Granite Peaks Gi, Llc

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of competency evaluation documentation and an interview with Testing Personnel #1 (TP #1), the technical consultant failed to perform and document semi-annual competency evaluations for 1 of 5 Testing Personnel during their first year of performing moderately complex patient testing on the BioFire GI Film Array analyzer. The laboratory runs 173 bacteriology tests per year. Findings include: 1. A review of competency evaluation records at approximately 11:42 AM on 2/28/24 revealed that 1 of 5 TP did not have documentation of a semi-annual competency assessment during their first year of performing moderately complex patient testing on the BioFire GI Film Array analyzer. 2. An interview with the TP #1 at approximately 11:42 AM on 2/28/24 confirmed that 1 of 5 TP reviewed since the last survey on 8/17 /2021 did not have documentation of a semi-annual competency assessment during their first year of performing moderately complex patient testing on the BioFire GI Film Array analyzer. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 laboratory test records review, lack of documentation, and interview with staff, the laboratory failed to enroll in an approved proficiency testing (PT) program for 3 of 3 subspecialties (Bacteriology, Parasitology, and Virology) included in the BioFire FilmArray Gastrointestinal (GI) Panel and required in subpart I. The laboratory began patient testing in 03/2019 and had tested approximately 36 samples. Findings include: 1. The BioFire GI Panel reports include testing for 22 targets in the subspecialties of Bacteriology, Parasitology, and Virology. 2. The laboratory lacked documentation of enrollment in approved PT programs for Bacteriology, Parasitology, and Virology. 3. Staff confirmed on 08/15/2019 at approximately 10:00 AM, they had not enrolled in approved PT programs for the 3 subspecialties. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the Individualized Quality Control Plan (IQCP), lack of documentation, and interview with staff, the laboratory director failed to establish a quality assessment program. The laboratory began patient testing in 03/2019 and had performed testing on approximately 36 samples. Findings include: 1. The laboratory's IQCP requires "continual participation in this institutions quality program that addresses specimen handling and erroneous specimen labeling". 2. The laboratory lacked documentation of a written quality program. 3. Staff stated on 08/15/2019 at approximately 11:00 AM the laboratory lacked a written quality assessment program to monitor, assess, and when indicated, correct problems identified in all phases of testing. -- 2 of 2 --