Pocatello Children's Clinic

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of laboratory procedures, Piccolo quality control (QC) logs and an interview with the laboratory general supervisor (GS) on 5/12/2022, the laboratory failed to perform QC with the frequency required by the manufacturer for direct bilirubin and c-reactive protein (CRP) testing . The findings include: 1. A review of the laboratories Individualized Quality Control Plan ((IQCP) for direct bilirubin and CRP testing on the Piccolo identified that QC must be performed with each new lot and at least every 30 days as per manufacturer. 2. A review of the Piccolo QC logs identified that the laboratory failed to perform direct bilirubin QC in January, February, and April of 2022. 3. A review of the Piccolo QC logs identified that the laboratory failed to perform CRP QC in January and February of 2022. 4. An interview with the GS on 5/12/2022 at 1045 am confirmed the above findings. 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 D5785

Summary Statement of Deficiencies 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 record review of personnel documents and an interview with the general supervisor, the laboratory failed to establish and follow procedures to assess the technical supervisor competency since the last survey on July 14, 2016. Findings: 1. A review of personnel documents and laboratory procedures and policies, revealed the laboratory failed to establish in writing and assess the competency for the technical supervisor listed on the CMS-209 Personnel Report form. 2. An interview on April 11, 2018 at 10:30 AM, with the general supervisor, confirmed the laboratory failed to establish and assess the competency for the technical supervisor. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 -- This STANDARD is not met as evidenced by: Based on a record review of final patient reports and an interview with the general supervisor, the laboratory failed to indicate the name and the address of the reference laboratory where laboratory tests were reported on patients for the period reviewed in February 2018. Findings: 1. A review of patient laboratory test reports revealed the name and the address of the reference laboratory where tests were performed failed to be included on the patient's test reports. 2. An interview on April 11, 2018, at 10:00 AM, with the general supervisor, confirmed the name and the address of the reference laboratory as failed to be indicated on patient laboratory reports. D6170 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(a) Each individual performing high complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on personnel qualifications and an interview with the general supervisor, the laboratory failed to ensure the high-complexity testing personnel were qualified to perform complete blood counts (CBC) atypical cell identification since the last survey on July 14, 2016. Findings: 1. A record review of personnel diplomas, revealed 2 out 4 testing personnel failed to meet the qualifications for high-complexity testing since the last survey. 2. An interview on April 11, 2018, at 8:15 AM, with the general supervisor, confirmed that 2 testing personnel failed to meet the personnel qualifications for high-complexity testing. -- 2 of 2 --