Healing Corner, Llc

Summary Statement of Deficiencies 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 surveyor review of proficiency testing (PT) records and interview with the laboratory director, the laboratory director did not attest to the routine integration of the samples into the patient workload using the laboratory's routine methods for five out of five chemistry events in 2017 and 2018. Findings include: 1. Review of API (American Proficiency Institute) chemistry PT records show the laboratory director has not signed the attestation statements for two out of two events in 2017. 2. Review of ACP (American College of Physicians) Medical Laboratory Evaluation Program chemistry PT records show the laboratory director has not signed the attestation statements for three out of three events in 2018. 3. Interview with the laboratory director on January 22, 2019 at 10:30 AM confirms the director has not signed the attestation statements for five out of five chemistry events in 2017 and 2018. This is a repeat deficiency previously cited on September 9, 2015. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and interview with the laboratory director, the laboratory has not maintained a copy of instrument printouts for PT testing for one out of two chemistry PT events in 2017. Findings include: 1. Review of event one and event two of API (American Proficiency Institute) chemistry PT records from 2017 shows the record does not include Viva-E analyzer instrument printouts for the first chemistry event in 2017. 2. Interview with the laboratory director on January 22, 2019 at 10:30 AM confirms that the laboratory did not maintain instrument printouts from one out of two chemistry PT events in 2017. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of test records and interview with the laboratory director, the laboratory has not retained analytic records to show reagents were not used past their expiration date, or that calibrations were performed or verified and controls tested with reagent lot number changes on the Viva-E chemistry analyzer. Findings include: 1. Review of Viva-E analyzer records shows no historic records of previously used reagents, including lot numbers, expiration dates, or start and end dates of use. 2. Interview with the laboratory director on January 22, 2019 at 12:30 PM confirmed analytic system activity records were not retained for two years as specified in the requirements at 493.1252 through 493.1289. This is a repeat deficiency previously cited on January 28, 2014 and March 1, 2017. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and interview with the laboratory director, the laboratory did not maintain the chemistry PT result reports for one of three events in 2018. Findings include: 1. Review of events one, two, and three of the ACP (American College of Physicians) Medical Laboratory Evaluation Program PT records from 2018 shows the record does not include the result report from the PT provider for the second chemistry event in 2018. 2. Interview with the laboratory director on January 22, 2019 at 10:30 AM confirms that the laboratory did not maintain the chemistry PT result report for one of three chemistry events in 2018. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL -- 2 of 8 -- CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures, observation of urine specimens, and interview with the laboratory director, the laboratory does not follow their written procedure for specimen labeling. Findings include: 1. Review of the "Urine Collection with Patient Instructions" procedure shows the procedure specifically states the container (cup) should be labeled with the patient identification information. 2. Observation on January 22, 2019 at 11:30 AM of urine specimens for toxicology testing show the specimen container lid is labeled with patient identification, with no patient information present on the specimen cup, for eleven out of eleven urine specimens. 3. Interview with the laboratory director on January 22, 2019 at 11:45 AM confirms the laboratory has not followed their procedure for specimen labeling. This is a repeat deficiency previously cited on March 1, 2017. 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 procedure manual and interview with the laboratory director, the current laboratory director has not approved, signed, and dated procedures before use. Findings include: 1. Review of "QC Policy" and "Calibration, Calibration Verifications (AMR) (Analytical Measurement Range) and Assay Correlations" procedures in the laboratory manual shows no evidence of review and approval of the procedures by the current laboratory director. 2. Interview with the laboratory director on January 22, 2019 at 10:45 AM confirmed the current laboratory director has not approved, signed and dated the "QC Policy" and "Calibration, Calibration Verifications (AMR) and Assay Correlations" procedures. This is a repeat deficiency previously cited on March 1, 2017. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on surveyor review of the procedure manual and interview with the laboratory director, the laboratory did not document the date of discontinuance for procedures that are no longer in use. Findings include: 1. Review of the laboratory procedure -- 3 of 8 -- manual showed no date of discontinuance for the venipuncture procedure. 2. Interview with the laboratory director on January 22, 2019 at 12:45 PM revealed the venipuncture procedure is no longer in use and the laboratory did not document the date of discontinuance. This is a repeat deficiency previously cited on March 1, 2017. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor review of maintenance records and interview with the laboratory director, the laboratory did not document quarterly maintenance for the Viva-E chemistry analyzer as required by the manufacturer for four out of four quarters in 2018. 1. Review of the 2018 Siemens Viva-E chemistry analyzer "Monthly/Quarterly /As Needed Maintenance" records showed no documented quarterly maintenance for four out of four quarters in 2018. 2. Interview with the laboratory director on January 22, 2019 at 11:30 AM confirmed the laboratory did not document quarterly maintenance for four out of four quarters in 2018. This is a repeat deficiency previously cited on January 28, 2014. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor comparison of previous CMS (Centers for Medicare and Medicaid Services) Form 2567 (Statement of Deficiencies and