Medical Center Barbour

Summary Statement of Deficiencies D0000 The following deficiencies are a result of off-site proficiency testing (PT) desk review of scores in the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and verified with the laboratory's proficiency testing provider, American Proficiency Institute (API). The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director . 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: 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 -- Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Uric Acid, an analyte in the specialty of Chemistry. The laboratory failed two consecutive 2025 PT events, resulting in initial unsuccessful proficiency testing performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Uric Acid. The laboratory failed two consecutive 2025 PT events, resulting in initial unsuccessful proficiency testing performance. The findings include: 1. A review of the CASPER Reports revealed the laboratory received failing scores for Uric Acid in two consecutive API PT events, as follows: A) 2025 Core Chemistry Event #1: Uric Acid-60% B) 2025 Core Chemistry Event #2: Uric Acid-60% 2. A review of the laboratory's proficiency testing evaluation reports from the API website confirmed these findings. . D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on off-site proficiency testing desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D6016. . D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports -- 2 of 3 -- 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program for Uric Acid for two consecutive 2025 PT events. Refer to D2096. . -- 3 of 3 --

Summary Statement of Deficiencies 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 a review of the American Proficiency Institute (API) Proficiency Testing (PT) records, and an interview with the Technical Supervisor (TS)/General Supervisor (GS), the laboratory failed to implement a mechanism to verify the accuracy of the B- type natriuretic peptide (BNP), a non regulated analyte. The surveyor noted the PT evaluation failures occurred in two consecutive events out of six events from 2023- 2024. The findings include: 1. A review of the API PT records revealed the laboratory BNP evaluation scores were 20 percent for the following events: a) 2023 Chemistry First Event b) 2023 Chemistry Second Event 2. An interview with the TC/GS on 02- 25-2025 at approximately 2:36 PM revealed the PT unsatisfactory scores for both events resulted from the selection and submission of the incorrect test method to API. The same reasons were documented under the Laboratory Director's (or designee) review of PT evaluations. 3. The TC/GS confirmed the above findings during the exit conference on 02-26-2025 at 3:59 PM. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on a review of the 2023-2024 personnel records and an interview with the Technical Supervisor (TS)/General Supervisor (GS) and the Testing Personnel 12 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 -- (TP12), the Technical Consultant (TC) failed to assess and document the annual competency of individuals responsible for moderate complexity testing in the Cardio- Pulmonary department. The surveyor noted five of the nineteen Testing Personnel (TP) listed on the CMS 209 (Laboratory Personnel Report did not have the required annual evaluations in 2023. The findings include: 1. A review of Cardio-Pulmonary personnel records revealed the Technical Consultant failed to perform and document the 2023 annual competency assessments for the following TP. 1. TP12 2. TP13 3. TP14 4. TP15 5. TP16 2. The TS/GS and TP12 confirmed the above findings on 02- 25-2025 at 4:31 PM during the day one exit conference. -- 2 of 2 --

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 the Seimens epoc System records, and an interview with the Laboratory Manager, the laboratory failed to ensure the optional IQCP (Individualized Quality Control Plan) was valid before performing patient testing from November 2022 through March 2023. The surveyor noted the document failed to included three of three required elements for a valid IQCP. The findings include: 1. A review of records for the Seimens epoc System (used by Respiratory Therapy for Arterial Blood Gas [ABG] testing) revealed the laboratory ran Level 1 and 3 quality controls (QC) on ABG test cards on the two readers (#34489 and #34595) approximately once a month, as follows: A) 11/22/2022: Two levels of QC on both readers B) 12/29/2022: Two levels of QC on both readers C) 1/18/2023: Two levels of QC on both readers D) 1/29 /2023: Two levels of QC on Reader #34595 only E) 2/10/2023: Level 3 on Reader #34489 and Level 1 on Reader #34595 F) 3/14/2023: Two levels of QC on both readers 2. A review of the epoc System Procedure Manual on page 12 of 33, under "QUALITY CONTROL" revealed, "...From each lot in each shipment of cards, analyzed at least two (2) levels of fluid controls in duplicate using any verified reader." 