Summary:
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 on proficiency testing (PT) records review, and an interview with the facility's CEO (not included on CMS-209), the laboratory failed to enroll in an approved PT program for Gram stain testing performed in the specialty of microbiology since the laboratory's last survey was completed on 5/11/21. The laboratory performs approximately 143 microbiology cultures annually. Findings include: 1. Based on a review of the laboratory's PT records revealed the laboratory was not participating in PT testing for Gram staining in the specialty of microbiology since the last survey was conducted on 5/11/21. 2. An interview with the facility's CEO (not included on CMS- 209) on January 19, 2024, at approximately 11:15 AM, confirmed that the laboratory failed to enroll in PT for Gram staining in the specialty of microbiology since the last survey was conducted on 5/11/21. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manual, and an interview with the facility's CEO (not included on CMS-209) the laboratory failed to assess the competency of, or establish a written policy or procedure for assessing the competency of personnel in the positions of clinical consultant (CC), technical supervisor (TS), and general supervisor (GS) since the laboratory's last survey on 5/11 /21. The laboratory performs approximately 145,330 tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual revealed that the laboratory failed to assess the competency of, or establish a written policy or procedure for assessing the competency for the CC, the TS, or for the GS listed on CMS Form-209 since the last survey was completed on 5/11/21. The laboratory performs approximately 145,330 tests annually. 2. Based on an interview with the GS on January 19, 2024, at approximately 11:45 AM, confirmed that the laboratory failed to assess the competency of or establish a written policy or procedure for assessing the competency of personnel in the positions of CC, TS, and GS. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures manual, proficiency testing (PT) records review, and an interview with the facility's CEO (not included on CMS-209), the laboratory failed to establish a written policy or procedure for, and failed to evaluate PT results that were not evaluated or scored by the PT provider since the laboratory's last survey on 5/11/21. The laboratory performs approximately 145,330 tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual revealed the laboratory failed to establish a written policy or procedure for evaluating PT scores that were not evaluated or scored by the PT provider since the last survey was conducted on 5/11/21. 2. A review of the laboratory's PT records reveled the laboratory did not evaluate the accuracy of any analyte for which the PT provider did not evaluate or score since the last survey was conducted on 5/11/21. 3. An interview with the facility's CEO (not on CMS-209), on January 19, 2024, at approximately 11:30 AM, confirmed that the laboratory failed to establish a written policy or procedure for, and evaluate any PT scores that the PT provider did not evaluate or score since the laboratory's last survey was conducted on 5 /11/21. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for -- 2 of 6 -- specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)