Acp - Arthritis Associates

Summary Statement of Deficiencies 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)

Summary Statement of Deficiencies 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 of competency evaluation policies and forms and interview with facility personnel, the laboratory failed to follow established written policies to assess competency of laboratory personnel. Findings include: 1. The laboratory performs patient testing under the sub-specialty of Routine Chemistry, with an approximate annual test volume of 80. 2. The Laboratory Personnel Report, Form CMS-209 submitted for review during the survey conducted on 01/29/20 indicated that the laboratory had two testing personnel (TP). 3. The laboratory's established policy titled, "Competency Evaluation for Personnel Performing Clinical Testing" indicates for any newly hired personnel that competency evaluations will occur at six months, twelve months and annually thereafter. 4. No documentation of an annual competency evaluation was presented for review for 2018 and 2019 for two out of two testing personnel. 5. The facility personnel confirmed that the laboratory did not have documentation of a competency evaluation for 2018 and 2019 for the two testing personnel referenced above. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. 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 lack of Quality Assessment (QA) documentation and interview with the facility personnel, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the preanalytic systems. Findings include: 1. No written QA policies and procedures specific to the preanalytic systems were presented for review during the survey. 2. The facility personnel confirmed that the laboratory could not produce evidence of established preanalytic QA policies at the time of the survey. 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 lack of Quality Assessment (QA) documentation and interview with the facility personnel, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems. Findings include: 1. No written QA policies and procedures specific to the postanalytic system were presented for review during the survey. 2. The facility personnel confirmed that the laboratory could not produce evidence of an established postanalytic QA policy at the time of the survey. -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual and interview with the facility personnel, the laboratory failed to have the current laboratory director approve and sign test procedures before use. Findings include: 1. The laboratory performs synovial fluid testing in the sub-specialty of Routine Chemistry, with an approximate annual test volume of 80. 2. The procedure manual presented for review was not approved, signed and dated by the current laboratory director. 3. Review of the audit records for CLIA# 03D0996441 in the CMS database indicated the current laboratory director has been listed as director since 08/30/2016. 4. The facility personnel confirmed that the procedure manual indicated above was not approved, signed and dated by the current laboratory director before use. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on lack of training documentation for one out of one testing personnel and 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 -- interview with the facility personnel, the laboratory director failed to ensure that all testing personnel receive the appropriate training and demonstrate that they can perform all testing operations reliably and accurately prior to testing patients' specimens. Findings include: 1. No initial training documentation was presented for review for one testing personnel who performed one patient test (EMRN# 210542) on 01/06/17. 2. The facility personnel confirmed that the laboratory failed to have documentation of initial training for the testing personnel indicated above, demonstrating that they can perform all testing operations reliably and accurately prior to testing patients' specimens. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on lack of policies and procedures for review and interview with the facility personnel, the laboratory director failed to ensure that policies and procedures are established for monitoring individuals who perform patient testing to assure that they are competent and maintain their competency to perform test procedures and report test results promptly and proficiently. Findings include: 1. No policies and procedures as indicated above were presented for review during the survey. 2. The facility personnel confirmed that the labortatory did not have established policies and procedures in place at the time of the survey for monitoring individuals who perform patient testing. -- 2 of 2 --