Adventist Health Tulare

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's proficiency testing (PT) records from the American Proficiency Institute (API) and interviews with the technical supervisor (TS), administrative director (AD), and laboratory quality manager (LQM), it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the subspecialty of Coagulation on the second event of 2023 (Q2-2023). The findings include: 1. Based on review of the API PT records, an unacceptable score of 20 percent was obtained for the subspecialty of Coagulation for Q2-2023 for Partial Thromboplastin Time (PTT) analyte. 2. The TS, AD, and LQM confirmed by interviews on August 22, 2024, at approximately 11:00 a.m. that the laboratory received the proficiency testing score of 20 percent as described in statement #1. 3. Based on the laboratory's annual testing declaration submitted on the day of the survey on August 22, 2024; the laboratory analyzed and reported approximately 193,120 Hematology samples that included Coagulation tests during the time the laboratory had unsatisfactory proficiency testing results for PTT. 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. 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 -- This STANDARD is not met as evidenced by: Based on an interview with the laboratory's technical supervisor (TS) and the surveyor's observation of the reagent materials and solutions used in the laboratory during the facility's tour, it was determined that the laboratory failed to completely label various reagents and solutions to indicate the identity, opening, preparation, and expiration dates when such materials were used in the laboratory. The findings include: 1. Based on the surveyor's observation during the laboratory tour on August 22, 2024, at approximately 12:00 pm.; an incomplete labelling of various reagents and solutions were found. For example: a. The Gram's staining reagents found by the processing area lacked initials of testing personnel, opening or expiration date labels. b. The de-ionized water found inside the Microbiology biological safety hood had no lot number, aliquot date, expiration date or initials of personnel. c. The optical lens cleaner bottles found in multiple sections of the laboratory had no open date or initials of personnel. d. The currently in-use KOH reagent (Lot# 633178, expiry date: 3-29- 2025) had no open date or initials of personnel. e. 10% Bleach, Methanol and Ethanol had no initials of personnel, lot number, preparation, and expiry dates in various sections of the laboratory. f. The back-up stains for the Hematek stainer had no identity label in the glass containers, lot number, open and expiration dates. g. The saline squirt bottle found beside Grifols analyzer for Immunohematology had no aliquot date, lot number, and initials. 2. The TS affirmed by interview on August 22, 2024, at approximately 12:00 p.m. that the reagents and solutions found during the tour were not labeled correctly with the identity, opening, preparation, and expiration dates as mentioned in statement #1. 3. Based on the laboratory's annual testing declaration submitted at the time of the survey, the laboratory analyzed and reported approximately 70,876 Microbiology, 193,120 Hematology, and 5,501 Immunohematology test samples during the time various reagents and solutions had incomplete labelling. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory tour, examination of laboratory reagents, and interviews with the laboratory's technical supervisor (TS); it was determined that the laboratory failed in using reagents when they have exceeded their expiration date. The findings include: 1. Based on the surveyor's observations during the laboratory tour, the Epredia immersion oil tube with lot number 120533 used for manual differential count had expired since 4/2024. Five more tubes of the same brand, lot number and expiry date were found in the drawer at Hematology bench. 2. The TS affirmed on August 22, 2024 at approximately 12:30 p.m. that the laboratory was using the reagent listed on #1 beyond its expiration date. 3. Based on the laboratory's submitted testing declaration test volume, the laboratory tested and reported approximately 192,646 Hematology tests samples that included the manual differential count tests where expired reagent are used. D6082 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on the interviews with the technical supervisor, administrative director, and laboratory quality manager, observations during the laboratory tour, review of the laboratory's policies and procedures, preventive maintenance, proficiency testing (PT) records and review of fourteen randomly selected patient records on August 22, 2024, the laboratory director is herein cited for failure to ensure that several aspects of the analytic, and postanalytic phases of the laboratory testing were monitored. 1. Less than 80 percent in Coagulation PT results. See D2121 2. Incomplete labelling of various reagents and solutions. See D5415 3. Use of expired reagent. See D5417 -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing High Complexity Testing: Laboratory director was not met. The laboratory director, high complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D2162) D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Compatibility Testing, resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 100% of acceptable responses in two out of three consecutive PT events for the analyte, Compatibility Testing, as follows: 2020 2021 Q3 Q2 Compatibility Testing 80% 80% Q2 = Second Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, Compatibility Testing. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing High Complexity Testing: Laboratory director was not met. The laboratory director, high complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6089) D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on a desk review of CMS PT records, it was determined the laboratory director, high complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, Compatibility Testing, Total, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (see D2016 and D2162) -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) result reports, quality control documents, an interview with the technical superior and laboratory personnel and thirteen (13) random patient sampling (including urine drug abuse testing) reviewed from 10/19/2018 to 03/14/2019, it was determined that the laboratory failed to follow the manufacturer's instructions in a manner that provides test results within the laboratory's stated performance specifications for urine drug screen testing using the Bio-Rad TOX/See moderate complexity test kit. The findings included: a. The laboratory performed urine drug screen testing using the Bio-Rad moderate complexity test kit. The manufacturer's product insert stated under LIMITATIONS, "1. The TOX/See Drug Screen Test provides only a qualitative, preliminary, analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method." b. On 03/14/2019 (survey date) 14:00, the technical supervisor and laboratory personnel confirmed that the patients' electronic medical records (EMR) did not specify the manufacturer's limitations and that a secondary analytical method assay was performed on the patient's final report for urine drug screen test results as mandated in the manufacturers package insert instructions. No documentation could be retrieved that confirmatory drug of abuse test was performed consistently on every urine drug screening test as required by the manufacturer. c. Based on the laboratory's annual testing provided on 03/18/2019, the laboratory analyzed and reported 557 urine drug screen test results. 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 --