3. During an interview on 3/29/2023 at 3:00 PM, the surveyor explained the laboratory is required to perform two levels of QC each day of patient testing unless 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 -- an IQCP has been implemented, and approved by the Laboratory Director. The Laboratory Manager stated the Respiratory Therapy laboratory had implemented an IQCP, and it was in the back of the procedure manual. 4. As the interview continued on 3/29/2023 at 3:15 PM, the surveyor and Laboratory Manager reviewed the "IQCP" in the procedure manual. The surveyor noted the Laboratory's "IQCP" was actually the manufacturer's example of a "Risk Assessment", and the laboratory had failed to make it specific for their facility. The "IQCP" further failed to include a "QC Plan" (specifying the number, type, frequency of testing, and acceptability criteria of the quality controls), and the laboratory must at least adhere to the manufacturer's instructions in QC performance, which they had failed to do on 1/29/2023 and 2/10 /2023. In addition, the IQCP failed to include a Quality Assurance Plan (to monitor for any performance issues or problems). The surveyor also explained the Laboratory Director must review and document approval (via signature and date) of the IQCP before implementation. 5. On 3/29/2023 at 3:30 PM, the surveyor asked about patient ABG testing on the epoc System. The Laboratory Manager stated patient testing began 11/15/2023, and as of 3/29/2023, 135 patient ABG's were run, with QC only run on the six dates listed above. . 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 a review of the Seimens epoc System records, and an interview with the Laboratory Manager, the laboratory failed to ensure two levels of quality controls were performed each day of patient testing from November 2022 through March 2023. The findings include: 1. A review of records for the Seimens epoc System (used by Respiratory Therapy for Arterial Blood Gas [ABG] testing) revealed the laboratory ran Level 1 and 3 quality controls (QC) on ABG test cards on the two readers (#34489 and #34595) approximately once a month, as follows: A) 11/22/2022: Two levels of QC on both readers B) 12/29/2022: Two levels of QC on both readers C) 1/18/2023: Two levels of QC on both readers D) 1/29/2023: Two levels of QC on Reader #34595 only E) 2/10/2023: Level 3 on Reader #34489 and Level 1 on Reader #34595 F) 3/14 /2023: Two levels of QC on both readers 2. During an interview on 3/29/2023 at 3:00 PM, the surveyor explained the laboratory is required to perform two levels of QC each day of patient testing unless an IQCP has been implemented, and approved by the Laboratory Director. The Laboratory Manager stated the Respiratory Therapy laboratory had implemented an IQCP, and it was in the back of the procedure manual. However, a review of the document revealed it was not a valid IQCP. [Refer to D5445.] 3. On 3/29/2023 at 3:30 PM, the surveyor asked about patient ABG testing on the epoc System. The Laboratory Manager stated patient testing began 11/15/2023, and as of 3/29/2023, 135 patient ABG's were run, with QC only run on the six dates listed above. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 2 of 2 --

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 a review of the CASPER report #155, and API (American Proficiency Institute) proficiency test evaluations, the laboratory failed to successful participate in Toxicology testing for Alcohol (blood) for two consecutive testing events, Event #2 and #3, 2022. These failures resulted in an initial unsuccessful proficiency testing failure. The findings include: Refer to D2109. D2109 TOXICOLOGY CFR(s): 493.845(a) 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 -- 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 a review of the CASPER report #155, and API (American Proficiency Institute) proficiency test evaluations, the laboratory failed to perform satisfactorily in Alcohol testing (Toxicology) for two of three consecutive testing events, Event #2 and #3, 2022. The findings include: 1. A review of the CASPER report revealed the laboratory scored the following in Alcohol testing: a) Event #2, 2022 = 60 % b) Event #3, 2022 = 60 % 2. A review of the API proficiency testing evaluations confirmed the laboratory scored the above mentioned scores. -- 2 of 2 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control records for qualitative Clostridium difficile (C. diff) testing performed on the Meridian Bioscience illumigene C. difficile platform and an interview with the Technical Supervisor (also the Laboratory Manager), the laboratory failed to perform QC each day of patient testing in 2018-2021, in the absence of an IQCP (Individualized Quality Control Plan). The findings include: 1. A review of the Meridian Bioscience illumigene C. difficile QC records revealed positive and negative QC was only performed when a new test kit lot number was opened on 7/5/2018, 10/4/2018, 2/22/2019, 5/23/2019, 9/3/2019, 1/23/2020, 5/6/2020, 9/23/2020, 12/2/2020, 5/24/2021, and 9/28/2021. 