Oroville Hospital Dept Of Pathology

Summary Statement of Deficiencies D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures for the evaluation of three of three annual statistics and failed to document one of three statistics (refer to D5629); failed to follow written policies and procedures for the establishment of individual workload limits (refer to D5633); failed to follow written policies and procedures to reassess workload limits at least every six months (refer to D5637); and failed to follow written policies and procedures to ensure the laboratory maintained records of the total number of slides examined and the total number of hours spent examining slides per 24-hour period (refer to D5645). 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 review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of Technical Supervisors and Cytotechnologists. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- The laboratory failed to assess the competency of three of three Technical Supervisors and one of one Cytotechnologist in 2020, 2021 and to the date of the survey in 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to assess the competency of the Technical Supervisors and Cytotechnologists. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for three of three Technical Supervisors and one of one Cytotechnologists in 2020, 2021 and to the date of the survey in 2022. Technical Supervisors include: -Laboratory Director/Technical Supervisor #1 -Technical Supervisor #2 -Technical Supervisor #3 Cytotechnologists include: - Cytotechnologist 3. During an interview on March 22, 2022 at 10:20 AM, these findings were confirmed by the Laboratory Director/Technical Supervisor #1. D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures for an annual statistical evaluation of three of three required cytology statistics. The laboratory failed to document one of three required annual statistics for 2020 and 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an annual statistical evaluation of three of three required cytology statistics. Statistics include: - The number of cytology cases examined; - The number of specimens processed by specimen type; - The number of patient cases reported by diagnosis (including the number reported as unsatisfactory). 2. The Survey Team requested and the laboratory failed to provide of one of three required annual statistic for 2020 and 2021. Statistic includes: - The number of patient cases reported by diagnosis (including the number reported as unsatisfactory). 3. During an interview on March 22, 2022 at 10:20 AM, these findings were confirmed by the Laboratory Director/Technical Supervisor #1. D5633 CYTOLOGY CFR(s): 493.1274(d)(1) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1) The technical supervisor establishes a maximum workload limit for each individual who performs primary screening. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to follow laboratory policies and procedures to ensure individual maximum workload limits were established for individuals performing primary screening. The laboratory failed to ensure workload limits were established for three of three Technical Supervisors and one of one Cytotechnologists for 2020, 2021 and to the date of the survey in 2022. Findings include: 1. The laboratory failed to follow the written procedure CYTOLOGY WORK LOAD POLICY FOR CYTOTECHNOLOGIST AND PATHOLOGIST which stated: "at least every six months the medical director further establishes each cytotechnologist's maximum slide screening workload limit..." "If a pathologist is a primary screened, then pathologist will follow all the workload policies just like cytotechnologist." 2. The Survey Team requested and the laboratory failed to provide individual maximum workload limits for three of three Technical Supervisors and one of one Cytotechnologists for 2020, 2021 and to the date of the survey in 2022. Technical Supervisors include: - Laboratory Director/Technical Supervisor #1 - Technical Supervisor #2 - Technical Supervisor #3 Cytotechnologist includes: - Cytotechnologist 3. During an interview on March 22, 2022 at 10:20 AM, these findings were confirmed by the Laboratory Director/Technical Supervisor #1. D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to follow the procedure for reassessment of workload limits for three of three Technical Supervisors and one of one Cytotechnologists every six months in 2020 and 2021. Findings include: 1. The laboratory failed to follow the written procedure CYTOLOGY WORK LOAD POLICY FOR CYTOTECHNOLOGIST AND PATHOLOGIST which stated: "Given the legal maximum, at least every six months the medical director further establishes each cytotechnologist's maximum slide screening workload limit. If a pathologist is a primary screener, then pathologist will follow all the workload policies just like cytotechnologist". 2. The Survey Team requested and the laboratory failed to provide documentation of reassessment of workload limits for three of three Technical Supervisors and one of one Cytotechnologists in 2020 and 2021. Technical Supervisors include: - Laboratory Director/Technical Supervisor #1 - Technical Supervisor #2 - Technical Supervisor #3 Cytotechnologist includes: - Cytotechnologist 3. During an interview on March 22, 2022 at 10:20 AM, these findings were confirmed by the Laboratory Director/Technical Supervisor #1. D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of -- 3 of 6 -- the site or laboratory. