NPSD Data Spotlight - Patient Safety and COVID-19: A Qualitative Analysis of Concerns During the Public Health Emergency

Patient Safety and

COVID-19:

A Qualitative Analysis

of Concerns During

the Public Health

Emergency

NPSD Data Spotlight

This document is in the public domain and may be used and reprinted without permission. Citation of the source is

appreciated. Suggested citation: NPSD Data Spotlight, Patient Safety and COVID-19: A Qualitative Analysis of

Concerns During the Public Health Emergency, 2021. Rockville, MD: Agency for Healthcare Research and Quality;

November 2021. AHRQ Pub. No. 22-0005.

Patient Safety and COVID-19

Patient Safety and COVID-19 Page | ii

A Qualitative Analysis of Concerns During the Public Health Emergency

PREPARED BY:

Health Services Advisory Group, Inc.

3133 E. Camelback Road, Suite 100

Phoenix, AZ, 85016

ActioNet, Inc.

3110 Lord Baltimore Drive, Suite 104

Baltimore, MD 21244

DEVELOPED FOR:

AHRQ contract HHSA290201700002C

Patient Safety and COVID-19 Page | iii

Table of Contents

Introduction ................................................................................................................................ 1

Results ....................................................................................................................................... 2

Descriptions of Events or Unsafe Conditions .......................................................................................................... 4

Device Events .................................................................................................................................................. 4

Pressure Injury ................................................................................................................................................. 5

Blood and Blood Product ................................................................................................................................. 5

Medication or Other Substance ....................................................................................................................... 5

Analysis of Structured Data Elements in COVID-19 Related Reports .................................................................... 5

Descriptions of Other Contributing Factors ............................................................................................................. 6

Conclusions ............................................................................................................................... 8

Appendix A. Methodology and Limitations .................................................................................10

Methodology .............................................................................................................................10

Methodological Limitations .................................................................................................................................... 11

Patient Safety and COVID-19 Page | 1

Introduction

The Severe Acute Respiratory Syndrome

Coronavirus 2 (SARS-CoV-2) public health

emergency (PHE) of 2020 has had dramatic

impacts on the healthcare industry worldwide.

The transmission of SARS-CoV-2 caused

widespread incidence of Coronavirus Disease

• The Agency for Healthcare Research and

Quality (AHRQ) Patient Safety Organization

(PSO) program has received nearly 5,500

records of patient safety concerns in which

the COVID-

19 public health emergency

(PHE) was included as part of the description

of the event or unsafe condition.

• Among a sample of records analyzed, the

most common description of the patient

safety concern, in 26.6% of records, was that

a patient had either

tested positive for

COVID-

19 or was a person under

investigation (PUI).

• Procedural issues with COVID-19 testing

represented 13.0% of records analyzed. The

results indicate a need to close the loop on

critical processes, such as testing, during a

PHE.

•

The exposure of patients and staff to

individuals with positive COVID-

19 test

results was identified in 18.2% of records

analyzed. Results indicate opportunities to

improve communication for patient transfers,

and to ensure proper isolation and personal

protective equipment (PPE) usage.

•

Patient safety concerns such as falls,

pressure injuries, and adverse medication

events were reported less often in relation to

COVID-19 than policy- and procedure-

related concerns.

•

Some descriptions point to interactions

between staff workloads, policies and

procedures, and treatment methods that

may have contributed to specific pressure

injury incidents.

2019 (CO

VID-19), with a wide range of

presentations. In some cases, individuals were

asymptomatic or presented with only mild

symptoms such as fever and cough. Other cases

resulted in severe illness or death. As COVID-19

spread throughout communities, the healthcare

industry experienced unanticipated changes in

demand for services that simultaneously

overwhelmed some providers and services in the

system, while reducing demand for others.

