Tate County Hospital Dba Highland Hills Medical Ct

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing program. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 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: Based on surveyor desk review of the laboratory proficiency testing (PT) records 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 -- (graded copies from the American Proficiency Institute (API) and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 8/12/2024, the laboratory failed to achieve satisfactory performance in two of two testing events (2024-Event 1, and 2024-Event 2) resulting in unsuccessful participation in routine chemistry for PCO2 BLOOD GAS. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute (API) and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 8 /12/2024, the laboratory has not successfully performed proficiency testing for PCO2 BLOOD GAS in two of two testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for PCO2 BLOOD GAS: PCO2 BLOOD GAS: Year 2024-1st Event 40% Year 2024-2nd Event 60% 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 surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 8/12/2024, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. 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: Based on surveyor desk review of the laboratory proficiency testing records (graded -- 2 of 3 -- copies from the American Proficiency Institute and CASPER report 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 8/12/2024, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) events and interview with the laboratory manager/GS as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to retain proficiency test records for Hematology and Chemistry for two of five PT events. Findings include: 1. Review of the Hematology proficiency testing records for Events 2 and 3 of 2022 and Events 1, 2, and 3 of 2023 revealed the laboratory failed to retain the Hematology attestation statement and analyzer printouts for Event 1 of 2023(1 of 5 events). 2. Review of the Chemistry proficiency testing records for Events 2 and 3 of 2022 and Events 1, 2 and 3 of 2023 revealed the laboratory failed to retain the Core Chemistry attestation statements and analyzer printouts for Events 1 and 2 of 2023(2 of 5 events). 3. In an interview on 2/7/2024 at 2:30 p.m., the laboratory manager/GS confirmed Hematology analyzer printouts and attestation statement for Event 1 and Core Chemistry attestation statement and analyzer printouts for event 1 and event 2 were unavailable the day of survey. 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 the laboratory's proficiency testing records, lack of verification of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- accuracy, and interview with the general supervisor (GS) listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to verify the accuracy, at least twice annually, for Reticulocyte Count (retic count) and HIV-1 p24 testing for 2 of 4 verifications. Findings included: 1. Review of proficiency testing records and lack of verification records for retic count and HIV-1 p24 revealed no twice annual test verification was performed for 2 of 4 verifications due for the year 2022. 2. During an interview with the GS on 2/7/2023 at 3:00 p.m. it was confirmed no twice annual test verifications for retic count and HIV-1 p24 were performed for the year 2022. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the number of deficiencies cited for analytic systems, the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 492.1283 or monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289. Refer to D5447- (Failure to perform 2 levels of quantitative QC each day of patient testing.) Refer to D5449- (Failure to perform 2 levels of qualitative QC each day of patient testing.) Refer to D5479 - (Failure to report QC in the same measurement/reaction as patients are reported.) Refer to D5551 -(Failure to perform QC each day of blood bank testing.) 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 the MiniSed Automated sedimentation rate (ESR) quality control (QC) log, patient test log and interview with the laboratory manager/GS as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the testing personnel failed to include at least two levels of quality control each day of patient testing. Approximately 10 patients were reported on 9 of 85 days of testing ESR when no QC was performed. Findings Include: 1. According to the MiniSed Automated ESR QC and patient logs 6/4/2022 through 8/30/2022 revealed QC was not documented as performed each day when patients for ESR were tested and reported. 