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to follow written policies and procedures to ensure records would be maintained of the total number of slides examined and the total number of hours spent examining slides. The laboratory failed to maintain records of the total number of slides examined and the total number of hours spent examining slides during each 24-hour period during 2020, 2021 and to the date of the survey in 2022 for three of three Technical Supervisors. Cross refer to D6133 Findings include: 1. The laboratory failed to follow the written procedure CYTOLOGY WORK LOAD POLICY FOR CYTOTECHNOLOGISTS AND PATHOLOGISTS which stated: "The cytology laboratory maintains records of the number of slides examined and the number of hours devoted to screening and the number of hours devoted to other duties in 24-hour period. The record is documented in (Daily Cytology Slides Workload Log)". 2. The Survey Team requested and the laboratory failed to provide records of the total number of slides examined and the total number of hours three of three Technical Supervisor spent examining cytology specimen slides during each 24-hour period in 2020, 2021 and to the date of the survey in 2022. Technical Supervisors include: - Laboratory Director/Technical Supervisor #1 - Technical Supervisor #2 - Technical Supervisor #3 3. During an interview on March 22, 2022 at 10:20 AM, these findings were confirmed by the Laboratory Director/Technical Supervisor #1. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the Laboratory Director failed to ensure quality assessment programs were established to assure the quality of cytology services and identify failures in quality as they occurred in 2020, 2021 and to the date of the survey in 2022. Findings include: 1. The Survey Team requested and the Laboratory Director failed to ensure written policies and procedures were established for a quality assessment program for all phases of cytology testing. 2. The Survey Team requested and the Laboratory Director failed to provide records of an established quality assessment program and failed to identify and document failures in quality as they occurred in 2020, 2021 and to the date of the survey in 2022. 3. During an interview on March 22, 2022 at 10:20 AM, these findings were confirmed by the Laboratory Director/Technical Supervisor #1. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to -- 4 of 6 -- process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the Laboratory Director failed to ensure written policies and procedures were established to assess, monitor and maintain the competency of three of three Technical Supervisors and one of one Cytotechnologists performing cytology test procedures in 2020, 2021 and to the date of the survey in 2022. Cross refer to D5209 Findings include: 1. The Laboratory Director failed to ensure written policies and procedures were established to assess the competency of the Technical Supervisors and the Cytotechnologist. 2. During an interview on March 22, 2022 at 10:20 AM, these findings were confirmed by the Laboratory Director /Technical Supervisor #1. D6130 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(c)(2)(3) (c) In cytology, the technical supervisor or the individual qualified under 493.1449(k) (2)-- (c)(2) Must establish the workload limit for each individual examining slides and (c)(3) Must reassess the workload limit for each individual examining slides at least every 6 months and adjust as necessary. This STANDARD is not met as evidenced by: Based on the lack of laboratory records and interview it was determined that the Technical Supervisor failed to establish individual workload limits and failed to reassess workload limits at least every six months for three of three Technical Supervisors and one of one Cytotechnologists in 2020, 2021 and to the date of the survey in 2022. Cross refer to D5633 and D5637 Findings include: 1. The Survey Team requested and the Technical Supervisor failed to provide documentation that the Technical Supervisor established individual maximum workload limits for three of three Technical Supervisors and one of one Cytotechnologists in 2020, 2021 and to the date of the survey in 2022. Technical Supervisors include: - Laboratory Director /Technical Supervisor #1 - Technical Supervisor #2 - Technical Supervisor #3 Cytotechnologist includes: - Cytotechnologist 2. The Survey Team requested and the Technical Supervisor failed to provide documentation of reassessment of workload limits for three of three Technical Supervisors and one of one Cytotechnologists in 2020 and 2021. Technical Supervisors include: - Laboratory Director/Technical Supervisor #1 - Technical Supervisor #2 - Technical Supervisor #3 Cytotechnologist includes: - Cytotechnologist 3. During an interview on March 22, 2022 at 10:20 AM, these findings were confirmed by the Laboratory Director/Technical Supervisor #1. D6133 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(c)(6) In cytology, the technical supervisor or the individual qualified under 439.1449(k)(2), if responsible for screening cytology slide preparations, must document the number of cytology slides screened in 24 hours and the number of hours devoted during each 24- hour period to screening cytology slides. -- 5 of 6 -- This STANDARD is not met as evidenced by: Based on lack of laboratory records and interview it was determined that three of three Technical Supervisors performing primary screening of cytology specimen slides failed to document the number of slides screened and the number of hours devoted to screening slides during each 24-hour period in 2020, 2021 and to the date of the survey in 2022. Findings include: 1. The Survey Team requested and the Technical Supervisors failed to provide records of the total number of slides screened and the total number of hours three of three Technical Supervisor devoted to screening cytology specimen slides during each 24-hour period in 2020, 2021 and to the date of the survey in 2022. Technical Supervisors include: - Laboratory Director/Technical Supervisor #1 - Technical Supervisor #2 - Technical Supervisor #3 2. During an interview on March 22, 2022 at 10:20 AM, these findings were confirmed by the Laboratory Director/Technical Supervisor #1. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 6 of 6 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of 2018 - 2019 proficiency reports from API (American Proficiency Institute), laboratory proficiency testing records for i-STAT, and laboratory reports for Blood gases and ACT (Activated Clotting Time); and interview with Laboratory Person-5, it was determined that the proficiency testing samples were not tested with the regular patient workload by personnel routinely testing at point-of-care and Interventional Radiology. Findings included: a. The i-STAT hand-held analyzers were routinely used by point-of-care nursing staff to provide Blood gas results using the Abbott G3+ cartridges and by Interventional Radiology staff to provide clotting times using the ACT-Kaolin cartridges; both classified Non-waived complexity. A few examples selected at random were as follows: Date Accession Test --------------------------------------------------- 7/20/18 GMRC-576785 Blood gases 1/11 /19 GMRC-632930 ACT 3/28/19 ACCHA002065 ACT 8/20/19 GMRC-711438 Blood gases b. Attestation Statements of laboratory proficiency testing records for i- STAT Blood gases and ACT Kaolin documented that all samples in 2018-2019 were tested by Testing Person-5 and Testing Person-37 in the laboratory. c. Laboratory Person-5 affirmed (1/14/20 @ 12pm) the afforementioned findings; and thus, the proficiency testing samples were not tested as required with the regular patient workload by personnel routinely performing testing at point-of-care and Interventional Radiology. d. The reliability and quality of patients' results for Blood gases and ACT could not be assured without proficiency testing by personnel Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- routinely testing patients specimen. Annual test volumes were as follows: Analyte Year Volume ------------------------------------------------------ Blood gases 2018 60 specimen " " 2019 142 specimen ACT 2018 11 tests " 2019 22 tests . D2057 VIROLOGY CFR(s): 493.831(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of 2018 laboratory reports for HIV Ag Ab Combo, laboratory proficiency testing records, and proficiency testing evaluations from CAP (College of American Pathologists); and interview with Laboratory Person-5, it was determined that the laboratory failed to participate in Event C of 2018, testing for HIV. Findings included: a. Laboratory reports for HIV were randomly selected from 2018, as follows: Date ID- Acct -------------------------------------------- 5/30/18 8579064 6/11/18 8598894 7/17/18 8661045 8/10/18 8701546 9/14/18 8761190 9/18/18 8766714 b. Laboratory proficiency testing records documented all 5 out of 5 samples were tested for HIV on 9/13/18 with acceptable QC. c. However, the CAP Evaluation revealed the laboratory reported "code 11, Unable to analyze" for HIV, for 5 out of 5 proficiency samples. d. Laboratory Person-5 affirmed (1/14/20 @ 12pm) the aforementioned findings, that the proficiency samples were tested, but results were not reported to CAP; and thus, the laboratory failed to participate in proficiency testing for HIV. e. The reliability and quality of results reported for HIV could not be assured without performing proficiency testing. The laboratory reported 3,875 results for HIV during the timeframe May - October 2018. . 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 review of PFA (Platelet Function assays) test records, the lack of laboratory documents, and interview with Testing Person-5, it was determined that the laboratory failed to at least twice annually verify the accuracy of testing in 2018 - 2020. Findings included: a. Seven test records and reports randomly selected from 2018, 2019, and 2020 were reviewed. (See D5447). b. The laboratory was unable to provide records and documents verifying the accuracy of testing in the timeframe 2018 to 2/12/20. c. Laboratory Person-5 affirmed (2/12/20 @ 2:29pm) the lack of aforementioned records; and thus the laboratory failed to at least twice annually verify the accuracy of the PFA test. d. The reliability and quality of results reported could not be assured -- 2 of 6 -- when the laboratory failed to at least twice annually verify the accuracy of testing as required. Based on the laboratory's tally for 2018, the laboratory reported approximately 32 results annually for the timeframe 2018 to 2/12/20. . D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on review of laboratory written procedure and manufacturer's instructions for RPR, the lack of written procedure, and interview with Laboratory Person-5, it was determined that the laboratory failed to provide written procedure for titering Reactive control material. Findings included:. a. The laboratory used a commercial test kit for performing RPR. b. The manufacturer's instructions included procedure to titer reactivity, but did not specify titering Reactive control material for quality control purpose. c. The laboratory written procedure failed to include instructions for titering quality control when titering reactive specimen. d. Laboratory Person-5 affirmed (1/14 /20 @ 3pm) the aforementioned findings; and thus, the laboratory's failure to provide required written procedures not provided by the manufacturer. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of patients PFA (Platelet Function analysis) test records from 2018 - 2020, the lack of laboratory QC records, and interview with Laboratory Person-5, it was determined that the laboratory failed to include two control materials of different concentrations at least once each day of testing patient specimen. Findings included: a. The laboratory test for Platelet function using the Siemens PFA-100 instrument included membranes coated with Collagen and Epinephrine (EPI) followed by membranes coated with Collagen and ADP (Adenosine diphosphate). Records selected at random were as follows: Date ID Tests reported ------------------------------------------------------------ 7/24/18 T350278 PFA Collagen/ EPI 8/27/18 M372779 PFA Collagen / EPI 10/30/18 T380361 PFA Collagen / EPI (continued) 1/13/19 X454111 PFA Collagen / EPI 5/13/19 M460341 PFA Collagen / EPI and " " PFA Collagen / ADP 6/28/19 F373922 PFA Collagen / EPI 1/02/20 H472290 PFA Collagen / EPI b. Laboratory QC records documented that No control materials were tested on the aforementioned dates. c. Laboratory Person-5 affirmed (2 /12/20 @ 5:09pm) the lack of QC records for the aforementioned dates; and thus the laboratory failed to perform quality controls each day of testing as required. d. The reliability and quality of results reported could not be assured without the required -- 3 of 6 -- quality control materials each day of testing. Based on the laboratory's test volume for 2019 (email, 2/12/20), the laboratory reported approximately 24 collagen/ EPI results and 8 Collagen/ ADP results annually. . D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory RPR worksheet and 2018-2019 proficiency testing records, the lack of laboratory quality control records, and interview with Laboratory Person-5, it was determined that the laboratory failed to test Reactive QC for titered reactivity when titering patients specimen. Findings included: a. The laboratory titered RPR Reactive patients specimen and proficiency testing samples. b. The laboratory QC records failed to include results of titered Reactive control material when patients specimen were titered for their reactivity: Date ACC # RPR result ------------------------------------------------------------ 6/17/19 M469371 Reactive 1:2 Dilution " F368993 Reactive 1:8 Dilution c. The laboratory failed to provide for review QC records of titered Reactive Control results when titering Reactive proficiency testing samples from API (American Proficiency Institute) for 6 out of 6 events in 2018-2019. d. Testing Person-5 affirmed (1/14/20 @ 3pm) the aforementioned findings and that it was not the laboratory's practice to titer the Reactive Control when titering Reactive specimen. e. The reliability and quality of titered RPR results could not be assured in the absence of titered Reactive QC. The laboratory reported 1,005 RPR results annually. . D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the laboratory tests list, observation of two Stago Compact Max analyzers, the automated Hologic test system, manual bacterial cultures, the OSOM test kits for HcG, and the Abbott Architect analyzer; the lack of laboratory documents, and interview with Laboratory Person-5, it was determined that the laboratory failed to have systems that twice a year evaluated the relationship of test results using different instruments or methodologies. Findings included: a. Coagulation 1) The laboratory had two Stago Compact Max analyzers for Fibrinogen, Partial Throboplastin Time (PTT), and Prothrombin Time (ProTime). Laboratory Person-5 affirmed (1/14/20 @ 5pm) that the two Stago analyzers were used interchangeably. 2) -- 4 of 6 -- The laboratory failed to provide records or documents correlating results between the two Stago analyzers in 2018 and 2019. b. Gc (Gonnococcus, Neisseria gonnorhoeae) 1) The laboratory tested for Gc by two different methods: routine bacterial culture and the Hologic automated molecular method. 2) The laboratory failed to provide records or documents correlating Gc results between the culture and molecular methods in 2018 and 2019. c. hCG (Human chorionic gonadotropin, Pregnancy test) 1) The laboratory tested serum specimen for hCG by two different methods: the manual OSOM test kit and the automated Abbott Architect analyzer. 2) The laboratory failed to provide records or documents correlating hCG results between the manual and automated methods in 2018 and 2019. d. Laboratory Person-5 affirmed (1/14/20 @ 5: 30pm) the aforementioned findings and that the laboratory lacked an overall written policy and specific procedures for correlating results in Coag, Gc, and hCG. e. The reliable correlation and quality of results obtained from interchangeable instruments or different methods could not be assured in the absence of twice annual comparative analyses for Coag, Gc, and hCG. . 