Summary:
Summary Statement of Deficiencies D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of the Electronic Medical Records (EMR) and interview with the Testing Personnel (TP), the laboratory failed to retain Test Requisition (TR) for Throat Culture test from November 2016 to the date of survey. The TP # 1 listed on CMS form 209 confirmed on 11/14/18 at 11:00 am that the TR were not retained. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the Testing Personnel (TP), the laboratory failed to ensure that the Test Report Date (TRD) was indicated on the FR for Throat Culture test from May 2016 to the date of survey. 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 2 -- TP # 1 listed on CMS form 209 confirmed on 11/14/18 at 10:35 am that the TRD was not on the FR. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the Testing Personnel (TP), the laboratory failed to correct problems in the postanalytic system for reporting Throat Culture (TC) results May 2016 to the date of the survey. The findings include: 1. The laboratory reported 'Date/Time of Observation' same as the collection time of specimen on "Lab Order Details" report. 2. The TP # 1 listed on CMS form 209 confirmed on 11/14/18 at 10:30 am that laboratory failed to correct problems in reporting TC results. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files and interview with the Testing Personnel (TP), the Technical Consultant (TC) failed to fullfil performance of Competency Assessment (CA) responsibility in the calendar year 2017 and 2018. The finding includes: 1. Six of Six CA was performed by TP who had an associate degree. 2. The TP # 1 listed on CMS form 209 confirmed on 11/14/18 at 10:00 am that the TC did not perform CA. -- 2 of 2 --