2. A review and comparison between the ESR QC logs and the patient logs revealed on the following days an ESR test was performed on patients' specimens and no QC was documented as tested on 9 of 85 days: 6/04/2022 - 1 patient result reported -- 2 of 10 -- 6/20/2022 - 1 patient result reported 6/28/2022 - 2 patient results reported 7/01/2022 - 1 patient result reported 7/05/2022 - 1 patient result reported 8/14/2022 - 1 patient result reported 8/16/2022 - 1 patient result reported 8/17/2022 - 1 patient result reported 8/26/2022 - 1 patient result reported 3. In an interview, the lab manager/GS confirmed on 2/7/2024 at 11:30 a.m, two levels of QC were not performed when ESR was tested on patients using the MiniSed ESR automated analyzer and results reported on the above mentioned days. 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 lack of an IQCP (Individualized Quality Control Plan), a review of quality control (QC) records for Abbott HIV 1/2 Ag/Ab Combo test kit and interview with the lab manager/general supervisor (GS) as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to document a positive and negative control on each day of patient testing for 15 of 15 days when the HIV 1/2 Ag/Ab Combo kit was used. Findings Include: 1. There was no IQCP (Individualized Quality Control Plan) available for review on the day of survey. An IQCP is required if two levels of quality control (QC) are not performed each day of use for moderate/high complexity testing. No QC was performed on 15 of 15 days when the HIV 1/2 Ag/Ab Combo kit was used. 2. Review of Abbott HIV 1/2 Ag/Ab Combo kit QC and patient result logs from 6/2/2022 through 12/11/2023. On the following days patients were tested with no QC performed on the day of patient testing: 6/02/2022 - 1 patient result reported 6/04/2022 - 1 patient result reported 6/07 /2022 - 1 patient result reported 6/16/2022 - 1 patient result reported 7/01/2022 - 1 patient result reported 8/02/2022 - 1 patient result reported 8/10/2022 - 1 patient result reported 8/11/2022 - 5 patient results reported 8/27/2022 - 1 patient result reported 7 /25/2023 - 1 patient result reported 8/12/2023 - 1 patient result reported 9/19/2023 - 1 patient result reported 11/01/2023 - 1 patient result reported 12/07/2023 - 1 patient result reported 12/11/2023 - 1 patient result reported 3. Interview with the lab manager /GS on 2/7/2024 at 12:00 p.m, confirmed that testing personnel was performing two levels of QC (positive and negative) each day of patient testing with the Abbott HIV 1 /2 Ag/Ab Combo kit but did not document the QC as performed. Patient results were manually entered into the LIS (laboratory information system), but QC was not. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: -- 3 of 10 -- Based on review of nine of nine ImmunoCard A Toxin C. Diff quality control (QC) and patient records, and interview with the laboratory manager/GS, the laboratory failed to document as performed the QC results for ImmunoCard A Toxin C. Diff in the same manner(reaction) as the patients results. Findings Include: 1. Based on review of the ImmunoCard A Toxin logs, the log sheets included lot numbers for both positive and negative controls, expiration dates, external QC results, patients' results, testing personnel initials, patient labels, time and date. On the log sheet, the testing personnel are instructed to "Select P for Pass or F for Fail for External QC results. Write P for Positive or N for Negative in the patient result field." 2. Review of the ImmnunoCard A Toxin C. Diff log sheets 6/22/2023 through 1/19/2024, revealed the patient's C. Diff results were written on the log as negative or positive. For the QC results, a "P" (pass) or "F" (fail) was circled on the log sheet to indicate the result of the QC. 3. Nine of nine QC and patient results from 6/22/2023 through 1/19/2024, were observed documented on the log sheet as P(pass) or F(fail). 4. Interview with the laboratory manager/GS confirmed this is the documentation protocol used by the testing personnel to report QC and patient C. Diff results. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of Immunohematology quality control (QC) records and the blood bank patient workbook from 6/18/2023 through 12/12/2023, the laboratory failed to document the performance of quality control on each day of patient blood bank testing. Findings include: Review of Immunohematology QC records from 6/18/2023 through 12/12/2023 revealed the laboratory failed to document the performance of quality control, to include the following, to indicate the Immunohematology reagents were functioning properly before patient specimens were analyzed and reported. 