Vibra Hospital Of Clear Lake

Summary Statement of Deficiencies D0000 An initial onsite survey was completed on 01/17/2025. The laboratory was found out of compliance with the CLIA regulations. The condition not met was: D6063 - 42 C.F. R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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 on the review of the laboratory's policy, the method verification records, and confirmed in an interview, the laboratory failed to document verification of the laboratory's reference ranges for 1 of 1 new chemistry instrument implemented in 2023: iSTAT instrument. The findings were: 1. Review of the laboratory's policy titled LABORATORY QUALITY ASSESSMENT PLAN, revised on 3/2023, under Verification of Performance Specifications revealed, "When new non-waived test tests /methods are introduced into the laboratory, the manufacturer's stated claims for the performance specifications of accuracy, precision, reportable range, and reference range are verified before testing patients." 2. Review of the laboratory's method verification records reveal no documentation of the laboratory's verification of reference ranges for 1 of 1 new chemistry instrument: iSTAT MN300 Analyzer (SN: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 430978) prior to patient testing. 3. An interview on 01/17/2025 at 4:49 pm in the office, the testing personnel #8 (as indicated on CMS 209 form) confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on the review of the laboratory's aqueous/liquid QC records in 2024 and confirmed in an interview, the laboratory failed to have documentation of monitoring QC values over time for 3 of 3 quantative analytes performed on iSTAT analyzer for 12 of 12 months reviewed: pH, pCO2, and pO2. The findings were: 1. Review of the iSTAT analyzer aqueous/liquid QC records in 2024 revealed the laboratory performed 3 of 3 analytes on CG4+ cartridge on iSTAT instrument (SN: 430978) with quantitive values. CG4+ cartridge analytes pH pCO2 pO2 2. Further review of the iSTAT analyzer aqueous/liquid QC records in 2024 revealed no documentation of the laboratory monitoring the QC values over time for 3 of 3 quantative analytes performed on iSTAT analyzer for 12 of 12 months reviewed. 3. An interview on 01/17 /2025 on 3:45 pm in the office, the testing personnel #8 (as indicated on CMS 209 form) confirmed the above findings. Key: QC=Quality Control CMS=Center of Medicare and Medicaid Services D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on the review of the laboratory's establishment verification records, the laboratory's policy, QCP records in IQCP plan, and confirmed in an interview, the laboratory failed to establish a QCP to support the modification in quality control testing to every 30 days for 1 of 1 iSTAT analyzer. The findings were: 1. Review of the laboratory's establishment verification records for iSTAT Analyzer (SN: 430978) -- 2 of 8 -- revealed the verification of performance of the iSTAT analyzer in use was in January, 2023. 2. Review of the laboratory's policy titled Risk Assessment revealed "Type of quality control: External Quality Control Normal Value Abnormal Value. Frequency: Two levels of liquid controls every 30 days or the first day of patient testing each month." 3. Surveyor requested for the laboratory's QCP to support the reduction in QC frequency from every day of patient testing to every 30 days, but none was provided. 4. Review the laboratoyr's CMS 116 application, provided by the laboratory on 01/17/2025, revealed the annual testing volume was 180. 5. An interview on 01/17 /2025 at 2:00 pm in the office, the testing personnel #8 (as indicated on CMS 209 form) confirmed the above findings. The testing personnel #8 stated the laboratory performs two levels of external quality control with the new lot batch of reagents and when there is no patient testing in a month. Key: QCP=Quality Control Plan IQCP=Individualized quality control plan D5785

Summary Statement of Deficiencies D0000 An unannounced complaint investigation was conducted on 09/10/2024. The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity D6033 - 42 C.F.R. 493.1409 Technical Consultant, moderate complexity Complaint TX00514443 was substantiated with mandatory condition level deficiencies cited. 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 a review of the laboratory's submitted CMS form 209 and confirmed in an interview with facility personnel, the position of laboratory director was vacant from January 1, 2024, to September 10, 2024 (refer to D6003). D6003 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1405 AND 493.1406 The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or 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 -- both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the Laboratory is located; and (b)(2)(ii) Have had laboratory training or experience consisting of: (b)(2)(ii)(A) At least one year directing or supervising non- waived laboratory testing; or (b)(2)(ii)(B) Beginning September 1, 1993, have at least 20 continuing medical education credit hours in laboratory practice commensurate with the director responsibilities defined in 493.1407; or (b)(2)(ii)(C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section obtained during medical residency. (For example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution; and (b)(3)(i) Be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or (b)(3)(ii) Have had at least one year experience directing or supervising non-waived laboratory testing; (b)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; (b)(4)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing; and (b)(4)(iii) In addition, have at least one year of supervisory laboratory experience in non-waived testing; or (b)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; (b)(5)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing; and (b)(5)(iii) In addition, have at least 2 years of supervisory laboratory experience in non-waived