Annual Proficiency Testing (PT) Enrollment Is Essential

By Sara Desmond, MLS (ASCP), ACHC Program Director, Clinical Laboratories

Proficiency testing requirements exist to ensure that laboratory tests performed by all laboratories achieve an acceptable level of accuracy and consistency. At this time of the year, all laboratories should be enrolling with an approved Proficiency Testing provider to evaluate testing done in their facilities.

On the surface, this is a rather easy regulation to meet. However, over the course of the past year, Accreditation Commission for Health Care (ACHC) has observed an increase the numbers of citations for this condition level requirement as laboratories have failed to enroll in the required PT programs.

Annual enrollment is addressed in Standard 04.00.00.

STANDARD 04.00.00

Enrollment and testing of samples                                         §493.801

Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in Subpart I and is approved by CMS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients’ specimens.

Note: This is a condition level requirement of the Clinical Laboratory Improvement Amendments (CLIA).

Each laboratory must determine the extent of patient testing it performs. The laboratory should review its test menu and determine which specialties, subspecialties, and analytes the laboratory must enroll in to meet this requirement. This is a good time to take inventory of all the tests and methods used within the laboratory.

Enrollment must be in a CMS-approved PT program that offers modules containing at least three testing events annually (excluding mycobacteriology, which requires only two testing events annually) with a minimum of five samples per event. A list of approved proficiency testing providers can be found at http://www.cms.gov/clia.

Proficiency testing enrollment and participation is required for each CLIA certificate other than a Certificate of Waiver. A facility offering testing at more than one site, with testing included under a single certificate, must enroll in an approved PT program(s) for the collective tests covered under that certificate, not for each site. PT is not required for waived tests, although the laboratory is highly encouraged to enroll in PT for waived tests.

Regulated Analytes − Non-Waived Testing for Which PT Is Required 

There are special requirements for enrollment in Cytology Proficiency Testing that are addressed in Standards 09.05.00 and 09.05.01. The laboratory must ensure that all individuals reading gynecological cytology slides participate in a CMS-approved cytology PT program. This includes pathologists, cytologists, and any other individuals qualified to perform gynecological cytology testing.

STANDARD 09.05.00

Cytology Proficiency Testing (PT)                               §493.853, §493.855

The specialty of pathology includes, for purposes of proficiency testing, the subspecialty of cytology limited to gynecologic examinations.

To participate successfully in a cytology proficiency testing program for gynecologic examinations (Pap smears), the laboratory must meet the requirements of this section.

Note: This is a CLIA condition level requirement.

STANDARD 09.05.01

Individual Testing for Cytology PT                                             §493.855(a)

The laboratory must ensure that each individual engaged in the examination of gynecologic preparations is enrolled in a proficiency testing program approved by CMS by January 1, 1995, if available in the State in which he or she is employed.

The laboratory must ensure that each individual is tested at least once per year and obtains a passing score.

To ensure this annual testing of individuals, an announced or unannounced testing event will be conducted on-site in each laboratory at least once each year. Laboratories will be notified of the time of each announced on-site testing event at least 30 days prior to each event. Additional testing events will be conducted as necessary in each State or region for the purpose of testing individuals who miss the on-site testing event and for retesting individuals.

Additional information related to Cytology PT can be found at: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CytologyProficiencyTesting.

Updates from the CDC

Updated Blood Lead Reference Value

The U.S. Centers for Disease Control and Prevention (CDC) recently updated its blood lead reference value (BLRV) from 5 µg/dL to 3.5 µg/dL in response to the Lead Exposure Prevention and Advisory Committee (LEPAC) recommendation made on May 14, 2021.

The BLRV is intended to identify children with higher levels of lead in their blood compared to the levels of most children, based on the 97.5th percentile of the blood lead level (BLL) distribution in U.S. children ages 1 to 5 years.