The

reorganization of services required to attend to the

immediate needs of the PHE pulled resources

away from traditional programs for quality

improvement and patient safety. Yet patient safety

concerns and the need for quality service delivery

have remained throughout the PHE. This brief

presents one perspective on the COVID-19 PHE

and its impact on patient safety concerns in

hospitals.

The Agency for Healthcare Research and Quality

(AHRQ) implements the Patient Safety

Organization (PSO) program for the Department

of Health and Human Services (HHS) as

mandated by the Patient Safety and Quality

Improvement Act of 2005 (PSQIA).

Some AHRQ-

listed PSOs voluntarily submit data stemming from

reports by providers to the Patient Safety

Organization Privacy Protection Center

(PSOPPC) using the Common Formats for Event

Reporting – Hospital (CFER-H) V1.2 and V2.0.

The data consist of a set of structured data

elements, and unstructured free text that describe

the nature of patient safety concerns and the

factors contributing to those concerns. The data

are not a representative sample of patient safety

concerns nationally.

As part of its response to the COVID-19 PHE,

AHRQ performed a pilot study of data collected through the PSO program to answer two questions:

First, could the CFER-H data be used for the timely analysis of reports on patient safety concerns.

Allen, S. 2021 global healthcare outlook. Deloitte Insights. 2021, Deloitte Development LLC.

Blumenthal D, Fowler EJ, Abrams M, Collins SR. Covid-19 – Implications for the Health Care System. N Engl J Med

2020; 383:1483-1488.

The HHS Office for Civil Rights enforces the confidentiality provisions of the PSQIA and its implementing regulation.

Highlights

Patient Safety and COVID-19 Page | 2

Second, to what extent can the unstructured free text collected through the CFER-H be leveraged to

generate meaningful understanding about patient safety concerns as they relate to the COVID-19 PHE.

The results are not intended to be a systematic analysis of how COVID-19 contributed to patient safety

concerns. Rather, the intent is to understand the capacity of the unstructured text to inform our

understanding of these patient safety concerns.

All results are aggregated and paraphrased to maintain the non-identification of data and anonymity of

the contributing providers and PSOs. The data used for this analysis include reports on patient safety

concerns with initial report dates between March 10, 2020 and October 18, 2020. The initial report date

represents the date a provider completed the Healthcare Event Reporting Form and entered the data

into the provider system. The results presented in this report, therefore, are indicative of events that

occurred during the first seven months of the COVID-19 PHE, and they are not a reflection of the current

state of affairs.

Results

Table 1 presents the summary results of analysis for the Description of the Event or Unsafe Condition

or the Description of Additional Details of Event or Unsafe Condition reported using the CFER-HV1.2

and V2.0 systems. Of the 320 records analyzed, 19 (5.9%) explicitly identified patients as having a

negative COVID-19 test result and are not considered further in this analysis. With respect to the

timeliness of reporting, the analysis identified that the average time between a provider entering the

report into their system and submission to the PSOPPC was 146.8 days, or just under five months, with

a standard deviation of 31.0 days.

The most commonly reported type of event was the identification of a patient with a positive test result

or a patient under investigation (PUI) for COVID-19 (n = 80; 26.6%). For these records, the description

of a positive test result or PUI status was the entirety of the unstructured text provided. No other patient

safety event was identified in the record (e.g., fall, pressure injury, medication event, etc.).

Given that no specific patient safety concern was identified in the free text for these reports, the

structured data was analyzed further. Nearly all of these reports were submitted under the event type

category of Healthcare-Associated Infection. The reports generally included demographic data about

the patient (typically patient age and sex), provided a location in the facility, and often included data on

contributing factors (typically categorized as Human Factors). The report date, or the date that the event

is reported into a system by a provider, indicated that all 80 records with this limited information were

reported between March 2020 and May 2020. During the initial outbreak of the COVID-19 PHE, when

little information was known about the nature of the virus and its mode of transmission, these records

may represent providers who reported COVID-19 positive cases as a patient safety concern out of an

abundance of caution. There is no evidence in these reports that any other type of patient safety concern

occurred.