1. Positive control for ABO Antisera (ABO grouping) 2. Positive and negative control for Rh Antisera (Rh typing) 3. Positive and negative control for Anti-human globulin sera (Coombs sera) 4. Positive control for antibody screening cells Quality control was not performed on the following days when patients and donors were tested: 6/18 /2023 - Patient #BY96170 - Type, Rh, Crossmatch - 1 unit (W069123132691) 6/30 /2023 - Patient #12/22/97- Type, Rh, Ab Screen 7/15/2023 - Patient #07/31/11- Type, Rh, Ab Screen 7/17/2023 - Unit Retype- W069123133754, W06923119579, W069123107226, W069123133757, W069123130984 7/18/2023 - Patient #9/11/42 - Type, Rh, Ab Screen Crossmatch- 1 unit (W069123119579) 7/31/2023 - Unit Retype- W069123107372, W069123109053, W069123127504, W06912312686, W069123122178, W06912322257, W069123121899, W06912312898, W069123121394, W069123107402, W069123134355 8/14/2023 - Patient #131655- Type, Rh 8/14/2023 - Unit Retype- W069123135591, W069123136081, -- 4 of 10 -- W06912315687, W069123135198, W069123108864, W06912314803, W069123134800, W069123134811 8/23/2023 - Patient #10098 - Type, Rh 8/24/2023 - Unit Retype - W069123136359, W069123131067, W069123121787, W069123787 8 /24/2023 - Type Rh, Ab Screen 8/25/2023 - Patient #08/02/88 - Crossmatch- W06912316359 9/6/2023 - Patient #4/21/77 -Type, Rh, Ab Screen 9/12/2023 - Patient #12/9/94 - Type, Rh, Ab Screen 9/16/2023 - Patient #12/9/94 - Type, Rh 11/13/2023 - Patient #3/7/93 - Type, Rh, Ab Screen 11/19/2023 - Patient #17631 - Type, Rh, Ab Screen 11/23/2023 - Patient #18133 - Type, Rh, Ab Screen 1/20/2022 - No Patient # recorded - Type, Rh, Crossmatch -3 units(W042521092820, W042521092821, W042522004788) 1/25/2022 - Patient #1056753 -Type, Rh, Crossmatch -2 units (W036221563489, W036221564300) 10/27/2022 - Patient #1066892 - Type, Rh, Antibody Screen D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 1 /24/2024, the laboratory failed to maintain satisfactory performance in two of two testing events (2023 - Events 2 and 3) resulting in unsuccessful performance in Immunohematology for Compatibility Testing. Refer to D2181. 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 -- D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and CASPER reports 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 1/24 /2024, the laboratory has not successfully performed proficiency testing for Compatibility Testing in two of two testing events. Findings include: A review of the laboratory records from the American Proficiency Institute and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for Compatibility Testing: Year 2023 - 2nd Event: 60% Year 2023 - 3rd Event: 80% -- 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 Sysmex CA-600 coagulation system manufacturer operator's manual, coagulation quality control (QC) records from 6/30/21 through 5/18/22, and confirmation with the general supervisor at 5:00 p.m. on 5/18/22, the laboratory did not establish a normal patient mean (NPM) when changing to a new lot of Prothrombin reagent (Innovin) as required by the manufacturer's instructions. Both the NPM and ISI values are used to calculate the INR (international normalized ratio) which is reported as part of the Prothrombin Time results. Findings include: 1. According to the CA-600 manufacturer's instructions, the NPM has to be entered into the analyzer along with the ISI value (assigned to each specific Innovin lot) in order for the analyzer to calculate an accurate patient INR (international normalized ratio) which is reported with the Prothrombin Time result. 2. Based on review of the Coagulation QC records from 6/30/21 through 5/18/22, there was no documentation of the start date for Innovin lot # 549763 (expiration date 11/28/22) which was in use the day of survey. 3. Based on observation of the coagulation instrument, the following values were entered for the INR calculation: a. ISI value of 1.01. (assigned for Innovin lot # 549763). b. Innovin lot # 549786 (expiration date 9/24/23) which has an assigned ISI value of 1.05. 4. There was no documentation available the day of survey to indicate that the laboratory had established a NPM (normal patient mean) with the current lot number of Innovin (549763) per the manufacturer's instructions. 4. Interview with the laboratory manager at 5:00 p.m. on 5/18/22 confirmed that when Innovin Lot# 549763 was put into use, the NPM (normal patient mean) was not 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 -- established. The ISI value was changed in the instrument, but the lot number of Innovin was not. The manager was unable to give a definite timeframe other than 3-4 months ago. 5. According to the volume form and QC records, approximately 350 patient Prothrombin Times had been tested and resulted during this time period. -- 2 of 2 --