Southeast Idaho Family Practice

Summary Statement of Deficiencies D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a direct observation of microbiology media, review of control logs and an interview with the technical consultant (TC) on 6/22/2022, the laboratory failed to perform quality control (QC) on group A beta strep agar. The findings include: 1. A direct observation during the laboratory tour identified Hardy group A beta strep agar lot number 504712 expiration 2022-07-11. 2. A review of the laboratory's Bacitracin and group A beta strep agar QC log identified that the laboratory failed to perform QC on group A beta strep agar lot number 504712 to show the ability of the media to support growth and the ability to inhibit growth of specific organisms. 3. An interview with the TC on 6/22/2022 at 3:22 pm confirmed that the laboratory failed to perform QC on group A beta strep agar to show the ability to support growth and inhibit specific organisms for lot number 504712. 4. The laboratory reports performing 165 group A beta streptococcus cultures annually. 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 D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from American Academy of Family Physicians (AAFP) and an interview with the laboratory lead on February 22, 2021, the laboratory failed to establish and maintain the accuracy for potassium hydroxide (KOH) testing at least twice annually. The findings include: 1. A review of PT records from AAFP identified that the laboratory failed to verify the accuracy of KOH testing biannually for 2020. 2. An interview with the laboratory lead on 2/22/21 at 1:30 pm confirmed that the laboratory failed to biannually verify the accuracy of KOH testing for 2020. 3. The laboratory reports performing 130 KOH test annually. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of training documentation and competency assessments, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview on 2/22/2021 with the laboratory lead, the laboratory failed to establish and follow written policies and procedures to assess testing personnel in accordance with 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 -- 42 C.F.R. 493.1413(b)(8). The findings include: 1. A review of training and competency records identified that two (2) of nine (9) testing personnel listed on the CMS 209 had start days after the previous survey (6/28/2018) and the laboratory failed to have documentation of initial training. 2. A review of training and competency records identified that one (1) of nine (9) testing personnel listed on the CMS 209 failed to have documentation of six (6) month competency which included the six parameters as listed in 42 C.F.R. 493.1413(b)(8). 3. A review of training and competency records identified seven (7) of nine (10) testing personnel listed on the CMS 209 failed to have documentation of annual competency which included the six parameters as listed in 42 C.F.R. 493.1413(b)(8) for 2019 and 2020. 4. An interview with the with the laboratory lead on 2/22/2021 at 1:00 pm confirmed that the laboratory failed to document initial training, six (6) month competencies and annual competencies for 2019 and 2020. 5. The laboratory reports performing 25,916 tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory lead, the laboratory failed to verify the accuracy of potassium hydroxide (KOH), urine sediment examinations, and post-vasectomy examinations at least twice annually since the last survey on September 28, 2016. Findings: 1. A record review revealed the laboratory failed to document the accuracy of KOH, post-vasectomy examinations, and urine microscopic examinations at least semiannually since the last survey. 2. An interview on June 28, 2018 at 8:55 AM, with the laboratory lead, confirmed the laboratory failed to perform and document the accuracy of KOH, urine microscopic and post- vasectomy examinations at least semiannually. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on an observation of reagents in the laboratory refrigerator and an interview with the laboratory lead, the laboratory failed to label the expiration dates on 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 5 -- control vials for the Cell-Dyn Emerald complete blood count (CBC) analyzer as found at the time of the survey. Findings: 1. An observation of the laboratory refrigerator on June 28, 2018 at 10:00 AM revealed the Cell-Dyn CBC control vials failed to be labeled with the expiration dates. 2. An interview on June 28, 2018 at 10:05 AM, with the laboratory lead, confirmed the laboratory failed to label the CBC quality control vials with expiration dates. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory lead, the laboratory failed to establish the number, type and frequency of reagent testing controls for the bacitracin test (A disk) used for the identification of Group A streptococci organisms and serum human chorionic gonadotropin (hCG) test since the last survey on September 28, 2016. Findings: 1. A review of the laboratory's Individualized Quality Control Plan (IQCP) and procedure for serum hCG testing revealed the quality control plan failed to include the number, type, and frequency of quality control reagents used to perform the identification of Group A streptococci from throat specimens and serum hCG pregnancy test since the last survey. 2. An interview on June 28, 2018 at 10:10 AM, with the laboratory lead, confirmed the IQCP and procedures failed to establish the number, type, and frequency of control reagents in the test system since the last survey. D5463 CONTROL PROCEDURES CFR(s): 493.1256(d)(7)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Over time, rotate control material testing among all operators who perform the test. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control records and an interview with the laboratory lead, the laboratory failed to rotate the testing of Cell-Dyn 18 Plus quality controls used on the Cell-Dyn Emerald complete blood count (CBC) analyzer among all testing personnel since the last survey on September 28, 2016. Findings: 1. A review of the quality control records from July 3, 2017 through May 18, 2018, for the Emerald CBC analyzer, revealed the laboratory lead performed the daily quality controls. 2. An interview on June 28, 2018, at 9:30 AM, with the laboratory lead -- 2 of 5 -- confirmed that she was the only testing personnel who performed quality control tests for CBCs. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a quality control records review and an interview with the laboratory lead, the laboratory failed to meet the quality control requirements for the Cell-Dyn Emerald complete blood count (CBC) analyzer prior to reporting patient CBC results since the last survey on September 28, 2016. Findings: 1. A review of CBC quality control records from July 3, 2017 through May 18, 2018 revealed patient CBCs were reported for 4 days (8/4/2017, 2/20/2018, 2/16/2018, and 4/26/2019) when two out of three levels of controls were out of manufacturer's reference range. 2. An interview on June 28, 2018 at 9:45 AM, with the laboratory lead, confirmed the laboratory failed to verify the results of quality control testing were within the manufacturer's reference range prior to reporting patient CBC results. D5783