Honorhealth Medical Group Saguaro

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 review of Proficiency Testing (PT) records for 2019 and interview with the facility personnel, the laboratory failed to enroll in an HHS approved PT program for the regulated analytes, Infectious Mononucleosis (Mono) and Thyroid Stimulating Hormone (TSH), tested in the specialties of Diagnostic Immunology and Chemistry, which are included in subpart I . Findings include: 1. The laboratory uses the Sure- Vue serum Mono test kit to perform patient testing under the specialty of Diagnostic Immunology, with an approximate annual test volume of 16,733. 2. Review of the laboratory's PT records for 2019 indicated the laboratory was enrolled in 'method code# 4210, Mono Immunoserology, Sure-Vue (Waived)'. The laboratory participated in three PT events during 2019 under the waived method. 3. No other documentation was presented for review during the survey conducted on 2/28/2020 to indicate the laboratory participated in PT for the regulated analyte, Mono, using the serum method. 4. The laboratory performs TSH testing in the specialty of Chemistry. The laboratory's approximate annual test volume for the specialty of Chemistry is 1,459,019. 5. No documentation was presented for review during the survey to indicate the laboratory was enrolled in a HHS-approved PT program for the 1st and 2nd PT event of 2019 for the regulated analyte, TSH, listed in subpart I, for which 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 3 -- laboratory performs patient testing. 6. The facility personnel confirmed that the laboratory failed to enroll in PT for serum Mono during 2019 and failed to enroll in PT for TSH for the first two testing events of 2019. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records from 2018 and interview with the facility personnel, the laboratory failed to document

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records for 2017 for testing performed in the specialty of Chemistry and interview with the technical consultant, the laboratory director failed to sign the PT attestation statement. Findings include: 1. The PT attestation statement presented for review for the first testing event of 2017 lacked the director's signature. 2. The technical consultant confirmed that the PT attestation statement indicated above was not signed by the laboratory director. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) policies for review, review of Proficiency Testing (PT) records and interview with the facility personnel, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated correct problems identified in the general laboratory systems including, but not limited to, proficiency testing performance and employee 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 -- competency. Findings include: 1. No QA documentation was presented for review during the survey to indicate the laboratory had established written policies and procedures for an ongong mechanism to monitor, assess, and when indicated correct problems identified with employee training and competency. See D6029, D6053 and D6054 for specific findings. 2. No documentation was presented for review during the survey to indicate that the