The second most common type of patient safety concern identified in the data was related to a COVID-

19 test not being performed, ordered, or sent properly (n = 39; 13.0%). These descriptions of events

included:

• Improper screening or failure to ask screening questions

• Failure to collect swab

• Miscommunication between staff on testing procedures

• Lack of feedback from the lab on test results

The median number of days between a provider entering the report into their system and the submission of that report to

the PSOPPC was 147.5 days.

Patient Safety and COVID-19 Page | 3

• Patient failures to obtain proper COVID-19 test prior to arrival for procedure

Table 1. Summary Description of Patient Safety Concerns

Summary Description

Number of Records

Percentage of Records

Positive COVID-19 Test Result or PUI

26.6%

COVID-19 test not performed/ordered/sent

13.0%

Patient incorrectly transferred/discharged

9.6%

Staff or patient exposure

8.6%

Other

8.6%

Medication

5.6%

Fall

5.3%

Device

4.7%

Pressure injury

3.3%

Blood

3.3%

Proper PPE

3.0%

Against medical advice

2.0%

Altercation

1.7%

Perinatal

1.3%

Surgery

1.3%

Death

0.7%

Environmental services issue

0.7%

Delayed treatment

0.3%

Contraband

0.3%

Total

301

100.0%

There were 19 reports in the sample that explicitly identified the patient as receiving a negative COVID-19 test result. These reports have been excluded from

further analysis.

In eight of the 39 records (20.5%), the delay in COVID-19 testing was described as directly being linked

to delays in patient care. In several cases, specimens collected for testing were either lost in transit to

the lab, or the results were not communicated back to the submitting provider, requiring additional testing

be performed after significant delays. Additionally, nearly half of the records reviewed related to testing

(n = 16) noted a failure of the patient to obtain a test in advance of a procedure.

Potential patient and staff exposure to individuals testing positive for COVID-19, or PUI, presented

another large group of patient safety concerns identified in the records. Within this group, 29 records

(9.6%) were associated with the transfer or discharge of a patient such as:

• Patients transferred between units without masking or testing

• Patients transferred between units without notifying the receiving unit

• Failure to follow visitation restrictions (e.g., allowing multiple visitors for a single patient)

• Patient discharge without providing test results

Transfer-related concerns often involved the failure to notify the receiving unit that a patient was being

transferred. In some instances, receiving units did not have beds or staffing available to receive the

Patient Safety and COVID-19 Page | 4

patient, or the unit had been designated for treating patients that did not align with the transfer patient’s

COVID-19 status (e.g., positive or negative test results). In addition, there were another 26 records

(8.6%) in which individuals were exposed to patients or staff identified as testing positive for COVID-19.

In several instances, the exposure occurred because staff were not following PPE protocols, such as

removing exposed PPE before treating non-COVID-19 patients or wearing PPE when working with

patients who had positive test results. In other cases, the exposure occurred with an asymptomatic

individual, and was later identified when the individual tested positive.

Of the 301 records analyzed, another 26 (8.6%) identified a cluster of other patient safety concerns

associated with delays in care associated with the following:

• Lab staff being unable or unwilling to draw labs on patients who tested positive for COVID-19 or

were PUI

• Lost lab specimens and results

• Improper screening of patients on presentation

• Incomplete, incorrect, or missing documentation

Policies and procedures have changed rapidly throughout the COVID-19 PHE for front-line staff, and

the effective communication of those changes played a role in some instances where care delays

occurred. In other instances, the increased workloads experienced by hospital staff and laboratories

may have also contributed to miscommunications and errors in order entry, specimen handling, and

accurate documentation.

