Summary:
Summary Statement of Deficiencies D0000 A Validation Survey was performed at Leonard J. Chabert Medical Center, Respiratory-CLIA # 19D0881447 on December 3 through 7, 2018. Leonard J. Chabert Medical Center, Respiratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1403: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1421: Laboratories performing moderate complexity testing; Testing Personnel D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure the Laboratory Director signed the attestation statement for one (1) of five (5) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's College of American Pathologists (CAP) proficiency records for 2017 and 2018 revealed the Laboratory Director did not sign the attestation statement for the following event: 2018 Blood Oximetry 1st Event SO-A 2. In interview on December 5, 2018 at approximately 1:00 pm, Personnel 2 stated it was an oversight that the Laboratory Director did not sign the identified attestation statement. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to document the review of the performance evaluation for proficiency testing. Findings: 1. Review of the laboratory's College of American Pathologists (CAP) proficiency records for 2017 and 2018 revealed the laboratory did not have documentation of a performance evaluation by the Laboratory Director for the following event: 2018 Blood Oximetry SO-B. 2. In interview on December 5, 2018 at approximately 1:00 pm, Personnel 2 stated it was an oversight that the Laboratory Director did not sign the identified evaluation form. 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 on observation, record review, and interview with personnel, the laboratory failed to perform complete reference range studies for the GEM 4000 Premier analyzers. Findings: 1. Observation by surveyor during laboratory tour on December 3 revealed the laboratory utilizes two (2) GEM 4000 Premier analyzers for blood gas testing. 2. In interview on December 5, 2018 at 3:30 pm, Personnel 2 stated the reference ranges in use were from a study previously performed and utilized with previous analyzer. 3. Review of the laboratory's performance verification studies revealed the reference range studies did not include documentation of verification of the normal values for use with the GEM 4000 Premier analyzers. 4. In further interview on December 5, 2018 at 3:30 pm, Personnel 2 stated the laboratory did not perform any further studies before putting the previous reference ranges into use. 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 observation, record review, and interview with personnel, the laboratory failed to have a complete Individualized Quality Control Plan (IQCP) to support the reduction in frequency of quality control (QC). Findings: 1. Observation by surveyor -- 2 of 5 -- during the laboratory tour on December 3, 2018 revealed the laboratory utilized two (2) GEM 4000 Premier analyzers for blood gas testing. 2. Review of the laboratory's IQCP documents revealed the laboratory did not include in-house data to support the reduction in frequency of external QC. 3. Further review of the laboratory's IQCP Quality Assessment Plan revealed "The IQCP will be reviewed annually for new occurrences, frequency of occurrences, and changes of severity;" however, there was not documentation of performance of an annual review. 4. In interview on December 3, 2018 at 1:39 pm, Personnel 2 stated the laboratory runs external QC, CVP solutions, when cartridge is changed, approximately every twenty eight (28) days. 5. In further interview on December 5, 2018, Personnel 2 stated the laboratory only tests the external QC with cartridge changes. 6. Review of the laboratory's Task 1 and 3 forms revealed the laboratory performs 10, 632 blood gas tests annually. 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 observation, record review, and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Findings: 1. The Laboratory Director failed to ensure that complete verification procedures were performed. Refer to D6013. 2. The Laboratory Director failed to ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require