Logan Health Primary Care

Summary Statement of Deficiencies D0000 Definitions: LAB #7 located in Lakeside, MT LAB #2 located in Kalispell, MT LAB #6 located in Kalispell, MT LAB #8 located in Kalispell, MT D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. 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. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on an off-site review of College of American Pathologists (CAP) proficiency testing (PT) records, laboratory policy, and interviews with two of two point of care (POC) coordinators, the laboratory failed to test proficiency testing samples with the laboratory's regular patient workload (Cross Refer D2007); the laboratory engaged in inter-laboratory communications (Cross Refer D2011); and failed to document the handling, preparation and processing of proficiency testing samples including maintaining accurate copies of all records for a minimum of two years from August of 2021 to August of 2023. (Cross Refer 2015). D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- laboratory's routine methods This STANDARD is not met as evidenced by: Based on an off-site review of College of American Pathologists (CAP) Whole Blood Coagulation Proficiency Testing (PT) records and an email with one of two point of care (POC) coordinators (POC #1 and POC #2), one out of nine laboratories failed to follow their policy using the laboratory's routine methods for labeling proficiency samples for 2022 event WP9-C and 2023 event WP9-B. Findings: 1. A review of CAP's Whole Blood Coagulation Survey Results Form for the 2022 event WP9-C listed PT samples as WP9-11, WP9-12, WP9-13, WP9-14, and WP9-15, which did not correlate with the laboratory's sample IDs labeled as O, O, O, O, and O. 2. A review of CAP's Whole Blood Coagulation Survey Results Form for 2023 event WP9- B listed PT samples as WP9-06, WP9-07, WP9-08, WP9-09, and WP9-10, which did not correlate with the laboratory's sample IDs labeled as VC0000000, VC0000000, VC000000, VC000000, and VC. 3. A review of Policy POC 153.0 revealed Lab #8 failed to follow its policy to "Enter Patient ID" for each CAP PT sample tested for Whole Blood Coagulation for 2022 event WP9-C and for 2023 event WP9-B. 4. An email from POC #1 on August 29, 2023, at 10:25 PM contained data that confirmed lab #8 failed to follow their policy and label each PT sample using the laboratory's routine method for 2022 event WP9-C and 2023 event WP9-B. D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based on an off-site review of policies, College of American Pathologists (CAP) proficiency testing (PT) records, and interviews with two of two point of care (POC) coordinators (POC #1 and POC #2), the point of care office engaged in inter- laboratory comunication with nine out of nine separate CLIA laboratories by reviewing and submitting proficiency test results prior to the event deadline for College of American Pathologists (CAP) Whole Blood Coagulation Survey (WP9) for 2023 Events A and B, 2022 Events A, B and C and 2021 Events B and C. Findings: 1. A review of Policy No: POC.118 revealed the "POC Coordinator oversees PT deadlines and result entry into appropriate forms" and the POC coordinators failed to follow their policy to prevent "Inter-Laboratory or site communication about PT samples is prohibited until after deadline for submission of results." 2. A review of PT records for CAP Whole Blood Coagulation Survey revealed Telcor (software used to interface testing devices to any laboratory information system or electronic medical records) PT raw data being reviewed and submitted to CAP for nine separate CLIA Laboratories (Lab #1, Lab #2, Lab #3, Lab #4, Lab #5, Lab #6, Lab #7, Lab #8, and Lab #9) by the POC coordinators prior to the event due dates for the following events: 2023 WP9-A Event Due Date: 2/14/2023 Lab# (Dates of Telcor raw data): Lab #1 (2 -- 2 of 4 -- /13/2023), Labs #2, #5, and #7 (1/25/2023), Lab #3 (02/01/2023), Lab #4 (02/08 /2023), Lab #6 and #9 (1/26/2023), Lab #8 (2/08/2023) 2023 WP9-B Due Date: 6/06 /2023 Lab# (Dates of Telcor raw data): Lab #1 (5/22/2023), Lab #2 (5/19/2023), Lab #3 (06/01/2023), Lab #4 and #5 (5/31/2023), Lab #6 (5/23/2023), Lab #7 (5/24/2023), Lab #8 (6/05/2023), Lab #9 (5/25/2023) 2022 WP9-A Due Date: 3/15/2022 Lab# (Dates of Telcor raw data): Lab #1, Lab #4 (3/01/2022), Lab #3 (03/15/2022), Lab #5 (3/07/2022), Lab #6 and #2 (2/23/2022), Lab #8 (3/02/2022), Lab #9 (3/09/2022) 2022 WP9-B Due Date: 6/07/2022 Lab# (Dates of Telcor raw data): Lab #1 (6/07 /2022), Lab #2, #3, and #7 (5/25/2022), Lab #4, #6, and #8 (5/26/2022), Lab #5 (6/08 /2022), Lab #9 (5/31/2022) 2022 WP9-C Due Date: 9/20/2022 Lab# (Dates of Telcor raw data): Lab #1 (9/16/2022), Lab #2 (9/06/2022), Lab #3 (09/09/2022), Lab #4 (09 /20/2022), Lab #5 (9/14/2022), Lab #6 and #7 (9/07/2022), Lab #8 and #9 (9/15/2022) 2021 WP9-B Due Date: 6/08/2021 Lab# (Dates of Telcor raw data): Lab #1, Lab #7 (5 /19/2021), Lab #9 (6/4/2021) 2021 WP9-C Due Date: 9/21/2021 Lab# (Dates of Telcor raw data): Lab #1 (9/20/2021), Lab #3 (9/21/2021), Lab #7 (9/08/2021), Lab #9 (9/09/2021) 3. An interview with POC #2 on August 22, 2023, at 3:30 PM confirmed that the POC coordinators print the PT raw data from Telcor and enter the data into the CAP website for all POC laboratories for years 2021, 2022, and 2023. 4. A review of Lab #8's CAP WP9-C 2022 results sheet revealed handwritten values paired with PT samples WP9-11 - WP9-15 with no documentation of who or how the results were matched with the raw data dated 9/15/2022 with sample IDs labeled as O, O, O, O, and O. (Cross Refer D2007) 5. A review of Lab #8's CAP WP9-B 2023 results sheet revealed handwritten values paired with PT samples WP9-06 - WP9-10 with no documentation of who or how the results were matched with the raw data dated 6/05/2023 with sample IDs labeled as VC0000000, VC0000000, VC000000, VC000000, and VC. (Cross Refer D2007) D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on an off-site review of College of American Pathologists (CAP) Whole Blood Coagulation proficiency testing (PT) records and an email with one of the two point of care (POC) coordinators (POC #1 and POC #2), the laboratory failed to document the handling, preparation, and processing of proficiency testing samples, including maintaining accurate copies of all records for a minimum of two years from the date of the proficiency testing event from August 2021 to August 2023. Findings: 1. No documentation of sample handling, preparation, and processing of PT samples were available for review for nine out of nine laboratories (Lab #1, Lab #2, Lab #3, Lab #4, Lab #5, Lab #6, Lab #7, Lab #8, and Lab #9). 2. A review of Lab #8 CAP WP9-B 2022 records lacked a signed attestation sheet. 3. A review of policy POC.118 -- 3 of 4 -- revealed Labs #2, #4, #5, #6, and #8 failed to follow their procedures and retain 2 years of data as stated, "PT Survey results and all documentation is maintained within the POC department in an organized manner for no less than two years." 4. An email on August 29, 2023, at 10:25 PM from POC #1 confirmed that the laboratory failed to maintain the proficiency records as required by their policy for two years from August 2021 to August 2023. -- 4 of 4 --