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 review of laboratory records and policies and interview; the laboratory failed to be enrolled in an HHS approved proficiency testing program for its blood gas testing. Findings include: 1. Review of laboratory records revealed that there was no documentation to show that the laboratory performed proficiency testing for blood gases. 2. On 11/13/18 at 11:00 AM, the surveyor asked the laboratory director to provide her with proficiency testing records. None was made available to the surveyor. The laboratory director told the surveyor that the technical consultant had enrolled the laboratory in proficiency testing a few days prior to the surveyor. The technical consultant told the surveyor that he was not sure the laboratory was enrolled in proficiency testing. 3. On 11/13/18 at 12:00 PM, the surveyor's findings were confirmed by the technical consultant. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 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 -- 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review and interview, the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1267, and 493.1281 through 493.1299 for it blood gas testing. Findings include: 1. The laboratory lacked a comprehensive procedure manual that encompassed, specifically, how this laboratory at this location operates. See tags D5203 and D5403 2. The laboratory director failed to ensure that personnel were qualified, trained, and competent to perform all phases of the testing process, including QC prior to patient testing. See tags D5209, D5417, D5431, and D5437 3. The laboratory failed to verify the accuracy, precision, and reportable range of the Istat analyzer prior to testing patients' specimens. See tag D5421 4. Test reports did not include the name and address of the laboratory performing the testing. See tag D5805 D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review and interview, the laboratory failed to establish and follow written policies and procedures that ensure positive identification and optimum integrity of patients' specimens from the time of collection through completion of testing and reporting of results. Findings include: 1. Review of the laboratory's policies and procedures revealed that there were no written procedures that described the laboratory's system for how it identifies its patients during the testing process. 2. At 1: 30 PM on 11/13/18, the surveyor asked testing personnel how she identifies patients with similar names. Testing personnel told the surveyor that since she only performed one patients' test at a time, she just knew the patients by name. 3. At 2:30 PM on 11/13 /18, the laboratory director confirmed that there were no written procedures to ensure positive identification of patients specimens. 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, consultant competency. This STANDARD is not met as evidenced by: Based on review and interview, the laboratory failed to establish and following written policies and procedures to assess employee and consultant competency. Findings include: 1. Review of laboratory policies and procedures revealed that there were only procedures that say personnel competency should be performed on testing personnel. However, there were no procedures that described what parameters were to be included for the assessment. 2. Review of Laboratory Personnel Report - CLIA -- 2 of 10 -- (FORM CMS 209) revealed that the following personnel were listed on the form. a. Laboratory Director who also serves as the Clinical Consultant b. A total of 1 Technical Consultant c. A total of 1 Testing Person 3. Review of personnel records revealed that there was no documentation to show what parameters should be included in the competency assessment for the following personnel: a. Technical Consultant b. Clinical Consultant c. Testing Personnel 4. At 2:30 PM on 11/13/18, the laboratory director confirmed the surveyor's findings. 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 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)