Summary:
Summary Statement of Deficiencies 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 review of documentation presented for review and interview with office personnel (OP #1), the Laboratory Director (LD) failed to ensure that there was an adequate quality assessment (QA) and quality control plan (QC) in place, that personnel had training, were competent and had current & approved procedures to follow, to provide accurate and reliable patient results.. Findings include: See D6093, D6098, D6103, D6106, D6107, D6120, D6127 D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on lack of documentation and interview with office personnel (OP #1), the laboratory director (LD) failed to ensure appropriate Quality Assurance (QA) and Quality Control (QC) policies and procedures were developed and being followed by all laboratory personnel. Findings include: 1. A review of the documents presented at time of survey identified that the LD failed to ensure there was a QA policy in place that includes all three (3) phases of testing. 2. A review of the "Lab Quality Assurance Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- for KOH Testing" under #5 "QC Measures", stated that the microscope QC included Calibration weekly. 3. A lack of documentation identified that the LD failed to ensure that weekly microscope calibration was performed. 4. In an interview with office personnel (OP #1), at 2:30 pm, she stated she could not assist me in providing further documents for this lab. 5. Interview with the LD could not be completed as she was off this day. Email requests for a phone interview with the LD twice, have not been successful. 6. The determination of the number of histological procedures performed annually could not be made as the CMS form 116 under specialties (Histology #610) was left blank. D6098 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(8) (e)(8) Ensure that reports of test results include pertinent information required for interpretation; This STANDARD is not met as evidenced by: Based on lack of documentation and interview with office personnel (OP #1), the laboratory director (LD) failed to provide selected patient reports for assessment. Findings include: 1. There were no patient reports provided for review. 2. Interview with OP #1 at 2:30 pm confirmed that she could not provide any additional documents for this lab. 3. Interview with the LD could not be completed as she was off this day. Email requests for a phone interview post survey, with the LD twice, have not been successful. 4. The determination of the number of histological procedures performed annually could not be made as the CMS form 116 under specialties (Histology #610) was left blank. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) (e)(13) 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 documentation, attempts to interview the laboratory director (LD), and interview with office personnel (OP #1), the laboratory director (LD) failed to ensure policies and procedures for the training and competencies of all testing personnel were established. Findings include: 1. A lack of documentation provided at time of survey identified that the laboratory director (LD) failed to ensure that there was a policy for the training of all individuals performing any of the three (3) phases of testing. 2. The CMS 209 form identified three (3) new personnel since last CoC survey, one (1) Physicians Assistant and two (2) MD's. 3. In an interview with OP #1 at 2:00 pm, she stated she could not provide any documentation for this lab. 4. Interview with the LD could not be completed as she was off this day. Email requests for a phone interview with the LD twice, have not been successful.. 5. Determination of the number of histological procedures performed annually could not be made as the CMS form 116 under specialties (Histology #610) was left blank. -- 2 of 4 -- D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) (e)(14) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and This STANDARD is not met as evidenced by: Based on lack of documentation at time of survey and an interview with office personnel #1 (OP #1), the laboratory director (LD) failed to ensure a current & approved procedure manual was available to all testing personnel (TP) involved in any of the three (3) phases of testing. Findings include: 1. Upon review of the documents provided for review, the LD failed to ensure there was a policy/procedure for dermatology specimen collection, specimen rejection, specimen labeling, stain QC documentation, patient contact follow up and for