Marana Health Center

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 from 2021 for testing performed in the specialties of Chemistry and Hematology and interview with the facility personnel, the laboratory director failed to sign the PT attestation statements in a timely manner. Findings include: 1. The laboratory performs testing in the specialties of Chemistry and Hematology, with an approximate annual test volume of 275,226. 2. The PT attestation statements presented for review for the first event of 2021 for PT samples tested in the specialties of Chemistry and Hematology were signed and dated by the laboratory director on 3/23/2022. 3. The laboratory uses American Association of Bioanalysts (AAB) as their PT provider. The AAB PT schedule for the 1st event of 2021 for samples tested in Chemistry and Hematology indicated the result due date as 2/26/2021. 4. The facility personnel acknowledged that the laboratory director failed to sign the PT attestation statements indicated above at the time of the PT testing event which occurred in February 2021. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- This STANDARD is not met as evidenced by: Based on lack of manufacturer's package inserts presented for review for testing performed on the Sysmex i-1000 Hematology analyzer, Roche C-311 Chemistry analyzer and Roche E-411 Endocrinology analyzer and interview with the facility personnel, the laboratory failed to retain the manufacturer's package insert for at least 2 years for each lot of Quality Control (QC) and Calibration material used on the analyzers by the laboratory. Findings include: 1. The laboratory performs patient testing using the Sysmex i-1000 Hematology analyzer, Roche C-311 Chemistry analyzer and Roche E-411 Endocrinology analyzer, with an approximate annual test volume of 275,226. 2. During the survey conducted on March 24, 2022, no evidence was presented for review to indicate the laboratory retained the manufacturers' assay information sheets for at least 2 years for each lot of QC and Calibration material that were used by the laboratory. 3. The facility personnel interviewed on March 24, 2022 at approximately 3:20pm confirmed that the laboratory failed to retain the manufacturers' assay information sheets for at least 2 years for each lot QC and Calibration material used on the analyzers indicated above. 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 lack of employee competency policies and procedures for review and interview with the facility personnel, the laboratory failed to establish policies and procedures to assess the competency of the Technical Consultant. Findings include: 1. The CMS-209, Laboratory Personnel form submitted for review during the survey conducted on March 24, 2022 listed one Technical Consultant who provides technical oversight for testing performed in the specialties of Chemistry and Hematology. 2. No documentation was presented for review to indicate the laboratory established policies and procedures to assess the competency of the Technical Consultant. 3. The facility personnel confirmed that the laboratory did not have policies and procedures established to assess the competency of the laboratory personnel indicated above. 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: (A) Based on review of Proficiency Testing (PT) records from 2020 and 2021, review of established Quality Assessment (QA) policies and procedures and interview with the facility personnel, the laboratory failed to follow established QA policies to document

Summary Statement of Deficiencies 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 direct inspection of Quality Control (QC) material for testing performed in the specialties of Chemistry and Hematology, review of laboratory test procedures and interview with the facility personnel, the laboratory failed to label QC reagents with the proper open expiration date. Findings include: 1. The laboratory performs testing on the Sysmex XS-1000i hematology analyzer with an approximate annual test volume of 42,036 and performs testing on the Cobas 311 and Cobas e411 Chemistry analyzers with an approximate annual test volume of 135,347. 2. Direct inspection of the QC reagents for the analyzers indicated above revealed the laboratory failed to indicate the proper open expiration date. 3. Review of the laboratory's Complete Blood Count (CBC) test procedures indicated the hematology QC (3 levels) has an open expiration date of 14 days. 4. Review of the laboratory's test procedures for Routine Chemistry and Endocrinology testing indicated the QC has an open expiration date ranging from 14 days to the printed expiration date, depending on the control material. The laboratory utilizes approximately 17 different controls for testing performed on the Cobas analyzers. 5. The facility personnel confirmed that the laboratory failed to label the control material indicated above with the proper open expiration dates. 4. The facility personnel confirmed that the laboratory failed to document the open expiration date on the Affirm reagents that were in use at the time of the survey. 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 -- D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the performance verification documentation for testing performed on the Cobas 311 and Cobas e411 analyzers and interview with the facility personnel, the laboratory failed to have the performance verification for each analyzer signed and approved prior to testing patient specimens. Findings include: 1. The laboratory began using two new analyzers, Cobas 311 and Cobas e411, in May 2018. The laboratory's approximate annual test volume for testing performed in the sub-specialties of Routine Chemistry and Endocrinology is 135,347. 2. No documentation was provided for review to indicate the laboratory director or technical consultant analyzed, approved and signed the performance verification data for each analyzer prior to patient testing. 3. The facility personnel confirmed that the laboratory did not have a signed, approved copy of the performance verification as indicated above. -- 2 of 2 --