Preferred Hospital Leasing Hemphill Inc

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based upon review of the laboratory's list of non-waived tests, proficiency testing policy, proficiency testing records patient test records and interview of facility personnel, the laboratory failed to enroll in a proficiency testing program for the Bacteriology, Parasitology and Virology pathogens tested using the Biofire GI panel. The laboratory tested 62 patient specimens (for 22 targets each) between January 21, 2022 and January 25, 2023. The findings included: 1. Review of the laboratory's list of non-waived tests provided during the onsite inspection found the laboratory tested patient specimens using the Biofire GI panel which includes the following pathogens: Adenovirus F40/41 Astrovirus Clostridium Dificile Toxin A\B Campylobacter Cryptosporidium Cyclospora cayetanensis Entamoeba histolytica Enteroaggregative E. coli Enteropathogenic E coli Enterotoxigenic E coli Giardia lamblia Norovirus G I /II Plesiomonas shigelloides Rotavirus A Shigella/ Enteroinvasive E. coli Salmonella Sapovirus Shiga-like Toxin E. coli Vibrio (V. parahaemoliticus/ V. vulnificus/ V. cholera) Vibrio Cholerae Yersinia enterocolitica 2. Review of the laboratory's own written policy 44-06 titled Proficiency Testing (10/14/19) found on page one under Procedure: "The Laboratory shall participate in a proficiency testing program covering all Laboratory specialties and subspecialties for which the Laboratory is 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 -- approved to perform tests." 3. Review of proficiency testing records found no evidence of the laboratory participating in a proficiency testing program in 2022 for the GI panel. 4. Review of patient test records provided found the laboratory tested 62 patient specimens (for 22 targets each) between January 21, 2022 and January 25, 2023. 5. During interview of the General Supervisor listed on the CMS report 209 Laboratory Personnel Report conducted January 25, 2023 at 11:33 AM, he confirmed that he had not enrolled in a proficiency testing program for the GI panel until the enrollment period for 2023. D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on a review of laboratory documents, laboratory policy, the Centers for Medicare and Medicaid Services (CMS) 116 application, and confirmed in an interview, the laboratory failed to retain the supporting data utilized to conduct the risk assessment (RA) portion of the laboratory's individualized quality control plan (IQCP) used to reduce the quality control (QC) frequency from every day of patient testing for two of two moderate complexity tests with and IQCP reviewed in 2022. The findings include: 1. Review of the laboratory IQCP binder included the following two moderate complexity procedures in use by the laboratory with the following quality control plan (QCP) obtained from laboratory policy "Alere Triage Cardiac Panel" and "Sure-Vie Serum/Urine hCG", respectively: Alere Triage Cardiac Panel: External Quality Control: "Level 1 and 2 liquid controls are tested with new Box/lot of test materials or every 30 days, whichever comes first." Sure-Vue Serum hCG: External Control: "Serum Controls - Serum controls are ran with every new box opened or every 30 days which ever comes first. Note: Per CMS guidelines a risk assessment has been performed and Sabine County Hospital Laboratory has determined for this moderate complex test, and IQCP was developed. For further explanation refer to the IQCP to the IQCP information." 2. Review of the laboratory's IQCP risk assessment activities used in the determination of potential failures and errors for the testing process, did not include the supporting laboratory data used in the risk assessment evaluation. Surveyor queried for the supporting laboratory data used in the risk assessment on 1/26/2023 at 09:30 hours, in the conference room, and none was provided. 