The new BLRV of 3.5 μg/dL may create challenges for laboratories that perform blood lead testing. Laboratories may encounter increased workloads because of additional repeat and confirmatory testing. Some laboratories may need to

• Reduce lower reporting limit policies. 
• Adopt new repeat testing practices. 
• Improve limits of detection of laboratory-developed tests. 
• Acquire new instrumentation. 
• Validate new laboratory-developed tests. 
• Clarify minimum volume requirements for pediatric capillary samples. 
• Update data handling systems to report blood lead levels to the tenth of a µg/dL (i.e., X.X µg/dL) if they currently report BLLs only in integer values. 
• Take extra steps to prevent common lead contamination in laboratory consumables and the laboratory environment to prevent false positives in reporting at these lower levels. 

Online resources 

• CDC Childhood Lead Poisoning Prevention Program  
• Screening Young Children for Lead Poisoning: Guidance for State and Local Public Health Officials (see Appendix C “The Lead Lab”) 
• Laboratory Methods − Analysis of whole human blood for Pb, Cd, Hg, Se, and Mn by ICP-DRC-MS for biomonitoring and acute exposures 
• Laboratory Response Network – Chemical (LRN-C) Program
• Association of Public Health Laboratories (APHL) – National Biomonitoring Network 
• APHL – Biomonitoring Toolkit 
• Clinical and Laboratory Standards Institute (CLSI) − CLSI C40-A2 "Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine; Approved Guideline - Second Edition" October 2013

Burkholderia pseudomallei 

Testing at the Centers for Disease Control and Prevention (CDC) has identified the bacterial DNA of Burkholderia pseudomallei in an aromatherapy room spray in the home of the Georgia resident who was infected with and died from Burkholderia pseudomallei infection (melioidosis) in July 2021. This Georgia patient was the fourth melioidosis case since March 2021 in a cluster that involved three other patients in Kansas, Minnesota, and Texas. The cluster was described previously in an August 9, 2021, HAN Health Update 448 titled HAN Health Update 448: New Case Identified: Multistate Investigation of Non-travel Associated Burkholderia pseudomallei Infections (Melioidosis) in Four Patients: Georgia, Kansas, Minnesota, and Texas—2021. For more information on the latest discovery, click here.

CDC Launches Virtual Reality Laboratory Training Course

on Personal Protective Equipment

To address evolving training needs, especially amid the COVID-19 pandemic, CDC has released a new virtual reality (VR) laboratory training course on personal protective equipment (PPE).

The basic-level course was designed to enhance clinical laboratory scientists' understanding of how PPE can help reduce the risk of exposure to hazardous materials and prevent transmission of infectious agents. The course also demonstrates the most effective ways to don and doff PPE in the correct order to minimize contamination and potential exposures. The course allows clinical and public health laboratory learners to practice PPE skills in a virtual environment.

LabTrainingVR: Personal Protective Equipment Edition is now live on CDC TRAIN and STEAM.

LOINC Test Code Mapping Tool

CDC recently updated its LOINC In Vitro Diagnostic (LIVD) Test Code Mapping Tool for SARS-CoV-2 Tests. The SNOMED-CT for multiple saliva terms listed in Vendor Specimen Description have changed based on input from SNOMED International. Users should select oral saliva “(258560004^Oral saliva sample^SCT)” to identify the specimen if it is from oral saliva.

Previous mappings erroneously identified the specimen type as being obtained directly from the salivary gland “(119342007^Saliva specimen^SCT).” All changes are listed in the Release Notes tab for the mapping tool on the LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests.

Introduction to Laboratory Risk Management

CDC’s Division of Laboratory Systems recently began offering an Introduction to Laboratory Risk Management (LRM) eLearning course. This is the first in a series of courses focused on developing risk management strategies for laboratory settings. Relevant to laboratories involved in COVID-19 testing, the course takes about one hour to complete, and learners can earn 1.0 P.A.C.E.® credits.

After completing the course, the learner should be able to:

• Recognize the importance and benefits of risk management.
• Define terms associated with risk management.
• List the major processes in risk management and associated activities.
• Identify the importance of ensuring dynamic continual improvement.

Want to learn more about ACHC Clinical Laboratory Accreditation?
✔️ Visit our Lab Program & Services page.

ACHC Charity Golf Tournament

We're excited to announce our golf tournament is back on track! Join us on May 16, 2022, as we help raise funds for children's organizations.

Register by January 1, and save up to $200.

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