testing; (b)(6) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under 493.1406; or (b)(7) On or before February 28, 1992, qualified under State law to direct a laboratory in the State in which the laboratory is located. Laboratory director qualifications on or before February 28, 1992 The laboratory director must be qualified to manage and direct the laboratory personnel and test performance. (a) The laboratory director must possess a current license as a laboratory director issued by the State, if such licensing exists; and (b) The laboratory director must: (b)(1) Be a physician certified in anatomical or clinical pathology (or both) by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (b)(2) Be a physician who: (b)(2)(i) Is certified by the American Board of Pathology or the American Osteopathic Board of Pathology in at least one of the laboratory specialties; or (b)(2)(ii) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board in one of the laboratory specialties; or (b)(2)(iii) Is certified by the American Society of Cytology to practice cytopathology or possesses qualifications that are equivalent to those required for such certification; or (b)(2)(iv) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(3) For the subspecialty of oral pathology only, be certified by the American Board of Oral Pathology, American Board of Pathology or the American Osteopathic Board of Pathology or possesses qualifications that are equivalent to those required for certification; (b)(4) Hold an earned doctoral degree from an accredited institution with a chemical, physical, or biological science as a major subject and (b)(4)(i) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board acceptable to HHS in one of -- 2 of 4 -- the laboratory specialties; or (b)(4)(ii) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(5) With respect to individuals first qualifying before July 1, 1971, have been responsible for the direction of a laboratory for 12 months between July 1, 1961, and January 1, 1968, and, in addition, either: (b)(5)(i) Was a physician and subsequent to graduation had at least 4 years of pertinent full-time laboratory experience; (b)(5)(ii) Held a master's degree from an accredited institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 4 years of pertinent full- time laboratory experience; (b)(5)(iii) Held a bachelor's degree from an accredited institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 6 years of pertinent full-time laboratory experience; or (b)(5)(iv) Achieved a satisfactory grade through an examination conducted by or under the sponsorship of the U.S. Public Health Service on or before July 1, 1970; or (b)(6) Qualify under State law to direct the laboratory in the State in which the laboratory is located. Note: The January 1, 1968 date for meeting the 12 months' laboratory direction requirement in paragraph (b)(5) of this section may be extended 1 year for each year of full-time laboratory experience obtained before January 1, 1958 required by State law for a laboratory director license. An exception to the July 1, 1971 qualifying date in paragraph (b)(5) of this section was made provided that the individual requested qualification approval by October 21, 1975 and had been employed in a laboratory for at least 3 years of the 5 years preceding the date of submission of his qualifications. This STANDARD is not met as evidenced by: Based on a review of the laboratory's submitted CMS form 209, review of patient records, and confirmed in an interview with facility personnel, the position of laboratory director was unfilled from January 1, 2024, to September 10, 2024. The findings were: 1. The laboratory ceased patient testing September 4, 2024. 2. A review of the laboratory's submitted CMS form 209 found it was signed by the laboratory director who verbally accepted the position effective September 10, 2024, the day of the complaint investigation. 3. A review of records found the laboratory director resigned effective December 31, 2023, and the position of laboratory director was vacant from January 1, 2024, to September 9, 2024. 4. A review of patient final results found the laboratory tested patients from January 1, 2024 to September 3, 2024 with no laboratory director in place. 5. In an interview on 09/10/2024, via telephone call with the laboratory director at 12:30 hours, he stated he was signing the contract that day and would be the laboratory director and technical consultant for the laboratory. Key: CMS - Centers for Medicare and Medicaid Services D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of laboratory records and confirmed in an interview with facility personnel, the position of technical consultant was unfilled from January 1, 2024, to September 10, 2024 (refer to D6034). -- 3 of 4 -- D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on a review of the laboratory's submitted CMS form 209, review of patient records, and confirmed in an interview with facility personnel, the position of technical consultant was unfilled from January 1, 2024, to September 10, 2024. The findings were: 1. The laboratory ceased patient testing September 4, 2024. 2. A review of the laboratory's submitted CMS form 209 found it was signed by the laboratory director who verbally accepted the position effective September 10, 2024, the day of the complaint investigation. 3. A review of records found the laboratory director who was also the technical consultant resigned effective December 31, 2023, and the position of technical consultant was vacant from January 1, 2024, to September 9, 2024. 4. A review of patient final results found the laboratory tested patients from January 1, 2024 to September 3, 2024 with no qualified technical consultant in place. 5. In an interview on 09/10/2024, via telephone call with the laboratory director at 12:30 hours, he stated he was signing the contract that day and would be the laboratory director and technical consultant for the laboratory. Key: CMS - Centers for Medicare and Medicaid Services -- 4 of 4 --