3. Review of laboratory test volumes, provided by the general supervisor (GS), listed the following annual test volumes for 2022: hCG Serum: 145 Alere Triage Cardiac Panel: 28 4. In an interview, on 1/29/2023 at 09:38 hours, in the conference room, testing person (TP) 1 confirmed that the laboratory failed to retain the supporting laboratory data used for the RA evaluation portion of the laboratory's IQCP. 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. -- 2 of 10 -- This STANDARD is not met as evidenced by: Based upon review of the laboratory's list of non-waived tests, proficiency testing policy, proficiency testing records patient test records and interview of facility personnel, the laboratory failed to enroll in a proficiency testing program or have a means of verifying the accuracy of results for the Chemistry analyte Ammonia. The laboratory tested 44 patient specimens for Ammonia between May 6, 2021 and January 25, 2023. The findings included: 1. Review of the laboratory's list of non- waived tests provided during the onsite inspection found the laboratory tested patient specimens for Ammonia using the Ortho Vitros 5600 Chemistry analyzer 2. Review of the laboratory's own written policy 44-06 titled Proficiency Testing (10/14/19) found on page one under Procedure: "The Laboratory shall participate in a proficiency testing program covering all Laboratory specialties and subspecialties for which the Laboratory is approved to perform tests." 3. Review of proficiency testing records found no evidence of the laboratory participating in a proficiency testing program in 2021 or 2022 for Ammonia and they did not have another means to verify the accuracy of results. 4. Review of patient test records provided found the laboratory tested 44 patient specimens for Ammonia between May 6, 2021 and January 25, 2023. 5. During interview of the General Supervisor listed on the CMS report 209 Laboratory Personnel Report conducted January 25, 2023 at 11:33 AM, he confirmed that he had not enrolled in a proficiency testing program for Ammonia until January 25, 2023. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based upon review of the laboratory's verification study for the Cell Dyn Ruby hematology analyzer, the laboratory's own written policy, patient test records and interview of facility personnel, the laboratory failed to verify the reference ranges for the parameters of the Complete Blood Count (CBC) using the Cell Dyn Ruby were appropriate for the patient population before testing patient specimens. The laboratory reported an annual volume of 32,200 Hematology tests. The findings included: 1. Review of the laboratory's verification study found no verification of reference ranges for the Cell dyn Ruby (Serial Number 7121fBG) installed in October 2019. 2. Review of the laboratory's own written procedure titled Cell-Dyn Ruby Operation Guide (Effective 1/2020) found on page 8 under the Heading Reporting Results: Reference ranges for the various tests and age groups can be found in the LIS. Reference Range: WBC 4.8-10.8 mm3 RBC (M) 4.7-6.1 mil (F) 4.2-5.4 Hgb (M) 14-18 g/dl (F) 12-16 g /dl Hct (M) 42-52% (F) 37-47% MCV (M) 80-94 fl (F) 81-99 fl MCH 27-31 pg MCHC 32-36 g/dl RDW 11.5-15.5 % Plt 130-400 x10^3 MPV 7.4-10.4 fl Gran % 43- 65% Lymph% 20.5-45.5% Mono% 5.5-11.7% Eos % 0.0-0.2% Baso% 0.0-0.1% 3. Review of final patient reports printed from the LIS for male and female patients found the following reference ranges: Male: WBC 4.0-11.0 x10^3 RBC 4.5-6.1 x10^6 Hgb 14.0 - 17.0 g/dL Hct 42.0 -52.0 % MCV 80-94 fL MCH 27.0 - 31.0 pg MCHC -- 3 of 10 -- 33.0 -37.0 g/dL RDW 11.5-14.5 % Plt 150 - 400 x10^3 MPV 7.4 - 11.5 fL Gran % 45 - 70% Lymph% 15.0 - 60.0% Mono% 2.0 -10.0% Eos % 0.0 - 7.0% Baso% 0.0 -2.0% Female: WBC 4.0-11.0 x10^3 RBC 3.5-6.0 x10^6 Hgb 12.0 - 16.0 g/dL Hct 36.0 - 48.0 % MCV 81 - 99 fL MCH 27.0 - 31.0 pg MCHC 33.0 -37.0 g/dL RDW 11.5-14.5 % Plt 150 - 400 x10^3 MPV 7.4 - 11.5 fL Gran % 45 - 70% Lymph% 15.0 - 60.0% Mono% 2.0 -10.0% Eos % 0.0 - 7.0% Baso% 0.0 -2.0% 4. During interview of the general supervisor conducted January 26, 2023 at 11:01 AM he stated that the reference ranges in the LIS were from the previous hematology analyzer and he did not change them. 