In total, approximately two-thirds of the records analyzed identified a patient safety concern due to a

patient testing positive for COVID-19, being PUI, or due to operational challenges associated with

delivering care in the PHE. After accounting for records identifying patients’ testing status for COVID-

19, nearly 40 percent were associated with policy- and procedure-related issues such as closing the

loop on the testing process to ensure timely results are obtained, improving communication and patient

transfer protocols, ensuring that staff understand and follow proper safety protocols, and completing all

documentation in a timely and accurate manner.

Descriptions of Events or Unsafe Conditions

The CFER-H technical specifications capture 10 types of patient safety concerns (e.g., falls, device,

medication). Prior to drawing the sample of 320 reports for in-depth review, the unstructured free text

data for all records submitted to the PSOPPC since the beginning of the COVID-19 PHE were searched

for a reference to COVID-19. This search yielded a sample of 5,498 reports. The vast majority of records

with descriptions that included references to COVID-19 fell into the Other event type, or Healthcare-

Associate Infections (n = 5,097; 92.7%). Of the remaining 401 records, most contained descriptions of

patient safety concerns that happened to patients who were positive for COVID-19, but they did not

include information or otherwise indicate that the disease caused, contributed to, or exacerbated the

patient safety concern. There were, however, several notable descriptions of events where the COVID-

19 PHE played some role in the patient safety concern described.

The results presented in this section of the report are based on analysis of the 301 reports that were

sampled for in-depth review.

Device Events

Among the device or medical/surgical device concerns (n = 14; 4.7%), the most commonly described

incident was a device failure or malfunction, often associated with a ventilator. Additionally, several

incidents were described where backup devices were unavailable due to use with other patients. In a

Patient Safety and COVID-19 Page | 5

smaller set of records, device events occurred because of user error in operating the device, or because

a device was used with the wrong patient.

Pressure Injury

Among the pressure injury events (n = 10; 3.3%), several records identified the development of pressure

injuries due to the interaction between patient pronation and poor patient mobility. Four records identified

the development of multiple pressure injuries to the lips, tongue, ears, and cheeks from patients placed

in a prone position. Reporters identified staff workload as a factor that prevented assisting patient

mobility. The remaining pressure injuries were identified across multiple other contact points such as

the coccyx, buttocks, and feet.

Blood and Blood Product

Among the blood and blood product concerns (n = 10; 3.3%), there were three incidents involving an

adverse reaction to a transfusion. Additional near misses occurred when the wrong blood product (e.g.,

fresh frozen plasma versus COVID-19 convalescent plasma) was either entered into the ordering system

incorrectly or delivered by the blood bank. Two additional concerns described situations where too few

units of blood were ordered and where blood product was wasted because the bag broke or the unit

was left out unattended overnight.

Medication or Other Substance

Of the 17 (5.6%) safety concerns involving medications or other substances, 14 were related to either

an incorrect dose (e.g., overdose, extra dose, or missed dose), or an incorrect medication provided to a

patient. In two instances, adverse reactions to medications used to treat COVID-19 were identified. In

one instance, the reporter indicated the lack of a medication used to treat COVID-19 as the patient safety

concern.

Analysis of Structured Data Elements in COVID-19 Related Reports

Among the 301 reports analyzed, the structured data elements were also reviewed to determine

whether they provided additional meaningful information. The results of the analysis indicate that the

structured data elements submitted by PSOs and their contracted providers are highly specific to the

PSO submitting the data. The PSO program relies on voluntary data submission. Thus, while analysis

of the structured data elements showed that a limited number of data elements are available for each

event type, these are not always submitted by all contributing PSOs.

PSOs generally provided data elements for the location in the facility where the event occurred and

contributing factors to the events reported. For incidents that involved a patient, the PSOs reported

patient age and sex for 26 (8.6%) records, with race and ethnicity not being reported for any records.

The extent of harm to the patient and expected duration of harm were also reported with moderate

consistency.