2. During an interview on 10/28 /2021 at approximately 2:15 PM, the surveyor asked if Meridian Bioscience illumigene C. difficile QC was run each day of patient testing. The Technical Supervisor stated the testing personnel performed QC whenever a new lot number or shipment of C. diff test kits were opened, as per manufacturer's instructions. The surveyor explained whenever the manufacturer's requirements were less stringent that the CLIA requirement of positive/negative QC each day of patient testing, the laboratory had the option of developing and implementing an IQCP. The Supervisor confirmed the laboratory had not implemented an IQCP. Each test kit contained 50 C. diff tests; QC was only run when the kit was first opened, and the other 48 tests were used for patient tests on days when QC was not performed. . 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 -- D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on reviews of personnel files and an interview with the Technical Supervisor (also the Laboratory Manager), the Technical Consultant failed to perform and document the semi-annual competency evaluations for three of six new Testing Personnel (TP) in the Main Laboratory, and one of two new TP in the Respiratory Therapy Laboratory. The findings include: 1. A review of the Form CMS-209 (Laboratory Personnel Report) for the Main Laboratory personnel revealed six new TP were hired since the previous survey on 6/28/2018. TP #4, TP #8 and TP #9 were recently hired in 2021; the other three had been employed for more than a year, as follows: A) TP #3: Hired and trained in May 2019; there was no competency assessment performed until 6/1/2020. B) TP #5: Hired and trained in February 2019; there was no competency assessment performed until November 2020. C) TP #7: Hired and trained in August/September 2018; there was no competency assessment performed until 8/3/2019. 2. A review of the Form CMS-209 (Laboratory Personnel Report) for the Respiratory Therapy Laboratory revealed two new TP hired since the previous survey on 6/28/2018. TP #5 was hired in October 2021. TP #4 was trained on 4/18/2020, however no competency assessment was performed until 4/8/2021. 3. During an interview on 10/27/2021 at 11:15 AM, the surveyor requested the semi- annual competency evaluations for the above testing personnel hired in 2018-2020. The Technical Supervisor stated semi-annual competency evaluations were not performed because she did not know this was a CLIA requirement. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 2 of 2 --

Summary Statement of Deficiencies D3035 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(ii) In addition, the laboratory must retain immunohematology records, blood and blood product records, and transfusion records as specified in 21 CFR 606.160(b)(3)(ii), (b) (3)(iv), (b)(3)(v), and (d). This STANDARD is not met as evidenced by: Based on a review of the Blood Banking records and an interview with the General Supervisor, the laboratory failed to document the lot numbers and expiration dates for the gel cards used for antibody screening since the previous survey (on 6/29/2016). The findings include: 1. During the entrance tour on 6/28/2018 at 9:30 AM, the General Supervisor included Antibody Screening using gel cards on the Blood Bank test menu. 2. A review of the Blood Bank records revealed the laboratory performed daily quality control on the antibody screen gel cards and other reagents, however the lot number and expiration dates of the cards was never documented. 3. During an interview with the General Supervisor on 6/28/2018 at 11:20 AM, the surveyor asked if the laboratory had a record of the lot numbers and expiry dates for gel cards in use for antibody screening for the last two years. The Supervisor referred to her records, and stated she had never noticed there was no place on the the Blood Bank QC log for the staff to record this information. Thus, the above noted finding were confirmed. . D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) 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 -- (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Beckman Coulter UniCel DxH 800 Hematology analyzer calibration records, quality control records, and an interview with the General Supervisor, the laboratory failed to follow the manufacturer's instructions to verify calibrations by running quality controls (QC) for one out of three 2017 calibrations of the Hematology analyzer. The findings include: 1. A review of calibration records for the Beckman Coulter DxH 800 revealed the instrument was calibrated on 7/31/2017 at 7:54 AM. 2. A review of the QC records revealed three levels of QC were run between 7:08-7:15 AM on this date, however the General Supervisor was unable to provide documentation of QC performed after the calibration at 7:54 AM on this date. 3. A review of the Calibration guidelines (available on a CD provided with the instrument, and thru the internet) revealed, in "Chapter 11 Quality Assurance ... Calibrate with Coulter S-CAL Calibrator ... 12. Verify your calibration with controls. ..." 