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 laboratory test menu, quality control (QC) documents, patient reports, and confirmed in interview, the laboratory failed to perform quality control every day of patient testing for the Alere Triage Tox Drug Screen, 94600 for 30 of 30 patients reviewed in May and October of 2022. The findings include: 1. Review of the laboratory test menu included moderate complexity "Triage Tox Drug Screen, 94600" test performed on the triage meter. 2. Review of laboratory policies did not include a policy approved by the laboratory director for the "Triage Tox Drug Screen". Surveyor queried the general supervisor (GS) for the quality control policy for the test and was informed by the GS that external liquid control was run every 30 days, and with every new lot. Surveyor queried for the laboratory's individual quality control plan (IQCP) to support the reduction in QC frequency from every day of patient testing to every 30 days, and with every new lot, but none was provided. 3. Review of the laboratory QC documents for May and October 2022, and patient testing records, had the following 30 patients tested with the Triage Tox Drug Screen, 94600 on days where QC was not performed. May 2022: 18 patients 5/2/2022: 2205020051 2205020082 5/3/2022: 2205030054 5/5/2022: 2205070017 5/11/2022: 2205110060 2205110069 5/13/2022: 2205130052 2205130073 5/14/2022: 2205140012 5/20/2022: 2205200040 5/21/2022: 2205210011 2205210027 5/23/2022: 2205230041 2205230053 5/25/2022: 2205250057 5/26/2022: 2205260008 5/28/2022: 2205280002 5/29/2022: 2205290004 October 2022: 12 patients 10/2/2022: 2210020058 10/05/2022: 2210050010 10/8/2022: 2210080006 10/12/2022: 2210120075 10/13/2022: 2210130019 2210130082 10/15/2022: 2210150005 10/16 /2022: 2210160022 10/19/2022: 2210190078 10/20/2022: 2210200008 10/29/2022: 2210290005 2210290024 3. In an interview on 1/26/2023 at 09:35 hours, in the conference room, testing person (TP) 1 confirmed that the laboratory did not perform an external liquid QC every day of patient testing for the moderate complexity test, Triage Tox Drug Screen, 94600. D5545 HEMATOLOGY -- 4 of 10 -- CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Review of APTT (Activated Partial Thromboplastin Time)and Prothrombin time quality control records, patient test records, and interview of facility personnel found that the laboratory tested one patient for Prothrombin Time in November, 2022 without testing at least two levels of quality control material at least every 8 hours when performing prothrombin Time testing using the ACL elite coagulation analyzer. The findings included: 1. A review of the laboratory's quality control records for November 2022 found that the laboratory failed to test at least 2 levels of quality control material every 8 hours for APTT and Prothrombin Time as follows: November 1, 2022 between 09:17 and November 2, 2022 08:17- 23 hours November 2, 2022 between 15:06 and November 3, 2022 08:27 - 17 hours 21 minutes November 3, 2022 between 08:27 and 17:08 8 hours 41 minutes November 3, 2022 between 17:08 and November 4, 2022 07:31 - 14 hours 23 minutes November 4, 2022 between 15:23 and November 6, 2022 18:09 - 50 hours 46 minutes November 6, 2022 between 18:09 and November 7, 2022 10:26 - 15 hours 49 minutes November 7, 2022 10:26 and November 8, 2022 09:11 - 23 hours 43 minutes November 8, 2022 09:11 and November 9, 2022 07:17 - 22 hours 6 minutes November 9, 2022 07:17 and November 10, 2022 08:30 - 25 hours 13 minutes November 10, 2022 08:30 and November 11, 2022 06:34 - 22 hours 4 minutes November 11, 2022 13:53 and November 13, 2022 02:41 - 36 hours 48 minutes November 13, 2022 16:02 and November 14, 2022 - 08:03 - 16 hours 1 minute November 14, 2022 - 08:03 and November 15, 2022 07:17 - 23 hours 14 minutes November 15,2022 17:53 and November 16, 2022 07:34 - 13 hours 40 minutes November 16, 2022 16:01 and November 17, 2022 08:51 - 15 hours 52 minutes November 17, 2022 20:12 and November 18, 2022 07:43 - 11 hours 31 minutes November 18, 2022 07:43 and November 19, 2022 08:43 - 25 hours November 19, 2022 08:43 and November 20, 2022 07:26 - 22 hours 43 minutes November 20, 