Within each event type module, there were also a limited number of structured data elements that

were reported consistently. These included the following data elements:

• Blood and blood product

Patient Safety and COVID-19 Page | 6

o Type of blood product

o Description of incorrect action

• Device

o Reuse of a single-use device

o Unique device identifier

• Fall

o Assisted or unassisted fall

o Type of injury as a result of fall

o Risk assessment prior to fall

o At risk of fall

• Healthcare-associated infection

o None

• Medication and other substance

o Incorrect action

o Stage the event originated

• Perinatal

o Type of perinatal event

o Patient affected by perinatal event

o Gestational age

• Pressure ulcer

o Most advanced stage of pressure ulcer

o Stage on admission

o Admission skin inspection documented

o Pressure ulcer prevention intervention in place

o Secondary patient morbidity

• Surgery or anesthesia

o Characteristics of surgical adverse outcome

o Incorrect action for surgical invasive procedure

Descriptions of Other Contributing Factors

The technical specifications for the CFER-H V1.2 and V2.0 data allow users to report Contributing

Factor(s) for an event, using structured data categories for environment, staff qualifications, supervision

and support, policies and procedures, data, communication, human factors, and other reasons. When

other reasons is selected as a contributing factor, the reporter may provide unstructured text to describe

what the contributing factor was. Analysis of 124 records for which “COVID-19” was referenced in the

Contributing Factors unstructured text, yielded the following as the most commonly referenced issues:

• COVID-19 related

• PPE related

• Knowledge deficit (coupled with COVID-19 related)

• Negative pressure room

• Isolation policy issue

• Chain of command related

Patient Safety and COVID-19 Page | 7

• Education or instruction deficit

• Handoff

• Shift change

• Refuse to provide Bilevel Positive Airway Pressure device (BPAP) on COVID-19 negative patient

• Positive COVID-19

• Exposure to associate who tested positive for COVID-19

• Patient unable to get COVID-19 testing

Most of the responses provided as unstructured text on contributing factors were short phrases like

those cited above. These descriptions contain less information than the Description of the Event or

Unsafe Condition, because of the brevity of the text. There were, however, a limited number of

responses that provided additional explanatory information. Some of these explanatory statements were

related to fall and pressure ulcer events, while others were provided with records form the other event

category. Table 2 presents text that paraphrases the data information submitted.

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Table 2. Paraphrased text describing other contributing factors for a limited number of records

Type of Event Descriptive Text About the Event Referencing COVID-19

Fall Event COVID-19 precautions cause a delay in care due to donning PPE.

Pressure Ulcer Event

Very busy environment due to COVID-19 crisis and less time and

attention paid to repositioning.

Pressure Ulcer Event

Patient is critically ill, intubated, COVID-19 positive, in multisystem organ

failure, NSTEMI

, requiring pressors, sedation; due to COVID-19

precautions and periods of hemodynamic instability, unable to provide

frequent repositioning.

Other Event

Too many things do. Train new staff, perform stat COVID-19 testing for

surgery/ED, process ED samples. Many areas for errors to occur

especially with increase in test volume.

Other Event

Due to COVID-19, Dr. canceled patient’s procedure and follow-up

appointment.

Other Event

High influx of pre-op/procedural COVID-19 testing and insufficient

manpower to complete in a timely manner.

Other Event

RPh

didn’t check pump because patient was PUI for COVID-19 to

reduce risk of transmission.

The descriptions presented in Table 2 are consistent with the findings obtained from analysis of the

Description of the Event or Unsafe Condition text. The results highlight how the COVID-19 PHE may

contribute to patient safety concerns by increasing both the volume of work to perform, and the speed

with which the policy and procedure environment is changing.

Conclusions

The results contained in this report provide insight into the ability of the CFER-H data to provide timely

information, and the capacity of the unstructured free text data to provide useful information. The results

also help inform some aspects of the healthcare industry’s preparedness for future PHEs.