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. This STANDARD is not met as evidenced by: Based on review of pathology reports, the lack of testing laboratory information, and interview with laboratory personnel, it was determined that pathology reports failed to state the address of the laboratory performing special histological stains. Findings included: a. The pathology report on 4/03/18 for Path#18-2560 included results reported by another laboratory, Integrated Oncology, but failed to state the reference laboratory's address. b. Laboratory personnel affirmed (1/15/20 @ 11am) that the Addendum Report named the laboratory as Integrated Oncology, but did not include it's address. c. The reliability and quality of pathology reports to incorporate addresses of other laboratories performing testing could not be assured. The laboratory annually received approximately 352 reports from other laboratories. . D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 5 of 6 -- Based on survey findings and deficiency cited, the Laboratory Director is herein cited for deficient practice in providing overall administration to ensure that the proficiency testing samples are tested as required. Findings included: a. The Laboratory Director failed to ensure that proficiency testing samples for i-STAT were tested with the regular workload by personnel routinely testing patients specimen. b. The testing personnel for i-STAT Blood gases and ACT reported a combined total of 71 results in 2018, and 164 results in 2019. . D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the laboratory's Personnel Reports (1/13/20) and laboratory records, the lack of laboratory documents, and interview with Laboratory Person-5, the Laboratory Director is herein cited for deficient practice in ensuring that prior to testing patients' specimens, all personnel demonstrated all testing reliably to obtain accurate results. Findings included: a. Upon request for laboratory personnel records for Testing Person-21, the laboratory provided records titled "Clinical Laboratory Scientist STUDENT TRAINING OBJECTIVES", dated May 2018 to June 2019. b. The laboratory was unable to provide records documenting Testing Person-21's demonstrations of reliable testing with accurate results after attaining CLS/Testing Person status on 9/24/19, prior to testing and reporting results. c. Laboratory Person-5 affirmed (1/14/20 @ 5:30pm) the aforementioned lack of records, that the laboratory had a Student Training program, and that it was the practice of the laboratory to regard Student training records for this purpose. d. The reliability, accuracy, and quality of results reported could not be assured when the Testing Personnel failed to demonstrate such performances of all testing after completing training as Students and attaining the level of Testing Persons as defined by State and federal requirements. . -- 6 of 6 --

Summary Statement of Deficiencies D2109 TOXICOLOGY CFR(s): 493.845(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 review of the second quarter (Q2-2016) of the American Proficiency Institute (API) proficiency testing records, and interview with the testing personnel, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the therapeutic drugs. The findings included: a. Q2-2016, API reported the following unsatisfactory proficiency testing scores: Analyte: Score: Event/Year: Acetaminophen 60% 2/2016 Carbamazepine 60% 2/2016 Digoxin 60% 2 /2016 Phenobarbital 60% 2/2016 Phenytoin 60% 2/2016 Salicylates 60% 2/2016 Theophylline 60% 2/2016 Vancomycin 60% 2/2016 b The laboratory's annual test volume declaration submitted for 2016-2017 for the above analytes approximately 19,654. c. The testing personnel affirmed (2/14/2018, 10:00 AM), that the laboratory received the above unsatisfactory proficiency testing scores. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on review and the lack of documentation for Serofuge Calibration (2016 and 2017), the laboratory has not established and follow its written policy procedure for record retention. The findings included: a. The laboratory has no documentation to 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 -- show for how long it will retain its records for Blood Bank b. The laboratory uses Serofuge instrument for cells washing in Blood Bank, but there was no documentation shown from years 2016 and 2017 of Serofuge Calibration performance. c. Based on the annual test volume submitted by the laboratory, there were approximately 2,523 Antibody screen and Compatibility testing analyzed and reported. d. The testing personnel affirmed (2/14/2018, 10AM), that there was no documentation to show for the years 2016 and 2017 Serofuge Calibration. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on request and the lack of documentation for date and time the laboratory receives its specimen, random patient sampling test results and interview with the testing personnel it was determined that the laboratory failed to document the date and time it receives a specimen. The findings included: a. The laboratory lacked documentation to show for its date and time it receives the specimen physically in the laboratory. b. For thirty three (33) out of thirty three random patient test results reviewed covering period from 1/1/2016 to 2/7/2018, the laboratory analyzed and reported test results for all specialties without documenting its received date and time. c. The testing personnel affirmed (2/14/2018, 10:00AM) that the laboratory has no documentation to show its date and time of specimen receipt. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)