions for the patient upon discharge from the hospital and the medical record remained incomplete 98 days after the patient was discharged.

b) On 08/17/16 at 3:12 p.m. an interview was conducted with Health Information Manager (HIM #2). HIM #2 stated there was no discharge summary available for Patient #5, #10, or #13 as required by policy. HIM #2 further stated s/he had notified the physician responsible for each medical record and the medical records department was expected to send reminders to physicians until the record was complete.

c) CNO #1 was also present during the interview on 08/17/16 at 3:12 p.m. CNO #1 stated the physician requirements for medical records were detailed in the Medical Staff Bylaws and there was no other policy regarding the requirements.