The reports submitted to the PSOPPC related to COVID-19 took, on average, just under five months

between reporting and submission. While this time frame may be timely with respect to the consideration

of longer-term policy- and decision-making, it is not likely to be sufficient for rapid responses to emerging

issues such as a global pandemic. In contrast, the AHRQ Network of Patient Safety Databases analysis

of all PSO data submissions through December 31, 2019 identified that the median time between

provider reporting and submission to the PSOPPC was 1.6 years. In comparison, this result indicates

that those PSOs and providers who were reporting patient safety concerns related to COVID-19 were

doing so more than three times more rapidly than had previously been observed. This suggests that the

PSO community has the capacity and capability to increase the timeliness and velocity of reporting, in

at least some circumstances.

Non-ST-elevation myocardial infarction (a type of heart attack).

Registered Pharmacist

Patient Safety and COVID-19 Page | 9

The qualitative review of the unstructured free text also resulted in the identification of several

meaningful findings. Even among a small sample of 301 records, distinct patterns began to emerge that

speak to how the COVID-19 pandemic may have impacted some patient safety concerns and offer

insights into how the healthcare industry might improve processes for care delivery. The results obtained

from this small sample of reports suggests that a more robust analysis of the unstructured free text data,

using tools such as natural language processing and taking advantage of the more than 2.1 million

records currently held by the PSOPPC, could potentially yield valuable insights for improvement in

patient safety.

The most frequently described patient safety concern was the statement that a patient had tested

positive for COVID-19 or was PUI. During the early stages of the PHE, less was known about the modes

of transmission for COVID-19. In light of such uncertainty, the diagnosis of a patient as positive for the

disease presents concern for how best to prevent transmission to other patients and staff.

Many of the patient safety concerns reported where COVID-19 was identified in the description of the

event were policy- or procedure-related events, such as improper or lost specimens and test results,

poor communication related to patient transfers, and the inadvertent exposure of patients and staff to

individuals with a positive test result. These policy- and procedure-related events are more likely to occur

in a rapidly changing environment, and when staff are experiencing higher than normal workloads.

Drawing from these findings, the healthcare industry has an opportunity to identify critical processes

related to current and future PHEs and implement policies and procedures to reduce failures at each

step of the process.

Among this sample of reports, patient safety concerns that are typically not associated with the COVID-

19 PHE (e.g., falls, pressure injuries, perinatal events, venous thromboembolisms, surgery and

anesthesia events, etc.) were reported substantially less often than policy- and procedure-related

concerns. When these types of patient safety concerns were reported, they were often described as a

patient safety event that occurred to a patient with COVID-19, rather than as an event that was caused

or made worse by COVID-19. Some descriptions, however, point to interactions between staff workloads

and treatments involving patient pronation that may have contributed to specific pressure injuries by

limiting the ability of staff reposition patients in a timely manner.

The COVID-19 PHE required the healthcare industry to identify and implement rapid changes in the

delivery of care and to triage patients in order to leverage resources for those in greatest need. Drawing

on data submitted to the AHRQ PSO program about patient safety concerns where COVID-19 was

referenced in the description, this brief examines the nature of the relationship between the PHE and

the types of concerns being reported. The findings point to a need for the industry to develop better

preparedness for identifying and implementing PHE-specific adaptations in a complex system, such as

maintaining the accuracy and completeness of critical care processes (e.g., screening and testing),

developing communication systems to effectively disseminate and implement changes across all levels

of staff, and identifying areas in which the PHE may interact with changes in the system to negatively

impact patient care.

