Summary:
Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems as specified for the laboratory systems for one (3rd quarter of 2018) of seven quarterly evaluations reviewed. Findings include: 1. On December 12, 2018 at 11:20 approximately 11:20 AM, record review of the quarterly quality assurance evaluations revealed there was no documentation to show the evaluation was performed for the third (May to August) quarter as follows: a. no documentation of the overall 3rd quarter in 2018 b. no documentation of complete blood count chart reviews for the 3rd quarter of 2018. 2. On December 12, 2018 at approximately 11:20 AM when requested, testing personnel #8 as listed on the CMS-209 was unable to provide the surveyor the documentation requested. 3. During the interview on December 12, 2018 at approximately 11:20 AM, testing personnel #8 confirmed there was no documentation to show the 3rd quarter quality assurance evaluation was performed and documented. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. 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 -- This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory technical consultant failed to evaluate ten (#1-#5 and #7-#11) of 11 testing personnel performing moderately complex hematology testing at least annually. Findings include: 1. On December 12, 2018 at 9:50 AM, record review of the competency evaluations revealed there was no documentation to show the competency evaluations had been performed and documented in 2017. 2. On December 12, 2018 at 9:50 AM when queried, testing personnel #8 as listed on the CMS-209 was unable to provide the surveyor the documentation requested. 3. During the interview on December 12, 2018 at 9:50 AM, testing personnel #8 confirmed there was no documentation for the 2017 competency evaluations. -- 2 of 2 --