2022 07:26 and November 21, 2022 08:04 - 24 hours 38 minutes November 21, 2022 15:39 and November 22, 2022 08:04 - 17 hours 25 minutes November 22, 2022 15:45 and November 23, 2022 07:58 - 16 hours 3 minutes November 23, 2022 07:58 and November 24, 2022 01:13 - 19 hours 15 minutes November 24, 2022 01:13 and November 25, 2022 08:31 - 31 hours 18 minutes November 25, 2022 08:31 and November 28, 2022 08:48 - 72 hours 18 minutes November 28, 2022 18:14 and November 29, 2022 08:14 - 16 hours November 29, 2022 15:45 and November 30, 2022 08:03 -16 hours 18 minutes 2. Review of patient test records found that the laboratory tested one patient specimens for APTT and Prothrombin Time on November 27, 2022 without testing quality control materials. Patient 50896 was tested for APTT and Prothrombin Time at 17:54, with the last quality control testing done 55 hours and 29 minutes before on November 25, 2022 at 18:14. 3. Interview of testing person one on the CMS Report 209 Laboratory Personnel Report confirmed during interview conducted January 26, 2023 at 3:18 PM that testing personnel only tested quality control materials at least once every 8 hours when patient specimens were tested, but they missed this one. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) -- 5 of 10 -- (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 a review of laboratory documents and confirmed in interview, the laboratory failed to perform a twice annual comparison of test results for three of three analytes performed on the Triage and the Vitros 5600 chemistry analyzer in 2022. The findings include: 1. Review of the laboratory test menu for 2022 had the following tests being performed on both the Triage and the Vitros 5600 chemistry analyzer: CKMB Troponin I BNP Surveyor queried for the twice-annual evaluation of test results, and none was provided. 2. Review of the laboratory-provided annual test volume had the following test totals for each analyzer: Triage: CKMB - 26 Troponin I - 28 BNP - 61 Vitros 5600 Chemistry Analyzer: CKMB - 8 Troponin I - 48 BNP - 647 3. In an interview on 1/26/2023 at 15:48 hours, in the conference room, testing person 1 confirmed that the laboratory had not performed a twice-annual comparison of test results for CKMB, Troponin I, and BNP between the two chemistry analyzers. D5783

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on August 5, 2021, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute proficiency testing records, the facility failed to achieve successful 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 -- performance in two of three consecutive testing events for the analyte Alanine Aminotransferase (ALT (SPGT)), resulting in unsuccessful performance. Refer to D2087 and D2096. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute proficiency testing records, the facility failed to attain a score of at least 80 percent of acceptable responses in two of three consecutive testing events in 2020 and 2021 for the analyte Alanine Aminotransferase (ALT (SPGT)) in Routine Chemistry. Findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory the laboratory received the following scores: Routine Chemistry - Third Event 2020 - ALT: 60 percent Routine Chemistry - Second Event 2021 - ALT: 0 percent 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute proficiency testing records, the facility failed to attain a satisfactory score in two of three consecutive testing events in 2020 and 2021 for the analyte Alanine Aminotransferase (ALT (SPGT)) in Routine Chemistry. Findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory the laboratory received the following scores: Routine Chemistry - Third Event 2020 - ALT: 60 percent Routine Chemistry - Second Event 2021 - ALT: 0 percent 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure -- 2 of 3 -- successful participation in a HHS approved proficiency testing program for analyte Alanine Aminotransferase (ALT (SPGT)). 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for analyte Alanine Aminotransferase (ALT (SPGT))in the specialty Routine Chemistry. Refer to D2087 and D2096. -- 3 of 3 --