4. During an interview on 6/27/2018 at 2:55 PM, the General Supervisor confirmed she was unable to find records of QC performed after the 7/31/2018 calibration, since the analyzer does not store data from earlier QC lot numbers. The Supervisor further stated laboratory policy stated testing personnel were supposed to run QC after all calibrations, thus confirming the above noted findings. . D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of Microbiology records and an interview with the General Supervisor, the surveyor determined, the laboratory failed to document the sterility and appearance of the physical characteristics of the media, and to check each lot number for the ability to support growth, and as appropriate, select or inhibit specific organisms. The findings include: 1. During the initial tour of the laboratory on 6/27 /2018 at approximately 9:30 AM, the General Supervisor provided a laboratory menu that included Urine, Wound, Sputum, Throat, and Blood Cultures performed on site. When asked about the procedure, the Supervisor explained the testing personnel set up the specimens on culture media (Blood, Chocolate, Mannitol, EMB [Eosin Methylene Blue], and Urine "Bi-plates" [Blood/MacConkey] agar); then bacterial growth had identification and sensitivities performed on the Vitek 2. 2. A review of the records in Microbiology revealed the facility routinely performed visual and sterility inspections on the Chocolate agar, and checked each new lot number of the media's ability to select and inhibit specific organisms. However there were no QC -- 2 of 4 -- records for the other types of culture media. 3. A further review of the records revealed the staff documented the appearance of some lot numbers of media on the shipping invoices when received in the laboratory. However, some of the shipping invoices were missing (as evidenced by the fact that not all of the lot numbers of Chocolate media in the above QC records were listed on the retained shipping invoices). 4. During an interview on 6/28/2018 at 9:30 AM, the General Supervisor confirmed the testing personnel was not documenting visual inspections and sterility checks for all lot numbers and shipments of media because the laboratory did not always receive the invoices from the hospital's shipping department. The laboratory had only performed and documented the QC on the Chocolate agar because they thought this was all that was required. 5. As the interview continued the Supervisor was then asked if the laboratory performed on-site QC (for the Blood Mannitol, EMB, and "Bi-plates") to check each lot number for the ability to support growth, and as appropriate, select or inhibit specific organisms, or if they had implemented an optional IQCP (Individualized Quality Control Plan) in 2016 with a QC Plan (and other required elements) that specified the manufacturer's QC was acceptable. The supervisor stated the lab did ensure each lot number of Blood and Chocolate had the ability to support growth when they re-grew the QC organisms each week (with no documentation of the lot numbers of media used). However, there was no record of QC for the other media types, and there was no documentation the laboratory had implemented an optional IQCP for the culture media in 2016 after the previous survey. Thus the above noted findings were confirmed. . D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a lack of Quality Control (QC) records for body fluid cell counts performed manually on the hemocytometer, and an interview with General Supervisor, the laboratory failed to ensure testing personnel documented and performed at least one level of QC in duplicate each eight hours before performing patient testing in 2016 - 2018. The findings include: 1. During the entrance tour on 6/27/2018 at approximately 9:30 AM, the General Supervisor included manual cell counts (using a hemocytometer) on Cerebral Spinal Fluid (CSF) on the Hematology test menu. 2. During the second day of the survey on 6/28/2018 at 11:30 AM, the surveyor requested QC records for manual cell counts on body fluids; the General Supervisor stated the laboratory did not do any QC when performing manual cell counts. The surveyor explained QC in duplicate was required by CLIA whenever manual cell counts on body fluids were performed to ensure the accuracy of the test performance. When asked how many patient tests were performed since the previous survey (on 6 /29/2016), the Supervisor printed a report from the Laboratory Information System, and stated 31 patient CSF cell counts were performed. Thus the above noted findings were confirmed. . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) -- 3 of 4 -- (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 a review of quality assurance documentation and interviews with the General Supervisor, the surveyor determined the laboratory failed to implement and perform effective quality assessment reviews to identify and correct problems identified in the analytical systems. The findings include: 1. A review of quality assurance documentation revealed the laboratory performed quality assurance activities, however the reviews were inadequate to discover and perform