Chca Woman's Hospital, Lp

Summary Statement of Deficiencies D0000 An announced validation survey of the laboratory was conducted on 11/04/2025 through 11/05/2025. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D6141 - 42 C.F.R. 493.1459 Condition: Laboratories performing high complexity testing; general supervisor D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 the review of the laboratory's policy, the proficiency testing records from 2024 to 2025, a list of testing personnel with areas of competency, and confirmed in an interview, the laboratory failed to ensure 3 of 4 routine chemistry proficiency testing events were analyzed by personnel who routinely perform chemistry testing in the laboratory. The findings were: 1. Review of the laboratory's policy titled "Laboratory Quality Management Plan", approved by the LD on 09/28/2025, under "PROFICIENCY TESTING" revealed "2. Proficiency testing samples will be integrated within the routine laboratory workload, and analyzed by personnel who routinely test patient samples in the same primary method systems as for patient samples." 2. Review of a list of testing personnel with areas of competency provided by the laboratory on 11/04/2025 revealed there were 15 testing personnel to perform routine chemistry. 3. Review of the CAP proficiency testing records from 2024 to 2025 revealed testing personnel#4 (as indicated on the CMS 209 form) attested to the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- analyzing 3 of 4 proficiency testing events for routine chemistry. NB2-A 2024 Neonatal Bilirubin, 2 challenges Testing personnel signed: TP#4 NB2-B 2024 Neonatal Bilirubin, 2 challenges Testing personnel signed: TP#4 NB2-B 2025 Neonatal Bilirubin, 5 challenges Testing personnel signed: TP#4 4. In an interview on 11/04/2025 at 1:40 pm in a conference room, the general supervisor #6 confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services TP=Testing personnel 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 CMS Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, onsite review of the laboratory's 2024 and 2025 College of American Pathologists (CAP) proficiency testing (PT) records and confirmed in an interview, the laboratory failed to attain successful performance for the analyte Albumin for two of three consecutive testing events, CAP 2024 C-B 2nd event and 2025 C-A 1st event, resulting in unsuccessful 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 review of the CMS Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, onsite review of the laboratory's 2024 and 2025 College of American Pathologists (CAP) proficiency testing (PT) records and confirmed in an interview, the laboratory failed to attain successful performance for the analyte Albumin for two of three consecutive testing events, CAP 2024 C-B 2nd event and 2025 C-A 1st event, resulting in unsuccessful performance. -- 2 of 14 -- The findings were: 1. Review of the CMS Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile revealed the laboratory failed to attain a satisfactory score of at least 80% in a specialty of routine Chemistry for a regulated analyte of Albumin for 2 of 3 consecutive proficiency testing events. CAP 2024 2nd event Albumin = 0% CAP 2025 1st event Albumin = 20% 2. Review of the laboratory's CAP PT records during an onsite survey for 2024 revealed the laboratory received unsatisfactory score of 0% for Albumin in 2024 2nd event. 3. Review of the laboratory's CAP PT records during an onsite survey for 2025 revealed the laboratory received unsatisfactory score of 20% for Albumin in 2025 1st event. 4. In an interview on 11/05/2025 at 3:05 pm, the general supervisor #6 (as indicated on CMS 209) confirmed the above findings. Key: CMS = Center for Medicare and Medicaid Services CAP = College of American Pathologist PT = Proficiency testing 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 review of manufacturer instructions, surveyor's observations, review of laboratory's test menu and volumes, new test/instrument verification studies, quality control records, patient test records and staff interview, the laboratory failed to meet analytic systems requirements for five of fifteen test platforms used by the laboratory in 2024 and 2025. Findings included: 1. The laboratory failed to follow its own policy when patient samples were assayed more than 30 minutes after collection on the Thromboelastograph- Coagulation (TEG) analyzer. Refer to D5401. 2. The laboratory failed to verify reference ranges for all specimen types on the iStat, and patient normal ranges on the Atelica analyzers. Refer to D5421 A and B. 3. The laboratory failed to have documentation of testing a control material with titered reactivity when patient's Rapid Plasma Reagin (RPR) titers were performed. Refer to D5451. 4. The laboratory failed to ensure one sample of control material was tested each 8 hours of testing on the i-Stat wireless analyzer. Refer to D5537. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the laboratory's records, and staff interview, the laboratory failed to follow its own policy five of thirty one times when patient samples were assayed more than 30 minutes after collection on the -- 3 of 14 -- Thromboelastograph- Coagulation (TEG) analyzer from January to August 2025. Findings include: 1. A review of the laboratory's policy titled 'Thromboeslatograph- Coagulation (TEG) Analyzer' revealed the following: "Assay the patient's sample within 30 minutes after collection." 2. A review of the laboratory's records from January to August 2025 revealed the following 5 patient's samples were received in the laboratory 30 minutes after collection: - Date: 2/18/25 Patient ID: F00038729383 Collection time: 10:06 Received: 11:47 Elapsed time: 101 minutes - Date: 4/12/25 Patient ID: F00038870089 Collection time: 18:24 Received: 20:43 Elapsed time: 139 minutes - Date: 5/23/25 Patient ID: F00038954546 Collection time: 13:37 Received: 14:15 Elapsed time: 38 minutes - Date: 8/8/25 Patient ID: F00039131838 Collection time: 16:03 Received: 16:42 Elapsed time:39 minutes - Date: 8/14/25 Patient ID: F00039131838 Collection time: 09:45 Received: 10:23 Elapsed time: 38 minutes 3. In an interview on 11/4/25 at 3:30 p.m. in the conference room, after review of the records, the hematology general supervisor confirmed the above findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)