Patient Safety and COVID-19 Page | 10

Appendix A. Methodology and Limitations

Methodology

The data for this analysis was acquired through the AHRQ PSO program, and the patient safety work

product (PSWP) voluntarily submitted by PSOs to the PSO Privacy Protection Center (PSOPPC). The

PSWP is submitted using the AHRQ Common Formats for Event Reporting – Hospital (CFER-H) V1.2

and V2.0 technical specifications for patient safety concerns, and it covers events with initial report dates

from March 10, 2020 through October 18, 2020. The initial report date represents the date a provider

completed the Healthcare Event Reporting Form and entered the data into the provider system. The

patient safety concerns submitted to the PSOPPC for analysis include data elements containing

descriptions of the event in the reporter’s own words: the Description of the Event or Unsafe Condition

(data element 15) and Description of Additional Details of Event or Unsafe Condition (data element 87

in CFER-H V1.2 only). Additionally, when asked to indicate the factors contributing to the event or unsafe

condition, the Contributing Factor(s) for Event (data element 105) may be reported as “Other

Contributing Factor”, and unstructured text may be submitted to elaborate on the nature of the

contributing factor. These unstructured text data elements comprise the data used for this analysis.

The unstructured text in the Description of the Event or Unsafe Condition, Description of Additional

Details of Event or Unsafe Condition, and Contributing Factor(s) for Event were analyzed during a pilot

study in September 2020 to identify records where the word “covid” was used, including “covid”,

“covid19”, “covid-19”, and “covid- 19”. During the pilot study, 3,558 records were identified, and 100

were randomly sampled for qualitative content analysis to identify the nature of the patient safety event

that occurred. In November 2020, the pilot study was expanded to identify records that included the

terms “covid”, “ncov”, “cov2”, “sars”, “pneumonia”, or “severe acute respiratory”.

The expanded review

identified a total of 5,498 patient safety concerns reported between March and October 2020. From

these records, an additional 220 records were randomly sampled, stratified by the Category(s)

associated with the Event or Unsafe Condition (data element 21). The combined data from these two

samples were used to obtain the results displayed in Table 1. From the expanded review of patient

safety concerns in November 2020, the results in Table 2 were obtained from a sample of 124 records

out of the 318 (5.7% of 5,498) for which the Contributing Factor(s) for Event included free text associated

with the “Other Contributing Factor” response. Table 3 presents the number of records classified as

belonging to each event or unsafe condition category identified in the database as well as the number

sampled for analysis.

The term “pneumonia” yielded a substantial number of records that were unrelated to COVID-19. Additionally, the term

“severe acute respiratory” was used in one record that was unrelated to COVID-19. Because of these issues, records

identified using only these terms were removed from the sample; however, records which also included the terms “covid”,

“ncov”, “cov2” and “sars” were retained for analysis.

Patient Safety and COVID-19 Page | 11

Table 3. Number of Records by the Category(s) Associated with the Event or Unsafe Condition

Category of Event or Unsafe Condition

Number of Records

Identified

Number of Records

Sampled

Blood or blood product

Device of medical/surgical supply

Fall

Healthcare-associated infection

1,775

Medication or other substance

Perinatal

Pressure ulcer

Surgery or anesthesia

Venous thromboembolism

Other

3,322

132

Total

5,498

320

Methodological Limitations

The sampling was completed in two stages for this analysis, using different criteria for inclusion at each

stage. While the data sampled reflect the diversity of descriptions for patient safety concerns, the data

may not be representative of all patient safety concerns submitted to the PSOPPC. Furthermore,

because of the voluntary nature of data submission by PSOs and their providers, the database held by

the PSOPPC is not representative of the population of patient safety concerns in the United States.

Rather, the data presented here represent a cross-section of patient safety concerns submitted by a

subset of PSOs and providers. Data obtained from other sources, other PSOs, or other providers are

likely to yield different results. It is unknown to what extent the results of this analysis generalize to the

broader population. Furthermore, the records analyzed for the description of the patient safety concern,

and the records analyzed for contributing factors are not the same records. This analysis cannot,

therefore, connect the two sets of results together to draw broader conclusions about the relationships

between these data elements. Finally, because the data must be non-identified prior to presenting the

results, the analysis requires paraphrasing text and aggregation of results which prevents direct

presentation of the text submitted by PSOs and their providers.

Publication No. 22-0050

November 2021