Woodstock Pediatric Medicine Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 4, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory director (LD) failed to attest to the routine integration of PT samples into the laboratory test workload as required. Findings include: 1. American Proficiency Institute (API) PT document review revealed the LD failed to sign the attestation statements for the following Hematology/Coagulation PT events: 2016 -- Event 3; 2017 -- Event 3. 2. An interview with Staff #1 (CMS 209) on 9/4/18 in the breakroom at approximately 3:30 p.m. confirmed the LD did not sign the attestation statements for the aforementioned PT events. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on review of the policy and procedure manual (SOP) and staff interview, the laboratory failed to establish and follow written policies and procedures to assess employee competency. Findings include: 1. SOP review revealed the laboratory failed to establish and follow a six-procedure competency policy and procedure for initial, six month, and annual employee competencies. 2. An interview with Staff #1 (CMS 209) on 9/4/18 in the breakroom at approximately 3:30 p.m. confirmed the laboratory failed to establish and follow a six-procedure policy and procedure for evaluating laboratory personnel. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the policy and procedure manual (SOP) and staff interview, the laboratory failed to establish and follow a written policy to perform proficiency testing (PT) as required. Findings include: 1. SOP review revealed the laboratory failed to establish and follow a policy and procedure for performing PT. 2. SOP review revealed the laboratory failed to establish and follow a policy and procedure for record retention. 2. An interview with Staff #1 (CMS 209) on 9/4/18 in the breakroom confirmed the SOP did not contain a policy and procedure for PT or for record retention. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on hematology calibration document review and staff interview, the laboratory failed to perform instrument calibrations every six months as required. Findings include: 1. Horiba Micros 60 hematology calibration document revealed the laboratory failed to perform instrument calibrations between 11/12/16 and 11/2/17. There was also no documentation of an instrument calibration performed between 11/2 /17 and the time of survey. 2. An interview with Staff #1 (CMS 209) on 9/4/18 in the breakroom at approximately 12:15 p.m. confirmed Horiba Micros 60 hematology analyzer calibrations were not performed during the aforementioned gaps in 2017 and 2018 thus far. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) document review and staff interview, the laboratory failed to perform QC in bacteriology as required. Findings include: 1. QC document review revealed the laboratory failed to perform QC for the Taxo discs and bacteriology media for 2017 and 2018 thus far. 2. QC document review revealed the laboratory failed to perform an incubated sterility check for the bacteriology media for 2017 and 2018 thus far.. 3. An interview with Staff #1 (CMS 209) in the breakroom on 9/4/18 at approximately 3:30 p.m. confirmed the aforementioned QC was not performed for 2017 and 2018 thus far. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of proficiency test (PT) document, testing personnel (TP documents), policy and procedure manual (SOP) review, and staff interview, the laboratory director failed to provide overall managment and direction of the laboratory as required. Findings include: Refer to D2009, D5477, D D6004, D6018, D6019, D6029, and D6032 D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform -- 3 of 7 -- test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on testing personnel (TP) document review and staff interview, the laboratory director (LD) failed to delegate the duties of the technical consultant to qualified personnel. Findings include: 1. TP document review revealed the 2016 annual competencies were performed by unqualified TP for the following TP: Staff #s (CMS 209) -- 3, 4, 5, 6, 7, 8, and 9. 2. TP document review revealed the 2017 annual competencies were performed by unqualified TP for the following TP: Staff #s (CMS 209) -- 3, 4, 6, 7, 8, 9 and 10. 3. An interview with Staff #1 (CMS 209) on 9/4/18 in the breakroom confirmed competencies for the aforementioned TP were performed by unqualified TP. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require